This electronic document was downloaded from the GPO web site, November 2003,
and is provided for information purposes only. The Code of Federal Regulations,
Title 9, is updated January 1 of each year.
The most current version of the regulations may be found at the
GPO web site.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317]
[Page 153-154]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart A--General
Sec.
317.1 Labels required; supervision by Program employee.
317.2 Labels: definition; required features.
317.3 Approval of abbreviations of marks of inspection; preparation of
marking devices bearing inspection legend without advance
approval prohibited; exception.
317.4 Labeling approval.
317.5 Generically approved labeling.
317.6 Approved labels to be used only on products to which they are
applicable.
317.7 Products for foreign commerce; printing labels in foreign
language permissible; other deviations.
317.8 False or misleading labeling or practices generally; specific
prohibitions and requirements for labels and containers.
317.9 Labeling of equine products.
[[Page 154]]
317.10 Reuse of official inspection marks; reuse of containers bearing
official marks, labels, etc.
317.11 Labeling, filling of containers, handling of labeled products to
be only in compliance with regulations.
317.12 Relabeling products; requirements.
317.13 Storage and distribution of labels and containers bearing
official marks.
317.14-317.15 [Reserved]
317.16 Labeling and containers of custom prepared products.
317.17 Interpretation and statement of labeling policy for cured
products; special labeling requirements concerning nitrate and
nitrite.
317.18 Quantity of contents labeling.
317.19 Definitions and procedures for determining net weight
compliance.
317.20 Scale requirements for accurate weights, repairs, adjustments,
and replacement after inspection.
317.21 Scales: testing of.
317.22 Handling of failed product.
317.23 [Reserved]
317.24 Packaging materials.
Subpart B--Nutrition Labeling
317.300 Nutrition labeling of meat or meat food products.
317.301 [Reserved]
317.302 Location of nutrition information.
317.303-317.307 [Reserved]
317.308 Labeling of meat or meat food products with number of servings.
317.309 Nutrition label content.
317.310-317.311 [Reserved]
317.312 Reference amounts customarily consumed per eating occasion.
317.313 Nutrient content claims; general principles.
317.314-317.342 [Reserved]
317.343 Significant participation for voluntary nutrition labeling.
317.344 Identification of major cuts of meat products.
317.345 Guidelines for voluntary nutrition labeling of single-
ingredient, raw products.
317.346-317.353 [Reserved]
317.354 Nutrient content claims for "good source," "high," and
"more".
317.355 [Reserved]
317.356 Nutrient content claims for "light" or "lite".
317.357-317.359 [Reserved]
317.360 Nutrient content claims for calorie content.
317.361 Nutrient content claims for the sodium content.
317.362 Nutrient content claims for fat, fatty acids, and cholesterol
content.
317.363 Nutrient content claims for "healthy".
317.364-317.368 [Reserved]
317.369 Labeling applications for nutrient content claims.
317.370-317.379 [Reserved]
317.380 Label statements relating to usefulness in reducing or
maintaining body weight.
317.381-317.399 [Reserved]
317.400 Exemption from nutrition labeling.
Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.
Source: 35 FR 15580, Oct. 3, 1970, unless otherwise noted.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.1]
[Page 154-155]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart A--General
Sec. 317.1 Labels required; supervision by Program employee.
(a) When, in an official establishment, any inspected and passed
product is placed in any receptacle or covering constituting an
immediate container, there shall be affixed to such container a label as
described in Sec. 317.2 except that the following do not have to bear
such a label.
(1) Wrappings of dressed carcasses and primal parts in an
unprocessed state, bearing the official inspection legend, if such
wrappings are intended solely to protect the product against soiling or
excessive drying during transportation or storage, and the wrappings
bear no information except company brand names, trade marks, or code
numbers which do not include any information required by Sec. 317.2;
(2) Uncolored transparent coverings, such as cellophane, which bear
no written, printed, or graphic matter and which enclose any unpackaged
or packaged product bearing all markings required by part 316 of this
subchapter which are clearly legible through such coverings;
(3) Animal and transparent artificial casings bearing only the
markings required by part 316 of this subchapter;
(4) Stockinettes used as "operative devices", such as those
applied to cured meats in preparation for smoking, whether or not such
stockinettes are removed following completion of the operations for
which they were applied;
(5) Containers such as boil-in bags, trays of frozen dinners, and
pie pans which bear no information except company brand names,
trademarks, code numbers, directions for preparation and serving
suggestions, and which are
[[Page 155]]
enclosed in a consumer size container that bears a label as described in
Sec. 317.2;
(6) Containers of products passed for cooking or refrigeration and
moved from an official establishment under Sec. 311.1 of this
subchapter.
(b) Folders and similar coverings made of paper or similar
materials, whether or not they completely enclose the product and which
bear any written, printed, or graphic matter, shall bear all features
required on a label for an immediate container.
(c) No covering or other container which bears or is to bear a label
shall be filled, in whole or in part, except with product which has been
inspected and passed in compliance with the regulations in this
subchapter, which is not adulterated and which is strictly in accordance
with the statements on the label. No such container shall be filled, in
whole or in part, and no label shall be affixed thereto, except under
supervision of a Program employee.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.2]
[Page 155-163]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart A--General
Sec. 317.2 Labels: definition; required features.
(a) A label within the meaning of this part shall mean a display of
any printing, lithographing, embossing, stickers, seals, or other
written, printed, or graphic matter upon the immediate container (not
including package liners) of any product.
(b) Any word, statement, or other information required by this part
to appear on the label must be prominently placed thereon with such
conspicuousness (as compared with other words, statements, designs, or
devices, in the labeling) and in such terms as to render it likely to be
read and understood by the ordinary individual under customary
conditions of purchase and use. In order to meet this requirement, such
information must appear on the principal display panel except as
otherwise permitted in this part. Except as provided in Sec. 317.7, all
words, statements, and other information required by or under authority
of the Act to appear on the label or labeling shall appear thereon in
the English language: Provided, however, That in the case of products
distributed solely in Puerto Rico, Spanish may be substituted for
English for all printed matter except the USDA inspection legend.
(c) Labels of all products shall show the following information on
the principal display panel (except as otherwise permitted in this
part), in accordance with the requirements of this part or, if
applicable, part 319 of this subchapter:
(1) The name of the product, which in the case of a product which
purports to be or is represented as a product for which a definition and
standard of identity or composition is prescribed in part 319 of this
subchapter, shall be the name of the food specified in the standard, and
in the case of any other product shall be the common or usual name of
the food, if any there be, and if there is none, a truthful descriptive
designation, as prescribed in paragraph (e) of this section;
(2) If the product is fabricated from two or more ingredients, the
word "ingredients" followed by a list of the ingredients as prescribed
in paragraph (f) of this section;
(3) The name and place of business of the manufacturer, packer, or
distributor for whom the product is prepared, as prescribed in paragraph
(g) of this section;
(4) An accurate statement of the net quantity of contents, as
prescribed in paragraph (h) of this section;
(5) An official inspection legend and, except as otherwise provided
in paragraph (i) of this section, the number of the official
establishment, in the form required by part 312 of this subchapter;
(6) Any other information required by the regulations in this part
or part 319 of this subchapter.
(d) The principal display panel shall be the part of a label that is
most likely to be displayed, presented, shown, or examined under
customary conditions of display for sale. Where packages bear alternate
principal display panels, information required to be placed on the
principal display panel shall be duplicated on each principal display
panel. The principal display panel shall be large enough to accommodate
all the mandatory label information required to be placed thereon by
this part and part 319 of this subchapter with clarity and
conspicuousness and without obscuring of such information by
[[Page 156]]
designs or vignettes or crowding. In determining the area of the
principal display panel, exclude tops, bottoms, flanges at tops and
bottoms of cans, and shoulders and necks of bottles or jars. The
principal display panel shall be:
(1) In the case of a rectangular package, one entire side, the area
of which is at least the product of the height times the width of that
side.
(2) In the case of a cylindrical or nearly cylindrical container:
(i) An area that is 40 percent of the product of the height of the
container times the circumference of the container, or
(ii) A panel, the width of which is one-third of the circumference
and the height of which is as high as the container: Provided, however,
That if there is immediately to the right or left of such principal
display panel, a panel which has a width not greater than 20 percent of
the circumference and a height as high as the container, and which is
reserved for information prescribed in paragraphs (c) (2), (3), and (5),
such panel shall be known as the "20 percent panel" and such
information may be shown on that panel in lieu of showing it on the
principal display panel.
(3) In the case of a container of any other shape, 40 percent of the
total surface of the container.
(e) Any descriptive designation used as a product name for a product
which has no common or usual name shall clearly and completely identify
the product. Product which has been prepared by salting, smoking,
drying, cooking, chopping, or otherwise shall be so described on the
label unless the name of the product implies, or the manner of packaging
shows that the product was subjected to such preparation. The
unqualified terms "meat," "meat byproduct," "meat food product,"
and terms common to the meat industry but not common to consumers such
as "picnic," "butt," "cala," "square," "loaf," "spread,"
"delight," "roll," "plate," "luncheon," and "daisy" shall not
be used as names of a product unless accompanied with terms descriptive
of the product or with a list of ingredients, as deemed necessary in any
specific case by the Administrator in order to assure that the label
will not be false or misleading.
(f)(1) The list of ingredients shall show the common or usual names
of the ingredients arranged in the descending order of predominance,
except as otherwise provided in this paragraph.
(i) The terms spice, natural flavor, natural flavoring, flavor and
flavoring may be used in the following manner:
(A) The term "spice" means any aromatic vegetable substance in the
whole, broken, or ground form, with the exceptions of onions, garlic and
celery, whose primary function in food is seasoning rather than
nutritional and from which no portion of any volatile oil or other
flavoring principle has been removed. Spices include the spices listed
in 21 CFR 182.10, and 184.
(B) The term "natural flavor," "natural flavoring," "flavor"
or "flavoring" means the essential oil, oleoresin, essence or
extractive, protein hydrolysate, distillate, or any product or roasting,
heating or enzymolysis, which contains the flavoring constituents
derived from a spice, fruit or fruit juice, vegetable or vegetable
juice, edible yeast, herb, bark, bud, root, leaf or any other edible
portion of a plant, meat, seafood, poultry, eggs, dairy products, or
fermentation products thereof, whose primary function in food is
flavoring rather than nutritional. Natural flavors include the natural
essence or extractives obtained from plants listed in 21 CFR 182.10,
182.20, 182.40, 182.50 and 184, and the substances listed in 21 CFR
172.510. The term natural flavor, natural flavoring, flavor or flavoring
may also be used to designate spices, powered onion, powdered garlic,
and powdered celery.
(ii) The term "corn syrup" may be used to designate either corn
syrup or corn syrup solids.
(iii) The term "animal and vegetable fats" or "vegetable and
animal fats" may be used to designate the ingredients of mixtures of
such edible fats in product designated "compound" or "shortening."
"Animal fats" as used herein means fat derived from inspected and
passed cattle, sheep, swine, or goats.
(iv) When a product is coated with pork fat, gelatin, or other
approved
[[Page 157]]
substance and a specific declaration of such coating appears contiguous
to the name of the product, the ingredient statement need not make
reference to the ingredients of such coating.
(v) When two meat ingredients comprise at least 70 percent of the
meat and meat byproduct ingredients of a formula and when neither of the
two meat ingredients is less than 30 percent by weight of the total meat
and meat byproducts used, such meat ingredients may be interchanged in
the formula without a change being made in the ingredients statement on
labeling materials: Provided, That the word "and" in lieu of a comma
shall be shown between the declaration of such meat ingredients in the
statement of ingredients.
(vi)(A) Product ingredients which are present in individual amounts
of 2 percent or less by weight may be listed in the ingredients
statement in other than descending order of predominance: Provided, That
such ingredients are listed by their common or usual names at the end of
the ingredients statement and preceded by a quantifying statement, such
as "Contains ---------- percent of ---------- ," "Less than --------
--percent of ---------- ." The percentage of the ingredient(s) shall be
filled in with a threshold level of 2 percent, 1.5 percent, 1.0 percent,
or 0.5 percent, as appropriate. No ingredient to which the quantifying
statement applies may be present in an amount greater than the stated
threshold. Such a quantifying statement may also be utilized when an
ingredients statement contains a listing of ingredients by individual
components. Each component listing may utilize the required quantifying
statement at the end of each component ingredients listing.
(B) Such ingredients may be adjusted in the product formulation
without a change being made in the ingredients statement on the
labeling, provided that the adjusted amount complies with
Sec. 318.7(c)(4) and part 319 of this subchapter, and does not exceed
the amount shown in the quantifying statement. Any such adjustments to
the formulation shall be provided to the inspector-in-charge.
(2) On containers of frozen dinners, entrees, pizzas, and similar
consumer packaged products in cartons the ingredient statement may be
placed on the front riser panel: Provided, That the words "see
ingredients" followed immediately by an arrow is placed on the
principal display panel immediately above the location of such statement
without intervening print or designs.
(3) The ingredient statement may be placed on the 20 percent panel
adjacent to the principal display panel and reserved for required
information, in the case of a cylindrical or nearly cylindrical
container.
(4) The ingredients statement may be placed on the information
panel, except as otherwise permitted in this subchapter.
(g)(1) The name or trade name of the person that prepared the
product may appear as the name of the manufacturer or packer without
qualification on the label. Otherwise the name of the distributor of the
product shall be shown with a phrase such as "Prepared for * * *". The
place of business of the manufacturer, packer, or distributor shall be
shown on the label by city, State, and postal ZIP code when such
business is listed in a telephone or city directory, and if not listed
in such directory, then the place of business shall be shown by street
address, city, State, and postal ZIP code.
(2) The name and place of business of the manufacturer, packer, or
distributor may be shown:
(i) On the principal display panel, or
(ii) On the 20 percent panel adjacent to the principal display panel
and reserved for required information, in the case of a cylindrical or
nearly cylindrical container, or
(iii) On the front riser panel of frozen food cartons, or
(iv) On the information panel.
(h)(1) The statement of net quantity of contents shall appear on the
principal display panel of all containers to be sold at retail intact,
in conspicuous and easily legible boldface print or type in distinct
contrast to other matter on the container, and shall be declared in
accordance with the provisions of this paragraph.
[[Page 158]]
(2) The statement as it is shown on a label shall not be false or
misleading and shall express an accurate statement of the quantity of
contents of the container. Reasonable variations caused by loss or gain
of moisture during the course of good distribution practices or by
unavoidable deviations in good manufacturing practices will be
recognized. Variations from stated quantity of contents shall be as
provided in Sec. 317.19. The statement shall not include any term
qualifying a unit of weight, measure, or count such as "jumbo quart,"
"full gallon," "giant quart," "when packed," "minimum," or words
of similar importance.
(3) The statement shall be placed on the principal display panel
within the bottom 30 percent of the area of the panel in lines generally
parallel to the base: Provided, That on packages having a principal
display panel of 5 square inches or less, the requirement for placement
within the bottom 30 percent of the area of the label panel shall not
apply when the statement meets the other requirements of this paragraph
(h). In any case, the statement may appear in more than one line. The
terms "net weight" or "net wt." shall be used when stating the net
quantity of contents in terms of weight, and the term "net contents"
or "content" when stating the net quantity of contents in terms of
fluid measure.
(4) Except as provided in Sec. 317.7, the statement shall be
expressed in terms of avoirdupois weight or liquid measure. Where no
general consumer usage to the contrary exists, the statement shall be in
terms of liquid measure, if the product is liquid, or in terms of weight
if the product is solid, semisolid viscous or a mixture of solid and
liquid. For example, a declaration of \3/4\-pound avoirdupois weight
shall be expressed as "Net Wt. 12 oz." except as provided for in
paragraph (h)(5) of this section for random weight packages; a
declaration of 1\1/2\ pounds avoirdupois weight shall be expressed as
"Net Wt. 24 oz. (1 lb. 8 oz.)," "Net Wt. 24 oz. (1\1/2\ lb.)," or
"Net Wt. 24 oz. (1.5 lbs.)."
(5) On packages containing 1 pound or 1 pint and less than 4 pounds
or 1 gallon, the statement shall be expressed as a dual declaration both
in ounces and (immediately thereafter in parentheses) in pounds, with
any remainder in terms of ounces or common or decimal fraction of the
pound, or in the case of liquid measure, in the largest whole units with
any remainder in terms of fluid ounces or common or decimal fractions of
the pint or quart, except that on random weight packages the statement
shall be expressed in terms of pounds and decimal fractions of the
pound, for packages over 1 pound, and for packages which do not exceed 1
pound the statement may be in decimal fractions of the pound in lieu of
ounces. Paragraph (h)(9) of this section permits certain exceptions from
the provisions of this paragraph for margarine packages, random weight
consumer size packages, and packages of less than \1/2\ ounce net
weight. Pargraph (h)(12) of this section permits certain exceptions from
the provision of this paragraph for multi-unit packages.
(6) The statement shall be in letters and numerals in type size
established in relationship to the area of the principal display panel
of the package and shall be uniform of all packages of substantially the
same size by complying with the following type specifications:
(i) Not less than one-sixteenth inch in height on packages, the
principal display panel of which has an area of 5 square inches or less;
(ii) Not less than one-eighth inch in height on packages, the
principal display panel of which has an area of more than 5 but not more
than 25 square inches;
(iii) Not less than three-sixteenths inch in height on packages, the
principal display panel of which has an area of more than 25 but not
more than 100 square inches;
(iv) Not less than one-quarter inch in height on packages, the
principal display panel of which has an area of more than 100 but not
more than 400 square inches.
(v) Not less than one-half inch in height on packages, the principal
display panel of which has an area of more than 400 square inches.
(7) The ratio of height to width of letters and numerals shall not
exceed a differential of 3 units to 1 unit (no more than 3 times as high
as it is wide). Heights pertain to upper case or
[[Page 159]]
capital letters. When upper and lower case or all lower case letters are
used, it is the lower case letter "o" or its equivalent that shall
meet the minimum standards. When fractions are used, each component
numeral shall meet one-half the height standards.
(8) The statement shall appear as a distinct item on the principal
display panel and shall be separated by a space at least equal to the
height of the lettering used in the statement from other printed label
information appearing above or below the statement and by a space at
least equal to twice the width of the letter "N" of the style of type
used in the quantity of contents statement from other printed label
information appearing to the left or right of the statement. It shall
not include any term qualifying a unit of weight, measure, or count such
as, "jumbo quart," "full gallon," "giant quart," "when packed,"
"Minimum" or words of similar import.
(9) The following exemptions from the requirements contained in this
paragraph (h) are hereby established:
(i) Individually wrapped, random weight consumer size packages
shipped in bulk containers (as specified in paragraph (h)(11) of this
section) and meat products that are subject to shrinkage through
moisture loss during good distribution practices and are designated as
gray area type of products as defined under Sec. 317.19 need not bear a
net weight statement when shipped from an official establishment,
provided that a net weight shipping statement which meets the
requirements of paragraph (h)(2) of this section is applied to their
shipping container prior to shipping it from the official establishment.
Net weight statements so applied to the shipping container are exempt
from the type size, dual declaration, and placement requirements of this
paragraph, if an accurate statement of net weight is shown conspicuously
on the principal display panel of the shipping container. The net weight
also shall be applied directly to random weight consumer size packages
prior to retail display and sale. The net weight statement on random
weight consumer size packages for retail sale shall be exempt from the
type size, dual declaration, and placement requirements of this
paragraph, if an accurate statement of net weight is shown conspicuously
on the principal display panel of the package.
(ii) Individually wrapped and labeled packages of less than \1/2\
ounce net weight and random weight consumer size packages shall be
exempt from the requirements of this paragraph if they are in a shipping
container and the statement of net quantity of contents on the shipping
container meets the requirements of paragraph (h)(2) of this section;
(iii) Individually wrapped and labeled packages of less than \1/2\
ounce net weight bearing labels declaring net weight, price per pound,
and total price, shall be exempt from the type size, dual declaration,
and placement requirements of this paragraph, if an accurate statement
of net weight is shown conspicuously on the principal display panel of
the package.
(iv) Margarine in 1 pound rectangular packages (except packages
containing whipped or soft margarine or packages that contain more than
four sticks) is exempt from the requirements of paragraphs (h) (3) and
(5) of this section regarding the placement of the statement of the net
quantity of contents within the bottom 30 percent of the principal
display panel and that the statement be expressed both in ounces and in
pounds, if the statement appears as "1 pound" or "one pound" in a
conspicuous manner on the principal display panel.
(v) Sliced shingle packed bacon in rectangular packages is exempt
from the requirements of paragraphs (h)(3) and (h)(5) of this section
regarding the placement of the statement of the net quantity of contents
within the bottom 30 percent of the principal display panel, and that
the statement be expressed both in ounces and in pounds, if the
statement appears in a conspicuous manner on the principal display
panel.
(10) Labels for containers which bear any representation as to the
number of servings contained therein shall bear, contiguous to such
representation, and in the same size type as is used for such
representation, a statement of the net quantity of each such serving.
(11) As used in this section, a "ran- dom weight consumer size
package" is
[[Page 160]]
one which is one of a lot, shipment or delivery of packages of the same
product with varying weights and with no fixed weight pattern.
(12) On a multiunit retail package, a statement of the net quantity
of contents shall appear on the outside of the package and shall include
the number of individual units, the quantity of each individual unit,
and in parentheses, the total net quantity of contents of the multiunit
package in terms of avoirdupois or fluid ounces, except that such
declaration of total quantity need not be followed by an additional
parenthetical declaration in terms of the largest whole units and
subdivisions thereof, as required by paragraph (h)(5) of this section.
For the purposes of this section, "multiunit retail package" means a
package containing two or more individually packaged units of the
identical commodity and in the same quantity, with the individual
packages intended to be sold as part of the multiunit retail package but
capable of being individually sold in full compliance with all
requirements of the regulations in this part. Open multiunit retail
packages that do not obscure the number of units and the labeling
thereon are not subject to this paragraph if the labeling of each
individual unit complies with the requirements of paragraphs (h) (2),
(3), (6), and (8) of this section.
(i) The official establishment number of the official establishment
in which the product was processed under inspection shall be placed as
follows:
(1) Within the official inspection legend in the form required by
part 312 of this subchapter; or
(2) Outside the official inspection legend elsewhere on the exterior
of the container or its labeling, e.g., the lid of a can, if shown in a
prominent and legible manner in a size sufficient to insure easy
visibility and recognition and accompanied by the prefix "EST"; or
(3) Off the exterior of the container, e.g., on a metal clip used to
close casings or bags, or on the back of a paper label of a canned
product, or on other packaging or labeling material in the container,
e.g., on aluminum pans and trays placed within containers, when a
statement of its location is printed contiguous to the official
inspection legend, such as "EST. No. on Metal Clip" or "Est. No. on
Pan", if shown in a prominent and legible manner in a size sufficient
to insure easy visibility and recognition; or
(4) On an insert label placed under a transparent covering if
clearly visible and legible and accompanied by the prefix "EST".
(j) Labels of any product within any of the following paragraphs
shall show the information required by such paragraph for such product:
(1) A label for product which is an imitation of another food shall
bear the word "imitation" immediately preceding the name of the food
imitated and in the same size and style of lettering as in that name and
immediately thereafter the word "ingredients:" and the names of the
ingredients arranged in the order of their predominance.
(2) If a product purports to be or is represented for any special
dietary use by man, its label shall bear a statement concerning its
vitamin, mineral, and other dietary properties upon which the claim for
such use is based in whole or in part and shall be in conformity with
regulations (21 CFR part 125) established pursuant to sections 403, and
701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343, 371).
(3) When an artificial smoke flavoring or an smoke flavoring is
added as an ingredient in the formula of a meat food product, as
permitted in part 318 of this subchapter, there shall appear on the
label, in prominent letters and contiguous to the name of the product, a
statement such as "Artificial Smoke Flavoring Added" or "Smoke
Flavoring Added," as may be applicable, and the ingredient statement
shall identify any artificial smoke flavoring or smoke flavoring so
added as an ingredient in the formula of the meat food product.
(4) When any other artificial flavoring is permitted under part 318
of this subchapter to be added to a product, the ingredient statement
shall identify it as "Artificial Flavoring."
(5) When artificial coloring is added to edible fats as permitted
under part 318 of this subchapter such substance shall be declared on
the label in a prominent manner and contiguous to
[[Page 161]]
the name of the product by the words "Artificially colored" or
"Artificial coloring added" or "With added artificial coloring."
When natural coloring such as annatto is added to edible fats as
permitted under part 318 of this subchapter, such substance shall be
declared on the label in the same manner by a phrase such as "Colored
with annatto."
(6) When product is placed in a casing to which artificial coloring
is applied as permitted under part 318 of this subchapter, there shall
appear on the label, in a prominent manner and contiguous to the name of
the product, the words, "Artificially colored."
(7) If a casing is removed from product at an official establishment
and there is evidence of artificial coloring on the surface of the
product, there shall appear on the label, in a prominent manner and
contiguous to the name of product, the words "Artificially colored."
(8) When a casing is colored prior to its use as a covering for
product and the color is not transferred to the product enclosed in the
casing, no reference to color need appear on the label but no such
casing may be used if it is misleading or deceptive with respect to
color, quality, or kind of product, or otherwise.
(9) Product which bears or contains any other artificial coloring,
as permitted under part 318 of this subchapter, shall bear a label
stating that fact on the immediate container or if there is none, on the
product.
(10) When an antioxidant is added to product as permitted under part
318 of this subchapter, there shall appear on the label in prominent
letters and contiguous to the name of the product, a statement
identifying the officially approved specific antioxidant by its common
name or abbreviation thereof and the purpose for which it is added, such
as, "BHA, BHT, and Propylgallate added to help protect flavor."
(11) Containers of meat packed in borax or other preservative for
export to a foreign country which permits the use of such preservative
shall, at the time of packing, be marked "for export," followed on the
next line by the words "packed in preservative," or such equivalent
statement as may be approved for this purpose by the Administrator and
directly beneath this there shall appear the word "establishment" or
abbreviation thereof, followed by the number of the establishment at
which the product is packed. The complete statement shall be applied in
a conspicuous location and in letters not less than 1 inch in height.
(12) Containers of other product packed in, bearing, or containing
any chemical preservative shall bear a label stating that fact.
(13)(i) On the label of any "Mechanically Separated (Species)"
described in Sec. 319.5(a) of this subchapter, the name of such product
shall be followed immediately by the phrase "for processing" unless
such product has a protein content of not less than 14 percent and a fat
content of not more than 30 percent.
(ii) When any "Mechanically Separated (Species)" described in
Sec. 319.5 of this subchapter is used as an ingredient in the
preparation of a meat food product and such "Mechanically Separated
(Species)" contributes 20 mg or more of calcium to a serving of such
meat food product, the label of such meat food product shall state the
calcium content of such meat food product, determined and expressed as
the percentage of the U.S. Recommended Daily Allowance (U.S. RDA) in a
serving in accordance with 21 CFR 101.9(b)(1), (c)(7) (i) and (iv), and
(e), as part of any nutrition information included on such label, or if
such meat food product does not bear nutrition labeling information, as
part of a prominent statement in immediate conjunction with the list of
ingredients, as follows: "A ------ serving contains ----% of the U.S.
RDA of calcium", with the blanks to be filled in, respectively, with
the quantity of such product that constitutes a serving and the amount
of calcium provided by such serving: Provided, That, calcium content
need not be stated where (a) the percent of the U.S. RDA of calcium to
be declared would not differ from the percent of the U.S. RDA that would
be declared if the meat food product contained only hand deboned
ingredients or (b) the calcium content of a serving of the meat food
product would be 20 percent of the U.S. RDA or more
[[Page 162]]
if the meat food product contained only hand deboned ingredients.
(k) Packaged products which require special handling to maintain
their wholesome condition shall have prominently displayed on the
principal display panel of the label the statement: "Keep
Refrigerated," "Keep Frozen," "Perishable Keep Under
Refrigeration," or such similar statement as the Administrator may
approve in specific cases. Products that are distributed frozen during
distribution and thawed prior to or during display for sale at retail
shall bear the statement on the shipping container: "Keep Frozen." The
consumer-size containers for such products shall bear the statement
"Previously Handled Frozen for Your Protection, Refreeze or Keep
Refrigerated." For all perishable canned products the statement shall
be shown in upper case letters one-fourth inch in height for containers
having a net weight of 3 pounds or less, and for containers having a net
weight over 3 pounds, the statement shall be in upper case letters at
least one-half inch in height.
(l) Safe handling instructions shall be provided for: All meat and
meat products of cattle, swine, sheep, goat, horse, other equine that do
not meet the requirements contained in Sec. 318.17, or that have not
undergone other processing that would render them ready-to-eat; and all
comminuted meat patties not heat processed in a manner that conforms to
the time and temperature combinations in the Table for Permitted Heat-
Processing Temperature/Time Combinations For Fully-Cooked Patties in
Sec. 318.23, except as exempted under paragraph (l)(4) of this section.
(1)(i) Safe handling instructions shall accompany every meat or meat
product, specified in this paragraph (l) destined for household
consumers, hotels, restaurants, or similar institutions and shall appear
on the label. The information shall be in lettering no smaller than one-
sixteenth of an inch in size and shall be prominently placed with such
conspicuousness (as compared with other words, statements, designs or
devices in the labeling) as to render it likely to be read and
understood by the ordinary individual under customary conditions of
purchase and use.
(ii) The safe handling information shall be presented on the label
under the heading "Safe Handling Instructions" which shall be set in
type size larger than the print size of the rationale statement and
handling statements as discussed in paragraphs (l)(2) and (l)(3) of this
section. The safe handling information shall be set off by a border and
shall be one color type printed on a single color contrasting background
whenever practical.
(2) The labels of the meat and meat products specified in this
paragraph (l) shall include the following rationale statement as part of
the safe handling instructions, "This product was prepared from
inspected and passed meat and/or poultry. Some food products may contain
bacteria that could cause illness if the product is mishandled or cooked
improperly. For your protection, follow these safe handling
instructions." This statement shall be placed immediately after the
heading and before the safe handling statements.
(3) Meat and meat products, specified in this paragraph (l), shall
bear the labeling statements:
(i) Keep refrigerated or frozen. Thaw in refrigerator or microwave.
(Any portion of this statement that is in conflict with the product's
specific handling instructions, may be omitted, e.g., instructions to
cook without thawing.) (A graphic illustration of a refrigerator shall
be displayed next to the statement.);
(ii) Keep raw meat and poultry separate from other foods. Wash
working surfaces (including cutting boards), utensils, and hands after
touching raw meat or poultry. (A graphic illustration of soapy hands
under a faucet shall be displayed next to the statement.);
(iii) Cook thoroughly. (A graphic illustration of a skillet shall be
displayed next to the statement.); and
(iv) Keep hot foods hot. Refrigerate leftovers immediately or
discard. (A graphic illustration of a thermometer shall be displayed
next to the statement.)
[[Page 163]]
(4) Meat or meat products intended for further processing at another
official establishment are exempt from the requirements prescribed in
paragraphs (l)(1) through (l)(3) of this section.
(m)(1) The information panel is that part of a label that is the
first surface to the right of the principal display panel as observed by
an individual facing the principal display panel, with the following
exceptions:
(i) If the first surface to the right of the principal display panel
is too small to accommodate the required information or is otherwise
unusable label space, e.g., folded flaps, tear strips, opening flaps,
heat-sealed flaps, the next panel to the right of this part of the label
may be used.
(ii) If the package has one or more alternate principal display
panels, the information panel is to the right of any principal display
panel.
(iii) If the top of the container is the principal display panel and
the package has no alternate principal display panel, the information
panel is any panel adjacent to the principal display panel.
(2) (i) Except as otherwise permitted in this part, all information
required to appear on the principal display panel or permitted to appear
on the information panel shall appear on the same panel unless there is
insufficient space. In determining the sufficiency of the available
space, except as otherwise prescribed in this part, any vignettes,
designs, and any other nonmandatory information shall not be considered.
If there is insufficient space for all required information to appear on
a single panel, it may be divided between the principal display panel
and the information panel, provided that the information required by any
given provision of this part, such as the ingredients statement, is not
divided and appears on the same panel.
(ii) All information appearing on the information panel pursuant to
this section shall appear in one place without intervening material,
such as designs or vignettes.
[35 FR 15580, Oct. 3, 1970]
Editorial Note: For Federal Register citations affecting Sec. 317.2,
see the List of CFR Sections Affected, which appears in the Finding Aids
section of the printed volume and on GPO Access.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.3]
[Page 163-164]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart A--General
Sec. 317.3 Approval of abbreviations of marks of inspection; preparation of marking devices bearing inspection legend without advance approval prohibited;
exception.
(a) The Administrator may approve and authorize the use of
abbreviations of marks of inspection under the regulations in this
subchapter. Such abbreviations shall have the same force and effect as
the respective marks for which they are authorized abbreviations.
(b) Except for the purposes of preparing and submitting a sample or
samples of the same to the Administrator for approval, no brand
manufacturer, printer, or other person shall cast, print, lithograph, or
otherwise make any marking device containing any official mark or
simulation thereof, or any label bearing any such mark or simulation,
without the written authority therefor of the Administrator. However,
when any such sample label, or other marking device, is approved by the
Administrator, additional supplies of the approved label, or marking
device, may be made for use in accordance with the regulations in this
subchapter, without further approval by the Administrator. The
provisions of this paragraph apply only to labels, or other marking
devices, bearing or containing an official inspection legend shown in
Sec. 312.2(b), Sec. 312.3(a) (only the legend appropriate for horse meat
food products) or Sec. 312.3(b) (only the legend appropriate for other
(nonhorse) equine meat food products), or any abbreviations, copy or
representation thereof.
(c) No brand manufacturer or other person shall cast or otherwise
make, without an official certificate issued in quadruplicate by a
Program employee, a brand or other marking device containing an official
inspection legend, or simulation thereof, shown in Sec. 312.2(a),
Sec. 312.3(a) (only the legend appropriate for horse carcasses and parts
of horse carcasses), Sec. 312.3(b) (only the legend appropriate for
other equine (nonhorse) carcasses and parts of other (nonhorse) equine
carcasses) or Sec. 312.7(a).
(1) The certificate is a Food Safety and Inspection Service form for
signature by a Program employee and the
[[Page 164]]
official establishment ordering the brand or other marking device,
bearing a certificate serial number and a letterhead and the seal of the
United States Department of Agriculture. The certificate authorizes the
making of only the brands or other marking devices of the type and
quantity listed on the certificate.
(2) After signing the certificate, the Program employee and the
establishment shall each keep a copy, and the remaining two copies shall
be given to the brand or other marking device manufacturer.
(3) The manufacturer of the brands or other marking devices shall
engrave or otherwise mark each brand or other marking device with a
permanent identifying serial number unique to it. The manufacturer shall
list on each of the two copies of the certificate given to the
manufacturer the number of each brand or other marking device authorized
by the certificate. The manufacturer shall retain one copy of the
certificate for the manufacturer's records and return the remaining copy
with the brands or other marking devices to the Program employee whose
name and address are given on the certificate as the recipient.
(4) In order that all such brands or other marking devices bear
identifying numbers, within one year after June 24, 1985, an
establishment shall either replace each such brand or other marking
device which does not bear an identifying number, or, under the
direction of the inspector-in-charge, mark such brand or other marking
device with a permanent identifying number.
(Recordkeeping requirements approved by the Office of Management and
Budget under control number 0583-0015)
[35 FR 15580, Oct. 3, 1970, as amended at 50 FR 21422, May 24, 1985]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.4]
[Page 164-165]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart A--General
Sec. 317.4 Labeling approval.
(a) No final labeling shall be used on any product unless the sketch
labeling of such final labeling has been submitted for approval to the
Food Labeling Division, Regulatory Programs, Food Safety and Inspection
Service, and approved by such division, accompanied by FSIS form,
Application for Approval of Labels, Marking, and Devices, except for
generically approved labeling authorized for use in Sec. 317.5(b). The
management of the official establishment or establishment certified
under a foreign inspection system, in accordance with part 327 of this
subchapter, must maintain a copy of all labeling used, along with the
product formulation and processing procedure, in accordance with part
320 of this subchapter. Such records shall be made available to any duly
authorized representative of the Secretary upon request.
(b) The Food Labeling Division shall permit submission for approval
of only sketch labeling, as defined in Sec. 317.4(d), for all products,
except as provided in Sec. 317.5(b) (2)-(9) and except for temporary use
of final labeling as prescribed in paragraph (f) of this section.
(c) All labeling required to be submitted for approval as set forth
in Sec. 317.4(a) shall be submitted in duplicate to the Food Labeling
Division, Regulatory Programs, Food Safety and Inspection Service, U.S.
Department of Agriculture, Washington, DC 20250. A parent company for a
corporation may submit only one labeling application (in duplicate form)
for a product produced in other establishments that are owned by the
corporation.
(d) "Sketch" labeling is a printer's proof or equivalent which
clearly shows all labeling features, size, location, and indication of
final color, as specified in Sec. 317.2. FSIS will accept sketches that
are hand drawn, computer generated or other reasonable facsimiles that
clearly reflect and project the final version of the labeling.
Indication of final color may be met by: submission of a color sketch,
submission of a sketch which indicates by descriptive language the final
colors, or submission with the sketch of previously approved final
labeling that indicates the final colors.
(e) Inserts, tags, liners, pasters, and like devices containing
printed or graphic matter and for use on, or to be placed within,
containers and coverings of product shall be submitted for approval in
the same manner as provided for labeling in Sec. 317.4(a), except that
such devices which contain no reference to product and bear no
misleading feature shall be used without
[[Page 165]]
submission for approval as prescribed in Sec. 317.5(b)(7).
(f)(1) Consistent with the requirements of this section, temporary
approval for the use of a final label or other final labeling that may
otherwise be deemed deficient in some particular may be granted by the
Food Labeling Division. Temporary approvals may be granted for a period
not to exceed 180 calendar days, under the following conditions:
(i) The proposed labeling would not misrepresent the product;
(ii) The use of the labeling would not present any potential health,
safety, or dietary problems to the consumer;
(iii) Denial of the request would create undue economic hardship;
and
(iv) An unfair competitive advantage would not result from the
granting of the temporary approval.
(2) Extensions of temporary approvals may also be granted by the
Food Labeling Division provided that the applicant demonstrates that new
circumstances, meeting the above criteria, have developed since the
original temporary approval was granted.
(g) The inspector-in-charge shall approve meat carcass ink brands
and meat food product ink and burning brands, which comply with parts
312 and 316 of this subchapter.
[60 FR 67454, Dec. 29, 1995]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.5]
[Page 165-166]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart A--General
Sec. 317.5 Generically approved labeling.
(a)(1) An official establishment or an establishment certified under
a foreign inspection system, in accordance with part 327 of this
subchapter, is authorized to use generically approved labeling, as
defined in paragraph (b) of this section, without such labeling being
submitted for approval to the Food Safety and Inspection Service in
Washington or the field, provided the labeling is in accordance with
this section and shows all mandatory features in a prominent manner as
required in Sec. 317.2, and is not otherwise false or misleading in any
particular.
(2) The Food Safety and Inspection Service shall select samples of
generically approved labeling from the records maintained by official
establishments and establishments certified under foreign inspection
systems, in accordance with part 327 of this subchapter, as required in
Sec. 317.4, to determine compliance with labeling requirements. Any
finding of false or misleading labeling shall institute the proceedings
prescribed in Sec. 335.12.
(b) Generically approved labeling is labeling which complies with
the following:
(1) Labeling for a product which has a product standard as specified
in part 319 of this subchapter or the Standards and Labeling Policy Book
and which does not contain any special claims, such as quality claims,
nutrient content claims, health claims, negative claims, geographical
origin claims, or guarantees, or which is not a domestic product labeled
in a foreign language;
(2) Labeling for single-ingredient products (such as beef steak or
lamb chops) which does not contain any special claims, such as quality
claims, nutrient content claims, health claims, negative claims,
geographical origin claims, or guarantees, or which is not a domestic
product labeled with a foreign language;
(3) Labeling for containers of products sold under contract
specifications to Federal Government agencies, when such product is not
offered for sale to the general public, provided that the contract
specifications include specific requirements with respect to labeling,
and are made available to the inspector-in-charge;
(4) Labeling for shipping containers which contain fully labeled
immediate containers, provided such labeling complies with Sec. 316.13;
(5) Labeling for products not intended for human food, provided they
comply with part 325 of this subchapter;
(6) Meat inspection legends, which comply with parts 312 and 316 of
this subchapter;
(7) Inserts, tags, liners, pasters, and like devices containing
printed or graphic matter and for use on, or to be placed within
containers, and coverings of products, provided such devices contain no
reference to product and bear no misleading feature;
(8) Labeling for consumer test products not intended for sale; and
(9) Labeling which was previously approved by the Food Labeling
Division
[[Page 166]]
as sketch labeling, and the final labeling was prepared without
modification or with the following modifications:
(i) All features of the labeling are proportionately enlarged or
reduced, provided that all minimum size requirements specified in
applicable regulations are met and the labeling is legible;
(ii) The substitution of any unit of measurement with its
abbreviation or the substitution of any abbreviation with its unit of
measurement, e.g., "lb." for "pound," or "oz." for "ounce," or
of the word "pound" for "lb." or "ounce" for "oz.";
(iii) A master or stock label has been approved from which the name
and address of the distributor are omitted and such name and address are
applied before being used (in such case, the words "prepared for" or
similar statement must be shown together with the blank space reserved
for the insertion of the name and address when such labels are offered
for approval);
(iv) Wrappers or other covers bearing pictorial designs, emblematic
designs or illustrations, e.g., floral arrangements, illustrations of
animals, fireworks, etc. are used with approved labeling (the use of
such designs will not make necessary the application of labeling not
otherwise required);
(v) A change in the language or the arrangement of directions
pertaining to the opening of containers or the serving of the product;
(vi) The addition, deletion, or amendment of a dated or undated
coupon, a cents-off statement, cooking instructions, packer product code
information, or UPC product code information;
(vii) Any change in the name or address of the packer, manufacturer
or distributor that appears in the signature line;
(viii) Any change in the net weight, provided the size of the net
weight statement complies with Sec. 317.2;
(ix) The addition, deletion, or amendment of recipe suggestions for
the product;
(x) Any change in punctuation;
(xi) Newly assigned or revised establishment numbers for a
particular establishment for which use of the labeling has been approved
by the Food Labeling Division, Regulatory Programs;
(xii) The addition or deletion of open dating information;
(xiii) A change in the type of packaging material on which the label
is printed;
(xiv) Brand name changes, provided that there are no design changes,
the brand name does not use a term that connotes quality or other
product characteristics, the brand name has no geographic significance,
and the brand name does not affect the name of the product;
(xv) The deletion of the word "new" on new product labeling;
(xvi) The addition, deletion, or amendment of special handling
statements, provided that the change is consistent with Sec. 317.2(k);
(xvii) The addition of safe handling instructions as required by
Sec. 317.2(l);
(xviii) Changes reflecting a change in the quantity of an ingredient
shown in the formula without a change in the order of predominance shown
on the label, provided that the change in quantity of ingredients
complies with any minimum or maximum limits for the use of such
ingredients prescribed in parts 318 and 319 of this subchapter;
(xix) Changes in the color of the labeling, provided that sufficient
contrast and legibility remain;
(xx) A change in the product vignette, provided that the change does
not affect mandatory labeling information or misrepresent the content of
the package;
(xxi) A change in the establishment number by a corporation or
parent company for an establishment under its ownership;
(xxii) Changes in nutrition labeling that only involve quantitative
adjustments to the nutrition labeling information, except for serving
sizes, provided the nutrition labeling information maintains its
accuracy and consistency;
(xxiii) Deletion of any claim, and the deletion of non-mandatory
features or non-mandatory information; and
(xxiv) The addition or deletion of a direct translation of the
English language into a foreign language for products marked "for
export only."
[60 FR 67455, Dec. 29, 1995]
[[Page 167]]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.6]
[Page 167]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart A--General
Sec. 317.6 Approved labels to be used only on products to which they are applicable.
Labels shall be used only on products for which they are approved,
and only if they have been approved for such products in accordance with
Sec. 317.3: Provided, That existing stocks of labels approved prior to
the effective date of this section and the quantity of which has been
identified to the circuit supervisor as being in storage on said date at
the official establishment or other identified warehouse for the account
of the operator of the official establishment may be used until such
stocks are exhausted, but not later than 1 year after the effective date
of this section unless such labels conform to all the requirements of
this part and part 319 of this subchapter. The Administrator may upon
the show of good cause grant individual extension of time as he deems
necessary.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.7]
[Page 167]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart A--General
Sec. 317.7 Products for foreign commerce; printing labels in foreign language permissible; other deviations.
Labels to be affixed to packages of products for foreign commerce
may be printed in a foreign language and may show the statement of the
quantity of contents in accordance with the usage of the country to
which exported and other deviations from the form of labeling required
under this part may be approved for such product by the Administrator in
specific cases: Provided,
(a) That the proposed labeling accords to the specifications of the
foreign purchaser,
(b) That it is not in conflict with the laws of the country to which
the product is intended for export, and
(c) That the outside container is labeled to show that it is
intended for export; but if such product is sold or offered for sale in
domestic commerce, all the requirements of this subchapter apply. The
inspection legend and the establishment number shall in all cases appear
in English but in addition, may appear literally translated in a foreign
language.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.8]
[Page 167-172]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart A--General
Sec. 317.8 False or misleading labeling or practices generally; specific prohibitions and requirements for labels and containers.
(a) No product or any of its wrappers, packaging, or other
containers shall bear any false or misleading marking, label, or other
labeling and no statement, word, picture, design, or device which
conveys any false impression or gives any false indication of origin or
quality or is otherwise false or misleading shall appear in any marking
or other labeling. No product shall be wholly or partly enclosed in any
wrapper, packaging, or other container that is so made, formed, or
filled as to be misleading.
(b) The labels and containers of product shall comply with the
following provisions, as applicable:
(1) Terms having geographical significance with reference to a
locality other than that in which the product is prepared may appear on
the label only when qualified by the word "style," "type," or
"brand," as the case may be, in the same size and style of lettering
as in the geographical term, and accompanied with a prominent qualifying
statement identifying the country, State, Territory, or locality in
which the product is prepared, using terms appropriate to effect the
qualification. When the word "style" or "type" is used, there must
be a recognized style or type of product identified with and peculiar to
the area represented by the geographical term and the product must
possess the characteristics of such style or type, and the word
"brand" shall not be used in such a way as to be false or misleading:
Provided, That a geographical term which has come into general usage as
a trade name and which has been approved by the Administrator as being a
generic term may be used without the qualifications provided for in this
paragraph. The terms "frankfurter," "vi- enna," "bologna,"
"lebanon bologna," "braunschweiger," "thuringer," "genoa,"
"leona," "berliner," "hol- stein," "goteborg," "milan,"
"polish," "italian," and their modifications, as applied to
sausages, the terms "bruns- wick" and "irish" as applied to stews
[[Page 168]]
and the term "boston" as applied to pork shoulder butts need not be
accompanied with the word "style," "type," or "brand," or a
statement identifying the locality in which the product is prepared.
(2) Such terms as "farm" or "country" shall not be used on
labels in connection with products unless such products are actually
prepared on the farm or in the country: Provided, That if the product is
prepared in the same way as on the farm or in the country these terms,
if qualified by the word "style" in the same size and style of
lettering, may be used: Provided further, That the term "farm" may be
used as part of a brand designation when qualified by the word "brand"
in the same size and style of lettering, and followed with a statement
identifying the locality in which the product is prepared: And Provided
further, That the provisions of this paragraph shall not apply to
products prepared in accordance with Sec. 319.106 of this subchapter.
Sausage containing cereal shall not be labeled "farm style" or
"country style," and lard not rendered in an open kettle shall not be
designated as "farm style" or "country style."
(3) The requirement that the label shall contain the name and place
of business of the manufacturer, packer, or distributor shall not
relieve any establishment from the requirement that its label shall not
be misleading in any particular.
(4) The term "spring lamb" or "genuine spring lamb" is
applicable only to carcasses of new-crop lambs slaughtered during the
period beginning in March and terminating not beyond the close of the
week containing the first Monday in October.
(5)(i) Coverings shall not be of such color, design, or kind as to
be misleading with respect to color, quality, or kind of product to
which they are applied. For example, transparent or semitransparent
coverings for such articles as sliced bacon or fresh (uncooked) meat and
meat food products shall not bear lines or other designs of red or other
color which give a false impression of leanness of the product.
Transparent or semitransparent wrappers, casings, or coverings for use
in packaging cured, cured and smoked, or cured and cooked sausage
products, and sliced ready-to-eat meat food products may be color tinted
or bear red designs on 50 percent of such wrapper or covering: Provided,
That the transparent or semitransparent portion of the principal display
panel is free of color tinting and red designs: And provided further,
That the principal display panel provides at least 20 percent
unobstructed clear space, consolidated in one area so that the true
nature and color of the product is visible to the consumer.
(ii) Packages for sliced bacon that have a transparent opening shall
be designed to expose, for viewing, the cut surface of a representative
slice. Packages for sliced bacon which meet the following specifications
will be accepted as meeting the requirements of this subparagraph
provided the enclosed bacon is positioned so that the cut surface of the
representative slice can be visually examined:
(a) For shingle-packed sliced bacon, the transparent window shall be
designed to reveal at least 70 percent of the length (longest dimension)
of the representative slice, and this window shall be at least 1\1/2\
inches wide. The transparent window shall be located not more than five-
eighths inch from the top or bottom edge of a 1-pound or smaller package
and not more than three-fourths inch from either the top or bottom edge
of a package larger than 1 pound.
(b) For stack-packed sliced bacon, the transparent window shall be
designed to reveal at least 70 percent of the length (longest dimension)
of the representative slice and be at least 1\1/2\ inches wide.
(6) The word "fresh" shall not be used on labels to designate
product which contains any sodium nitrate, sodium nitrite, potassium
nitrate, or potassium nitrite, or which has been salted for
preservation.
(7)(i) No ingredient shall be designated on the label as a spice,
flavoring, or coloring unless it is a spice, flavoring, or coloring, as
the case may be. An ingredient that is both a spice and a coloring, or
both a flavoring and a coloring, shall be designated as
[[Page 169]]
"spice and coloring", or "flavoring and coloring", as the case may
be, unless such ingredient is designated by its common or usual name.
(ii) Any ingredient not designated in Sec. 317.2(f)(1)(i) of this
part whose function is flavoring, either in whole or in part, must be
designated by its common or usual name. Those ingredients which are of
livestock and poultry origin must be designated by names that include
the species and livestock and poultry tissues from which the ingredients
are derived.
(8) As used on labels of product, the term "gelatin" shall mean
(i) the jelly prepared in official establishments by cooking pork skins,
tendons, or connective tissue from inspected and passed product, and
(ii) dry commercial gelatin or the jelly resulting from its use.
(9) Product (other than canned product) labeled with the term
"loaf" as part of its name:
(i) If distributed from the official establishment in consumer size
containers may be in any shape;
(ii) If distributed in a container of a size larger than that sold
intact at retail the product shall be prepared in rectangular form, or
as in paragraph (b)(9)(iii) of this section;
(iii) If labeled as an "Old Fashioned Loaf" shall be prepared in a
traditional form, such as rectangular with rounded top or circular with
flat bottom and rounded top.
(10) The term "baked" shall apply only to product which has been
cooked by the direct action of dry heat and for a sufficient time to
permit the product to assume the characteristics of a baked article,
such as the formation of a brown crust on the surface, rendering out of
surface fat, and the caramelization of the sugar if applied. Baked
loaves shall be heated to a temperature of at least 160 deg.F. and
baked pork cuts shall be heated to an internal temperature of at least
170 deg.F.
(11) When products such as loaves are browned by dipping in hot
edible oil or by a flame, the label shall state such fact, e.g., by the
words "Browned in Hot Cottonseed Oil" or "Browned by a Flame," as
the case may be, appearing as part of the product name.
(12) The term "meat" and the names of particular kinds of meat,
such as beef, veal, mutton, lamb, and pork, shall not be used in such
manner as to be false or misleading.
(13) The word "ham," without any prefix indicating the species of
animal from which derived, shall be used in labeling only in connection
with the hind legs of swine. Ham shanks as such or ham shank meat as
such or the trimmings accruing in the trimming and shaping of hams shall
not be labeled "ham" or "ham meat" without qualification. When used
in connection with a chopped product the term "ham" or "ham meat"
shall not include the skin.
(14) The terms "shankless" and "hockless" shall apply only to
hams and pork shoulders from which the shank or hock has been completely
removed, thus eliminating the entire tibia and fibula, or radius and
ulna, respectively, together with the overlying muscle, skin, and other
tissue.
(15) Such terms as "meat extract" or "extract of beef" without
qualification shall not be used on labels in connection with products
prepared from organs or other parts of the carcass, other than fresh
meat. Extracts prepared from any parts of the carcass other than fresh
meat may be properly labeled as extracts with the true name of the parts
from which prepared. In the case of extract in fluid form, the word
"fluid" shall also appear on the label, as, for example, "fluid
extract of beef."
(16) [Reserved]
(17) When any product is enclosed in a container along with a
packing substance such as brine, vinegar, or agar jelly, a declaration
of the packing substance shall be printed prominently on the label as
part of the name of the product, as for example, "frankfurts packed in
brine," "lamb tongue packed in vinegar," or "beef tongue packed in
agar jelly," as the case may be. The packing substance shall not be
used in such a manner as will result in the container being so filled as
to be misleading.
(18) "Leaf lard" is lard prepared from fresh leaf fat.
(19) When lard or hardened lard is mixed with rendered pork fat or
hardened rendered pork fat, the mixture
[[Page 170]]
shall be designated as "rendered pork fat" or "hardened rendered pork
fat," as the case may be.
(20) Oil, stearin, or stock obtained from beef or mutton fats
rendered at a temperature above 170 deg.F. shall not be designated as
"oleo oil," "oleo stearin," or "oleo stock," respectively.
(21) When not more than 20 percent of beef fat, mutton fat, oleo
stearin, vegetable stearin, or hardened vegetable fat is mixed with lard
or with rendered pork fat, there shall appear on the label, contiguous
to and in the same size and style of lettering as the name of the
product, the words "beef fat added," "mutton fat added," "oleo
stearin added," "vegetable stearin added," or "hardened vegetable
fat added," as the case may be. If more than 20 percent is added, the
product name shall refer to the particular animal fat or fats used, such
as, "Lard and Beef Fat." The designation "vegetable fat" is
applicable to vegetable oil, vegetable stearin, or a combination of such
oil and stearin, whereas the designations "vegetable oil" and
"vegetable stearin" shall be applicable only to the oil and the
stearin respectively, when used in meat food products.
(22) Cooked, cured, or pickled pigs feet, pigs knuckles, and similar
products, shall be labeled to show that the bones remain in the product,
if such is the case. The designation "semi-boneless" shall not be used
if less than 50 percent of the total weight of bones has been removed.
(23) When monoglycerides, diglycerides, and/or polyglycerol esters
of fatty acids are added to rendered animal fat or a combination of such
fat and vegetable fat, there shall appear on the label in a prominent
manner and contiguous to the name of the product a statement such as
"With Monoglycerides and Diglycerides Added," or "With Diglycerides
and Monoglycerides," or "With Polyglycerol Esters of Fatty Acids" as
the case may be.
(24) Section 407 of the Federal Food, Drug, and Cosmetic Act
contains provisions with respect to colored margarine or colored
oleomargarine (21 U.S.C. 347) which are set forth herein as footnote.
\1\
---------------------------------------------------------------------------
\1\ "Sec. 407(a) Colored oleomargarine or colored margarine which
is sold in the same State or Territory in which it is produced shall be
subject in the same manner and to the same extent to the provisions of
this Act as if it had been introduced in interstate commerce.
(b) No person shall sell, or offer for sale, colored oleomargarine
or colored margarine unless--
(1) Such oleomargarine or margarine is packaged,
(2) The net weight of the contents of any package sold in a retail
establishment is one pound or less,
(3) There appears on the label of the package (A) The word
`oleomargarine' or `margarine' in type or lettering at least as large as
any other type or lettering on such label, and (B) A full and accurate
statement of all the ingredients contained in such oleomargarine, or
margarine, and
(4) Each part of the contents of the package is contained in a
wrapper which bears the word `oleomargarine' or `margarine' in type or
lettering not smaller than 20-point type.
The requirements of this subsection shall be in addition to and not
in lieu of any of the other requirements of this Act.
(c) No person shall possess in a form ready for serving colored
oleomargarine or colored margarine at a public eating place unless a
notice that oleomargarine or margarine is served is displayed
prominently and conspicuously in such place and in such manner as to
render it likely to be read and understood by the ordinary individual
being served in such eating place or is printed or is otherwise set
forth on the menu in type or lettering not smaller than that normally
used to designate the serving of other food items. No person shall serve
colored oleomargarine or colored margarine at a public eating place,
whether or not any charge is made therefor, unless (1) each separate
serving bears or is accompanied by labeling identifying it as
oleomargarine or margarine, or (2) each separate serving thereof is
triangular in shape.
(d) Colored oleomargarine or colored margarine when served with
meals at a public eating place shall at the time of such service be
exempt from the labeling requirements of section 343 of this Act (except
subsection (a) and (f) of section 343 of this title) if it complies with
the requirements of subsection (b) of this section.
(e) For the purpose of this section colored oleomargarine or colored
margarine is oleomargarine or margarine having a tint or shade
containing more than one and six tenths degrees of yellow or of yellow
and red collectively, but with an excess of yellow over red, measured in
terms of Lovibond tintometer scale or its equivalent" (21 U.S.C. 347).
---------------------------------------------------------------------------
[[Page 171]]
(25) When approved proteolytic enzymes as permitted in part 318 of
this subchapter are used on steaks or other raw meat cuts, there shall
appear on the label, in a prominent manner, contiguous to the product
name, the statement, "Tenderized with [approved enzyme]," to indicate
the use of such enzymes. Any other approved substance which may be used
in the solution shall also be included in the statement.
When approved inorganic chlorides as permitted in part 318 of this
subchapter are used on steaks or other raw meat cuts there shall appear
on the label in a prominent manner, contiguous to the product name, the
statement, "Tenderized with (names of approved inorganic chloride(s))"
to indicate the use of such inorganic chlorides. Any other approved
substance which may be in the solution shall also be included in the
statement.
(26) When dimethylpolysiloxan is added as an antifoaming agent to
rendered fats, its presence shall be declared on the label contiguous to
the name of the product. Such declaration shall read
"Dimethylpolysiloxan Added."
(27) When pizzas are formulated with crust containing calcium
propionate or sodium propionate, there shall appear on the label
contiguous to the name of the product the statement "-------- added to
retard spoilage of crust" preceded by the name of the preservative.
(28) Sausage of the dry varieties treated with potassium sorbate or
propylparaben (propyl p-hydroxybenzoate) as permitted by part 318 of
this subchapter, shall be marked or labeled with a statement disclosing
such treatment and the purpose thereof, such as "dipped in a potassium
sorbate solution to retard mold growth."
(29) Meat of goats shall be identified as goat meat or chevon.
(30) The term "Chitterlings" shall apply to the large intestines
of swine, or young bovine animals when preceded with the word "Calf"
or "Veal." Meat food products that contain chitterlings or calf or
veal chitterlings, in accordance with Sec. 318.6(b)(8) of this
subchapter shall be identified with product names that refer to such
ingredients, as for instance, "Chitterling Loaf," "Chitterling Pie,"
or "Calf Chitterlings and Gravy," and shall be packed in containers
having a capacity of 3 pounds or less and of a kind usually sold at
retail intact and bearing such other information as is required by this
part.
(31) Products that contain blood from livestock as permitted by part
318 of this subchapter shall be labeled with a name that includes the
term "blood," and the specific kind of blood shall be declared in the
ingredient statement, e.g., "Swine blood," in the manner required by
this part.
(32) A calendar date may be shown on labeling when declared in
accordance with the provisions of this subparagraph:
(i) The calendar date shall express the month of the year and the
day of the month for all products and also the year in the case of
products hermetically sealed in metal or glass containers, dried or
frozen products, or any other products that the Administrator finds
should be labeled with the year because the distribution and marketing
practices with respect to such products may cause a label without a year
identification to be misleading.
(ii) Immediately adjacent to the calendar date shall be a phrase
explaining the meaning of such date, in terms of "packing" date,
"sell by" date, or "use before" date, with or without a further
qualifying phrase, e.g., "For Maximum Freshness" or "For Best
Quality", and such phrases shall be approved by the Administrator as
prescribed in Sec. 317.4.
(33) [Reserved]
(34) The terms "All," "Pure," "100%," and terms of similar
connotation shall not be used on labels for products to identify
ingredient content, unless the product is prepared solely from a single
ingredient.
(35) When agar-agar is used in canned jellied meat food products, as
permitted in part 318 of this subchapter, there shall appear on the
label in a prominent manner, contiguous to the product name, a statement
to indicate the use of agar-agar.
[[Page 172]]
(36) When sodium alginate, calcium carbonate, and lactic acid and
calcium carbonate (or glucono delta-lactone) are used together in a dry
binding matrix in restructured, formed meat food products, as permitted
in part 318 of this subchapter, there shall appear on the label
contiguous to the product name, a statement to indicate the use of
sodium alginate, calcium carbonate and lactic acid and calcium carbonate
(or glucono delta-lactone).
(37) The labels of sausages encased in natural casings made from
meat or poultry viscera shall identify the type of meat or poultry from
which the casings were derived, if the casings are from a different type
of meat or poultry than the encased meat or poultry. The identity of the
casing, if required, may be placed on the principal display panel or in
the ingredient statement. Establishments producing, manufacturing, or
using natural sausage casings are to maintain records documenting the
meat or poultry source in accordance with part 320 of this chapter.
(38) The labels of sausages encased in regenerated collagen casings
shall disclose this fact on the product label. The fact that the sausage
is encased in collagen may be placed on the principal display panel or
in the ingredient statement.
(39) When transglutaminase enzyme is used to bind pieces of meat to
form a cut of meat, or to reform a piece of meat from a multiple cuts,
there shall appear on the label, as part of the product name, a
statement that indicates that the product has been "formed" or
"reformed," in addition to other preparation steps, e.g., "Formed
Beef Tenderloin" or "Reformed and Shaped Beef Tenderloin."
[35 FR 15580, Oct. 3, 1970]
Editorial Note: For Federal Register citations affecting Sec. 317.8,
see the List of CFR Sections Affected, which appears in the Finding Aids
section of the printed volume and on GPO Access.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.9]
[Page 172]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart A--General
Sec. 317.9 Labeling of equine products.
The immediate containers of any equine products shall be labeled to
show the kinds of animals from which derived when the products are sold,
transported, offered for sale or transportation or received for
transportation in commerce.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.10]
[Page 172]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart A--General
Sec. 317.10 Reuse of official inspection marks; reuse of containers bearing official marks, labels, etc.
(a) No official inspection legend or other official mark which has
been previously used shall be used again for the identification of any
product, except as provided for in paragraph (b) of this section.
(b) All stencils, marks, labels, or other labeling on previously
used containers, whether relating to any product or otherwise, shall be
removed or obliterated before such containers are used for any product,
unless such labeling correctly indicates the product to be packed
therein and such containers are refilled under the supervision of a
Program employee.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.11]
[Page 172]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart A--General
Sec. 317.11 Labeling, filling of containers, handling of labeled products to be only in compliance with regulations.
(a) No person shall in any official establishment apply or affix, or
cause to be applied or affixed, any label to any product prepared or
received in such establishment, or to any container thereof, or fill any
container at such an establishment, except in compliance with the
regulations in this subchapter.
(b) No covering or other container shall be filled, in whole or in
part, at any official establishment with any product unless it has been
inspected and passed in compliance with the regulations in this
subchapter, is not adulterated, and is strictly in accordance with the
statements on the label, and such filling is done under the supervision
of a Program employee.
(c) No person shall remove, or cause to be removed from an official
establishment any product bearing a label unless such label is in
compliance with the regulations in this subchapter, or any product not
bearing a label required by such regulations.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.12]
[Page 172-173]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart A--General
Sec. 317.12 Relabeling products; requirements.
When it is claimed by an official establishment that any of its
products which bore labels bearing official
[[Page 173]]
marks has been transported to a location other than an official
establishment, and it is desired to relabel the product because the
labels have become mutilated or otherwise damaged, a request for
relabeling the product shall be sent to the Administrator, accompanied
with a statement of the reasons therefor. Labeling material intended for
relabeling inspected and passed product shall not be transported from an
official establishment until permission has been received from the
Administrator. The relabeling of inspected and passed product with
labels bearing any official marks shall be done under the supervision of
a Program inspector. The official establishment shall reimburse the
Program, in accordance with the regulations of the Department, for any
cost involved in supervising the relabeling of such product.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.13]
[Page 173]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart A--General
Sec. 317.13 Storage and distribution of labels and containers bearing official marks.
Labels, wrappers, and containers bearing any official marks, with or
without the establishment number, may be transported from one official
establishment to any other official establishment provided such
shipments are made with the prior authorization of the inspector in
charge at point of origin, who will notify the inspector in charge at
destination concerning the date of shipment, quantity, and type of
labeling material involved. No such material shall be used at the
establishment to which it is shipped unless such use conforms with the
requirements of this subchapter.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.16]
[Page 173]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart A--General
Sec. 317.16 Labeling and containers of custom prepared products.
Products that are custom prepared under Sec. 303.1(a)(2) of this
subchapter must be packaged immediately after preparation and must be
labeled (in lieu of information otherwise required by this part 317)
with the words "Not For Sale" in lettering not less than three-eighth
inch in height. Such exempted custom prepared products or their
containers may bear additional labeling provided such labeling is not
false or misleading.
[37 FR 4071, Feb. 26, 1972]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.17]
[Page 173-174]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart A--General
Sec. 317.17 Interpretation and statement of labeling policy for cured products; special labeling requirements concerning nitrate and nitrite.
(a) With respect to sections 1(n) (7), (9), and (12) of the Act and
Sec. 317.2, any substance mixed with another substance to cure a product
must be identified in the ingredients statement on the label of such
product. For example, curing mixtures composed of such ingredients as
water, salt, sugar, sodium phosphate, sodium nitrate, and sodium nitrite
or other permitted substances which are added to any product, must be
identified on the label of the product by listing each such ingredient
in accordance with the provisions of Sec. 317.2.
(b) Any product, such as bacon and pepperoni, which is required to
be labeled by a common or usual name or descriptive name in accordance
with Sec. 317.2(c)(1) and to which nitrate or nitrite is permitted or
required to be added may be prepared without nitrate or nitrite and
labeled with such common or usual name or descriptive name when
immediately preceded with the term "Uncured" as part of the product
name in the same size and style of lettering as the product name,
provided that the product is found by the Administrator to be similar in
size, flavor, consistency, and general appearance to such product as
commonly prepared with nitrate or nitrite, or both.
(c)(1) Products described in paragraph (b) of this section or
Sec. 319.2 of this subchapter, which contain no nitrate or nitrite shall
bear the statement "No Nitrate or Nitrite Added." This statement shall
be adjacent to the product name in lettering of easily readable style
and at least one-half the size of the product name.
(2) Products described in paragraph (b) of this section and
Sec. 319.2 of this subchapter shall bear, adjacent to the product name
in lettering of easily readable style and at least one-half the
[[Page 174]]
size of the product name, the statement "Not Preserved--Keep
Refrigerated Below 40 deg.F. At All Times" unless they have been
thermally processed to Fo 3 or more; they have been fermented
or pickled to pH of 4.6 or less; or they have been dried to a water
activity of 0.92 or less.
(3) Products described in paragraph (b) of this section and
Sec. 319.2 of this subchapter shall not be subject to the labeling
requirements of paragraphs (b) and (c) of this section if they contain
an amount of salt sufficient to achieve a brine concentration of 10
percent or more.
[37 FR 16863, Aug. 22, 1972, as amended at 44 FR 48961, Aug. 21, 1979]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.18]
[Page 174]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart A--General
Sec. 317.18 Quantity of contents labeling.
Sections 317.18 through 317.22 of this part prescribe the procedures
to be followed for determining net weight compliance and prescribe the
reasonable variations from the declared net weight on the labels of
immediate containers of products in accordance with Sec. 317.2(h) of
this part.
[55 FR 49834, Nov. 30, 1990]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.19]
[Page 174-175]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart A--General
Sec. 317.19 Definitions and procedures for determining net weight compliance.
(a) For the purpose of Secs. 317.18 through 317.22 of this part, the
reasonable variations allowed, definitions, and procedures to be used in
determining net weight and net weight compliance are described in the
National Institute of Standards and Technology (NIST) Handbook 133,
"Checking the Net Contents of Packaged Goods," Third Edition,
September 1988, and Supplements 1, 2, 3, and 4 dated September 1990,
October 1991, October 1992, and October 1994, respectively, which are
incorporated by reference, with the exception of the NIST Handbook 133
and Supplements 1, 3, and 4 requirements listed in paragraphs (b) and
(c) of this section. Those provisions incorporated by reference herein,
are considered mandatory requirements. This incorporation was approved
by the Director of the Federal Register in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. (These materials are incorporated as they
exist on the date of approval.) A notice of any change in the Handbook
cited herein will be published in the Federal Register. Copies may be
purchased from the Superintendent of Documents, U.S. Government Printing
Office, Washington, DC 20402. It is also available for inspection at the
Office of the Federal Register Information Center, 800 North Capitol
Street NW., suite 700, Washington, DC 20408.
(b) The following NBS Handbook 133 requirements are not incorporated
by reference.
Chapter 2--General Considerations
2.13.1 Polyethylene Sheeting and Film
2.13.2 Textiles
2.13.3 Mulch
Chapter 3--Methods of Test for Packages Labeled by Weight
3.11. Aerosol Packages
3.14. Glazed Raw Seafood and Fish
3.15. Canned Coffee
3.16. Borax
3.17. Flour
Chapter 4--Methods of Test for Packages Labeled by Volume
4.7. Milk
4.8. Mayonnaise and Salad Dressing
4.9. Paint, Varnish, and Lacquers--Nonaerosol
4.11. Peat Moss
4.12. Bark Mulch
4.15. Ice Cream Novelties
Chapter 5--Methods of Test for Packages Labeled by Count, Length, Area,
Thickness, or Combinations of Quantities
5.4. Polyethylene Sheeting
5.5. Paper Plates
5.6. Sanitary Paper Products
5.7. Pressed and Blown Glass Tumblers and Stemware
Appendix D: Package Net Contents Regulations
D.1.1. U.S. Department of Health and Human Services, Food and Drug
Administration
D.1.2. Department of Agriculture, Food Safety and Inspection Service
D.1.3. Federal Trade Commission
D.1.4. Environmental Protection Agency
D.1.5. U.S. Department of the Treasury, Bureau of Alcohol, Tobacco, and
Firearms
(c) The following requirements of Supplement 1, dated September
1990, Supplement 3, dated October 1992, and Supplement 4, dated 1994, of
NIST Handbook 133 are not incorporated by reference.
[[Page 175]]
Supplement 1
Chapter 2 General Considerations
2.13.1. Polyethylene Sheeting and Film
2.13.2. Textiles
2.13.3. Mulch
Chapter 3 Methods of Test for Packages Labeled by Weight
3.11.4. Exhausting the Aerosol Container
Chapter 4 Methods of Test for Packages Labeled by Volume
4.6.4. Method D: Determining the Net Contents of Compressed Gas in
Cylinders
4.7. Milk
4.16. Fresh Oysters Labeled by Volume
Chapter 5 Methods of Test for Packages Labeled by Count, Length, Area,
Thickness, or Combinations of Quantities
5.4. Polyethylene Sheeting
Supplement 3
Chapter 3 Methods of Test for Packages Labeled by Weight
3.17. Flour and Dry Pet Food
Chapter 5 Methods of Test for Packages Labeled by Count, Length, Area,
Thickness, or Combination of Quantities
5.4. Polyethylene Sheeting
5.5. Paper Plates
5.8. Baler Twine
Appendix A. Forms and Worksheets
Supplement 4
3.11 Aerosol Packages
3.11.1 Equipment
3.11.2 Preparation for Test
3.11.3 The Determination of Net Contents: Part 1
3.11.4 Exhausting the Aerosol Container
3.11.5 The Determination of Net Contents: Part 2
Appendix A. Report Forms
[55 FR 49834, Nov. 30, 1990, as amended at 60 FR 12884, March 9, 1995]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.20]
[Page 175]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart A--General
Sec. 317.20 Scale requirements for accurate weights, repairs, adjustments, and replacement after inspection.
(a) All scales used to weigh meat products sold or otherwise
distributed in commerce in federally inspected meat establishments shall
be installed, maintained and operated to insure accurate weights. Such
scales shall meet the applicable requirements contained in National
Institute of Standards and Technology Handbook 44, "Specifications,
Tolerances, and Other Technical Requirements for Weighing and Measuring
Devices", 1999 Edition, November 1998, which is incorporated by
reference. This incorporation was approved by the Director of the
Federal Register in accordance with 5 U.S.C.. 552(a) and 1 CFR part 51.
(These materials are incorporated as they exist on the date of
approval.) Copies may be purchased from the Superintendent of Documents,
U.S. Government Printing Office, Washington, DC 20402. It is also
available for inspection at the Office of the Federal Register
Information Center, 800 North Capitol Street NW., suite 700, Washington,
DC 20408.
(b) All scales used to weigh meat products sold or otherwise
distributed in commerce or in States designated under section 301(c) of
the Federal Meat Inspection Act, shall be of sufficient capacity to
weigh the entire unit and/or package.
(c) No scale shall be used at a federally inspected establishment to
weigh meat products unless it has been found upon test and inspection,
as specified in NIST Handbook 44, to provide accurate weight. If a scale
is reinspected or retested and found to be inaccurate, or if any
repairs, adjustments or replacements are made to a scale, it shall not
be used until it has been inspected and tested by a USDA official, or a
State or local government weights and measures official, or State
registered or licensed scale repair firm or person, and it must meet all
accuracy requirements as specified in NIST Handbook 44. If a USDA
inspector has put a retain tag on a scale it can only be removed by a
USDA inspector. As long as the tag is on the scale, it shall not be
used.
[55 FR 49834, Nov. 30, 1990, as amended at 60 FR 12884, Mar. 9, 1995; 64
FR 53187, Oct. 1, 1999]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.21]
[Page 175-176]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart A--General
Sec. 317.21 Scales: testing of.
(a) The operator of each official establishment that weighs meat
food products shall cause such scales to be tested for accuracy, in
accordance with the technical requirements of NIST Handbook 44, at least
once during the calendar year. In cases where the scales are found not
to maintain accuracy between tests, more frequent tests may be required
and monitored by an authorized USDA program official.
[[Page 176]]
(b) The operator of each official establishment shall display on or
near each scale a valid certification of the scale's accuracy from a
State or local government's weights and measures authority or from a
State registered or licensed scale repair firm or person, or shall have
alternative documented procedures showing that the scale has been tested
for accuracy in accordance with the requirements of NIST Handbook 44.
[55 FR 49834, Nov. 30, 1990, as amended at 62 FR 45024, Aug. 25, 1997;
65 FR 34389, May 30, 2000; 66 FR 52486, Oct. 16, 2001]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.22]
[Page 176]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart A--General
Sec. 317.22 Handling of failed product.
Any lot of product which is found to be out of compliance with net
weight requirements upon testing in accordance with Sec. 317.19 shall be
handled as follows:
(a) A lot tested in an official establishment and found not to
comply with net weight requirements may be reprocessed and must be
reweighed and remarked to satisfy the net weight requirements of this
section and be reinspected, in accordance with the requirements of this
part.
(b) A lot tested outside of an official establishment and found not
to comply with net weight requirements must be reweighed and remarked
with a proper net weight statement, provided that such reweighing and
remarking shall not deface, cover, or destroy any other marking or
labeling required under this subchapter and the net quantity of contents
is shown with the same prominence as the most conspicuous feature of a
label.
[55 FR 49834, Nov. 30, 1990]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.24]
[Page 176-177]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart A--General
Sec. 317.24 Packaging materials.
(a) Edible products may not be packaged in a container which is
composed in whole or in part of any poisonous or deleterious substances
which may render the contents adulterated or injurious to health. All
packaging materials must be safe for their intended use within the
meaning of section 409 of the Federal Food, Drug, and Cosmetic Act, as
amended (FFDCA).
(b) Packaging materials entering the official establishment must be
accompanied or covered by a guaranty, or statement of assurance, from
the packaging supplier under whose brand name and firm name the material
is marketed to the official establishment. The guaranty shall state that
the material's intended use complies with the FFDCA and all applicable
food additive regulations. The guaranty must identify the material,
e.g., by the distinguishing brand name or code designation appearing on
the packaging material shipping container; must specify the applicable
conditions of use, including temperature limits and any other pertinent
limits specified under the FFDCA and food additive regulations; and must
be signed by an authorized official of the supplying firm. The guaranty
may be limited to a specific shipment of an article, in which case it
may be part of or attached to the invoice covering such shipment, or it
may be general and continuing, in which case, in its application to any
article or other shipment of an article, it shall be considered to have
been given at the date such article was shipped by the person who gives
the guaranty. Guaranties consistent with the Food and Drug
Administration's regulations regarding such guaranties (21 CFR 7.12 and
7.13) will be acceptable. The management of the establishment must
maintain a file containing guaranties for all food contact packaging
materials in the establishment. The file shall be made available to
Program inspectors or other Department officials upon request. While in
the official establishment, the identity of all packaging materials must
be traceable to the applicable guaranty.
(c) The guaranty by the packaging supplier will be accepted by
Program inspectors to establish that the use of material complies with
the FFDCA and all applicable food additive regulations.
(d) The Department will mmnitor the use of packaging material in
official establishments to assure that the requirements of paragraph (a)
of this section are met, and may question the basis for any guaranty
described under paragraph (b) of this section. Official establishments
and packaging suppliers providing written guaranties to those official
establishments will be
[[Page 177]]
permitted an opportunity to provide information tm designated Department
officials as needed to verify the basis for any such guaranty. The
required information will include, but is not limited to, manufacturing
firm's name, trade name or code designation for the material, complete
chemical composition, and use. Selection of a material for review does
not in itself affect a material's acceptability. Materials may continue
to be used during the review period. However, if information requested
from the supplier is not provided within the time indicated in the
request--a minimum of 30 days--any applicable guaranty shall cease to be
effective, and approval to continue using the specified packaging
material in official establishments may be denied. The Administrator may
extend this time where reasonable grounds for extension are shown, as,
for example, where data must be obtained from suppliers.
(e) The Administrator may disapprove for use in official
establishmelts packaging materials whose use cannot be confirmed as
complying with FFDCA and applicable food additive regulations. Before
approval to use a packaging material is finally denied by the
Administrator, the affected official establishment and the supplier of
the material shall be given notice and the opportunity to present their
views to the Administrator. If the official establishment and the
supplier do not accept the Administrator's determination, a hearing in
accordance with applicable rules of practice will be held to resolve
such dispute. Approval to use the materials pending the outcome of the
presentation of views or hearing shall be denied if the Administrator
determines that such use may present an imminent hazard to public
health.
(f) Periodically, the Administrator will issue to inspectors a
listing, by distinguishing brand name or code designation, of packaging
materials that have been reviewed and that fail to meet the requirements
of paragraph (a) of this section. Listed materials will not be permitted
for use in official establishments. If a subsequent review of any
material indicates that it meets the requirements of paragraph (a), the
material will be deleted from the listing.
(g) Nothing in this section shall affect the authority of Program
inspectors to refuse a specific material if he/she determines the
material may render products adulterated or injurious to health.
[49 FR 2235, Jan. 19, 1984. Redesignated at 55 FR 49833, Nov. 30, 1990]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.300]
[Page 177]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart B--Nutrition Labeling
Sec. 317.300 Nutrition labeling of meat or meat food products.
Source: 58 FR 664, Jan. 6, 1993, unless otherwise noted.
(a) Nutrition labeling shall be provided for all meat or meat food
products intended for human consumption and offered for sale, except
single-ingredient, raw products, in accordance with the requirements of
Sec. 317.309; except as exempted under Sec. 317.400 of this subpart.
(b) Nutrition labeling may be provided for single-ingredient, raw
meat or meat food products in accordance with the requirements of
Secs. 317.309 and 317.345. Significant participation in voluntary
nutrition labeling shall be measured by the Agency in accordance with
Secs. 317.343 and 317.344 of this subpart.
[58 FR 664, Jan. 6, 1993, as amended at 60 FR 176, Jan. 3, 1995]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.302]
[Page 177-178]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart B--Nutrition Labeling
Sec. 317.302 Location of nutrition information.
(a) Nutrition information on a label of a packaged meat or meat food
product shall appear on the label's principal display panel or on the
information panel, except as provided in paragraphs (b) and (c) of this
section.
(b) Nutrition information for gift packs may be shown at a location
other than on the product label, provided that the labels for these
products bear no nutrition claim. In lieu of on the product label,
nutrition information may be provided by alternate means such as product
label inserts.
(c) Meat or meat food products in packages that have a total surface
area
[[Page 178]]
available to bear labeling greater than 40 square inches but whose
principal display panel and information panel do not provide sufficient
space to accommodate all required information may use any alternate
panel that can be readily seen by consumers for the nutrition
information. In determining the sufficiency of available space for the
nutrition information, the space needed for vignettes, designs, and
other nonmandatory label information on the principal display panel may
be considered.
[58 FR 664, Jan. 6, 1993, as amended at 59 FR 40213, Aug. 8, 1994; 60 FR
176, Jan. 3, 1995]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.308]
[Page 178]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart B--Nutrition Labeling
Sec. 317.308 Labeling of meat or meat food products with number of servings.
The label of any package of a meat or meat food product that bears a
representation as to the number of servings contained in such package
shall meet the requirements of Sec. 317.2(h)(10).
[58 FR 664, Jan. 6, 1993, as amended at 60 FR 176, Jan. 3, 1995]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.309]
[Page 178-197]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart B--Nutrition Labeling
Sec. 317.309 Nutrition label content.
(a) All nutrient and food component quantities shall be declared in
relation to a serving as defined in this section.
(b)(1) The term "serving" or "serving size" means an amount of
food customarily consumed per eating occasion by persons 4 years of age
or older, which is expressed in a common household measure that is
appropriate to the product. When the product is specially formulated or
processed for use by infants or by toddlers, a serving or serving size
means an amount of food customarily consumed per eating occasion by
infants up to 12 months of age or by children 1 through 3 years of age,
respectively.
(2) Except as provided in paragraphs (b)(8), (b)(12), and (b)(14) of
this section and for products that are intended for weight control and
are available only through a weight-control or weight-maintenance
program, serving size declared on a product label shall be determined
from the "Reference Amounts Customarily Consumed Per Eating Occasion--
General Food Supply" (Reference Amount(s)) that appear in
Sec. 317.312(b) using the procedures described in this paragraph (b).
For products that are both intended for weight control and available
only through a weight-control program, a manufacturer may determine the
serving size that is consistent with the meal plan of the program. Such
products must bear a statement, "for sale only through the ------
program" (fill in the blank with the name of the appropriate weight-
control program, e.g., Smith's Weight Control), on the principal display
panel. However, the Reference Amounts in Sec. 317.312(b) shall be used
for purposes of evaluating whether weight-control products that are
available only through a weight-control program qualify for nutrition
claims.
(3) The declaration of nutrient and food component content shall be
on the basis of the product "as packaged" for all products, except
that single-ingredient, raw products may be declared on the basis of the
product "as consumed" as set forth in Sec. 317.345(a)(1). In addition
to the required declaration on the basis of "as packaged" for products
other than single-ingredient, raw products, the declaration may also be
made on the basis of "as consumed," provided that preparation and
cooking instructions are clearly stated.
(4) For products in discrete units (e.g., hot dogs, and individually
packaged products within a multi-serving package), and for products
which consist of two or more foods packaged and presented to be consumed
together where the ingredient represented as the main ingredient is in
discrete units (e.g., beef fritters and barbecue sauce), the serving
size shall be declared as follows:
(i) If a unit weighs 50 percent or less of the Reference Amount, the
serving size shall be the number of whole units that most closely
approximates the Reference Amount for the product category.
(ii) If a unit weighs more than 50 percent but less than 67 percent
of the Reference Amount, the manufacturer may declare one unit or two
units as the serving size.
(iii) If a unit weighs 67 percent or more but less than 200 percent
of the
[[Page 179]]
Reference Amount, the serving size shall be one unit.
(iv) If a unit weighs 200 percent or more of the Reference Amount,
the manufacturer may declare one unit as the serving size if the whole
unit can reasonably be consumed at a single eating occasion.
(v) For products that have Reference Amounts of 100 grams (or
milliliter) or larger and are individual units within a multi-serving
package, if a unit contains more than 150 percent but less than 200
percent of the Reference Amount, the manufacturer may decide whether to
declare the individual unit as 1 or 2 servings.
(vi) For products which consist of two or more foods packaged and
presented to be consumed together where the ingredient represented as
the main ingredient is in discrete units (e.g., beef fritters and
barbecue sauce), the serving size may be the number of discrete units
represented as the main ingredient plus proportioned minor ingredients
used to make the Reference Amount for the combined product as determined
in Sec. 317.312(c).
(vii) For packages containing several individual single-serving
containers, each of which is labeled with all required information
including nutrition labeling as specified in this section (i.e., are
labeled appropriately for individual sale as single-serving containers),
the serving size shall be 1 unit.
(5) For products in large discrete units that are usually divided
for consumption (e.g., pizza), for unprepared products where the entire
contents of the package is used to prepare large discrete units that are
usually divided for consumption (e.g. pizza kit), and for products which
consist of two or more foods packaged and presented to be consumed
together where the ingredient represented as the main ingredient is a
large discrete unit usually divided for consumption, the serving size
shall be the fractional slice of the ready-to-eat product (e.g., \1/8\
quiche, \1/4\ pizza) that most closely approximates the Reference Amount
for the product category. The serving size may be the fraction of the
package used to make the Reference Amount for the unprepared product
determined in Sec. 317.312(d) or the fraction of the large discrete unit
represented as the main ingredient plus proportioned minor ingredients
used to make the Reference Amount of the combined product determined in
Sec. 317.312(c). In expressing the fractional slice, manufacturers shall
use \1/2\, \1/3\, \1/4\, \1/5\, \1/6\, or smaller fractions that can be
generated by further division by 2 or 3.
(6) For nondiscrete bulk products (e.g., whole roast beef, marinated
beef tenderloin, large can of chili), and for products which consist of
two or more foods packaged and presented to be consumed together where
the ingredient represented as the main ingredient is a bulk product
(e.g., roast beef and gravy), the serving size shall be the amount in
household measure that most closely approximates the Reference Amount
for the product category and may be the amount of the bulk product
represented as the main ingredient plus proportioned minor ingredients
used to make the Reference Amount for the combined product determined in
Sec. 317.312(c).
(7) For labeling purposes, the term "common household measure" or
"common household unit" means cup, tablespoon, teaspoon, piece, slice,
fraction (e.g., \1/4\ pizza), ounce (oz), or other common household
equipment used to package food products (e.g., jar or tray). In
expressing serving size in household measures, except as specified in
paragraphs (b)(7)(iv), (v), and (vi) of this section, the following
rules shall be used:
(i) Cups, tablespoons, or teaspoons shall be used wherever possible
and appropriate. Cups shall be expressed in \1/4\- or \1/3\-cup
increments, tablespoons in whole number of tablespoons for quantities
less than \1/4\ cup but greater than or equal to 2 tablespoons (tbsp),
1, 1\1/3\, 1\1/2\, or 1 \2/3\ tbsp for quantities less than 2 tbsp but
greater than or equal to 1 tbsp, and teaspoons in whole number of
teaspoons for quantities less than 1 tbsp but greater than or equal to 1
teaspoon (tsp), and in \1/4\-tsp increments for quantities less than 1
tsp.
(ii) If cups, tablespoons or teaspoons are not applicable, units
such as piece, slice, tray, jar, and fraction shall be used.
[[Page 180]]
(iii) If cups, tablespoons and teaspoons, or units such as piece,
slice, tray, jar, or fraction are not applicable, ounces may be used.
Ounce measurements shall be expressed in 0.5-ounce increments most
closely approximating the Reference Amount with rounding indicated by
the use of the term "about" (e.g., about 2.5 ounces).
(iv) A description of the individual container or package shall be
used for single-serving containers and meal-type products and for
individually packaged products within multi-serving containers (e.g.,
can, box, package, meal, or dinner). A description of the individual
unit shall be used for other products in discrete units (e.g., chop,
slice, link, or patty).
(v) For unprepared products where the entire contents of the package
is used to prepare large discrete units that are usually divided for
consumption (e.g., pizza kit), the fraction or portion of the package
may be used.
(vi) For products that consist of two or more distinct ingredients
or components packaged and presented to be consumed together (e.g., ham
with a glaze packet), the nutrition information may be declared for each
component or as a composite. The serving size may be provided in
accordance with the provisions of paragraphs (b)(4), (b)(5), and (b)(6)
of this section.
(vii) For nutrition labeling purposes, a teaspoon means 5
milliliters (mL), a tablespoon means 15 mL, a cup means 240 mL, and 1 oz
in weight means 28 grams (g).
(viii) When a serving size, determined from the Reference Amount in
Sec. 317.312(b) and the procedures described in this section, falls
exactly half way between two serving sizes (e.g., 2.5 tbsp),
manufacturers shall round the serving size up to the next incremental
size.
(8) A product that is packaged and sold individually and that
contains less than 200 percent of the applicable Reference Amount shall
be considered to be a single-serving container, and the entire content
of the product shall be labeled as one serving, except for products that
have Reference Amounts of 100 g (or mL) or larger, manufacturers may
decide whether a package that contains more than 150 percent but less
than 200 percent of the Reference Amount is 1 or 2 servings. Packages
sold individually that contain 200 percent or more of the applicable
Reference Amount may be labeled as a single-serving if the entire
content of the package can reasonably be consumed at a single-eating
occasion.
(9) A label statement regarding a serving shall be the serving size
expressed in common household measures as set forth in paragraphs (b)(2)
through (b)(8) of this section and shall be followed by the equivalent
metric quantity in parenthesis (fluids in milliliters and all other
foods in grams), except for single-serving containers.
(i) For a single-serving container, the parenthetical metric
quantity, which will be presented as part of the net weight statement on
the principal display panel, is not required except where nutrition
information is required on a drained weight basis according to paragraph
(b)(11) of this section. However, if a manufacturer voluntarily provides
the metric quantity on products that can be sold as single-servings,
then the numerical value provided as part of the serving size
declaration must be identical to the metric quantity declaration
provided as part of the net quantity of contents statement.
(ii) The gram or milliliter quantity equivalent to the household
measure should be rounded to the nearest whole number except for
quantities that are less than 5 g (mL). The gram (mL) quantity between 2
and 5 g (mL) should be rounded to the nearest 0.5 g (mL) and the g (mL)
quantity less than 2 g (mL) should be expressed in 0.1-g (mL)
increments.
(iii) In addition, serving size may be declared in ounce, in
parenthesis, following the metric measure separated by a slash where
other common household measures are used as the primary unit for serving
size, e.g., 1 slice (28 g/1 oz) for sliced bologna. The ounce quantity
equivalent to the metric quantity should be expressed in 0.1-oz
increments.
(iv) If a manufacturer elects to use abbreviations for units, the
following abbreviations shall be used: tbsp for tablespoon, tsp for
teaspoon, g for gram, mL for milliliter, and oz for ounce.
[[Page 181]]
(10) Determination of the number of servings per container shall be
based on the serving size of the product determined by following the
procedures described in this section.
(i) The number of servings shall be rounded to the nearest whole
number except for the number of servings between 2 and 5 servings and
random weight products. The number of servings between 2 and 5 servings
shall be rounded to the nearest 0.5 serving. Rounding should be
indicated by the use of the term "about" (e.g., about 2 servings;
about 3.5 servings).
(ii) When the serving size is required to be expressed on a drained
solids basis and the number of servings varies because of a natural
variation in unit size (e.g., pickled pigs feet), the manufacturer may
state the typical number of servings per container (e.g., usually 5
servings).
(iii) For random weight products, a manufacturer may declare
"varied" for the number of servings per container provided the
nutrition information is based on the Reference Amount expressed in
ounces. The manufacturer may provide the typical number of servings in
parenthesis following the "varied" statement (e.g., varied
(approximately 8 servings per pound)).
(iv) For packages containing several individual single-serving
containers, each of which is labeled with all required information
including nutrition labeling as specified in this section (i.e., are
labeled appropriately for individual sale as single-serving containers),
the number of servings shall be the number of individual packages within
the total package.
(v) For packages containing several individually packaged multi-
serving units, the number of servings shall be determined by multiplying
the number of individual multi-serving units in the total package by the
number of servings in each individual unit.
(11) The declaration of nutrient and food component content shall be
on the basis of product as packaged or purchased with the exception of
products that are packed or canned in water, brine, or oil but whose
liquid packing medium is not customarily consumed. Declaration of the
nutrient and food component content of products that are packed in
liquid which is not customarily consumed shall be based on the drained
solids.
(12) Serving size for meal-type products as defined in
Sec. 317.313(l) shall be the entire content (edible portion only) of the
package.
(13) Another column of figures may be used to declare the nutrient
and food component information in the same format as required by
Sec. 317.309(e),
(i) Per 100 grams, 100 milliliters, or 1 ounce of the product as
packaged or purchased.
(ii) Per one unit if the serving size of a product in discrete units
in a multi-serving container is more than one unit.
(14) If a product consists of assortments of meat or meat food
products (e.g., variety packs) in the same package, nutrient content
shall be expressed on the entire package contents or on each individual
product.
(15) If a product is commonly combined with other ingredients or is
cooked or otherwise prepared before eating, and directions for such
combination or preparations are provided, another column of figures may
be used to declare the nutrient contents on the basis of the product as
consumed for the product alone (e.g., a cream soup mix may be labeled
with one set of Daily Values for the dry mix (per serving), and another
set for the serving of the final soup when prepared (e.g., per serving
of cream soup mix and 1 cup of vitamin D fortified whole milk)):
Provided, That the type and quantity of the other ingredients to be
added to the product by the user and the specific method of cooking and
other preparation shall be specified prominently on the label.
(c) The declaration of nutrition information on the label or in
labeling of a meat or meat food product shall contain information about
the level of the following nutrients, except for those nutrients whose
inclusion, and the declaration of amounts, is voluntary as set forth in
this paragraph. No nutrients or food components other than those listed
in this paragraph as either mandatory or voluntary may be included
within the nutrition label. Except as provided for in paragraph (f) or
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(g) of this section, nutrient information shall be presented using the
nutrient names specified and in the following order in the formats
specified in paragraph (d) or (e) of this section.
(1) "Calories, total," "Total calories," or "Calories": A
statement of the caloric content per serving, expressed to the nearest
5-calorie increment up to and including 50 calories, and 10-calorie
increment above 50 calories, except that amounts less than 5 calories
may be expressed as zero. Energy content per serving may also be
expressed in kilojoule units, added in parenthesis immediately following
the statement of the caloric content.
(i) Caloric content may be calculated by the following methods.
Where either specific or general food factors are used, the factors
shall be applied to the actual amount (i.e., before rounding) of food
components (e.g., fat, carbohydrate, protein, or ingredients with
specific food factors) present per serving.
(A) Using specific Atwater factors (i.e., the Atwater method) given
in Table 13, page 25, "Energy Value of Foods--Basis and Derivation,"
by A. L. Merrill and B. K. Watt, United States Department of Agriculture
(USDA), Agriculture Handbook No. 74 (Slightly revised February 1973),
which is incorporated by reference. Table 13 of the "Energy Value of
Foods--Basis and Derivation," Agriculture Handbook No. 74 is
incorporated as it exists on the date of approval. This incorporation by
reference was approved by the Director of the Federal Register in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. It is available for
inspection at the Office of the Federal Register, suite 700, 800 North
Capitol Street, NW., Washington, DC, or at the office of the FSIS Docket
Clerk, Room 3171, South Building, 14th and Independence Avenue, SW.,
Washington, DC. Copies of the incorporation by reference are available
from the Product Assessment Division, Regulatory Programs, Food Safety
and Inspection Service, U.S. Department of Agriculture, Room 329, West
End Court Building, Washington, DC 20250-3700;
(B) Using the general factors of 4, 4, and 9 calories per gram for
protein, total carbohydrate, and total fat, respectively, as described
in USDA's Agriculture Handbook No. 74 (Slightly revised February 1973),
pages 9-11, which is incorporated by reference. Pages 9-11, Agriculture
Handbook No. 74 is incorporated as it exists on the date of approval.
This incorporation by reference was approved by the Director of the
Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.
(The availability of this incorporation by reference is given in
paragraph (c)(1)(i)(A) of this section.);
(C) Using the general factors of 4, 4, and 9 calories per gram for
protein, total carbohydrate less the amount of insoluble dietary fiber,
and total fat, respectively, as described in USDA's Agriculture Handbook
No. 74 (Slightly revised February 1973), pages 9-11, which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. (The availability of this incorporation by reference is given
in paragraph (c)(1)(i)(A) of this section.); or
(D) Using data for specific food factors for particular foods or
ingredients approved by the Food and Drug Administration (FDA) and
provided in parts 172 or 184 of 21 CFR, or by other means, as
appropriate.
(ii) "Calories from fat": A statement of the caloric content
derived from total fat as defined in paragraph (c)(2) of this section
per serving, expressed to the nearest 5-calorie increment, up to and
including 50 calories, and the nearest 10-calorie increment above 50
calories, except that label declaration of "calories from fat" is not
required on products that contain less than 0.5 gram of fat per serving
and amounts less than 5 calories may be expressed as zero. This
statement shall be declared as provided in paragraph (d)(5) of this
section.
(iii) "Calories from saturated fat" or "Calories from saturated"
(VOLUNTARY): A statement of the caloric content derived from saturated
fat as defined in paragraph (c)(2)(i) of this section per serving may be
declared voluntarily, expressed to the nearest 5-calorie increment, up
to and including 50 calories, and the nearest 10-calorie increment above
50 calories, except that amounts less than 5 calories may be expressed
as zero. This statement shall be indented under the statement
[[Page 183]]
of calories from fat as provided in paragraph (d)(5) of this section.
(2) "Fat, total" or "Total fat": A statement of the number of
grams of total fat per serving defined as total lipid fatty acids and
expressed as triglycerides. Amounts shall be expressed to the nearest
0.5 (\1/2\)-gram increment below 5 grams and to the nearest gram
increment above 5 grams. If the serving contains less than 0.5 gram, the
content shall be expressed as zero.
(i) "Saturated fat" or "Saturated": A statement of the number of
grams of saturated fat per serving defined as the sum of all fatty acids
containing no double bonds, except that label declaration of saturated
fat content information is not required for products that contain less
than 0.5 gram of total fat per serving if no claims are made about fat
or cholesterol content, and if "calories from saturated fat" is not
declared. Saturated fat content shall be indented and expressed as grams
per serving to the nearest 0.5 (\1/2\)-gram increment below 5 grams and
to the nearest gram increment above 5 grams. If the serving contains
less than 0.5 gram, the content shall be expressed as zero.
(A) "Stearic Acid" (VOLUNTARY): A statement of the number of grams
of stearic acid per serving may be declared voluntarily, except that
when a claim is made about stearic acid, label declaration shall be
required. Stearic acid content shall be indented under saturated fat and
expressed to the nearest 0.5 (\1/2\)-gram increment below 5 grams and
the nearest gram increment above 5 grams. If the serving contains less
than 0.5 gram, the content shall be expressed as zero.
(B) [Reserved]
(ii) "Polyunsaturated fat" or "Polyunsaturated" (VOLUNTARY): A
statement of the number of grams of polyunsaturated fat per serving
defined as cis,cis-methylene-interrupted polyunsaturated fatty acids may
be declared voluntarily, except that when monounsaturated fat is
declared, or when a claim about fatty acids or cholesterol is made on
the label or in labeling of a product other than one that meets the
criteria in Sec. 317.362(b)(1) for a claim for "fat free," label
declaration of polyunsaturated fat is required. Polyunsaturated fat
content shall be indented and expressed as grams per serving to the
nearest 0.5 (\1/2\)-gram increment below 5 grams and to the nearest gram
increment above 5 grams. If the serving contains less than 0.5 gram, the
content shall be expressed as zero.
(iii) "Monounsaturated fat" or "Monounsaturated" (VOLUNTARY): A
statement of the number of grams of monounsaturated fat per serving
defined as cis-monounsaturated fatty acids may be declared voluntarily,
except that when polyunsaturated fat is declared, or when a claim about
fatty acids or cholesterol is made on the label or in labeling of a
product other than one that meets the criteria in Sec. 317.362(b)(1) for
a claim for "fat free," label declaration of monounsaturated fat is
required. Monounsaturated fat content shall be indented and expressed as
grams per serving to the nearest 0.5 (\1/2\)-gram increment below 5
grams and to the nearest gram increment above 5 grams. If the serving
contains less than 0.5 gram, the content shall be expressed as zero.
(3) "Cholesterol": A statement of the cholesterol content per
serving expressed in milligrams to the nearest 5-milligram increment,
except that label declaration of cholesterol information is not required
for products that contain less than 2 milligrams of cholesterol per
serving and make no claim about fat, fatty acids, or cholesterol
content, or such products may state the cholesterol content as zero. If
the product contains 2 to 5 milligrams of cholesterol per serving, the
content may be stated as "less than 5 milligrams."
(4) "Sodium": A statement of the number of milligrams of sodium
per serving expressed as zero when the serving contains less than 5
milligrams of sodium, to the nearest 5-milligram increment when the
serving contains 5 to 140 milligrams of sodium, and to the nearest 10-
milligram increment when the serving contains greater than 140
milligrams.
(5) "Potassium" (VOLUNTARY): A statement of the number of
milligrams of potassium per serving may be declared voluntarily, except
that when a
[[Page 184]]
claim is made about potassium content, label declaration shall be
required. Potassium content shall be expressed as zero when the serving
contains less than 5 milligrams of potassium, to the nearest 5-milligram
increment when the serving contains 5 to 140 milligrams of potassium,
and to the nearest 10-milligram increment when the serving contains
greater than 140 milligrams.
(6) "Carbohydrate, total" or "Total carbohydrate": A statement
of the number of grams of total carbohydrate per serving expressed to
the nearest gram, except that if a serving contains less than 1 gram,
the statement "Contains less than 1 gram" or "less than 1 gram" may
be used as an alternative, or, if the serving contains less than 0.5
gram, the content may be expressed as zero. Total carbohydrate content
shall be calculated by subtraction of the sum of the crude protein,
total fat, moisture, and ash from the total weight of the product. This
calculation method is described in USDA's Agriculture Handbook No. 74
(Slightly revised February 1973), pages 2 and 3, which is incorporated
by reference. Pages 2 and 3, Agriculture Handbook No. 74 is incorporated
as it exists on the date of approval. This incorporation by reference
was approved by the Director of the Federal Register in accordance with
5 U.S.C. 552(a) and 1 CFR part 51. (The availability of this
incorporation by reference is given in paragraph (c)(1)(i)(A) of this
section.)
(i) "Dietary fiber": A statement of the number of grams of total
dietary fiber per serving, indented and expressed to the nearest gram,
except that if a serving contains less than 1 gram, declaration of
dietary fiber is not required, or, alternatively, the statement
"Contains less than 1 gram" or "less than 1 gram" may be used, and
if the serving contains less than 0.5 gram, the content may be expressed
as zero.
(A) "Soluble fiber" (VOLUNTARY): A statement of the number of
grams of soluble dietary fiber per serving may be declared voluntarily
except when a claim is made on the label or in labeling about soluble
fiber, label declaration shall be required. Soluble fiber content shall
be indented under dietary fiber and expressed to the nearest gram,
except that if a serving contains less than 1 gram, the statement
"Contains less than 1 gram" or "less than 1 gram" may be used as an
alternative, and if the serving contains less than 0.5 gram, the content
may be expressed as zero.
(B) "Insoluble fiber" (VOLUNTARY): A statement of the number of
grams of insoluble dietary fiber per serving may be declared voluntarily
except when a claim is made on the label or in labeling about insoluble
fiber, label declaration shall be required. Insoluble fiber content
shall be indented under dietary fiber and expressed to the nearest gram,
except that if a serving contains less than 1 gram, the statement
"Contains less than 1 gram" or "less than 1 gram" may be used as an
alternative, and if the serving contains less than 0.5 gram, the content
may be expressed as zero.
(ii) "Sugars": A statement of the number of grams of sugars per
serving, except that label declaration of sugars content is not required
for products that contain less than 1 gram of sugars per serving if no
claims are made about sweeteners, sugars, or sugar alcohol content.
Sugars shall be defined as the sum of all free mono- and disaccharides
(such as glucose, fructose, lactose, and sucrose). Sugars content shall
be indented and expressed to the nearest gram, except that if a serving
contains less than 1 gram, the statement "Contains less than 1 gram"
or "less than 1 gram" may be used as an alternative, and if the
serving contains less than 0.5 gram, the content may be expressed as
zero.
(iii) "Sugar alcohol" (VOLUNTARY): A statement of the number of
grams of sugar alcohols per serving may be declared voluntarily on the
label, except that when a claim is made on the label or in labeling
about sugar alcohol or sugars when sugar alcohols are present in the
product, sugar alcohol content shall be declared. For nutrition labeling
purposes, sugar alcohols are defined as the sum of saccharide
derivatives in which a hydroxyl group replaces a ketone or aldehyde
group and whose use in the food is listed by FDA (e.g., mannitol or
xylitol) or is generally recognized as safe (e.g., sorbitol). In lieu
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of the term "sugar alcohol," the name of the specific sugar alcohol
(e.g., "xylitol") present in the product may be used in the nutrition
label, provided that only one sugar alcohol is present in the product.
Sugar alcohol content shall be indented and expressed to the nearest
gram, except that if a serving contains less than 1 gram, the statement
"Contains less then 1 gram" or "less than 1 gram" may be used as an
alternative, and if the serving contains less than 0.5 gram, the content
may be expressed as zero.
(iv) "Other carbohydrate" (VOLUNTARY): A statement of the number
of grams of other carbohydrate per serving may be declared voluntarily.
Other carbohydrate shall be defined as the difference between total
carbohydrate and the sum of dietary fiber, sugars, and sugar alcohol,
except that if sugar alcohol is not declared (even if present), it shall
be defined as the difference between total carbohydrate and the sum of
dietary fiber and sugars. Other carbohydrate content shall be indented
and expressed to the nearest gram, except that if a serving contains
less than 1 gram, the statement "Contains less than 1 gram" or "less
than 1 gram" may be used as an alternative, and if the serving contains
less than 0.5 gram, the content may be expressed as zero.
(7) "Protein": A statement of the number of grams of protein per
serving expressed to the nearest gram, except that if a serving contains
less than 1 gram, the statement "Contains less than 1 gram" or "less
than 1 gram" may be used as an alternative, and if the serving contains
less than 0.5 gram, the content may be expressed as zero. When the
protein in products represented or purported to be for adults and
children 4 or more years of age has a protein quality value that is a
protein digestibility-corrected amino acid score of less than 20
expressed as a percent, or when the protein in a product represented or
purported to be for children greater than 1 but less than 4 years of age
has a protein quality value that is a protein digestibility-corrected
amino acid score of less than 40 expressed as a percent, either of the
following shall be placed adjacent to the declaration of protein content
by weight: The statement "not a significant source of protein," or a
listing aligned under the column headed "Percent Daily Value" of the
corrected amount of protein per serving, as determined in paragraph
(c)(7)(ii) of this section, calculated as a percentage of the Daily
Reference Value (DRV) or Reference Daily Intake (RDI), as appropriate,
for protein and expressed as percent of Daily Value. When the protein
quality in a product as measured by the Protein Efficiency Ratio (PER)
is less than 40 percent of the reference standard (casein) for a product
represented or purported to be for infants, the statement "not a
significant source of protein" shall be placed adjacent to the
declaration of protein content. Protein content may be calculated on the
basis of the factor of 6.25 times the nitrogen content of the food as
determined by appropriate methods of analysis in accordance with
Sec. 317.309(h), except when the procedure for a specific food requires
another factor.
(i) A statement of the corrected amount of protein per serving, as
determined in paragraph (c)(7)(ii) of this section, calculated as a
percentage of the RDI or DRV for protein, as appropriate, and expressed
as percent of Daily Value, may be placed on the label, except that such
a statement shall be given if a protein claim is made for the product,
or if the product is represented or purported to be for infants or
children under 4 years of age. When such a declaration is provided, it
shall be placed on the label adjacent to the statement of grams of
protein and aligned under the column headed "Percent Daily Value," and
expressed to the nearest whole percent. However, the percentage of the
RDI for protein shall not be declared if the product is represented or
purported to be for infants and the protein quality value is less than
40 percent of the reference standard.
(ii) The corrected amount of protein (grams) per serving for
products represented or purported to be for adults and children 1 or
more years of age is equal to the actual amount of protein (grams) per
serving multiplied by the amino acid score corrected for protein
digestibility. If the corrected score is above 1.00, then it shall be
set at 1.00.
[[Page 186]]
The protein digestibility-corrected amino acid score shall be determined
by methods given in sections 5.4.1, 7.2.1, and 8 in "Protein Quality
Evaluation, Report of the Joint FAO/WHO Expert Consultation on Protein
Quality Evaluation," Rome, 1990, which is incorporated by reference.
Sections 5.4.1, 7.2.1, and 8 of the "Report of the Joint FAO/WHO Expert
Consultation on Protein Quality Evaluation," as published by the Food
and Agriculture Organization of the United Nations/World Health
Organization, is incorporated as it exists on the date of approval. This
incorporation by reference was approved by the Director of the Federal
Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. It is
available for inspection at the Office of the Federal Register, suite
700, 800 North Capitol Street, NW., Washington, DC, or at the office of
the FSIS Docket Clerk, Room 3171, South Building, 14th and Independence
Avenue, SW., Washington, DC. Copies of the incorporation by reference
are available from the Product Assessment Division, Regulatory Programs,
Food Safety and Inspection Service, U.S. Department of Agriculture, Room
329, West End Court Building, Washington, DC 20250-3700. For products
represented or purported to be for infants, the corrected amount of
protein (grams) per serving is equal to the actual amount of protein
(grams) per serving multiplied by the relative protein quality value.
The relative protein quality value shall be determined by dividing the
subject product's protein PER value by the PER value for casein. If the
relative protein value is above 1.00, it shall be set at 1.00.
(iii) For the purpose of labeling with a percent of the DRV or RDI,
a value of 50 grams of protein shall be the DRV for adults and children
4 or more years of age, and the RDI for protein for children less than 4
years of age, infants, pregnant women, and lactating women shall be 16
grams, 14 grams, 60 grams, and 65 grams, respectively.
(8) Vitamins and minerals: A statement of the amount per serving of
the vitamins and minerals as described in this paragraph, calculated as
a percent of the RDI and expressed as percent of Daily Value.
(i) For purposes of declaration of percent of Daily Value as
provided for in paragraphs (d) through (g) of this section, products
represented or purported to be for use by infants, children less than 4
years of age, pregnant women, or lactating women shall use the RDI's
that are specified for the intended group. For products represented or
purported to be for use by both infants and children under 4 years of
age, the percent of Daily Value shall be presented by separate
declarations according to paragraph (e) of this section based on the RDI
values for infants from birth to 12 months of age and for children under
4 years of age. Similarly, the percent of Daily Value based on both the
RDI values for pregnant women and for lactating women shall be declared
separately on products represented or purported to be for use by both
pregnant and lactating women. When such dual declaration is used on any
label, it shall be included in all labeling, and equal prominence shall
be given to both values in all such labeling. All other products shall
use the RDI for adults and children 4 or more years of age.
(ii) The declaration of vitamins and minerals as a percent of the
RDI shall include vitamin A, vitamin C, calcium, and iron, in that
order, and shall include any of the other vitamins and minerals listed
in paragraph (c)(8)(iv) of this section when they are added, or when a
claim is made about them. Other vitamins and minerals need not be
declared if neither the nutrient nor the component is otherwise referred
to on the label or in labeling or advertising and the vitamins and
minerals are:
(A) Required or permitted in a standardized food (e.g., thiamin,
riboflavin, and niacin in enriched flour) and that standardized food is
included as an ingredient (i.e., component) in another product; or
(B) Included in a product solely for technological purposes and
declared only in the ingredients statement. The declaration may also
include any of the other vitamins and minerals listed in paragraph
(c)(8)(iv) of this section when they are naturally occurring in the
food. The additional vitamins and
[[Page 187]]
minerals shall be listed in the order established in paragraph
(c)(8)(iv) of this section.
(iii) The percentages for vitamins and minerals shall be expressed
to the nearest 2-percent increment up to and including the 10-percent
level, the nearest 5-percent increment above 10 percent and up to and
including the 50-percent level, and the nearest 10-percent increment
above the 50-percent level. Amounts of vitamins and minerals present at
less than 2 percent of the RDI are not required to be declared in
nutrition labeling but may be declared by a zero or by the use of an
asterisk (or other symbol) that refers to another asterisk (or symbol)
that is placed at the bottom of the table and that is followed by the
statement "Contains less than 2 percent of the Daily Value of this
(these) nutrient (nutrients)." Alternatively, if vitamin A, vitamin C,
calcium, or iron is present in amounts less than 2 percent of the RDI,
label declaration of the nutrient(s) is not required if the statement
"Not a significant source of ------ (listing the vitamins or minerals
omitted)" is placed at the bottom of the table of nutrient values.
(iv) The following RDI's and nomenclature are established for the
following vitamins and minerals which are essential in human nutrition:
Vitamin A, 5,000 International Units
Vitamin C, 60 milligrams
Calcium, 1.0 gram
Iron, 18 milligrams
Vitamin D, 400 International Units
Vitamin E, 30 International Units
Thiamin, 1.5 milligrams
Riboflavin, 1.7 milligrams
Niacin, 20 milligrams
Vitamin B6, 2.0 milligrams
Folate, 0.4 milligram
Vitamin B12, 6 micrograms
Biotin, 0.3 milligram
Pantothenic acid, 10 milligrams
Phosphorus, 1.0 gram
Iodine, 150 micrograms
Magnesium, 400 milligrams
Zinc, 15 milligrams
Copper, 2.0 milligrams
(v) The following synonyms may be added in parenthesis immediately
following the name of the nutrient or dietary component:
Vitamin C--Ascorbic acid
Thiamin--Vitamin B1
Riboflavin--Vitamin B2
Folate--Folacin
Calories--Energy
(vi) A statement of the percent of vitamin A that is present as
beta-carotene may be declared voluntarily. When the vitamins and
minerals are listed in a single column, the statement shall be indented
under the information on vitamin A. When vitamins and minerals are
arrayed horizontally, the statement of percent shall be presented in
parenthesis following the declaration of vitamin A and the percent of
Daily Value of vitamin A in the product (e.g., "Percent Daily Value:
Vitamin A 50 (90 percent as beta-carotene)"). When declared, the
percentages shall be expressed in the same increments as are provided
for vitamins and minerals in paragraph (c)(8)(iii) of this section.
(9) For the purpose of labeling with a percent of the DRV, the
following DRV's are established for the following food components based
on the reference caloric intake of 2,000 calories:
------------------------------------------------------------------------
Food component Unit of measurement DRV
------------------------------------------------------------------------
Fat................................... grams (g)............... 65
Saturated fatty acids................. do...................... 20
Cholesterol........................... milligrams (mg)......... 300
Total carbohydrate.................... grams (g)............... 300
Fiber................................. do...................... 25
Sodium................................ milligrams (mg)......... 2,400
Potassium............................. do...................... 3,500
Protein............................... grams (g)............... 50
------------------------------------------------------------------------
(d)(1) Nutrient information specified in paragraph (c) of this
section shall be presented on products in the following format, except
on products on which dual columns of nutrition information are declared
as provided for in paragraph (e) of this section, on those products on
which the simplified format is permitted to be used as provided for in
paragraph (f) of this section, on products for infants and children less
than 4 years of age as provided for in Sec. 317.400(c), and on products
in packages that have a total surface area available to bear labeling of
40 or less square inches as provided for in paragraph (g) of this
section.
(i) The nutrition information shall be set off in a box by use of
hairlines and shall be all black or one color type, printed on a white
or other neutral
[[Page 188]]
contrasting background whenever practical.
(ii) All information within the nutrition label shall utilize:
(A) A single easy-to-read type style,
(B) Upper and lower case letters,
(C) At least one point leading (i.e., space between two lines of
text) except that at least four points leading shall be utilized for the
information required by paragraphs (d)(7) and (d)(8) of this section,
and
(D) Letters should never touch.
(iii) Information required in paragraphs (d)(3), (d)(5), (d)(7), and
(d)(8) of this section shall be in type size no smaller than 8 point.
Except for the heading "Nutrition Facts," the information required in
paragraphs (d)(4), (d)(6), and (d)(9) of this section and all other
information contained within the nutrition label shall be in type size
no smaller than 6 point. When provided, the information described in
paragraph (d)(10) of this section shall also be in type no smaller than
6 point.
(iv) The headings required by paragraphs (d)(2), (d)(4), and (d)(6)
of this section (i.e., "Nutrition Facts," "Amount per Serving," and
"% Daily Value*"), the names of all nutrients that are not indented
according to requirements of paragraph (c) of this section (i.e.,
Calories, Total fat, Cholesterol, Sodium, Potassium, Total carbohydrate,
and Protein), and the percentage amounts required by paragraph
(d)(7)(ii) of this section shall be highlighted by bold or extra bold
type or other highlighting (reverse printing is not permitted as a form
of highlighting) that prominently distinguishes it from other
information. No other information shall be highlighted.
(v) A hairline rule that is centered between the lines of text shall
separate "Amount Per Serving" from the calorie statements required in
paragraph (d)(5) of this section and shall separate each nutrient and
its corresponding percent of Daily Value required in paragraphs
(d)(7)(i) and (d)(7)(ii) of this section from the nutrient and percent
of Daily Value above and below it.
(2) The information shall be presented under the identifying heading
of "Nutrition Facts" which shall be set in a type size larger than all
other print size in the nutrition label and, except for labels presented
according to the format provided for in paragraph (d)(11) of this
section, unless impractical, shall be set the full width of the
information provided under paragraph (d)(7) of this section.
(3) Information on serving size shall immediately follow the
heading. Such information shall include:
(i) "Serving Size": A statement of the serving size as specified
in paragraph (b)(9) of this section.
(ii) "Servings Per Container": The number of servings per
container, except that this statement is not required on single-serving
containers as defined in paragraph (b)(8) of this section.
(4) A subheading "Amount Per Serving" shall be separated from
serving size information by a bar.
(5) Information on calories shall immediately follow the heading
"Amount Per Serving" and shall be declared in one line, leaving
sufficient space between the declaration of "Calories" and "Calories
from fat" to allow clear differentiation, or, if "Calories from
saturated fat" is declared, in a column with total "Calories" at the
top, followed by "Calories from fat" (indented), and "Calories from
saturated fat" (indented).
(6) The column heading "% Daily Value," followed by an asterisk
(e.g., "% Daily Value*"), shall be separated from information on
calories by a bar. The position of this column heading shall allow for a
list of nutrient names and amounts as described in paragraph (d)(7) of
this section to be to the left of, and below, this column heading. The
column headings "Percent Daily Value," "Percent DV," or "% DV" may
be substituted for "% Daily Value."
(7) Except as provided for in paragraph (g) of this section, and
except as permitted by Sec. 317.400(d)(2), nutrient information for both
mandatory and any voluntary nutrients listed in paragraph (c) of this
section that are to be declared in the nutrition label, except vitamins
and minerals, shall be declared as follows:
(i) The name of each nutrient, as specified in paragraph (c) of this
section, shall be given in a column and
[[Page 189]]
followed immediately by the quantitative amount by weight for that
nutrient appended with a "g" for grams or "mg" for milligrams.
(ii) A listing of the percent of the DRV as established in
paragraphs (c)(7)(iii) and (c)(9) of this section shall be given in a
column aligned under the heading "% Daily Value" established in
paragraph (d)(6) of this section with the percent expressed to the
nearest whole percent for each nutrient declared in the column described
in paragraph (d)(7)(i) of this section for which a DRV has been
established, except that the percent for protein may be omitted as
provided in paragraph (c)(7) of this section. The percent shall be
calculated by dividing either the amount declared on the label for each
nutrient or the actual amount of each nutrient (i.e., before rounding)
by the DRV for the nutrient, except that the percent for protein shall
be calculated as specified in paragraph (c)(7)(ii) of this section. The
numerical value shall be followed by the symbol for percent (i.e., %).
(8) Nutrient information for vitamins and minerals shall be
separated from information on other nutrients by a bar and shall be
arrayed horizontally (e.g., Vitamin A 4%, Vitamin C 2%, Calcium 15%,
Iron 4%) or may be listed in two columns, except that when more than
four vitamins and minerals are declared, they may be declared vertically
with percentages listed under the column headed "% Daily Value."
(9) A footnote, preceded by an asterisk, shall be placed beneath the
list of vitamins and minerals and shall be separated from that list by a
hairline.
(i) The footnote shall state: Percent Daily Values are based on a
2,000 calorie diet. Your daily values may be higher or lower depending
on your calorie needs.
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Calories: 2,000 2,500
----------------------------------------------------------------------------------------------------------------
Total fat............................ Less than.............. 65 g................... 80 g
Saturated fat........................ Less than.............. 20 g................... 25 g
Cholesterol.......................... Less than.............. 300 mg................. 300 mg
Sodium............................... Less than.............. 2,400 mg............... 2,400 mg
Total carbohydrate................... ....................... 300 g.................. 375 g
Dietary fiber........................ ....................... 25 g................... 30 g
----------------------------------------------------------------------------------------------------------------
(ii) If the percent of Daily Value is given for protein in the
Percent of Daily Value column as provided in paragraph (d)(7)(ii) of
this section, protein shall be listed under dietary fiber, and a value
of 50 g shall be inserted on the same line in the column headed
"2,000" and value of 65 g in the column headed "2,500."
(iii) If potassium is declared in the column described in paragraph
(d)(7)(i) of this section, potassium shall be listed under sodium and
the DRV established in paragraph (c)(9) of this section shall be
inserted on the same line in the numeric columns.
(iv) The abbreviations established in paragraph (g)(2) of this
section may be used within the footnote.
(10) Caloric conversion information on a per-gram basis for fat,
carbohydrate, and protein may be presented beneath the information
required in paragraph (d)(9), separated from that information by a
hairline. This information may be presented horizontally (i.e.,
"Calories per gram: Fat 9, Carbohydrate 4, Protein 4") or vertically
in columns.
(11)(i) If the space beneath the information on vitamins and
minerals is not adequate to accommodate the information required in
paragraph (d)(9) of this section, the information required in paragraph
(d)(9) may be moved to the right of the column required in paragraph
(d)(7)(ii) of this section and set off by a line that distinguishes it
and sets it apart from the percent of Daily Value information. The
caloric conversion information provided for in paragraph (d)(10) of this
section may be presented beneath either side or along the full length of
the nutrition label.
(ii) If the space beneath the mandatory declaration of iron is not
adequate to accommodate any remaining vitamins and minerals to be
declared or the information required in paragraph (d)(9) of this
section, the remaining information may be moved to the right and set off
by a line that distinguishes it and sets it apart from the percent of
Daily Value information given to the left. The caloric conversion
information provided for in paragraph (d)(10) of this section may be
presented beneath either side or along the full length of the nutrition
label.
(iii) If there is not sufficient continuous vertical space (i.e.,
approximately
[[Page 190]]
3 inches) to accommodate the required components of the nutrition label
up to and including the mandatory declaration of iron, the nutrition
label may be presented in a tabular display in which the footnote
required by paragraph (d)(9) of the section is given to the far right of
the label, and additional vitamins and minerals beyond the four that are
required (i.e., vitamin A, vitamin C, calcium, and iron) are arrayed
horizontally following declarations of the required vitamins and
minerals.
(12) The following sample label illustrates the provisions of
paragraph (d) of this section:
[[Page 191]]
[GRAPHIC] [TIFF OMITTED] TC11SE91.013
(13)(i) Nutrition labeling on the outer label of packages of meat or
meat food products that contain two or more products in the same
packages (e.g., variety packs) or of packages that are used
interchangeably for the same type of food (e.g., meat salad containers)
may use an aggregate display.
(ii) Aggregate displays shall comply with format requirements of
paragraph
[[Page 192]]
(d) of this section to the maximum extent possible, except that the
identity of each food shall be specified to the right of the "Nutrition
Facts" title, and both the quantitative amount by weight (i.e., g/mg
amounts) and the percent Daily Value for each nutrient shall be listed
in separate columns under the name of each food.
(14) When nutrition labeling appears in a second language, the
nutrition information may be presented in a separate nutrition label for
each language or in one nutrition label with the information in the
second language following that in English. Numeric characters that are
identical in both languages need not be repeated (e.g., "Protein/
Proteinas 2 g"). All required information must be included in both
languages.
(e) Nutrition information may be presented for two or more forms of
the same product (e.g., both "raw" and "cooked") or for common
combinations of foods as provided for in paragraph (b) of this section,
or for different units (e.g., per 100 grams) as provided for in
paragraph (b) of this section, or for two or more groups for which RDI's
are established (e.g., both infants and children less than 4 years of
age) as provided for in paragraph (c)(8)(i) of this section. When such
dual labeling is provided, equal prominence shall be given to both sets
of values. Information shall be presented in a format consistent with
paragraph (d) of this section, except that:
(1) Following the subheading of "Amount Per Serving," there shall
be two or more column headings accurately describing the forms of the
same product (e.g., "raw" and "roasted"), the combinations of foods,
the units, or the RDI groups that are being declared. The column
representing the product as packaged and according to the label serving
size based on the Reference Amount in Sec. 317.312(b) shall be to the
left of the numeric columns.
(2) When the dual labeling is presented for two or more forms of the
same product, for combinations of foods, or for different units, total
calories and calories from fat (and calories from saturated fat, when
declared) shall be listed in a column and indented as specified in
paragraph (d)(5) of this section with quantitative amounts declared in
columns aligned under the column headings set forth in paragraph (e)(1)
of this section.
(3) Quantitative information by weight required in paragraph
(d)(7)(i) of this section shall be specified for the form of the product
as packaged and according to the label serving size based on the
Reference Amount in Sec. 317.312(b).
(i) Quantitative information by weight may be included for other
forms of the product represented by the additional column(s) either
immediately adjacent to the required quantitative information by weight
for the product as packaged and according to the label serving size
based on the Reference Amount in Sec. 317.312(b) or as a footnote.
(A) If such additional quantitative information is given immediately
adjacent to the required quantitative information, it shall be declared
for all nutrients listed and placed immediately following and
differentiated from the required quantitative information (e.g.,
separated by a comma). Such information shall not be put in a separate
column.
(B) If such additional quantitative information is given in a
footnote, it shall be declared in the same order as the nutrients are
listed in the nutrition label. The additional quantitative information
may state the total nutrient content of the product identified in the
second column or the nutrient amounts added to the product as packaged
for only those nutrients that are present in different amounts than the
amounts declared in the required quantitative information. The footnote
shall clearly identify which amounts are declared. Any subcomponents
declared shall be listed parenthetically after principal components
(e.g., \1/2\ cup skim milk contributes an additional 40 calories, 65 mg
sodium, 6 g total carbohydrate (6 g sugars), and 4 g protein).
(ii) Total fat and its quantitative amount by weight shall be
followed by an asterisk (or other symbol) (e.g., "Total fat (2 g)*")
referring to another asterisk (or symbol) at the bottom of the nutrition
label identifying the form(s) of the product for which quantitative
information is presented.
[[Page 193]]
(4) Information required in paragraphs (d)(7)(ii) and (d)(8) of this
section shall be presented under the subheading "% DAILY VALUE" and in
columns directly under the column headings set forth in paragraph (e)(1)
of this section.
(5) The following sample label illustrates the provisions of
paragraph (e) of this section:
[[Page 194]]
[GRAPHIC] [TIFF OMITTED] TC11SE91.014
(f)(1) Nutrition information may be presented in a simplified format
as set forth herein when any required nutrients, other than the core
nutrients
[[Page 195]]
(i.e., calories, total fat, sodium, total carbohydrate, and protein),
are present in insignificant amounts. An insignificant amount shall be
defined as that amount that may be rounded to zero in nutrition
labeling, except that for total carbohydrate, dietary fiber, sugars and
protein, it shall be an amount less than 1 gram.
(2) The simplified format shall include information on the following
nutrients:
(i) Total calories, total fat, total carbohydrate, sodium, and
protein;
(ii) Any of the following that are present in more than
insignificant amounts: Calories from fat, saturated fat, cholesterol,
dietary fiber, sugars, vitamin A, vitamin C, calcium, and iron; and
(iii) Any vitamins and minerals listed in paragraph (c)(8)(iv) of
this section when they are added in fortified or fabricated foods.
(3) Other nutrients that are naturally present in the product in
more than insignificant amounts may be voluntarily declared as part of
the simplified format.
(4) Any required nutrient, other than a core nutrient, that is
present in an insignificant amount may be omitted from the tabular
listing, provided that the following statement is included at the bottom
of the nutrition label, "Not a significant source of --------." The
blank shall be filled in with the appropriate nutrient or food
component. Alternatively, amounts of vitamins and minerals present in
insignificant amounts may be declared by the use of an asterisk (or
symbol) that is placed at the bottom of the table of nutrient values and
that is followed by the statement "Contains less than 2 percent of the
Daily Value of this (these) nutrient (nutrients)."
(5) Except as provided for in paragraph (g) of this section and in
Sec. 317.400(c) and (d), nutrient information declared in the simplified
format shall be presented in the same manner as specified in paragraphs
(d) or (e) of this section, except that the footnote required in
paragraph (d)(9) of this section is not required. When the footnote is
omitted, an asterisk shall be placed at the bottom of the label followed
by the statement "Percent Daily Values are based on a 2,000 calorie
diet" and, if the term "Daily Value" is not spelled out in the
heading, a statement that "DV" represents "Daily Value."
(g) Foods in packages that have a total surface area available to
bear labeling of 40 or less square inches may modify the requirements of
paragraphs (c) through (f) of this section and Sec. 317.302(a) by one or
more of the following means:
(1)(i) Presenting the required nutrition information in a tabular or
linear (i.e., string) fashion, rather than in vertical columns if the
product has a total surface area available to bear labeling of less than
12 square inches, or if the product has a total surface area available
to bear labeling of 40 or less square inches and the package shape or
size cannot accommodate a standard vertical column or tabular display on
any label panel. Nutrition information may be given in a linear fashion
only if the package shape or size will not accommodate a tabular
display.
(ii) When nutrition information is given in a linear display, the
nutrition information shall be set off in a box by the use of a
hairline. The percent Daily Value is separated from the quantitative
amount declaration by the use of parenthesis, and all nutrients, both
principal components and subcomponents, are treated similarly. Bolding
is required only on the title "Nutrition Facts" and is allowed for
nutrient names for "Calories," "Total fat," "Cholesterol,"
"Sodium," "Total carbohydrate," and "Protein."
(2) Using any of the following abbreviations:
Serving size--Serv size
Servings per container--Servings
Calories from fat--Fat cal
Calories from saturated fat--Sat fat cal
Saturated fat--Sat fat
Monounsaturated fat--Monounsat fat
Polyunsaturated fat--Polyunsat fat
Cholesterol--Cholest
Total carbohydrate--Total carb
Dietary fiber--Fiber
Soluble fiber--Sol fiber
Insoluble fiber--Insol fiber
Sugar alcohol--Sugar alc
Other carbohydrate--Other carb
(3) Omitting the footnote required in paragraph (d)(9) of this
section and
[[Page 196]]
placing another asterisk at the bottom of the label followed by the
statement "Percent Daily Values are based on a 2,000 calorie diet"
and, if the term "Daily Value" is not spelled out in the heading, a
statement that "DV" represents "Daily Value."
(4) Presenting the required nutrition information on any other label
panel.
(h) Compliance with this section shall be determined as follows:
(1) A production lot is a set of food production consumer units that
are from one production shift. Alternatively, a collection of consumer
units of the same size, type, and style produced under conditions as
nearly uniform as possible, designated by a common container code or
marking, constitutes a production lot.
(2) The sample for nutrient analysis shall consist of a composite of
a minimum of six consumer units, each from a production lot.
Alternatively, the sample for nutrient analysis shall consist of a
composite of a minimum of six consumer units, each randomly chosen to be
representative of a production lot. In each case, the units may be
individually analyzed and the results of the analyses averaged, or the
units would be composited and the composite analyzed. In both cases, the
results, whether an average or a single result from a composite, will be
considered by the Agency to be the nutrient content of a composite. All
analyses shall be performed by appropriate methods and procedures used
by the Department for each nutrient in accordance with the "Chemistry
Laboratory Guidebook," or, if no USDA method is available and
appropriate for the nutrient, by appropriate methods for the nutrient in
accordance with the 1990 edition of the "Official Methods of Analysis"
of the AOAC International, formerly Association of Official Analytical
Chemists, 15th ed., which is incorporated by reference, unless a
particular method of analysis is specified in Sec. 317.309(c), or, if no
USDA, AOAC, or specified method is available and appropriate, by other
reliable and appropriate analytical procedures as so determined by the
Agency. The "Official Methods of Analysis" is incorporated as it
exists on the date of approval. This incorporation by reference was
approved by the Director of the Federal Register in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. Copies may be purchased from the AOAC
International, 2200 Wilson Blvd., suite 400, Arlington, VA 22201. It is
also available for inspection at the Office of the Federal Register
Information Center, suite 700, 800 North Capitol Street, NW.,
Washington, DC.
(3) Two classes of nutrients are defined for purposes of compliance:
(i) Class I. Added nutrients in fortified or fabricated foods; and
(ii) Class II. Naturally occurring (indigenous) nutrients. If any
ingredient which contains a naturally occurring (indigenous) nutrient is
added to a food, the total amount of such nutrient in the final food
product is subject to Class II requirements unless the same nutrient is
also added, which would make the total amount of such nutrient subject
to Class I requirements.
(4) A product with a label declaration of a vitamin, mineral,
protein, total carbohydrate, dietary fiber, other carbohydrate,
polyunsaturated or monounsaturated fat, or potassium shall be deemed to
be misbranded under section 1(n) of the Federal Meat Inspection Act (21
U.S.C. 601(n)(1)) unless it meets the following requirements:
(i) Class I vitamin, mineral, protein, dietary fiber, or potassium.
The nutrient content of the composite is at least equal to the value for
that nutrient declared on the label.
(ii) Class II vitamin, mineral, protein, total carbohydrate, dietary
fiber, other carbohydrate, polyunsaturated or monounsaturated fat, or
potassium. The nutrient content of the composite is at least equal to 80
percent of the value for that nutrient declared on the label; Provided,
That no regulatory action will be based on a determination of a nutrient
value which falls below this level by an amount less than the
variability generally recognized for the analytical method used in that
product at the level involved, and inherent nutrient variation in a
product.
(5) A product with a label declaration of calories, sugars, total
fat, saturated fat, cholesterol, or sodium shall be deemed to be
misbranded under section 1(n) of the Federal Meat Inspection Act
[[Page 197]]
(21 U.S.C. 601(n)(1)) if the nutrient content of the composite is
greater than 20 percent in excess of the value for that nutrient
declared on the label; Provided, That no regulatory action will be based
on a determination of a nutrient value which falls above this level by
an amount less than the variability generally recognized for the
analytical method used in that product at the level involved, and
inherent nutrient variation in a product.
(6) The amount of a vitamin, mineral, protein, total carbohydrate,
dietary fiber, other carbohydrate, polyunsaturated or monounsaturated
fat, or potassium may vary over labeled amounts within good
manufacturing practice. The amount of calories, sugars, total fat,
saturated fat, cholesterol, or sodium may vary under labeled amounts
within good manufacturing practice.
(7) Compliance will be based on the metric measure specified in the
label statement of serving size.
(8) The management of the establishment must maintain records to
support the validity of nutrient declarations contained on product
labels. Such records shall be made available to the inspector or any
duly authorized representative of the Agency upon request.
(9) The compliance provisions set forth in paragraph (h) (1) through
(8) of this section shall not apply to single-ingredient, raw meat
(including ground beef) products, including those that have been
previously frozen, when nutrition labeling is based on the most current
representative data base values contained in USDA's National Nutrient
Data Bank or its published form, the Agriculture Handbook No. 8 series
available from the Government Printing Office.
(Paperwork requirements were approved by the Office of Management and
Budget under control number 0583-0088)
[58 FR 664, Jan. 6, 1993; 58 FR 43788, Aug. 18, 1993; 58 FR 47627, Sept.
10, 1993; 59 FR 45194, Sept. 1, 1994; 60 FR 176, Jan. 3, 1995]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.312]
[Page 197-203]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart B--Nutrition Labeling
Sec. 317.312 Reference amounts customarily consumed per eating occasion.
(a) The general principles followed in arriving at the reference
amounts customarily consumed per eating occasion (Reference Amount(s)),
as set forth in paragraph (b) of this section, are:
(1) The Reference Amounts are calculated for persons 4 years of age
or older to reflect the amount of food customarily consumed per eating
occasion by persons in this population group. These Reference Amounts
are based on data set forth in appropriate national food consumption
surveys.
(2) The Reference Amounts are calculated for an infant or child
under 4 years of age to reflect the amount of food customarily consumed
per eating occasion by infants up to 12 months of age or by children 1
through 3 years of age, respectively. These Reference Amounts are based
on data set forth in appropriate national food consumption surveys. Such
Reference Amounts are to be used only when the product is specially
formulated or processed for use by an infant or by a child under 4 years
of age.
(3) An appropriate national food consumption survey includes a large
sample size representative of the demographic and socioeconomic
characteristics of the relevant population group and must be based on
consumption data under actual conditions of use.
(4) To determine the amount of food customarily consumed per eating
occasion, the mean, median, and mode of the consumed amount per eating
occasion were considered.
(5) When survey data were insufficient, FSIS took various other
sources of information on serving sizes of food into consideration.
These other sources of information included:
(i) Serving sizes used in dietary guidance recommendations or
recommended by other authoritative systems or organizations;
(ii) Serving sizes recommended in comments;
(iii) Serving sizes used by manufacturers and grocers; and
[[Page 198]]
(iv) Serving sizes used by other countries.
(6) Because they reflect the amount customarily consumed, the
Reference Amount and, in turn, the serving size declared on the product
label are based on only the edible portion of food, and not bone, seed,
shell, or other inedible components.
(7) The Reference Amount is based on the major intended use of the
product (e.g., a mixed dish measurable with a cup as a main dish and not
as a side dish).
(8) The Reference Amounts for products that are consumed as an
ingredient of other products, but that may also be consumed in the form
in which they are purchased (e.g., ground beef), are based on use in the
form purchased.
(9) FSIS sought to ensure that foods that have similar dietary
usage, product characteristics, and customarily consumed amounts have a
uniform Reference Amount.
(b) The following Product Categories and Reference Amounts shall be
used as the basis for determining serving sizes for specific products:
Table 1--Reference Amounts Customarily Consumed per Eating Occasion--
Infant and Toddler Foods \1,2,3\
------------------------------------------------------------------------
Reference
Product category amount
------------------------------------------------------------------------
Infant & Toddler Foods:
Dinner Dry Mix............................................ 15 g
Dinner, ready-to-serve, strained type..................... 60 g
Dinner, soups, ready-to-serve junior type................. 110 g
Dinner, stew or soup ready-to-serve toddlers.............. 170 g
Plain meats and meat sticks, ready-to-serve............... 55 g
------------------------------------------------------------------------
\1\ These values represent the amount of food customarily consumed per
eating occasion and were primarily derived from the 1977-1978 and the
1987-1988 Nationwide Food Consumption Surveys conducted by the U.S.
Department of Agriculture.
\2\ Unless otherwise noted in the Reference Amount column, the Reference
Amounts are for the ready-to-serve or almost ready-to-serve form of
the product (i.e., heat and serve). If not listed separately, the
Reference Amount for the unprepared form (e.g., dehydrated cereal) is
the amount required to make one Reference Amount of the prepared form.
\3\ Manufacturers are required to convert the Reference Amount to the
label serving size in a household measure most appropriate to their
specific product using the procedures established by regulation.
Table 2--Reference Amounts Customarily Consumed Per Eating Occasion--
General Food Supply \1,2,3,4,5\
------------------------------------------------------------------------
Reference amount Reference amount
Product category ----------------------------------------
Ready-to-serve Ready-to-cook
------------------------------------------------------------------------
Egg mixtures, (western style 110 g n/a.
omelet, souffle, egg foo young
.
Lard, margarine, shortening.... 1 tbsp n/a.
Salad and potato toppers; e.g., 7 g n/a.
bacon bits.
Bacon (bacon, beef breakfast 15 g 54 g=bacon. 30 g =
strips, pork breakfast strips, breakfast strips.
pork rinds).
Dried; e.g., jerky, dried beef, 30 g n/a.
Parma ham sausage products
with a moisture/protein ratio
of less than 2:1; e.g.,
pepperoni.
Snacks; e.g., meat snack food 30 g n/a.
sticks.
Luncheon meat, bologna, 55 g n/a.
Canadian style bacon, pork
pattie crumbles, beef pattie
crumbles, blood pudding,
luncheon loaf, old fashioned
loaf, berlinger, bangers,
minced luncheon roll,
thuringer, liver sausage,
mortadella, uncured sausage
(franks), ham and cheese loaf,
P&P loaf, scrapple souse, head
cheese, pizza loaf, olive
loaf, pate, deviled ham,
sandwich spread, teawurst,
cervelet, Lebanon bologna,
potted meat food product, taco
fillings, meat pie fillings.
Linked meat sausage products, 55 g n/a. 75 g=uncooked
Vienna sausage, frankfurters, sausage.
pork sausage, imitation
frankfurters, bratwurst,
kielbasa, Polish sausage,
summer sausage, mettwurst,
smoked country sausage, smoked
sausage, smoked or pickled
meat, pickled pigs feet.
Entrees without sauce, cuts of 85 g 114 g.
meat including marinated,
tenderized, injected cuts of
meat, beef patty, corn dog,
croquettes, fritters, cured
ham, dry cured ham, dry cured
cappicola, corned beef,
pastrami, country ham, pork
shoulder picnic, meatballs,
pureed adult foods.
Canned meats, canned beef, 55 g n/a.
canned pork. \4\.
Entrees with sauce, barbecued 140 g n/a.
meats in sauce.
Mixed dishes NOT measurable 140 g (plus 55 g n/a.
with a cup; \5\ e.g., burrito, for products with
egg roll, enchilada, pizza, sauce toppings)
pizza roll, quiche, all types
of sandwiches, cracker and
meat lunch type packages,
gyro, stromboli, burger on a
bun, frank on a bun, calzone,
taco, pockets stuffed with
meat, foldovers, stuffed
vegetables with meat, shish
kabobs, empanada.
Mixed dishes measurable with a 1 cup n/a.
cup; e.g., meat casserole,
macaroni and cheese with meat,
pot pie, spaghetti with sauce,
meat chili, chili with beans,
meat hash, creamed chipped
beef, beef ravioli in sauce,
beef stroganoff, Brunswick
stew, goulash, meat stew,
ragout, meat lasagna, meat
filled pasta.
Salads--pasta or potato, potato 140 g n/a.
salad with bacon, macaroni and
meat salad.
Salads--all other meat, salads, 100 g n/a.
ham salad.
[[Page 199]]
Soups--all varieties........... 245 g n/a.
Major main entree type sauce; 125 g n/a.
e.g., spaghetti sauce with
meat, spaghetti sauce with
meatballs.
Minor main entree sauce; e.g., \1/4\ cup n/a.
pizza sauce with meat, gravy.
Seasoning mixes dry, bases, ................... ..................
extracts, dried broths and
stock/juice, freeze dry trail
mix products with meat..
As reconstituted:
Amount to make one Reference
Amount of the final dish;
e.g.,
Gravy...................... \1/4\ cup n/a.
Major main entree type 125 g n/a.
sauce.
Soup....................... 245 g n/a.
Entree measurable with a 1 cup n/a.
cup.
------------------------------------------------------------------------
\1\ These values represent the amount of food customarily consumed per
eating occasion and were primarily derived from the 1977-78 and the
1987-88 Nationwide Food Consumption Surveys conducted by the U.S.
Department of Agriculture.
\2\ Manufacturers are required to convert the Reference Amounts to the
label serving size in a household measure most appropriate to their
specific product using the procedures established by regulation.
\3\ Examples listed under Product Category are not all inclusive or
exclusive. Examples are provided to assist manufacturers in
identifying appropriate product Reference Amount.
\4\ If packed or canned in liquid, the Reference Amount is for the
drained solids, except for products in which both the solids and
liquids are customarily consumed.
\5\ Pizza sauce is part of the pizza and is not considered to be sauce
topping.
(c) For products that have no Reference Amount listed in paragraph
(b) of this section for the unprepared or the prepared form of the
product and that consist of two or more foods packaged and presented to
be consumed together (e.g., lunch meat with cheese and crackers), the
Reference Amount for the combined product shall be determined using the
following rules:
(1) For bulk products, the Reference Amount for the combined product
shall be the Reference Amount, as established in paragraph (b) of this
section, for the ingredient that is represented as the main ingredient
plus proportioned amounts of all minor ingredients.
(2) For products where the ingredient represented as the main
ingredient is one or more discrete units, the Reference Amount for the
combined product shall be either the number of small discrete units or
the fraction of the large discrete unit that is represented as the main
ingredient that is closest to the Reference Amount for that ingredient
as established in paragraph (b) of this section plus proportioned
amounts of all minor ingredients.
(3) If the Reference Amounts are in compatible units, they shall be
summed (e.g., ingredients in equal volumes such as tablespoons). If the
Reference Amounts are in incompatible units, the weights of the
appropriate volumes should be used (e.g., grams of one ingredient plus
gram weight of tablespoons of a second ingredient).
(d) If a product requires further preparation, e.g., cooking or the
addition of water or other ingredients, and if paragraph (b) of this
section provides a Reference Amount for the product in the prepared
form, then the Reference Amount for the unprepared product shall be
determined using the following rules:
(1) Except as provided for in paragraph (d)(2) of this section, the
Reference Amount for the unprepared product shall be the amount of the
unprepared product required to make the Reference Amount for the
prepared product as established in paragraph (b) of this section.
(2) For products where the entire contents of the package is used to
prepare one large discrete unit usually divided for consumption, the
Reference Amount for the unprepared product shall be the amount of the
unprepared product required to make the fraction of the large discrete
unit closest to the Reference Amount for the prepared product as
established in paragraph (b) of this section.
(e) The Reference Amount for an imitation or substitute product or
altered product as defined in Sec. 317.313(d), such
[[Page 200]]
as a "low calorie" version, shall be the same as for the product for
which it is offered as a substitute.
(f) The Reference Amounts set forth in paragraphs (b) through (e) of
this section shall be used in determining whether a product meets the
criteria for nutritional claims. If the serving size declared on the
product label differs from the Reference Amount, and the product meets
the criteria for the claim only on the basis of the Reference Amount,
the claim shall be followed by a statement that sets forth the basis on
which the claim is made. That statement shall include the Reference
Amount as it appears in paragraph (b) of this section followed, in
parentheses, by the amount in common household measure if the Reference
Amount is expressed in measures other than common household measures.
(g) The Administrator, on his or her own initiative or on behalf of
any interested person who has submitted a labeling application, may
issue a proposal to establish or amend a Product Category or Reference
Amount identified in paragraph (b) of this section.
(1) Labeling applications and supporting documentation to be filed
under this section shall be submitted in quadruplicate, except that the
supporting documentation may be submitted on a computer disc copy. If
any part of the material submitted is in a foreign language, it shall be
accompanied by an accurate and complete English translation. The
labeling application shall state the applicant's post office address.
(2) Pertinent information will be considered as part of an
application on the basis of specific reference to such information
submitted to and retained in the files of the Food Safety and Inspection
Service. However, any reference to unpublished information furnished by
a person other than the applicant will not be considered unless use of
such information is authorized (with the understanding that such
information may in whole or part be subject to release to the public) in
a written statement signed by the person who submitted it. Any reference
to published information should be accompanied by reprints or
photostatic copies of such references.
(3) The availability for public disclosure of labeling applications,
along with supporting documentation, submitted to the Agency under this
section will be governed by the rules specified in subchapter D, title
9.
(4) Data accompanying the labeling application, such as food
consumption data, shall be submitted on separate sheets, suitably
identified. If such data has already been submitted with an earlier
labeling application from the applicant, the present labeling
application must provide the data.
(5) The labeling application must be signed by the applicant or by
his or her attorney or agent, or (if a corporation) by an authorized
official.
(6) The labeling application shall include a statement signed by the
person responsible for the labeling application, that to the best of his
or her knowledge, it is a representative and balanced submission that
includes unfavorable information, as well as favorable information,
known to him or her pertinent to the evaluation of the labeling
application.
(7) Labeling applications for a new Reference Amount and/or Product
Category shall be accompanied by the following data which shall be
submitted in the following form to the Director, Food Labeling Division,
Regulatory Programs, Food Safety and Inspection Service, Washington, DC
20250:
________________________________________________________________________
(Date)
The undersigned, ------------ submits this labeling application
pursuant to 9 CFR 317.312 with respect to Reference Amount and/or
Product Category.
Attached hereto, in quadruplicate, or on a computer disc copy, and
constituting a part of this labeling application, are the following:
(i) A statement of the objective of the labeling application;
(ii) A description of the product;
(iii) A complete sample product label including nutrition label,
using the format established by regulation;
(iv) A description of the form in which the product will be
marketed;
(v) The intended dietary uses of the product with the major use
identified (e.g., ham as a luncheon meat);
(vi) If the intended use is primarily as an ingredient in other
foods, list of foods or food categories in which the product will be
used
[[Page 201]]
as an ingredient with information on the prioritization of the use;
(vii) The population group for which the product will be offered for
use (e.g., infants, children under 4 years of age);
(viii) The names of the most closely-related products (or in the
case of foods for special dietary use and imitation or substitute foods,
the names of the products for which they are offered as substitutes);
(ix) The suggested Reference Amount (the amount of edible portion of
food as consumed, excluding bone, skin or other inedible components) for
the population group for which the product is intended with full
description of the methodology and procedures that were used to
determine the suggested Reference Amount. In determining the Reference
Amount, general principles and factors in paragraph (a) of this section
should be followed.
(x) The suggested Reference Amount shall be expressed in metric
units. Reference Amounts for foods shall be expressed in grams except
when common household units such as cups, tablespoons, and teaspoons are
more appropriate or are more likely to promote uniformity in serving
sizes declared on product labels. For example, common household measures
would be more appropriate if products within the same category differ
substantially in density such as mixed dishes measurable with a cup.
(A) In expressing the Reference Amount in grams, the following
general rules shall be followed:
(1) For quantities greater than 10 grams, the quantity shall be
expressed in nearest 5 grams increment.
(2) For quantities less than 10 grams, exact gram weights shall be
used.
(B) [Reserved]
(xi) A labeling application for a new subcategory of food with its
own Reference Amount shall include the following additional information:
(A) Data that demonstrate that the new subcategory of food will be
consumed in amounts that differ enough from the Reference Amount for the
parent category to warrant a separate Reference Amount. Data must
include sample size, and the mean, standard deviation, median, and modal
consumed amount per eating occasion for the product identified in the
labeling application and for other products in the category. All data
must be derived from the same survey data.
(B) Documentation supporting the difference in dietary usage and
product characteristics that affect the consumption size that
distinguishes the product identified in the labeling application from
the rest of the products in the category.
(xii) In conducting research to collect or process food consumption
data in support of the labeling application, the following general
guidelines should be followed.
(A) Sampled population selected should be representative of the
demographic and socioeconomic characteristics of the target population
group for which the food is intended.
(B) Sample size (i.e., number of eaters) should be large enough to
give reliable estimates for customarily consumed amounts.
(C) The study protocol should identify potential biases and describe
how potential biases are controlled for or, if not possible to control,
how they affect interpretation of results.
(D) The methodology used to collect or process data including study
design, sampling procedures, materials used (e.g., questionnaire,
interviewer's manual), procedures used to collect or process data,
methods or procedures used to control for unbiased estimates, and
procedures used to correct for nonresponse, should be fully documented.
(xiii) A statement concerning the feasibility of convening
associations, corporations, consumers, and other interested parties to
engage in negotiated rulemaking to develop a proposed rule.
Yours very truly,
Applicant_________________________________________________________
By________________________________________________________________
(Indicate authority)
(8) Upon receipt of the labeling application and supporting
documentation, the applicant shall be notified, in writing, of the date
on which the labeling application was received. Such notice shall inform
the applicant that the labeling application is undergoing Agency review
and that the applicant shall subsequently be notified of the Agency's
decision to consider for further review or deny the labeling
application.
(9) Upon review of the labeling application and supporting
documentation, the Agency shall notify the applicant, in writing, that
the labeling application is either being considered for further review
or that it has been summarily denied by the Administrator.
(10) If the labeling application is summarily denied by the
Administrator, the written notification shall state the reasons
therefor, including why the Agency has determined that the proposed
Reference Amount and/or Product Category is false or misleading. The
notification letter shall inform the applicant that the applicant may
submit a written statement by way of answer to the notification, and
that the applicant shall have the right to request a hearing with
respect to
[[Page 202]]
the merits or validity of the Administrator's decision to deny the use
of the proposed Reference Amount and/or Product Category.
(i) If the applicant fails to accept the determination of the
Administrator and files an answer and requests a hearing, and the
Administrator, after review of the answer, determines the initial
determination to be correct, the Administrator shall file with the
Hearing Clerk of the Department the notification, answer, and the
request for a hearing, which shall constitute the complaint and answer
in the proceeding, which shall thereafter be conducted in accordance
with the Department's Uniform Rules of Practice.
(ii) The hearing shall be conducted before an administrative law
judge with the opportunity for appeal to the Department's Judicial
Officer, who shall make the final determination for the Secretary. Any
such determination by the Secretary shall be conclusive unless, within
30 days after receipt of notice of such final determination, the
applicant appeals to the United States Court of Appeals for the circuit
in which the applicant has its principal place of business or to the
United States Court of Appeals for the District of Columbia Circuit.
(11) If the labeling application is not summarily denied by the
Administrator, the Administrator shall publish in the Federal Register a
proposed rule to amend the regulations to authorize the use of the
Reference Amount and/or Product Category. The proposal shall also
summarize the labeling application, including where the supporting
documentation can be reviewed. The Administrator's proposed rule shall
seek comment from consumers, the industry, consumer and industry groups,
and other interested persons on the labeling application and the use of
the proposed Reference Amount and/or Product Category. After public
comment has been received and reviewed by the Agency, the Administrator
shall make a determination on whether the proposed Reference Amount and/
or Product Category shall be approved for use on the labeling of meat
food products.
(i) If the Reference Amount and/or Product Category is denied by the
Administrator, the Agency shall notify the applicant, in writing, of the
basis for the denial, including the reason why the Reference Amount and/
or Product Category on the labeling was determined by the Agency to be
false or misleading. The notification letter shall also inform the
applicant that the applicant may submit a written statement by way of
answer to the notification, and that the applicant shall have the right
to request a hearing with respect to the merits or validity of the
Administrator's decision to deny the use of the proposed Reference
Amount and/or Product Category.
(A) If the applicant fails to accept the determination of the
Administrator and files an answer and requests a hearing, and the
Administrator, after review of an answer, determines the initial
determination to be correct, the Administrator shall file with the
Hearing Clerk of the Department the notification, answer, and the
request for a hearing, which shall constitute the complaint and answer
in the proceeding, which shall thereafter be conducted in accordance
with the Department's Uniform Rules of Practice.
(B) The hearing shall be conducted before an administrative law
judge with the opportunity for appeal to the Department's Judicial
Officer, who shall make the final determination for the Secretary. Any
such determination by the Secretary shall be conclusive unless, within
30 days after receipt of the notice of such final determination, the
applicant appeals to the United States Court of Appeals for the circuit
in which the applicant has its principal place of business or to the
United States Court of Appeals for the District of Columbia Circuit.
(ii) If the Reference Amount and/or Product Category is approved,
the Agency shall notify the applicant, in writing, and shall also
publish in the Federal Register a final rule amending the regulations to
authorize the
[[Page 203]]
use of the Reference Amount and/or Product Category.
(Paperwork requirements were approved by the Office of Management and
Budget under control number 0583-0088)
[58 FR 664, Jan. 6, 1993; 58 FR 43788, Aug. 18, 1993 as amended at 58 FR
47627, Sept. 10, 1993; 59 FR 45196, Sept. 1, 1994; 60 FR 186, Jan. 3,
1995]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.313]
[Page 203-206]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart B--Nutrition Labeling
Sec. 317.313 Nutrient content claims; general principles.
(a) This section applies to meat or meat food products that are
intended for human consumption and that are offered for sale.
(b) A claim which, expressly or by implication, characterizes the
level of a nutrient (nutrient content claim) of the type required in
nutrition labeling pursuant to Sec. 317.309, may not be made on a label
or in labeling of that product unless the claim is made in accordance
with the applicable provisions in this subpart.
(1) An expressed nutrient content claim is any direct statement
about the level (or range) of a nutrient in the product, e.g., "low
sodium" or "contains 100 calories."
(2) An implied nutrient content claim is any claim that:
(i) Describes the product or an ingredient therein in a manner that
suggests that a nutrient is absent or present in a certain amount (e.g.,
"high in oat bran"); or
(ii) Suggests that the product, because of its nutrient content, may
be useful in maintaining healthy dietary practices and is made in
association with an explicit claim or statement about a nutrient (e.g.,
"healthy, contains 3 grams (g) of fat").
(3) Except for claims regarding vitamins and minerals described in
paragraph (q)(3) of this section, no nutrient content claims may be made
on products intended specifically for use by infants and children less
than 2 years of age unless the claim is specifically provided for in
subpart B of this part.
(4) Reasonable variations in the spelling of the terms defined in
applicable provisions in this subpart and their synonyms are permitted
provided these variations are not misleading (e.g., "hi" or "lo").
(c) Information that is required or permitted by Sec. 317.309 to be
declared in nutrition labeling, and that appears as part of the
nutrition label, is not a nutrient content claim and is not subject to
the requirements of this section. If such information is declared
elsewhere on the label or in labeling, it is a nutrient content claim
and is subject to the requirements for nutrient content claims.
(d) A "substitute" product is one that may be used interchangeably
with another product that it resembles, i.e., that it is
organoleptically, physically, and functionally (including shelf life)
similar to, and that it is not nutritionally inferior to unless it is
labeled as an "imitation."
(1) If there is a difference in performance characteristics that
materially limits the use of the product, the product may still be
considered a substitute if the label includes a disclaimer adjacent to
the most prominent claim as defined in paragraph (j)(2)(iii) of this
section, informing the consumer of such difference (e.g., "not
recommended for frying").
(2) This disclaimer shall be in easily legible print or type and in
a size no less than that required by Sec. 317.2(h) for the net quantity
of contents statement, except where the size of the claim is less than
two times the required size of the net quantity of contents statement,
in which case the disclaimer statement shall be no less than one-half
the size of the claim but no smaller than \1/16\-inch minimum height,
except as permitted by Sec. 317.400(d)(2).
(e)(1) Because the use of a "free" or "low" claim before the
name of a product implies that the product differs from other products
of the same type by virtue of its having a lower amount of the nutrient,
only products that have been specially processed, altered, formulated,
or reformulated so as to lower the amount of the nutrient in the
product, remove the nutrient from the product, or not include the
nutrient in the product, may bear such a claim (e.g., "low sodium beef
noodle soup").
(2) Any claim for the absence of a nutrient in a product, or that a
product is low in a nutrient when the product has not been specially
processed, altered,
[[Page 204]]
formulated, or reformulated to qualify for that claim shall indicate
that the product inherently meets the criteria and shall clearly refer
to all products of that type and not merely to the particular brand to
which the labeling attaches (e.g., "lard, a sodium free food").
(f) A nutrient content claim shall be in type size and style no
larger than two times that of the statement of identity and shall not be
unduly prominent in type style compared to the statement of identity.
(g) Labeling information required in Secs. 317.313, 317.354,
317.356, 317.360, 317.361, 317.362, and 317.380, whose type size is not
otherwise specified, is required to be in letters and/or numbers no less
than \1/16\ inch in height, except as permitted by Sec. 317.400(d)(2).
(h) [Reserved]
(i) Except as provided in Sec. 317.309 or in paragraph (q)(3) of
this section, the label or labeling of a product may contain a statement
about the amount or percentage of a nutrient if:
(1) The use of the statement on the product implicitly characterizes
the level of the nutrient in the product and is consistent with a
definition for a claim, as provided in subpart B of this part, for the
nutrient that the label addresses. Such a claim might be, "less than 10
g of fat per serving;"
(2) The use of the statement on the product implicitly characterizes
the level of the nutrient in the product and is not consistent with such
a definition, but the label carries a disclaimer adjacent to the
statement that the product is not "low" in or a "good source" of the
nutrient, such as "only 200 milligrams (mg) sodium per serving, not a
low sodium product." The disclaimer must be in easily legible print or
type and in a size no less than required by Sec. 317.2(h) for the net
quantity of contents, except where the size of the claim is less than
two times the required size of the net quantity of contents statement,
in which case the disclaimer statement shall be no less than one-half
the size of the claim but no smaller than \1/16\-inch minimum height,
except as permitted by Sec. 317.400(d)(2);
(3) The statement does not in any way implicitly characterize the
level of the nutrient in the product and it is not false or misleading
in any respect (e.g., "100 calories" or "5 grams of fat"), in which
case no disclaimer is required.
(4) "Percent fat free" claims are not authorized by this
paragraph. Such claims shall comply with Sec. 317.362(b)(6).
(j) A product may bear a statement that compares the level of a
nutrient in the product with the level of a nutrient in a reference
product. These statements shall be known as "relative claims" and
include "light," "reduced," "less" (or "fewer"), and "more"
claims.
(1) To bear a relative claim about the level of a nutrient, the
amount of that nutrient in the product must be compared to an amount of
nutrient in an appropriate reference product as specified in this
paragraph (j).
(i)(A) For "less" (or "fewer") and "more" claims, the
reference product may be a dissimilar product within a product category
that can generally be substituted for one another in the diet or a
similar product.
(B) For "light," "reduced," and "added" claims, the reference
product shall be a similar product, and
(ii)(A) For "light" claims, the reference product shall be
representative of the type of product that includes the product that
bears the claim. The nutrient value for the reference product shall be
representative of a broad base of products of that type; e.g., a value
in a representative, valid data base; an average value determined from
the top three national (or regional) brands, a market basket norm; or,
where its nutrient value is representative of the product type, a market
leader. Firms using such a reference nutrient value as a basis for a
claim, are required to provide specific information upon which the
nutrient value was derived, on request, to consumers and appropriate
regulatory officials.
(B) For relative claims other than "light," including "less" and
"more" claims, the reference product may be the same as that provided
for "light" in paragraph (j)(1)(ii)(A) of this section or it may be
the manufacturer's regular product, or that of another manufacturer,
that has been offered for sale to the public on a regular basis for a
[[Page 205]]
substantial period of time in the same geographic area by the same
business entity or by one entitled to use its trade name, provided the
name of the competitor is not used on the labeling of the product. The
nutrient values used to determine the claim when comparing a single
manufacturer's product to the labeled product shall be either the values
declared in nutrition labeling or the actual nutrient values, provided
that the resulting labeling is internally consistent (i.e., that the
values stated in the nutrition information, the nutrient values in the
accompanying information, and the declaration of the percentage of
nutrient by which the product has been modified are consistent and will
not cause consumer confusion when compared), and that the actual
modification is at least equal to the percentage specified in the
definition of the claim.
(2) For products bearing relative claims:
(i) The label or labeling must state the identity of the reference
product and the percent (or fraction) of the amount of the nutrient in
the reference product by which the nutrient has been modified, (e.g.,
"50 percent less fat than `reference product' " or "\1/3\ fewer
calories than `reference product' "); and
(ii) This information shall be immediately adjacent to the most
prominent claim in easily legible boldface print or type, in distinct
contrast to other printed or graphic matter, that is no less than that
required by Sec. 317.2(h) for net quantity of contents, except where the
size of the claim is less than two times the required size of the net
quantity of contents statement, in which case the referral statement
shall be no less than one-half the size of the claim, but no smaller
than \1/16\-inch minimum height, except as permitted by
Sec. 317.400(d)(2).
(iii) The determination of which use of the claim is in the most
prominent location on the label or labeling will be made based on the
following factors, considered in order:
(A) A claim on the principal display panel adjacent to the statement
of identity;
(B) A claim elsewhere on the principal display panel;
(C) A claim on the information panel; or
(D) A claim elsewhere on the label or labeling.
(iv) The label or labeling must also bear:
(A) Clear and concise quantitative information comparing the amount
of the subject nutrient in the product per labeled serving size with
that in the reference product; and
(B) This statement shall appear adjacent to the most prominent claim
or to the nutrition information.
(3) A relative claim for decreased levels of a nutrient may not be
made on the label or in labeling of a product if the nutrient content of
the reference product meets the requirement for a "low" claim for that
nutrient.
(k) The term "modified" may be used in the statement of identity
of a product that bears a relative claim that complies with the
requirements of this part, followed immediately by the name of the
nutrient whose content has been altered (e.g., "modified fat `product'
"). This statement of identity must be immediately followed by the
comparative statement such as "contains 35 percent less fat than
`reference product'." The label or labeling must also bear the
information required by paragraph (j)(2) of this section in the manner
prescribed.
(l) For purposes of making a claim, a "meal-type product" shall be
defined as a product that:
(1) Makes a significant contribution to the diet by weighing at
least 6 ounces, but no more than 12 ounces per serving (container), and
(2) Contains ingredients from two or more of the following four food
groups:
(i) Bread, cereal, rice and pasta group,
(ii) Fruits and vegetables group,
(iii) Milk, yogurt, and cheese group, and
(iv) Meat, poultry, fish, dry beans, eggs, and nuts group, and
(3) Is represented as, or is in a form commonly understood to be a
breakfast, lunch, dinner, meal, main dish, entree, or pizza. Such
representations may be made either by statements, photographs, or
vignettes.
(m) [Reserved]
[[Page 206]]
(n) Nutrition labeling in accordance with Sec. 317.309, shall be
provided for any food for which a nutrient content claim is made.
(o) Compliance with requirements for nutrient content claims shall
be in accordance with Sec. 317.309(h).
(p)(1) Unless otherwise specified, the reference amount customarily
consumed set forth in Sec. 317.312(b) through (e) shall be used in
determining whether a product meets the criteria for a nutrient content
claim. If the serving size declared on the product label differs from
the reference amount customarily consumed, and the amount of the
nutrient contained in the labeled serving does not meet the maximum or
minimum amount criterion in the definition for the descriptor for that
nutrient, the claim shall be followed by the criteria for the claim as
required by Sec. 317.312(f) (e.g., "very low sodium, 35 mg or less per
55 grams").
(2) The criteria for the claim shall be immediately adjacent to the
most prominent claim in easily legible print or type and in a size that
is no less than that required by Sec. 317.2(h) for net quantity of
contents, except where the size of the claim is less than two times the
required size of the net quantity of contents statement, in which case
the criteria statement shall be no less than one-half the size of the
claim but no smaller than \1/16\-inch minimum height, except as
permitted by Sec. 317.400(d)(2).
(q) The following exemptions apply:
(1) Nutrient content claims that have not been defined by regulation
and that appear as part of a brand name that was in use prior to
November 27, 1991, may continue to be used as part of that brand name,
provided they are not false or misleading under section 1(n) of the Act
(21 U.S.C. 601(n)(1)).
(2) [Reserved]
(3) A statement that describes the percentage of a vitamin or
mineral in the food, including foods intended specifically for use by
infants and children less than 2 years of age, in relation to a
Reference Daily Intake (RDI) as defined in Sec. 317.309 may be made on
the label or in the labeling of a food without a regulation authorizing
such a claim for a specific vitamin or mineral.
(4) The requirements of this section do not apply to infant formulas
and medical foods, as described in 21 CFR 101.13(q)(4).
(5) [Reserved]
(6) Nutrient content claims that were part of the name of a product
that was subject to a standard of identity as of November 27, 1991, are
not subject to the requirements of paragraph (b) of this section whether
or not they meet the definition of the descriptive term.
(7) Implied nutrient content claims may be used as part of a brand
name, provided that the use of the claim has been authorized by FSIS.
Labeling applications requesting approval of such a claim may be
submitted pursuant to Sec. 317.369.
[58 FR 664, Jan. 6, 1993; 58 FR 43788, Aug. 18, 1993, as amended at 58
FR 47627, Sept. 10, 1993; 59 FR 40213, Aug. 8, 1994; 59 FR 45196, Sept.
1, 1994; 60 FR 187, Jan. 3, 1995]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.343]
[Page 206-207]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart B--Nutrition Labeling
Sec. 317.343 Significant participation for voluntary nutrition labeling.
(a) In evaluating significant participation for voluntary nutrition
labeling, FSIS will consider only the major cuts of single-ingredient,
raw meat products, as identified in Sec. 317.344, including those that
have been previously frozen.
(b) FSIS will judge a food retailer to be participating at a
significant level if the retailer provides nutrition labeling
information for at least 90 percent of the major cuts of single-
ingredient, raw meat products, listed in Sec. 317.344, that it sells,
and if the nutrition label is consistent in content and format with the
mandatory program, or nutrition information is displayed at point-of-
purchase in an approriate manner.
(c) To determine whether there is significant participation by
retailers under the voluntary nutrition labeling guidelines, FSIS will
select a representative sample of companies allocated by type and size.
(d) FSIS will find that significant participation by food retailers
exists if at least 60 percent of all companies that are evaluated are
participating in accordance with the guidelines.
(e) FSIS will evaluate significant participation of the voluntary
program every 2 years beginning in May 1995.
[[Page 207]]
(1) If significant participation is found, the voluntary nutrition
labeling guidelines shall remain in effect.
(2) If significant participation is not found, FSIS shall initiate
rulemaking to require nutrition labeling on those products under the
voluntary program.
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.344]
[Page 207]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart B--Nutrition Labeling
Sec. 317.344 Identification of major cuts of meat products.
The major cuts of single-ingredient, raw meat products are: Beef
chuck blade roast, beef loin top loin steak, beef rib roast large end,
beef round eye round steak, beef round top round steak, beef round tip
roast, beef chuck arm pot roast, beef loin sirloin steak, beef round
bottom round steak, beef brisket (whole, flat half, or point half), beef
rib steak small end, beef loin tenderloin steak, ground beef regular
without added seasonings, ground beef about 17% fat, pork loin chop,
pork loin country style ribs, pork loin top loin chop boneless, pork
loin rib chop, pork spareribs, pork loin tenderloin, pork loin sirloin
roast, pork shoulder blade steak, pork loin top roast boneless, ground
pork, lamb shank, lamb shoulder arm chop, lamb shoulder blade chop, lamb
rib roast, lamb loin chop, lamb leg (whole, sirloin half, or shank
half), veal shoulder arm steak, veal shoulder blade steak, veal rib
roast, veal loin chop, and veal cutlets.
[58 FR 664, Jan. 6, 1993, as amended at 59 FR 45196, Sept. 1, 1994]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.345]
[Page 207-208]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart B--Nutrition Labeling
Sec. 317.345 Guidelines for voluntary nutrition labeling of single-ingredient, raw products.
(a) Nutrition information on the cuts of single-ingredient, raw meat
products, including those that have been previously frozen, shall be
provided in the following manner:
(1) If a retailer or manufacturer chooses to provide nutrition
information on the label of these products, these products shall be
subject to all requirements of the mandatory nutrition labeling program,
except that nutrition labeling may be declared on the basis of either
"as consumed" or "as packaged." In addition, the declaration of the
number of servings per container need not be included in nutrition
labeling of single-ingredient, raw meat products (including ground
beef), including those that have been previously frozen.
(2) A retailer may choose to provide nutrition information at the
point-of-purchase, such as by posting a sign, or by making the
information readily available in brochures, notebooks, or leaflet form
in close proximity to the food. The nutrition labeling information may
also be supplemented by a video, live demonstration, or other media. If
a nutrition claim is made on point-of-purchase materials all of the
requirements of the mandatory nutrition labeling program apply. However,
if only nutrition information--and not a nutrition claim--is supplied on
point-of-purchase materials:
(i) The requirements of the mandatory nutrition labeling program
apply, but the nutrition information may be supplied on an "as
packaged" or "as consumed," basis;
(ii) The listing of percent of Daily Value for the nutrients (except
vitamins and minerals specified in Sec. 317.309(c)(8)) and footnote
required by Sec. 317.309(d)(9) may be omitted; and
(iii) The point-of-purchase materials are not subject to any of the
format requirements.
(b) [Reserved]
(c) The declaration of nutrition information may be presented in a
simplified format as specified in Sec. 317.309(f) for the mandatory
nutrition labeling program.
(d) The nutrition label data should be based on either the raw or
cooked edible portions of meat cuts with external cover fat at trim
levels reflecting current marketing practices. If data are based on
cooked portions, the methods used to cook the products must be specified
and should be those which do not add nutrients from other ingredients
such as flour, breading, and salt. Additional nutritional data may be
presented on an optional basis for the raw or cooked edible portions of
the separable lean of meat cuts.
(e) Nutrient data that are the most current representative data base
values contained in USDA's National Nutrient Data Bank or its published
form, the Agriculture Handbook No. 8 series, may be used for nutrition
labeling of single-ingredient, raw meat products (including ground
beef), including
[[Page 208]]
those that have been previously frozen. These data may be composite data
that reflect different quality grades of beef or other variables
affecting nutrient content. Alternatively, data that reflect specific
grades or other variables may be used, except that if data are used on
labels attached to a product which is labeled as to grade of meat or
other variables, the data must represent the product in the package when
such data are contained in the representative data base. When data are
used on labels attached to a product, the data must represent the edible
meat tissues present in the package.
(f) If the nutrition information is in accordance with paragraph (e)
of this section, a nutrition label or labeling will not be subject to
the Agency compliance review under Sec. 317.309(h), unless a nutrition
claim is made on the basis of the representative data base values.
(g) Retailers may use data bases that they believe reflect the
nutrient content of single-ingredient, raw meat products (including
ground beef), including those that have been previously frozen; however,
such labeling shall be subject to the compliance procedures of paragraph
(e) of this section and the requirements specified in this subpart for
the mandatory nutrition labeling program.
[58 FR 664, Jan. 6, 1993, as amended at 58 FR 47627, Sept. 10, 1993; 60
FR 189, Jan. 3, 1995]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.354]
[Page 208-209]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart B--Nutrition Labeling
Sec. 317.354 Nutrient content claims for "good source," "high," and "more."
(a) General requirements. Except as provided in paragraph (e) of
this section, a claim about the level of a nutrient in a product in
relation to the Reference Daily Intake (RDI) or Daily Reference Value
(DRV) established for that nutrient (excluding total carbohydrate) in
Sec. 317.309(c), may only be made on the label or in labeling of the
product if:
(1) The claim uses one of the terms defined in this section in
accordance with the definition for that term;
(2) The claim is made in accordance with the general requirements
for nutrient content claims in Sec. 317.313; and
(3) The product for which the claim is made is labeled in accordance
with Sec. 317.309.
(b) "High" claims. (1) The terms "high," "rich in," or
"excellent source of" may be used on the label or in labeling of
products, except meal-type products as defined in Sec. 317.313(l),
provided that the product contains 20 percent or more of the RDI or the
DRV per reference amount customarily consumed.
(2) The terms defined in paragraph (b)(1) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 317.313(l), provided that:
(i) The product contains a food that meets the definition of
"high" in paragraph (b)(1) of this section; and
(ii) The label or labeling clearly identifies the food that is the
subject of the claim (e.g., "the serving of broccoli in this meal is
high in vitamin C").
(c) "Good Source" claims. (1) The terms "good source,"
"contains," or "provides" may be used on the label or in labeling of
products, except meal-type products as described in Sec. 317.313(l),
provided that the product contains 10 to 19 percent of the RDI or the
DRV per reference amount customarily consumed.
(2) The terms defined in paragraph (c)(1) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 317.313(l), provided that:
(i) The product contains a food that meets the definition of "good
source" in paragraph (c)(1) of this section; and
(ii) The label or labeling clearly identifies the food that is the
subject of the claim (e.g., "the serving of sweet potatoes in this meal
is a good source of fiber").
(d) Fiber claims. (1) If a nutrient content claim is made with
respect to the level of dietary fiber, i.e., that the product is high in
fiber, a good source of fiber, or that the product contains "more"
fiber, and the product is not "low" in total fat as defined in
Sec. 317.362(b)(2) or, in the case of a meal-type product, is not
"low" in total fat as defined in Sec. 317.362(b)(3), then the labeling
shall disclose the level of total
[[Page 209]]
fat per labeled serving size (e.g., "contains 12 grams (g) of fat per
serving"); and
(2) The disclosure shall appear in immediate proximity to such claim
and be in a type size no less than one-half the size of the claim.
(e) "More" claims. (1) A relative claim using the terms "more"
and "added" may be used on the label or in labeling to describe the
level of protein, vitamins, minerals, dietary fiber, or potassium in a
product, except meal-type products as defined in Sec. 317.313(l),
provided that:
(i) The product contains at least 10 percent more of the RDI or the
DRV for protein, vitamins, minerals, dietary fiber, or potassium
(expressed as a percent of the Daily Value) per reference amount
customarily consumed than an appropriate reference product as described
in Sec. 317.313(j)(1); and
(ii) As required in Sec. 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the nutrient is greater relative to the RDI or DRV are
declared in immediate proximity to the most prominent such claim (e.g.,
"contains 10 percent more of the Daily Value for fiber than `reference
product' "); and
(B) Quantitative information comparing the level of the nutrient in
the product per labeled serving size with that of the reference product
that it replaces is declared adjacent to the most prominent claim or to
the nutrition information (e.g., "fiber content of `reference product'
is 1 g per serving; `this product' contains 4 g per serving").
(2) A relative claim using the terms "more" and "added" may be
used on the label or in labeling to describe the level of protein,
vitamins, minerals, dietary fiber, or potassium in meal-type products as
defined in Sec. 317.313(l), provided that:
(i) The product contains at least 10 percent more of the RDI or the
DRV for protein, vitamins, minerals, dietary fiber, or potassium
(expressed as a percent of the Daily Value) per 100 g of product than an
appropriate reference product as described in Sec. 317.313(j)(1); and
(ii) As required in Sec. 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the nutrient is greater relative to the RDI or DRV are
declared in immediate proximity to the most prominent such claim (e.g.,
"contains 10 percent more of the Daily Value for fiber per 3 ounces
(oz) than does `reference product' "), and
(B) Quantitative information comparing the level of the nutrient in
the meal-type product per specified weight with that of the reference
product that it replaces is declared adjacent to the most prominent
claim or to the nutrition information (e.g., "fiber content of
`reference product' is 2 g per 3 oz; `this product' contains 5 g per 3
oz").
[60 FR 189, Jan. 3, 1995]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.356]
[Page 209-211]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart B--Nutrition Labeling
Sec. 317.356 Nutrient content claims for "light" or "lite."
(a) General requirements. A claim using the terms "light" or
"lite" to describe a product may only be made on the label or in
labeling of the product if:
(1) The claim uses one of the terms defined in this section in
accordance with the definition for that term;
(2) The claim is made in accordance with the general requirements
for nutrient content claims in Sec. 317.313; and
(3) The product for which the claim is made is labeled in accordance
with Sec. 317.309.
(b) "Light" claims. The terms "light" or "lite" may be used on
the label or in labeling of products, except meal-type products as
defined in Sec. 317.313(l), without further qualification, provided
that:
(1) If the product derives 50 percent or more of its calories from
fat, its fat content is reduced by 50 percent or more per reference
amount customarily consumed compared to an appropriate reference product
as described in Sec. 317.313(j)(1); or
(2) If the product derives less than 50 percent of its calories from
fat:
(i) The number of calories is reduced by at least one-third (33\1/3\
percent) per reference amount customarily consumed compared to an
appropriate reference product as described in Sec. 317.313(j)(1); or
[[Page 210]]
(ii) Its fat content is reduced by 50 percent or more per reference
amount customarily consumed compared to the appropriate reference
product as described in Sec. 317.313(j)(1); and
(3) As required in Sec. 317.313(j)(2) for relative claims:
(i) The identity of the reference product and the percent (or
fraction) that the calories and the fat were reduced are declared in
immediate proximity to the most prominent such claim (e.g., "\1/3\
fewer calories and 50 percent less fat than the market leader"); and
(ii) Quantitative information comparing the level of calories and
fat content in the product per labeled serving size with that of the
reference product that it replaces is declared adjacent to the most
prominent claim or to the nutrition information (e.g., "lite `this
product'--200 calories, 4 grams (g) fat; regular `reference product'--
300 calories, 8 g fat per serving"); and
(iii) If the labeled product contains less than 40 calories or less
than 3 g fat per reference amount customarily consumed, the percentage
reduction for that nutrient need not be declared.
(4) A "light" claim may not be made on a product for which the
reference product meets the definition of "low fat" and "low
calorie."
(c)(1)(i) A product for which the reference product contains 40
calories or less and 3 g fat or less per reference amount customarily
consumed may use the terms "light" or "lite" without further
qualification if it is reduced by 50 percent or more in sodium content
compared to the reference product; and
(ii) As required in Sec. 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the sodium was reduced are declared in immediate
proximity to the most prominent such claim (e.g., "50 percent less
sodium than the market leader"); and
(B) Quantitative information comparing the level of sodium per
labeled serving size with that of the reference product it replaces is
declared adjacent to the most prominent claim or to the nutrition
information (e.g., "lite `this product'--500 milligrams (mg) sodium per
serving; regular `reference product'--1,000 mg sodium per serving").
(2)(i) A product for which the reference product contains more than
40 calories or more than 3 g fat per reference amount customarily
consumed may use the terms "light in sodium" or "lite in sodium" if
it is reduced by 50 percent or more in sodium content compared to the
reference product, provided that "light" or "lite" is presented in
immediate proximity with "in sodium" and the entire term is presented
in uniform type size, style, color, and prominence; and
(ii) As required in Sec. 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the sodium was reduced are declared in immediate
proximity to the most prominent such claim (e.g., "50 percent less
sodium than the market leader"); and
(B) Quantitative information comparing the level of sodium per
labeled serving size with that of the reference product it replaces is
declared adjacent to the most prominent claim or to the nutrition
information (e.g., or "lite `this product'--170 mg sodium per serving;
regular `reference product'--350 mg per serving").
(3) Except for meal-type products as defined in Sec. 317.313(l), a
"light in sodium" claim may not be made on a product for which the
reference product meets the definition of "low in sodium."
(d)(1) The terms "light" or "lite" may be used on the label or
in labeling of a meal-type product as defined in Sec. 317.313(l),
provided that:
(i) The product meets the definition of:
(A) "Low in calories" as defined in Sec. 317.360(b)(3); or
(B) "Low in fat" as defined in Sec. 317.362(b)(3); and
(ii)(A) A statement appears on the principal display panel that
explains whether "light" is used to mean "low fat," "low
calories," or both (e.g., "Light Delight, a low fat meal"); and
(B) The accompanying statement is no less than one-half the type
size of the "light" or "lite" claim.
(2)(i) The terms "light in sodium" or "lite in sodium" may be
used on the
[[Page 211]]
label or in labeling of a meal-type product as defined in
Sec. 317.313(l), provided that the product meets the definition of "low
in sodium" as defined in Sec. 317.361(b)(5)(i); and
(ii) "Light" or "lite" and "in sodium" are presented in
uniform type size, style, color, and prominence.
(3) The term "light" or "lite" may be used in the brand name of
a product to describe the sodium content, provided that:
(i) The product is reduced by 50 percent or more in sodium content
compared to the reference product;
(ii) A statement specifically stating that the product is "light in
sodium" or "lite in sodium" appears:
(A) Contiguous to the brand name; and
(B) In uniform type size, style, color, and prominence as the
product name; and
(iii) As required in Sec. 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the sodium was reduced are declared in immediate
proximity to the most prominent such claim; and
(B) Quantitative information comparing the level of sodium per
labeled serving size with that of the reference product it replaces is
declared adjacent to the most prominent claim or to the nutrition
information.
(e) Except as provided in paragraphs (b) through (d) of this
section, the terms "light" or "lite" may not be used to refer to a
product that is not reduced in fat by 50 percent, or, if applicable, in
calories by \1/3\ or, when properly qualified, in sodium by 50 percent
unless:
(1) It describes some physical or organoleptic attribute of the
product such as texture or color and the information (e.g., "light in
color" or "light in texture") so stated, clearly conveys the nature
of the product; and
(2) The attribute (e.g., "color" or "texture") is in the same
style, color, and at least one-half the type size as the word "light"
and in immediate proximity thereto.
(f) If a manufacturer can demonstrate that the word "light" has
been associated, through common use, with a particular product to
reflect a physical or organoleptic attribute to the point where it has
become part of the statement of identity, such use of the term "light"
shall not be considered a nutrient content claim subject to the
requirements in this part.
(g) The term "lightly salted" may be used on a product to which
has been added 50 percent less sodium than is normally added to the
reference product as described in Sec. 317.313(j)(1)(i)(B) and
(j)(1)(ii)(B), provided that if the product is not "low in sodium" as
defined in Sec. 317.361(b)(4), the statement "not a low sodium food,"
shall appear adjacent to the nutrition information and the information
required to accompany a relative claim shall appear on the label or
labeling as specified in Sec. 317.313(j)(2).
[60 FR 189, Jan. 3, 1995]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.360]
[Page 211-214]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart B--Nutrition Labeling
Sec. 317.360 Nutrient content claims for calorie content.
(a) General requirements. A claim about the calorie or sugar content
of a product may only be made on the label or in labeling of the product
if:
(1) The claim uses one of the terms defined in this section in
accordance with the definition for that term;
(2) The claim is made in accordance with the general requirements
for nutrient content claims in Sec. 317.313; and
(3) The product for which the claim is made is labeled in accordance
with Sec. 317.309.
(b) Calorie content claims. (1) The terms "calorie free," "free
of calories," "no calories," "zero calories," "without calories,"
"trivial source of calories," "negligible source of calories," or
"dietarily insignificant source of calories" may be used on the label
or in labeling of products, provided that:
(i) The product contains less than 5 calories per reference amount
customarily consumed and per labeled serving size; and
(ii) If the product meets this condition without the benefit of
special processing, alteration, formulation, or reformulation to lower
the caloric content, it is labeled to clearly refer to all products of
its type and not merely to the particular brand to which the label
attaches.
[[Page 212]]
(2) The terms "low calorie," "few calories," "contains a small
amount of calories," "low source of calories," or "low in calories"
may be used on the label or in labeling of products, except meal-type
products as defined in Sec. 317.313(l), provided that:
(i)(A) The product has a reference amount customarily consumed
greater than 30 grams (g) or greater than 2 tablespoons (tbsp) and does
not provide more than 40 calories per reference amount customarily
consumed; or
(B) The product has a reference amount customarily consumed of 30 g
or less or 2 tbsp or less and does not provide more than 40 calories per
reference amount customarily consumed and per 50 g (for dehydrated
products that must be reconstituted before typical consumption with
water or a diluent containing an insignificant amount, as defined in
Sec. 317.309(f)(1), of all nutrients per reference amount customarily
consumed, the per-50-g criterion refers to the "as prepared" form).
(ii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
the caloric content, it is labeled to clearly refer to all products of
its type and not merely to the particular brand to which the label
attaches.
(3) The terms defined in paragraph (b)(2) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 317.313(l), provided that:
(i) The product contains 120 calories or less per 100 g of product;
and
(ii) If the product meets this condition without the benefit of
special processing, alteration, formulation, or reformulation to lower
the calorie content, it is labeled to clearly refer to all products of
its type and not merely to the particular brand to which it attaches.
(4) The terms "reduced calorie," "reduced in calories,"
"calorie reduced," "fewer calories," "lower calorie," or "lower
in calories" may be used on the label or in labeling of products,
except meal-type products as defined in Sec. 317.313(l), provided that:
(i) The product contains at least 25 percent fewer calories per
reference amount customarily consumed than an appropriate reference
product as described in Sec. 317.313(j)(1); and
(ii) As required in Sec. 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the calories differ between the two products are declared
in immediate proximity to the most prominent such claim (e.g., lower
calorie `product'--"33\1/3\ percent fewer calories than our regular
`product' "); and
(B) Quantitative information comparing the level of calories in the
product per labeled serving size with that of the reference product that
it replaces is declared adjacent to the most prominent claim or to the
nutrition information (e.g., "calorie content has been reduced from 150
to 100 calories per serving").
(iii) Claims described in paragraph (b)(4) of this section may not
be made on the label or in labeling of products if the reference product
meets the definition for "low calorie."
(5) The terms defined in paragraph (b)(4) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 317.313(l), provided that:
(i) The product contains at least 25 percent fewer calories per 100
g of product than an appropriate reference product as described in
Sec. 317.313(j)(1); and
(ii) As required in Sec. 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the calories differ between the two products are declared
in immediate proximity to the most prominent such claim (e.g., "calorie
reduced `product', 25% less calories per ounce (oz) (or 3 oz) than our
regular `product' "); and
(B) Quantitative information comparing the level of calories in the
product per specified weight with that of the reference product that it
replaces is declared adjacent to the most prominent claim or to the
nutrition information (e.g., "calorie content has been reduced from 110
calories per 3 oz to 80 calories per 3 oz").
(iii) Claims described in paragraph (b)(5) of this section may not
be made on the label or in labeling of products
[[Page 213]]
if the reference product meets the definition for "low calorie."
(c) Sugar content claims. (1) Terms such as "sugar free," "free
of sugar," "no sugar," "zero sugar," "without sugar,"
"sugarless," "trivial source of sugar," "negligible source of
sugar," or "dietarily insignificant source of sugar" may reasonably
be expected to be regarded by consumers as terms that represent that the
product contains no sugars or sweeteners, e.g., "sugar free," or "no
sugar," as indicating a product which is low in calories or
significantly reduced in calories. Consequently, except as provided in
paragraph (c)(2) of this section, a product may not be labeled with such
terms unless:
(i) The product contains less than 0.5 g of sugars, as defined in
Sec. 317.309(c)(6)(ii), per reference amount customarily consumed and
per labeled serving size or, in the case of a meal-type product, less
than 0.5 g of sugars per labeled serving size;
(ii) The product contains no ingredient that is a sugar or that is
generally understood by consumers to contain sugars unless the listing
of the ingredient in the ingredients statement is followed by an
asterisk that refers to the statement below the list of ingredients,
which states: "Adds a trivial amount of sugar," "adds a negligible
amount of sugar," or "adds a dietarily insignificant amount of
sugar;" and
(iii)(A) It is labeled "low calorie" or "reduced calorie" or
bears a relative claim of special dietary usefulness labeled in
compliance with paragraphs (b)(2), (b)(3), (b)(4), or (b)(5) of this
section; or
(B) Such term is immediately accompanied, each time it is used, by
either the statement "not a reduced calorie product," "not a low
calorie product," or "not for weight control."
(2) The terms "no added sugar," "without added sugar," or "no
sugar added" may be used only if:
(i) No amount of sugars, as defined in Sec. 317.309(c)(6)(ii), or
any other ingredient that contains sugars that functionally substitute
for added sugars is added during processing or packaging;
(ii) The product does not contain an ingredient containing added
sugars such as jam, jelly, or concentrated fruit juice;
(iii) The sugars content has not been increased above the amount
present in the ingredients by some means such as the use of enzymes,
except where the intended functional effect of the process is not to
increase the sugars content of a product, and a functionally
insignificant increase in sugars results;
(iv) The product that it resembles and for which it substitutes
normally contains added sugars; and
(v) The product bears a statement that the product is not "low
calorie" or "calorie reduced" (unless the product meets the
requirements for a "low" or "reduced calorie" product) and that
directs consumers' attention to the nutrition panel for further
information on sugar and calorie content.
(3) Paragraph (c)(1) of this section shall not apply to a factual
statement that a product, including products intended specifically for
infants and children less than 2 years of age, is unsweetened or
contains no added sweeteners in the case of a product that contains
apparent substantial inherent sugar content, e.g., juices.
(4) The terms "reduced sugar," "reduced in sugar," "sugar
reduced," "less sugar," "lower sugar," or "lower in sugar" may be
used on the label or in labeling of products, except meal-type products
as defined in Sec. 317.313(l), provided that:
(i) The product contains at least 25 percent less sugars per
reference amount customarily consumed than an appropriate reference
product as described in Sec. 317.313(j)(1); and
(ii) As required in Sec. 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the sugars differ between the two products are declared
in immediate proximity to the most prominent such claim (e.g., "this
product contains 25 percent less sugar than our regular product"); and
(B) Quantitative information comparing the level of the sugar in the
product per labeled serving size with that of the reference product that
it replaces is declared adjacent to the most prominent claim or to the
nutrition information (e.g., "sugar content has
[[Page 214]]
been lowered from 8 g to 6 g per serving").
(5) The terms defined in paragraph (c)(4) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 317.313(l), provided that:
(i) The product contains at least 25 percent less sugars per 100 g
of product than an appropriate reference product as described in
Sec. 317.313(j)(1); and
(ii) As required in Sec. 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the sugars differ between the two products are declared
in immediate proximity to the most prominent such claim (e.g., "reduced
sugar `product'--25% less sugar than our regular `product' "); and
(B) Quantitative information comparing the level of the nutrient in
the product per specified weight with that of the reference product that
it replaces is declared adjacent to the most prominent claim or to the
nutrition information (e.g., "sugar content has been reduced from 17 g
per 3 oz to 13 g per 3 oz").
[60 FR 191, Jan. 3, 1995]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.361]
[Page 214-216]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart B--Nutrition Labeling
Sec. 317.361 Nutrient content claims for the sodium content.
(a) General requirements. A claim about the level of sodium in a
product may only be made on the label or in labeling of the product if:
(1) The claim uses one of the terms defined in this section in
accordance with the definition for that term;
(2) The claim is made in accordance with the general requirements
for nutrient content claims in Sec. 317.313; and
(3) The product for which the claim is made is labeled in accordance
with Sec. 317.309.
(b) Sodium content claims. (1) The terms "sodium free," "free of
sodium," "no sodium," "zero sodium," "without sodium," "trivial
source of sodium," "negligible source of sodium," or "dietarily
insignificant source of sodium" may be used on the label or in labeling
of products, provided that:
(i) The product contains less than 5 milligrams (mg) of sodium per
reference amount customarily consumed and per labeled serving size or,
in the case of a meal-type product, less than 5 mg of sodium per labeled
serving size;
(ii) The product contains no ingredient that is sodium chloride or
is generally understood by consumers to contain sodium unless the
listing of the ingredient in the ingredients statement is followed by an
asterisk that refers to the statement below the list of ingredients,
which states: "Adds a trivial amount of sodium," "adds a negligible
amount of sodium" or "adds a dietarily insignificant amount of
sodium"; and
(iii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
the sodium content, it is labeled to clearly refer to all products of
its type and not merely to the particular brand to which the label
attaches.
(2) The terms "very low sodium" or "very low in sodium" may be
used on the label or in labeling of products, except meal-type products
as defined in Sec. 317.313(l), provided that:
(i)(A) The product has a reference amount customarily consumed
greater than 30 grams (g) or greater than 2 tablespoons (tbsp) and
contains 35 mg or less sodium per reference amount customarily consumed;
or
(B) The product has a reference amount customarily consumed of 30 g
or less or 2 tbsp or less and contains 35 mg or less sodium per
reference amount customarily consumed and per 50 g (for dehydrated
products that must be reconstituted before typical consumption with
water or a diluent containing an insignificant amount, as defined in
Sec. 317.309(f)(1), of all nutrients per reference amount customarily
consumed, the per-50-g criterion refers to the "as prepared" form);
and
(ii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
the sodium content, it is labeled to clearly refer to all products of
its type and not merely to the particular brand to which the label
attaches.
(3) The terms defined in paragraph (b)(2) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 317.313(l), provided that:
[[Page 215]]
(i) The product contains 35 mg or less of sodium per 100 g of
product; and
(ii) If the product meets this condition without the benefit of
special processing, alteration, formulation, or reformulation to lower
the sodium content, it is labeled to clearly refer to all products of
its type and not merely to the particular brand to which the label
attaches.
(4) The terms "low sodium," "low in sodium," "little sodium,"
"contains a small amount of sodium," or "low source of sodium" may
be used on the label and in labeling of products, except meal-type
products as defined in Sec. 317.313(l), provided that:
(i)(A) The product has a reference amount customarily consumed
greater than 30 g or greater than 2 tbsp and contains 140 mg or less
sodium per reference amount customarily consumed; or
(B) The product has a reference amount customarily consumed of 30 g
or less or 2 tbsp or less and contains 140 mg or less sodium per
reference amount customarily consumed and per 50 g (for dehydrated
products that must be reconstituted before typical consumption with
water or a diluent containing an insignificant amount, as defined in
Sec. 317.309(f)(1), of all nutrients per reference amount customarily
consumed, the per-50-g criterion refers to the "as prepared" form);
and
(ii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
the sodium content, it is labeled to clearly refer to all products of
its type and not merely to the particular brand to which the label
attaches.
(5) The terms defined in paragraph (b)(4) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 317.313(l), provided that:
(i) The product contains 140 mg or less sodium per 100 g of product;
and
(ii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
the sodium content, it is labeled to clearly refer to all products of
its type and not merely to the particular brand to which the label
attaches.
(6) The terms "reduced sodium," "reduced in sodium," "sodium
reduced," "less sodium," "lower sodium," or "lower in sodium" may
be used on the label or in labeling of products, except meal-type
products as defined in Sec. 317.313(l), provided that:
(i) The product contains at least 25 percent less sodium per
reference amount customarily consumed than an appropriate reference
product as described in Sec. 317.313(j)(1); and
(ii) As required in Sec. 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the sodium differs between the two products are declared
in immediate proximity to the most prominent such claim (e.g., "reduced
sodium `product', 50 percent less sodium than regular `product' "); and
(B) Quantitative information comparing the level of sodium in the
product per labeled serving size with that of the reference product that
it replaces is declared adjacent to the most prominent claim or to the
nutrition information (e.g., "sodium content has been lowered from 300
to 150 mg per serving").
(iii) Claims described in paragraph (b)(6) of this section may not
be made on the label or in labeling of a product if the nutrient content
of the reference product meets the definition for "low sodium."
(7) The terms defined in paragraph (b)(6) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 317.313(l), provided that:
(i) The product contains at least 25 percent less sodium per 100 g
of product than an appropriate reference product as described in
Sec. 317.313(j)(1); and
(ii) As required in Sec. 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the sodium differs between the two products are declared
in immediate proximity to the most prominent such claim (e.g., "reduced
sodium `product'--30% less sodium per 3 oz than our `regular product'
"); and
(B) Quantitative information comparing the level of sodium in the
product per specified weight with that of
[[Page 216]]
the reference product that it replaces is declared adjacent to the most
prominent claim or to the nutrition information (e.g., "sodium content
has been reduced from 220 mg per 3 oz to 150 mg per 3 oz").
(iii) Claims described in paragraph (b)(7) of this section may not
be made on the label or in labeling of products if the nutrient content
of the reference product meets the definition for "low sodium."
(c) The term "salt" is not synonymous with "sodium." Salt refers
to sodium chloride. However, references to salt content such as
"unsalted," "no salt," "no salt added" are potentially misleading.
(1) The term "salt free" may be used on the label or in labeling
of products only if the product is "sodium free" as defined in
paragraph (b)(1) of this section.
(2) The terms "unsalted," "without added salt," and "no salt
added" may be used on the label or in labeling of products only if:
(i) No salt is added during processing;
(ii) The product that it resembles and for which it substitutes is
normally processed with salt; and
(iii) If the product is not sodium free, the statement, "not a
sodium free product" or "not for control of sodium in the diet"
appears adjacent to the nutrition information of the product bearing the
claim.
(3) Paragraph (c)(2) of this section shall not apply to a factual
statement that a product intended specifically for infants and children
less than 2 years of age is unsalted, provided such statement refers to
the taste of the product and is not false or otherwise misleading.
[60 FR 192, Jan. 3, 1995]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.362]
[Page 216-221]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart B--Nutrition Labeling
Sec. 317.362 Nutrient content claims for fat, fatty acids, and cholesterol content.
(a) General requirements. A claim about the level of fat, fatty
acid, and cholesterol in a product may only be made on the label or in
labeling of products if:
(1) The claim uses one of the terms defined in this section in
accordance with the definition for that term;
(2) The claim is made in accordance with the general requirements
for nutrient content claims in Sec. 317.313; and
(3) The product for which the claim is made is labeled in accordance
with Sec. 317.309.
(b) Fat content claims. (1) The terms "fat free," "free of fat,"
"no fat," "zero fat," "without fat," "nonfat," "trivial source
of fat," "negligible source of fat," or "dietarily insignificant
source of fat" may be used on the label or in labeling of products,
provided that:
(i) The product contains less than 0.5 gram (g) of fat per reference
amount customarily consumed and per labeled serving size or, in the case
of a meal-type product, less than 0.5 g of fat per labeled serving size;
(ii) The product contains no added ingredient that is a fat or is
generally understood by consumers to contain fat unless the listing of
the ingredient in the ingredients statement is followed by an asterisk
that refers to the statement below the list of ingredients, which
states: "Adds a trivial amount of fat," "adds a negligible amount of
fat," or "adds a dietarily insignificant amount of fat"; and
(iii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
the fat content, it is labeled to clearly refer to all products of its
type and not merely to the particular brand to which the label attaches.
(2) The terms "low fat," "low in fat," "contains a small amount
of fat," "low source of fat," or "little fat" may be used on the
label and in labeling of products, except meal-type products as defined
in Sec. 317.313(l), provided that:
(i)(A) The product has a reference amount customarily consumed
greater than 30 g or greater than 2 tablespoons (tbsp) and contains 3 g
or less of fat per reference amount customarily consumed; or
(B) The product has a reference amount customarily consumed of 30 g
or less or 2 tbsp or less and contains 3 g or less of fat per reference
amount customarily consumed and per 50 g (for dehydrated products that
must be reconstituted before typical consumption with water or a diluent
containing an
[[Page 217]]
insignificant amount, as defined in Sec. 317.309(f)(1), of all nutrients
per reference amount customarily consumed, the per-50-g criterion refers
to the "as prepared" form).
(ii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
the fat content, it is labeled to clearly refer to all products of its
type and not merely to the particular brand to which the label attaches.
(3) The terms defined in paragraph (b)(2) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 317.313(l), provided that:
(i) The product contains 3 g or less of total fat per 100 g of
product and not more than 30 percent of calories from fat; and
(ii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
the fat content, it is labeled to clearly refer to all products of its
type and not merely to the particular brand to which the label attaches.
(4) The terms "reduced fat," "reduced in fat," "fat reduced,"
"less fat," "lower fat," or "lower in fat" may be used on the
label or in labeling of products, except meal-type products as defined
in Sec. 317.313(l), provided that:
(i) The product contains at least 25 percent less fat per reference
amount customarily consumed than an appropriate reference product as
described in Sec. 317.313(j)(1); and
(ii) As required in Sec. 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the fat differs between the two products are declared in
immediate proximity to the most prominent such claim (e.g., "reduced
fat--50 percent less fat than our regular `product' "); and
(B) Quantitative information comparing the level of fat in the
product per labeled serving size with that of the reference product that
it replaces is declared adjacent to the most prominent claim or to the
nutrition information (e.g., "fat content has been reduced from 8 g to
4 g per serving").
(iii) Claims described in paragraph (b)(4) of this section may not
be made on the label or in labeling of a product if the nutrient content
of the reference product meets the definition for "low fat."
(5) The terms defined in paragraph (b)(4) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 317.313(l), provided that:
(i) The product contains at least 25 percent less fat per 100 g of
product than an appropriate reference product as described in
Sec. 317.313(j)(1); and
(ii) As required in Sec. 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the fat differs between the two products are declared in
immediate proximity to the most prominent such claim (e.g., "reduced
fat `product', 33 percent less fat per 3 oz than our regular `product'
"); and
(B) Quantitative information comparing the level of fat in the
product per specified weight with that of the reference product that it
replaces is declared adjacent to the most prominent such claim or to the
nutrition information (e.g., "fat content has been reduced from 8 g per
3 oz to 5 g per 3 oz").
(iii) Claims described in paragraph (b)(5) of this section may not
be made on the label or in labeling of a product if the nutrient content
of the reference product meets the definition for "low fat."
(6) The term "------ percent fat free" may be used on the label or
in labeling of products, provided that:
(i) The product meets the criteria for "low fat" in paragraph
(b)(2) or (b)(3) of this section;
(ii) The percent declared and the words "fat free" are in uniform
type size; and
(iii) A "100 percent fat free" claim may be made only on products
that meet the criteria for "fat free" in paragraph (b)(1) of this
section, that contain less than 0.5 g of fat per 100 g, and that contain
no added fat.
(iv) A synonym for "------ percent fat free" is "------ percent
lean."
(c) Fatty acid content claims. (1) The terms "saturated fat free,"
"free of saturated fat," "no saturated fat,"
[[Page 218]]
"zero saturated fat," "without saturated fat," "trivial source of
saturated fat," "negligible source of saturated fat," or "dietarily
insignificant source of saturated fat" may be used on the label or in
labeling of products, provided that:
(i) The product contains less than 0.5 g of saturated fat and less
than 0.5 g trans fatty acids per reference amount customarily consumed
and per labeled serving size or, in the case of a meal-type product,
less than 0.5 g of saturated fat and less than 0.5 g trans fatty acids
per labeled serving size;
(ii) The product contains no ingredient that is generally understood
by consumers to contain saturated fat unless the listing of the
ingredient in the ingredients statement is followed by an asterisk that
refers to the statement below the list of ingredients, which states:
"Adds a trivial amount of saturated fat," "adds a negligible amount
of saturated fat," or "adds a dietarily insignificant amount of
saturated fat;" and
(iii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
saturated fat content, it is labeled to clearly refer to all products of
its type and not merely to the particular brand to which the label
attaches.
(2) The terms "low in saturated fat," "low saturated fat,"
"contains a small amount of saturated fat," "low source of saturated
fat," or "a little saturated fat" may be used on the label or in
labeling of products, except meal-type products as defined in
Sec. 317.313(l), provided that:
(i) The product contains 1 g or less of saturated fat per reference
amount customarily consumed and not more than 15 percent of calories
from saturated fat; and
(ii) If the product meets these conditions without benefit of
special processing, alteration, formulation, or reformulation to lower
saturated fat content, it is labeled to clearly refer to all products of
its type and not merely to the particular brand to which the label
attaches.
(3) The terms defined in paragraph (c)(2) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 317.313(l), provided that:
(i) The product contains 1 g or less of saturated fat per 100 g and
less than 10 percent calories from saturated fat; and
(ii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
saturated fat content, it is labeled to clearly refer to all products of
its type and not merely to the particular brand to which the label
attaches.
(4) The terms "reduced saturated fat," "reduced in saturated
fat," "saturated fat reduced," "less saturated fat," "lower
saturated fat," or "lower in saturated fat" may be used on the label
or in labeling of products, except meal-type products as defined in
Sec. 317.313(l), provided that:
(i) The product contains at least 25 percent less saturated fat per
reference amount customarily consumed than an appropriate reference
product as described in Sec. 317.313(j)(1); and
(ii) As required in Sec. 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the saturated fat differs between the two products are
declared in immediate proximity to the most prominent such claim (e.g.,
"reduced saturated fat `product', contains 50 percent less saturated
fat than the national average for `product' "); and
(B) Quantitative information comparing the level of saturated fat in
the product per labeled serving size with that of the reference product
that it replaces is declared adjacent to the most prominent claim or to
the nutrition information (e.g., "saturated fat reduced from 3 g to 1.5
g per serving").
(iii) Claims described in paragraph (c)(4) of this section may not
be made on the label or in labeling of a product if the nutrient content
of the reference product meets the definition for "low saturated fat."
(5) The terms defined in paragraph (c)(4) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 317.313(l), provided that:
(i) The product contains at least 25 percent less saturated fat per
100 g of
[[Page 219]]
product than an appropriate reference product as described in
Sec. 317.313(j)(1); and
(ii) As required in Sec. 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the saturated fat differs between the two products are
declared in immediate proximity to the most prominent such claim (e.g.,
"reduced saturated fat `product'," "50 percent less saturated fat
than our regular `product' "); and
(B) Quantitative information comparing the level of saturated fat in
the product per specified weight with that of the reference product that
it replaces is declared adjacent to the most prominent claim or to the
nutrition information (e.g., "saturated fat content has been reduced
from 2.5 g per 3 oz to 1.5 g per 3 oz").
(iii) Claims described in paragraph (c)(5) of this section may not
be made on the label or in labeling of a product if the nutrient content
of the reference product meets the definition for "low saturated fat."
(d) Cholesterol content claims. (1) The terms "cholesterol free,"
"free of cholesterol," "zero cholesterol," "without cholesterol,"
"no cholesterol," "trivial source of cholesterol," "negligible
source of cholesterol," or "dietarily insignificant source of
cholesterol" may be used on the label or in labeling of products,
provided that:
(i) The product contains less than 2 milligrams (mg) of cholesterol
per reference amount customarily consumed and per labeled serving size
or, in the case of a meal-type product as defined in Sec. 317.313(l),
less than 2 mg of cholesterol per labeled serving size;
(ii) The product contains no ingredient that is generally understood
by consumers to contain cholesterol, unless the listing of the
ingredient in the ingredients statement is followed by an asterisk that
refers to the statement below the list of ingredients, which states:
"Adds a trivial amount of cholesterol," "adds a negligible amount of
cholesterol," or "adds a dietarily insignificant amount of
cholesterol";
(iii) The product contains 2 g or less of saturated fat per
reference amount customarily consumed or, in the case of a meal-type
product as defined in Sec. 317.313(l), 2 g or less of saturated fat per
labeled serving size; and
(iv) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
cholesterol content, it is labeled to clearly refer to all products of
its type and not merely to the particular brand to which it attaches; or
(v) If the product meets these conditions only as a result of
special processing, alteration, formulation, or reformulation, the
amount of cholesterol is reduced by 25 percent or more from the
reference product it replaces as described in Sec. 317.313(j)(1) and for
which it substitutes as described in Sec. 317.313(d) that has a
significant (e.g., 5 percent or more of a national or regional market)
market share. As required in Sec. 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the cholesterol was reduced are declared in immediate
proximity to the most prominent such claim (e.g., "cholesterol free
`product', contains 100 percent less cholesterol than `reference
product' "); and
(B) Quantitative information comparing the level of cholesterol in
the product per labeled serving size with that of the reference product
that it replaces is declared adjacent to the most prominent claim or to
the nutrition information (e.g., "contains no cholesterol compared with
30 mg in one serving of `reference product' ").
(2) The terms "low in cholesterol," "low cholesterol,"
"contains a small amount of cholesterol," "low source of
cholesterol," or "little cholesterol" may be used on the label or in
labeling of products, except meal-type products as defined in
Sec. 317.313(l), provided that:
(i)(A) If the product has a reference amount customarily consumed
greater than 30 g or greater than 2 tbsp:
(1) The product contains 20 mg or less of cholesterol per reference
amount customarily consumed; and
(2) The product contains 2 g or less of saturated fat per reference
amount customarily consumed; or
(B) If the product has a reference amount customarily consumed of 30
g or less or 2 tbsp or less:
[[Page 220]]
(1) The product contains 20 mg or less of cholesterol per reference
amount customarily consumed and per 50 g (for dehydrated products that
must be reconstituted before typical consumption with water or a diluent
containing an insignificant amount, as defined in Sec. 317.309(f)(1), of
all nutrients per reference amount customarily consumed, the per-50-g
criterion refers to the "as prepared" form); and
(2) The product contains 2 g or less of saturated fat per reference
amount customarily consumed.
(ii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
cholesterol content, it is labeled to clearly refer to all products of
its type and not merely to the particular brand to which the label
attaches; or
(iii) If the product contains 20 mg or less of cholesterol only as a
result of special processing, alteration, formulation, or reformulation,
the amount of cholesterol is reduced by 25 percent or more from the
reference product it replaces as described in Sec. 317.313(j)(1) and for
which it substitutes as described in Sec. 317.313(d) that has a
significant (e.g., 5 percent or more of a national or regional market)
market share. As required in Sec. 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the cholesterol has been reduced are declared in
immediate proximity to the most prominent such claim (e.g., "low
cholesterol `product', contains 85 percent less cholesterol than our
regular `product' "); and
(B) Quantitative information comparing the level of cholesterol in
the product per labeled serving size with that of the reference product
that it replaces is declared adjacent to the most prominent claim or to
the nutrition information (e.g., "cholesterol lowered from 30 mg to 5
mg per serving").
(3) The terms defined in paragraph (d)(2) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 317.313(l), provided that:
(i) The product contains 20 mg or less of cholesterol per 100 g of
product;
(ii) The product contains 2 g or less of saturated fat per 100 g of
product; and
(iii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
cholesterol content, it is labeled to clearly refer to all products of
its type and not merely to the particular brand to which the label
attaches.
(4) The terms "reduced cholesterol," "reduced in cholesterol,"
"cholesterol reduced," "less cholesterol," "lower cholesterol," or
"lower in cholesterol" may be used on the label or in labeling of
products or products that substitute for those products as specified in
Sec. 317.313(d), excluding meal-type products as defined in
Sec. 317.313(l), provided that:
(i) The product has been specifically formulated, altered, or
processed to reduce its cholesterol by 25 percent or more from the
reference product it replaces as described in Sec. 317.313(j)(1) and for
which it substitutes as described in Sec. 317.313(d) that has a
significant (e.g., 5 percent or more of a national or regional market)
market share;
(ii) The product contains 2 g or less of saturated fat per reference
amount customarily consumed; and
(iii) As required in Sec. 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the cholesterol has been reduced are declared in
immediate proximity to the most prominent such claim (e.g., "25 percent
less cholesterol than `reference product' "); and
(B) Quantitative information comparing the level of cholesterol in
the product per labeled serving size with that of the reference product
that it replaces is declared adjacent to the most prominent claim or to
the nutrition information (e.g., "cholesterol lowered from 55 mg to 30
mg per serving").
(iv) Claims described in paragraph (d)(4) of this section may not be
made on the label or in labeling of a product if the nutrient content of
the reference product meets the definition for "low cholesterol."
(5) The terms defined in paragraph (d)(4) of this section may be
used on the label or in labeling of a meal-type
[[Page 221]]
product as defined in Sec. 317.313(l), provided that:
(i) The product has been specifically formulated, altered, or
processed to reduce its cholesterol by 25 percent or more from the
reference product it replaces as described in Sec. 317.313(j)(1) and for
which it substitutes as described in Sec. 317.313(d) that has a
significant (e.g., 5 percent or more of a national or regional market)
market share;
(ii) The product contains 2 g or less of saturated fat per 100 g of
product; and
(iii) As required in Sec. 317.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the cholesterol has been reduced are declared in
immediate proximity to the most prominent such claim (e.g., "25% less
cholesterol than `reference product' "); and
(B) Quantitative information comparing the level of cholesterol in
the product per specified weight with that of the reference product that
it replaces is declared adjacent to the most prominent claim or to the
nutrition information (e.g., "cholesterol content has been reduced from
35 mg per 3 oz to 25 mg per 3 oz).
(iv) Claims described in paragraph (d)(5) of this section may not be
made on the label or in labeling of a product if the nutrient content of
the reference product meets the definition for "low cholesterol."
(e) "Lean" and "Extra Lean" claims. (1) The term "lean" may be
used on the label or in labeling of a product, provided that the product
contains less than 10 g of fat, 4.5 g or less of saturated fat, and less
than 95 mg of cholesterol per 100 g of product and per reference amount
customarily consumed for individual foods, and per 100 g of product and
per labeled serving size for meal-type products as defined in
Sec. 317.313(l).
(2) The term "extra lean" may be used on the label or in labeling
of a product, provided that the product contains less than 5 g of fat,
less than 2 g of saturated fat, and less than 95 mg of cholesterol per
100 g of product and per reference amount customarily consumed for
individual foods, and per 100 g of product and per labeled serving size
for meal-type products as defined in Sec. 317.313(l).
[60 FR 193, Jan. 3, 1995]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.363]
[Page 221-222]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart B--Nutrition Labeling
Sec. 317.363 Nutrient content claims for "healthy."
(a) The term "healthy," or any other derivative of the term
"health," may be used on the labeling of any meat or meat food
product, provided that the product is labeled in accordance with
Sec. 317.309 and Sec. 317.313.
(b)(1) The product shall meet the requirements for "low fat" and
"low saturated fat," as defined in Sec. 317.362, except that single-
ingredient, raw products may meet the total fat and saturated fat
criteria for "extra lean" in Sec. 317.362.
(2) The product shall not contain more than 60 milligrams (mg) of
cholesterol per reference amount customarily consumed, per labeled
serving size, and, only for foods with reference amounts customarily
consumed of 30 grams (g) or less or 2 tablespoons (tbsp) or less, per 50
g, and, for dehydrated products that must be reconstituted with water or
a diluent containing an insignificant amount, as defined in
Sec. 317.309(f)(1), of all nutrients, the per-50-g criterion refers to
the prepared form, except that:
(i) A meal-type product, as defined in Sec. 317.313(l), and
including meal-type products that weigh more than 12 ounces (oz) per
serving (container), shall not contain more than 90 mg of cholesterol
per labeled serving size; and
(ii) Single-ingredient, raw products may meet the cholesterol
criterion for "extra lean"in Sec. 317.362.
(3) The product shall not contain more than 360 mg of sodium, except
that it shall not contain more than 480 mg of sodium effective through
January 1, 2003, per reference amount customarily consumed, per labeled
serving size, and, only for foods with reference amounts customarily
consumed of 30 g or less or 2 tbsp or less, per 50 g, and, for
dehydrated products that must be reconstituted with water or a diluent
containing an insignificant amount, as defined in Sec. 317.309(f)(1), of
all nutrients, the per-50-g criterion refers to the prepared form,
except that:
[[Page 222]]
(i) A meal-type product, as defined in Sec. 317.313(l), and
including meal-type products that weigh more than 12 oz per serving
(container), shall not contain more than 480 mg of sodium, except that
it shall not contain more than 600 mg of sodium effective through
January 1, 2003, per labeled serving size; and
(ii) The requirements of this paragraph (b)(3) do not apply to
single-ingredient, raw products.
(4) The product shall contain 10 percent or more of the Reference
Daily Intake or Daily Reference Value as defined in Sec. 317.309 for
vitamin A, vitamin C, iron, calcium, protein, or fiber per reference
amount customarily consumed prior to any nutrient addition, except that:
(i) A meal-type product, as defined in Sec. 317.313(l), and
including meal-type products that weigh at least 6 oz but less than 10
oz per serving (container), shall meet the level for two of the
nutrients per labeled serving size; and
(ii) A meal-type product, as defined in Sec. 317.313(l), and
including meal-type products that weigh 10 oz or more per serving
(container), shall meet the level for three of the nutrients per labeled
serving size.
[59 FR 24228, May 10, 1994, as amended at 60 FR 196, Jan. 3, 1995; 63 FR
7281, Feb. 13, 1998; 64 FR 72492, Dec. 28, 1999]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.369]
[Page 222-227]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart B--Nutrition Labeling
Sec. 317.369 Labeling applications for nutrient content claims.
(a) This section pertains to labeling applications for claims,
express or implied, that characterize the level of any nutrient required
to be on the label or in labeling of product by this subpart.
(b) Labeling applications included in this section are:
(1) Labeling applications for a new (heretofore unauthorized)
nutrient content claim,
(2) Labeling applications for a synonymous term (i.e., one that is
consistent with a term defined by regulation) for characterizing the
level of a nutrient, and
(3) Labeling applications for the use of an implied claim in a brand
name.
(c) Labeling applications and supporting documentation to be filed
under this section shall be submitted in quadruplicate, except that the
supporting documentation may be submitted on a computer disc copy. If
any part of the material submitted is in a foreign language, it shall be
accompanied by an accurate and complete English translation. The
labeling application shall state the applicant's post office address.
(d) Pertinent information will be considered as part of an
application on the basis of specific reference to such information
submitted to and retained in the files of the Food Safety and Inspection
Service. However, any reference to unpublished information furnished by
a person other than the applicant will not be considered unless use of
such information is authorized (with the understanding that such
information may in whole or part be subject to release to the public) in
a written statement signed by the person who submitted it. Any reference
to published information should be accompanied by reprints or
photostatic copies of such references.
(e) If nonclinical laboratory studies accompany a labeling
application, the applicant shall include, with respect to each
nonclinical study included with the application, either a statement that
the study has been, or will be, conducted in compliance with the good
laboratory practice regulations as set forth in part 58 of chapter 1,
title 21, or, if any such study was not conducted in compliance with
such regulations, a brief statement of the reason for the noncompliance.
(f) If clinical investigations accompany a labeling application, the
applicant shall include, with respect to each clinical investigation
included with the application, either a statement that the investigation
was conducted in compliance with the requirements for institutional
review set forth in part 56 of chapter 1, title 21, or was not subject
to such requirements in accordance with Sec. 56.194 or Sec. 56.105, and
that it was conducted in compliance with the requirements for informed
consents set forth in part 50 of chapter 1, title 21.
(g) The availability for public disclosure of labeling applications,
along
[[Page 223]]
with supporting documentation, submitted to the Agency under this
section will be governed by the rules specified in subchapter D, title
9.
(h) The data specified under this section to accompany a labeling
application shall be submitted on separate sheets, suitably identified.
If such data has already been submitted with an earlier labeling
application from the applicant, the present labeling application must
provide the data.
(i) The labeling application must be signed by the applicant or by
his or her attorney or agent, or (if a corporation) by an authorized
official.
(j) The labeling application shall include a statement signed by the
person responsible for the labeling application, that to the best of his
or her knowledge, it is a representative and balanced submission that
includes unfavorable information, as well as favorable information,
known to him or her pertinent to the evaluation of the labeling
application.
(k)(1) Labeling applications for a new nutrient content claim shall
be accompanied by the following data which shall be submitted in the
following form to the Director, Food Labeling Division, Regulatory
Programs, Food Safety and Inspection Service, Washington, DC 20250.
________________________________________________________________________
(Date)
The undersigned, ----------, submits this labeling application
pursuant to 9 CFR 317.369 with respect to (statement of the claim and
its proposed use).
Attached hereto, in quadruplicate, or on a computer disc copy, and
constituting a part of this labeling application, are the following:
(i) A statement identifying the nutrient content claim and the
nutrient that the term is intended to characterize with respect to the
level of such nutrient. The statement shall address why the use of the
term as proposed will not be misleading. The statement shall provide
examples of the nutrient content claim as it will be used on labels or
labeling, as well as the types of products on which the claim will be
used. The statement shall also specify the level at which the nutrient
must be present or what other conditions concerning the product must be
met for the appropriate use of the term in labels or labeling, as well
as any factors that would make the use of the term inappropriate.
(ii) A detailed explanation supported by any necessary data of why
use of the food component characterized by the claim is of importance in
human nutrition by virtue of its presence or absence at the levels that
such claim would describe. This explanation shall also state what
nutritional benefit to the public will derive from use of the claim as
proposed and why such benefit is not available through the use of
existing terms defined by regulation. If the claim is intended for a
specific group within the population, the analysis shall specifically
address nutritional needs of such group, and scientific data sufficient
for such purpose, and data and information to the extent necessary to
demonstrate that consumers can be expected to understand the meaning of
the term under the proposed conditions of use.
(iii) Analytical data that demonstrates the amount of the nutrient
that is present in the products for which the claim is intended. The
assays should be performed on representative samples in accordance with
317.309(h). If no USDA or AOAC methods are available, the applicant
shall submit the assay method used, and data establishing the validity
of the method for assaying the nutrient in the particular food. The
validation data shall include a statistical analysis of the analytical
and product variability.
(iv) A detailed analysis of the potential effect of the use of the
proposed claim on food consumption, and any corresponding changes in
nutrient intake. The analysis shall specifically address the intake of
nutrients that have beneficial and negative consequences in the total
diet. If the claim is intended for a specific group within the
population, the analysis shall specifically address the dietary
practices of such group, and shall include data sufficient to
demonstrate that the dietary analysis is representative of such group.
Yours very truly,
Applicant_________________________________________________________
By________________________________________________________________
(Indicate authority)
(2) Upon receipt of the labeling application and supporting
documentation, the applicant shall be notified, in writing, of the date
on which the labeling application was received. Such notice shall inform
the applicant that the labeling application is undergoing Agency review
and that the applicant shall subsequently be notified of the Agency's
decision to consider for further review or deny the labeling
application.
(3) Upon review of the labeling application and supporting
documentation, the Agency shall notify the applicant,
[[Page 224]]
in writing, that the labeling application is either being considered for
further review or that it has been summarily denied by the
Administrator.
(4) If the labeling application is summarily denied by the
Administrator, the written notification shall state the reasons
therefor, including why the Agency has determined that the proposed
nutrient content claim is false or misleading. The notification letter
shall inform the applicant that the applicant may submit a written
statement by way of answer to the notification, and that the applicant
shall have the right to request a hearing with respect to the merits or
validity of the Administrator's decision to deny the use of the proposed
nutrient content claim.
(i) If the applicant fails to accept the determination of the
Administrator and files an answer and requests a hearing, and the
Administrator, after review of the answer, determines the initial
determination to be correct, the Administrator shall file with the
Hearing Clerk of the Department the notification, answer, and the
request for a hearing, which shall constitute the complaint and answer
in the proceeding, which shall thereafter be conducted in accordance
with the Department's Uniform Rules of Practice.
(ii) The hearing shall be conducted before an administrative law
judge with the opportunity for appeal to the Department's Judicial
Officer, who shall make the final determination for the Secretary. Any
such determination by the Secretary shall be conclusive unless, within
30 days after receipt of notice of such final determination, the
applicant appeals to the United States Court of Appeals for the circuit
in which the applicant has its principal place of business or to the
United States Court of Appeals for the District of Columbia Circuit.
(5) If the labeling application is not summarily denied by the
Administrator, the Administrator shall publish in the Federal Register a
proposed rule to amend the regulations to authorize the use of the
nutrient content claim. The proposal shall also summarize the labeling
application, including where the supporting documentation can be
reviewed. The Administrator's proposed rule shall seek comment from
consumers, the industry, consumer and industry groups, and other
interested persons on the labeling application and the use of the
proposed nutrient content claim. After public comment has been received
and reviewed by the Agency, the Administrator shall make a determination
on whether the proposed nutrient content claim shall be approved for use
on the labeling of meat and meat food products.
(i) If the claim is denied by the Administrator, the Agency shall
notify the applicant, in writing, of the basis for the denial, including
the reason why the claim on the labeling was determined by the Agency to
be false or misleading. The notification letter shall also inform the
applicant that the applicant may submit a written statement by way of
answer to the notification, and that the applicant shall have the right
to request a hearing with respect to the merits or validity of the
Administrator's decision to deny the use of the proposed nutrient
content claim.
(A) If the applicant fails to accept the determination of the
Administrator and files an answer and requests a hearing, and the
Administrator, after review of the answer, determines the initial
determination to be correct, the Administrator shall file with the
Hearing Clerk of the Department the notification, answer, and the
request for a hearing, which shall constitute the complaint and answer
in the proceeding, which shall thereafter be conducted in accordance
with the Department's Uniform Rules of Practice.
(B) The hearing shall be conducted before an administrative law
judge with the opportunity for appeal to the Department's Judicial
Officer, who shall make final determination for the Secretary. Any such
determination by the Secretary shall be conclusive unless, within 30
days after receipt of the notice of such final determination, the
applicant appeals to the United States Court of Appeals for the circuit
in which the applicant has its principal place of business or to the
United States Court of Appeals for the District of Columbia Circuit.
(ii) If the claim is approved, the Agency shall notify the
applicant, in
[[Page 225]]
writing, and shall also publish in the Federal Register a final rule
amending the regulations to authorize the use of the claim.
(l)(1) Labeling applications for a synonymous term shall be
accompanied by the following data which shall be submitted in the
following form to the Director, Food Labeling Division, Regulatory
Programs, Food Safety and Inspection Service, Washington, DC 20250:
________________________________________________________________________
(Date)
The undersigned, ------------ submits this labeling application
pursuant to 9 CFR 317.369 with respect to (statement of the synonymous
term and its proposed use in a nutrient content claim that is consistent
with an existing term that has been defined under subpart B of part
317).
Attached hereto, in quadruplicate, or on a computer disc copy, and
constituting a part of this labeling application, are the following:
(i) A statement identifying the synonymous term, the existing term
defined by a regulation with which the synonymous term is claimed to be
consistent, and the nutrient that the term is intended to characterize
the level of. The statement shall address why the use of the synonymous
term as proposed will not be misleading. The statement shall provide
examples of the nutrient content claim as it will be used on labels or
labeling, as well as the types of products on which the claim will be
used. The statement shall also specify whether any limitations not
applicable to the use of the defined term are intended to apply to the
use of the synonymous term.
(ii) A detailed explanation supported by any necessary data of why
use of the proposed term is requested, including whether the existing
defined term is inadequate for the purpose of effectively characterizing
the level of a nutrient. This explanation shall also state what
nutritional benefit to the public will derive from use of the claim as
proposed, and why such benefit is not available through the use of
existing terms defined by regulation. If the claim is intended for a
specific group within the population, the analysis shall specifically
address nutritional needs of such group, scientific data sufficient for
such purpose, and data and information to the extent necessary to
demonstrate that consumers can be expected to understand the meaning of
the term under the proposed conditions of use.
Yours very truly,
Applicant_________________________________________________________
By________________________________________________________________
(Indicate authority)
(2) Upon receipt of the labeling application and supporting
documentation, the applicant shall be notified, in writing, of the date
on which the labeling application was received. Such notice shall inform
the applicant that the labeling application is undergoing Agency review
and that the applicant shall subsequently be notified of the Agency's
decision to consider for further review or deny the labeling
application.
(3) Upon review of the labeling application and supporting
documentation, the Agency shall notify the applicant, in writing, that
the labeling application is either being considered for further review
or that it has been summarily denied by the Administrator.
(4) If the labeling application is summarily denied by the
Administrator, the written notification shall state the reasons
therefor, including why the Agency has determined that the proposed
synonymous term is false or misleading. The notification letter shall
inform the applicant that the applicant may submit a written statement
by way of answer to the notification, and that the applicant shall have
the right to request a hearing with respect to the merits or validity of
the Administrator's decision to deny the use of the proposed synonymous
term.
(i) If the applicant fails to accept the determination of the
Administrator and files an answer and requests a hearing, and the
Administrator, after review of the answer, determines the initial
determination to be correct, the Administrator shall file with the
Hearing Clerk of the Department the notification, answer, and the
request for a hearing, which shall constitute the complaint and answer
in the proceeding, which shall thereafter be conducted in accordance
with the Department's Uniform Rules of Practice.
(ii) The hearing shall be conducted before an administrative law
judge with the opportunity for appeal to the Department's Judicial
Officer, who shall make the final determination for the Secretary. Any
such determination by the Secretary shall be conclusive unless, within
30 days after receipt of notice of such final determination, the
applicant appeals to the United States Court of Appeals for the circuit
in which the applicant has its principal
[[Page 226]]
place of business or to the United States Court of Appeals for the
District of Columbia Circuit.
(5) If the claim is approved, the Agency shall notify the applicant,
in writing, and shall publish in the Federal Register a notice informing
the public that the synonymous term has been approved for use.
(m)(1) Labeling applications for the use of an implied nutrient
content claim in a brand name shall be accompanied by the following data
which shall be submitted in the following form to the Director, Food
Labeling Division, Regulatory Programs, Food Safety and Inspection
Service, Washington, DC 20250:
________________________________________________________________________
(Date)
The undersigned, ------------ submits this labeling application
pursuant to 9 CFR 317.369 with respect to (statement of the implied
nutrient content claim and its proposed use in a brand name).
Attached hereto, in quadruplicate, or on a computer disc copy, and
constituting a part of this labeling application, are the following:
(i) A statement identifying the implied nutrient content claim, the
nutrient the claim is intended to characterize, the corresponding term
for characterizing the level of such nutrient as defined by a
regulation, and the brand name of which the implied claim is intended to
be a part. The statement shall address why the use of the brand-name as
proposed will not be misleading. The statement shall provide examples of
the types of products on which the brand name will appear. It shall also
include data showing that the actual level of the nutrient in the food
would qualify the label of the product to bear the corresponding term
defined by regulation. Assay methods used to determine the level of a
nutrient shall meet the requirements stated under labeling application
format in paragraph (k)(1)(iii) of this section.
(ii) A detailed explanation supported by any necessary data of why
use of the proposed brand name is requested. This explanation shall also
state what nutritional benefit to the public will derive from use of the
brand name as proposed. If the branded product is intended for a
specific group within the population, the analysis shall specifically
address nutritional needs of such group and scientific data sufficient
for such purpose.
Yours very truly,
Applicant_________________________________________________________
By________________________________________________________________
(2) Upon receipt of the labeling application and supporting
documentation, the applicant shall be notified, in writing, of the date
on which the labeling application was received. Such notice shall inform
the applicant that the labeling application is undergoing Agency review
and that the applicant shall subsequently be notified of the Agency's
decision to consider for further review or deny the labeling
application.
(3) Upon review of the labeling application and supporting
documentation, the Agency shall notify the applicant, in writing, that
the labeling application is either being considered for further review
or that it has been summarily denied by the Administrator.
(4) If the labeling application is summarily denied by the
Administrator, the written notification shall state the reasons
therefor, including why the Agency has determined that the proposed
implied nutrient content claim is false or misleading. The notification
letter shall inform the applicant that the applicant may submit a
written statement by way of answer to the notification, and that the
applicant shall have the right to request a hearing with respect to the
merits or validity of the Administrator's decision to deny the use of
the proposed implied nutrient content claim.
(i) If the applicant fails to accept the determination of the
Administrator and files an answer and requests a hearing, and the
Administrator, after review of the answer, determines the initial
determination to be correct, the Administrator shall file with the
Hearing Clerk of the Department the notification, answer, and the
request for a hearing, which shall constitute the complaint and answer
in the proceeding, which shall thereafter be conducted in accordance
with the Department's Uniform Rules of Practice.
(ii) The hearing shall be conducted before an administrative law
judge with the opportunity for appeal to the Department's Judicial
Officer, who shall make the final determination for the Secretary. Any
such determination by the Secretary shall be conclusive unless, within
30 days after receipt of notice of such final determination, the
applicant appeals to the United States Court of Appeals for the circuit
in
[[Page 227]]
which the applicant has its principal place of business or to the United
States Court of Appeals for the District of Columbia Circuit.
(5) If the labeling application is not summarily denied by the
Administrator, the Administrator shall publish a notice of the labeling
application in the Federal Register seeking comment on the use of the
implied nutrient content claim. The notice shall also summarize the
labeling application, including where the supporting documentation can
be reviewed. The Administrator's notice shall seek comment from
consumers, the industry, consumer and industry groups, and other
interested persons on the labeling application and the use of the
implied nutrient content claim. After public comment has been received
and reviewed by the Agency, the Administrator shall make a determination
on whether the implied nutrient content claim shall be approved for use
on the labeling of meat food products.
(i) If the claim is denied by the Administrator, the Agency shall
notify the applicant, in writing, of the basis for the denial, including
the reason why the claim on the labeling was determined by the Agency to
be false or misleading. The notification letter shall also inform the
applicant that the applicant may submit a written statement by way of
answer to the notification, and that the applicant shall have the right
to request a hearing with respect to the merits or validity of the
Administrator's decision to deny the use of the proposed implied
nutrient content claim.
(A) If the applicant fails to accept the determination of the
Administrator and files an answer and requests a hearing, and the
Administrator, after review of the answer, determines the initial
determination to be correct, the Administrator shall file with the
Hearing Clerk of the Department the notification, answer, and the
request for a hearing, which shall thereafter be conducted in accordance
with the Department's Uniform Rules of Practice.
(B) The hearing shall be conducted before an administrative law
judge with the opportunity for appeal to the Department's Judicial
Officer, who shall make the final determination for the Secretary. Any
such determination by the Secretary shall be conclusive unless, within
30 days after receipt of the notice of such final determination, the
applicant appeals to the United States Court of Appeals for the circuit
in which the applicant has its principal place of business or to the
United States Court of Appeals for the District of Columbia Circuit.
(ii) If the claim is approved, the Agency shall notify the
applicant, in writing, and shall also publish in the Federal Register a
notice informing the public that the implied nutrient content claim has
been approved for use.
(Paperwork requirements were approved by the Office of Management and
Budget under control number 0583-0088)
[58 FR 664, Jan. 6, 1993, as amended at 59 FR 45196, Sept. 1, 1994; 60
FR 196, Jan. 3, 1995]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.380]
[Page 227-228]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart B--Nutrition Labeling
Sec. 317.380 Label statements relating to usefulness in reducing or maintaining body weight.
(a) General requirements. Any product that purports to be or is
represented for special dietary use because of usefulness in reducing
body weight shall bear:
(1) Nutrition labeling in conformity with Sec. 317.309 of this
subpart, unless exempt under that section, and
(2) A conspicuous statement of the basis upon which the product
claims to be of special dietary usefulness.
(b) Nonnutritive ingredients. (1) Any product subject to paragraph
(a) of this section that achieves its special dietary usefulness by use
of a nonnutritive ingredient (i.e., one not utilized in normal
metabolism) shall bear on its label a statement that it contains a
nonnutritive ingredient and the percentage by weight of the nonnutritive
ingredient.
(2) A special dietary product may contain a nonnutritive sweetener
or other ingredient only if the ingredient is safe for use in the
product under the applicable law and regulations of this chapter. Any
product that achieves its special dietary usefulness in reducing or
maintaining body weight through the use of a nonnutritive sweetener
shall bear on its label the statement
[[Page 228]]
required by paragraph (b)(1) of this section, but need not state the
percentage by weight of the nonnutritive sweetener. If a nutritive
sweetener(s) as well as nonnutritive sweetener(s) is added, the
statement shall indicate the presence of both types of sweetener; e.g.,
"Sweetened with nutritive sweetener(s) and nonnutritive sweetener(s)."
(c) "Low calorie" foods. A product purporting to be "low
calorie" must comply with the criteria set forth for such foods in
Sec. 317.360.
(d) "Reduced calorie" foods and other comparative claims. A
product purporting to be "reduced calorie" or otherwise containing
fewer calories than a reference food must comply with the criteria set
forth for such foods in Sec. 317.360(b) (4) and (5).
(e) "Label terms suggesting usefulness as low calorie or reduced
calorie foods". (1) Except as provided in paragraphs (e)(2) and (e)(3)
of this section, a product may be labeled with terms such as "diet,"
"dietetic," "artificially sweetened," or "sweetened with
nonnutritive sweetener" only if the claim is not false or misleading,
and the product is labeled "low calorie" or "reduced calorie" or
bears another comparative calorie claim in compliance with the
applicable provisions in this subpart.
(2) Paragraph (e)(1) of this section shall not apply to any use of
such terms that is specifically authorized by regulation governing a
particular food, or, unless otherwise restricted by regulation, to any
use of the term "diet" that clearly shows that the product is offered
solely for a dietary use other than regulating body weight, e.g., "for
low sodium diets."
(3) Paragraph (e)(1) of this section shall not apply to any use of
such terms on a formulated meal replacement or other product that is
represented to be of special dietary use as a whole meal, pending the
issuance of a regulation governing the use of such terms on foods.
(f) "Sugar free" and "no added sugar". Criteria for the use of
the terms "sugar free" and "no added sugar" are provided for in
Sec. 317.360(c).
[58 FR 664, Jan. 6, 1993; 58 FR 43788, Aug. 18, 1993, as amended at 58
FR 47627, Sept. 10, 1993; 58 FR 66075, Dec. 17, 1993; 60 FR 196, Jan. 3,
1995]
[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.400]
[Page 228-229]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart B--Nutrition Labeling
Sec. 317.400 Exemption from nutrition labeling.
(a) The following meat or meat food products are exempt from
nutrition labeling:
(1) Food products produced by small businesses provided that the
labels for these products bear no nutrition claims or nutrition
information,
(i) A food product, for the purposes of the small business
exemption, is defined as a formulation, not including distinct flavors
which do not significantly alter the nutritional profile, sold in any
size package in commerce.
(ii) For purposes of this paragraph, a small business is any single-
plant facility or multi-plant company/firm that employs 500 or fewer
people and produces no more than the following amounts of pounds of the
product qualifying the firm for exemption from this subpart:
(A) During the first year of implementation of nutrition labeling,
from July 1994 to July 1995, 250,000 pounds or less,
(B) During the second year of implementation of nutrition labeling,
from July 1995 to July 1996, 175,000 pounds or less, and
(C) During the third year of implementation and subsequent years
thereafter, 100,000 pounds or less.
(iii) For purposes of this paragraph, calculation of the amount of
pounds shall be based on the most recent 2-year average of business
activity. Where firms have been in business less than 2 years or where
products have been produced for less than 2 years, reasonable estimates
must indicate that the annual pounds produced will not exceed the
amounts specified.
(2) Products intended for further processing, provided that the
labels for these products bear no nutrition claim or nutrition
information,
(3) Products that are not for sale to consumers, provided that the
labels for these products bear no nutrition claims or nutrition
information,
(4) Products in small packages that are individually wrapped
packages of less than \1/2\ ounce net weight, provided that the labels
for these products bear
[[Page 229]]
no nutrition claims or nutrition information,
(5) Products custom slaughtered or prepared,
(6) Products intended for export, and
(7) The following products prepared and served or sold at retail
provided that the labels or the labeling of these products bear no
nutrition claims or nutrition information:
(i) Ready-to-eat products that are packaged or portioned at a retail
store or similar retail-type establishment; and
(ii) Multi-ingredient products (e.g., sausage) processed at a retail
store or similar retail-type establishment.
(b) Restaurant menus generally do not constitute labeling or fall
within the scope of these regulations.
(c)(1) Foods represented to be specifically for infants and children
less than 2 years of age shall bear nutrition labeling as provided in
paragraph (c)(2) of this section, except such labeling shall not include
calories from fat, calories from saturated fat, saturated fat, stearic
acid, polyunsaturated fat, monounsaturated fat, and cholesterol.
(2) Foods represented or purported to be specifically for infants
and children less than 4 years of age shall bear nutrition labeling
except that:
(i) Such labeling shall not include declarations of percent of Daily
Value for total fat, saturated fat, cholesterol, sodium, potassium,
total carbohydrate, and dietary fiber;
(ii) Nutrient names and quantitative amounts by weight shall be
presented in two separate columns;
(iii) The heading "Percent Daily Value" required in
Sec. 317.309(d)(6) shall be placed immediately below the quantitative
information by weight for protein;
(iv) The percent of the Daily Value for protein, vitamins, and
minerals shall be listed immediately below the heading "Percent Daily
Value"; and
(v) Such labeling shall not include the footnote specified in
Sec. 317.309(d)(9).
(d)(1) Products in packages that have a total surface area available
to bear labeling of less than 12 square inches are exempt from nutrition
labeling, provided that the labeling for these products bear no
nutrition claims or other nutrition information. The manufacturer,
packer, or distributor shall provide, on the label of packages that
qualify for and use this exemption, an address or telephone number that
a consumer can use to obtain the required nutrition information (e.g.,
"For nutrition information call 1-800-123-4567").
(2) When such products bear nutrition labeling, either voluntarily
or because nutrition claims or other nutrition information is provided,
all required information shall be in a type size no smaller than 6 point
or all upper case type of \1/16\-inch minimum height, except that
individual serving-size packages of meat products that have a total area
available to bear labeling of 3 square inches or less may provide all
required information in a type size no smaller than \1/32\-inch minimum
height.
[58 FR 664, Jan. 6, 1993, as amended at 58 FR 47627, Sept. 10, 1993; 59
FR 45196, Sept. 1, 1994; 60 FR 196, Jan. 3, 1995]
