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U.S. Food and Drug Administration
The NEW FOOD LABEL
Grocery store aisles have become avenues to greater nutritional knowledge.
The new food label makes it possible. Under new regulations from the Food
and Drug Administration of the Department of Health and Human Services and
the Food Safety and Inspection Service of the U.S. Department of
Agriculture, the food label offers more complete, useful and accurate
nutrition information than ever before.
The purpose of the food label reform was simple: to clear up confusion that
has prevailed on supermarket shelves for years, to help consumers choose
more healthful diets, and to offer an incentive to food companies to
improve the nutritional qualities of their products.
Among key features are:
- nutrition labeling for almost all foods. Consumers now can learn
about the nutritional qualities of almost all of the products they
buy.
- a new, distinctive, easy-to-read format that enables consumers to more
quickly find the label and the information they need to make healthful
food choices
- information on the amount per serving of saturated fat, cholesterol,
dietary fiber, and other nutrients that are of major health concern to
today's consumers
- nutrient reference values, expressed as %Daily Values, that help
consumers see how a food fits into an overall daily diet
- uniform definitions for terms that describe a food's nutrient
content--such as "light," "low-fat," and "high-fiber"--to ensure that
such terms mean the same for any product on which they appear. These
descriptors are particularly helpful for consumers trying to moderate
their intake of calories or fat and other nutrients, or for those
trying to increase their intake of certain nutrients, such as fiber.
- claims about the relationship between a nutrient or food and a disease
or health-related condition, such as calcium and osteoporosis, and fat
and cancer. These are helpful for people who are concerned about
eating foods that may help keep them healthier longer.
- standardized serving sizes that make nutritional comparisons of
similar products easier
- declaration of total percentage of juice in juice drinks. This
enables consumers to know exactly how much juice is in a product.
- voluntary nutrition information for many raw foods.
NLEA
These and other changes are part of final rules published in the Federal
Register in 1992 and 1993. FDA's rules implement the provisions of t he
Nutrition Labeling and Education Act of 1990 (NLEA), which, among other
things, requires nutrition labeling for most foods (except meat and
poultry) and authorizes the use of nutrient content claims and appropriate
FDA-approved health claims.
Meat and poultry products regulated by USDA are not covered by NLEA.
However, USDA's regulations closely parallel FDA's rules, summarized here.
Nutrition Labeling--Applicable Foods
The regulations, most of which went into effect in 1994, call for nutrition
labeling for most foods. In addition, they set up voluntary programs for
nutrition information for many raw foods: the 20 most frequently eaten raw
fruits, vegetables and fish each, under FDA's voluntary point-of-purchase
nutrition information program, and the 45 best-selling cuts of meat, under
USDA's program.
Although voluntary, FDA's program for raw produce and fish carries a strong
incentive for retailers to participate. The program will remain voluntary
only if at least 60 percent of a nationwide sample of retailers continue to
provide the necessary information. (In a 1994 survey, FDA found that more
than 70 percent of U.S. food stores were complying.
Nutrition information also will be provided for some restaurant foods. The
current regulations require nutrition information for foods about which
health or nutrient-content claims are made on restaurant signs or placards.
In June 1993, FDA proposed similar requirements for restaurant menu items
with such claims. Under that proposal, restaurants would have to provide a
"reasonable basis" for making claims. They would be given some flexibility
in demonstrating that reasonable basis. For example, they could rely on
recipes endorsed by medical or dietary groups.
ƒ Nutrition Labeling--Exemptionsƒ
Under NLEA, some foods are exempt from nutrition labeling. These include:
- food served for immediate consumption, such as that served in hospital
cafeterias and airplanes, and that sold by food service vendors--for
example, mall cookie counters, sidewalk vendors, and vending machines
- ready-to-eat food that is not for immediate consumption but is
prepared primarily on site--for example, bakery, deli, and candy store
items
- food shipped in bulk, as long as it is not for sale in that form to
consumers
- medical foods, such as those used to address the nutritional needs of
patients with certain diseases
- plain coffee and tea, some spices, and other foods that contain no
significant amounts of any nutrients.
Food produced by small businesses also is exempt, under 1993 amendments to
NLEA. The NLEA amendments provide for a system in which exemptions are
based on the number of people a company employs and the number of units
within a product line it makes yearly.
Under this system, the allowances for each factor are gradually lowered.
Between May 9, 1995, and May 8, 1996, a food is exempt from nutrition
labeling if the company whose name appears on the label employs fewer than
300 full-time equivalent employees and makes fewer than 400,000 units of
the product yearly. After May 1997, only businesses with fewer than 100
full-time equivalent employees producing fewer than 100,000 units within a
product line for U.S. distribution can qualify for an exemption.
Almost all companies seeking an exemption will have to notify FDA that they
meet the criteria. Those that do not have to notify FDA are U.S. firms
with fewer than 10 employees making fewer than 10,000 units of a food in a
year.
Although these foods are exempt, they are free to carry nutrition
information, when appropriate--as long as it complies with the new
regulations. Also, they will lose their exemption if their labels carry a
nutrient content or health claim or any other nutrition information.
Nutrition information about game meats--such as deer, bison, rabbit, quail,
wild turkey, and ostrich--is not required on individual packages. Instead,
it can be given on counter cards, signs, or other point-of-purchase
materials. Because few nutrient data exist for these foods, FDA believes
that allowing this option will enable game meat producers to give first
priority to collecting appropriate data and make it easier for them to
update the information as it becomes available.
ƒ Nutrition Panel Titleƒ
The new food label features a revamped nutrition panel. It has a new
title, "Nutrition Facts," which replaced "Nutrition Information Per
Serving." The new title signals that the product has been labeled according
to the new regulations. Also, for the first time, there are requirements
on type size, style, spacing, and contrast to ensure a more distinctive,
easy-to-read label.
ƒ Serving Sizesƒ
The serving size remains the basis for reporting each food s nutrient
content. However, unlike in the past, when the serving size was up to the
discretion of the food manufacturer, serving sizes now are more uniform and
reflect the amounts people actually eat. They also must be expressed in
both common household and metric measures.
FDA allows as common household measures: the cup, tablespoon, teaspoon,
piece, slice, fraction (such as "1/4 pizza"), and common household
containers used to package food products (such as a jar or tray). Ounces
may be used, but only if a common household unit is not applicable and an
appropriate visual unit is given-for example, 1 oz (28g/about 1/2 pickle).
Grams (g) and milliliters (mL) are the metric units that are used in
serving size statements.
NLEA defines serving size as the amount of food customarily eaten at one
time. The serving sizes that appear on food labels are based on
FDA-established lists of "Reference Amounts Customarily Consumed Per Eating
Occasion."
These reference amounts, which are part of the regulations, are broken down
into 139 FDA-regulated food product categories, including 11 groups of
foods specially formulated or processed for infants or children under 4.
They list the amounts of food customarily consumed per eating occasion for
each category, based primarily on national food consumption surveys. FDA s
list also gives the suggested label statement for serving size declaration.
For example, the category "breads (excluding sweet quick type), rolls" has
a reference amount of 50 g, and the appropriate label statement for sliced
bread or roll is " piece(s) ( g)" or, for unsliced bread, "2 oz (56 g/ inch
slice)."
The serving size of products that come in discrete units, such as cookies,
candy bars, and sliced products, is the number of whole units that most
closely approximates the reference amount. Cookies are an example. Under
the "bakery products" category, cookies have a reference amount of 30 g.
The household measure closest to that amount is the number of cookies that
comes closest to weighing 30 g. Thus, the serving size on the label of a
package of cookies in which each cookie weighs 13 g would read "2 cookies
(26 g)."
If one unit weighs more than 50 percent but less than 200 percent of the
reference amount, the serving size is one unit. For example, the reference
amount for bread is 50 g; therefore, the label of a loaf of bread in which
each slice weighs more than 25 g would state a serving size of one slice.
Certain rules apply to food products that are packaged and sold
individually. If such an individual package is less than 200 percent of
the applicable reference amount, the item qualifies as one serving. Thus,
a 360-mL (12-fluid-ounce) can of soda is one serving, since the reference
amount for carbonated beverages is 240 mL (8 ounces).
However, if the product has a reference amount of 100 g or 100 mL or more
and the package contains more than 150 percent but less than 200 percent of
the reference amount, manufacturers have the option of deciding whether the
product can be one or two servings.
An example is a 15-ounce (420 g) can of soup. The serving size reference
amount for soup is 245 g. Therefore, the manufacturer has the option to
declare the can of soup as one or two servings.
ƒ Nutrition Informationƒ
There is a new set of dietary components on the nutrition panel. The
mandatory (boldface) and voluntary components and the order in which they
must appear are:
-ƒ total caloriesƒ
-ƒ calories from fatƒ
- calories from saturated fat
-ƒ total fatƒ
-ƒ saturated fatƒ
- polyunsaturated fat
- monounsaturated fat
-ƒ cholesterolƒ
-ƒ sodiumƒ
- potassium
-ƒ total carbohydrateƒ
-ƒ dietary fiberƒ
- soluble fiber
- insoluble fiber
-ƒ sugarsƒ
- sugar alcohol (for example, the sugar substitutes xylitol, mannitol
and sorbitol)
- other carbohydrate (the difference between total carbohydrate and the
sum of dietary fiber, sugars, and sugar alcohol if declared)
-ƒ proteinƒ
-ƒ vitamin Aƒ
- percent of vitamin A present as beta-carotene
-ƒ vitamin Cƒ
-ƒ calciumƒ
-ƒ ironƒ
- other essential vitamins and minerals
If a claim is made about any of the optional components, or if a food is
fortified or enriched with any of them, nutrition information for these
components becomes mandatory.
These mandatory and voluntary components are the only ones allowed on the
nutrition panel. The listing of single amino acids, maltodextrin, calories
from polyunsaturated fat, and calories from carbohydrates, for example, may
not appear as part of the Nutrition Facts on the label.
The required nutrients were selected because they address today s health
concerns. The order in which they must appear reflects the priority of
current dietary recommendations.
Thiamin, riboflavin and niacin are no longer required in nutrition labeling
because deficiencies of each are no longer considered of public health
significance. However, they may be listed voluntarily.
ƒ Nutrition Panel Formatƒ
The format for declaring nutrient content per serving also has been
revised. Now, all nutrients must be declared as percentages of the Daily
Values--the new label reference values. The amount, in grams or
milligrams, of macronutrients (such as fat, cholesterol, sodium,
carbohydrates, and protein) still must be listed to the immediate right of
each of the names of each of these nutrients. But, for the first time, a
column headed "%Daily Value" appears.
Requiring nutrients to be declared as a percentage of the Daily Values is
intended to prevent misinterpretations that arise with quantitative values.
For example, a food with 140 milligrams (mg) of sodium could be mistaken
for a high-sodium food because 140 is a relatively large number. In
actuality, however, that amount represents less than 6 percent of the Daily
Value for sodium, which is 2,400 mg.
On the other hand, a food with 5 g of saturated fat could be construed as
being low in that nutrient. In fact, that food would provide one-fourth
the total Daily Value because 20 g is the Daily Value for saturated fat
based on a 2,000-calorie diet.
ƒ Nutrition Panel Footnoteƒ
The %Daily Value listing carries a footnote saying that the percentages are
based on a 2,000-calorie diet. Some nutrition labels--at least those on
larger packages--have these additional footnotes:
- a sentence noting that a person s individual nutrient goals are based
on his or her calorie needs
- lists of the daily values for selected nutrients for a 2,000- and a
2,500-calorie diet.
An optional footnote for packages of any size is the number of calories per
gram of fat (9), and carbohydrate and protein (4).
ƒ Format Modificationsƒ
In limited circumstances, variations in the format of the nutrition panel
are allowed. Some are mandatory. For example, the labels of foods for
children under 2 (except infant formula, which has special labeling rules
under the Infant Formula Act of 1980) may not carry information about
saturated fat, polyunsaturated fat, monounsaturated fat, cholesterol,
calories from fat, or calories from saturated fat.
The reason is to prevent parents from wrongly assuming that infants and
toddlers should restrict their fat intake, when, in fact, they should not.
Fat is important during these years to ensure adequate growth and
development.
The labels of foods for children under 4 may not include the %Daily Values
for total fat, saturated fat, cholesterol, sodium, potassium, total
carbohydrate, and dietary fiber. They may carry %Daily Values for protein,
vitamins and minerals, however. These nutrients are the only ones for
which FDA has set Daily Values for this age group.
Thus, the top portion of the "Nutrition Facts" panels of foods for children
under 4 will consist of two columns. The nutrients names will be listed
on the left and their quantitative amounts will be on the right. The
bottom portion will provide the %Daily Values for protein, vitamins and
minerals. Only the calorie conversion information may be given as a
footnote.
Some foods qualify for a simplified label format. This format is allowed
when the food contains insignificant amounts of seven or more of the
mandatory nutrients and total calories. "Insignificant" means that a
declaration of zero could be made in nutrition labeling, or, for total
carbohydrate, dietary fiber, and protein, the declaration states "less than
1 g."
For foods for children under 2, the simplified format may be used if the
product contains insignificant amounts of six or more of the following:
calories, total fat, sodium, total carbohydrate, dietary fiber, sugars,
protein, vitamins A and C, calcium, and iron.
If the simplified format is used, information on total calories, total fat,
total carbohydrate, protein, and sodium--even if they are present in
insignificant amounts--must be listed. Other nutrients, along with
calories from fat, must be shown if they are present in more than
insignificant amounts. Nutrients added to the food must be listed, too.
Some format exceptions exist for small and medium-size packages. Packages
with less than 12 square inches of available labeling space (about the size
of a package of chewing gum) do not have to carry nutrition information
unless a nutrient content or health claim is made for the product.
However, they must provide an address or telephone number for consumers to
obtain the required nutrition information.
If manufacturers wish to provide nutrition information on these packages
voluntarily, they have several options: (1) present the information in a
smaller type size than that required for larger packages, or (2) present
the information in a tabular or linear (string) format.
The tabular and linear formats also may be used on packages that have less
than 40 square inches available for labeling and insufficient space for the
full vertical format.
Other options for packages with less than 40 square inches of label space
are:
- abbreviating names of dietary components
- omitting all footnotes, except for the statement that %Daily Values
are based on a 2,000-calorie diet
- placing nutrition information on other panels readily seen by
consumers.
A select group of packages with more than 40 square inches of labeling
space is allowed a format exception, too. These are packages with
insufficient vertical space (about 3 inches) to accommodate the required
information. Some examples are bread bags, pie boxes, and bags of frozen
vegetables. On these packages, the "Nutrition Facts" panel may appear
horizontally, with footnote information appearing to the far right.
For larger packages in which there is not sufficient space on the principal
display panel or the information panel to the right, FDA allows nutrition
information to appear on any label panel that is readily seen by consumers.
This intent lessens the chances of overcrowding of information and
encourages manufacturers to provide the greatest amount of nutrition
information possible.
For products that require additional preparation before eating, such as dry
cake mixes and dry pasta dinners, or that are usually eaten with one or
more additional foods, such as breakfast cereals with milk, FDA encourages
manufacturers to provide voluntarily a second column of nutrition
information. This is known as dual declaration.
With this variation, the first column, which is mandatory, contains
nutrition information for the food as purchased. The second gives
information about the food as prepared and eaten.
Still another variation is the aggregate display. This is allowed on
labels of variety-pack food items, such as ready-to-eat cereals and
assorted flavors of individual ice cream cups. With this display, the
quantitative amount and %Daily Value for each nutrient are listed in
separate columns under the name of each food.
ƒ Daily Values--DRVsƒ
The new label reference value, Daily Value, comprises two sets of dietary
standards: Daily Reference Values (DRVs) and Reference Daily Intakes
(RDIs). Only the Daily Value term appears on the label, though, to make
label reading less confusing.
DRVs have been established for macronutrients that are sources of energy:
fat, carbohydrate (including fiber), and protein; and for cholesterol,
sodium and potassium, which do not contribute calories.
DRVs for the energy-producing nutrients are based on the number of calories
consumed per day. A daily intake of 2,000 calories has been established as
the reference. This level was chosen, in part, because it approximates the
caloric requirements for postmenopausal women. This group has the highest
risk for excessive intake of calories and fat.
DRVs for the energy-producing nutrients are calculated as follows:
- fat based on 30 percent of calories
- saturated fat based on 10 percent of calories
- carbohydrate based on 60 percent of calories
- protein based on 10 percent of calories. (The DRV for protein applies
only to adults and children over 4. RDIs for protein for special
groups have been established.)
- fiber based on 11.5 g of fiber per 1,000 calories.
Because of current public health recommendations, DRVs for some nutrients
represent the uppermost limit that is considered desirable.The DRVs for
fats and sodium are:
- total fat: less than 65 g
- saturated fat: less than 20 g
- cholesterol: less than 300 mg
- sodium: less than 2,400 mg
ƒ Daily Values--RDIsƒ
The RDI replaces the term "U.S. RDA," which was introduced in 1973 as a
label reference value for vitamins, minerals and protein in voluntary
nutrition labeling. The name change was sought because of confusion that
existed over "U.S. RDAs," the values determined by FDA and used on food
labels, and "RDAs" (Recommended Dietary Allowances), the values determined
by the National Academy of Sciences for various population groups and used
by FDA to figure the U.S. RDAs.
However, the values for the new RDIs remain the same as the old U.S. RDAs
for the time being.
ƒ Nutrient Content Descriptorsƒ
The regulations also spell out what terms may be used to describe the level
of a nutrient in a food and how they can be used. These are the core
terms:
-ƒ Free. ƒ This term means that a product contains no amount of, or only
trivial or "physiologically inconsequential" amounts of, one or more
of these components: fat, saturated fat, cholesterol, sodium, sugars,
and calories. For example, "calorie-free" means fewer than 5 calories
per serving and "sugar-free" and "fat-free" both mean less than 0.5 g
per serving. Synonyms for "free" include "without," "no" and "zero."
-ƒ Low. ƒ This term can be used on foods that can be eaten frequently
without exceeding dietary guidelines for one or more of these
components: fat, saturated fat, cholesterol, sodium, and calories.
Thus, descriptors are defined as follows:
-ƒ low-fatƒ : 3 g or less per serving
-ƒ low-saturated fatƒ : 1 g or less per serving
-ƒ low-sodiumƒ : 140 mg or less per serving
-ƒ very low sodiumƒ : 35 mg or less per serving
-ƒ low-cholesterolƒ : 20 mg or less and 2 g or less of saturated fat
per serving
-ƒ low-calorieƒ : 40 calories or less per serving.
Synonyms for low include "little," "few," and "low source of."
-ƒ Lean and extra leanƒ . These terms can be used to describe the fat
content of meat, poultry, seafood, and game meats.
-ƒ leanƒ : less than 10 g fat, 4.5 g or less saturated fat, and less
than 95 mg cholesterol per serving and per 100 g.
-ƒ extra leanƒ : less than 5 g fat, less than 2 g saturated fat, and
less than 95 mg cholesterol per serving and per 100 g.
-ƒ Highƒ . This term can be used if the food contains 20 percent or more
of the Daily Value for a particular nutrient in a serving.
-ƒ Good sourceƒ . This term means that one serving of a food contains 10
to 19 percent of the Daily Value for a particular nutrient.
-ƒ Reducedƒ . This term means that a nutritionally altered product
contains at least 25 percent less of a nutrient or of calories than
the regular, or reference, product. However, a reduced claim can t be
made on a product if its reference food already meets the requirement
for a "low" claim.
-ƒ Lessƒ . This term means that a food, whether altered or not, contains
25 percent less of a nutrient or of calories than the reference food.
For example, pretzels that have 25 percent less fat than potato chips
could carry a "less" claim. "Fewer" is an acceptable synonym.
-ƒ Lightƒ . This descriptor can mean two things:
First, that a nutritionally altered product contains one-third fewer
calories or half the fat of the reference food. If the food derives
50 percent or more of its calories from fat, the reduction must be 50
percent of the fat.
Second, that the sodium content of a low-calorie, low-fat food has
been reduced by 50 percent. In addition, "light in sodium" may be
used on food in which the sodium content has been reduced by at least
50 percent.
The term "light" still can be used to describe such properties as
texture and color, as long as the label explains the intent-for
example, "light brown sugar" and "light and fluffy."
-ƒ Moreƒ . This term means that a serving of food, whether altered or
not, contains a nutrient that is at least 10 percent of the Daily
Value more than the reference food. The 10 percent of Daily Value
also applies to "fortified," "enriched" and "added" claims, but in
those cases, the food must be altered.
Alternative spelling of these descriptive terms and their synonyms are
allowed--for example, "hi" and "lo"--as long as the alternatives are not
misleading.
ƒ Other Definitionsƒ
The regulations also address other claims. Among them:
-ƒ Percent fat freeƒ : A product bearing this claim must be a low-fat or
a fat-free product. In addition, the claim must accurately reflect
the amount of fat present in 100 g of the food. Thus, if a food
contains 2.5 g fat per 50 g, the claim must be "95 percent fat free."
-ƒ Impliedƒ : These types of claims are prohibited when they wrongfully
imply that a food contains or does not contain a meaningful level of a
nutrient. For example, a product claiming to be made with an
ingredient known to be a source of fiber (such as "made with oat
bran") is not allowed unless the product contains enough of that
ingredient (for example, oat bran) to meet the definition for "good
source" of fiber. As another example, a claim that a product contains
"no tropical oils" is allowed--but only on foods that are "low" in
saturated fat because consumers have come to equate tropical oils with
high saturated fat.
-ƒ Meals and main dishesƒ : Claims that a meal or main dish is "free" of
a nutrient, such as sodium or cholesterol, must meet the same
requirements as those for individual foods. Other claims can be used
under special circumstances. For example, "low-calorie" means the
meal or main dish contains 120 calories or less per 100 g.
"Low-sodium" means the food has 140 mg or less per 100 g.
"Low-cholesterol" means the food contains 20 mg cholesterol or less
per 100 g and no more than 2 g saturated fat. "Light" means the meal
or main dish is low-fat or low-calorie.
-ƒ Standardized foodsƒ : Any nutrient content claim, such as "reduced
fat," "low calorie," and "light," may be used in conjunction with a
standardized term if the new product has been specifically formulated
to meet FDA s criteria for that claim, if the product is not
nutritionally inferior to the traditional standardized food, and the
new product complies with certain compositional requirements set by
FDA. A new product bearing a claim also must have performance
characteristics similar to the referenced traditional standardized
food. If the product doesn t, and the differences materially limit
the product s use, its label must state the differences (for example,
not recommended for baking) to inform consumers.
-ƒ Healthyƒ :A "healthy" food must be low in fat and saturated fat and
contain limited amounts of cholesterol and sodium. In addition, if
it s a single-item food, it must provide at least 10 percent of one or
more of vitamins A or C, iron, calcium, protein, or fiber. If it s a
meal-type product, such as frozen entrees and multi-course frozen
dinners, it must provide 10 percent of two or three of these vitamins
or minerals or of protein or fiber, in addition to meeting the other
criteria.
Limits on sodium will be phased in. By January 1996, FDA-regulated
individual foods labeled "healthy" must provide no more than 480 mg of
sodium per serving. After Jan. 1, 1998, the sodium limit for
FDA-regulated foods will drop to 360 mg per serving for individual
foods and 480 mg per serving for meal-type products that carry the
"healthy" claims. Effective dates for the sodium phase-in for
USDA-regulated products are November 1995 and November 1997. The
sodium limits match FDA s.
ƒ Fresh ƒ
Although not mandated by NLEA, FDA has issued a regulation for the term
"fresh." The agency took this step because of concern over the term s
possible misuse on some food labels.
The regulation defines the term "fresh" when it is used to suggest that a
food is raw or unprocessed. In this context, "fresh" can be used only on a
food that is raw, has never been frozen or heated, and contains no
preservatives. (Irradiation at low levels is allowed.) "Fresh frozen,"
"frozen fresh," and "freshly frozen" can be used for foods that are quickly
frozen while still fresh. Blanching (brief scalding before freezing to
prevent nutrient breakdown) is allowed.
Other uses of the term "fresh," such as in "fresh milk" or "freshly baked
bread," are not affected.
ƒ Baby Foodsƒ
FDA is not allowing broad use of nutrient claims on infant and toddler
foods. However, the agency may propose later claims specifically for these
foods. The terms "unsweetened" and "unsalted" are allowed on these foods,
however, because they relate to taste and not nutrient content.
ƒ Health Claimsƒ
Claims for eight relationships between a nutrient or a food and the risk of
a disease or health-related condition are now allowed. They can be made in
several ways: through third-party references, such as the National Cancer
Institute; statements; symbols, such as a heart; and vignettes or
descriptions. Whatever the case, the claim must meet the requirements for
authorized health claims; for example, they cannot state the degree of risk
reduction and can only use "may" or "might" in discussing the nutrient or
food-disease relationship. And they must state that other factors play a
role in that disease.
The claims also must be phrased so that consumers can understand the
relationship between the nutrient and the disease and the nutrient s
importance in relationship to a daily diet.
An example of an appropriate claim is: "While many factors affect heart
disease, diets low in saturated fat and cholesterol may reduce the risk of
this disease."
The allowed nutrient-disease relationship claims and rules for their use
are:
-ƒ Calcium and osteoporosisƒ : To carry this claim, a food must contain
20 percent or more of the Daily Value for calcium (200 mg) per
serving, have a calcium content that equals or exceeds the food s
content of phosphorus, and contain a form of calcium that can be
readily absorbed and used by the body. The claim must name the target
group most in need of adequate calcium intakes (that is, teens and
young adult white and Asian women) and state the need for exercise and
a healthy diet. A product that contains 40 percent or more of the
Daily Value for calcium must state on the label that a total dietary
intake greater than 200 percent of the Daily Value for calcium (that
is, 2,000 mg or more) has no further known benefit.
-ƒ Fat and cancerƒ : To carry this claim, a food must meet the descriptor
requirements for "low-fat" or, if fish and game meats, for "extra
lean."
-ƒ Saturated fat and cholesterol and coronary heart disease (CHD)ƒ : This
claim may be used if the food meets the definitions for the
descriptors "low saturated fat," "low-cholesterol," and "low-fat," or,
if fish and game meats, for "extra lean." It may mention the link
between reduced risk of CHD and lower saturated fat and cholesterol
intakes to lower blood cholesterol levels.
-ƒ Fiber-containing grain products, fruits and vegetables and cancerƒ :
To carry this claim, a food must be or must contain a grain product,
fruit or vegetable and meet the descriptor requirements for "low-fat,"
and, without fortification, be a "good source" of dietary fiber.
-ƒ Fruits, vegetables and grain products that contain fiber and risk of
ƒ CHDƒ : To carry this claim, a food must be or must contain fruits,
vegetables and grain products. It also must meet the descriptor
requirements for "low saturated fat," "low-cholesterol," and "low-fat"
and contain, without fortification, at least 0.6 g soluble fiber per
serving.
-ƒ Sodium and hypertension (high blood pressure)ƒ : To carry this claim,
a food must meet the descriptor requirements for "low-sodium."
-ƒ Fruits and vegetables and cancerƒ : This claim may be made for fruits
and vegetables that meet the descriptor requirements for "low-fat" and
that, without fortification, for "good source" of at least one of the
following: dietary fiber or vitamins A or C. This claim relates diets
low in fat and rich in fruits and vegetables (and thus vitamins A and
C and dietary fiber) to reduced cancer risk. FDA authorized this
claim in place of an antioxidant vitamin and cancer claim.
-ƒ Folic acid and neural tube defectsƒ : On Jan. 4, 1994, FDA authorized
the use of a health claim about the relationship between folic acid
and the risk of neural tube birth defects for dietary supplements and
for foods in conventional food form that are naturally high in folic
acid. (In 1992, the U.S. Public Health Service had recommended that
all women of childbearing age consume 0.4 mg folic acid daily to
reduce their risk of giving birth to a child affected with a neural
tube defect.) FDA plans to issue a final rule to allow the folic
acid-neural tube defect claim for fortified foods, too.
ƒ Ingredient Labelingƒ
The list of ingredients has undergone some changes, too. Chief among them
is a requirement for full ingredient labeling on "standardized foods,"
which previously were exempt. Ingredient declaration is now required on
all foods that have more than one ingredient.
Also, the ingredient list includes, when appropriate:
- FDA-certified color additives, such as FD&C Blue No. 1, by name
- sources of protein hydrolysates, which are used in many foods as
flavors and flavor enhancers
- declaration of caseinate as a milk derivative in the ingredient list
of foods that claim to be non-dairy, such as coffee whiteners.
The main reason for these new requirements is that some people may be
allergic to such additives and now may be better able to avoid them.
As required by NLEA, beverages that claim to contain juice now must declare
the total percentage of juice on the information panel. In addition, FDA s
regulation establishes criteria for naming juice beverages. For example,
when the label of a multi-juice beverage states one or more--but not
all--of the juices present, and the predominantly named juice is present in
minor amounts, the product s name must state that the beverage is flavored
with that juice or declare the amount of the juice in a 5 percent
range--for example, "raspberry-flavored juice blend" or "juice blend, 2 to
7 percent raspberry juice."
ƒ Economic Impactƒ
It is estimated that the new food label will cost FDA-regulated food
processors between $1.4 billion and $2.3 billion over the next 20 years.
The benefits to public health--measured in monetary terms--are estimated to
well exceed the costs. Potential benefits include decreased rates of
coronary heart disease, cancer, osteoporosis, obesity, high blood pressure,
and allergic reactions to food.
ƒ Obtaining Regulations and Related Informationƒ
Reprints ofƒ Federal Registerƒ documents on FDA s food labeling rules can
be ordered by calling the National Technical Information Service at (703)
487-4650. Ask for #PB-93-139905. The cost is $91.
The Jan. 6 document also can be downloaded from the National Agricultural
Library s electronic bulletin board, Agricultural Library Forum (ALF). The
electronic bulletin board can be accessed 24 hours a day, seven days a
week. The telephone numbers are (301) 504-6510, (301) 504-5111, (301)
504-5496, and (301) 504-5497. For assistance, call the FDA/USDA Food
Labeling Education Information Center at (301) 504-5719.
The January and April 1993 documents also are included in the April 1,
1993, edition of theƒ Code of Federal Regulations,ƒ which is available from
the Government Printing Office (Title 21, Parts 100-169) for $21. This may
be ordered by calling (202) 512-1800.
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ƒ% Back to Homeƒ
_Publication No. BG 95-12.
May 1995.
_