Please see the Final Rule published on January 12, 2007.
[Federal Register: November 25, 2005 (Volume 70, Number 226)]
[Proposed Rules]
[Page 71041-71057]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25no05-16]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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[[Page 71041]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. 2004P-0183]
Food Labeling: Nutrient Content Claims, Expansion of the Nutrient
Content Claim ``Lean''
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
its food labeling regulations for the expanded use of the nutrient
content claim ``lean'' on the labels of foods categorized as ``mixed
dishes not measurable with a cup'' that meet certain criteria for total
fat, saturated fat, and cholesterol content. This proposal responds to
a nutrient content claim petition submitted by Nestlé Prepared
Foods Co. (Nestlé) under the Federal Food, Drug, and Cosmetic
Act (the act). This action also is being taken to provide reliable
information that would assist consumers in maintaining healthy dietary
practices.
DATES: Submit written or electronic comments by February 8, 2006.
ADDRESSES: You may submit comments, identified by Docket No. 2004P-
0183, by any of the following methods:
Electronic Submissions
Submit electronic comments in the following ways:
<bullet> Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
<bullet> Agency Web site: http://www.fda.gov/dockets/ecomments.
Follow the instructions for submitting comments on the agency Web site.
Written Submissions
Submit written submissions in the following ways:
<bullet> FAX: 301-827-6870.
<bullet> Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
To ensure more timely processing of comments, FDA is no longer
accepting comments submitted to the agency by e-mail. FDA encourages
you to continue to submit electronic comments by using the Federal
eRulemaking Portal or the agency Web site, as described in the
Electronic Submissions portion of this paragraph.
Instructions: All submissions received must include the agency name
and docket number for this rulemaking. All comments received may be
posted without change to http://www.fda.gov/ohrms/dockets/default.htm,
including any personal information provided. For additional information
on submitting comments, see the ``Comments'' heading of the
SUPPLEMENTARY INFORMATION section of this document.
Docket: For access to the docket to read background documents or
comments received, go to http://www.fda.gov/ohrms/dockets/default.htm
and insert the docket number, found in brackets in the heading of this
document, into the ``Search'' box and follow the prompts and/or go to
the Division of Dockets Management, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Vincent de Jesus, Center for Food
Safety and Applied Nutrition (HFS-830), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1774.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background
II. Petitions and Grounds
III. Proposed Action
A. Need for Regulations
B. Proposed Amendments
IV. Preliminary Regulatory Impact Analysis
A. Need for Regulation
B. Regulatory Options
C. Benefits
D. Costs
V. Regulatory Flexibility Analysis
VI. Unfunded Mandates
VII. Federalism
VIII. Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Comments
XI. References
I. Background
On November 8, 1990, President George H.W. Bush signed into law the
Nutrition Labeling and Education Act of 1990 (the 1990 amendments)
(Public Law 101-535), which amended the Federal Food, Drug, and
Cosmetic Act (the act). Section 403(r)(1)(A) of the act (21 U.S.C.
343(r)(1)(A)), which was added by the 1990 amendments, states that a
food is misbranded if it is intended for human consumption which is
offered for sale and for which a claim is made in its label or labeling
that expressly or implicitly characterizes the level of any nutrient of
the type required to be declared in nutrition labeling, unless such
claim uses terms defined in regulations by FDA under section
403(r)(2)(A) of the act.\1\ In 1993, FDA established regulations that
implemented the 1990 amendments (58 FR 2066 through 2941, January 6,
1993). Among these regulations, Sec. 101.13 (21 CFR 101.13) sets forth
general principles for nutrient content claims (see 58 FR 2302, January
6, 1993). Other sections in part 101, subpart D (21 CFR part 101,
subpart D), define specific nutrient content claims, such as ``free,''
``low,'' ``reduced,'' ``light,'' ``good source,'' ``high,'' and
``more,'' for a variety of nutrients and include several synonyms for
each of the defined terms. In addition, Sec. 101.69 outlines the
procedures for petitioning the agency to authorize additional nutrient
content claims.
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\1\ The requirements in section 403(r)(2) of the act, for all
nutrient content claims, apply to foods and food labeling unless an
exemption applies for the food or the claim under section 403(r)(2)
of the act, another section of the act, or FDA regulations.
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In the 1991 proposed rule for ``Nutrient Content Claims, General
Principles, Petitions, Definition of Terms'' (the general principles
proposal) (56 FR 60421, November 27, 1991), FDA did not include a
definition for ``lean.'' However, in the same issue of the Federal
Register, the Food Safety and Inspection Service (FSIS) of the U.S.
Department of Agriculture (USDA) issued a proposed rule that included a
definition for ``lean'' for labeling individual foods and meal-type
products (a collective term used for meal and main dish products)
[[Page 71042]]
containing meat and poultry (56 FR 60302, November 27, 1991).\2\ After
evaluating the comments to the general principles proposal, FDA
determined that seafood, game meat, meal products, and main dish
products that it regulated had a contribution to the diet that was
similar to the USDA-regulated products and that FDA should establish a
definition for ``lean'' for such products. Consequently, FDA defined
``lean'' for seafood, game meat, meal, and main dish products (Sec.
101.62(e)) in the final rule for nutrient content claims (58 FR 2302)
using the same criteria that USDA used in its final rule for the
``lean'' claim (58 FR 632, January 6, 1993).\3\ FDA's definition of
``lean'' includes flesh foods, such as seafood and game meat products,
which are foods that are similar to USDA-regulated meat and poultry
products, and also includes meal-type products (i.e., main dishes and
meal products) which are included in the USDA definition. FDA's
definition of ``lean,'' however, does not extend to other individual
foods including ``mixed dishes not measurable with a cup.'' Such
dishes, e.g., burritos, egg rolls, enchiladas, pizza, quiches, and
sandwiches, are generally similar to the foods subject to the
definition of ``main dish'' (Sec. 101.13(m)) but do not meet the
weight criterion for ``main dish'' foods (6 ounces (oz) per labeled
serving). The reference amount customarily consumed (RACC) for ``mixed
dishes not measurable with a cup'' is 140 grams (g) (5 oz) (Sec.
101.12(b), table 2), which is 1 oz less than the 6 oz per labeled
serving required to qualify as a ``main dish.''\4\ Thus, food products
that are categorized as ``mixed dishes not measurable with a cup'' and
that weigh less than 6 oz are not eligible to bear a ``lean'' nutrient
content claim under Sec. 101.62(e).
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\2\ USDA also defined ``extra lean,'' which FDA later defined by
regulation, in addition to ``lean.'' However, Nestlé did not
request a definition for ``extra lean'' in its petition.
\3\ Specifically, in order to be eligible to bear a claim,
seafood and game meat products must contain less than 10 grams (g)
total fat, 4.5 g or less of saturated fat, and less than 95
milligrams (mg) cholesterol per reference amount customarily
consumed (RACC) and per 100 g, and for meals and main dishes, per
100 g and per labeled serving.
\4\ If the ``mixed dish not measurable with a cup'' food were
packaged in a way such that it met all of the requirements for a
main dish, as specified in Sec. 101.13(m), it could be considered a
``main dish'' and would be eligible to bear a ``lean'' claim under
FDA's current regulations.
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FDA has authority to define the nutrient content claim ``lean'' for
foods categorized as ``mixed dishes not measurable with a cup.'' FDA
may take this action under section 403(r) of the act. FDA, by
regulation, may define terms to be used for nutrient content claims
that characterize the level of total fat, saturated fat, and
cholesterol in these foods. Section 403(r) of the act authorizes the
agency to issue regulations defining terms for use in nutrient content
claims and establishes a process through which a person can petition
the agency to define terms to characterize the level of a nutrient for
use in a nutrient content claim (see section 403(r)(2)(A)(i) and (r)(4)
of the act). Section 403(r)(1)(A) of the act states that a food is
misbranded if it bears a claim that characterizes the level of a
nutrient of the type required to be in nutrition labeling unless the
claim uses terms which are defined in FDA regulations adopted under
section 403(r)(2) of the act. The proposed rule, if finalized as
proposed, will define the term ``lean'' for use on ``mixed dishes not
measurable with a cup'' that are regulated by FDA and that meet the
criteria in the rule for total fat, saturated fat, and cholesterol.
II. Petitions and Grounds
FDA received a nutrient content claim petition from Nestlé
(Docket No. 2004P-0183) (Ref. 1) requesting that the agency amend the
nutrient content claim regulation for ``lean'' (Sec. 101.62(e)) to
include ``mixed dishes not measurable with a cup'' as defined in the
``reference amounts customarily consumed per eating occasion''
regulation (Sec. 101.12), based on certain qualifying criteria for
total fat, saturated fat, and cholesterol. Nestlé submitted the
petition on January 9, 2004, under section 403(r)(4) of the act and
Sec. 101.69. In accordance with section 403(r)(4)(A)(i) of the act and
Sec. 101.69(m)(3), FDA filed the Nestlé petition on April 22,
2004. This proposed rule responds to Nestlé's request that FDA
define the term ``lean'' for ``mixed dishes not measurable by a cup.''
In its petition, Nestlé contended that American eating
habits have changed significantly since FDA authorized the ``lean''
claim in 1993. Nestlé argued that, in the past decade,
convenience has been an emerging theme with consumers and cited market
research studies by NPD Group showing that the percentage of meals that
are completely homemade has decreased, while the use of ready-to-eat
and frozen foods has steadily risen. Nestlé also cited a 2003
survey by the market research group Information Resources, Inc. (IRI),
in which consumers identify ``speed/ease of preparation'' as the most
important factor in their food choices and assert that this is even
more important than price. Nestlé presented additional data from
IRI and NPD Group showing that consumers are eating fewer complete
traditional meals, eating more snacks, and spending less time preparing
meals at home. Nestlé also suggested that consumers are more
interested in nutrition and healthy foods, as evidenced by an increased
consumer demand for nutritious food selections. Nestlé cited
surveys by the Natural Marketing Institute (NMI) in which two-thirds of
Americans indicate they are eating healthier than they used to and that
one-third of Americans choose food primarily based on nutritional
content. One of the surveys indicated that 54 percent of adults read
nutrition labels most or all of the time.
Furthermore, Nestlé cited a trend in substantially increased
portion sizes over the past 30 years, as determined by USDA data from
the Nationwide Food Consumption Survey and the Continuing Survey of
Food Intake by Individuals. This trend, they said, is demonstrated by
the increase in sizes of food items such as cheeseburgers, increasing
from 5.8 oz to 7.2 oz, and salty snacks, increasing from 1.0 oz to 1.6
oz, between 1977 and 1996. Nestlé suggests that allowing a
``lean'' nutrient content claim on foods in the category of ``mixed
dishes not measurable with a cup'' that have smaller portion sizes than
many other food alternatives would provide consumers with readily
recognizable healthful alternatives to other foods with larger portion
sizes. Nestlé argued that manufacturers who want to encourage
portion control by marketing healthier food options with smaller
portion sizes are hindered by the current FDA regulations limiting the
``lean'' nutrient content claim to seafood, game meat, main dish, and
meal products. These regulations do not allow for foods that may be
similar to main dish and meal products but with slightly smaller
portion sizes (e.g., ``mixed dishes not measurable with a cup'') to
have a ``lean'' claim. Because of this, Nestlé believes that the
number of healthy, portable food options available to consumers has
been limited. The FDA regulations, Nestlé stated, have acted as
an impediment for consumers to choose healthy foods that are similar to
meal-type products but, because of their smaller portion sizes, do not
qualify as meal-type products that are eligible for the ``lean''
nutrient content claim. Nestlé asserted that these trends of
convenience and healthier eating call for an expansion of the ``lean''
definition to include foods identified as ``mixed dishes not measurable
with a cup'' and also that this expansion may offer consumers healthy
food options that do not have increasingly larger portion sizes.
[[Page 71043]]
In its petition, Nestlé also pointed out the lack of
consistency between FDA and USDA regulations regarding the claim
``lean.'' Nestlé stated that USDA-regulated individual foods and
meal-type products, which contain meat and poultry, are permitted to
bear the ``lean'' claim under USDA regulations (9 CFR 317.362(e) and
381.462(e), respectively). Nestlé noted that, unlike FDA, USDA
does not limit the use of the ``lean'' claim to specific individual
foods. Thus, any meat or poultry product subject to USDA regulation,
including those that are similar to foods in FDA's category of ``mixed
dishes not measurable with a cup'' category and that meet the USDA
nutrient requirements, may bear the ``lean'' claim. Nestlé
asserted that, although there is a distinction between the types of
foods regulated by the USDA and FDA, consumers are unlikely to be aware
of such a distinction. Therefore, Nestlé stated that there
should be some consistency across the requirements for nutrient content
claims. It contended that an amended definition for ``lean'' for use on
``mixed dishes not measurable with a cup'' would reduce the disparity
between FDA and USDA regulations. Nestlé also stated that the
expansion of the ``lean'' claim advances the FDA ``Initiative on
Consumer Health Information for Better Nutrition'' by contributing to
the goal of making sure that consumers have access to the latest
information when making decisions about their diet.
To accomplish the request to include ``mixed dishes not measurable
with a cup'' in an amended definition of ``lean'' in Sec. 101.62(e),
Nestlé suggested two different possible methods for determining
the criteria that could apply for the total fat, saturated fat, and
cholesterol content of such dishes eligible to bear the claim. For each
of these methods, Nestlé took into consideration the reference
intakes for fat for adults and for children that were established by
the Institute of Medicine (IOM) of the National Academies, i.e.,
acceptable macronutrient distribution ranges of 20 to 35 percent of
energy intake from fat for adults and 25 to 40 percent intake from fat
for children (IOM, Dietary Reference Intakes for Energy, Carbohydrate,
Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids, 2002).
Nestlé also considered the FDA-established daily reference value
(DRV) for total fat of 65 g, which is based on a reference caloric
intake of 2,000 calories, that is used in nutrition labeling (Sec.
101.9(c)(9)). With regard to saturated fat and cholesterol,
Nestlé considered the IOM's recommendation ``that saturated
fatty acids * * * and cholesterol consumption be as low as possible
while consuming a nutritionally adequate diet,'' as well as the FDA-
established DRV for saturated fatty acids of 20 g and the DRV for
cholesterol of 300 mg, based on a reference caloric intake of 2,000
calories, that is used in nutrition labeling (Sec. 101.9(c)(9)).
The first possible method suggested by Nestlé uses the
existing ``lean'' nutrient criteria for main dishes as the basis of the
definition. Nestlé proposes new criteria for total fat,
saturated fat, and cholesterol based on the percentage of the
proportion of an estimated weight for ``mixed dishes not measurable
with a cup'' and the minimum weight of a main dish product that is
eligible for a ``lean'' claim. In short, Nestlé stated that the
reduction in the nutrient criteria would be in proportion to the
reduction in weight between the average weight of ``mixed dishes not
measurable with a cup,'' which is 132.53 g in their estimation, and the
minimum weight of a meal-type product, which is 6 oz (170.1 g). The
percentage of the proportion of these weights (132.53 g / 170.1 g x
100) equals 0.78 or 78 percent. Seventy-eight percent of the current
nutrient criterion value for fat (10 g fat multiplied by 78 percent)
would result in nutrient value of 7.8 g fat. Seventy-eight percent of
the current nutrient criterion value for saturated fat (4.5 g sat fat
multiplied by 78 percent) equals 3.5 g saturated fat. Seventy-eight
percent of the current nutrient criterion value for cholesterol (95
milligrams (mg) cholesterol multiplied by 78 percent) equals 74.1 mg
cholesterol. This would translate into unrounded criteria for ``lean''
for ``mixed dishes not measurable by a cup'' of: 7.8 g total fat, 3.5 g
saturated fat, and 74.1 mg cholesterol. Nestlé applied these
criteria on a per-RACC basis. Nestlé stated that the foods in
this category play a smaller role in the diet compared to meal-type
products and believed that the more restrictive ``lean'' criteria in
its petition were appropriate. The RACC for ``mixed dishes not
measurable with a cup'' is 140 g. Thus, the practical effect of
applying Nestlé's suggested nutrient criteria on a per-RACC
basis makes the levels more restrictive (proportionally) for ``mixed
dishes not measurable with a cup'' than for main dishes. For example,
the 7.8 g total fat per 140 g would be equivalent, proportionally, to
5.6 g fat per 100 g. The current main dish total fat criterion is 10 g
per 100 g and per labeled serving.
The second possible method suggested by Nestlé would
determine the nutrient criteria for ``lean'' according to
Nestlé's estimated calorie contribution of ``mixed dishes not
measurable with a cup'' in the total diet. Nestlé looked at 34
grocery store-bought food items categorized as ``mixed dishes not
measurable with a cup'' and determined that the average number of
calories per 100 g was 214.41 calories. Taking the current dietary
recommendation of 30 percent\5\ of calories from fat, Nestlé
established that 30 percent of calories from fat in ``mixed dishes not
measurable with a cup'' (214.41 calories multiplied 30 percent) would
equal 64.32 calories per 100 g from fat. The calories from fat
converted to grams of fat (64.32 calories from fat / 9 calories of fat
per g) would equal 7.15 g of fat per 100 g. Following the same
calculation for determining total fat, 10 percent of calories from
saturated fat\6\ (214.41 calories multiplied by 10 percent) equals
21.441 calories per 100 g and converted to saturated fat grams (21.441
calories / 9 calories saturated fat per g) equals 2.382 g saturated fat
per 100 g. There are no cholesterol intake guideline criteria expressed
as a percentage of calories comparable to the fat and saturated fat
guidelines, thus, the cholesterol criteria would be derived from the
current main dish criteria in the same way described in the first
method, which equaled 74.1 mg cholesterol. This would translate into
criteria for ``lean'' for ``mixed dishes not measurable by a cup'' as
follows: 7.15 g total fat (7 g rounded), 2.382 g saturated fat (2.5 g
rounded), and 74.1 mg cholesterol (75 mg rounded). Although
Nestlé calculated the criteria using this method on a per-100 g
basis, Nestlé applied the criteria for purposes of determining
eligibility of foods to bear the ``lean'' claim on a per-RACC basis.
The criteria are proportionally more restrictive for ``mixed dishes not
measurable with a cup'' than for main dishes, and slightly more
restrictive than the other method Nestlé set forth in its
petition. For this method, 7 g total fat per 140 g would be equivalent,
proportionally, to 5 g fat per 100 g.
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\5\ Nestlé refers to the IOM AMDRs for current dietary
recommendations (see Attachment 20 of the petition (Ref. 1)). The
AMDR for total fat intake is between 20 and 35 percent of calories
for adults. This range also corresponds to the recommendations
provided in the 2005 Dietary Guidelines for Americans (Ref. 2).
Nestlé noted that the midpoint is 27.5 percent and rounds
this number up to 30 percent. This value of 30 percent is consistent
with the current DRV for fat established by FDA.
\6\ Nestlé refers to the dietary recommendation provided
by the NIH, NHLBI, National Cholesterol Education Program (see
Attachment 25 of the petition (Ref. 1)).
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[[Page 71044]]
III. Proposed Action
A. Need for Regulations
As stated earlier, in the proposed rule for nutrition labeling (56
FR 60302, November 27, 1991), FSIS proposed the ``lean'' claim for meat
and poultry products. Because all the products that USDA regulates with
regard to nutrition labeling consist in whole or in part of meat and
poultry (with certain exceptions for some egg products), USDA permits
use of the term ``lean'' across the spectrum of foods whose nutrition
labeling it regulates (provided they meet the nutrient requirements for
the claim). FDA adopted a regulation similar to the FSIS regulation for
the nutrient content claim ``lean'' for use on seafood, game meat, meal
products, and main dish products (Sec. 101.62(e)). The current FDA
regulations do not allow for use of the claim ``lean'' on ``mixed
dishes not measurable with a cup'' because they are considered
individual foods for which there is no ``lean'' definition other than
for seafood and game meat. Moreover, the FDA regulations do not allow
for the use of the claim ``lean'' on a food in the category of ``mixed
dishes not measurable with a cup'' when the product as packaged does
not meet the minimum weight criterion to qualify as a ``main dish.''
The current FDA regulations thus prohibit a manufacturer from labeling
FDA-regulated ``mixed dishes not measurable with a cup'' with a
``lean'' claim, while manufacturers are able to use the claim on such
foods that are regulated by USDA. For example, a food such as a starch
based wrap, with chicken, broccoli, and cheddar cheese that is subject
to USDA regulation, is able to bear a ``lean'' claim under USDA
regulations, but a similar wrap with just broccoli and cheese and
without chicken, that would not be subject to USDA regulation, could
not bear a ``lean'' claim under current FDA regulations.
FDA has reviewed Nestlé's petition and appreciates its
concerns about the differences between current FDA and USDA regulations
as to the eligibility for a ``lean'' nutrient content claim for foods
in the category of ``mixed dishes not measurable with a cup.'' In the
nutrient content claims final rule (58 FR 2302 at 2343), in providing a
definition for the term ``lean'' for seafood and game meat and meal-
type products, the agency stated that such a definition would enable
consumers to compare the nutritional values of products that may serve
as substitutes for one another in creating a balanced diet. Because of
the requirement in Sec. 101.13(m) that, among other things, products
must weigh a minimum of 6 oz in order to be considered main dish
products, and that by current regulation only seafood and game meat and
meals and main dish products may bear the ``lean'' claim, FDA
acknowledges that a whole group of products (namely ``mixed dishes not
measurable with a cup'') may be prohibited from bearing the ``lean''
claim because of the prohibition on using the claim on individual foods
other than seafood and game meat that do not meet the criteria for main
dishes, including the 6 oz weight criterion.
FDA acknowledges Nestlé's argument, as demonstrated by the
data submitted in the petition, that these types of products, which
include egg rolls, burritos, and other handheld sandwich-like products,
have found their way into the American diet and serve as a convenient
``meals-on-the-go'' eating option that is consistent with America's
changing lifestyle. They provide a ``heat and eat,'' no-utensils-
required, alternative to other types of food products. As market
research by ACNielsen Syndicated Data indicates,\7\ the sandwiches/
snacks category has seen significant growth in the past 5 years, with a
43-percent increase in dollar sales since 1999. As such, this category
has become a well established product category that consumers have come
to rely on.
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\7\ ACNielsen Syndicated Data, see Attachment 7 of the petition
(Ref. 1).
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FDA also acknowledges Nestlé's arguments that there is a
growing interest in healthful alternatives to traditional food options,
including vegetarian alternatives. This interest is demonstrated by a
30-percent increase in sales in the past year, according to ACNielsen,
in the ``Frozen Sandwich and Snack, Nutrition category'' and even by
the increasing markets for ``meal-replacement bars'' and ``liquid meal-
replacements.'' Although not included in the ``mixed dishes not
measurable with a cup'' category of foods, the increasing markets for
the meal-replacement bars and liquid meal-replacement foods support the
trend of Americans choosing more portable foods, especially foods that
consumers consider healthful alternatives.
In evaluating the information that Nestlé presented in its
petition, FDA acknowledges that portable food products, particularly
those that are nutrient (i.e., fat, saturated fat, and cholesterol) and
portion controlled, serve a useful purpose in assisting consumers in
selecting a diet that is consistent with current dietary
recommendations (i.e., IOM acceptable macronutrient distribution
ranges, DRVs established by FDA, and the 2005 Dietary Guidelines for
Americans).
The agency has tentatively concluded that providing for a ``lean''
claim on ``mixed dishes not measurable with a cup'' will provide
consumers with a means to distinguish, in this well established
category, among the variety of portion controlled products so that they
may select those products that are limited in fat, saturated fat, and
cholesterol as opposed to their ``full fat'' alternatives. The agency
acknowledges the potential that ``mixed dishes not measurable with a
cup'' that are eligible to bear a ``lean'' claim offer in delivering a
convenient food that can provide nutritional benefits and help improve
the quality of Americans' diets.
In its petition, Nestlé suggested that by allowing ``mixed
dishes not measurable with a cup'' to bear a ``lean'' claim, these
products would provide a way of addressing ever-expanding portion sizes
and the accompanying increase in caloric levels by allowing
manufacturers to encourage portion control by marketing healthier food
options with smaller portion sizes. Nestlé suggested that this
category of product will offer more choices to consumers looking for
healthful foods with small portion sizes. More healthful food choices
in this category may encourage the consumption of small portions and
thus aid in addressing the problem of excess calorie intake.
As opposed to frozen entrees that qualify as meal-type products
which are limited in size with the entire package and contain as few as
6 oz, however, many ``mixed dishes not measurable by a cup'' are
packaged two to a package, or about 10 oz per package. Consequently,
the agency is concerned that rather than eating just one of the
portions provided, thus limiting portion size, consumers may instead
consume the entire package, thus doubling their caloric and nutrient
intake as opposed to lowering it. The agency particularly seeks
information and data, as comments to this proposed rule, about whether
consumers may eat an entire package of these multi-pack ``mixed dishes
not measurable with a cup'' that may result in excess calorie intake,
rather than improved portion control of healthier food options that is
a desired outcome of this proposed rule, if finalized as proposed.
The agency has tentatively concluded that providing a ``lean''
definition for ``mixed dishes not measurable with a cup'' will provide
more consistency with similar USDA products and help consumers
construct a diet that is consistent with current dietary
recommendations (i.e., keeping dietary
[[Page 71045]]
intake of total fat, saturated fat, and cholesterol limited).
Therefore, as discussed in the following section, the agency is
proposing such a definition.
B. Proposed Amendments
In proposing a definition for the use of the nutrient content claim
``lean'' by eligible foods classified as ``mixed dishes not measurable
with cup,'' the agency considered the following options: (1) Require
the existing FDA nutrient requirements used by other FDA-regulated
foods that are eligible for a ``lean'' claim, such as meal-type
products; (2) require the existing USDA requirements for individual
foods that are eligible to bear a ``lean'' claim (such foods would
include foods in the ``mixed dishes not measurable with a cup''
category); (3) require either of the two methods for determining
nutrient values proposed by the petitioner; or (4) require new nutrient
requirements for ``mixed dishes not measurable with a cup.''
In evaluating the various options, FDA considered whether it was
appropriate to apply the nutrient criteria to only the RACC for ``mixed
dishes not measurable with a cup'' and not to both the RACC and per 100
g as is currently used for seafood and game meat. Foods in the ``mixed
dish not measurable with a cup'' category have a single RACC. Foods
considered ``seafood'' or ``game meat'' have multiple RACCs that differ
depending on their use. The requirements for a ``lean'' claim for
seafood or game meat are on a per-RACC and per-100 g basis. The use of
the 100 g basis, in addition to the per-RACC basis, prevents some of
the inconsistency that could occur within an entire category of
products with multiple RACCs (i.e., canned fish with a 55 g RACC and a
fish entr[eacute]e that has a much larger 140 g RACC do not end up with
the same exact nutrient requirements). The ``mixed dish not measurable
with a cup'' category of individual foods, however, has only one RACC
and does not need to have an additional 100 g basis requirement to
insure consistency of application. Thus, the agency tentatively
concludes that the requirements for a ``lean'' claim for foods
considered ``mixed dishes not measurable with a cup'' will need to be
based on a per-RACC basis only.
The agency first considered the options of requiring the existing
nutrient requirements for other FDA-regulated foods that are eligible
to bear the ``lean'' claim and the USDA nutrient requirements for a
``lean'' claim for individual foods. The agency decided not to propose
these options. The current nutrient criteria for these options are less
than 10 g fat, 4.5 g or less saturated fat, and less than 95 mg of
cholesterol per RACC and per 100 g for seafood and game meat or for
meal-type products, per 100 g and per labeled serving. As explained in
the following paragraphs, the agency determined that it would be
appropriate to consider nutrient criteria that differ from the current
requirements. In addition, when establishing nutrient criteria for the
category of ``mixed dishes not measurable with a cup'' that are
eligible to bear the ``lean'' claim, the agency determined that it
would only apply the nutrient criteria to the RACC (140 g) and not to
both the RACC and per 100 g as it does for the individual foods
(seafood and game meat) currently eligible to bear the ``lean'' claim.
Further, when applying the current nutrient criteria to the RACC of 140
g, the agency determined that the nutrient criteria for fat, saturated
fat, and cholesterol would be more restrictive than necessary for these
foods to be considered ``lean'' when considered in the context of the
total daily diet. Therefore, the agency decided not to propose the
current nutrient criteria to the RACC for ``mixed dishes not measurable
with a cup.''
FDA adopted the USDA nutrient requirements for ``lean,'' in the
1993 nutrient content claim final rule (58 FR 2302 at 2342), for
seafood and game meats and for meal-type and main dish products
because, in part, the agency recognized that seafood and game products
play a comparable role in the diet to that of meat and poultry products
and like meat and poultry products, contribute to the total dietary
intake of fat, saturated fat, and cholesterol. In addition, FDA-
regulated meal-type products are consumed in the same manner as USDA-
regulated meal-type products covered by the FSIS rule on the ``lean''
claim. FDA determined that the equivalent definition of these terms
would enable consumers to compare the nutritional values of meat
products and meal-type products that may serve as substitutes for one
another in a balanced diet (58 FR 2302 at 2343). The levels of total
fat and saturated fat that were chosen by USDA for the ``lean''
criteria were based on a ratio of saturated fat to total fat that would
be 40 percent, which is representative of the ratio of saturated fat to
total fat inherent in ruminant muscle (58 FR 2302 at 2342).
The agency has concluded, however, that not all of the factors
considered in the 1993 final rule apply to the foods in the FDA-
regulated category ``mixed dishes not measurable with a cup.'' The
``mixed dishes not measurable with a cup'' category may not play a
comparable role in the diet to that of meat and poultry products; may
not contribute to the total dietary intake of fat, saturated fat, and
cholesterol like meat and poultry products; and may not be consumed in
the same manner as USDA-regulated meal-type products. FDA-regulated
``mixed dishes not measurable with a cup,'' which are similar in
composition to meal and main dish products (i.e., they are multi-
component products), are smaller in size compared to the meal-type
products. The agency believes that, although similar in composition to
meal-type products, the restriction in size of the products in this
category results in a different role in the diet than meal-type
products. These foods are likely to be chosen by consumers to reduce
portion sizes of meals for a reduced calorie contribution, or as
healthy snack alternatives to those ``mixed dishes not measurable with
a cup'' that are higher in fats. Because of their size requirements,
meal-type products comprise a larger percent (in weight and in
calories) of the daily diet than ``mixed dishes not measurable'' do.
Further, the foods that FDA regulates in this category include those
that have no meat, poultry, seafood, or game meat as ingredients and,
therefore, it would be appropriate for these foods to have lower fat
criteria than foods in those categories, based on their dissimilar
ingredient contents and smaller calorie contribution. While it is
possible that foods in the ``mixed dishes not measurable with a cup''
category could have similar nutrient profiles to USDA-regulated meat
and poultry products (e.g., an entr[eacute]e-type turnover containing
cheese), many foods that fall into this category, especially those
foods that do not contain any cheese, would have very different total
fat, saturated fat, and cholesterol profiles. Therefore, because foods
in the category of ``mixed dishes not measurable with a cup'' may not
make the same contribution to the total dietary fat, saturated fat, and
cholesterol and have a different role in the total diet as other FDA-
regulated foods in this category or as other USDA-regulated individual
foods in this category, FDA has tentatively concluded that the nutrient
criteria ``lean'' for ``mixed dishes not measurable with a cup'' should
not necessarily be the same as the criteria used for other individual
foods and for meal-type products.
Applying the current nutrient criteria to the RACC for ``mixed
dishes not measurable with a cup'' (i.e., less than 10 g fat per 140 g,
4.5 g or less saturated fat per 140 g, and less than 95 mg cholesterol
per 140 g) results in criteria that, proportionally on a per-100 g
basis,
[[Page 71046]]
are comparable to the two methods proposed by the petitioner. The
nutrient criteria for this option, when computed on a per-100 g basis,
would be less than 7.1 g fat, 3.2 g or less saturated fat, and less
than 68 mg cholesterol. However, a main dish (170 g portion) that met
the current nutrient criteria for a ``lean'' claim would contribute
less than 5.9 g total fat, 2.6 g or less saturated fat, and less than
56 mg cholesterol per 100 g (see discussion infra in footnote 8 of this
document). Given the smaller portion sizes of ``mixed dishes not
measurable with a cup,'' different composition than similar USDA-
regulated foods, and different contribution to the total daily diet,
``mixed dishes not measurable with a cup'' labeled as ``lean'' should
not be contributing proportionally more fat, saturated fat, and
cholesterol than a main dish that bears the ``lean'' claim. If ``mixed
dishes not measurable with a cup'' did contribute proportionally more
fat, saturated fat, and cholesterol per 100 g product consumed,
consumers who may include more lean ``mixed dishes not measurable with
a cup'' in their diets would inadvertently be consuming more of these
fats. Therefore, the agency tentatively decided not to propose this
option.
The agency also considered the nutrient criteria based on the two
different methods that Nestlé described in its petition to
calculate the nutrient requirements for the ``lean'' definition. The
agency decided not to propose these options. These methods are
described in section II of this document. One method described by
Nestlé uses the existing requirements for total fat, saturated
fat, and cholesterol content in the nutrient content claim ``lean'' for
meal-type products and reduces those requirements for ``mixed dishes
not measurable with a cup'' in proportion to the reduction in portion
size. ``Mixed dishes not measurable with a cup'' are multi-component
foods that are similar to main dish and meal products, but smaller in
size. In describing this method in its petition, Nestlé assumed
an estimated average weight of 132.53 g for foods in this category
compared to the 170.1 g (6 oz) minimum weight criterion for main
dishes. This resulted in nutrient criteria of 7.8 g fat, 3.5 g
saturated fat, and 74.1 mg cholesterol. These criteria are applied on a
per-RACC basis. When the nutrient criteria are applied on a per-RACC
basis and then computed on a per-100 g basis to compare with the other
options, the nutrient criteria are less than 5.6 g fat per 100 g, 2.5 g
or less saturated fat per 100 g, and less than 53 mg cholesterol per
100 g. These values are slightly more restrictive than what the agency
is proposing to require and more restrictive than necessary for
consumers to be able to maintain a diet that is within the current
dietary recommendations for fat, saturated fat, and cholesterol, as
discussed in the proposed option. Further, Nestlé did not
describe the basis for its estimated average weight of ``mixed dishes
not measurable with a cup'' as 132.53 g when calculating the nutrient
criteria. Thus, Nestlé provided no rationale for why a portion
size of 132.53 g should be used in computing the nutrient criteria in
lieu of the RACC of 140 g for ``mixed dishes not measurable with a
cup.'' Consequently, for all these reasons, FDA tentatively decided not
to propose the nutrient requirements for ``lean'' based on
Nestlé's assumed average weight for ``mixed dishes not
measurable with a cup.''
The other method suggested by Nestlé determined nutrient
values (based on recommended intakes) using an estimated calorie
contribution of foods in the ``mixed dishes not measurable with a cup''
category as the basis of the definition. This suggested method relates
current dietary recommendations for the percentage of nutrients in the
overall diet to the percentage distribution of the nutrients in the
individual food item (e.g., the current dietary recommendation of 30
percent fat in the diet would result in the product containing 30
percent of its calories from fat). This method of determining nutrient
requirements is problematic for a number of reasons. One reason is that
such a method is not one FDA has used to determine nutrient
requirements for nutrient content claims. Additionally, recommendations
for intake of these nutrients expressed as a percentage of calories are
available for only total fat and saturated fat. Intake of cholesterol
has no such recommendation. Consequently, this suggested method is used
only for determining the requirements of two of the three nutrients,
with the cholesterol requirement being determined using the alternate
method suggested by Nestlé. Therefore, the determination of the
nutrient requirements is not consistent using this method. Also,
Nestlé calculated the nutrients on a per-100 g basis but
proposed to apply them on a per-RACC basis. It is unclear why
Nestlé calculated the requirements in this way, as opposed to
originally calculating the requirements on a per-RACC basis (using the
RACC of 140 g). To determine the total fat requirement, for example,
Nestlé determined how many calories were in 100 g of an average
``mixed dish not measurable with a cup'' (214.4 calories / 100 g),
calculated 30 percent of this value (64.32 calories), converted
calories to gram weight (7.147 g fat), and applied this value to a per-
RACC basis. Using the method as suggested by the petitioner (when the
nutrient criteria are applied on a per-RACC basis and then computed on
a per-100 g basis to compare with the other options), the nutrient
criteria from this method are less than 5 g fat per 100 g, 2.5 g or
less saturated fat, and less than 53 mg cholesterol per 100 g. These
values are slightly more restrictive than what the agency is proposing
to require and more restrictive than necessary for consumers to be able
to maintain a diet that is within current dietary recommendations for
fat, saturated fat, and cholesterol, as discussed in the proposed
option. For all these reasons, the agency tentatively decided not to
propose the nutrient criteria derived using this method.
The agency tentatively decided to determine new nutrient
requirements specific to the ``mixed dishes not measurable with a cup''
category and to use the RACC for ``mixed dishes not measurable with a
cup'' in deriving the nutrient criteria. As discussed earlier in this
document, the agency wants to ensure that ``mixed dishes not measurable
with a cup'' that are labeled ``lean'' will help consumers construct a
diet that is consistent with current dietary recommendations. Thus,
consumers who incorporate these products into their diets as healthy
snacks or choose smaller portions for controlled calorie intake at
meals should be able to keep their dietary intake of total fat,
saturated fat, and cholesterol at or below the DRVs established by FDA
and within current ranges set forth in the IOM acceptable macronutrient
distribution ranges (AMDRs) and the 2005 Dietary Guidelines for
Americans. Because FDA-regulated foods within the category ``mixed
dishes not measurable with a cup'' do not necessarily contribute to the
diet in the same manner as meal-type products regulated by FDA (e.g.,
they are not used as meal replacements, and would not necessarily have
the same fat, saturated fat, and cholesterol content as the USDA-
regulated counterparts), we have tentatively concluded that the
nutrient criteria should be more restrictive than these other products
to reflect the contribution to the overall diet and the different fat
content.
FDA determined that it could achieve better criteria, which would
enable consumers to maintain intakes of fat within current dietary
recommendations without being as restrictive as the other
[[Page 71047]]
options, by basing the nutrient criteria for fat, saturated fat, and
cholesterol on the current criteria for main dishes, but applying the
criteria to the RACC (140 g) for ``mixed dishes not measurable with a
cup'' rather than the minimum weight for main dishes (170.1 g). The
agency chose the main dish minimum weight requirement of 170.1 g (6 oz)
for use in its calculations, rather than the 283.4 g (10 oz) minimum
weight requirement for meal products, because main dishes are closer to
``mixed dishes not measurable with a cup'' in portion size and
contribution to the overall diet. The current regulations require main
dish products bearing a ``lean'' claim to have less than 10 g total
fat, 4.5 g or less saturated fat, and less than 95 mg cholesterol per
100 g and per labeled serving. Because the minimum weight criterion for
main dishes and the RACC for ``mixed dishes not measurable with a cup''
are both considered a serving and much closer in portion size than meal
products at 10 oz, the agency decided that using the nutrient criteria
based on the minimum weight for main dishes would be appropriate for
calculating the criteria for ``mixed dishes not measurable with a
cup.'' Further, to be eligible for a ``lean'' nutrient content claim, a
main dish must meet the nutrient criteria on a per-labeled-serving
basis.\8\ Thus, the agency chose the serving size for a main dish that
would have to meet the nutrient criteria for ``lean'' (i.e., 170 g) as
a basis to establish the criteria for ``mixed dishes not measurable
with a cup'' per RACC. The RACC for ``mixed dishes not measurable with
a cup'' is 140 g (5 oz).
---------------------------------------------------------------------------
\8\ If a food qualifying as a main dish meets the per-labeled-
serving basis for a ``lean'' claim, it also meets the per-100 g
basis. For example, a main dish with a 170 g labeled serving size
containing less than 10 g fat, 4.5 g or less saturated fat, and less
than 95 mg cholesterol per labeled serving could bear a lean claim
because it meets both the per-labeled-serving basis and the per-100
g basis (i.e., the food would contain less than 5.8 g fat, 2.6 g or
less saturated fat, and less than 55.9 mg cholesterol per 100 g).
However, a food qualifying as a main dish that meets the per-100 g
basis for a ``lean'' claim might not meet the per-labeled-serving
basis. For example, a main dish containing 10 g fat, 4.5 g saturated
fat, and 95 mg cholesterol per 100 g would contain 17 g fat, 7.7 g
saturated fat, and 162 mg cholesterol per 170 g labeled serving.
---------------------------------------------------------------------------
FDA proposes to establish the fat, saturated fat, and cholesterol
criteria for the definition of ``lean'' for ``mixed dishes not
measurable with a cup'' by calculating the percent of the proportion of
the weight of the RACC for ``mixed dishes not measurable with a cup''
(140 g) to the minimum weight of main dishes (170.1 g) and multiplying
the percent by the nutrient criteria for fat, saturated fat, and
cholesterol for main dishes. The proportion in weight is 140 g / 170.1
g, which equals 0.82 or 82 percent. Eighty-two percent of the current
nutrient criterion value for fat (10 g fat multiplied by 82 percent)
equals a nutrient value of 8.2 g fat per RACC. Eighty-two percent of
the current nutrient criterion value for saturated fat (4.5 g sat fat
multiplied by 82 percent) equals 3.69 g saturated fat. Eighty-two
percent of the current nutrient criterion value for cholesterol (95 mg
cholesterol multiplied by 82 percent) equals 77.9 mg cholesterol. This
proportional reduction results in rounded values of 8 g total fat, 3.5
g saturated fat, and 80 mg cholesterol. Calculating the proposed
nutrient criteria for ``mixed dishes not measurable with a cup'' per
RACC from the current nutrient content criteria on the minimum weight
for main dishes provides proposed criteria for ``mixed dishes not
measurable with a cup'' that are comparable in their contribution of
fat, saturated fat, and cholesterol on a per-100 g basis to that
contributed by main dishes on a per-100 g basis.\9\ The proposed
nutrient criteria are less restrictive than the other options
considered and would potentially allow more foods for increased
consumer choice. Consumers could achieve a diet using ``lean'' ``mixed
dishes not measurable with a cup'' that is consistent with current
dietary recommendations.
---------------------------------------------------------------------------
\9\ For example, a 170 g main dish that meets the nutrient
content criteria of less than 10 g per labeled serving of 170 g, 4.5
or less saturated fat per 170 g, and less than 95 mg cholesterol per
labeled serving of 170 g would provide less than 5.8 g fat, 2.6 g or
less saturated fat, and less than 55.9 mg cholesterol per 100 g. As
a comparison, a mixed dish that contains less than 8 g fat, 3.5 g or
less saturated fat, and less than 80 mg cholesterol would provide
less than 5.7 g fat, 2.5 g or less saturated fat, and less than 57
mg cholesterol per 100 g.
---------------------------------------------------------------------------
Therefore, to bear a ``lean'' claim, FDA proposes in Sec.
101.62(e)(2) that food items falling within the RACC for ``mixed dishes
not measurable with a cup'' must have less than 8 g total fat, 3.5 g or
less saturated fat, and less than 80 mg cholesterol per RACC. The
agency is proposing to revise current Sec. 101.62(e) to include the
proposed provision. FDA requests comments on these criteria for ``mixed
dishes not measurable with a cup.''
In proposing the nutrient requirements, the agency considered
including a requirement for trans fat, but decided against including it
in this proposal. Currently, there is no daily value for trans fatty
acids, but it is well known that trans fatty acids increase serum
total- and LDL-cholesterol levels. FDA has issued an advanced notice of
proposed rulemaking (ANPRM) to solicit comments on establishing trans
fat nutrient content claims; to establish qualifying criteria for trans
fat in current nutrient content claims for saturated fatty acids and
cholesterol, lean and extra lean claims, and health claims that contain
a message about cholesterol-raising lipids; and, in addition, to
establish disclosure and disqualifying criteria to help consumers make
healthy food choices. The agency also solicited comment on whether it
should consider statements about trans fat, either alone or in
combination with saturated fat and cholesterol, as a footnote in the
Nutrition Facts panel or as a disclosure statement in conjunction with
claims (68 FR 41507, July 11, 2003). FDA believes that it would be
premature to consider a specific trans fat nutrient requirement for use
of the nutrient content claim ``lean'' by eligible foods classified as
``mixed dishes not measurable with a cup,'' until it has evaluated the
merits of a level of trans fat based on the data and information it is
currently evaluating in the context of the ANPRM.
Pending issuance of a final rule defining the ``lean'' nutrient
content claim that characterizes the fat, saturated fat, and
cholesterol content in qualifying foods that fall within the RACC
established for ``mixed dishes not measurable with a cup,'' FDA intends
to consider the exercise of its enforcement discretion on a case by
case basis when the ``lean'' nutrient content claim in food labeling is
based on the definition in this proposed rule and when the labeling
containing such a claim is not otherwise false or misleading. The act's
enforcement provisions commit complete discretion to the Secretary (and
by delegation to FDA) to decide how and when they should be exercised.
Heckler v. Chaney, 470 U.S. 821 at 835 (1985); see also Schering Corp.
v. Heckler, 779 F.2d 683 at 685-86 (D.C. Cir. 1985) (stating that the
provisions of the act ``authorize, but do not compel the FDA to
undertake enforcement activity''). Until the agency issues a final rule
for the ``lean'' nutrient content claim for foods classified as ``mixed
dishes not measurable with a cup,'' the agency believes that its
exercise of enforcement discretion will help alleviate consumer
confusion by encouraging greater consistency and uniformity in the
marketplace for such claims, and thereby assist consumers in making
informed dietary choices about their fat, saturated fat, and
cholesterol intake.
IV. Preliminary Regulatory Impact Analysis
FDA has examined the impacts of the proposed rule under Executive
Order 12866. Executive Order 12866 directs
[[Page 71048]]
agencies to assess all costs and benefits of available regulatory
alternatives and, when regulation is necessary, to select regulatory
approaches that maximize net benefits (including potential economic,
environmental, public health and safety, and other advantages;
distributive impacts; and equity). Executive Order 12866 classifies a
rule as significant if it meets any one of a number of specified
conditions, including having an annual effect on the economy of $100
million, adversely affecting a sector of the economy in a material way,
adversely affecting competition, or adversely affecting jobs. A
regulation is also considered a significant regulatory action if it
raises novel legal or policy issues. The agency believes that this
proposed rule is not a significant regulatory action as defined by the
Executive order.
A. Need for Regulation
Unlike foods classified as either meal products or main dish
products, many foods classified as ``mixed dishes not measurable with a
cup'' are not currently allowed to make a ``lean'' nutrient content
claim because the RACC is less than 6 oz. Allowing a ``lean'' nutrient
content claim on the labels of ``mixed dishes not measurable with a
cup'' may facilitate more nutritious eating choices by consumers.
Moreover, better choices regarding fat, saturated fat, and cholesterol
consumption are especially important considering current concern with
obesity, other diseases related to being overweight, and heart disease.
Finally, USDA currently allows the ``lean'' claim on all foods that
they regulate, including individual foods, and allowing the claim on
FDA-regulated foods would increase consistency in allowable claims
between the two agencies.
B. Regulatory Options
We considered the following regulatory options: (1) Take no new
regulatory action; (2) adopt Nestlé's petitioned criteria for
fat, saturated fat, and cholesterol; (3) extend the current FDA
criteria for making a ``lean'' claim for ``meal products'' and ``main
dish products'' to ``mixed dishes not measurable with a cup,'' and (4)
adopt the proposed criteria for fat, saturated fat, and cholesterol
contents necessary for making a ``lean'' claim for ``mixed dishes not
measurable with a cup.'' FDA requests comments on benefits, costs, and
any other aspects of these (and any other) alternatives.
Option 1: Take No New Regulatory Action
The first regulatory option, take no action, would require denying
the Nestlé petition requesting that FDA authorize a nutrient
content claim ``lean'' for ``mixed dishes not measurable with a cup.''
Taking no regulatory action to amend the definition of ``lean'' is the
state of the world and our baseline. By convention, we treat the option
of taking no new regulatory action as the baseline for determining the
costs and benefits of the other options. Therefore, we associate
neither costs nor benefits with this option. The consequences of taking
no action are reflected in the costs and benefits of the other options.
Option 2: Propose Nestlé's Petitioned Criteria for Fat,
Saturated Fat, and Cholesterol
A second option is to allow ``mixed dishes not measurable with a
cup'' to make a ``lean'' claim based on criteria derived from the
Nestlé petition. In that petition two methods are used to derive
the criteria for fat, saturated fat, and cholesterol contents for
allowing a ``lean'' claim for ``mixed dishes not measurable with a
cup.'' One method is to establish ``lean'' criteria for fat, saturated
fat, and cholesterol contents of ``mixed dishes not measurable with a
cup'' with an estimated average weight of 132.53 g, proportional to
existing criteria for ``lean'' ``meal products'' with minimum weights
of 170.1 g. This method produces criteria of 7.8 g of total fat, 3.5 g
of saturated fat, and 74.1 milligrams (mg) of cholesterol per RACC (140
g). The second method uses an estimated average calorie contribution of
214 calories from ``mixed dishes not measurable with a cup'' and the
recommendations for dietary fat intake reported by IOM and
recommendations from the National Cholesterol Education Program on
saturated fat intake. This method produces criteria of 7 g of total
fat, 2.5 g of saturated fat, and 75 mg of cholesterol per RACC. We use
the criteria for fat, saturated fat, and cholesterol contents from the
latter, more restrictive method for analyzing the regulatory impact for
this option.
This option is the most restrictive of the all options considered
in terms of allowable fat, saturated fat, and cholesterol contents and
would result in the greatest percent reduction in fat content in the
``mixed dishes not measurable with a cup'' category compared to the
other three options. However, the market share of all FDA-regulated
``mixed dishes not measurable with a cup'' expected to make a ``lean''
claim under this option (6 percent) and the reduction in total dietary
fat consumption may be the lowest compared to the other options. While
the costs of this option would be voluntarily incurred, we estimate the
extent of resources allocated to new product development,
reformulation, relabeling, and discontinued product lines would be the
lowest compared to the other options.
Option 3: Extend the Current Criteria for Fat, Saturated Fat, and
Cholesterol for ``Lean''
A third option is to extend the same criteria of less than 10 g of
total fat, 4.5 g of saturated fat, and 95 mg of cholesterol per 100 g
and per labeled serving currently used to allow the ``lean'' claim for
``meal products'' or ``main dish products,'' to allow ``mixed dishes
not measurable with a cup'' to make a ``lean'' claim on a per-RACC
basis. This is the least restrictive of the options considered here in
terms of allowable fat, saturated fat, and cholesterol content and
would result in a smaller percent reduction in fat content in the
``mixed dishes not measurable with a cup'' category than under the
other three options. In addition, the market share of all FDA-regulated
``mixed dishes not measurable with a cup'' expected to make a ``lean''
claim under this option (10 percent), and the reduction in total
dietary fat consumption may be the highest of the options. While the
costs of this option would be voluntarily incurred, we estimate the
extent of resources allocated to new product development,
reformulation, relabeling, and discontinued product lines to be the
highest of the options.
Option 4: The Proposed Regulatory Action
A fourth option is to allow ``mixed dishes not measurable with a
cup'' to contain a ``lean'' claim based on the proposed criteria of 8 g
of total fat, 3.5 g or less of saturated fat, and 80 mg of cholesterol
per RACC. This option may be considered moderately restrictive compared
to the other options in terms of allowable fat, saturated fat, and
cholesterol content, and may result in a moderate percent reduction in
fat content in the ``mixed dishes not measurable with a cup'' category
compared with the other three options. In addition, the market share
for all FDA-regulated ``mixed dishes not measurable with a cup''
expected to make a ``lean'' claim under this option (8 percent), and
the reduction in total dietary fat consumption may be considered
moderate compared with the
[[Page 71049]]
other options as well. While the costs of this option would be
voluntarily incurred, we estimate the resources allocated to new
product development, reformulation, relabeling, and discontinued
product lines to be moderate relative to the other options.
C. Benefits
The benefits from this proposed rule would derive from the ability
of consumers to make healthier dietary choices among the foods in the
category of ``mixed dishes not measurable with a cup'' based on the fat
content of these foods, when such foods bear the ``lean'' nutrient
content claim. The ``lean'' claim makes it easier for consumers to find
foods in this category that do not exceed a certain amount of fat,
saturated fat, and cholesterol. If consumers substitute ``lean''
``mixed dishes not measurable with a cup'' for other foods in this
category that are higher in fat, we would expect them to benefit from
the improved ability to maintain healthy weights and stay within
recommended intakes for fat, saturated fat, and cholesterol. We
estimate the health benefits from this proposed rule would come from
the reduction in total fat, saturated fat, and cholesterol consumption
that would result. Reduced fat, saturated fat, and cholesterol
consumption would be expected to help consumers maintain healthier body
weights.
1. An Overview of Likely ``Lean'' ``Mixed Dishes Not Measurable With a
Cup''
The expected effects of the proposed rule would be small because
there are a small number of ``mixed dishes not measurable with a cup''
under FDA regulatory authority that would be eligible to make the
``lean'' claim, should one be allowed. Although foods classified as
``mixed dishes not measurable with a cup'' that are subject to USDA
regulatory oversight are currently allowed to make a ``lean'' claim, we
think that very few foods such as many sandwiches, burritos, pizza
pockets, and egg rolls that are currently subject to FDA regulatory
oversight, would qualify for the ``lean'' claim based on the criteria
in any of the regulatory options. The Nestlé petition identified
the rapidly growing frozen sandwich and snack category as containing
likely candidate products within ``mixed dishes not measurable with a
cup'' for making the ``lean'' claim, should one be allowed. For
example, according to the Nestlé petition, growth in ``mixed
dishes not measurable with a cup'' that make a ``lean'' claim could
likely come from the Weight Watchers Smartwiches, Amy's Pocket
Sandwiches, and Nestlé's Lean Pockets product lines (Ref. 1).
2. Structure of the Benefits Analysis
To estimate the reduction in fat consumption that would result from
the regulatory options, we first estimate the current share of total
food consumption in the ``mixed dishes not measurable with a cup''
category. We estimate the total consumption of all ``mixed dishes not
measurable with a cup'' and the total consumption of all food. Total
food consumption is from food prepared and consumed in the home as well
as from food served and consumed away from home. We then estimate the
fraction of that total that would be subject to FDA ``lean'' labeling
requirements. We develop a conceptual framework to estimate the share
of ``mixed dishes not measurable with a cup'' that is likely to make a
new ``lean'' claim, and use published information on the market share
of products that make ``fat'' claims to estimate the maximum market
share of ``lean'' ``mixed dishes not measurable with a cup.'' We
estimate the percent reduction in total dietary fat intake that would
result from consuming newly allowed ``lean'' ``mixed dishes not
measurable with a cup'' instead of alternative food products.
Alternatives to ``mixed dishes not measurable with a cup'' that make
the ``lean'' claim could be any other ``mixed dish not measurable with
a cup'' including those under the regulatory oversight of USDA.
Finally, we discuss important considerations that may affect the
distribution of the reduction in dietary fat intake across consumers of
different overweight status.
3. Estimating Current Consumption of ``Mixed Dishes Not Measurable With
a Cup'' Subject to FDA Regulatory Oversight
We used the data from the 1997 U.S. Economic Census and North
American Industry Classification System (NAICS) code 4451 for grocery
stores to estimate current consumption of all ``mixed dishes not
measurable with a cup'' (Ref. 3). We then refined that estimate so that
it includes only those ``mixed dishes not measurable with a cup'' that
are subject to FDA regulatory oversight. The use of only NAICS 4451 for
this purpose may underestimate true consumption of ``mixed dishes not
measurable with a cup'' to the extent that there are other NAICS codes
that also contain sales of these products. However, sales of these
products reported in other NAICS codes are probably small.
We used merchandise lines 103 (Frozen foods (including packaged
foods sold in frozen state)), 106 (Bakery products not baked on the
premises, except frozen), and 124 (all other meals and snacks) within
NAICS 4451 as the basis to estimate current consumption of ``mixed
dishes not measurable with a cup.'' We assume that half of all frozen
foods from merchandise line 103 are either frozen meal products and
main dish products, or frozen ``mixed dishes not measurable with a
cup'' with RACCs of 140 g (about 5 oz); we further assume that two-
thirds of that total is for frozen meal products and main dish products
and one-third is for frozen ``mixed dishes not measurable with a cup.''
Consequently, we estimate that within merchandise line 103 there were
approximately $3.2 billion in annual sales of frozen ``mixed dishes not
measurable with a cup'' in 1997.
We used a similar framework to estimate current consumption of
``mixed dishes not measurable with a cup'' with RACCs of 140 g (about 5
oz) for merchandise lines 106 and 124. We assume that three-quarters of
the sales reported for NAICS 4451, merchandise line 106, are for cakes,
pies, cookies, and related items, while one-quarter of the sales from
this line are for ``mixed dishes not measurable with a cup'' (e.g.,
quiches and entr[eacute]e-type turnovers). Consequently, we estimate
the total annual sales of ``mixed dishes not measurable with a cup''
from that category to be approximately $1.8 billion. Finally, we assume
that half of all sales of merchandise line 124 are for ``mixed dishes
not measurable with a cup,'' which leads us to estimate that
approximately $1.3 billion in annual sales of ``mixed dishes not
measurable with a cup'' came from that merchandise line in 1997.
Based on the analysis in the previous paragraphs, our estimate of
total consumption of ``mixed dishes not measurable with a cup,''
derived from total sales from that category, is approximately $6.3
billion (i.e., $3.2 billion plus $1.8 billion plus $1.3 billion,
rounded to the nearest 100 million) for 1997. We estimate that half of
this total is subject to USDA regulatory oversight, while half would be
subject to the ``lean'' requirements outlined in the policy options
considered in this analysis. Consequently, we estimate that total
consumption of ``mixed dishes not measurable with a cup'' subject to
FDA regulatory oversight is approximately $3.2 billion (i.e., $6.3
billion / 2, rounded to the nearest 100 million).
[[Page 71050]]
4. The Share of Total Food Consumption From ``Mixed Dishes Not
Measurable With a Cup'' Subject to FDA Regulatory Oversight
Total food consumption consists of food purchased at retail grocery
and other establishments and consumed elsewhere, and food consumed at
food service establishments. From the 1997 U.S. Economic Census, total
sales of all groceries and other foods for human consumption off-the-
premises reported for NAICS 4451 were about $274 billion (Ref. 3).
Consequently, we estimate that consumption of ``mixed dishes not
measurable with a cup'' subject to FDA regulatory oversight represents
approximately 1.2 percent of all consumption of food purchased for
consumption off-the-premises ($3.2 billion / $274 billion).
We used USDA data to estimate the fraction of total food consumed
(both in-home as well as away-from-home consumption) that is subject to
packaged food labeling requirements (in-home consumption exclusively)
in order to estimate the percent of total food consumed from ``mixed
dishes not measurable with a cup.'' The percentage of food consumed
away from home is estimated as 43 percent of total U.S. food
consumption expenditures based on the 2003 consumer price index for
food computed by the Economic Research Service (Ref. 4). Consequently,
we estimate that 57 percent of food consumed is purchased for
consumption at home (i.e., 100 percent - 43 percent), and that the
universe of ``mixed dishes not measurable with a cup'' that could
potentially make a ``lean'' claim accounts for approximately 0.67
percent of total consumption (1.2 percent x 57 percent). For the
purpose of this analysis, we assume that the fraction of total food
purchases at retail outlets from ``mixed dishes not measurable with a
cup'' has not significantly changed since 1997.
5. The Conceptual Model for Estimating Consumption of ``Lean'' ``Mixed
Dishes Not Measurable With a Cup''
We assume that the demand for ``mixed dishes not measurable with a
cup,'' like that for other food categories, depends on nutrition
attributes, consumer taste, and price, and that consumers will optimize
their food choices by substituting among these characteristics. A study
by Teisl and Levy found evidence that consumers substitute among
nutrient, price, and taste characteristics in their food choices (Ref.
5). In general, consumers prefer the taste of foods that are higher in
fat content (all else equal), and studies have documented that those
foods are lower in cost per calorie compared with foods with lower fat
contents (Ref. 6). Drewnowski and Specter report evidence suggesting
that nutrition-conscious consumers will pay a premium for food products
they perceive as being relatively nutritious at the expense of taste
(Ref. 6). These researchers suggest that balanced diets lower in fat
and refined sugars are generally more expensive than diets higher in
fat and refined sugar.
We estimate that demand for ``mixed dishes not measurable with a
cup'' making ``lean'' claims will come from health-conscious consumers
who are assumed to value the nutritional characteristics of ``lean''
``mixed dishes not measurable with a cup'' over the taste
characteristics of other ``mixed dishes not measurable with a cup.'' We
do not have the quantitative data and other information on consumer
preferences for taste and nutritious characteristics that would allow
us to directly estimate consumers' substitution between nutrition and
taste, but we know that the demand for more nutritious products in the
``mixed dishes not measurable with a cup'' category will increase as
the nutritious content of the products increase, assuming that taste
characteristics and prices are held constant. Consequently, we estimate
that the demand for ``lean'' ``mixed dishes not measurable with a cup''
will depend on the fat, saturated fat, and cholesterol contents
relative to that of all other ``mixed dishes not measurable with a
cup.''
In this analysis, we isolated fat content as the property of
interest. In order to generate a plausible estimate of the demand for
``mixed dishes not measurable with a cup'' under FDA regulatory
oversight that would make a ``lean'' claim, we make the following
assumptions:
<bullet> We assume a positive relationship between fat content and
consumer taste, so that near current levels of consumption of ``mixed
dishes not measurable with a cup,'' a reduction in fat content leads to
a reduction in consumer preference, all else the same.
<bullet> We assume a continuum of fat contents in all ``mixed
dishes not measurable with a cup'' that make fat claims, and estimate
the maximum market share based on where the ``lean'' criteria fall
within that continuum. We assume the continuum in fat contents range
from a low represented by the low-fat criteria (i.e., 3 g per RACC, or
140 g) to a high represented by the average fat content of ``mixed
dishes not eligible to make any fat claim.''
<bullet> We assume ``mixed dishes not measurable with a cup'' that
make a ``lean'' claim will contain less fat, have different taste
characteristics, and be priced at a premium (all else the same) over
``mixed dishes not measurable with a cup'' with higher fat contents,
including some that make fat claims but are ineligible to make a
``lean'' claim.
<bullet> We assume that the maximum market share for ``lean''
``mixed dishes not measurable with a cup'' will be proportional to the
fat contents of other ``mixed dishes not measurable with a cup'' making
fat claims based on where ``lean'' criteria fall within the continuum
of fat contents. In other words, we assume that fat content drives
market share within the segment of the market making claims about fat.
<bullet> We assume that all demand for ``lean'' ``mixed dishes not
measurable with a cup'' will come from consumers of similar foods in
this category that contain higher fat contents (including those with
reduced fat nutrient content claims as well as those that do not make
nutrient content claims) and have better taste. Current consumers of
similar ``mixed dishes not measurable with a cup'' except for their
higher fat contents may prefer ``lean'' mixed dishes because of their
more nutritious, lower fat characteristics. Moreover, consumers of
similar ``mixed dishes not measurable with a cup'' except for their
lower fat contents, such as low-fat products may instead choose similar
``lean'' ``mixed dishes not measurable with a cup'' because of taste.
We estimated the maximum potential market share for ``lean''
``mixed dishes not measurable with a cup'' using published information
on the market share for all FDA-regulated products that make ``fat''
claims. ``Mixed dishes not measurable with a cup'' with fat contents
lower than ``lean'' ``mixed dishes not measurable with a cup'' would
have smaller market shares, while those that make fat claims but have
higher fat contents than ``lean'' mixed dishes not measurable with a
cup'' would have greater market shares up to an estimated maximum
potential market share. In a study using the 2001 Food Label and
Package Survey data, LeGault et al. found that 33.7 percent of all FDA-
regulated product sales were from products that had some type of
nutrient content claim, and that 17.2 percent of all product sales had
some type of reduced fat claim (i.e., fat free, low or reduced fat,
lite, etc.) (Ref. 7). We assume that the maximum share of all FDA-
regulated ``mixed dishes not measurable with a cup'' that could make a
``lean'' claim is 17.2 percent.
[[Page 71051]]
6. Estimating the Market Share of ``Lean'' ``Mixed Dishes Not
Measurable With a Cup''
We estimate the market share for ``lean'' ``mixed dishes not
measurable with a cup'' based on the lower fat contained in such
products that would be eligible to bear the ``lean'' claim under each
policy option, compared with the average for ``mixed dishes not
measurable with a cup'' that are likely consumption-substitutes. We
estimate the average nutrient contents in ``mixed dishes not measurable
with a cup'' of likely consumption-substitutes using the nutrient
contents of several ``mixed dishes not measurable with a cup'' that are
reported in the USDA National Nutrient Database for Standard Reference
(Ref. 8). Our sample of likely consumption-substitute ``mixed dishes
not measurable with a cup'' is drawn from likely candidate products,
similar to those suggested in the Nestlé petition, in the Weight
Watchers Smartwich, Amy's Pocket Sandwich, and Nestlé's Lean
Pockets product lines. The nutrient contents reported in the table 1 of
this document include several different fresh and frozen sandwich
products, and are reported on a per-140 g basis rather than per-100 g
basis as in the USDA database. This modification allows us to better
compare the levels of fat, saturated fat, and cholesterol in these
``mixed dishes not measurable with a cup'' with the ``lean''
requirements specified in each policy option. We implicitly assume that
the distribution of nutrient contents of the reported items is
representative of that for all likely substitute ``mixed dishes not
measurable with a cup.''
To incorporate uncertainty in our estimates we assume that fat,
saturated fat, and cholesterol contents of ``mixed dishes not
measurable with a cup'' are lognormally distributed with means equal to
the averages of the reported contents, and standard deviations equal to
the natural logarithm of the standard deviations of the reported
contents across the ``mixed dishes not measurable with a cup.'' The
lognormal distribution is appropriate to use because it incorporates
the idea that relatively few candidate consumption-substitute ``mixed
dishes not measurable with a cup'' would have nutrient levels much
different from the mean as would be implied by the use of a normal
distribution. The parameters that describe the lognormal distribution
are the natural logarithms of the mean and variance in the data. The 5
percent (low) and 95 percent (high) estimates are reported along with
the average contents in table 1 of this document.
Table 1.--Nutrient Contents of Some Likely Substitutes for ``Lean'' ``Mixed Dishes Not Measurable With a Cup''
----------------------------------------------------------------------------------------------------------------
Total Fat (g per Saturated Fat (g Cholesterol (mg per
One Serving 140 g RACC) per 140 g RACC) 140 g RACC)
----------------------------------------------------------------------------------------------------------------
Hot Pockets, Beef and Cheddar Stuffed 20 9 52
Sandwich, frozen
--------------------------------------------------------------------------------------------
-----------------------------------------------======================
-----------------------------------------------
---------------------------------------------------------------------
----------------------------------------------- ======================
======================================================================
-----------------------------------------------
-----------------------------------------------
======================================================================
----------------------------------------------------------------------
-----------------------------------------------=======================
----------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
The maximum fat content that would be allowed under option 2 is
between 47 and 70 percent of the average (i.e., (7 / 15) x 100 and 7 /
10 x 100) with a mean of 58 percent of the average fat content of the
foods assumed to be likely substitute ``mixed dishes not measurable
with a cup,'' and for option 3 the maximum fat content for ``lean'' is
between 67 and 100 percent (i.e., (10 / 15) x 100 and (10 / 10) x 100)
with a mean of 83 percent of the average fat content of the foods
assumed to be likely consumption-substitute ``mixed dishes not
measurable with a cup.'' FDA proposed maximum fat content for ``lean''
is between 53 and 80 percent (i.e., (8 / 15) x 100 and (8 / 10) x 100)
with a mean of 67 percent of the average fat content of the foods
assumed to be likely consumption-substitute ``mixed dishes not
measurable with a cup.'' The maximum fat content for ``low fat'' is
about 25 percent of the average content of the foods listed (i.e., 3 /
12 x 100). We note that these estimates of the difference in fat
contents between ``lean'' ``mixed dishes not measurable with a cup''
and likely consumption-substitute ``mixed dishes not measurable with a
cup'' may understate the true difference to the extent that some
``lean'' ``mixed dishes not measurable with a cup'' will have fat
contents below the maximum allowed, which is the value used in the
computation.
Based on an assumed continuum of fat contents ranging from 25
percent of
[[Page 71052]]
the average (low-fat) to the average fat content in likely consumption-
substitute ``mixed dishes not measurable with a cup'' not eligible to
make fat claims we estimate a market share for ``lean'' ``mixed dishes
not measurable with a cup'' of 6 percent using the industry-petitioned
criteria (i.e., (58 percent - 25 percent) x 17.2 percent of mixed
dishes that have reduced fat claims, rounded to the nearest percent);
10 percent using the criteria in option 3 (i.e., (83 percent - 25
percent) x 17.2 percent of mixed dishes that have reduced fat claims,
rounded to the nearest percent); and 7 percent using the proposed
criteria (i.e., 67 percent - 25 percent) x 17.2 percent of mixed dishes
that have reduced fat claims, rounded to the nearest percent). In order
to incorporate uncertainty in our estimate of market share, we assume a
uniform distribution with a range of 0 to 8 percent using FDA-proposed
criteria, from 0 to 7 percent using the industry-proposed criteria, and
from 0 to 10 percent by extending the current criteria for ``main dish
products.'' The estimated ``lean'' market share and estimated fat
contents relative to likely consumption-substitute ``mixed dishes not
measurable with a cup'' are summarized in table 2 of this document.
Table 2.--Fat Content Relative to Likely Consumption-Substitutes and the Market Share for ``Lean'' ``Mixed
Dishes Not Measurable With a Cup''
----------------------------------------------------------------------------------------------------------------
Fat Content in ``Lean'' Relative to
the Average Fat Content in Likely Market Share of ``Lean''
Consumption-Substitute ``Mixed Dishes ``Mixed Dishes Not
Not Measurable With a Cup'' Measurable With a Cup''
----------------------------------------------------------------------------------------------------------------
Option 2: Industry-petitioned Low: 47 percent 0 to 7 percent
High: 70 percent
Average: 58 percent
---------------------------------------------------------------------------------------
----------------------------------------------=========================================
----------------------------------------------------------------------------------------------------------------
7. Estimating the Reduction in Fat Consumption From Allowing the
``Lean'' Claim
The use of the estimated market share for ``lean'' ``mixed dishes
not measurable with a cup'' may overstate the reduction in fat
consumption if many consumers already consume FDA-regulated products
that would be eligible for the ``lean'' claim (without the claim on the
label). Moreover, it is possible that some consumers may switch to
``lean'' ``mixed dishes not measurable with a cup'' once they become
available, from the ``low-fat'' alternatives they currently consume
because of better taste. We estimate that one-half of all consumption
of ``lean'' ``mixed dishes not measurable with a cup'' would be from
consumers that would switch from other ``mixed dishes not measurable
with a cup'' that contain the same amount or less fat.
Table 3 of this document shows the expected ``lean'' market share,
percent reduction in fat consumption from the ``mixed dishes not
measurable with a cup'' category, and the percent reduction in fat
consumption relative to current total fat consumption for each option
considered here. Based on the criteria for fat, saturated fat, and
cholesterol contents stated in each policy option, we estimate that the
total amount of fat consumed for 0 to 7 percent of ``mixed dishes not
measurable with a cup'' will decline by between 10 and 24 percent
(i.e., [(1 - 0.80) x 100] / 2, and [(1 - 0.53) x 100)] / 2) with a mean
of 17 percent under the proposed option. For option 3, extending the
current criteria for ``main dish products'' we expect the total amount
of fat consumed for 0 to 12 percent of ``mixed dishes not measurable
with a cup'' to decline by between 0 and 17 percent (i.e., [(1 - 1) x
100] / 2, and [(1 - 0.67) x 100)] / 2), with a mean of 9 percent. Under
the industry petitioned option we expect the total amount of fat
consumed for 0 to 6 percent of ``mixed dishes not measurable with a
cup'' to decline by between 15 and 26 percent (i.e., [(1 - 0.70) x 100]
/ 2, and [(1 - 0.47) x 100)] / 2), with a mean of 21 percent.
Because ``mixed dishes not measurable with a cup'' that are subject
to FDA labeling requirements make up approximately 0.67 percent of
total consumption, we estimate that total fat consumption could decline
by about 0.01 percent (i.e., 8 percent of ``mixed dishes not measurable
with a cup'' x 17 percent fat reduction (using the mean) x 0.67 percent
of total consumption rounded to the nearest hundredth) using the FDA
proposed ``lean'' criteria, assuming that consumers do not increase
their consumption of other foods including main dishes with weights
over 6 oz and other foods with higher fat contents.
Table 3.--Market Share and Percent Reduction in Fat Consumption From
Newly Labeled ``Lean'' ``Mixed Dishes Not Measurable With a Cup''
------------------------------------------------------------------------
Mean Percent
Expected Reduction in Mean
Market Share Fat in ``Mixed Percent
of ``Lean'' Dishes Not Reduction
``Mixed Dishes Measurable in Total
Not Measurable With a Cup'' Fat
With a Cup'' Subject to FDA Consumption
Oversight
------------------------------------------------------------------------
Option 2: Industry- 6 percent 21 percent 0.0084
petitioned percent
---------------------------------------------
----------------------------
[[Page 71053]]
=================
------------------------------------------------------------------------
As table 3 of this document shows, the reduction in fat consumption
resulting from this proposed rule is likely to be quite small.
Additional factors may mitigate further the reduction in fat intake
resulting from the proposed rule. Because consumers may increase their
consumption of other foods with higher fat and cholesterol contents to
compensate for the lower fat and cholesterol contents of ``lean''
``mixed dishes not measurable with a cup,'' the mean estimated
reduction in total fat and cholesterol consumption may be less than
0.01 percent. Moreover, we may be overestimating the reduction in fat
consumption by not accounting for the increase in fat intake for
current consumers of lower fat substitutes who, given the opportunity,
would choose ``lean'' ``mixed dishes not measurable with a cup''
because of their perceived better taste. To incorporate uncertainty in
the estimate, we assume the reduction in fat consumption from this
proposed rule to be uniformly distributed between 0 and 0.02 percent,
with 0.01 percent as the mean.
8. The Distribution of Obese and Overweight Consumers Across Income
Groups
The distribution of overweight and obese consumers across income
groups may be important when valuing the benefits from the proposed
rule. Drewnowski and Spector find evidence that the highest rates of
obesity occur among population groups with the highest poverty rates
and the least education (Ref. 6). If the obesity rates are negatively
related to income and education, and if low income consumers respond
more to the higher prices than the lower fat contents of ``lean''
products, then the overall benefits from this proposed rule may be
lower than anticipated.
Prices for ``lean'' products will be higher than those for products
with no nutrient content claim. For example, data collected by FDA on
market shares for frozen dinners making nutrient content claims
suggests an estimated average price of $2.92 per product, for a $0.32
price premium on frozen dinners making a ``healthy'' claim compared
with frozen dinners of comparable size making a less stringent nutrient
content claim (Ref. 9). We interpret this premium to imply that
consumers of those frozen dinners place a $0.32 price premium (or 12.3
percent) per dinner on ``nutrition'' characteristics. Assuming that
consumers hold the same preferences for taste and nutrition
characteristics for ``mixed dishes not measurable with a cup'' as they
do for frozen dinners, we estimate a price premium (all else the same)
for ``mixed dishes not measurable with a cup'' that make a ``lean''
claim to be somewhere between 0 and 12.3 percent (note we estimate that
the ``nutritious'' premium may be lower than 12.3 percent because the
nutrition criteria required for a ``lean'' claim are less stringent
than that required for the ``healthy'' claim).
Consuming foods with lower fat content helps consumers who are not
overweight with few health risks to maintain recommended fat intakes,
and helps overweight and obese consumers at higher risk to reduce their
fat intakes to recommended levels. Because obese people have the
highest health risks, the benefits from reducing their fat consumption
are acute and immediate, while those for reducing the dietary fat
intake for trim consumers with low health risks are latent and realized
only after a long period of time. We assume that the benefits obtained
from this proposed rule by low-risk consumers will be smaller than
those obtained by overweight and other high-risk consumers. If the
obese population is disproportionately represented by lower income
consumers, then that income groups' relatively large response to the
higher prices for ``lean'' ``mixed dishes not measurable with a cup''
will result in reduced benefits.
Consequently, the health benefits derived from the enhanced ability
of consumers to make healthier dietary choices among foods in the
category of ``mixed dishes not measurable with a cup'' subject of FDA
regulatory oversight based on their fat contents, when such foods bear
the ``lean'' nutrient content claim will be small. The category of
``mixed dishes not measurable with a cup'' comprises only 1.3 percent
of total food consumption, and we estimated that between 0 and 7
percent of this category would actually bear a ``lean'' claim under the
FDA proposed rule. Finally, we estimated that consumers would reduce
their consumption of fat by between 0 and 0.02 percent of current fat
consumption with passage of the proposed rule.
D. Costs
The costs incurred by manufacturers of ``mixed dishes not
measurable with a cup'' who choose to label their products as ``lean''
would be voluntarily incurred because no manufacturer would incur them
if it weren't profitable to do so. Nevertheless, we do anticipate an
allocation of resources devoted to product reformulation, relabeling,
new product development, and the discontinuation of product lines, as a
result of this proposed rule, and that the magnitude of this resource
allocation is important for characterizing the broader economic impact
on society.
The voluntarily incurred costs of the proposed rule include costs
of reformulating and relabeling ``mixed dishes not measurable with a
cup'' that would be newly able to make the ``lean'' claim, as well as
the costs from discontinued production and new product development.
``Mixed dishes not measurable with a cup'' that currently satisfy the
proposed ``lean'' criteria, but as yet, are not permitted to make the
claim, would only incur labeling costs from this proposed rule, while
those that reformulate will incur both reformation and labeling costs.
The reformulating process includes laboratory testing of recipes that
meet the required ``lean'' criteria, researching market prices and
availability of new ingredients and necessary equipment, production
testing in increasingly large batch sizes, and finally, consumer
testing and marketing evaluations. At any stage in the process a
product may be dropped from reformulation consideration. Products that
undergo a portion of the process, but that are eventually dropped from
consideration also constitute a reformulation cost. Labeling costs for
``lean'' products include the costs of testing food products to verify
that the levels of fat, saturated fat, and cholesterol in the
[[Page 71054]]
package are consistent with the ``lean'' claim, as well as the fixed
and variable printing costs for the new label and the storage costs
associated with disposing old labels.
We used the FDA Reformulation Cost Model (Ref. 10), the FDA
Decision to Reformulate Model (Ref. 11), and the FDA Labeling Cost
Model (Ref. 12) to estimate the reformulation and labeling costs from
making ``lean'' claims on ``mixed dishes not measurable with a cup.''
Data from NAICS 311412, Frozen Specialties NEC, incorporated in the
Reformulation Cost Model were used in simulations to estimate the
reformulation costs of ``mixed dishes not measurable with a cup.'' The
total costs computed for the broad NAICS code are adjusted to account
for the fraction of products within that category that are subject to
FDA regulatory oversight and estimated to make the ``lean'' claim for
each option.
Based on the earlier framework used to estimate the size of the
market for ``mixed dishes not measurable with a cup,'' we assume that
50 percent of the products in NAICS 311412 are ``mixed dishes not
measurable with a cup,'' half are subject to FDA regulatory oversight,
and 8 percent of those products will either reformulate in order to
meet the ``lean'' criteria, or only relabel if they already meet the
``lean'' criteria. We assume a uniform distribution between 0 and 0.08
of the market share for ``lean'' ``mixed dishes not measurable with a
cup'' (subject to FDA regulatory oversight) for the proposed option,
and a uniform distribution between 0 and 0.07 for the industry-
petitioned option. We justify the wide range because of the uncertainty
surrounding our assumptions.
Using FDA's Decision to Reformulate Model, we estimate that between
80 and 100 percent of the affected products using the ``lean'' label
for ``mixed dishes not measurable with a cup'' will be reformulated
products. The estimates generated from that model are derived from
interviews with experts on the probability of reformulation by NAICS
code or product category. Estimates at the lower end of the range
(i.e., closer to 80 percent) represent those products that would incur
higher reformulation costs if major ingredient substitutions are
necessary to meet the ``lean'' criteria. At this range of difficulty
the Decision to Reformulate Model estimates that between 5 and 6
percent of ``mixed dishes not measurable with a cup'' would be
discontinued because the net benefits to the company from their
reformulation are lower than those for their discontinuation. Estimates
at the higher end of the range (i.e., closer to 100 percent) represent
those products that require only minor but critical ingredient
substitutions. No product lines would be terminated at this end of the
range.
We assume that the fraction of the ``lean'' market that would incur
reformulation costs is uniformly distributed between 80 and 100
percent, with the fraction that only requires relabeling estimated as
the remainder (i.e., between 0 and 20 percent). We used the average of
the estimates generated from the Reformulation Cost Model for 80 and
100 percent reformulation rates. The estimates generated by the
Reformulation Cost Model are derived from experts' information on
detailed reformulation costs by NAICS code including market research,
product testing, consumer testing, and marketing costs and are reported
as low, middle, and high values. We characterize uncertainty in our
simulation by assuming triangular distributions for the 80 and 100
percent reformulation rates generated from the Reformulation Cost
Model, using the reported low, middle, and high values from that model
as the low, medium, and high parameters in that distribution.
We assume that the costs of product lines that become discontinued
are due to insufficient consumer demand, and those for new product
development if this proposed rule were issued are equal to each other.
This reflects the assumption that growth in the number of ``mixed
dishes not measurable with a cup'' will not change as a result of this
proposed rule. The Reformulation Cost Model estimates that for major
ingredient substitution requirements between 5 and 6 percent of product
lines will be discontinued. We assume the costs of products that are
discontinued and those for new product development are both uniformly
distributed between 0 and 6 percent of the costs of reformulation.
We ran the Reformulation Cost Model for the case when minor and
noncritical ingredient substitutions are necessary (in which case, 100
percent of the market will be reformulated products) and also for the
case when minor but critical ingredient substitutions are necessary (in
which case, 80 percent of the market will be reformulated products).
The relabeling costs are estimated from FDA's Labeling Cost Model,
which also generates cost estimates by NAICS code. We further
characterize uncertainty in our simulation by assuming a triangular
distribution for labeling costs (for between 0 and 20 percent of the
``lean'' market) using the estimates of the low, medium, and high costs
generated from the Labeling Cost Model as the low, medium, and high
parameters in that distribution.
Table 4 of this document reports ranges for estimates of
reformulation costs, labeling costs, discontinued product line costs,
and total costs for the proposed and industry-petitioned options, and
for time periods of 12 and 24 months for each option. The range
reported for reformation costs from the proposed rule incorporates
uncertainties in both the estimate of the ``lean'' market share, the
probability for reformulation, and the reformulation costs generated by
the Reformulation Cost Model. The range reported for the labeling costs
from the proposed rule incorporates uncertainty in the estimates of the
``lean'' market share, reformulation costs, and the labeling costs
generated by the Labeling Cost Model. The range of estimates reported
for costs from discontinued product lines and new product development
incorporate uncertainty in the estimates of the ``lean'' market share,
reformulation costs, as well as the fraction of discontinued product
lines generated from the Probability of Reformulation Model. The range
of estimates of total costs reported in table 4 reflects uncertainties
in the estimates of all of the individual costs components. The low and
high estimates in the respective ranges are the 5- and 95-percent
the distributional assumptions made for each of the component costs.
[[Page 71055]]
Table 4.--Voluntarily Incurred Change-Over Costs for Making a ``Lean'' Claim
----------------------------------------------------------------------------------------------------------------
Proposed Option (8% Market Option 2: Industry-Petition (6% Option 3: Extend Current
Share) Market Share) Criteria to ``Mixed Dishes Not
-------------------------------------------------------------------- Measurable With a Cup'' (10%
Market Share)
12-month 24-month 12-month 24-month ---------------------------------
compliance compliance compliance compliance 12-month 24-month
(dollars) (dollars) (dollars) (dollars) compliance compliance
(dollars) (dollars)
----------------------------------------------------------------------------------------------------------------
Reformulation costs
----------------------------------------------------------------------------------------------------------------
low 657,000 423,000 365,000 267,000 821,000 529,000
---------------------------------------------------------------
---------------------------------------------------------------
¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤
Labeling costs
----------------------------------------------------------------------------------------------------------------
low 12,000 14,000 7,000 9,000 15,000 18,000
----------------------------------------------
----------------------------------------------
¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤
Discontinued
----------------------------------------------------------------------------------------------------------------
low 7,000 4,000 4,000 3,000 8,000 5,000
----------------------------------------------
----------------------------------------------
¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤
New product development
----------------------------------------------------------------------------------------------------------------
low 3,000 2,000 2,000 1,000 4,000 3,000
----------------------------------------------
----------------------------------------------
¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤
Total costs
----------------------------------------------------------------------------------------------------------------
low 1,095,000 749,000 583,000 441,000 1,369,000 936,000
---------------------------------------------------------------
---------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
Table 5 of this document reports the annualized change-over costs
for the proposed rule, which we computed assuming the discount rates of
3 and 7 percent over an infinite time horizon for assumed 12- and 24-
month periods for relabeling and reformulation. For a 12-month period
all costs are assumed to be incurred in the beginning of the second
year. For a 24-month period all costs are assumed to be incurred in the
beginning of the third year. Because producers choose the time period
for the reformulation and relabeling of products, the actual time
periods for the changes can be of any length, with the costs differing
from those in table 5. From our labeling cost and reformulation models,
however, we expect that costs would be substantially higher for time
periods under 12 months, and substantially lower for time periods over
24 months. We also expect that the time periods chosen would be shorter
and the costs higher, the greater the perceived consumer response to
these product claims.
Table 5.--Annualized Voluntarily Incurred Change-Over Costs for Proposed
Rule
------------------------------------------------------------------------
12-Month 24-Month
Period Period
------------------------------------------------------------------------
3 percent discount rate
------------------------------------------------------------------------
5 percent (low) $32,000 $21,000
-------------------------------------------------------------
--------------------------------------------------------------
7 percent discount rate
------------------------------------------------------------------------
5 percent (low) $72,000 $46,000
-------------------------------------------------------------
------------------------------------------------------------------------
V. Regulatory Flexibility Analysis
FDA has examined the economic implications of this proposed rule as
required by the Regulatory Flexibility Act (5 U.S.C. 601-612). The
Regulatory Flexibility Act requires that agencies analyze regulatory
options that would minimize any significant impact of a rule on small
entities. The proposed rule, if finalized, would permit firms to add a
``lean'' claim to their labels if their products meet certain criteria.
Small
[[Page 71056]]
firms may voluntary add this claim if they so choose. No small firm,
however, will choose to bear the cost of adding the ``lean'' claim to
its product labels unless the firm believes that it will lead to
increased sales of its product sufficient to justify the costs. The
rule would not mandate that firms make any labeling changes. This
proposed rule, if finalized, would not impose compliance costs on any
small business. Therefore, the agency certifies that the proposed rule
will not have a significant economic impact on a substantial number of
small entities.
VI. Unfunded Mandates
Section 202(a) of the Unfunded Mandates Reform Act of 1995 (Public
Law 104-4) requires that agencies prepare a written statement which
includes an assessment of anticipated costs and benefits, before
proposing ``any rule that includes a Federal mandate that may result in
the expenditure by State, local, and tribal governments, in the
aggregate, or by the private sector, of $100,000,000 or more (adjusted
annually for inflation) in any one year.'' The current threshold after
adjustment for inflation is $115 million, using the most current (2003)
Implicit Price Deflator for the Gross Domestic Product (GDP) (i.e.,
$100 million x [2003 Implicit GDP deflator / 1995 GDP deflator]). FDA
does not expect this proposed rule to result in any 1-year expenditure
that would meet or exceed this amount, and has determined that this
proposed rule does not constitute a significant rule under the Unfunded
Mandates Reform Act.
VII. Federalism
FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. FDA has determined that
the rule does not contain policies that have substantial direct effects
on the States, on the relationship between the National Government and
the States, or on the distribution of power and responsibilities among
the various levels of government. Accordingly, the agency has
tentatively concluded that the rule does not contain policies that have
federalism implications as defined in the Executive order and,
consequently, a federalism summary impact statement is not required.
VIII. Environmental Impact
FDA has determined under 21 CFR 25.32(p) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
IX. Paperwork Reduction Act of 1995
FDA has tentatively concluded that this proposed rule contains no
collection of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 is not
required.
X. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. If you base your comments on
scientific evidence or data, please submit copies of the specific
information along with your comments. Received comments may be seen in
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
XI. References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
(FDA has verified the Web site addresses, but we are not responsible
for subsequent changes to the Web sites after this document publishes
in the Federal Register.)
1. Petition to expand ``lean'' nutrient content claim, submitted
by Nestlé Prepared Foods Corp., January 4, 2004.
2. U.S. Department of Health and Human Services and U.S.
Department of Agriculture, Dietary Guidelines for Americans, 2005.
3. U.S. Census Bureau, 1997 Economic Census, December 17, 2002.
4. Economic Research Service, http://www.ers.usda.gov/Briefing/CPIFoodAndExpenditures/Data/cpiforecasts.htm
, accessed November 8,
2004.
5. Teisl, M., and A. Levy, ``Does Nutrition Labeling Lead to
Healthier Eating?'' Journal of Food Distribution Research, October
1997.
6. Drewnowski, A., and S. Specter, ``Poverty and Obesity: The
Role of Energy Density and Energy Costs,'' The American Journal of
Clinical Nutrition, vol. 79, 1:6-16, January 2004.
7. LeGault, L., M. Brandt, N. McCabe, C. Adler, A. Brown, and S.
Brecher, ``2000-2001 Food Label and Package Survey: An Update on
Prevalence of Nutrition Labeling and Claims on Processed, Packaged
Foods,'' Journal of the American Dietetic Association, 104:952-958,
2004.
8. USDA, National Nutrient Database for Standard Reference,
Release 18 (2005), http://www.nal.usda.gov/fnic/foodcomp/search/,
accessed on September 15, 2005.
9. Mancini, D., FDA, Center for Food Safety and Applied
Nutrition, memorandum to file, May 23, 2002.
10. RTI International, Cost of Reformulating Foods and
Cosmetics, Final Report, prepared for Ed Puro, FDA, Center for Food
Safety and Applied Nutrition, prepared by White, W.J., E. Gledhill,
S. Karns, and M. Muth, RTI Project Number 08184.003, July 2002.
11. RTI International, Modeling the Decision to Reformulate
Foods and Cosmetics, Final Report, prepared for David Zorn, FDA,
Center for Food Safety and Applied Nutrition, prepared by Muth, M.,
S. Karns, D. Anderson, M. Coglaiti, and M. Fanjoy, RTI Project
Number 08184.005, October 2003.
12. RTI International, FDA Labeling Cost Model, Final Report,
prepared for Amber Jessup, FDA, Center for Food Safety and Applied
Nutrition, prepared by Muth, M., E. Gledhill, and S. Karns, RTI
Project Number 06673.010, January 2003.
List of Subjects in 21 CFR Part 101
Food labeling, Nutrition, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 101 be amended as follows:
PART 101--FOOD LABELING
1. The authority citation for 21 CFR part 101 continues to read as
follows:
Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342,
343, 348, 371; 42 U.S.C. 243, 264, 271.
2. Section 101.62 is amended by revising paragraph (e) to read as
follows:
Sec. 101.62 Nutrient content claims for fat, fatty acid, and
cholesterol content of foods.
* * * * *
(e) ``Lean'' and ``extra lean'' claims. (1) The term ``lean'' may
be used on the label or in labeling of foods, except meal products as
defined in Sec. 101.13(l) and main dish products as defined in Sec.
101.13(m), provided that the food is a seafood or game meat product
and, as packaged, contains less than 10 g total fat, 4.5 g or less
saturated fat, and less than 95 mg cholesterol per reference amount
customarily consumed and per 100 g;
(2) The term defined in paragraph (e)(1) of this section may be
used on the label or in labeling of a mixed dish not measurable with a
cup as defined in table 2 of Sec. 101.12(b), provided that the food
contains less than 8 g total fat, 3.5 g or less saturated fat, and less
than 80 mg cholesterol per reference amount customarily consumed;
(3) The term defined in paragraph (e)(1) of this section may be
used on the
[[Page 71057]]
label or in labeling of meal products as defined in Sec. 101.13(l) or
main dish products as defined in Sec. 101.13(m), provided that the
food contains less than 10 g total fat, 4.5 g or less saturated fat,
and less than 95 mg cholesterol per 100 g and per labeled serving;
(4) The term ``extra lean'' may be used on the label or in labeling
of foods, except meal products as defined in Sec. 101.13(l) and main
dish products as defined in Sec. 101.13(m), provided that the food is
a discrete seafood or game meat product and as packaged contains less
than 5 g total fat, less than 2 g saturated fat, and less than 95 mg
cholesterol per reference amount customarily consumed and per 100 g;
and
(5) The term defined in paragraph (e)(4) of this section may be
used on the label or in labeling of meal products as defined in Sec.
101.13(l) and main dish products as defined in Sec. 101.13(m),
provided that the food contains less than 5 g of fat, less than 2 g of
saturated fat, and less than 95 mg of cholesterol per 100 g and per
labeled serving.
* * * * *
Dated: November 18, 2005.
Michael M. Landa,
Deputy Director for Regulatory Affairs, Center for Food Safety and
Applied Nutrition.
[FR Doc. 05-23293 Filed 11-23-05; 8:45 am]
BILLING CODE 4160-01-S