[Federal Register Volume 70, Number 226 (Friday, November 25, 2005)]
[Proposed Rules]
[Pages 71041-71057]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-23293]


 ========================================================================
 Proposed Rules
                                                 Federal Register
 ________________________________________________________________________
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 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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  Federal Register / Vol. 70, No. 226 / Friday, November 25, 2005 / 
Proposed Rules  

[[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 Nestl[eacute] Prepared 
Foods Co. (Nestl[eacute]) 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:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     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:
     FAX: 301-827-6870.
     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, Nestl[eacute] 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 Nestl[eacute] 
(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. Nestl[eacute] 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 Nestl[eacute] petition on April 22, 
2004. This proposed rule responds to Nestl[eacute]'s request that FDA 
define the term ``lean'' for ``mixed dishes not measurable by a cup.''
    In its petition, Nestl[eacute] contended that American eating 
habits have changed significantly since FDA authorized the ``lean'' 
claim in 1993. Nestl[eacute] 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. Nestl[eacute] 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. Nestl[eacute] 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. Nestl[eacute] also suggested that consumers are more 
interested in nutrition and healthy foods, as evidenced by an increased 
consumer demand for nutritious food selections. Nestl[eacute] 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, Nestl[eacute] 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. Nestl[eacute] 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. Nestl[eacute] 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, Nestl[eacute] believes that the 
number of healthy, portable food options available to consumers has 
been limited. The FDA regulations, Nestl[eacute] 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. Nestl[eacute] 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, Nestl[eacute] also pointed out the lack of 
consistency between FDA and USDA regulations regarding the claim 
``lean.'' Nestl[eacute] 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). Nestl[eacute] 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. Nestl[eacute] 
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, Nestl[eacute] 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. Nestl[eacute] 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), 
Nestl[eacute] 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, Nestl[eacute] 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). 
Nestl[eacute] 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, 
Nestl[eacute] 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 Nestl[eacute] uses the 
existing ``lean'' nutrient criteria for main dishes as the basis of the 
definition. Nestl[eacute] 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, Nestl[eacute] 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. Nestl[eacute] applied these 
criteria on a per-RACC basis. Nestl[eacute] 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 Nestl[eacute]'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 Nestl[eacute] would 
determine the nutrient criteria for ``lean'' according to 
Nestl[eacute]'s estimated calorie contribution of ``mixed dishes not 
measurable with a cup'' in the total diet. Nestl[eacute] 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, Nestl[eacute] 
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 
Nestl[eacute] calculated the criteria using this method on a per-100 g 
basis, Nestl[eacute] 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 Nestl[eacute] 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\ Nestl[eacute] 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). 
Nestl[eacute] 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\ Nestl[eacute] 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 Nestl[eacute]'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 Nestl[eacute]'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 Nestl[eacute]'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 Nestl[eacute] 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, Nestl[eacute] 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. Nestl[eacute] 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 Nestl[eacute] 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 
Nestl[eacute] 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, Nestl[eacute] 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, Nestl[eacute] 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, Nestl[eacute] 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 
Nestl[eacute]'s assumed average weight for ``mixed dishes not 
measurable with a cup.''
    The other method suggested by Nestl[eacute] 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 Nestl[eacute]. Therefore, the determination of the 
nutrient requirements is not consistent using this method. Also, 
Nestl[eacute] calculated the nutrients on a per-100 g basis but 
proposed to apply them on a per-RACC basis. It is unclear why 
Nestl[eacute] 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, 
Nestl[eacute] 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 Nestl[eacute]'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 Nestl[eacute] 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 Nestl[eacute]'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 
Nestl[eacute] 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 Nestl[eacute] 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 Nestl[eacute] 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 Nestl[eacute]'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:
     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.
     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.''
     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.
     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.
     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 Nestl[eacute] petition, in the Weight 
Watchers Smartwich, Amy's Pocket Sandwich, and Nestl[eacute]'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 
levels computed by the computer simulation software @Risk\TM\, given 
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
---------------------------------------------------------------
---------------------------------------------------------------
ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½
Labeling costs
----------------------------------------------------------------------------------------------------------------
  low                12,000           14,000            7,000            9,000           15,000           18,000
----------------------------------------------
----------------------------------------------
ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½
Discontinued
----------------------------------------------------------------------------------------------------------------
  low                 7,000            4,000            4,000            3,000            8,000            5,000
----------------------------------------------
----------------------------------------------
ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½
New product development
----------------------------------------------------------------------------------------------------------------
  low                 3,000            2,000            2,000            1,000            4,000            3,000
----------------------------------------------
----------------------------------------------
ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½
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 Nestl[eacute] 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