[Federal Register Volume 72, Number 8 (Friday, January 12, 2007)]
[Rules and Regulations]
[Pages 1455-1459]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-330]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 2004P-0183]
RIN 0910-ZA27


Food Labeling: Nutrient Content Claims, Expansion of the Nutrient 
Content Claim ``Lean''

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending 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 final rule 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 is also being taken to provide reliable 
information that would assist consumers in maintaining healthy dietary 
practices.

DATES: This final rule is effective January 12, 2007.

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:

I. Background

    In the Federal Register of November 25, 2005 (70 FR 71041), FDA 
published a proposed rule to amend the definition of the nutrient 
content claim ``lean'' (21 CFR 101.62) to include foods categorized as 
``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. FDA issued this proposed rule in response to a 
petition filed under section 403(r)(4) of the act (21 U.S.C. 343(r)(4)) 
and in part 101 (21 CFR part 101) in Sec.  101.69. Section 
403(r)(2)(A)(i) of the act (21 U.S.C. 343(r)(2)(A)(i)) states that a 
nutrient content claim may be made only if the characterization of the 
level made in the claim uses terms which are defined in regulations of 
the Secretary of Health and Human Services (the Secretary) (and, by 
delegation, FDA). Section 403(r)(4) of the act sets out the procedures 
that FDA is to follow upon receiving a nutrient content claim petition.
    On January 9, 2004, Nestl[eacute] (the petitioner) submitted a 
petition requesting that the agency amend the nutrient content claim 
regulation for ``lean'' (21 CFR 101.62(e)) to include ``mixed dishes 
not measurable with a cup'' as defined in the ``Reference amounts 
customarily consumed per eating occasion'' regulation (21 CFR 101.12), 
based on certain qualifying criteria for total fat, saturated fat, and 
cholesterol. FDA filed the petition for comprehensive review in 
accordance with section 403(r)(4) of the act on April 22, 2004.
    FDA's definition of the nutrient content claim ``lean'' includes 
flesh foods, such as seafood and game meat products, which are foods 
that are similar to the U.S. Department of Agriculture (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. Prior to the publication of this final rule, FDA's 
definition of ``lean,'' did not extend to foods categorized as ``mixed 
dishes not measurable with a cup.'' Such foods, e.g., burritos, egg 
rolls, enchiladas, pizza, quiches, and sandwiches, are generally 
similar to the foods subject to the definition of ``main dish'' (21 CFR 
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) (21 CFR 101.12(b), Table 2), which is 1 oz less than 
the 6 oz per labeled serving required to qualify as a ``main dish.'' 
Thus, food products categorized as ``mixed dishes not measurable with a 
cup'' and that weigh less than 6 oz were not eligible to bear a 
``lean'' nutrient content claim under Sec.  101.62(e).
    FDA considered the evidence presented in the petition as part of 
its review, as well as information previously considered by the agency 
in the January 6, 1993, nutrient content claim final rule (58 FR 2302). 
Based on the available evidence, FDA acknowledged the following in the 
proposed rule (70 FR 71041 at 71044):
    <bullet> ``mixed dishes not measurable with a cup'' 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;
    <bullet> This category has become a well established product 
category that consumers have come to rely on; and
    <bullet> There is a growing interest in healthful alternatives to 
traditional food options, including vegetarian alternatives.
    FDA believes that portable food products, particularly those that 
are

[[Page 1456]]

nutrient (i.e., total 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 (e.g., 
Dietary Guidelines for Americans 2005). In this final rule, the agency 
concludes 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., limiting dietary intake of 
saturated fat and cholesterol). The agency determined that the nutrient 
requirements for ``mixed dishes not measurable with a cup'' required in 
this final rule would allow it to achieve criteria which would enable 
consumers to maintain intakes of fat within current dietary 
recommendations without being unnecessarily restrictive. The agency is 
basing the nutrient criteria for total fat, saturated fat, and 
cholesterol on the current criteria for main dishes (21 CFR 101.13(m)), 
but applying the criteria to the RACC (140 grams (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.

II. Summary of Comments and the Agency's Response

    The agency received comments to the proposed rule from an 
individual consumer, a food manufacturer, an industry trade 
organization, a public interest foundation, and the petitioner. Three 
comments supported the proposed rule. One comment noted the need for 
consumer education for developing understanding of the nutrient content 
claim ``lean'' and the role of calories and nutrients in the diet. The 
remaining comments requested changes to the proposed rule. The latter 
comments and FDA's responses are set forth in this section (section II 
of this document), except the comment addressing the agency's 
regulatory impact analysis is discussed in the ``Analysis of Impact'' 
section of this document.
    (Comment 1) One comment opposed the proposed rule because the 
proposed fat levels are too high. The comment did not provide any 
specific information or data in support of their position.
    (Response) FDA disagrees with the comment. As we discussed in the 
proposed rule, the agency believes that the method we chose to 
establish total fat, saturated fat, and cholesterol levels (i.e., 
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 total fat, saturated fat, and cholesterol for 
main dishes) is less restrictive than the other options considered and 
would potentially allow more foods for increased consumer choice. 
Moreover, we stated that consumers could achieve a diet using ``lean'' 
``mixed dishes not measurable with a cup'' that is consistent with 
current dietary recommendations (70 FR 71041 at 71047). We retain this 
view in the final rule and this comment has not provided us with any 
information to support revising the proposed method for determining 
total fat, saturated fat, and cholesterol levels.
    (Comment 2) Another comment opposing the proposed rule recommended 
that, if ``lean'' is considered to be a claim that represents 
``healthier'' food options, nutrient eligibility criteria be modified 
for both FDA- and USDA- regulated foods to include limitations in 
``negative'' nutrients'' (such as sodium) and include ``good'' nutrient 
requirements.
    (Response) FDA disagrees with the comment. The term ``lean'' is a 
description of fat content. As a nutrient content claim, ``lean'' was 
first established by the USDA as a descriptor to allow consumers to 
distinguish between products of varying fat content (56 FR 60302, 
November 27, 1991). FDA subsequently established the claim ``lean'' for 
products that it regulated that had a contribution to the diet that was 
similar to the USDA-regulated products (i.e., seafood, game meat, meal 
products, and main dish products) (58 FR 632, January 6, 1993). FDA has 
already established other nutrient content claims to address a wider 
range of nutrients other than the nutrients describing fat content 
(e.g. healthy (21 CFR 101.65(d))). FDA believes that all nutrient 
requirements for the claim ``lean'' should remain descriptors of fat 
content in order for ``lean'' to continue to allow consumers to 
distinguish between products of varying fat content. Therefore, FDA is 
making no changes in response to this comment.
    (Comment 3) One comment stated that FDA and USDA nutrient content 
claim requirements for foods in the ``mixed dishes not measurable with 
a cup'' category should be consistent and that different criteria will 
be confusing and provide no benefit for consumers or manufacturers.
    (Response) FDA is aware of the difference between the FDA and USDA 
nutrient requirements as it acknowledged this difference in the 
proposed rule, and the agency considered these differences in 
developing FDA's proposed definition for ``lean.'' FDA has concluded, 
as described in the proposed rule, that FDA-regulated ``mixed dishes 
not measurable with a cup'' 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 total 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. Because of the similarity in portion 
size and contribution to the overall diet to FDA-regulated main dishes, 
FDA has concluded that it is more appropriate to base the nutrient 
criteria for total fat, saturated fat, and cholesterol on the current 
criteria for main dishes, but apply the criteria to the RACC for 
``mixed dishes not measurable with a cup.'' Calculating the 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 criteria for ``mixed dishes not measurable with a cup'' 
that are comparable in their contribution of total fat, saturated fat, 
and cholesterol on a per 100-g basis to that contributed by main dishes 
on a per 100-g basis. Moreover, the comment provided no basis for its 
assertion that the definition provides no benefit and would be 
confusing to consumers or manufacturers. Therefore, FDA is making no 
changes in response to this comment.
    FDA is adopting as a final rule, without change, the proposed 
amendment to the ``lean'' definition in Sec.  101.62(e) by allowing 
eligible foods categorized as ``mixed dishes not measurable with cup'' 
use of the nutrient content claim ``lean.''

III. Analysis of Economic Impacts

A. Regulatory Impact Analysis

    FDA has examined the impacts of the final rule under Executive 
Order 12866. Executive Order 12866 directs 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;

[[Page 1457]]

distributive impacts; and equity). The agency believes that this final 
rule is not a significant regulatory action as defined by the Executive 
order.
    Regulatory options
    We considered regulatory options as follows: (1) Take no new 
regulatory action; and (2) adopt as final the proposed regulatory 
action allowing ``mixed dishes not measurable with a cup'' to contain a 
``lean'' claim based on the proposed criteria of 8 grams of total fat, 
3.5 grams or less of saturated fat, and 80 milligrams of cholesterol 
per reference amount customarily consumed.
    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): Adopt as Final the Proposed Regulatory Action
    <bullet> Benefits
    In the analysis of the proposed rule, we used sales data from the 
1997 Economic Census, the prevalence of reduced-fat claims from FDA's 
Food Label and Packaging Survey, and the fat contents of representative 
``mixed dishes not measurable with a cup'' from USDA's National 
Nutrient Database for Standard Reference to estimate the reduction in 
fat consumption to be between 0 and 0.02 percent, with a mean of 0.01 
percent that would result from this rule. Moreover, we suggested that 
the magnitude of the reduction in total fat intake from consuming 
``lean'' ``mixed dishes not measurable with a cup'' may be tempered if 
consumers supplement their ``lean'' selections with other higher-fat 
selections from other food categories. Finally, we suggested that there 
would be a price premium for ``mixed dishes not measurable with a 
cup,'' and to the extent that income and overweight status are 
negatively correlated, consumers at risk of overweight related diseases 
may be comparatively less likely to purchase ``lean'' ``mixed dishes 
not measurable with a cup'' than their higher-income counterparts with 
less-acute, weight-related health risks. This could mitigate overall 
health benefits from what they otherwise would be.
    (Comment 4) One comment stated that our estimate of 0.67 percent of 
total food consumption represented by ``mixed dishes not measurable 
with a cup'' that could qualify for the ``lean'' claim, understates the 
full impact of this rule because it neglects to account for dynamic 
aspects of the market including growing consumer interest in healthier 
diets, and new product development. In addition, the comment suggested 
that the discussion of possible consumption behavior that would 
mitigate any reduction in fat intake, such as increased consumption of 
higher fat-containing foods to compensate for the consumption of 
reduced fat ``lean'' ``mixed dishes not measurable with a cup,'' is 
inappropriate for policies designed to promote the consumption of lean 
foods. The comment also stated that the discussion on possible 
diminishing effect on health benefits if there is a price premium for 
``lean'' ``mixed dishes not measurable with a cup,'' and if incomes and 
health risks from overweight status are negatively correlated, is also 
inappropriate for the same reason. Finally, the comment suggested that 
any policy measure tending to increase consumption of lean foods, 
including a successful publicity campaign to increase consumption of 
green vegetables, could have both the ``compensating'' and price 
premium distributional effects.
    (Response) FDA disagrees that our estimate of 0.67 percent of total 
food purchases that could potentially make a ``lean'' claim is 
inappropriate for this analysis because it does not consider dynamic 
aspects of consumption and production that would favor such products. 
While we do not disagree with the possibility of a general trend toward 
healthier diets and lifestyles, we believe the trend would just as 
likely affect the markets for food products from all categories as it 
would ``mixed dishes not measurable with a cup.'' Moreover, to 
characterize uncertainty in our methods used in the analysis, we 
estimated the upper end of the range for the reduction in fat intake 
that would result from this rule, to be 100 percent more than the mid-
point which was estimated using the 0.67 percent share of total 
purchases that could potentially make a ``lean'' claim. Consequently, 
we believe that our estimated range incorporates a wide range of 
uncertainty, and is reasonable and based on sound data and assumptions.
    In regulatory analyses, it is frequently easier to obtain 
quantitative estimates of the costs compared to the benefits of a rule 
because credible cost data is usually easier to obtain. The relative 
scarcity of quantitative estimates of benefits elevates the importance 
of qualitative descriptions in the benefits analysis. In the analysis 
of the proposed rule, FDA framed the qualitative discussion of the 
benefits from allowing the ``lean'' claim on ``mixed dishes not 
measurable with a cup'' on the theoretical framework used by Teisl and 
Levy in a study to address a related question (Ref. 1).
    Consistent with Teisl and Levy, FDA assumed that consumer demand 
for a food product depends on its price, taste characteristics, and 
nutritional characteristics. The results obtained by Teisl and Levy 
indicate that all three characteristics are important determinants of 
consumer purchase behavior, and also that there is evidence of 
``switching'' consumption behavior among many food products so that 
overall nutrient consumption (e.g., fat in that study) tends to remain 
constant or change less than predicted by a simple comparison of the 
nutrient contents of the products. In the analysis of the proposed rule 
we did not quantitatively estimate the size of the ``switching'' 
effect, but rather suggested its existence in order to fully describe 
the range of benefits of the final rule.
    Consistent with our theoretical model, we also addressed the 
implications of a premium on the price for ``lean'' labeled ``mixed 
dishes not measurable with a cup,'' which may affect the size of the 
health benefits from the rule. The qualitative discussion is of 
heightened importance since evidence exists of a negative correlation 
between obesity and health risks from overweight status and income 
(Ref. 2). We agree that any regulation that promotes the consumption of 
lean foods, including a successful publicity campaign to increase 
consumption of green vegetables, could have both the ``compensating'' 
and price premium effects, and in the analysis of the proposed rule we 
applied that concept to ``mixed dishes not measurable with a cup.''
    <bullet> Costs
    There were no comments on the analysis of the costs, including 
estimates made of the voluntarily incurred change-over costs from the 
proposed rule. All 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 were not profitable to do so. We reproduce the 
estimated annualized voluntarily incurred re-labeling and reformulation 
costs estimated in the

[[Page 1458]]

analysis of the proposed rule using both a 3-percent and 7-percent 
discount rate.

                                      Table 1.--Annualized Voluntarily Incurred Change-Over Costs for Proposed Rule
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                                                        12-Month Time Period                                      24-Month Time Period
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3-percent discount rate
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5 percent (low)                                                                        $32,000                                                   $21,000
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mean                                                                                  $250,000                                                  $151,000
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95 percent (high)                                                                     $515,000                                                  $308,000
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7-percent discount rate
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5 percent (low)                                                                        $72,000                                                   $46,000
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mean                                                                                  $561,000                                                  $326,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
95 percent (high)                                                                   $1,158,000                                                  $666,000
--------------------------------------------------------------------------------------------------------------------------------------------------------

    In table 1 of this document, we report the annualized change-over 
costs for the proposed rule computed assuming discount rates of 3 
percent 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 the table. 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 (Refs. 3 and 4). 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.

B. Regulatory Flexibility Analysis

    We have examined the economic implications of this final rule as 
required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a 
rule has a significant economic impact on a substantial number of small 
entities, the Regulatory Flexibility Act requires the agency to analyze 
regulatory options that would minimize the economic impact of the rule 
on small entities.
    As previously explained, the final rule will not generate any 
compliance costs for any small entities because it does not require 
small entities to undertake any new activity. No small business will 
choose to use the ``lean'' nutrient content claim authorized by this 
rule unless it believes that doing so will increase private benefits by 
more than it increases private costs. Accordingly, the agency certifies 
that the final rule will not have a significant economic impact on a 
substantial number of small entities. Under the Regulatory Flexibility 
Act, no further analysis is required.

C. Unfunded Mandates

    Section 202(a) of the Unfunded Mandates Reform Act of 1995 (2 
U.S.C. 1532(a)) requires that agencies prepare a written statement, 
which includes an assessment of anticipated costs and benefits, before 
issuing any final rule ``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 
$122 million, using the most current (2005) Implicit Price Deflator for 
the Gross Domestic Product. FDA does not expect this final rule to 
result in any 1-year expenditure that would meet or exceed this amount.

IV. Environmental Impact

    FDA has determined under 21 CFR 25.32(p) that this action is of the 
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.

V. Paperwork Reduction Act of 1995

    FDA concludes that the labeling provisions of this final rule are 
not subject to review by the Office of Management and Budget because 
they do not constitute a ``collection of information'' under the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Rather, the food 
labeling nutrient content claim ``lean'' is a ``public disclosure of 
information originally supplied by the Federal Government to the 
recipient for the purpose of disclosure to the public'' (5 U.S.C. 
1320.3(c)(2)).

VI. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
will have a preemptive effect on State law. Section 4(a) of the 
Executive Order requires agencies to ``construe * * * a Federal statute 
to preempt State law only where the statute contains an express 
preemption provision or there is some other clear evidence that the 
Congress intended preemption of State law, or where the exercise of 
State authority conflicts with the exercise of Federal authority under 
the Federal statute.'' Section 403A of the act (21 U.S.C. 343-1) is an 
express preemption provision. Section 403A(a)(5) of the act (21 U.S.C.

[[Page 1459]]

343-1(a)(5)) provides that: * * * no State or political subdivision of 
a State may directly or indirectly establish under any authority or 
continue in effect as to any food in interstate commerce-- * * * ``(5) 
any requirement respecting any claim of the type described in section 
403(r)(1) made in the label or labeling of food that is not identical 
to the requirement of section 403(r) * * *.''
    Currently, this provision operates to preempt States from imposing 
nutrient content claim labeling requirements concerning the claim 
``lean'' because FDA has imposed such requirements under section 403(r) 
of the act. This final rule amends existing food labeling regulations 
to add a definition for the claim ``lean'' for eligible foods 
categorized as ``mixed dishes not measurable with a cup.'' Although 
this rule has a preemptive effect, in that it would preclude States 
from promulgating any nutrient content claim labeling requirements for 
the claim ``lean'' that are not identical to those required by this 
final rule, this preemptive effect is consistent with what Congress set 
forth in section 403A of the act. Section 403A(a)(5) of the act 
displaces both State legislative requirements and State common law 
duties. Medtronic v. Lohr, 518 U.S. 470, 503 (1996) (Breyer, J., 
concurring in part and concurring in judgment); id. at 510 (O'Connor, 
J., joined by Rehnquist, C.J., Scalia, J., and Thomas, J., concurring 
in part and dissenting in part); Cipollone v. Liggett Group, Inc., 505 
U.S. 504, 521 (1992) (plurality opinion); id. at 548-49 (Scalia, J., 
joined by Thomas, J., concurring in judgment in part and dissenting in 
part).
    FDA believes that the preemptive effect of the final rule is 
consistent with Executive Order 13132. Section 4(e) of the Executive 
order provides that ``when an agency proposes to act through 
adjudication or rulemaking to preempt State law, the agency shall 
provide all affected State and local officials notice and an 
opportunity for appropriate participation in the proceedings.'' FDA 
provided the States with an opportunity for appropriate participation 
in this rulemaking when it sought input from all stakeholders through 
publication of the proposed rule in the Federal Register on November 
25, 2005 (70 FR 71041). FDA received no comments from any states on the 
proposed rulemaking.
    In addition, on February 16, 2006, FDA's Division of Federal and 
State Relations provided notice by fax and email transmission to State 
health commissioners, State agriculture commissioners, food program 
directors, and drug program directors as well as FDA field personnel, 
of FDA's intended amendment to add a definition for the claim ``lean'' 
for eligible foods categorized as ``mixed dishes not measurable with a 
cup'' (21 CFR 101.62(e)). The notice provided the States with further 
opportunity for input on the rule. It advised the States of the 
publication of the proposed rule and encouraged State and local 
governments to review the notice and to provide any comments to the 
docket (docket number 2004P-0183), opened in the November 25, 2005 
Federal Register, by a date 75 days from the date of the notice (i.e., 
by March 2, 2006), or to contact certain named individuals. FDA 
received no comments in response to this notice. The notice has been 
filed in the above numbered docket.
    In conclusion, the agency believes that it has complied with all of 
the applicable requirements under the Executive order and has 
determined that the preemptive effects of this rule are consistent with 
Executive Order 13132.

VIII. References

    The following references have been placed on display in the 
Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852 and may be seen by interested persons between 9 a.m. and 4 
p.m., Monday through Friday.

    1. Teisl, M. and A. Levy, ``Does Nutrition Labeling Lead to 
Healthier Eating?'' Journal of Food Distribution Research, October 
1997.
    2. Drewnowski, A., and S. Specter, ``Poverty and Obesity: The 
Role of Energy Density and Energy Costs,'' The American Journal of 
Clinical Nutrition, Vol. 79, No. 1: 6-16, January 2004.
    3. RTI International, ``Cost of Reformulating Foods and 
Cosmetics, Final Report,'' prepared for Ed Puro, FDA, Center for 
Food Safety and Applied Nutrition (CFSAN), prepared by White, W.J., 
E. Gledhill, S. Karns, and M. Muth, RTI Project Number 08184.003, 
July 2002.
    4. RTI International, ``FDA Labeling Cost Model, Final Report,'' 
prepared for Amber Jessup, FDA, CFSAN, 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.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
101 is amended as follows:

PART 101--FOOD LABELING

0
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.

0
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 Sec.  101.12(b) in table 2, 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 label or in the 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 the 
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: January 8, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-330 Filed 1-11-07; 8:45 am]
BILLING CODE 4160-01-S