Federal Register / Vol. 72, No. 8 / Friday, January 12, 2007 / Rules and Regulations 1455 

State County (Fee/acre/yr) 

VERMONT ................. ALL COUNTIES ...................................................................................................................................... 29.20 

VIRGINIA ................... ALL COUNTIES ...................................................................................................................................... 29.20 

WASHINGTON .......... ADAMS, ASOTIN, BENTON, CHELAN, COLUMBIA, DOUGLAS, FRANKLIN, GARFIELD, GRANT, 

KITTITAS, KLICKITAT, LINCOLN, OKANOGAN, SPOKANE, WALLA WALLA, WHITMAN, 

YAKIMA,.

$14.60 

FERRY, PEND OREILLE, STEVENS ..................................................................................................... 21.90 

CLALLAM, CLARK, COWLITZ, GRAYS HARBOR ISLAND, JEFFERSON, KING, KITSAP, LEWIS, 

MASON, PACIFIC, PIERCE, SAN JUAN, SKAGIT, SKAMANIA, SNOHOMISH, THURSTON, 

WAHKIAKUM, WHATCOM.

29.20 

WEST VIRGINIA ........ ALL COUNTIES ...................................................................................................................................... 29.20 

WISCONSIN .............. ALL COUNTIES ...................................................................................................................................... 21.90 

WYOMING ................. ALBANY, CAMPBELL, CARBON, CONVERSE, GOSHEN, HOT SPRINGS, JOHNSON, LARAMIE, 

LINCOLN, NATRONA, NIOBRARA, PLATTE, SHERIDAN, SWEETWATER, FREMONT, 

SUBLETTE, UINTA, WASHAKIE.

7.28 

BIG HORN, CROOK, PARK, TETON, WESTON ................................................................................... 21.90 

ALL OTHER ZONES .................................................................................................................................................................. 5.74 

[FR Doc. E6–22365 Filed 1–11–07; 8:45 am] 

BILLING CODE 6717–01–P 

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. 

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 Nestle ́ Prepared 

Foods Co. (Nestle ́) 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 § 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, Nestle ́ (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 

§ 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): 

• ‘‘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; 

• This category has become a well 

established product category that 

consumers have come to rely on; and 

• 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 


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1456 Federal Register / Vol. 72, No. 8 / Friday, January 12, 2007 / Rules and Regulations 

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 

§ 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; 


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Federal Register / Vol. 72, No. 8 / Friday, January 12, 2007 / Rules and Regulations 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 

Nestle ́ 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 

• 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, weightrelated 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 fatcontaining 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.’’

• 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 


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1458 Federal Register / Vol. 72, No. 8 / Friday, January 12, 2007 / Rules and Regulations 

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

12-Month Time Period 24-Month Time Period 

3-percent discount rate 

5 percent 

(low) $32,000 $21,000 

mean $250,000 $151,000 

95 percent 

(high) $515,000 $308,000 

7-percent discount rate 

5 percent 

(low) $72,000 $46,000 

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. 


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Federal Register / Vol. 72, No. 8 / Friday, January 12, 2007 / Rules and Regulations 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. 

■ 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 

■ 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: 

§ 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 § 101.13(l) and 

main dish products as defined in 

§ 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 

§ 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 § 101.13(l) or main dish 

products as defined in § 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 

§ 101.13(l) and main dish products as 

defined in § 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 § 101.13(l) and main dish 

products as defined in § 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 


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