II 

110TH CONGRESS 

2D SESSION S. 3575 

To amend the Federal Food, Drug, and Cosmetic Act with respect to nutrition 

labeling of food offered for sale in food service establishments. 

IN THE SENATE OF THE UNITED STATES 

SEPTEMBER 25 (legislative day, SEPTEMBER 17), 2008 

Mr. CARPER (for himself and Ms. MURKOWSKI) introduced the following bill; 

which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act with 

respect to nutrition labeling of food offered for sale in 

food service establishments. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Labeling Education and Nutrition Act of 2008’’ or the 

6 ‘‘LEAN Act of 2008’’. 

7 (b) TABLE OF CONTENTS.—The table of contents of 

8 this Act is as follows: 

Sec. 1. Short title; table of contents. 

Sec. 2. Findings. 


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Sec. 3. Definitions. 

Sec. 4. Nutrition labeling exemption. 

Sec. 5. Voluntary nutrition labeling. 

Sec. 6. Mandatory nutrition labeling. 

Sec. 7. National uniformity. 

Sec. 8. Implementing regulations. 

Sec. 9. Effective dates. 

Sec. 10. Technical and conforming amendments. 

1 SEC. 2. FINDINGS. 

2 Congress finds that— 

3 (1) a healthy lifestyle includes a balanced diet 

4 as well as physical activity; 

5 (2) approximately more than 60 percent of 

6 American adults and 30 percent of American chil7 dren suffer from being overweight and obese, which 

8 can lead to many chronic health risks, including dia9 betes, heart disease, and hypertension; 

10 (3) the United States ranks last in reducing the 

11 number of preventable deaths resulting from obesity12 related chronic illnesses; 

13 (4) during the 2-decade period preceding the 

14 date of enactment of this Act, there has been a sig15 nificant increase in the number of meals prepared or 

16 eaten outside the home; 

17 (5) nutrition labeling pursuant to the Nutrition 

18 Labeling and Education Act of 1990 has increased 

19 significantly American consumers’ access to nutri20 tion information regarding the foods they consume; 


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1 (6) the Department of Agriculture and leading 

2 health groups recognize that many individuals re3 quire different information based on individual and 

4 specific health needs and risks; 

5 (7) the nutrients provided pursuant to the Nu6 trition Labeling and Education Act of 1990 provides 

7 consumers with all the tools needed to make healthy 

8 choices; 

9 (8) as of 2008, nutrition information for stand10 ard food items is voluntarily provided by various de11 livery methods at many major chains of food service 

12 establishments; 

13 (9) the nutrient content of a food offered for 

14 sale in a food service establishment can be deter15 mined with appropriate accuracy by consulting nu16 trient databases, cookbooks, laboratory analyses, or 

17 other sources that provide a reasonable basis for in18 formation regarding the nutrient content of a food, 

19 notwithstanding variability in the portion size, for20 mulation, and other characteristics of such food or 

21 its preparation method; and 

22 (10) public health and welfare are advanced if 

23 food service establishment nutrition information is 

24 not subject to frivolous litigation. 


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1 SEC. 3. DEFINITIONS. 

2 Section 403(q) of the Federal Food, Drug, and Cos3 metic Act (21 U.S.C. 343(q)) is amended by adding at 

4 the end the following: 

5 ‘‘(6) DEFINITIONS.—For purposes of subpara6 graphs (7) and (8): 

7 ‘‘(A) The term ‘standard food item’ means 

8 a food offered for sale at least 90 days per cal9 endar year, but does not include food not sepa10 rately offered for sale or food exempt under 

11 subparagraph (5)(C). 

12 ‘‘(B) The term ‘menu’ or ‘menu board’ 

13 means the primary writing on the premises of 

14 the food service establishment from which con15 sumers make their order selection. 

16 ‘‘(C) The term ‘reasonable basis’ means 

17 any means of determining nutrition information 

18 for a standard food item made without an in19 tent to deceive, including nutrient databases, 

20 cookbooks, laboratory analyses, and other rea21 sonable means. 

22 ‘‘(D) The term ‘food service establishment’ 

23 means an establishment that offers for sale food 

24 described in subclause (i) or (ii) of subpara25 graph (5)(A).’’. 


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1 SEC. 4. NUTRITION LABELING EXEMPTION. 

2 Section 403(q)(5)(A) of the Federal Food, Drug, and 

3 Cosmetic Act (21 U.S.C. 343(q)(5)(A)) is amended— 

4 (1) by adding at the end of subclause (i) the 

5 following: ‘‘except that such food shall not be consid6 ered exempt under this subclause for purposes of 

7 providing nutrition information under subparagraph 

8 (7) or (8).’’; and 

9 (2) by adding at the end of subclause (ii) the 

10 following: ‘‘except that such food shall not be consid11 ered exempt under this subclause for purposes of 

12 providing nutrition information under subparagraph 

13 (7) or (8).’’. 

14 SEC. 5. VOLUNTARY NUTRITION LABELING. 

15 Section 403(q) of the Federal Food, Drug, and Cos16 metic Act (21 U.S.C. 343(q)), as amended by section 3, 

17 is further amended by adding at the end the following: 

18 ‘‘(7) VOLUNTARY NUTRITION LABELING OF

19 FOOD SERVICE ESTABLISHMENT FOOD.—A food 

20 service establishment may provide nutrition informa21 tion for a food item under this subparagraph by 

22 meeting the following requirements: 

23 ‘‘(A) Providing nutrition information for 

24 all of the nutrients required by subparagraphs 

25 (1)(C) and (1)(D), determined with a reason26 able basis. 


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1 ‘‘(B) Disclosing such information in writ2 ten form on the premises of the food service es3 tablishment. 

4 ‘‘(C) Making such disclosure available 

5 upon request prior to purchase.’’. 

6 SEC. 6. MANDATORY NUTRITION LABELING. 

7 Section 403(q) of the Federal Food, Drug, and Cos8 metic Act (21 U.S.C. 343(q)), as amended by section 5, 

9 is further amended by adding at the end the following: 

10 ‘‘(8) IN GENERAL.—The labeling of a standard 

11 food item served or offered for sale in a food service 

12 establishment that is part of a chain that operates 

13 20 or more establishments under the same trade 

14 name (regardless of the type of ownership of the es15 tablishments) shall, except as provided in clause (E), 

16 disclose, in a clear and conspicuous manner in ac17 cordance with paragraph (f), the following informa18 tion, determined with a reasonable basis, as follows: 

19 ‘‘(A) DISCLOSURE OF CALORIES.— 

20 ‘‘(i) CALORIES ON THE MENU

21 BOARD.—The number of calories shall be 

22 disclosed prior to the point of purchase by 

23 1 of the following means: 

24 ‘‘(I) On the menu board. 


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1 ‘‘(II) On a sign presenting stand2 ard food items in a manner similar to 

3 the menu board and located on the 

4 same wall as the menu board. 

5 ‘‘(III) On a sign at eye level in 

6 the consumer queue prior to the point 

7 of purchase. 

8 ‘‘(ii) CALORIES ON THE MENU.—The 

9 number of calories shall be disclosed prior 

10 to the point of purchase by 1 of the fol11 lowing means: 

12 ‘‘(I) In the menu. 

13 ‘‘(II) In an insert that accom14 panies the menu. 

15 ‘‘(III) In an appendix that is at16 tached to the back of the menu. 

17 ‘‘(IV) In a supplemental menu 

18 that accompanies the menu. 

19 ‘‘(B) ADDITIONAL NUTRITION INFORMA20 TION.—The nutrition information for all nutri21 ents required by subparagraphs (1)(C) and 

22 (1)(D) shall be located on the premises of the 

23 food service establishment, in writing, and 

24 available to the consumer upon request prior to 

25 the point of purchase. 


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1 ‘‘(C) REFERRAL STATEMENT.—A menu, 

2 menu board, or other writing prior to the point 

3 of purchase shall bear a statement directing the 

4 consumer to the availability of additional nutri5 tion information required under clause (B). 

6 ‘‘(D) CALORIE INFORMATION STATE7 MENT.—If calories are not listed directly on a 

8 menu or menu board pursuant to subclause 

9 (i)(I), (i)(II), or (ii)(I) of clause (A), then the 

10 menu or menu board shall state the suggested 

11 daily caloric intake as 2000 calories or an alter12 native statement prescribed by the Secretary 

13 through guidance. 

14 ‘‘(E) APPLICABILITY.—This subparagraph 

15 shall not apply to— 

16 ‘‘(i) food offered for sale in a non17 profit food service establishment; 

18 ‘‘(ii) food that is not food described in 

19 subclause (i) or (ii) of subparagraph 

20 (5)(A); and 

21 ‘‘(iii) such other food as the Secretary 

22 may exempt by regulation. 

23 ‘‘(F) VIOLATIONS.—A person shall have 

24 knowingly or willfully violated the requirements 

25 of this paragraph if the person— 


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1 ‘‘(i) purposefully failed to make a dis2 closure required by this paragraph; or 

3 ‘‘(ii) made a disclosure under this 

4 paragraph with an intent to deceive. 

5 ‘‘(G) ONE DETERMINATION PER ITEM.—A 

6 reasonable basis determination of nutrition in7 formation shall be required only once per stand8 ard food item if the portion size is reasonably 

9 consistent and the food service establishment 

10 follows a standardized recipe and trains to a 

11 consistent method of preparation.’’. 

12 SEC. 7. NATIONAL UNIFORMITY. 

13 Section 403A(a)(4) of the Federal Food, Drug, and 

14 Cosmetic Act (21 U.S.C. 343–1(a)(4)) is amended to read 

15 as follows: 

16 ‘‘(4) any requirement for nutrition labeling of 

17 food that is not identical to the requirement of sec18 tion 403(q), except a requirement for nutrition label19 ing of food which is exempt under subclause (i) or 

20 (ii) of section 403(q)(5)(A), other than food served 

21 in an establishment that is not part of a chain that 

22 operates 20 or more establishments under the same 

23 trade name, or’’. 


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1 SEC. 8. IMPLEMENTING REGULATIONS. 

2 The Secretary of Health and Human Services (re3 ferred to in this section as the ‘‘Secretary’’) shall carry 

4 out the following: 

5 (1) Not later than 1 year after the date of en6 actment of this Act, the Secretary shall promulgate 

7 proposed regulations to mandate nutrition labeling 

8 of food service establishment food in accordance with 

9 section 403(q)(8) of the Federal Food, Drug, and 

10 Cosmetic Act (21 U.S.C. 343(q)(8)) (as added by 

11 section 6). 

12 (2) Not later than 2 years after the date of en13 actment of this Act, the Secretary shall promulgate 

14 final regulations to mandate nutrition labeling of 

15 food service establishment food in accordance with 

16 section 403(q)(8) of the Federal Food, Drug, and 

17 Cosmetic Act (21 U.S.C. 343(q)(8)) (as added by 

18 section 6). 

19 (3) If the Secretary determines that a nutrient 

20 other than a nutrient required by section 403(q)(8) 

21 of the Federal Food, Drug, and Cosmetic Act (21 

22 U.S.C. 343(q)(8)) should be included in the labeling 

23 of food menu items subject to such section 403(q)(8) 

24 for purposes of providing information regarding the 

25 nutritional value of such food that will assist con26 sumers in maintaining healthy dietary practices, the 


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1 Secretary may by regulation require that informa2 tion relating to such an additional nutrient be in3 cluded in the labeling of such food items. 

4 (4) If the Secretary determines that the infor5 mation relating to a nutrient required by section 

6 403(q)(8) of the Federal Food, Drug, and Cosmetic 

7 Act (21 U.S.C. 343(q)(8)) or paragraph (3) of this 

8 section to be included in the labeling of food menu 

9 items is not necessary to assist consumers in main10 taining healthy dietary practices, the Secretary may 

11 by regulation strike the requirement to include such 

12 information relating to such nutrient. 

13 (5) The Secretary may prescribe by regulation 

14 alternative clear and conspicuous means of meeting 

15 the requirements of section 403(q)(8)(A) of the Fed16 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

17 343(q)(8)(A)) (as added by section 6). 

18 SEC. 9. EFFECTIVE DATES. 

19 The amendments made by this Act shall take effect 

20 on the date of enactment of this Act, except that the 

21 amendment made by section 6 shall take effect 180 days 

22 after the Secretary of Health and Human Services pro23 mulgates final regulations under section 8(2). 


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1 SEC. 10. TECHNICAL AND CONFORMING AMENDMENTS. 

2 (a) Section 403(q)(1) of the Federal Food, Drug, and 

3 Cosmetic Act (21 U.S.C. 343(q)(1)) is amended by strik4 ing ‘‘subparagraphs (3), (4), and (5)’’ and inserting ‘‘sub5 paragraphs (3), (4), (5), (7), and (8).’’ 

6 (b) Section 403(q)(5)(G) of the Federal Food, Drug, 

7 and Cosmetic Act (21 U.S.C. 343(q)(5)(G)) is amended 

8 by striking ‘‘Subparagraphs (1), (2), (3) and (4)’’ and in9 serting ‘‘Subparagraphs (1), (2), (3), (4), (7) and (8).’’ 

Æ 


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