II 

113TH CONGRESS 

1ST SESSION S. 1653 

To amend the Federal Food, Drug, and Cosmetic Act to strengthen requirements related to nutrient information on food labels, and for other 

purposes. 

IN THE SENATE OF THE UNITED STATES 

NOVEMBER 5, 2013 

Mr. BLUMENTHAL 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 to 

strengthen requirements related to nutrient information 

on food labels, and for other purposes. 

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 ‘‘Food Labeling Modernization Act of 2013’’. 

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

7 this Act is as follows: 

Sec. 1. Short title; table of contents. 

Sec. 2. Additional requirements for front-of-packaging (FOP) labeling for processed foods. 

Sec. 3. Claims for conventional foods. 


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Sec. 4. Use of specific terms. 

Sec. 5. Modernization of the Nutrition Facts Panel. 

Sec. 6. Ingredient labels. 

Sec. 7. Caffeine content on information panel. 

Sec. 8. Effective date; regulations. 

Sec. 9. Definitions. 

1 SEC. 2. ADDITIONAL REQUIREMENTS FOR FRONT-OF-PACK2 AGING (FOP) LABELING FOR PROCESSED 

3 FOODS. 

4 (a) SUMMARY NUTRITION LABELING INFORMA5 TION.— 

6 (1) IN GENERAL.—Section 403 of Federal 

7 Food, Drug, and Cosmetic Act (21 U.S.C. 343) is 

8 amended by adding at the end the following new 

9 paragraph: 

10 ‘‘(z)(1) Except as provided in subparagraphs (3), (4), 

11 and (5) of paragraph (q), if it is food (other than a dietary 

12 supplement) intended for human consumption and is of13 fered for sale and otherwise required to bear nutrition la14 beling, unless its principal display panel bears summary 

15 nutrition information that reflects the overall nutritional 

16 value of the food or specified ingredients, as specified in 

17 accordance with regulations of the Secretary, and does not 

18 contain any summary nutritional information which is in 

19 addition to or inconsistent with the information required 

20 under this subparagraph.’’. 

21 (2) PRINCIPLES FOR IMPLEMENTING REGULA22 TIONS.—In promulgating regulations regarding the 


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1 summary nutrition information required under the 

2 amendment made by paragraph (1), the Secretary of 

3 Health and Human Services shall take into account 

4 published reports of the Institute of Medicine of the 

5 National Academy of Sciences regarding such infor6 mation and base regulations on the following prin7 ciples: 

8 (A) There should be a single simple, stand9 ard symbol system that displays calorie infor10 mation related to a common serving size, and 

11 information related to nutrients strongly associ12 ated with public health concerns. 

13 (B) Consumers should be able to quickly 

14 and easily comprehend the meaning of the sym15 bol system as an indicator of a product’s con16 tribution to a healthy diet. 

17 (C) The information should appear on all 

18 products that are required to bear nutrition la19 beling. 

20 (D) The information should— 

21 (i) appear in a consistent location on 

22 the principal display panels across prod23 ucts; 


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1 (ii) have a prominent design that vis2 ually contrasts with existing packaging de3 sign; and 

4 (iii) be sufficiently large. 

5 (E) The nutrition information should be 

6 consistent with the Nutrition Facts Panel and 

7 with the recommendations of the Dietary 

8 Guidelines of Americans. 

9 (F) The information should aim to facili10 tate consumer selection of healthy product op11 tions, including among nutritionally at-risk sub12 populations. 

13 (G) The Secretary should periodically 

14 evaluate the front-of-package information to as15 sess its ability to help facilitate consumer selec16 tion of healthy product options and the extent 

17 to which manufacturers are offering healthier 

18 products as a result of the disclosure. 

19 (H) The implementation of the information 

20 disclosure should be accompanied by appro21 priate consumer education and promotion cam22 paigns determined by the Secretary. 

23 (b) PERCENTAGE OF WHEAT AND GRAINS IN GRAIN24 BASED PRODUCTS.—Section 403(z) of Federal Food, 

25 Drug, and Cosmetic Act (21 U.S.C. 343(z)), as added by 


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1 subsection (a)(1), is further amended by adding at the end 

2 the following new subparagraph: 

3 ‘‘(2) If, in the case of food other than a dietary sup4 plement, the principal display panel bears— 

5 ‘‘(A) the phrase ‘made with whole grain’, the 

6 term ‘multigrain’, or similar descriptive phrases, 

7 terms, or representations with respect to whole grain 

8 content, unless the amount of whole grains, ex9 pressed as a percentage of total grains, is conspicu10 ously disclosed in immediate proximity to such de11 scriptive phrase, term, or representation; or 

12 ‘‘(B) the terms ‘wheat’ or ‘whole wheat’ on 

13 breads, pasta, crackers, or similar wheat-based prod14 ucts, unless the percentage of whole wheat by weight 

15 contained in the food is conspicuously declared in 

16 immediate proximity to that term or there is a con17 spicuous declaration that the food ‘contains no whole 

18 wheat’ in immediate proximity to that term.’’. 

19 (c) SWEETENERS, COLORING, AND FLAVORING.— 

20 Section 403(z) of the Federal Food, Drug, and Cosmetic 

21 Act (21 U.S.C. 343(z)) is further amended by adding at 

22 the end the following new subparagraph: 

23 ‘‘(3) If, in the case of food other than a dietary sup24 plement, it bears or contains any added artificial or nat25 ural coloring, any added artificial or natural non-caloric 


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1 sweetener, or any added artificial or natural flavoring, un2 less such fact is prominently stated on the principal dis3 play panel of a package or container of the food.’’. 

4 (d) CONFORMING AMENDMENT.—The second sen5 tence of section 403(k) of the Federal Food, Drug, and 

6 Cosmetic Act (21 U.S.C. 343(k)) is amended by striking 

7 ‘‘and (i)’’ and inserting ‘‘, (i), and (z)’’. 

8 (e) CONSTRUCTION.—Nothing in this section shall be 

9 construed as affecting any requirement in regulation in 

10 effect as of the date of the enactment of this Act with 

11 respect to matters that are required to be stated on the 

12 principal display panel of a package or container of food 

13 that is not required by an amendment made by this section 

14 or as restricting the authority of the Secretary of Health 

15 and Human Services to require additional information be 

16 disclosed on such a principal display panel. 

17 SEC. 3. CLAIMS FOR CONVENTIONAL FOODS. 

18 (a) STRUCTURE AND FUNCTION CLAIMS.— 

19 (1) GUIDANCE.—Not later than one year after 

20 the date of enactment of this Act, the Secretary of 

21 Health and Human Services shall issue comprehen22 sive guidance clarifying the application of section 

23 403(r) of the Federal Food, Drug, and Cosmetic Act 

24 (21 U.S.C. 343(r)) with respect to the mechanisms 

25 by which a nutrient in food (other than a dietary 


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1 supplement) is intended to affect the structure or 

2 any function of the human body, or characterize the 

3 documented mechanism by which a nutrient in such 

4 food acts to maintain such structure or function. 

5 (2) SUBSTANTIATION OF CLAIM.—Section 

6 403(r) of Federal Food, Drug, and Cosmetic Act 

7 (21 U.S.C. 343(r)) is amended— 

8 (A) by redesignating subparagraph (7) as 

9 subparagraph (8); and 

10 (B) by inserting after subparagraph (6) 

11 the following: 

12 ‘‘(7) If the Secretary requests that a claim 

13 under paragraph (r)(1)(B) for food (other than a di14 etary supplement) be substantiated, then not later 

15 than 90 days after the date on which the Secretary 

16 makes such request, the manufacturer shall provide 

17 to the Secretary all documentation in the manufac18 turer’s possession relating to the claim.’’. 

19 (b) TRANS FATS.—Section 403(r)(2)(A) of Federal 

20 Food, Drug, and Cosmetic Act (21 U.S.C. 343(r)(2)(A)) 

21 is amended— 

22 (1) in subclause (iii)— 

23 (A) in the matter before item (I), by strik24 ing ‘‘fat or saturated fat’’ and inserting ‘‘fat, 

25 saturated fat, or trans fats’’; and 


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1 (B) in item (II), by striking ‘‘fat or satu2 rated fat’’ and inserting ‘‘fat, saturated fat, or 

3 trans fats’’; 

4 (2) in subclause (iv), by striking ‘‘saturated 

5 fat’’ and inserting ‘‘saturated fat or trans fats’’ each 

6 place it appears; 

7 (3) by redesignating subclauses (v) and (vi) as 

8 subclauses (vi) and (vii), respectively; and 

9 (4) by inserting after subclause (iv) the fol10 lowing new subclause: 

11 ‘‘(v) may not be made with respect to the level 

12 of trans fats in the food unless the food contains less 

13 than one gram of saturated fat per serving or, if the 

14 food contains more than one gram of saturated fat 

15 per serving, unless the label or labeling of the food 

16 discloses the level of saturated fat in the food in im17 mediate proximity to such claim and with appro18 priate prominence which shall be no less than one19 half the size of the claim with respect to the level 

20 of trans fats,’’. 

21 SEC. 4. USE OF SPECIFIC TERMS. 

22 (a) USE OF THE TERM ‘‘NATURAL’’.—Section 403 

23 of Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

24 343), as amended by section 2, is further amended by add25 ing at the end the following new paragraph: 


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1 ‘‘(aa) If, in the case of food other than a dietary sup2 plement, the label bears the term ‘natural’ and the food 

3 contains any artificial ingredient (including any artificial 

4 flavor or artificial color), including— 

5 ‘‘(1) any ingredient that is synthesized but has 

6 the same chemical structure as a naturally occurring 

7 ingredient; 

8 ‘‘(2) any ingredient that has undergone chem9 ical changes, such as corn syrup, high-fructose corn 

10 syrup, high-maltose corn syrup, maltodextrin, chemi11 cally modified starch, cocoa processed with alkali, 

12 but not including— 

13 ‘‘(A) food that has undergone traditional 

14 processes used to make food edible, to preserve 

15 food, or to make food safe for human consump16 tion (such as smoking, roasting, freezing, dry17 ing, and fermenting processes); or 

18 ‘‘(B) food that has undergone traditional 

19 physical processes that do not fundamentally 

20 alter the raw product or which only separate a 

21 whole intact food into component parts (such as 

22 grinding grains, separating eggs into albumen 

23 and yolk, or pressing fruits to produce juice); or 

24 ‘‘(3) any other artificially-created ingredient 

25 that the Secretary specifies in regulations.’’. 


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1 (b) USE OF TERM ‘‘HEALTHY’’.—The Secretary of 

2 Health and Human Services shall revise the regulations 

3 under the Federal Food, Drug, and Cosmetic Act relating 

4 to the use of the term ‘‘healthy’’ on the label of a food 

5 (other than a dietary supplement) to take into account the 

6 extent to which such food contains added sugars or whole 

7 grains. In the case of a food (other than a dietary supple8 ment) that contains grains, in revising such regulations, 

9 the Secretary shall not consider the food to be ‘‘healthy’’ 

10 unless at least half of those grains, by weight, are whole 

11 grains. 

12 SEC. 5. MODERNIZATION OF THE NUTRITION FACTS PANEL. 

13 (a) DISCLOSURE OF CALORIE INFORMATION.—Sec14 tion 403(q)(1) of the Federal Food, Drug, and Cosmetic 

15 Act (21 U.S.C. 343(q)(1)) is amended— 

16 (1) by striking the period at the end the clause 

17 (E) and inserting a comma; 

18 (2) by inserting after clause (E) the following 

19 new clause: 

20 ‘‘(F) in the case of food other than a die21 tary supplement— 

22 ‘‘(i) the percent of recommended daily 

23 calories that are provided by one serving of 

24 the product, based on a recommended daily 

25 consumption of calories determined by the 


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1 Secretary to be appropriate for members of 

2 the general population; and 

3 ‘‘(ii) at the discretion of the Sec4 retary, the percent of recommended daily 

5 calories that are provided by one serving of 

6 the product— 

7 ‘‘(I) for members of any sub8 population identified by the Secretary; 

9 and 

10 ‘‘(II) based on a recommended 

11 daily consumption of calories deter12 mined by the Secretary to be appro13 priate for members of such subpopula14 tion.’’; and 

15 (3) by adding, after the flush text following 

16 clause (F), as added by paragraph (2), the following: 

17 ‘‘The information required under clause (C)(i) shall, 

18 in the case of food other than a dietary supplement, 

19 appear in a typeface and design which is more 

20 prominent and conspicuous than that used for other 

21 information required under this subparagraph.’’. 

22 (b) SERVING SIZE.—Section 403(q)(1)(A)(i) of Fed23 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

24 343(q)(1)(A)(i)) is amended by inserting ‘‘, or, in the case 

25 of a food (other than a dietary supplement) that is packVerDate Mar 15 2010 01:47 Nov 06, 2013 Jkt 039200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S1653.IS S1653

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1 aged in an amount that could reasonably be consumed in 

2 a single-eating occasion, which is an amount equal to the 

3 amount of food contained in the package’’ before ‘‘, or’’. 

4 (c) DISCLOSURE OF INFORMATION RELATING TO

5 SUGAR ON NUTRITION FACT PANEL.— 

6 (1) IN GENERAL.—Section 403(q)(1) of Federal 

7 Food, Drug, and Cosmetic Act (21 U.S.C. 

8 343(q)(1)), as amended by subsection (a), is amend9 ed— 

10 (A) in subparagraph (D), by striking ‘‘sug11 ars’’ and inserting ‘‘sugars (and, in the case of 

12 food other than a dietary supplement, total sug13 ars, and, of that, added sugars)’’; and 

14 (B) by inserting after clause (F) the fol15 lowing new clause: 

16 ‘‘(G) in the case of food other than a die17 tary supplement— 

18 ‘‘(i) the percent of added sugars rec19 ommended for daily consumption that are 

20 provided by one serving of the product, 

21 based on a recommended daily consump22 tion of calories determined by the Sec23 retary to be appropriate for members of 

24 the general population; and 


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1 ‘‘(ii) at the discretion of the Sec2 retary, the percent of added sugars rec3 ommended for daily consumption that are 

4 provided by one serving of the product— 

5 ‘‘(I) for members of any sub6 population identified by the Secretary; 

7 and 

8 ‘‘(II) based on a recommended 

9 daily consumption of calories deter10 mined by the Secretary to be appro11 priate for members of such subpopula12 tion.’’. 

13 SEC. 6. INGREDIENT LABELS. 

14 (a) GROUPING OF SUGARS, NON-CALORIC SWEET15 ENERS, AND SUGAR ALCOHOLS FOR ORDERING OF PRE16 DOMINANCE.—Section 403 of the Federal Food, Drug, 

17 and Cosmetic Act (21 U.S.C. 343), as amended by sec18 tions 2 and 4, is amended by adding at the end the fol19 lowing new paragraph: 

20 ‘‘(bb) In case it is food other than a dietary supple21 ment and is fabricated from two or more ingredients, un22 less— 

23 ‘‘(A) any sugars, non-caloric sweeteners, or 

24 sugar alcohols are each treated as a group in the list 

25 of ingredients on the label, including for purposes of 


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1 determining the order of predominance of ingredi2 ents; and 

3 ‘‘(B) individual sugars, non-caloric sweeteners, 

4 and sugar alcohols are listed parenthetically within 

5 each such group in their order of predominance 

6 within the group.’’. 

7 (b) FORMAT OF INGREDIENT LABELS.— 

8 (1) IN GENERAL.—The Secretary of Health and 

9 Human Services shall include requirements for the 

10 format of the information required under section 

11 403(i) of the Federal Food, Drug, and Cosmetic Act 

12 (21 U.S.C. 343(i))— 

13 (A) for the purpose of improving the read14 ability of such information on the label of the 

15 food (other than a dietary supplement); and 

16 (B) that are, as determined by the Sec17 retary, necessary to assist consumers in main18 taining healthy dietary practices. 

19 (2) FORMAT REQUIREMENTS.—The format re20 quirements referred to in paragraph (1) shall include 

21 requirements for upper- and lower-case characters, 

22 serif and noncondensed font types, high-contrast be23 tween text and background, and bullet points be24 tween adjacent ingredients with appropriate exemp25 tions for small packages or other considerations. 


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1 SEC. 7. CAFFEINE CONTENT ON INFORMATION PANEL. 

2 Section 403(i) of the Federal Food, Drug, and Cos3 metic Act (21 U.S.C. 343(i)) is amended— 

4 (1) by striking ‘‘and (2)’’ and inserting ‘‘(2)’’; 

5 (2) by striking ‘‘and if the food purports’’ and 

6 inserting ‘‘, (3) if the food purports’’; and 

7 (3) by inserting ‘‘, and (4) if the food is food 

8 other than a dietary supplement and contains at 

9 least 10 milligrams of caffeine from all sources per 

10 serving, a statement (with appropriate prominence 

11 near the statement of ingredients required by this 

12 paragraph) of the number of milligrams of caffeine 

13 contained in one serving of the food and the size of 

14 such serving’’ after ‘‘vegetable juice contained in the 

15 food’’. 

16 SEC. 8. EFFECTIVE DATE; REGULATIONS. 

17 (a) EFFECTIVE DATE.—The amendments made by— 

18 (1) sections 3 through 7 shall take effect on the 

19 date that is 2 years after the date of enactment of 

20 this Act; and 

21 (2) section 2 shall take effect on the date that 

22 is 3 years after such date of enactment. 

23 (b) REGULATIONS.— 

24 (1) PROPOSED REGULATIONS.—The Secretary 

25 of Health and Human Services shall propose regula26 tions— 


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1 (A) not later than 1 year after the date of 

2 enactment of this Act, to implement the amend3 ments made by sections 3 through 7; and 

4 (B) not later than 2 years after such date 

5 of enactment, to implement the amendments 

6 made by section 2. 

7 (2) FINAL REGULATIONS.—The Secretary of 

8 Health and Human Services shall promulgate final 

9 regulations— 

10 (A) not later than 2 years after such date 

11 of enactment, to implement the amendments 

12 made by sections 3 through 7; and 

13 (B) not later than 3 years after such date 

14 of enactment to implement the amendments 

15 made by section 2. 

16 (3) DEADLINE.—If the Secretary of Health and 

17 Human Services does not issue a final regulation by 

18 the deadline specified in subparagraph (A) or (B) of 

19 paragraph (2), the corresponding proposed regula20 tion under subparagraph (A) or (B) of paragraph 

21 (1) shall become final on the respective deadline. 

22 SEC. 9. DEFINITIONS. 

23 In this Act, the terms ‘‘food’’ and ‘‘dietary supple24 ment’’ have the meanings given to such terms in section 


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1 201 of the Federal Food, Drug, and Cosmetic Act (21 

2 U.S.C. 321). 

Æ 


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