II 

118TH CONGRESS 

1ST SESSION S. 1289 

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 

APRIL 26, 2023 

Mr. BLUMENTHAL (for himself, Mr. WHITEHOUSE, Mr. MARKEY, Mr. BOOKER, and Mr. CARDIN) 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 2023’’. 

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-package labeling for foods. 


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Sec. 3. Claims for conventional foods. 

Sec. 4. Use of specific terms. 

Sec. 5. Format of ingredient list. 

Sec. 6. Declaration of phosphorus in the ingredient list. 

Sec. 7. Caffeine content on information panel. 

Sec. 8. Food allergen labeling. 

Sec. 9. Information about major food allergens and gluten-containing grains. 

Sec. 10. Submission and availability of food label information. 

Sec. 11. Standards of identity. 

Sec. 12. Study on fortification of corn masa flour. 

Sec. 13. Sugar alcohols and isolated fibers. 

Sec. 14. Infant and toddler beverages. 

Sec. 15. Formatting of information on principal display panels. 

Sec. 16. Sale of food online. 

Sec. 17. Definitions. 

Sec. 18. Regulations; delayed applicability. 

1 SEC. 2. ADDITIONAL REQUIREMENTS FOR FRONT-OF-PACK2 AGE LABELING FOR FOODS. 

3 (a) INTERPRETIVE NUTRITION INFORMATION.—Sec4 tion 403 of the Federal Food, Drug, and Cosmetic Act 

5 (21 U.S.C. 343) is amended by adding at the end the fol6 lowing: 

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

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

9 supplement) intended for human consumption and is of10 fered for sale and otherwise required to bear nutrition la11 beling, unless its principal display panel bears interpretive 

12 nutrition information. 

13 ‘‘(2) Final regulations regarding the interpretive nu14 trition information required under subparagraph (1) shall 

15 meet the following criteria: 

16 ‘‘(A) There shall be a standardized symbol sys17 tem that displays calorie information related to the 

18 serving size determined under paragraph (q)(1)(A), 


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1 and interpretive nutrition information related to the 

2 content of added sugars, sodium, saturated fat, and 

3 any other nutrients that the Secretary determines 

4 the highlighting of which will assist consumers in 

5 maintaining healthy dietary practices, including by 

6 highlighting products containing high levels of such 

7 nutrients. 

8 ‘‘(B) The system shall clearly distinguish be9 tween products of greater or lesser nutritional value. 

10 ‘‘(C) The information shall— 

11 ‘‘(i) appear in a consistent location on the 

12 principal display panels across products; 

13 ‘‘(ii) have a prominent design that visually 

14 contrasts with existing packaging design; and 

15 ‘‘(iii) be sufficiently large to be easily leg16 ible. 

17 ‘‘(3) In promulgating regulations regarding the inter18 pretive nutrition information required under subpara19 graph (1) and the standardized symbol system required 

20 under subparagraph (2)(A), the Secretary shall take into 

21 account published reports by the Health and Medicine Di22 vision of the National Academy of Sciences, Engineering, 

23 and Medicine regarding interpretive nutrition information, 

24 and base regulations on the following principles: 


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1 ‘‘(A) Consumers should be able to quickly and 

2 easily comprehend the meaning of the system as an 

3 indicator of a product’s contribution to a healthy 

4 diet without requiring specific or sophisticated nutri5 tional knowledge. 

6 ‘‘(B) The nutrition information should be con7 sistent with the Nutrition Facts Panel and with the 

8 recommendations of the Dietary Guidelines for 

9 Americans. 

10 ‘‘(C) The information should aim to facilitate 

11 consumer selection of healthy product options, in12 cluding among nutritionally at-risk subpopulations. 

13 ‘‘(4) The Secretary should periodically evaluate the 

14 standardized symbol system required under subparagraph 

15 (2)(A) to assess its effectiveness in facilitating consumer 

16 selection of healthy product options and the extent to 

17 which manufacturers are offering healthier products as a 

18 result of the disclosure. 

19 ‘‘(5) The implementation of this paragraph should be 

20 accompanied by appropriate consumer education and pro21 motion campaigns determined by the Secretary.’’. 

22 (b) PERCENTAGE OF WHEAT AND GRAINS IN GRAIN23 BASED PRODUCTS, AND AMOUNT OF REAL FRUIT, VEGE24 TABLE, AND YOGURT IN PRODUCTS BEARING FRUIT, 

25 VEGETABLE, AND YOGURT CLAIMS.—Section 403 of the 


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1 Federal Food, Drug, and Cosmetic Act, as amended by 

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

3 the following: 

4 ‘‘(aa) If, in the case of food other than a dietary sup5 plement, the principal display panel bears— 

6 ‘‘(1) the term ‘whole wheat’, ‘whole grain’, 

7 ‘made with whole grain’, or ‘multigrain’; 

8 ‘‘(2) a declaration of the whole grain content by 

9 weight; 

10 ‘‘(3) the term ‘wheat’ on a wheat bread, pasta, 

11 or similar product that is typically made from wheat; 

12 or 

13 ‘‘(4) any similar descriptive phrases, terms, or 

14 representations suggesting the product contains 

15 whole grains, 

16 unless the amounts of whole grains and refined grains, 

17 expressed as a percentage of total grains, are conspicu18 ously disclosed in immediate proximity to the most promi19 nent descriptive phrase, term, or representation using a 

20 font color and formatting of equivalent prominence to the 

21 descriptive phrase, term, or representation with respect to 

22 whole grain content, or unless 100 percent of the grains 

23 in the food are whole grains. 

24 ‘‘(bb)(1) If, in the case of food other than a dietary 

25 supplement, the principal display panel bears— 


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1 ‘‘(A) the term ‘fruit’, ‘fruity’, ‘froot’, ‘frooty’, or 

2 ‘fruit-flavored’; 

3 ‘‘(B) representations, depictions, or images of 

4 such ingredients; or 

5 ‘‘(C) any similar descriptive phrases, terms, or 

6 representations suggesting the product contains fruit 

7 or any specific type of fruit, 

8 unless the quantity per serving and form of fruit, includ9 ing only the nutrient-dense forms, is declared on the prin10 cipal display panel in a common household measure that 

11 is appropriate to the food, conspicuously, and in imme12 diate proximity to the most prominent term, representa13 tion, depiction, or image of fruit. 

14 ‘‘(2) The Secretary shall by regulation establish 

15 quantities below which such declaration shall state that 

16 the food does not contain any full serving of fruit. 

17 ‘‘(3) In this paragraph, the term ‘nutrient-dense’, 

18 with respect to the form of an ingredient derived from a 

19 fruit, means the whole, cut, dried, pulp, puree, 100-per20 cent juice, or fully reconstituted concentrate form, and not 

21 concentrates, powders, and other ingredients that are not 

22 whole, cut, dried, pulp, puree, 100-percent juice, or fully 

23 reconstituted concentrates. 

24 ‘‘(cc)(1) If, in the case of food other than a dietary 

25 supplement, the principal display panel bears— 


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1 ‘‘(A) the term ‘vegetable’ or ‘veggie’; 

2 ‘‘(B) representations, depictions, or images of 

3 such ingredients; or 

4 ‘‘(C) any similar descriptive phrases, terms, or 

5 representations suggesting the product contains 

6 vegetables or any specific type of vegetable, 

7 unless the quantity per serving and form of vegetable, in8 cluding only the nutrient-dense form, is declared on the 

9 principal display panel in a common household measure 

10 that is appropriate to the food, conspicuously, and in im11 mediate proximity to the most prominent term, represen12 tation, depiction, or image of vegetable. 

13 ‘‘(2) The Secretary shall by regulation establish 

14 quantities below which such declaration shall state that 

15 the food does not contain any full serving of vegetable. 

16 ‘‘(3) In this paragraph, the term ‘nutrient-dense’, 

17 with respect to the form of an ingredient derived from a 

18 vegetable, means the whole, cut, dried, pulp, puree, 100- 

19 percent juice, or fully reconstituted concentrate form, and 

20 not concentrates, powders, and other ingredients that are 

21 not whole, cut, dried, pulp, puree, 100-percent juice, or 

22 fully reconstituted concentrates. 

23 ‘‘(dd)(1) If, in the case of food other than a dietary 

24 supplement, the principal display panel bears the term ‘yo25 gurt’, unless— 


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1 ‘‘(A) the quantity per serving of yogurt is de2 clared on the principal display panel in a common 

3 household measure that is appropriate to the food, 

4 conspicuously, in immediate proximity to the term; 

5 or 

6 ‘‘(B) the first ingredient is cultured milk, cul7 tured cream, cultured partially skimmed milk, or 

8 cultured skim milk. 

9 ‘‘(2) The Secretary shall by regulation establish 

10 quantities below which such declaration shall state that 

11 the food does not contain any full serving of yogurt.’’. 

12 (c) COLORING AND FLAVORING.—Section 403 of the 

13 Federal Food, Drug, and Cosmetic Act, as amended by 

14 subsection (b), is further amended by adding at the end 

15 the following: 

16 ‘‘(ee) If, in the case of food other than a dietary sup17 plement, it bears or contains any artificial dye, or any 

18 added artificial or natural flavoring, unless such fact is 

19 prominently stated on the principal display panel of the 

20 packaging of the food. For the purposes of this paragraph, 

21 the term ‘artificial dye’ refers to a batch-certified dye cer22 tified under part 74 of title 21, Code of Federal Regula23 tions (or any successor regulations).’’. 

24 (d) SWEETENERS.— 


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

2 Food, Drug, and Cosmetic Act, as amended by sub3 section (c), is further amended by adding at the end 

4 the following: 

5 ‘‘(ff) If, in the case of food other than a dietary sup6 plement, it bears or contains any added artificial or nat7 ural noncaloric sweetener, unless such fact is prominently 

8 stated on the principal display panel of the packaging of 

9 the food.’’. 

10 (2) REPORT.— 

11 (A) IN GENERAL.—Not later than 2 years 

12 after the date of enactment of this Act, the Sec13 retary of Health and Human Services (referred 

14 to in this Act as the ‘‘Secretary’’) shall submit 

15 to Congress a report that— 

16 (i) evaluates whether— 

17 (I) manufacturers have increased 

18 the use of low- and no-calorie sweet19 eners; and 

20 (II) the use of low- and no-cal21 orie sweeteners has risen to a level 

22 that could result in negative health 

23 consequences; and 

24 (ii) describes actions that will be 

25 taken by the Secretary to address any inVerDate Sep 11 2014 23:15 May 01, 2023 Jkt 039200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S1289.IS S1289

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1 creased use of low- and no-calorie sweet2 eners. 

3 (B) MONITORING.—On completion of the 

4 report described in subparagraph (A), the Sec5 retary shall— 

6 (i) periodically monitor for increased 

7 use of low- and no-calorie sweeteners; and 

8 (ii) take action to address the use of 

9 low- and no-calorie sweeteners if the use 

10 has risen to a level that could result in 

11 negative health consequences. 

12 (e) CONSTRUCTION.—Nothing in this section, includ13 ing any amendment made by this section, shall be con14 strued as— 

15 (1) affecting any requirement in regulation in 

16 effect as of the date of the enactment of this Act 

17 with respect to matters that are required to be stat18 ed on the principal display panel of a package or 

19 container of food that is not required by an amend20 ment made by this section; or 

21 (2) restricting the authority of the Secretary of 

22 Health and Human Services to require additional in23 formation be disclosed on such a principal display 

24 panel. 


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1 SEC. 3. CLAIMS FOR CONVENTIONAL FOODS. 

2 (a) HEALTH-RELATED CLAIMS.— 

3 (1) IN GENERAL.—Section 403(r)(1)(B) of the 

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

5 343(r)(1)(B)) is amended by inserting after ‘‘health6 related condition’’ the following: ‘‘, describes the ef7 fect that a nutrient may have on the structure or 

8 function of the human body, characterizes the docu9 mented mechanism by which that nutrient acts to 

10 maintain such structure or function, or describes 

11 general well-being from consumption of that nutri12 ent,’’. 

13 (2) SUBSTANTIATION OF CLAIM.—Section 

14 403(r) of the Federal Food, Drug, and Cosmetic Act 

15 (21 U.S.C. 343(r)) is amended— 

16 (A) by redesignating subparagraph (7) as 

17 subparagraph (8); and 

18 (B) by inserting after subparagraph (6) 

19 the following: 

20 ‘‘(7) If the Secretary requests that a claim under sub21 paragraph (1)(B) for food (other than a dietary supple22 ment) be substantiated, then not later than 90 days after 

23 the date on which the Secretary makes such request, the 

24 manufacturer shall provide to the Secretary all docu25 mentation in the manufacturer’s possession relating to the 

26 claim.’’. 


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1 (3) INCOMPATIBLE WITH MAINTAINING

2 HEALTHY DIETARY PRACTICES.—Section 

3 403(r)(3)(A)(ii) of the Federal Food, Drug, and 

4 Cosmetic Act (21 U.S.C. 343(r)(2)(B)) is amended 

5 by striking ‘‘increases to persons in the general pop6 ulation the risk of a disease or health-related condi7 tion which is diet related’’ and inserting ‘‘may not 

8 be compatible with maintaining healthy dietary prac9 tices’’. 

10 (b) NUTRIENT CONTENT CLAIMS.— 

11 (1) IN GENERAL.—Section 403(r)(2) of the 

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

13 343(r)(2)) is amended by striking clause (B) and in14 serting the following: 

15 ‘‘(B) If a claim described in subparagraph (1)(A) is 

16 made with respect to a nutrient in a food and the Sec17 retary makes a determination that the food contains a nu18 trient at a level that may not be compatible with maintain19 ing healthy dietary practices, the label or labeling of such 

20 food shall contain, prominently and in immediate prox21 imity to such claim, a statement which indicates the food 

22 is high in such nutrient.’’. 

23 (2) REVISIONS TO REGULATIONS.—In promul24 gating the regulations required by section 18, the 

25 Secretary of Health and Human Services shall revise 


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1 section 101.13(h) of title 21, Code of Federal Regu2 lations, by— 

3 (A) updating the level of sodium requiring 

4 disclosure to align with the Daily Reference 

5 Value for sodium established in the final rule 

6 entitled ‘‘Food Labeling: Revision of the Nutri7 tion and Supplement Facts Labels’’ published 

8 by the Food and Drug Administration on May 

9 27, 2016 (81 Fed. Reg. 33741); 

10 (B) including a level of added sugars re11 quiring disclosure based on the Daily Reference 

12 Value for added sugars established in the final 

13 rule described in subparagraph (A); 

14 (C) eliminating the requirement that meal 

15 products containing more than 26 grams of fat 

16 and main dish products containing 19.5 grams 

17 of fat per labeled serving must disclose that fat 

18 is present in the food; and 

19 (D) authorizing the use of express and im20 plied ‘‘low added sugar’’ claims on products 

21 containing 3 grams of added sugars or less per 

22 reference amount customarily consumed (or per 

23 50 grams if the reference amount customarily 

24 consumed is 30 grams or less or 2 tablespoons 

25 or less). 


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1 (c) TRANS FATS.—Section 403(r)(2)(A) of the Fed2 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

3 343(r)(2)(A)) is amended— 

4 (1) by redesignating subclauses (v) and (vi) as 

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

6 (2) by inserting after subclause (iv) the fol7 lowing new subclause: 

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

9 of trans fats in the food, except on the Nutrition 

10 Facts Panel, unless the food contains less than one 

11 gram of saturated fat per serving or, if the food con12 tains more than one gram of saturated fat per serv13 ing, unless the label or labeling of the food discloses 

14 the level of saturated fat in the food in immediate 

15 proximity to such claim and with appropriate promi16 nence which shall be no less than one-half the size 

17 of the claim with respect to the level of trans fats,’’. 

18 (d) ADDED SUGARS.—Not more than 2 years after 

19 the date of enactment of this Act, the Secretary of Health 

20 and Human Services shall promulgate a final rule revising 

21 section 101.14 of title 21, Code of Federal Regulations, 

22 to include a disqualifying nutrient level for added sugars. 

23 SEC. 4. USE OF SPECIFIC TERMS. 

24 (a) USE OF THE TERM ‘‘NATURAL’’.— 


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1 (1) IN GENERAL.—In promulgating the regula2 tions required by section 18, the Secretary of Health 

3 and Human Services shall include regulations— 

4 (A) relating to use of the term ‘‘natural’’ 

5 on the labeling of food (other than a dietary 

6 supplement); 

7 (B) specifically addressing the use of such 

8 term on the principal display panel and the in9 formation panel; and 

10 (C) requiring that any such use includes a 

11 prominent disclosure explaining what the term 

12 ‘‘natural’’ does and does not mean in terms of 

13 ingredients and manufacturing processes. 

14 (2) DEFINITION.—The regulations promulgated 

15 pursuant to paragraph (1) shall define the term 

16 ‘‘natural’’— 

17 (A) to exclude, at a minimum, the use of 

18 any artificial food or ingredient (including any 

19 artificial flavor or added color); and 

20 (B) based on data, including data on con21 sumers’ understanding of the term as used in 

22 connection with food. 

23 (3) PROCESS.—In promulgating the regulations 

24 required by paragraph (1), the Secretary of Health 

25 and Human Services shall— 


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1 (A) conduct consumer surveys and studies 

2 and issue a timely call for relevant public sub3 missions regarding relevant consumer research, 

4 including with respect to consumer under5 standing of the term ‘‘natural’’ in relation to 

6 the term ‘‘organic’’; and 

7 (B) fully consider the results of such sur8 veys and studies, as well as such public submis9 sions. 

10 (b) USE OF TERM ‘‘HEALTHY’’.— 

11 (1) ADDED SUGARS AND WHOLE GRAINS.— 

12 (A) IN GENERAL.—In promulgating the 

13 regulations required by section 18, the Sec14 retary of Health and Human Services shall in15 clude regulations to revise the regulations under 

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

17 U.S.C. 301 et seq.) relating to the use of the 

18 term ‘‘healthy’’ on the labeling of a food (other 

19 than a dietary supplement) to take into account 

20 the extent to which such food contains added 

21 sugars or whole grains. 

22 (B) REQUIREMENT.—In making the revi23 sions required by subparagraph (A) in the case 

24 of a food (other than a dietary supplement) 

25 that contains grains, the Secretary of Health 


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1 and Human Services shall not consider the food 

2 to be ‘‘healthy’’ unless 100 percent of the 

3 grains are whole grains. 

4 (2) SODIUM.—In promulgating the regulations 

5 required by section 18, the Secretary of Health and 

6 Human Services shall revise the regulations under 

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

8 U.S.C. 301 et seq.) relating to the use of the term 

9 ‘‘healthy’’ on the labeling of a food (other than a di10 etary supplement) to align labeling requirements re11 lated to sodium with the daily value for sodium in 

12 the most recent Dietary Guidelines for Americans. 

13 (3) PRINCIPLES FOR IMPLEMENTING REGULA14 TIONS.—In promulgating regulations under para15 graphs (1) and (2) regarding the use of the term 

16 ‘‘healthy’’, the Secretary of Health and Human 

17 Services shall— 

18 (A) consider both food and nutrient cri19 teria; and 

20 (B) if requiring food labeled as ‘‘healthy’’ 

21 to contain healthful ingredients— 

22 (i) consider only ingredients that 

23 make up the core of a healthy eating pat24 tern; and 


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1 (ii) consider these ingredients only in 

2 their nutrient-dense forms (as such term in 

3 defined in paragraphs (bb) and (cc) of sec4 tion 403 of the Federal Food, Drug, and 

5 Cosmetic Act, as added by section 2(b) of 

6 this Act). 

7 SEC. 5. FORMAT OF INGREDIENT LIST. 

8 (a) IN GENERAL.—In promulgating the regulations 

9 required by section 18, the Secretary of Health and 

10 Human Services shall include requirements for the format 

11 of the information required under section 403(i) of the 

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

13 343(i))— 

14 (1) for the purpose of improving the readability 

15 of such information on the label of the food (other 

16 than a dietary supplement); and 

17 (2) that are, as determined by the Secretary, 

18 necessary to assist consumers in maintaining healthy 

19 dietary practices. 

20 (b) FORMAT REQUIREMENTS.—The format require21 ments described in subsection (a) shall include require22 ments for font size, uppercase and lowercase characters, 

23 serif and noncondensed font types, high-contrast between 

24 text and background, and bullet points between adjacent 


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1 ingredients with appropriate exemptions for small pack2 ages or other considerations. 

3 (c) ENFORCEMENT OF INGREDIENT LIST.—Not later 

4 than 2 years after the enactment of this Act, and every 

5 2 years thereafter, the Secretary of Health and Human 

6 Services shall submit a report to Congress on the Sec7 retary’s enforcement of— 

8 (1) section 403(i) of the Federal Food, Drug, 

9 and Cosmetic Act (21 U.S.C. 343(i)), including with 

10 respect to the regulations described in subsection 

11 (a); and 

12 (2) regulations of the Food and Drug Adminis13 tration on labeling of ingredients in section 101.4 of 

14 title 21, Code of Federal Regulations. 

15 SEC. 6. DECLARATION OF PHOSPHORUS IN THE INGRE16 DIENT LIST. 

17 Section 403 of the Federal Food, Drug, and Cosmetic 

18 Act (21 U.S.C. 343), as amended by section 2(d), is fur19 ther amended by adding at the end the following: 

20 ‘‘(gg) If it is a food intended for human consumption 

21 that is offered for sale and contains phosphorus, unless— 

22 ‘‘(1) the phrase ‘contains phosphorus’, along 

23 with the quantity of phosphorus in the product, re24 ported in milligrams per serving, is printed imme25 diately after or is adjacent to the list of ingredients 


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1 required under paragraphs (g) and (i), in a type size 

2 no smaller than the type size used in the list of in3 gredients; or 

4 ‘‘(2) the quantity of phosphorus contained in 

5 the product, in milligrams, is reported in the Nutri6 tion Facts Panel.’’. 

7 SEC. 7. CAFFEINE CONTENT ON INFORMATION PANEL. 

8 Section 403(i) of the Federal Food, Drug, and Cos9 metic Act (21 U.S.C. 343(i)) is amended— 

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

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

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

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

14 other than a dietary supplement and contains at 

15 least 10 milligrams of caffeine from all sources per 

16 serving, a statement (with appropriate prominence 

17 near the statement of ingredients required by this 

18 paragraph) of the number of milligrams of caffeine 

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

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

21 food’’. 

22 SEC. 8. FOOD ALLERGEN LABELING. 

23 (a) IN GENERAL.—Section 201(qq) of the Federal 

24 Food, Drug, and Cosmetic Act (21 U.S.C. 321(qq)) is 

25 amended by adding at the end the following: 


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1 ‘‘(3) Any other food ingredient that the Sec2 retary determines by regulation to be a major food 

3 allergen, based on the prevalence and severity of al4 lergic reactions to the food ingredient.’’. 

5 (b) UPDATE TO COMPLIANCE POLICY GUIDE.—Not 

6 later than 2 years after the date of enactment of this Act, 

7 the Secretary of Health and Human Services shall update 

8 the Food and Drug Administration’s Compliance Policy 

9 Guide, section 555.250, to conform with applicable laws 

10 related to major food allergens and gluten-containing 

11 grains, including requirements under sections 9 and 10 

12 of this Act. 

13 SEC. 9. INFORMATION ABOUT MAJOR FOOD ALLERGENS 

14 AND GLUTEN-CONTAINING GRAINS. 

15 (a) IN GENERAL.—Section 403(w) of the Federal 

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

17 amended— 

18 (1) in subparagraph (1)(A), by striking ‘‘is 

19 printed immediately after or is adjacent to the list 

20 of ingredients (in a type size no smaller than the 

21 type size used in the list of ingredients) required 

22 under subsections (g) and (i)’’ and inserting ‘‘is 

23 printed as specified in subparagraph (8)’’; 


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1 (2) in subparagraph (1)(B), by striking ‘‘in the 

2 list of ingredients required under subsections (g) 

3 and (i)’’ and inserting ‘‘as so printed’’; 

4 (3) in subparagraph (3), by striking ‘‘The infor5 mation’’ and inserting ‘‘Subject to subparagraph 

6 (8)(B), the information’’; 

7 (4) by adding at the end the following: 

8 ‘‘(8) The information required by subparagraph (1) 

9 to be conveyed to the consumer shall be— 

10 ‘‘(A) printed immediately after or adjacent to 

11 the list of ingredients (in a type size no smaller than 

12 the type size used in the list of ingredients) required 

13 under paragraphs (g) and (i); or 

14 ‘‘(B) in the case of a nonpackaged food being 

15 offered for sale at retail, and not subject to the re16 quirements of paragraphs (g) and (i), placed on a 

17 sign adjacent to the food (in a type size no smaller 

18 than the name of the food item).’’; 

19 (5) by inserting ‘‘or gluten-containing grain’’ 

20 after ‘‘food allergen’’ each place it appears in sub21 paragraphs (1), (2), (4), and (7); and 

22 (6) in subparagraph (7)(A)— 

23 (A) by striking ‘‘paragraph (6)’’ and in24 serting ‘‘subparagraph (6)’’; and 


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1 (B) by striking ‘‘allergen labeling require2 ments of this subsection’’ and inserting ‘‘aller3 gen and gluten-containing grain labeling re4 quirements of this paragraph’’. 

5 (b) HAZARD ANALYSIS AND PREVENTIVE CON6 TROLS.—Section 418 of the Federal Food, Drug, and Cos7 metic Act (21 U.S.C. 350g) is amended— 

8 (1) in subsection (b)(1)(A), by inserting ‘‘glu9 ten-containing grains,’’ after ‘‘allergens,’’; and 

10 (2) in subsection (o)(3)(D), by inserting ‘‘and 

11 gluten-containing grain’’ after ‘‘allergen,’’. 

12 (c) INSPECTIONS RELATING TO FOOD ALLERGENS.— 

13 Section 205 of the Food Allergen Labeling and Consumer 

14 Protection Act of 2004 (21 U.S.C. 374a) is amended by 

15 inserting ‘‘and gluten-containing grains,’’ after ‘‘aller16 gens’’ each place it appears. 

17 SEC. 10. SUBMISSION AND AVAILABILITY OF FOOD LABEL 

18 INFORMATION. 

19 The Federal Food, Drug, and Cosmetic Act is amend20 ed by inserting after section 403C of such Act (21 U.S.C. 

21 343–3) the following: 

22 ‘‘SEC. 403D. SUBMISSION AND AVAILABILITY OF FOOD 

23 LABEL INFORMATION. 

24 ‘‘(a) SUBMISSIONS.— 


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1 ‘‘(1) REQUIREMENT.—The Secretary shall re2 quire the manufacturer or importer of any food that 

3 is introduced or delivered for introduction into inter4 state commerce in package form to submit to the 

5 Secretary all information to be included in the label 

6 of the food, including— 

7 ‘‘(A) the nutrition facts panel; 

8 ‘‘(B) the ingredients list; 

9 ‘‘(C) an image of the principal display 

10 panel; 

11 ‘‘(D) major allergens and gluten-containing 

12 grains; 

13 ‘‘(E) claims under section 403(r)(1)(A) 

14 (commonly known as ‘nutrient-content claims’); 

15 ‘‘(F) claims under section 403(r)(1)(B) 

16 (commonly known as ‘health-related claims’); 

17 and 

18 ‘‘(G) other relevant information required 

19 by law to be published in the labeling of the 

20 food. 

21 ‘‘(2) UPDATES.—The Secretary shall require 

22 the manufacturer or importer of food to update or 

23 supplement the information submitted under para24 graph (1) with respect to the food in order to keep 

25 the information up-to-date and complete. 


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1 ‘‘(3) CIVIL PENALTY.—Whoever knowingly vio2 lates paragraph (1) with respect to any food shall be 

3 liable to the United States for a civil penalty in an 

4 amount not to exceed $10,000 for each day on which 

5 such violation continues with respect to such food. 

6 ‘‘(b) PUBLIC DATABASE.—The Secretary shall estab7 lish and maintain a public database containing the infor8 mation submitted under this section that— 

9 ‘‘(1) is available to the public through the 

10 website of the Food and Drug Administration; and 

11 ‘‘(2) allows members of the public to easily 

12 search and sort information.’’. 

13 SEC. 11. STANDARDS OF IDENTITY. 

14 (a) IN GENERAL.—Not later than 2 years after the 

15 date of enactment of this Act, the Secretary of Health and 

16 Human Services shall— 

17 (1) review standards of identity prescribed by 

18 regulation which require foods to contain— 

19 (A) minimum levels of nutrients that the 

20 Secretary determines are strongly associated 

21 with public health concerns; or 

22 (B) minimum levels of ingredients con23 taining high levels of such nutrients; and 

24 (2) report to the Committee on Energy and 

25 Commerce of the House of Representatives and the 


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1 Committee on Health, Education, Labor, and Pen2 sions of the Senate on the findings of such review. 

3 (b) AMENDMENTS.—In promulgating the regulations 

4 required by section 18, the Secretary of Health and 

5 Human Services shall amend standards of identity regula6 tions to— 

7 (1) provide for the use of salt substitutes where 

8 appropriate; and 

9 (2) require that yogurt, lowfat yogurt, and non10 fat yogurt contain a minimum level of live and active 

11 cultures per gram. 

12 SEC. 12. STUDY ON FORTIFICATION OF CORN MASA FLOUR. 

13 Not later than 2 years after the date of enactment 

14 of this Act, the Secretary of Health and Human Services 

15 shall submit a report to Congress on the effect of the final 

16 rule titled ‘‘Food Additives Permitted for Direct Addition 

17 to Food for Human Consumption; Folic Acid’’ published 

18 by the Food and Drug Administration on April 15, 2016 

19 (81 Fed. Reg. 22176), on folic acid intake in the United 

20 States population by race and ethnicity, comparing actual 

21 exposure with modeled exposure estimates from the final 

22 rule. 


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1 SEC. 13. SUGAR ALCOHOLS AND ISOLATED FIBERS. 

2 Section 403 of the Federal Food, Drug, and Cosmetic 

3 Act (21 U.S.C. 343), as amended by section 6, is further 

4 amended by adding at the end the following: 

5 ‘‘(hh) If it is a food intended for human consumption 

6 that is offered for sale and contains allulose, polydextrose, 

7 sugar alcohols, or isolated fibers, unless such fact is 

8 prominently stated on the principal display panel of the 

9 packaging of the food. The Secretary shall by regulation 

10 establish quantities above which such labeling shall include 

11 a warning that the food contains a level of allulose, 

12 polydextrose, sugar alcohols, or isolated fibers per serving 

13 determined by the Secretary to cause deleterious health 

14 effects.’’. 

15 SEC. 14. INFANT AND TODDLER BEVERAGES. 

16 In promulgating the regulations required by section 

17 18, the Secretary of Health and Human Services shall re18 vise— 

19 (1) section 101.3 of title 21, Code of Federal 

20 Regulations, to prohibit any beverage in powder or 

21 liquid form, other than infant formula, represented 

22 or purported to be for use by children more than 12 

23 months old, from being identified as ‘‘infant for24 mula’’ or use the term ‘‘formula’’ in combination 

25 with any other term; and 


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1 (2) part 102 of title 21, Code of Federal Regu2 lations, so that— 

3 (A) in the case of any powdered or liquid 

4 milk-based beverage that claims to be for con5 sumption by children 12 to 36 months of age, 

6 such beverage shall— 

7 (i) use as its common or usual name 

8 a descriptive term such as ‘‘milk-based 

9 drink’’; and 

10 (ii) if the beverage contains added 

11 sugars, nonnutritive sweeteners, or 

12 flavorings, include in such common or 

13 usual name a qualifying term such as 

14 ‘‘sweetened’’ or ‘‘flavored’’; 

15 (B) in the case of any powdered or liquid 

16 nondairy-milk-based beverage that claims to be 

17 for consumption by children 12 to 36 months of 

18 age, such beverage shall— 

19 (i) use as its common or usual name 

20 an appropriately descriptive term identi21 fying the source of protein, such as ‘‘soy22 based drink powder for 12–36 month 

23 olds’’; and 

24 (ii) if the beverage contains added 

25 sugars, nonnutritive sweeteners, or 


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1 flavorings, include in such common or 

2 usual name qualifying terms such as 

3 ‘‘sweetened’’ and ‘‘flavored’’ when applica4 ble; and 

5 (C) the labeling of a beverage described in 

6 subparagraph (A) or (B) shall— 

7 (i) contain a disclaimer that— 

8 (I) cautions against consumption 

9 of the beverage by infants, such as 

10 ‘‘DO NOT SERVE TO INFANTS 

11 UNDER 12 MONTHS OLD’’; and 

12 (II) such beverages are not rec13 ommended for children 12 to 24 

14 months of age and such consumption 

15 of such beverages is not required for 

16 a healthy diet, such as ‘‘This product 

17 contains added sugars. The Dietary 

18 Guidelines for Americans recommend 

19 to avoid food and beverages with 

20 added sugars for children younger 

21 than 24 months of age.’’; and 

22 (ii) not contain any statement sug23 gesting a recommended intake of such bev24 erages, such as ‘‘one cup a day’’. 


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1 SEC. 15. FORMATTING OF INFORMATION ON PRINCIPAL 

2 DISPLAY PANELS. 

3 The Secretary of Health and Human Services shall— 

4 (1) not later than 2 years after the date of en5 actment of this Act, conduct a study on the legibility 

6 of food labeling to determine updated recommenda7 tions for text size and color contrast that make food 

8 labeling information visually accessible to the major9 ity of consumers; 

10 (2) not later than 1 year after the completion 

11 of the study under paragraph (1), issue proposed 

12 regulations revising section 101.2(c) of title 21, 

13 Code of Federal Regulations, to— 

14 (A) set the scale of text size, taking into 

15 consideration the results of the study conducted 

16 under paragraph (1); and 

17 (B) establish new requirements for text 

18 and background color contrast, taking into con19 sideration the results of the study conducted 

20 under paragraph (1); and 

21 (3) not later than 2 years after the completion 

22 of the study under paragraph (1), finalize such pro23 posed regulations. 

24 SEC. 16. SALE OF FOOD ONLINE. 

25 (a) IN GENERAL.—Section 403 of the Federal Food, 

26 Drug, and Cosmetic Act (21 U.S.C. 343), as amended by 


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1 section 13, is further amended by adding at the end the 

2 following: 

3 ‘‘(ii)(1) If it is a food offered for sale online or by 

4 other remote written electronic means, unless all informa5 tion required to appear on the label or labeling is available 

6 to consumers at the point of selection prior to purchasing 

7 the food. 

8 ‘‘(2) The Secretary shall by regulation specify the for9 mat and manner in which the information required under 

10 subparagraph (1) is to be made available online to con11 sumers. Such regulations shall include— 

12 ‘‘(A) a requirement that the nutrition informa13 tion shall be in the same format as the nutrition in14 formation required under paragraph (q); and 

15 ‘‘(B) a requirement that the nutrition informa16 tion required under paragraph (q), the ingredient in17 formation required under paragraphs (g) and (i), 

18 and the allergen information required under para19 graph (w) shall— 

20 ‘‘(i) appear on the first product informa21 tion page that appears for the product on a mo22 bile device, internet website, or other landing 

23 page; 

24 ‘‘(ii) appear prominently and conspicuously 

25 (as compared with other words, statements, or 


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1 designs on the mobile device, internet website, 

2 or other landing page) so as to render the infor3 mation likely to be read and understood by the 

4 ordinary individual under customary conditions 

5 of online purchase; and 

6 ‘‘(iii) not contain intervening marketing in7 formation.’’. 

8 (b) PROHIBITED ACTS.— 

9 (1) IN GENERAL.—Section 301 of the Federal 

10 Food, Drug, and Cosmetic Act (21 U.S.C. 331) is 

11 amended by adding at the end the following: 

12 ‘‘(jjj) In the case of a person providing a platform 

13 for, or otherwise assisting, the sale of food online or by 

14 other remote written electronic means, the prevention by 

15 the person of the provision to consumers of information 

16 required under section 403(z) or the charging by such per17 son of an additional fee for the provision of such informa18 tion.’’. 

19 (2) PENALTIES.—Section 303 of the Federal 

20 Food, Drug, and Cosmetic Act (21 U.S.C. 333) is 

21 amended by adding at the end the following: 

22 ‘‘(h)(1) Notwithstanding subsection (a), any person 

23 who violates section 301(jjj) shall be liable to the United 

24 States for a civil penalty in an amount not to exceed 

25 $10,000 for each such violation, and not to exceed 


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1 $1,000,000 for all such violations adjudicated in a single 

2 proceeding. 

3 ‘‘(2) The Secretary shall provide the person subject 

4 to a penalty under paragraph (1) with a warning and op5 portunity to correct the violation prior to issuing the first 

6 civil penalty under that paragraph. 

7 ‘‘(3) In determining the amount of a civil penalty 

8 under paragraph (1), the Secretary shall take into consid9 eration whether the person is making efforts to correct 

10 the violation for which such person is subject to such civil 

11 penalty. 

12 ‘‘(4) No person shall be subject to criminal penalties 

13 as described in subsection (a) for a violation of section 

14 301(jjj).’’. 

15 (c) CIVIL MONETARY PENALTIES FOR VIOLATION OF

16 REQUIREMENTS FOR SALE OF FOOD ONLINE.—Section 

17 303 of the Federal Food, Drug, and Cosmetic Act (21 

18 U.S.C. 333) (as amended by subsection (b)(2)) is amended 

19 by adding at the end the following: 

20 ‘‘(i)(1) Notwithstanding subsection (a), any person 

21 who introduces into interstate commerce, delivers for in22 troduction into interstate commerce, receives in interstate 

23 commerce, or manufactures a food that is misbranded as 

24 described in section 403(z), or misbrands the food as de25 scribed in that section, shall be liable to the United States 


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1 for a civil penalty in an amount not to exceed $10,000 

2 for each such violation, and not to exceed $1,000,000 for 

3 all such violations adjudicated in a single proceeding. 

4 ‘‘(2) The Secretary shall provide the person subject 

5 to a penalty under paragraph (1) with a warning and op6 portunity to correct the violation prior to issuing the first 

7 civil penalty under that paragraph. 

8 ‘‘(3) In determining the amount of a civil penalty 

9 under paragraph (1), the Secretary shall take into consid10 eration whether the person is making efforts to correct 

11 the violation for which such person is subject to such civil 

12 penalty. 

13 ‘‘(4) No person shall be subject to criminal penalties 

14 as described in subsection (a) for a violation described in 

15 paragraph (1).’’. 

16 SEC. 17. DEFINITIONS. 

17 (a) DEFINITIONS APPLICABLE IN THIS ACT.—In this 

18 Act, the terms ‘‘food’’ and ‘‘dietary supplement’’ have the 

19 meanings given to such terms in section 201 of the Fed20 eral Food, Drug, and Cosmetic Act (21 U.S.C. 321). 

21 (b) DEFINITIONS APPLICABLE IN THE FEDERAL

22 FOOD, DRUG, AND COSMETIC ACT.—Section 201 of the 

23 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) 

24 is amended by adding at the end the following: 


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1 ‘‘(tt) The term ‘artificial’, with respect to food or any 

2 ingredient of food, means— 

3 ‘‘(1) food or an ingredient that is synthetically 

4 produced whether or not it has the same chemical 

5 structure as a naturally occurring food or ingredient; 

6 ‘‘(2) food or an ingredient that has undergone 

7 chemical changes through the introduction of syn8 thetic chemicals or processing aids (such as corn 

9 syrup, high-fructose corn syrup, high-maltose corn 

10 syrup, maltodextrin, chemically modified starch, and 

11 cocoa processed with alkali), excluding— 

12 ‘‘(A) food or an ingredient that has under13 gone traditional processes used to make food 

14 edible, to preserve food, or to make food safe 

15 for human consumption (such as smoking, 

16 roasting, freezing, drying, and fermenting proc17 esses); or 

18 ‘‘(B) food or an ingredient that has under19 gone traditional physical processes that do not 

20 fundamentally alter the raw product or which 

21 only separate a whole intact food into compo22 nent parts (such as grinding grains, separating 

23 eggs into albumen and yolk, or pressing fruits 

24 to produce juice); or 


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1 ‘‘(3) any food or ingredient that the Secretary 

2 specifies by regulation to be artificial for purposes of 

3 this Act. 

4 ‘‘(uu) The term ‘synthetic’, with respect to a sub5 stance in food or any ingredient of food, means a sub6 stance that is formulated or manufactured by a chemical 

7 process or by a process that chemically changes a sub8 stance extracted from a naturally occurring plant, animal, 

9 or mineral source, except that such term does not apply 

10 to a substance created by naturally occurring biological 

11 processes. 

12 ‘‘(vv) The term ‘gluten-containing grains’ means any 

13 one of the following grains (or any crossbred hybrid there14 of): 

15 ‘‘(1) Wheat, including any species belonging to 

16 the genus Triticum. 

17 ‘‘(2) Rye, including any species belonging to the 

18 genus Secale. 

19 ‘‘(3) Barley, including any species belonging to 

20 the genus Hordeum. 

21 ‘‘(ww) The term ‘gluten’ means the proteins that— 

22 ‘‘(1) naturally occur in a gluten-containing 

23 grain; and 

24 ‘‘(2) may cause adverse health effects in per25 sons with celiac disease. 


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1 ‘‘(xx) The term ‘online’ means on or by any system 

2 of data communication and transmission, such as the 

3 internet. 

4 ‘‘(yy) The term ‘online point of selection’ means any 

5 space in which consumers are allowed to purchase food 

6 online, including websites, e-commerce platforms, web ap7 plications, and mobile applications.’’. 

8 SEC. 18. REGULATIONS; DELAYED APPLICABILITY. 

9 (a) REGULATIONS.— 

10 (1) PROPOSED REGULATIONS.—Not later than 

11 1 year after the date of enactment of this Act, the 

12 Secretary of Health and Human Services, acting 

13 through the Commissioner of Food and Drugs, shall 

14 issue proposed regulations to carry out sections 2, 3, 

15 4, 5(a), 6, 7, 9, 10, 11, 13, 14, 16, and 17(b) and 

16 the amendments made by such sections. 

17 (2) FINAL REGULATIONS.—Not later than 2 

18 years after the date of enactment of this Act, the 

19 Secretary of Health and Human Services, acting 

20 through the Commissioner of Food and Drugs, shall 

21 finalize the regulations proposed pursuant to para22 graph (1). 

23 (3) FAILURE TO ISSUE FINAL REGULATION.—If 

24 the Secretary of Health and Human Services does 

25 not issue a final regulation as required by paragraph 


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1 (2) by the deadline specified in such paragraph, the 

2 corresponding proposed regulation shall become final 

3 on such deadline. 

4 (b) DELAYED APPLICABILITY.—The amendments 

5 made by sections 2, 3, 4, 5(a), 6, 7, 9, 10, 11, 13, 14, 

6 16, and 17(b) apply beginning on the date that is 3 years 

7 after the date of enactment of this Act. 

Æ 


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