II 

117TH CONGRESS 

1ST SESSION S. 2594 

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 

AUGUST 3, 2021 

Mr. BLUMENTHAL (for himself, Mr. WHITEHOUSE, and Mr. MARKEY) 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 2021’’. 

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. 

Sec. 3. Claims for conventional foods. 


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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) SUMMARY NUTRITION LABELING INFORMA4 TION.—Section 403 of the Federal Food, Drug, and Cos5 metic Act (21 U.S.C. 343) is amended by adding at the 

6 end the following: 

7 ‘‘(z)(1) SUMMARY NUTRITION INFORMATION.—Ex8 cept as provided in subparagraphs (3), (4), and (5) of 

9 paragraph (q), if it is food (other than a dietary supple10 ment) intended for human consumption and is offered for 

11 sale and otherwise required to bear nutrition labeling, un12 less its principal display panel bears summary nutrition 

13 information that reflects the overall nutritional value of 

14 the food or specified ingredients, as specified in accord15 ance with regulations of the Secretary, and does not con16 tain any summary nutritional information which is in ad17 dition to or inconsistent with the information required 

18 under this subparagraph. 


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1 ‘‘(2) REQUIRED CRITERIA FOR IMPLEMENTING REG2 ULATIONS.—Final regulations regarding the summary nu3 trition information required under subparagraph (1) shall 

4 meet the following criteria: 

5 ‘‘(A) There shall be a standardized symbol sys6 tem that displays calorie information related to the 

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

8 and information related to the content of saturated 

9 and trans fats, sodium, added sugars, and any other 

10 nutrients that the Secretary determines are strongly 

11 associated with public health concerns. 

12 ‘‘(B) The system shall employ an approach that 

13 clearly distinguishes between products of greater or 

14 lesser nutritional value. This system shall include— 

15 ‘‘(i) a warning symbol or symbols for prod16 ucts high in saturated or trans fats, sodium, 

17 added sugars, and any other nutrients the con18 sumption of which should be limited or discour19 aged; and 

20 ‘‘(ii) a stop-light, points, star, or other 

21 commonly recognized signaling system to scale 

22 or rank foods according to their overall health 

23 value. 

24 ‘‘(C) The information shall appear on all prod25 ucts that are required to bear nutrition labeling. 


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1 ‘‘(D) The information shall— 

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

3 principal display panels across products; 

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

5 contrasts with existing packaging design; and 

6 ‘‘(iii) be sufficiently large to be easily leg7 ible. 

8 ‘‘(3) PRINCIPLES FOR IMPLEMENTING REGULA9 TIONS.—In promulgating regulations regarding the sum10 mary nutrition information required under subparagraph 

11 (1), the Secretary shall take into account published re12 ports by the Health and Medicine Division of the National 

13 Academy of Sciences, Engineering, and Medicine regard14 ing such information, and base regulations on the fol15 lowing principles: 

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

17 easily comprehend the meaning of the system as an 

18 indicator of a product’s contribution to a healthy 

19 diet without requiring specific or sophisticated nutri20 tional knowledge. 

21 ‘‘(B) The nutrition information should be con22 sistent with the Nutrition Facts Panel and with the 

23 recommendations of the Dietary Guidelines for 

24 Americans. 


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

2 consumer selection of healthy product options, in3 cluding among nutritionally at-risk subpopulations. 

4 ‘‘(D) The Secretary should periodically evaluate 

5 the front-of-package information to assess its effec6 tiveness in facilitating consumer selection of healthy 

7 product options and the extent to which manufactur8 ers are offering healthier products as a result of the 

9 disclosure. 

10 ‘‘(E) The implementation of the information 

11 disclosure should be accompanied by appropriate 

12 consumer education and promotion campaigns deter13 mined by the Secretary.’’. 

14 (b) PERCENTAGE OF WHEAT AND GRAINS IN GRAIN15 BASED PRODUCTS, AND AMOUNT OF REAL FRUIT, VEGE16 TABLE, AND YOGURT IN PRODUCTS BEARING FRUIT, 

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

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

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

20 the following: 

21 ‘‘(aa) PERCENTAGE OF WHEAT AND GRAINS IN

22 GRAIN-BASED PRODUCTS.—If, in the case of food other 

23 than a dietary supplement, the principal display panel 

24 bears— 


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

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

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

4 weight; 

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

6 or similar product that is typically made from wheat; 

7 or 

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

9 representations suggesting the product contains 

10 whole grains, 

11 unless the amounts of whole grains and refined grains, 

12 expressed as a percentage of total grains, are conspicu13 ously disclosed in immediate proximity to the most promi14 nent descriptive phrase, term, or representation using a 

15 font color and formatting of equivalent prominence to the 

16 descriptive phrase, term, or representation with respect to 

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

18 in the food are whole grains. 

19 ‘‘(bb) AMOUNT OF FRUIT.— 

20 ‘‘(1) IN GENERAL.—If, in the case of food other 

21 than a dietary supplement, the principal display 

22 panel bears— 

23 ‘‘(A) the term ‘fruit’, ‘fruity’, ‘froot’, 

24 ‘frooty’, or ‘fruit-flavored’; 


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1 ‘‘(B) representations, depictions, or images 

2 of such ingredients; or 

3 ‘‘(C) any similar descriptive phrases, 

4 terms, or representations suggesting the prod5 uct contains fruit or any specific type of fruit, 

6 unless the quantity per serving and form of fruit, in7 cluding only the nutrient-dense forms, is declared on 

8 the principal display panel in a common household 

9 measure that is appropriate to the food, conspicu10 ously, and in immediate proximity to the most 

11 prominent term, representation, depiction, or image 

12 of fruit. 

13 ‘‘(2) QUANTITIES.—The Secretary shall by reg14 ulation establish quantities below which such dec15 laration shall state that the food does not contain 

16 any full serving of fruit. 

17 ‘‘(3) NUTRIENT-DENSE.—In this paragraph, 

18 the term ‘nutrient-dense’, with respect to the form 

19 of an ingredient derived from a fruit, means the 

20 whole, cut, dried, pulp, puree, 100-percent juice, or 

21 fully reconstituted concentrate form, and not con22 centrates, powders, and other ingredients that are 

23 not whole, cut, dried, pulp, puree, 100-percent juice, 

24 or fully reconstituted concentrates. 

25 ‘‘(cc) AMOUNT OF VEGETABLES.— 


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1 ‘‘(1) IN GENERAL.—If, in the case of food other 

2 than a dietary supplement, the principal display 

3 panel bears— 

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

5 ‘‘(B) representations, depictions, or images 

6 of such ingredients; or 

7 ‘‘(C) any similar descriptive phrases, 

8 terms, or representations suggesting the prod9 uct contains vegetables or any specific type of 

10 vegetable, 

11 unless the quantity per serving and form of vege12 table, including only the nutrient-dense form, is de13 clared on the principal display panel in a common 

14 household measure that is appropriate to the food, 

15 conspicuously, and in immediate proximity to the 

16 most prominent term, representation, depiction, or 

17 image of vegetable. 

18 ‘‘(2) QUANTITIES.—The Secretary shall by reg19 ulation establish quantities below which such dec20 laration shall state that the food does not contain 

21 any full serving of vegetable. 

22 ‘‘(3) NUTRIENT-DENSE.—In this paragraph, 

23 the term ‘nutrient-dense’, with respect to the form 

24 of an ingredient derived from a vegetable, means the 

25 whole, cut, dried, pulp, puree, 100-percent juice, or 


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1 fully reconstituted concentrate form, and not con2 centrates, powders, and other ingredients that are 

3 not whole, cut, dried, pulp, puree, 100-percent juice, 

4 or fully reconstituted concentrates. 

5 ‘‘(dd) AMOUNT OF YOGURT.— 

6 ‘‘(1) IN GENERAL.—If, in the case of food other 

7 than a dietary supplement, the principal display 

8 panel bears the term ‘yogurt’, unless— 

9 ‘‘(A) the quantity per serving of yogurt is 

10 declared on the principal display panel in a 

11 common household measure that is appropriate 

12 to the food, conspicuously, in immediate prox13 imity to the term; or 

14 ‘‘(B) the first ingredient is cultured milk, 

15 cultured cream, cultured partially skimmed 

16 milk, or cultured skim milk. 

17 ‘‘(2) QUANTITIES.—The Secretary shall by reg18 ulation establish quantities below which such dec19 laration shall state that the food does not contain 

20 any full serving of yogurt.’’. 

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

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

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

24 the following: 


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1 ‘‘(ee) COLORING AND FLAVORING.—If, in the case of 

2 food other than a dietary supplement, it bears or contains 

3 any artificial dye, or any added artificial or natural fla4 voring, unless such fact is prominently stated on the prin5 cipal display panel of the packaging of the food. For the 

6 purposes of this paragraph, the term ‘artificial dye’ refers 

7 to a batch-certified dye certified under part 74 of title 21, 

8 Code of Federal Regulations (or any successor regula9 tions).’’. 

10 (d) SWEETENERS.—Section 403 of the Federal Food, 

11 Drug, and Cosmetic Act, as amended by subsection (c), 

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

13 ‘‘(ff) SWEETENERS.—If, in the case of food other 

14 than a dietary supplement, it bears or contains any added 

15 artificial or natural noncaloric sweetener, unless such fact 

16 is prominently stated on the principal display panel of the 

17 packaging of the food.’’. 

18 (e) CONSTRUCTION.—Nothing in this section, includ19 ing any amendment made by this section, shall be con20 strued as— 

21 (1) affecting any requirement in regulation in 

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

23 with respect to matters that are required to be stat24 ed on the principal display panel of a package or 


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1 container of food that is not required by an amend2 ment made by this section; or 

3 (2) restricting the authority of the Secretary of 

4 Health and Human Services to require additional in5 formation be disclosed on such a principal display 

6 panel. 

7 SEC. 3. CLAIMS FOR CONVENTIONAL FOODS. 

8 (a) HEALTH-RELATED CLAIMS.— 

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

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

11 343(r)(1)(B)) is amended by inserting after ‘‘health12 related condition’’ the following: ‘‘, describes the ef13 fect that a nutrient may have on the structure or 

14 function of the human body, characterizes the docu15 mented mechanism by which that nutrient acts to 

16 maintain such structure or function, or describes 

17 general well-being from consumption of that nutri18 ent,’’. 

19 (2) SUBSTANTIATION OF CLAIM.—Section 

20 403(r) of the Federal Food, Drug, and Cosmetic Act 

21 (21 U.S.C. 343(r)) is amended— 

22 (A) by redesignating subparagraph (7) as 

23 subparagraph (8); and 

24 (B) by inserting after subparagraph (6) 

25 the following: 


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1 ‘‘(7) If the Secretary requests that a claim under sub2 paragraph (1)(B) for food (other than a dietary supple3 ment) be substantiated, then not later than 90 days after 

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

5 manufacturer shall provide to the Secretary all docu6 mentation in the manufacturer’s possession relating to the 

7 claim.’’. 

8 (3) INCOMPATIBLE WITH MAINTAINING

9 HEALTHY DIETARY PRACTICES.—Section 

10 403(r)(3)(A)(ii) of the Federal Food, Drug, and 

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

12 by striking ‘‘increases to persons in the general pop13 ulation the risk of a disease or health-related condi14 tion which is diet related’’ and inserting ‘‘may not 

15 be compatible with maintaining healthy dietary prac16 tices’’. 

17 (b) NUTRIENT CONTENT CLAIMS.— 

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

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

20 343(r)(2)) is amended by striking clause (B) and in21 serting the following: 

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

23 made with respect to a nutrient in a food and the Sec24 retary makes a determination that the food contains a nu25 trient at a level that may not be compatible with maintainVerDate Sep 11 2014 05:42 Aug 06, 2021 Jkt 019200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\S2594.IS S2594

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1 ing healthy dietary practices, the label or labeling of such 

2 food shall contain, prominently and in immediate prox3 imity to such claim, a statement which indicates the food 

4 is high in such nutrient.’’. 

5 (2) REVISIONS TO REGULATIONS.—In promul6 gating the regulations required by section 18, the 

7 Secretary of Health and Human Services shall revise 

8 section 101.13(h) of title 21, Code of Federal Regu9 lations, by— 

10 (A) updating the level of sodium requiring 

11 disclosure to align with the Daily Reference 

12 Value for sodium established in the final rule 

13 entitled ‘‘Food Labeling: Revision of the Nutri14 tion and Supplement Facts Labels’’ published 

15 by the Food and Drug Administration on May 

16 27, 2016 (81 Fed. Reg. 33741); 

17 (B) including a level of added sugars re18 quiring disclosure based on the Daily Reference 

19 Value for added sugars established in the final 

20 rule described in subparagraph (A); 

21 (C) eliminating the requirement that meal 

22 products containing more than 26 grams of fat 

23 and main dish products containing 19.5 grams 

24 of fat per labeled serving must disclose that fat 

25 is present in the food; and 


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1 (D) authorizing the use of express and im2 plied ‘‘low added sugar’’ claims on products 

3 containing 3 grams of added sugars or less per 

4 reference amount customarily consumed (or per 

5 50 grams if the reference amount customarily 

6 consumed is 30 grams or less or 2 tablespoons 

7 or less). 

8 (c) TRANS FATS.—Section 403(r)(2)(A) of the Fed9 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

10 343(r)(2)(A)) is amended— 

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

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

13 (2) by inserting after subclause (iv) the fol14 lowing new subclause: 

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

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

17 Facts Panel, unless the food contains less than one 

18 gram of saturated fat per serving or, if the food con19 tains more than one gram of saturated fat per serv20 ing, unless the label or labeling of the food discloses 

21 the level of saturated fat in the food in immediate 

22 proximity to such claim and with appropriate promi23 nence which shall be no less than one-half the size 

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


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

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

3 and Human Services shall promulgate a final rule revising 

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

5 to include a disqualifying nutrient level for added sugars. 

6 SEC. 4. USE OF SPECIFIC TERMS. 

7 (a) USE OF THE TERM ‘‘NATURAL’’.— 

8 (1) IN GENERAL.—In promulgating the regula9 tions required by section 18, the Secretary of Health 

10 and Human Services shall include regulations— 

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

12 on the labeling of food (other than a dietary 

13 supplement); 

14 (B) specifically addressing the use of such 

15 term on the principal display panel and the in16 formation panel; and 

17 (C) requiring that any such use includes a 

18 prominent disclosure explaining what the term 

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

20 ingredients and manufacturing processes. 

21 (2) DEFINITION.—The regulations promulgated 

22 pursuant to paragraph (1) shall define the term 

23 ‘‘natural’’— 


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

2 any artificial food or ingredient (including any 

3 artificial flavor or added color); and 

4 (B) based on data, including data on con5 sumers’ understanding of the term as used in 

6 connection with food. 

7 (3) PROCESS.—In promulgating the regulations 

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

9 and Human Services shall— 

10 (A) conduct consumer surveys and studies 

11 and issue a timely call for relevant public sub12 missions regarding relevant consumer research, 

13 including with respect to consumer under14 standing of the term ‘‘natural’’ in relation to 

15 the term ‘‘organic’’; and 

16 (B) fully consider the results of such sur17 veys and studies, as well as such public submis18 sions. 

19 (b) USE OF TERM ‘‘HEALTHY’’.— 

20 (1) ADDED SUGARS AND WHOLE GRAINS.— 

21 (A) IN GENERAL.—In promulgating the 

22 regulations required by section 18, the Sec23 retary of Health and Human Services shall in24 clude regulations to revise the regulations under 

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


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

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

3 than a dietary supplement) to take into account 

4 the extent to which such food contains added 

5 sugars or whole grains. 

6 (B) REQUIREMENT.—In making the revi7 sions required by subparagraph (A) in the case 

8 of a food (other than a dietary supplement) 

9 that contains grains, the Secretary of Health 

10 and Human Services shall not consider the food 

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

12 grains are whole grains. 

13 (2) SODIUM.—In promulgating the regulations 

14 required by section 18, the Secretary of Health and 

15 Human Services shall 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 term 

18 ‘‘healthy’’ on the labeling of a food (other than a di19 etary supplement) to align labeling requirements re20 lated to sodium with the daily value for sodium in 

21 the most recent Dietary Guidelines for Americans. 

22 (3) PRINCIPLES FOR IMPLEMENTING REGULA23 TIONS.—In promulgating regulations under para24 graphs (1) and (2) regarding the use of the term 


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

2 Services shall— 

3 (A) consider both food and nutrient cri4 teria; and 

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

6 to contain healthful ingredients— 

7 (i) consider only ingredients that 

8 make up the core of a healthy eating pat9 tern; and 

10 (ii) consider these ingredients only in 

11 their nutrient-dense forms (as such term in 

12 defined in paragraphs (bb) and (cc) of sec13 tion 403 of the Federal Food, Drug, and 

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

15 this Act). 

16 SEC. 5. FORMAT OF INGREDIENT LIST. 

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

18 required by section 18, the Secretary of Health and 

19 Human Services shall include requirements for the format 

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

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

22 343(i))— 

23 (1) for the purpose of improving the readability 

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

25 than a dietary supplement); and 


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

2 necessary to assist consumers in maintaining healthy 

3 dietary practices. 

4 (b) FORMAT REQUIREMENTS.—The format require5 ments described in subsection (a) shall include require6 ments for font size, uppercase and lowercase characters, 

7 serif and noncondensed font types, high-contrast between 

8 text and background, and bullet points between adjacent 

9 ingredients with appropriate exemptions for small pack10 ages or other considerations. 

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

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

13 2 years thereafter, the Secretary of Health and Human 

14 Services shall submit a report to Congress on the Sec15 retary’s enforcement of— 

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

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

18 respect to the regulations described in subsection 

19 (a); and 

20 (2) regulations of the Food and Drug Adminis21 tration on labeling of ingredients in section 101.4 of 

22 title 21, Code of Federal Regulations. 


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1 SEC. 6. DECLARATION OF PHOSPHORUS IN THE INGRE2 DIENT LIST. 

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

4 Act (21 U.S.C. 343), as amended by section 2(d), is fur5 ther amended by adding at the end the following: 

6 ‘‘(gg) PHOSPHORUS CONTENT.—If it is a food in7 tended for human consumption that is offered for sale and 

8 contains phosphorus, unless— 

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

10 with the quantity of phosphorus in the product, re11 ported in milligrams per serving, is printed imme12 diately after or is adjacent to the list of ingredients 

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

14 no smaller than the type size used in the list of in15 gredients; or 

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

17 the product, in milligrams, is reported in the Nutri18 tion Facts Panel.’’. 

19 SEC. 7. CAFFEINE CONTENT ON INFORMATION PANEL. 

20 Section 403(i) of the Federal Food, Drug, and Cos21 metic Act (21 U.S.C. 343(i)) is amended— 

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

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

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

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

26 other than a dietary supplement and contains at 


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1 least 10 milligrams of caffeine from all sources per 

2 serving, a statement (with appropriate prominence 

3 near the statement of ingredients required by this 

4 paragraph) of the number of milligrams of caffeine 

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

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

7 food’’. 

8 SEC. 8. FOOD ALLERGEN LABELING. 

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

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

11 amended by adding at the end the following: 

12 ‘‘(3) Any other food ingredient that the Sec13 retary determines by regulation to be a major food 

14 allergen, based on the prevalence and severity of al15 lergic reactions to the food ingredient.’’. 

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

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

18 the Secretary of Health and Human Services shall update 

19 the Food and Drug Administration’s Compliance Policy 

20 Guide, section 555.250, to conform with applicable laws 

21 related to major food allergens and gluten-containing 

22 grains, including requirements under sections 9 and 10 

23 of this Act. 


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1 SEC. 9. INFORMATION ABOUT MAJOR FOOD ALLERGENS 

2 AND GLUTEN-CONTAINING GRAINS. 

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

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

5 amended— 

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

7 printed immediately after or is adjacent to the list 

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

9 type size used in the list of ingredients) required 

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

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

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

13 list of ingredients required under subsections (g) 

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

15 (3) in subparagraph (3), by striking ‘‘The infor16 mation’’ and inserting ‘‘Subject to subparagraph 

17 (8)(B), the information’’; and 

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

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

20 to be conveyed to the consumer shall be— 

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

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

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

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

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

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1 quirements of paragraphs (g) and (i), placed on a 

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

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

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

5 after each reference to ‘‘food allergen’’ in subpara6 graphs (1), (2), (4), and (7); and 

7 (6) in subparagraph (7)(A)— 

8 (A) by striking ‘‘paragraph (6)’’ and in9 serting ‘‘subparagraph (6)’’; and 

10 (B) by striking ‘‘allergen labeling require11 ments of this subsection’’ and inserting ‘‘aller12 gen and gluten-containing grain labeling re13 quirements of this paragraph’’. 

14 (b) HAZARD ANALYSIS AND PREVENTIVE CON15 TROLS.—Section 418 of the Federal Food, Drug, and Cos16 metic Act (21 U.S.C. 350g) is amended— 

17 (1) in subsection (b)(1)(A), by inserting ‘‘glu18 ten-containing grains,’’ after ‘‘allergens,’’; and 

19 (2) in subsubsection (o)(3)(D), by inserting 

20 ‘‘and gluten-containing grain’’ after ‘‘allergen,’’. 

21 (c) INSPECTIONS RELATING TO FOOD ALLERGENS.— 

22 Section 205 of the Food Allergen Labeling and Consumer 

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

24 inserting ‘‘and gluten-containing grains,’’ after ‘‘aller25 gens’’ each place it appears. 


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1 SEC. 10. SUBMISSION AND AVAILABILITY OF FOOD LABEL 

2 INFORMATION. 

3 The Federal Food, Drug, and Cosmetic Act is amend4 ed by inserting after section 403C of such Act (21 U.S.C. 

5 343–3) the following: 

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

7 LABEL INFORMATION. 

8 ‘‘(a) SUBMISSIONS.— 

9 ‘‘(1) REQUIREMENT.—The Secretary shall re10 quire the manufacturer or importer of any food that 

11 is introduced or delivered for introduction into inter12 state commerce in package form to submit to the 

13 Secretary all information to be included in the label 

14 of the food, including— 

15 ‘‘(A) the nutrition facts panel; 

16 ‘‘(B) the ingredients list; 

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

18 panel; 

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

20 grains; 

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

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

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

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

25 and 


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1 ‘‘(G) other relevant information required 

2 by law to be published in the labeling of the 

3 food. 

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

5 the manufacturer or importer of food to update or 

6 supplement the information submitted under para7 graph (1) with respect to the food in order to keep 

8 the information up-to-date and complete. 

9 ‘‘(3) CIVIL PENALTY.—Whoever knowingly vio10 lates paragraph (1) with respect to any food shall be 

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

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

13 such violation continues with respect to such food. 

14 ‘‘(b) PUBLIC DATABASE.—The Secretary shall estab15 lish and maintain a public database containing the infor16 mation submitted under this section that— 

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

18 website of the Food and Drug Administration; and 

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

20 search and sort information.’’. 

21 SEC. 11. STANDARDS OF IDENTITY. 

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

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

24 Human Services shall— 


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1 (1) review standards of identity prescribed by 

2 regulation which require foods to contain— 

3 (A) minimum levels of nutrients that the 

4 Secretary determines are strongly associated 

5 with public health concerns; or 

6 (B) minimum levels of ingredients con7 taining high levels of such nutrients; and 

8 (2) report to the Committee on Energy and 

9 Commerce of the House of Representatives and the 

10 Committee on Health, Education, Labor, and Pen11 sions of the Senate on the findings of such review. 

12 (b) AMENDMENTS.—In promulgating the regulations 

13 required by section 18, the Secretary of Health and 

14 Human Services shall amend standards of identity regula15 tions to— 

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

17 appropriate; and 

18 (2) require that yogurt, lowfat yogurt, and non19 fat yogurt contain a minimum level of live and active 

20 cultures per gram. 

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

22 Not later than 2 years after the date of enactment 

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

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

25 rule titled ‘‘Food Additives Permitted for Direct Addition 


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

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

3 (81 Fed. Reg. 22176) on folic acid intake in the United 

4 States population by race and ethnicity, comparing actual 

5 exposure with modeled exposure estimates from the final 

6 rule. 

7 SEC. 13. SUGAR ALCOHOLS AND ISOLATED FIBERS. 

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

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

10 amended by adding at the end the following: 

11 ‘‘(hh) ALLULOSE, POLYDEXTROSE, SUGAR ALCO12 HOLS, AND ISOLATED FIBERS.—If it is a food intended 

13 for human consumption that is offered for sale and con14 tains allulose, polydextrose, sugar alcohols, or isolated fi15 bers, unless such fact is prominently stated on the prin16 cipal display panel of the packaging of the food. The Sec17 retary shall by regulation establish quantities above which 

18 such labeling shall include a warning that the food con19 tains a level of allulose, polydextrose, sugar alcohols, or 

20 isolated fibers per serving determined by the Secretary to 

21 cause deleterious health effects.’’. 

22 SEC. 14. INFANT AND TODDLER BEVERAGES. 

23 In promulgating the regulations required by section 

24 18, the Secretary of Health and Human Services shall re25 vise— 


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

2 Regulations, to prohibit any beverage in powder or 

3 liquid form, other than infant formula, represented 

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

5 months old, from being identified as ‘‘infant for6 mula’’ or use the term ‘‘formula’’ in combination 

7 with any other term; and 

8 (2) part 102 of title 21, Code of Federal Regu9 lations, so that— 

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

11 milk-based beverage that claims to be for con12 sumption by children 12 to 36 months of age, 

13 such beverage shall— 

14 (i) use as its common or usual name 

15 a descriptive term such as ‘‘milk-based 

16 drink’’; and 

17 (ii) if the beverage contains added 

18 sugars, nonnutritive sweeteners, or 

19 flavorings, include in such common or 

20 usual name a qualifying term such as 

21 ‘‘sweetened’’ or ‘‘flavored’’; 

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

23 nondairy-milk-based beverage that claims to be 

24 for consumption by children 12 to 36 months of 

25 age, such beverage shall— 


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1 (i) use as its common or usual name 

2 an appropriately descriptive term identi3 fying the source of protein, such as ‘‘soy4 based drink powder for 12–36 month 

5 olds’’; and 

6 (ii) if the beverage contains added 

7 sugars, nonnutritive sweeteners, or 

8 flavorings, include in such common or 

9 usual name qualifying terms such as 

10 ‘‘sweetened’’ and ‘‘flavored’’ when applica11 ble; and 

12 (C) the labeling of a beverage described in 

13 subparagraph (A) or (B) shall— 

14 (i) contain a disclaimer that— 

15 (I) cautions against consumption 

16 of the beverage by infants, such as 

17 ‘‘DO NOT SERVE TO INFANTS 

18 UNDER 12 MONTHS OLD’’; and 

19 (II) such beverages are not rec20 ommended for children 12 to 24 

21 months of age and such consumption 

22 of such beverages is not required for 

23 a healthy diet, such as ‘‘This product 

24 contains added sugars. The Dietary 

25 Guidelines for Americans recommend 


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1 to avoid food and beverages with 

2 added sugars for children younger 

3 than 24 months of age.’’; and 

4 (ii) not contain any statement sug5 gesting a recommended intake of such bev6 erages, such as ‘‘one cup a day’’. 

7 SEC. 15. FORMATTING OF INFORMATION ON PRINCIPAL 

8 DISPLAY PANELS. 

9 The Secretary of Health and Human Services shall— 

10 (1) not later than 2 years after the date of en11 actment of this Act, conduct a study on the legibility 

12 of food labeling to determine updated recommenda13 tions for text size and color contrast that make food 

14 labeling information visually accessible to the major15 ity of consumers; 

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

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

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

19 Code of Federal Regulations, to— 

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

21 consideration the results of the study conducted 

22 under paragraph (1); and 

23 (B) establish new requirements for text 

24 and background color contrast, taking into conVerDate Sep 11 2014 05:42 Aug 06, 2021 Jkt 019200 PO 00000 Frm 00030 Fmt 6652 Sfmt 6201 E:\BILLS\S2594.IS S2594

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1 sideration the results of the study conducted 

2 under paragraph (1); and 

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

4 of the study under paragraph (1), finalize such pro5 posed regulations. 

6 SEC. 16. SALE OF FOOD ONLINE. 

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

8 Act (21 U.S.C. 343), as amended by section 13, is further 

9 amended by adding at the end the following: 

10 ‘‘(ii) SALE OF FOOD ONLINE.— 

11 ‘‘(1) IN GENERAL.—If it is a food offered for 

12 sale online, unless all information required to appear 

13 on the label or labeling under this section is avail14 able to consumers at the online point of selection 

15 prior to purchasing the food. 

16 ‘‘(2) FORM AND MANNER.—The Secretary shall 

17 by regulation specify the format and manner in 

18 which the information required under subparagraph 

19 (1) is to be made available online to consumers. 

20 ‘‘(3) EXEMPTION.—A food shall be exempt 

21 from the requirements of this paragraph if it is a 

22 food that is offered for sale by a retailer with annual 

23 gross sales of not more than $500,000, or with an24 nual gross sales of foods or dietary supplements to 

25 consumers of not more than $50,000, so long as 


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1 such retailers do not provide nutrition information 

2 or make a nutrient content or health claim at the 

3 online point of purchase.’’. 

4 SEC. 17. DEFINITIONS. 

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

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

7 meanings given to such terms in section 201 of the Fed8 eral Food, Drug, and Cosmetic Act (21 U.S.C. 321). 

9 (b) DEFINITIONS APPLICABLE IN THE FEDERAL

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

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

12 is amended by adding at the end the following: 

13 ‘‘(ss) The term ‘artificial’, with respect to food or any 

14 ingredient of food, means— 

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

16 produced whether or not it has the same chemical 

17 structure as a naturally occurring food or ingredient; 

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

19 chemical changes through the introduction of syn20 thetic chemicals or processing aids (such as corn 

21 syrup, high-fructose corn syrup, high-maltose corn 

22 syrup, maltodextrin, chemically modified starch, and 

23 cocoa processed with alkali), excluding— 

24 ‘‘(A) food or an ingredient that has under25 gone traditional processes used to make food 


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

2 for human consumption (such as smoking, 

3 roasting, freezing, drying, and fermenting proc4 esses); or 

5 ‘‘(B) food or an ingredient that has under6 gone traditional physical processes that do not 

7 fundamentally alter the raw product or which 

8 only separate a whole intact food into compo9 nent parts (such as grinding grains, separating 

10 eggs into albumen and yolk, or pressing fruits 

11 to produce juice); or 

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

13 specifies by regulation to be artificial for purposes of 

14 this Act. 

15 ‘‘(tt) The term ‘synthetic’, with respect to a sub16 stance in food or any ingredient of food, means a sub17 stance that is formulated or manufactured by a chemical 

18 process or by a process that chemically changes a sub19 stance extracted from a naturally occurring plant, animal, 

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

21 to a substance created by naturally occurring biological 

22 processes. 

23 ‘‘(uu) The term ‘gluten-containing grains’ means any 

24 one of the following grains (or any crossbred hybrid there25 of): 


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

2 the genus Triticum. 

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

4 genus Secale. 

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

6 the genus Hordeum. 

7 ‘‘(vv) The term ‘gluten’ means the proteins that— 

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

9 grain; and 

10 ‘‘(2) may cause adverse health effects in per11 sons with celiac disease. 

12 ‘‘(ww) The term ‘online’ means on or by any system 

13 of data communication and transmission, such as the 

14 internet. 

15 ‘‘(xx) The term ‘online point of selection’ means any 

16 space in which consumers are allowed to purchase food 

17 online, including websites, e-commerce platforms, web ap18 plications, and mobile applications.’’. 

19 SEC. 18. REGULATIONS; DELAYED APPLICABILITY. 

20 (a) REGULATIONS.— 

21 (1) PROPOSED REGULATIONS.—Not later than 

22 1 year after the date of enactment of this Act, the 

23 Secretary of Health and Human Services, acting 

24 through the Commissioner of Food and Drugs, shall 

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


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1 4, 5(a), 6, 7, 9, 10, 11, 13, 14, 16, and 17(b) and 

2 the amendments made by such sections. 

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

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

5 Secretary of Health and Human Services, acting 

6 through the Commissioner of Food and Drugs, shall 

7 finalize the regulations proposed pursuant to para8 graph (1). 

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

10 the Secretary of Health and Human Services does 

11 not issue a final regulation as required by paragraph 

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

13 corresponding proposed regulation shall become final 

14 on such deadline. 

15 (b) DELAYED APPLICABILITY.—The amendments 

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

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

18 after the date of enactment of this Act. 

Æ 


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