I 

114TH CONGRESS 

1ST SESSION H. R. 4061 

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 HOUSE OF REPRESENTATIVES 

NOVEMBER 18, 2015 

Mr. PALLONE (for himself and Ms. DELAURO) introduced the following bill; 

which was referred to the Committee on Energy and Commerce 

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 2015’’. 

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. Food allergen labeling for sesame. 

Sec. 9. Information about major food allergens in nonprepackaged foods. 

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

Sec. 11. Definitions. 

Sec. 12. Effective date; regulations. 

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 the 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.’’. 


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1 (2) PRINCIPLES FOR IMPLEMENTING REGULA2 TIONS.—In promulgating regulations regarding the 

3 summary nutrition information required under the 

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

5 Health and Human Services shall take into account 

6 published reports of the Institute of Medicine of the 

7 National Academy of Sciences regarding such infor8 mation and base regulations on the following prin9 ciples: 

10 (A) There should be a single simple, stand11 ard symbol system that displays calorie infor12 mation related to a common serving size, and 

13 information related to nutrients strongly associ14 ated with public health concerns. 

15 (B) Consumers should be able to quickly 

16 and easily comprehend the meaning of the sym17 bol system as an indicator of a product’s con18 tribution to a healthy diet. 

19 (C) The information should appear on all 

20 products that are required to bear nutrition la21 beling. 

22 (D) The information should— 

23 (i) appear in a consistent location on 

24 the principal display panels across prod25 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 to be easily 

5 legible. 

6 (E) The nutrition information should be 

7 consistent with the Nutrition Facts Panel and 

8 with the recommendations of the Dietary 

9 Guidelines of Americans. 

10 (F) The information should aim to facili11 tate consumer selection of healthy product op12 tions, including among nutritionally at-risk sub13 populations. 

14 (G) The Secretary should periodically 

15 evaluate the front-of-package information to as16 sess its ability to help facilitate consumer selec17 tion of healthy product options and the extent 

18 to which manufacturers are offering healthier 

19 products as a result of the disclosure. 

20 (H) The implementation of the information 

21 disclosure should be accompanied by appro22 priate consumer education and promotion cam23 paigns determined by the Secretary. 

24 (b) PERCENTAGE OF WHEAT AND GRAINS IN GRAIN25 BASED PRODUCTS.—Section 403(z) of the Federal Food, 


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

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

3 the following new subparagraph: 

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

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

7 term ‘multigrain’, or similar descriptive phrases, 

8 terms, or representations with respect to whole grain 

9 content, unless the amount of whole grains, ex10 pressed as a percentage of total grains, is conspicu11 ously disclosed in immediate proximity to such de12 scriptive phrase, term, or representation; or 

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

14 breads, pasta, crackers, or similar wheat-based prod15 ucts, unless the percentage of whole wheat by weight 

16 contained in the food is conspicuously declared in 

17 immediate proximity to that term or there is a con18 spicuous declaration that the food ‘contains no whole 

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

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

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

22 Act (21 U.S.C. 343(z)), as amended, is further amended 

23 by adding at the end the following new subparagraph: 

24 ‘‘(3) If, in the case of food other than a dietary sup25 plement, it bears or contains any added artificial or natVerDate Sep 11 2014 22:09 Nov 21, 2015 Jkt 059200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H4061.IH H4061

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1 ural coloring, any added artificial or natural non-caloric 

2 sweetener, or any added artificial or natural flavoring, un3 less such fact is prominently stated on the principal dis4 play panel of a package or container of the food.’’. 

5 (d) CONFORMING AMENDMENT.—The second sen6 tence of section 403(k) of the Federal Food, Drug, and 

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

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

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

10 construed as affecting any requirement in regulation in 

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

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

13 principal display panel of a package or container of food 

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

15 or as restricting the authority of the Secretary of Health 

16 and Human Services to require additional information be 

17 disclosed on such a principal display panel. 

18 SEC. 3. CLAIMS FOR CONVENTIONAL FOODS. 

19 (a) HEALTH-RELATED CLAIMS.— 

20 (1) REGULATIONS AND GUIDANCE.—Not later 

21 than three years after the date of enactment of this 

22 Act, the Secretary of Health and Human Services 

23 shall— 

24 (A) promulgate a final rule clarifying the 

25 application of section 403(r) of the Federal 


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

2 343(r)) with respect to the mechanisms by 

3 which a nutrient in food (other than a dietary 

4 supplement) is intended to affect the structure 

5 or any function of the human body, or charac6 terize the documented mechanism by which a 

7 nutrient in such food acts to maintain such 

8 structure or function; and 

9 (B) issue guidance clarifying the applica10 tion of such section 403(r) with respect to the 

11 substantiation of claims pursuant to a request 

12 under section 403(r)(7) of such Act, as added 

13 by paragraph (2). 

14 (2) SUBSTANTIATION OF CLAIM.—Section 

15 403(r) of the Federal Food, Drug, and Cosmetic Act 

16 (21 U.S.C. 343(r)) is amended— 

17 (A) by redesignating subparagraph (7) as 

18 subparagraph (8); and 

19 (B) by inserting after subparagraph (6) 

20 the following: 

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

22 under subparagraph (1)(B) for food (other than a 

23 dietary supplement) be substantiated, then not later 

24 than 90 days after the date on which the Secretary 

25 makes such request, the manufacturer shall provide 


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1 to the Secretary all documentation in the manufac2 turer’s possession relating to the claim.’’. 

3 (b) TRANS FATS.—Section 403(r)(2)(A) of the Fed4 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

5 343(r)(2)(A)) is amended— 

6 (1) in subclause (iii)— 

7 (A) in the matter before item (I), by strik8 ing ‘‘fat or saturated fat’’ and inserting ‘‘fat, 

9 saturated fat, or trans fats’’; and 

10 (B) in item (II), by striking ‘‘fat or satu11 rated fat’’ and inserting ‘‘fat, saturated fat, or 

12 trans fats’’; 

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

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

15 place it appears; 

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

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

18 (4) by inserting after subclause (iv) the fol19 lowing new subclause: 

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

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

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

23 food contains more than one gram of saturated fat 

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

25 discloses the level of saturated fat in the food in imVerDate Sep 11 2014 22:09 Nov 21, 2015 Jkt 059200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H4061.IH H4061

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1 mediate proximity to such claim and with appro2 priate prominence which shall be no less than one3 half the size of the claim with respect to the level 

4 of trans fats,’’. 

5 (c) ADDED SUGARS.—Not more than 3 years after 

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

7 and Human Services shall promulgate a final rule revising 

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

9 to include a disqualifying nutrient level for added sugars. 

10 SEC. 4. USE OF SPECIFIC TERMS. 

11 (a) USE OF THE TERM ‘‘NATURAL’’.— 

12 (1) IN GENERAL.—Not later than two years 

13 after the date of enactment of this Act, the Sec14 retary of Health and Human Services shall promul15 gate a final rule— 

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

17 on the labeling of food (other than a dietary 

18 supplement); and 

19 (B) including provisions to specifically ad20 dress the use of such term on the principal dis21 play panel and the information panel. 

22 (2) DEFINITION.—The rule promulgated pursu23 ant to paragraph (1) shall define the term ‘‘nat24 ural’’— 


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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) or any synthetic 

4 substance; and 

5 (B) based on data, including data on con6 sumers’ understanding of the term as used in 

7 connection with food. 

8 (3) PROCESS.—In promulgating the rule re9 quired by paragraph (1), the Secretary of Health 

10 and Human Services shall— 

11 (A) conduct consumer surveys and studies 

12 and issue a timely call for relevant public sub13 missions regarding relevant consumer research, 

14 including with respect to consumer under15 standing of the term ‘‘natural’’ in relation to 

16 the term ‘‘organic’’; and 

17 (B) fully consider the results of such sur18 veys and studies, as well as such public submis19 sions. 

20 (b) USE OF TERM ‘‘HEALTHY’’.— 

21 (1) ADDED SUGARS AND WHOLE GRAINS.—The 

22 Secretary of Health and Human Services shall revise 

23 the regulations under the Federal Food, Drug, and 

24 Cosmetic Act relating to the use of the term 

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1 etary supplement) to take into account the extent to 

2 which such food contains added sugars or whole 

3 grains. 

4 (2) REQUIREMENTS.—In making the revisions 

5 to regulations required by paragraph (1)— 

6 (A) in the case of a food (other than a die7 tary supplement) that contains grains, the Sec8 retary shall not consider the food to be 

9 ‘‘healthy’’ unless at least half of those grains, 

10 by weight, are whole grains; and 

11 (B) the Secretary shall not allow a food to 

12 be labeled ‘‘healthy’’ if the food contains more 

13 than 10 percent of the daily value of added 

14 sugar per serving as determined by the Sec15 retary under section 403(q)(1)(F)(i) of the Fed16 eral Food, Drug, and Cosmetic Act, as added 

17 by section 5(c) of this Act. 

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

19 (a) DISCLOSURE OF CALORIE INFORMATION.—Sec20 tion 403(q)(1) of the Federal Food, Drug, and Cosmetic 

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

22 (1) by striking the period at the end of clause 

23 (E) and inserting a comma; 

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

25 new clause: 


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1 ‘‘(F) in the case of food other than a die2 tary supplement— 

3 ‘‘(i) the percent of recommended daily 

4 calories that are provided by one serving of 

5 the product, based on a recommended daily 

6 consumption of calories determined by the 

7 Secretary to be appropriate for members of 

8 the general population; and 

9 ‘‘(ii) at the discretion of the Sec10 retary, the percent of recommended daily 

11 calories that are provided by one serving of 

12 the product— 

13 ‘‘(I) for members of any sub14 population identified by the Secretary; 

15 and 

16 ‘‘(II) based on a recommended 

17 daily consumption of calories deter18 mined by the Secretary to be appro19 priate for members of such subpopula20 tion.’’; and 

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

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

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

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

25 appear in a typeface and design which is more 


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1 prominent and conspicuous than that used for other 

2 information required under this subparagraph.’’. 

3 (b) SERVING SIZE.—Section 403(q)(1)(A)(i) of the 

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

5 343(q)(1)(A)(i)) is amended by inserting ‘‘, or, in the case 

6 of a food (other than a dietary supplement) that is pack7 aged in an amount that could reasonably be consumed in 

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

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

10 (c) DISCLOSURE OF INFORMATION RELATING TO

11 SUGAR ON NUTRITION FACT PANEL.— 

12 (1) IN GENERAL.—Section 403(q)(1) of the 

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

14 343(q)(1)), as amended by subsection (a), is amend15 ed— 

16 (A) in subparagraph (D), by striking ‘‘sug17 ars’’ and inserting ‘‘sugars (and, in the case of 

18 food other than a dietary supplement, total sug19 ars, and of that, added sugars, disclosed in 

20 teaspoons as well as grams)’’; and 

21 (B) by inserting after clause (F) the fol22 lowing new clause: 

23 ‘‘(G) in the case of food other than a die24 tary supplement— 


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1 ‘‘(i) the percent of added sugars rec2 ommended for daily consumption that are 

3 provided by one serving of the product, 

4 based on a recommended daily consump5 tion of calories determined by the Sec6 retary to be appropriate for members of 

7 the general population; and 

8 ‘‘(ii) at the discretion of the Sec9 retary, the percent of added sugars rec10 ommended for daily consumption that are 

11 provided by one serving of the product— 

12 ‘‘(I) for members of any sub13 population identified by the Secretary; 

14 and 

15 ‘‘(II) based on a recommended 

16 daily consumption of calories deter17 mined by the Secretary to be appro18 priate for members of such subpopula19 tion.’’. 

20 SEC. 6. INGREDIENT LABELS. 

21 (a) FORMAT OF INGREDIENT LABELS.— 

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

23 Human Services shall include requirements for the 

24 format of the information required under section 


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1 403(i) of the Federal Food, Drug, and Cosmetic Act 

2 (21 U.S.C. 343(i))— 

3 (A) for the purpose of improving the read4 ability of such information on the label of the 

5 food (other than a dietary supplement); and 

6 (B) that are, as determined by the Sec7 retary, necessary to assist consumers in main8 taining healthy dietary practices. 

9 (2) FORMAT REQUIREMENTS.—The format re10 quirements referred to in paragraph (1) shall include 

11 requirements for upper- and lower-case characters, 

12 serif and noncondensed font types, high-contrast be13 tween text and background, and bullet points be14 tween adjacent ingredients with appropriate exemp15 tions for small packages or other considerations. 

16 (b) CHARACTERIZING INGREDIENTS IN NAME OR

17 PRIMARY DISPLAY PANEL.— 

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

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

20 amended by adding at the end the following new 

21 paragraph: 

22 ‘‘(aa) If the name or primary display panel of the 

23 food (other than a dietary supplement) refers to any char24 acterizing ingredient or component of the food, unless— 


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1 ‘‘(1) the characterizing ingredient or component 

2 is a predominant ingredient in the food; or 

3 ‘‘(2) the primary display panel of the food in4 cludes, in letters not less than one-half the height of 

5 the letters used in the name of the food, the percent6 age of the characterizing ingredient or component 

7 contained in each serving of the food.’’. 

8 (2) ENFORCEMENT OF CHARACTERIZING IN9 GREDIENTS.—Not later than 2 years after the date 

10 of enactment of this Act and every 2 years there11 after, the Secretary of Health and Human Services 

12 shall submit a report to the Congress on the Sec13 retary’s enforcement of— 

14 (A) section 403(aa) of the Federal Food, 

15 Drug, and Cosmetic, as added by paragraph 

16 (1); and 

17 (B) regulations of the Food and Drug Ad18 ministration on characterizing ingredients and 

19 components including section 102.5 of title 21, 

20 Code of Federal Regulations (and any successor 

21 regulations). 

22 SEC. 7. CAFFEINE CONTENT ON INFORMATION PANEL. 

23 Section 403(i) of the Federal Food, Drug, and Cos24 metic Act (21 U.S.C. 343(i)) is amended— 

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


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

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

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

4 other than a dietary supplement and contains at 

5 least 10 milligrams of caffeine from all sources per 

6 serving, a statement (with appropriate prominence 

7 near the statement of ingredients required by this 

8 paragraph) of the number of milligrams of caffeine 

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

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

11 food’’. 

12 SEC. 8. FOOD ALLERGEN LABELING FOR SESAME. 

13 (a) DEFINITION OF MAJOR FOOD ALLERGEN.—Sec14 tion 201(qq)(1) of the Federal Food, Drug, and Cosmetic 

15 Act (21 U.S.C. 321(qq)(1)) is amended by striking ‘‘and 

16 soybeans’’ and inserting ‘‘soybeans, and sesame’’. 

17 (b) REGULATION.—Not later than 3 years after the 

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

19 Human Services shall promulgate a final regulation under 

20 section 403(w) of the Federal Food, Drug, and Cosmetic 

21 Act (21 U.S.C. 343(x)) determining the manner in which 

22 sesame must be disclosed. 


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1 SEC. 9. INFORMATION ABOUT MAJOR FOOD ALLERGENS IN 

2 NONPREPACKAGED FOODS. 

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 subsections (g) and (i); or 

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

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1 quirements of subsections (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 (b) APPLICABILITY.—The amendments made by sub5 section (a) apply beginning on the date that is 3 years 

6 after the date of enactment of this Act. 

7 SEC. 10. SUBMISSION AND AVAILABILITY OF FOOD LABEL 

8 INFORMATION. 

9 The Federal Food, Drug, and Cosmetic Act is amend10 ed by inserting after section 403C of such Act (21 U.S.C. 

11 343–3) the following: 

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

13 LABEL INFORMATION. 

14 ‘‘(a) SUBMISSIONS.— 

15 ‘‘(1) REQUIREMENT.—The Secretary shall re16 quire the manufacturer or importer of any food that 

17 is introduced or delivered for introduction into inter18 state commerce in package form to submit to the 

19 Secretary all information to be included in the label 

20 of the food, including— 

21 ‘‘(A) the nutrition facts panel; 

22 ‘‘(B) ingredients; 

23 ‘‘(C) any natural or artificial flavoring; 

24 ‘‘(D) an image of the primary display 

25 panel; 


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1 ‘‘(E) allergy warnings or information; 

2 ‘‘(F) claims under section 403(r)(1)(A) 

3 (popularly referred to as ‘nutrient-content 

4 claims’); 

5 ‘‘(G) claims under section 403(r)(1)(B) 

6 (popularly referred to as ‘health-related 

7 claims’); and 

8 ‘‘(H) other relevant information as deter9 mined by the Secretary. 

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

11 the manufacturer or importer of food to update or 

12 supplement the information submitted under para13 graph (1) with respect to the food in order to keep 

14 the information up-to-date and complete. 

15 ‘‘(3) CIVIL PENALTY.—Whoever knowingly vio16 lates paragraph (1) with respect to any food shall be 

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

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

19 such violation continues with respect to such food. 

20 ‘‘(b) PUBLIC DATABASE.—The Secretary shall estab21 lish and maintain a public database containing the infor22 mation submitted under this section that— 

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

24 website of the Food and Drug Administration; and 


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1 ‘‘(2) is for a public database of searchable, sort2 able information.’’. 

3 SEC. 11. DEFINITIONS. 

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

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

6 meanings given to such terms in section 201 of the Fed7 eral Food, Drug, and Cosmetic Act (21 U.S.C. 321). 

8 (b) DEFINITIONS APPLICABLE IN THE FEDERAL

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

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

11 is amended by adding at the end the following: 

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

13 ingredient of food, means— 

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

15 produced but has the same chemical structure as a 

16 naturally occurring food or ingredient; 

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

18 chemical changes through the introduction of syn19 thetic chemicals or processing aids (such as corn 

20 syrup, high-fructose corn syrup, high-maltose corn 

21 syrup, maltodextrin, chemically modified starch, and 

22 cocoa processed with alkali), excluding— 

23 ‘‘(A) food or an ingredient that has under24 gone traditional processes used to make food 

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


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1 for human consumption (such as smoking, 

2 roasting, freezing, drying, and fermenting proc3 esses); or 

4 ‘‘(B) food or ingredient that has undergone 

5 traditional physical processes that do not fun6 damentally alter the raw product or which only 

7 separate a whole intact food into component 

8 parts (such as grinding grains, separating eggs 

9 into albumen and yolk, or pressing fruits to 

10 produce juice); or 

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

12 specifies by regulation to be artificial for purposes of 

13 this Act. 

14 ‘‘(tt) The term ‘synthetic’, with respect to a sub15 stance, means a substance that is formulated or manufac16 tured by a chemical process or by a process that chemi17 cally changes a substance extracted from a naturally oc18 curring plant, animal, or mineral source, except that such 

19 term does not apply to a substance created by naturally 

20 occurring biological processes.’’. 

21 SEC. 12. EFFECTIVE DATE; REGULATIONS. 

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

23 (1) sections 3, 4, 5, 6, 7, 10, and 11(b) shall 

24 take effect on the date that is 2 years after the date 

25 of enactment of this Act; and 


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1 (2) sections 2 and 9 shall take effect on the 

2 date that is 3 years after such date of enactment. 

3 (b) REGULATIONS.— 

4 (1) PROPOSED REGULATIONS.—The Secretary 

5 of Health and Human Services shall propose regula6 tions— 

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

8 enactment of this Act, to implement the amend9 ments made by sections 3, 4, 5, 6, 7, 9, 10, and 

10 11(b); and 

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

12 of enactment, to implement the amendments 

13 made by section 2. 

14 (2) FINAL REGULATIONS.—The Secretary of 

15 Health and Human Services shall promulgate final 

16 regulations— 

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

18 of enactment, to implement the amendments 

19 made by sections 3, 4, 5, 6, 7, 9, 10, and 11(b); 

20 and 

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

22 of enactment to implement the amendments 

23 made by section 2. 

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

25 Human Services does not issue a final regulation by 


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24 

•HR 4061 IH

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

2 paragraph (2), the corresponding proposed regula3 tion under subparagraph (A) or (B) of paragraph 

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

Æ 


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