I 

115TH CONGRESS 

2D SESSION H. R. 5425 

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 

APRIL 2, 2018 

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 2018’’. 

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. Nutrition facts panel compliance date. 

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. Applicability; regulations. 

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

3 FOODS. 

4 (a) SUMMARY NUTRITION LABELING INFORMA5 TION.—Section 403 of the Federal Food, Drug, and Cos6 metic Act (21 U.S.C. 343) is amended by adding at the 

7 end the following: 

8 ‘‘(z)(1) SUMMARY NUTRITION INFORMATION.—Ex9 cept as provided in subparagraphs (3), (4), and (5) of 

10 paragraph (q), if it is food (other than a dietary supple11 ment) intended for human consumption and is offered for 

12 sale and otherwise required to bear nutrition labeling, un13 less its principal display panel bears summary nutrition 

14 information that reflects the overall nutritional value of 

15 the food or specified ingredients, as specified in accord16 ance with regulations of the Secretary, and does not con17 tain any summary nutritional information which is in ad18 dition to or inconsistent with the information required 

19 under this subparagraph. 

20 ‘‘(2) REQUIRED CRITERIA FOR IMPLEMENTING REG21 ULATIONS.—Final regulations regarding the summary nuVerDate Sep 11 2014 22:26 Apr 03, 2018 Jkt 079200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H5425.IH H5425

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1 trition information required under subparagraph (1) shall 

2 meet the following criteria: 

3 ‘‘(A) There shall be a single, simple, standard 

4 symbol system that displays calorie information re5 lated to the serving size determined under paragraph 

6 (q)(1)(A), and information related to the content of 

7 saturated and trans fats, sodium, added sugars, and 

8 any other nutrients that the Secretary determines 

9 are strongly associated with public health concerns. 

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

11 clearly distinguishes between products of greater or 

12 lesser nutritional value. This system may include— 

13 ‘‘(i) a warning symbol or symbols for prod14 ucts high in saturated or trans fats, sodium, 

15 added sugars, or other nutrients the consump16 tion of which should be limited or discouraged; 

17 or 

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

19 commonly recognized signaling system to scale 

20 or rank foods according to their overall health 

21 value. 

22 ‘‘(C) The information shall appear on all prod23 ucts that are required to bear nutrition labeling. 

24 ‘‘(D) The information shall— 


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

2 principal display panels across products; 

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

4 contrasts with existing packaging design; and 

5 ‘‘(iii) be sufficiently large to be easily leg6 ible. 

7 ‘‘(3) PRINCIPLES FOR IMPLEMENTING REGULA8 TIONS.—In promulgating regulations regarding the sum9 mary nutrition information required under subparagraph 

10 (1), the Secretary shall take into account published re11 ports by the Health and Medicine Division of the National 

12 Academy of Sciences regarding such information, and base 

13 regulations on the following principles: 

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

15 easily comprehend the meaning of the symbol system 

16 as an indicator of a product’s contribution to a 

17 healthy diet without requiring specific or sophisti18 cated nutritional knowledge. 

19 ‘‘(B) The nutrition information should be con20 sistent with the Nutrition Facts Panel and with the 

21 recommendations of the Dietary Guidelines of Amer22 icans. 

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

24 consumer selection of healthy product options, in25 cluding among nutritionally at-risk subpopulations. 


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1 ‘‘(D) The Secretary should periodically evaluate 

2 the front-of-package information to assess its ability 

3 to help facilitate consumer selection of healthy prod4 uct options and the extent to which manufacturers 

5 are offering healthier products as a result of the dis6 closure. 

7 ‘‘(E) The implementation of the information 

8 disclosure should be accompanied by appropriate 

9 consumer education and promotion campaigns deter10 mined by the Secretary.’’. 

11 (b) PERCENTAGE OF WHEAT AND GRAINS IN GRAIN12 BASED PRODUCTS.—Section 403 of the Federal Food, 

13 Drug, and Cosmetic Act, as amended, is further amended 

14 by adding at the end the following: 

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

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

17 than a dietary supplement, the principal display panel 

18 bears— 

19 ‘‘(1) the terms ‘whole wheat’, ‘whole grain’, 

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

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

22 weight; 

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

24 or similar product that is typically made from wheat; 

25 or 


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

2 representations suggesting the product contains 

3 whole grains, 

4 unless the amount of whole grains, expressed as a percent5 age of total grains, is conspicuously disclosed in immediate 

6 proximity to the descriptive phrase, term, or representa7 tion, using a font, color, and formatting of equivalent 

8 prominence to the descriptive phrase, term, or representa9 tion with respect to whole grain content.’’. 

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

11 Section 403 of the Federal Food, Drug, and Cosmetic Act, 

12 as amended, is further amended by adding at the end the 

13 following: 

14 ‘‘(bb) SWEETENERS, COLORING, AND FLAVORING.— 

15 If, in the case of food other than a dietary supplement, 

16 it bears or contains any added artificial or natural color17 ing, any added artificial or natural non-caloric sweetener, 

18 or any added artificial or natural flavoring, unless such 

19 fact is prominently stated on the principal display panel 

20 of a package or container of the food.’’. 

21 (d) CONFORMING AMENDMENT.—The second sen22 tence of section 403(k) of the Federal Food, Drug, and 

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

24 ‘‘and (i)’’ and inserting ‘‘, (i), (z), (aa), and (bb)’’. 


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

2 construed as affecting any requirement in regulation in 

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

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

5 principal display panel of a package or container of food 

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

7 or as restricting the authority of the Secretary of Health 

8 and Human Services to require additional information be 

9 disclosed on such a principal display panel. 

10 SEC. 3. CLAIMS FOR CONVENTIONAL FOODS. 

11 (a) HEALTH-RELATED CLAIMS.— 

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

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

14 343(r)(1)(B)) is amended by inserting after ‘‘health15 related condition’’ the following: ‘‘, describes the ef16 fect that a nutrient may have on the structure or 

17 function of the human body, characterizes the docu18 mented mechanism by which that nutrient acts to 

19 maintain such structure or function, or describes 

20 general well-being from consumption of that nutri21 ent,’’. 

22 (2) SUBSTANTIATION OF CLAIM.—Section 

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

24 (21 U.S.C. 343(r)) is amended— 


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1 (A) by redesignating subparagraph (7) as 

2 subparagraph (8); and 

3 (B) by inserting after subparagraph (6) 

4 the following: 

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

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

7 dietary supplement) be substantiated, then not later 

8 than 90 days after the date on which the Secretary 

9 makes such request, the manufacturer shall provide 

10 to the Secretary all documentation in the manufac11 turer’s possession relating to the claim.’’. 

12 (b) TRANS FATS.—Section 403(r)(2)(A) of the Fed13 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

14 343(r)(2)(A)) is amended— 

15 (1) in subclause (iii)— 

16 (A) in the matter before item (I), by strik17 ing ‘‘fat or saturated fat’’ and inserting ‘‘fat, 

18 saturated fat, or trans fats’’; and 

19 (B) in item (II), by striking ‘‘fat or satu20 rated fat’’ and inserting ‘‘fat, saturated fat, or 

21 trans fats’’; 

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

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

24 place it appears; 


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

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

3 (4) by inserting after subclause (iv) the fol4 lowing new subclause: 

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

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

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

8 food contains more than one gram of saturated fat 

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

10 discloses the level of saturated fat in the food in im11 mediate proximity to such claim and with appro12 priate prominence which shall be no less than one13 half the size of the claim with respect to the level 

14 of trans fats,’’. 

15 (c) ADDED SUGARS.—Not more than 2 years after 

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

17 and Human Services shall promulgate a final rule revising 

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

19 to include a disqualifying nutrient level for added sugars. 

20 SEC. 4. USE OF SPECIFIC TERMS. 

21 (a) USE OF THE TERM ‘‘NATURAL’’.— 

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

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

24 Health and Human Services shall promulgate a final 

25 rule— 


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

2 on the labeling of food (other than a dietary 

3 supplement); and 

4 (B) including provisions to specifically ad5 dress the use of such term on the principal dis6 play panel and the information panel. 

7 (2) DEFINITION.—The rule promulgated pursu8 ant to paragraph (1) shall define the term ‘‘nat9 ural’’— 

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

11 any artificial food or ingredient (including any 

12 artificial flavor or added color); and 

13 (B) based on data, including data on con14 sumers’ understanding of the term as used in 

15 connection with food. 

16 (3) PROCESS.—In promulgating the rule re17 quired by paragraph (1), the Secretary of Health 

18 and Human Services shall— 

19 (A) conduct consumer surveys and studies 

20 and issue a timely call for relevant public sub21 missions regarding relevant consumer research, 

22 including with respect to consumer under23 standing of the term ‘‘natural’’ in relation to 

24 the term ‘‘organic’’; and 


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1 (B) fully consider the results of such sur2 veys and studies, as well as such public submis3 sions. 

4 (b) USE OF TERM ‘‘HEALTHY’’.— 

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

6 Secretary of Health and Human Services shall revise 

7 the regulations under the Federal Food, Drug, and 

8 Cosmetic Act relating to the use of the term 

9 ‘‘healthy’’ on the labeling of a food (other than a di10 etary supplement) to take into account the extent to 

11 which such food contains added sugars or whole 

12 grains. 

13 (2) REQUIREMENTS.—In making the revisions 

14 to regulations required by paragraph (1)— 

15 (A) in the case of a food (other than a die16 tary supplement) that contains grains, the Sec17 retary shall not consider the food to be 

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

19 by weight, are whole grains; and 

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

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

22 than 10 percent of the daily value of added 

23 sugar per serving. 


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1 SEC. 5. NUTRITION FACTS PANEL COMPLIANCE DATE. 

2 The Secretary of Health and Human Services shall 

3 not extend the compliance dates in the final rule entitled 

4 ‘‘Food Labeling: Revision of the Nutrition and Supple5 ment Facts Labels’’ published by the Food and Drug Ad6 ministration in the Federal Register on May 27, 2016 (or 

7 any successor rule), beyond the compliance dates proposed 

8 in the proposed rule entitled rule entitled ‘‘Food Labeling: 

9 Revision of the Nutrition and Supplement Facts Labels 

10 and Serving Sizes of Foods That Can Reasonably Be Con11 sumed at One Eating Occasion; Dual-Column Labeling; 

12 Updating, Modifying, and Establishing Certain Reference 

13 Amounts Customarily Consumed; Serving Size for Breath 

14 Mints; and Technical Amendments; Proposed Extension of 

15 Compliance Dates’’ published by the Food and Drug Ad16 ministration in the Federal Register on October 2, 2017. 

17 SEC. 6. INGREDIENT LABELS. 

18 (a) FORMAT OF INGREDIENT LABELS.— 

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

20 Human Services shall include requirements for the 

21 format of the information required under section 

22 403(i) of the Federal Food, Drug, and Cosmetic Act 

23 (21 U.S.C. 343(i))— 

24 (A) for the purpose of improving the read25 ability of such information on the label of the 

26 food (other than a dietary supplement); and 


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1 (B) that are, as determined by the Sec2 retary, necessary to assist consumers in main3 taining healthy dietary practices. 

4 (2) FORMAT REQUIREMENTS.—The format re5 quirements referred to in paragraph (1) shall include 

6 requirements for upper- and lower-case characters, 

7 serif and noncondensed font types, high-contrast be8 tween text and background, and bullet points be9 tween adjacent ingredients with appropriate exemp10 tions for small packages or other considerations. 

11 (b) CHARACTERIZING INGREDIENTS IN NAME OR

12 PRIMARY DISPLAY PANEL.— 

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

14 Food, Drug, and Cosmetic Act (21 U.S.C. 343), as 

15 amended, is further amended by adding at the end 

16 the following: 

17 ‘‘(cc) If the name or primary display panel of the food 

18 (other than a dietary supplement) refers to any character19 izing ingredient or component of the food, unless— 

20 ‘‘(1) the characterizing ingredient or component 

21 is a predominant ingredient in the food; or 

22 ‘‘(2) the primary display panel of the food in23 cludes, in letters not less than one-half the height of 

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1 age of each characterizing ingredient or component 

2 contained in the food.’’. 

3 (2) ENFORCEMENT OF CHARACTERIZING IN4 GREDIENTS.—Not later than 2 years after the date 

5 of enactment of this Act and every 2 years there6 after, the Secretary of Health and Human Services 

7 shall submit a report to the Congress on the Sec8 retary’s enforcement of— 

9 (A) section 403(cc) of the Federal Food, 

10 Drug, and Cosmetic, as added by paragraph 

11 (1); and 

12 (B) regulations of the Food and Drug Ad13 ministration on characterizing ingredients and 

14 components, including section 102.5 of title 21, 

15 Code of Federal Regulations (and any successor 

16 regulations). 

17 (c) DECLARATION OF PHOSPHORUS ON THE INGRE18 DIENT LABEL.— 

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

20 Food, Drug, and Cosmetic Act (21 U.S.C. 343 ), as 

21 amended, is further amended by adding at the end 

22 the following: 

23 ‘‘(dd) If it is a food intended for human consumption 

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


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

2 with the quantity of phosphorus in the product, re3 ported in milligrams per serving, is printed imme4 diately after or is adjacent to the list of ingredients 

5 required under subsections (g) and (i), in a type size 

6 no smaller than the type size used in the list of in7 gredients; or 

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

9 the product, in milligrams, is reported in the Nutri10 tion Facts Panel.’’. 

11 SEC. 7. CAFFEINE CONTENT ON INFORMATION PANEL. 

12 Section 403(i) of the Federal Food, Drug, and Cos13 metic Act (21 U.S.C. 343(i)) is amended— 

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

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

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

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

18 other than a dietary supplement and contains at 

19 least 10 milligrams of caffeine from all sources per 

20 serving, a statement (with appropriate prominence 

21 near the statement of ingredients required by this 

22 paragraph) of the number of milligrams of caffeine 

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

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

25 food’’. 


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1 SEC. 8. FOOD ALLERGEN LABELING FOR SESAME. 

2 Section 201(qq)(1) of the Federal Food, Drug, and 

3 Cosmetic Act (21 U.S.C. 321(qq)(1)) is amended by strik4 ing ‘‘and soybeans’’ and inserting ‘‘soybeans, and ses5 ame’’. 

6 SEC. 9. INFORMATION ABOUT MAJOR FOOD ALLERGENS IN 

7 NONPREPACKAGED FOODS. 

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

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

10 amended— 

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

12 printed immediately after or is adjacent to the list 

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

14 type size used in the list of ingredients) required 

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

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

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

18 list of ingredients required under subsections (g) 

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

20 (3) in subparagraph (3), by striking ‘‘The infor21 mation’’ and inserting ‘‘Subject to subparagraph 

22 (8)(B), the information’’; and 

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

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

25 to be conveyed to the consumer shall be— 


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

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

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

4 under subsections (g) and (i); or 

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

6 offered for sale at retail, and not subject to the re7 quirements of subsections (g) and (i), placed on a 

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

9 than the name of the food item).’’. 

10 (b) APPLICABILITY.—The amendments made by sub11 section (a) apply beginning on the date that is 3 years 

12 after the date of enactment of this Act. 

13 SEC. 10. SUBMISSION AND AVAILABILITY OF FOOD LABEL 

14 INFORMATION. 

15 The Federal Food, Drug, and Cosmetic Act is amend16 ed by inserting after section 403C of such Act (21 U.S.C. 

17 343–3) the following: 

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

19 LABEL INFORMATION. 

20 ‘‘(a) SUBMISSIONS.— 

21 ‘‘(1) REQUIREMENT.—The Secretary shall re22 quire the manufacturer or importer of any food that 

23 is introduced or delivered for introduction into inter24 state commerce in package form to submit to the 


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1 Secretary all information to be included in the label 

2 of the food, including— 

3 ‘‘(A) the nutrition facts panel; 

4 ‘‘(B) ingredients; 

5 ‘‘(C) an image of the primary display 

6 panel; 

7 ‘‘(D) allergy warnings or information; 

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

9 (popularly referred to as ‘nutrient-content 

10 claims’); 

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

12 (popularly referred to as ‘health-related 

13 claims’); and 

14 ‘‘(G) other relevant information required 

15 by law to be published in the labeling of the 

16 food. 

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

18 the manufacturer or importer of food to update or 

19 supplement the information submitted under para20 graph (1) with respect to the food in order to keep 

21 the information up-to-date and complete. 

22 ‘‘(3) CIVIL PENALTY.—Whoever knowingly vio23 lates paragraph (1) with respect to any food shall be 

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


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

2 such violation continues with respect to such food. 

3 ‘‘(b) PUBLIC DATABASE.—The Secretary shall estab4 lish and maintain a public database containing the infor5 mation submitted under this section that— 

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

7 website of the Food and Drug Administration; and 

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

9 search and sort information.’’. 

10 SEC. 11. DEFINITIONS. 

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

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

13 meanings given to such terms in section 201 of the Fed14 eral Food, Drug, and Cosmetic Act (21 U.S.C. 321). 

15 (b) DEFINITIONS APPLICABLE IN THE FEDERAL

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

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

18 is amended by adding at the end the following: 

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

20 ingredient of food, means— 

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

22 produced whether or not it has the same chemical 

23 structure as a naturally occurring food or ingredient; 

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

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1 thetic chemicals or processing aids (such as corn 

2 syrup, high-fructose corn syrup, high-maltose corn 

3 syrup, maltodextrin, chemically modified starch, and 

4 cocoa processed with alkali), excluding— 

5 ‘‘(A) food or an ingredient that has under6 gone traditional processes used to make food 

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

8 for human consumption (such as smoking, 

9 roasting, freezing, drying, and fermenting proc10 esses); or 

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

12 traditional physical processes that do not fun13 damentally alter the raw product or which only 

14 separate a whole intact food into component 

15 parts (such as grinding grains, separating eggs 

16 into albumen and yolk, or pressing fruits to 

17 produce juice); or 

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

19 specifies by regulation to be artificial for purposes of 

20 this Act. 

21 ‘‘(tt) The term ‘synthetic’, with respect to a sub22 stance, means a substance that is formulated or manufac23 tured by a chemical process or by a process that chemi24 cally changes a substance extracted from a naturally oc25 curring plant, animal, or mineral source, except that such 


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1 term does not apply to a substance created by naturally 

2 occurring biological processes.’’. 

3 SEC. 12. APPLICABILITY; REGULATIONS. 

4 (a) APPLICABILITY.—The amendments made by— 

5 (1) subsections (a) and (b) of section 3, sub6 sections (b)(1) and (c) of section 6, and sections 7, 

7 8, 10, and 11(b) shall apply beginning on the date 

8 that is 2 years after the date of enactment of this 

9 Act; and 

10 (2) sections 2 and 9 shall apply beginning on 

11 the date that is 3 years after such date of enact12 ment. 

13 (b) REGULATIONS.— 

14 (1) PROPOSED REGULATIONS.—The Secretary 

15 of Health and Human Services shall propose regula16 tions— 

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

18 enactment of this Act, to implement the amend19 ments made by subsections (a) and (b) of sec20 tion 3, subsections (b)(1) and (c) of section 6, 

21 and sections 7, 8, 9, 10, and 11(b); and 

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

23 of enactment, to implement the amendments 

24 made by section 2. 


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1 (2) FINAL REGULATIONS.—The Secretary of 

2 Health and Human Services shall promulgate final 

3 regulations— 

4 (A) not later than 2 years after the date 

5 of enactment of this Act, to implement the 

6 amendments made by subsections (a) and (b) of 

7 section 3, subsections (b)(1) and (c) of section 

8 6, and sections 7, 8, 9, 10, and 11(b); and 

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

10 of enactment to implement the amendments 

11 made by section 2. 

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

13 Human Services does not issue a final regulation by 

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

15 paragraph (2), the corresponding proposed regula16 tion under subparagraph (A) or (B) of paragraph 

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

Æ 


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