II 

115TH CONGRESS 

2D SESSION S. 2647 

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

purposes. 

IN THE SENATE OF THE UNITED STATES 

APRIL 11, 2018 

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 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. 


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Sec. 3. Claims for conventional foods. 

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. 


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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 single, simple, standard 

6 symbol system that displays calorie information re7 lated to the serving size determined under paragraph 

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

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

10 any other nutrients that the Secretary determines 

11 are strongly 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 may include— 

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

17 added sugars, or other nutrients the consump18 tion of which should be limited or discouraged; 

19 or 

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 regarding such information, and base 

14 regulations on the following principles: 

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

16 easily comprehend the meaning of the symbol system 

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

18 healthy diet without requiring specific or sophisti19 cated nutritional knowledge. 

20 ‘‘(B) The nutrition information should be con21 sistent with the Nutrition Facts Panel and with the 

22 recommendations of the Dietary Guidelines for 

23 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 ability 

6 to help facilitate consumer selection of healthy prod7 uct options and the extent to which manufacturers 

8 are offering healthier products as a result of the dis9 closure. 

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.—Section 403 of the Federal Food, 

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

17 by adding at the end the following: 

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

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

20 than a dietary supplement, the principal display panel 

21 bears— 

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

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

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

25 weight; 


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

2 or similar product that is typically made from wheat; 

3 or 

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

5 representations suggesting the product contains 

6 whole grains, unless the amount of whole grains, ex7 pressed as a percentage of total grains, is conspicu8 ously disclosed in immediate proximity to the de9 scriptive phrase, term, or representation, using a 

10 font, color, and formatting of equivalent prominence 

11 to the descriptive phrase, term, or representation 

12 with respect to whole grain content.’’. 

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

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

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

16 following: 

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

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

19 it bears or contains any added artificial or natural color20 ing, any added artificial or natural non-caloric sweetener, 

21 or any added artificial or natural flavoring, unless such 

22 fact is prominently stated on the principal display panel 

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

24 (d) CONFORMING AMENDMENT.—The second sen25 tence of section 403(k) of the Federal Food, Drug, and 


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

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

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

4 construed as affecting any requirement in regulation in 

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

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

7 principal display panel of a package or container of food 

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

9 or as restricting the authority of the Secretary of Health 

10 and Human Services to require additional information be 

11 disclosed on such a principal display panel. 

12 SEC. 3. CLAIMS FOR CONVENTIONAL FOODS. 

13 (a) HEALTH-RELATED CLAIMS.— 

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

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

16 343(r)(1)(B)) is amended by inserting after ‘‘health17 related condition’’ the following: ‘‘, describes the ef18 fect that a nutrient may have on the structure or 

19 function of the human body, characterizes the docu20 mented mechanism by which that nutrient acts to 

21 maintain such structure or function, or describes 

22 general well-being from consumption of that nutri23 ent,’’. 


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1 (2) SUBSTANTIATION OF CLAIM.—Section 

2 403(r) of the Federal Food, Drug, and Cosmetic Act 

3 (21 U.S.C. 343(r)) is amended— 

4 (A) by redesignating subparagraph (7) as 

5 subparagraph (8); and 

6 (B) by inserting after subparagraph (6) 

7 the following: 

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

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

10 dietary supplement) be substantiated, then not later 

11 than 90 days after the date on which the Secretary 

12 makes such request, the manufacturer shall provide 

13 to the Secretary all documentation in the manufac14 turer’s possession relating to the claim.’’. 

15 (b) TRANS FATS.—Section 403(r)(2)(A) of the Fed16 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

17 343(r)(2)(A)) is amended— 

18 (1) in subclause (iii)— 

19 (A) in the matter before item (I), by strik20 ing ‘‘fat or saturated fat’’ and inserting ‘‘fat, 

21 saturated fat, or trans fats’’; and 

22 (B) in item (II), by striking ‘‘fat or satu23 rated fat’’ and inserting ‘‘fat, saturated fat, or 

24 trans fats’’; 


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

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

3 place it appears; 

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

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

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

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

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

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

11 food contains more than one gram of saturated fat 

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

13 discloses the level of saturated fat in the food in im14 mediate proximity to such claim and with appro15 priate prominence which shall be no less than one16 half the size of the claim with respect to the level 

17 of trans fats,’’. 

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

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

20 and Human Services shall promulgate a final rule revising 

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

22 to include a disqualifying nutrient level for added sugars. 

23 SEC. 4. USE OF SPECIFIC TERMS. 

24 (a) USE OF THE TERM ‘‘NATURAL’’.— 


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

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

3 Health and Human Services shall promulgate a final 

4 rule— 

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

6 on the labeling of food (other than a dietary 

7 supplement); and 

8 (B) including provisions to specifically ad9 dress the use of such term on the principal dis10 play panel and the information panel. 

11 (2) DEFINITION.—The rule promulgated pursu12 ant to paragraph (1) shall define the term ‘‘nat13 ural’’— 

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

15 any artificial food or ingredient (including any 

16 artificial flavor or added color); and 

17 (B) based on data, including data on con18 sumers’ understanding of the term as used in 

19 connection with food. 

20 (3) PROCESS.—In promulgating the rule re21 quired by paragraph (1), the Secretary of Health 

22 and Human Services shall— 

23 (A) conduct consumer surveys and studies 

24 and issue a timely call for relevant public sub25 missions regarding relevant consumer research, 


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1 including with respect to consumer under2 standing of the term ‘‘natural’’ in relation to 

3 the term ‘‘organic’’; and 

4 (B) fully consider the results of such sur5 veys and studies, as well as such public submis6 sions. 

7 (b) USE OF TERM ‘‘HEALTHY’’.— 

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

9 Secretary of Health and Human Services shall revise 

10 the regulations under the Federal Food, Drug, and 

11 Cosmetic Act relating to the use of the term 

12 ‘‘healthy’’ on the labeling of a food (other than a di13 etary supplement) to take into account the extent to 

14 which such food contains added sugars or whole 

15 grains. 

16 (2) REQUIREMENTS.—In making the revisions 

17 to regulations required by paragraph (1)— 

18 (A) in the case of a food (other than a die19 tary supplement) that contains grains, the Sec20 retary shall not consider the food to be 

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

22 by weight, are whole grains; and 

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

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


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1 than 10 percent of the daily value of added 

2 sugar per serving. 

3 SEC. 5. NUTRITION FACTS PANEL COMPLIANCE DATE. 

4 The Secretary of Health and Human Services shall 

5 not extend the compliance dates in the final rule entitled 

6 ‘‘Food Labeling: Revision of the Nutrition and Supple7 ment Facts Labels’’ published by the Food and Drug Ad8 ministration in the Federal Register on May 27, 2016 (or 

9 any successor rule), beyond the compliance dates proposed 

10 in the proposed rule entitled ‘‘Food Labeling: Revision of 

11 the Nutrition and Supplement Facts Labels and Serving 

12 Sizes of Foods That Can Reasonably Be Consumed at One 

13 Eating Occasion; Dual-Column Labeling; Updating, Modi14 fying, and Establishing Certain Reference Amounts Cus15 tomarily Consumed; Serving Size for Breath Mints; and 

16 Technical Amendments; Proposed Extension of Compli17 ance Dates’’ published by the Food and Drug Administra18 tion in the Federal Register on October 2, 2017. 

19 SEC. 6. INGREDIENT LABELS. 

20 (a) FORMAT OF INGREDIENT LABELS.— 

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

22 Human Services shall include requirements for the 

23 format of the information required under section 

24 403(i) of the Federal Food, Drug, and Cosmetic Act 

25 (21 U.S.C. 343(i))— 


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1 (A) for the purpose of improving the read2 ability of such information on the label of the 

3 food (other than a dietary supplement); and 

4 (B) that are, as determined by the Sec5 retary, necessary to assist consumers in main6 taining healthy dietary practices. 

7 (2) FORMAT REQUIREMENTS.—The format re8 quirements referred to in paragraph (1) shall include 

9 requirements for upper- and lower-case characters, 

10 serif and noncondensed font types, high-contrast be11 tween text and background, and bullet points be12 tween adjacent ingredients with appropriate exemp13 tions for small packages or other considerations. 

14 (b) CHARACTERIZING INGREDIENTS IN NAME OR

15 PRIMARY DISPLAY PANEL.— 

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

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

18 amended, is further amended by adding at the end 

19 the following: 

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

21 (other than a dietary supplement) refers to any character22 izing ingredient or component of the food, unless— 

23 ‘‘(1) the characterizing ingredient or component 

24 is a predominant ingredient in the food; or 


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1 ‘‘(2) the primary display panel of the food in2 cludes, in letters not less than one-half the height of 

3 the letters used in the name of the food, the percent4 age of each characterizing ingredient or component 

5 contained in the food.’’. 

6 (2) ENFORCEMENT OF CHARACTERIZING IN7 GREDIENTS.—Not later than 2 years after the date 

8 of enactment of this Act and every 2 years there9 after, the Secretary of Health and Human Services 

10 shall submit a report to the Congress on the Sec11 retary’s enforcement of— 

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

13 Drug, and Cosmetic Act, as added by para14 graph (1); and 

15 (B) regulations of the Food and Drug Ad16 ministration on characterizing ingredients and 

17 components, including section 102.5 of title 21, 

18 Code of Federal Regulations (and any successor 

19 regulations). 

20 (c) DECLARATION OF PHOSPHORUS ON THE INGRE21 DIENT LABEL.—Section 403 of the Federal Food, Drug, 

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

23 amended by adding at the end the following: 

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

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

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

11 printed immediately after or is adjacent to the list 

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

13 type size used in the list of ingredients) required 

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

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

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

17 list of ingredients required under subsections (g) 

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

19 (3) in subparagraph (3), by striking ‘‘The infor20 mation’’ and inserting ‘‘Subject to subparagraph 

21 (8)(B), the information’’; and 

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

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

24 to be conveyed to the consumer shall be— 

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

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


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

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

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

4 offered for sale at retail, and not subject to the re5 quirements of paragraphs (g) and (i), placed on a 

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

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

8 SEC. 10. SUBMISSION AND AVAILABILITY OF FOOD LABEL 

9 INFORMATION. 

10 The Federal Food, Drug, and Cosmetic Act is amend11 ed by inserting after section 403C of such Act (21 U.S.C. 

12 343–3) the following: 

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

14 LABEL INFORMATION. 

15 ‘‘(a) SUBMISSIONS.— 

16 ‘‘(1) REQUIREMENT.—The Secretary shall re17 quire the manufacturer or importer of any food that 

18 is introduced or delivered for introduction into inter19 state commerce in package form to submit to the 

20 Secretary all information to be included in the label 

21 of the food, including— 

22 ‘‘(A) the nutrition facts panel; 

23 ‘‘(B) ingredients; 

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

25 panel; 


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1 ‘‘(D) allergy warnings or information; 

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

3 (popularly referred to as ‘nutrient-content 

4 claims’); 

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

6 (popularly referred to as ‘health-related 

7 claims’); and 

8 ‘‘(G) other relevant information required 

9 by law to be published in the labeling of the 

10 food. 

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

12 the manufacturer or importer of food to update or 

13 supplement the information submitted under para14 graph (1) with respect to the food in order to keep 

15 the information up-to-date and complete. 

16 ‘‘(3) CIVIL PENALTY.—Whoever knowingly vio17 lates paragraph (1) with respect to any food shall be 

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

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

20 such violation continues with respect to such food. 

21 ‘‘(b) PUBLIC DATABASE.—The Secretary shall estab22 lish and maintain a public database containing the infor23 mation submitted under this section that— 

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

25 website of the Food and Drug Administration; and 


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

2 search and sort 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 whether or not it has the same chemical 

16 structure as a 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 an ingredient that has under5 gone traditional physical processes that do not 

6 fundamentally alter the raw product or which 

7 only separate a whole intact food into compo8 nent parts (such as grinding grains, separating 

9 eggs into albumen and yolk, or pressing fruits 

10 to 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. APPLICABILITY; REGULATIONS. 

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

23 (1) subsections (a) and (b) of section 3, sub24 sections (b)(1) and (c) of section 6, and sections 7, 

25 8, 10, and 11(b) shall apply beginning on the date 


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

2 Act; and 

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

4 the date that is 3 years after such date of enact5 ment. 

6 (b) REGULATIONS.— 

7 (1) PROPOSED REGULATIONS.—The Secretary 

8 of Health and Human Services shall propose regula9 tions— 

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

11 enactment of this Act, to implement the amend12 ments made by subsections (a) and (b) of sec13 tion 3, subsections (b)(1) and (c) of section 6, 

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

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

16 of enactment, to implement the amendments 

17 made by section 2. 

18 (2) FINAL REGULATIONS.—The Secretary of 

19 Health and Human Services shall promulgate final 

20 regulations— 

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

22 of enactment of this Act, to implement the 

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

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

25 6, and sections 7, 8, 9, 10, and 11(b); and 


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

2 of enactment to implement the amendments 

3 made by section 2. 

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

5 Human Services does not issue a final regulation by 

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

7 paragraph (2), the corresponding proposed regula8 tion under subparagraph (A) or (B) of paragraph 

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

Æ 


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