I 

116TH CONGRESS 

1ST SESSION H. R. 2339 

To amend the Federal Food, Drug, and Cosmetic Act with respect to the 

sale and marketing of tobacco products, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

APRIL 18, 2019 

Mr. PALLONE (for himself and Ms. SHALALA) 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 with 

respect to the sale and marketing of tobacco products, 

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. 

4 This Act may be cited as the ‘‘Reversing the Youth 

5 Tobacco Epidemic Act of 2019’’. 

6 SEC. 2. TABLE OF CONTENTS. 

7 The table of contents of this Act is as follows: 

Sec. 1. Short title. 

Sec. 2. Table of contents. 

TITLE I—FOOD AND DRUG ADMINISTRATION 

Sec. 101. Cigarette graphic health warnings. 


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Sec. 102. Advertising and sales parity for all deemed tobacco products. 

Sec. 103. Reducing child and adolescent nicotine addiction. 

Sec. 104. Fees applicable to all tobacco products. 

Sec. 105. Regulation of products containing synthetic nicotine. 

TITLE II—FEDERAL TRADE COMMISSION 

Sec. 201. Advertising of tobacco products. 

1 TITLE I—FOOD AND DRUG 

2 ADMINISTRATION 

3 SEC. 101. CIGARETTE GRAPHIC HEALTH WARNINGS. 

4 (a) ISSUANCE DEADLINES.—Not later than 12 

5 months after the date of enactment of this Act, the Sec6 retary of Health and Human Services, acting through the 

7 Commissioner of Food and Drugs, shall publish a final 

8 rule pursuant to section 4(d) of the Federal Cigarette La9 beling and Advertising Act (15 U.S.C. 1333(d)). 

10 (b) CONFORMING CHANGE.—Section 4(d) of the Fed11 eral Cigarette Labeling and Advertising Act (15 U.S.C. 

12 1333(d)) is amended by striking ‘‘Not later than 24 

13 months after the date of enactment of the Family Smok14 ing Prevention and Tobacco Control Act, the Secretary’’ 

15 and inserting ‘‘The Secretary’’. 

16 SEC. 102. ADVERTISING AND SALES PARITY FOR ALL 

17 DEEMED TOBACCO PRODUCTS. 

18 (a) IN GENERAL.—Not later than 1 year after the 

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

20 Human Services, acting through the Commissioner of 

21 Food and Drugs, shall promulgate a final rule amending 


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1 part 1140 of subchapter K of title 21, Code of Federal 

2 Regulations— 

3 (1) to apply the provisions of such part 1140 to 

4 all tobacco products to which chapter IX of the Fed5 eral Food, Drug, and Cosmetic Act (21 U.S.C. 387a 

6 et seq.) applies pursuant to section 901(b) of such 

7 Act (21 U.S.C. 387a(b)), as amended by section 

8 103(a) of this Act; and 

9 (2) to make such changes as may be necessary 

10 for consistency with the amendments made by sec11 tion 103 of this Act. 

12 (b) EFFECTIVE DATE.—The final rule required by 

13 subsection (a) shall take effect on the date that is 2 years 

14 after the date of enactment of this Act. 

15 SEC. 103. REDUCING CHILD AND ADOLESCENT NICOTINE 

16 ADDICTION. 

17 (a) APPLICABILITY TO ALL TOBACCO PRODUCTS.— 

18 (1) IN GENERAL.—Subsection (b) of section 

19 901 of the Federal Food, Drug, and Cosmetic Act 

20 (21 U.S.C. 387a) is amended to read as follows: 

21 ‘‘(b) APPLICABILITY.—This chapter shall apply to all 

22 tobacco products.’’. 

23 (2) RULE OF CONSTRUCTION.—Paragraph (1) 

24 and the amendment made thereby shall not be con25 strued to limit the applicability of chapter IX of the 


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

2 387a et seq.) to— 

3 (A) products that were listed in section 

4 901(b) of such Act as in effect on the day be5 fore the date of enactment of this Act; and 

6 (B) products that were deemed by regula7 tion to be subject to such chapter pursuant to 

8 section 901(b) of such Act as in effect on the 

9 day before the date of enactment of this Act. 

10 (b) MINIMUM AGE RESTRICTIONS.—Section 906(d) 

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

12 387f(d)) is amended by striking paragraph (3) and insert13 ing the following: 

14 ‘‘(3) MINIMUM AGE RESTRICTIONS.— 

15 ‘‘(A) RESTRICTION.—It shall be unlawful 

16 for any retailer, manufacturer, distributor, 

17 third-party marketplace, or any other commer18 cial entity to sell a tobacco product to any per19 son younger than 21 years of age. 

20 ‘‘(B) AGE VERIFICATION.—To ensure com21 pliance with subparagraph (A), a retailer shall, 

22 at a minimum, verify by means of a govern23 ment-issued photographic identification the age 

24 of the individual purchasing the product as pre25 scribed in— 


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1 ‘‘(i) subpart B of part 1140 of sub2 chapter K of title 21, Code of Federal Reg3 ulations; and 

4 ‘‘(ii) successor regulations, including 

5 the regulation required by section 102 of 

6 the Reversing the Youth Tobacco Epidemic 

7 Act of 2019 and any applicable regulation 

8 imposing restrictions pursuant to para9 graph (1). 

10 ‘‘(C) NON-PREEMPTION.—Subparagraphs 

11 (A) and (B) shall not be construed to limit the 

12 authority of a State or political subdivision of 

13 a State, or the government of an Indian tribe, 

14 as such authority is described in section 916. 

15 ‘‘(D) REGULATIONS.—Not later than 180 

16 days after the date of enactment of the Revers17 ing the Youth Tobacco Epidemic Act of 2019, 

18 the Secretary shall promulgate a final regula19 tion to implement and enforce subparagraphs 

20 (A) and (B). 

21 ‘‘(E) TIMING.—Subparagraphs (A) and 

22 (B) shall take effect on the date that is 180 

23 days after the date of enactment of the Revers24 ing the Youth Tobacco Epidemic Act of 2019, 

25 regardless of whether the Secretary has promulVerDate Sep 11 2014 22:33 Apr 23, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H2339.IH H2339

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1 gated the final regulations required by subpara2 graph (D).’’. 

3 (c) PROHIBITION AGAINST REMOTE RETAIL

4 SALES.—Paragraph (4) of section 906(d) of the Federal 

5 Food, Drug, and Cosmetic Act (21 U.S.C. 387f(d)) is 

6 amended to read as follows: 

7 ‘‘(4) PROHIBITION AGAINST REMOTE RETAIL

8 SALES.—Not later than 2 years after the date of en9 actment of the Reversing the Youth Tobacco Epi10 demic Act of 2019, the Secretary shall promulgate 

11 a final regulation under paragraph (1) prohibiting 

12 the retail sale of all tobacco products, including elec13 tronic nicotine delivery systems and electronic nico14 tine delivery system accessories, other than retail 

15 sales through a direct, face-to-face exchange between 

16 a retailer and a consumer.’’. 

17 (d) PROHIBITING FLAVORING OF TOBACCO PROD18 UCTS.— 

19 (1) PROHIBITION.—Subparagraph (A) of sec20 tion 907(a)(1) of the Federal Food, Drug, and Cos21 metic Act (21 U.S.C. 387g(a)(1)) is amended to 

22 read as follows: 

23 ‘‘(A) SPECIAL RULE.—Beginning on the 

24 date that is 1 year after the date of enactment 

25 of the Reversing the Youth Tobacco Epidemic 


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1 Act of 2019, except as provided in subpara2 graph (C), a tobacco product or any of its com3 ponent parts or accessories (including the to4 bacco, filter, or paper) shall not contain, as a 

5 constituent (including a smoke constituent) or 

6 additive, an artificial or natural flavor (other 

7 than tobacco) that is a characterizing flavor of 

8 the tobacco product or tobacco smoke or an 

9 herb or spice, including menthol, mint, straw10 berry, grape, orange, clove, cinnamon, pine11 apple, vanilla, coconut, licorice, cocoa, chocolate, 

12 cherry, or coffee. Nothing in this subparagraph 

13 shall be construed to limit the Secretary’s au14 thority to take action under this section or 

15 other sections of this Act applicable to any arti16 ficial or natural flavor, herb, or spice.’’. 

17 (2) EXCEPTION.—Paragraph (1) of section 

18 907(a) of the Federal Food, Drug, and Cosmetic Act 

19 (21 U.S.C. 387g(a)) is amended by adding at the 

20 end the following new subparagraph: 

21 ‘‘(C) EXCEPTION FOR CHARACTERIZING

22 FLAVORS TO DECREASE SMOKING.—Notwith23 standing subparagraph (A), an electronic nico24 tine delivery system product or any component 

25 or part of such a product may contain, as a 


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1 constituent (including a smoke constituent) or 

2 additive, an artificial or natural flavor or an 

3 herb or spice, that is a characterizing flavor of 

4 the tobacco product or tobacco smoke so long as 

5 the Secretary, in coordination with the Commis6 sioner of Food and Drugs, determines that such 

7 characterizing flavor will be appropriate for the 

8 protection of public health because it— 

9 ‘‘(i) will significantly increase the like10 lihood of smoking cessation among current 

11 users of tobacco products; 

12 ‘‘(ii) will not increase the likelihood 

13 that individuals who do not use tobacco 

14 products, including youth, will start using 

15 such products; and 

16 ‘‘(iii) will not increase the likelihood of 

17 harm to the person using the product.’’. 

18 (3) SAVINGS PROVISION.—Section 907(a)(1) of 

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

20 U.S.C. 387g(a)(1)), as in effect on the date of enact21 ment of this Act, shall remain in effect until the 

22 amendments made to such section 907(a)(1) by this 

23 subsection take effect. 


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1 SEC. 104. FEES APPLICABLE TO ALL TOBACCO PRODUCTS. 

2 (a) INCREASE IN TOTAL AMOUNT.—Section 

3 919(b)(1)(K) of the Federal Food, Drug, and Cosmetic 

4 Act (21 U.S.C. 387s(b)(1)(K)) is amended by striking 

5 ‘‘$712,000,000’’ and inserting ‘‘$812,000,000’’. 

6 (b) APPLICATION OF USER FEES TO ALL CLASSES

7 OF TOBACCO PRODUCTS.—Paragraph (2) of section 

8 919(b) of the Federal Food, Drug, and Cosmetic Act (21 

9 U.S.C. 387s(b)(2)) is amended to read as follows: 

10 ‘‘(2) ALLOCATIONS OF ASSESSMENT BY CLASS

11 OF TOBACCO PRODUCTS.—The total user fees as12 sessed and collected under subsection (a) each fiscal 

13 year with respect to each class of tobacco products 

14 shall be an amount that is determined pursuant to 

15 a formula developed by the Secretary. Such formula 

16 shall ensure that the amount of fees collected is in17 creased by the total percentage change that occurred 

18 in the Consumer Price Index for all urban con19 sumers (all items; United States city average) for 

20 the 12-month period ending June 30 preceding the 

21 fiscal year.’’. 

22 (c) ALLOCATION OF ASSESSMENT WITHIN EACH

23 CLASS OF TOBACCO PRODUCT.—Section 919(b)(4) of the 

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

25 387s(b)(4)) is amended by striking ‘‘shall be the percent26 age determined for purposes of allocations under subVerDate Sep 11 2014 22:33 Apr 23, 2019 Jkt 089200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H2339.IH H2339

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1 sections (e) through (h) of section 625 of Public Law 108– 

2 357’’ and inserting ‘‘shall be the percentage determined 

3 by the Secretary’’. 

4 (d) CONFORMING AMENDMENTS.—Section 919(b) of 

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

6 387s(b)) is amended— 

7 (1) by striking paragraphs (5) and (7); and 

8 (2) by redesignating paragraph (6) as para9 graph (5). 

10 (e) APPLICABILITY.—The amendments made by this 

11 section apply beginning with fiscal year 2022. Section 919 

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

13 387s), as in effect on the day before the date of enactment 

14 of this Act, shall apply with respect to fiscal years pre15 ceding fiscal year 2022. 

16 SEC. 105. REGULATION OF PRODUCTS CONTAINING SYN17 THETIC NICOTINE. 

18 (a) IN GENERAL.—The Secretary of Health and 

19 Human Services, acting through the Commissioner of 

20 Food and Drugs, shall— 

21 (1) not later than 1 year after the date of en22 actment of this Act, issue an interim final rule pro23 viding for the regulation of products containing syn24 thetic nicotine under the Federal Food, Drug, and 

25 Cosmetic Act (21 U.S.C. 301 et seq.); and 


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1 (2) not later than 2 years after such date of en2 actment, issue a final rule providing for such regula3 tion. 

4 (b) SYNTHETIC NICOTINE DEFINED.—In this sec5 tion, the term ‘‘synthetic nicotine’’ means nicotine that is 

6 not made or derived from tobacco. 

7 TITLE II—FEDERAL TRADE 

8 COMMISSION 

9 SEC. 201. ADVERTISING OF TOBACCO PRODUCTS. 

10 (a) ADVERTISING OF ELECTRONIC NICOTINE DELIV11 ERY SYSTEMS.— 

12 (1) IN GENERAL.—It shall be unlawful— 

13 (A) to market, advertise, or promote any 

14 electronic nicotine delivery system in a manner 

15 that appeals to an individual under 21 years of 

16 age; or 

17 (B) to market, advertise, promote, or en18 dorse, or to compensate any person for the 

19 marketing, advertising, promotion, or endorse20 ment of, any electronic nicotine delivery system 

21 without clearly disclosing that the communica22 tion is an advertisement, unless the communica23 tion is unambiguously identifiable as an adver24 tisement. 

25 (2) ENFORCEMENT BY COMMISSION.— 


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1 (A) UNFAIR OR DECEPTIVE ACTS OR PRAC2 TICES.—A violation of paragraph (1) shall be 

3 treated as a violation of a regulation under sec4 tion 18(a)(1)(B) of the Federal Trade Commis5 sion Act (15 U.S.C. 57a(a)(1)(B)) regarding 

6 unfair or deceptive acts or practices. 

7 (B) POWERS OF COMMISSION.—The Com8 mission shall enforce paragraph (1) in the same 

9 manner, by the same means, and with the same 

10 jurisdiction, powers, and duties as though all 

11 applicable terms and provisions of the Federal 

12 Trade Commission Act (15 U.S.C. 41 et seq.) 

13 were incorporated into and made a part of this 

14 Act. Any person who violates such paragraph 

15 shall be subject to the penalties and entitled to 

16 the privileges and immunities provided in the 

17 Federal Trade Commission Act. 

18 (3) ENFORCEMENT BY STATE ATTORNEYS GEN19 ERAL.— 

20 (A) IN GENERAL.—If the attorney general 

21 of a State has reason to believe a violation of 

22 paragraph (1) has occurred or is occurring, the 

23 attorney general, in addition to any authority 

24 the attorney general may have to bring an ac25 tion in State court under the law of the State, 


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1 may bring a civil action in any court of com2 petent jurisdiction to— 

3 (i) enjoin further such violation by the 

4 defendant; 

5 (ii) enforce compliance with such 

6 paragraph; 

7 (iii) obtain civil penalties in the same 

8 amount as may be obtained by the Com9 mission in a civil action under section 5(m) 

10 of the Federal Trade Commission Act (15 

11 U.S.C. 45(m)); or 

12 (iv) obtain damages, restitution, or 

13 other compensation on behalf of residents 

14 of the State. 

15 (B) NOTICE.—Before filing an action 

16 under subparagraph (A), the attorney general 

17 of a State shall provide to the Commission a 

18 written notice of such action and a copy of the 

19 complaint for such action. If the attorney gen20 eral determines that it is not feasible to provide 

21 the notice described in this subparagraph before 

22 the filing of the action, the attorney general 

23 shall provide written notice of the action and a 

24 copy of the complaint to the Commission imme25 diately upon the filing of the action. 


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1 (C) AUTHORITY OF FEDERAL TRADE COM2 MISSION.— 

3 (i) IN GENERAL.—On receiving notice 

4 under subparagraph (B) of an action 

5 under subparagraph (A), the Commission 

6 shall have the right— 

7 (I) to intervene in the action; 

8 (II) upon so intervening, to be 

9 heard on all matters arising therein; 

10 and 

11 (III) to file petitions for appeal. 

12 (ii) LIMITATION ON STATE ACTION

13 WHILE FEDERAL ACTION IS PENDING.—If 

14 the Commission has instituted a civil ac15 tion for violation of paragraph (1) (re16 ferred to in this clause as the ‘‘Federal ac17 tion’’), no attorney general of a State may 

18 bring an action under subparagraph (A) 

19 during the pendency of the Federal action 

20 against any defendant named in the com21 plaint in the Federal action for any viola22 tion of such paragraph alleged in such 

23 complaint. 

24 (D) RELATIONSHIP WITH STATE-LAW

25 CLAIMS.— 


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1 (i) PRESERVATION OF STATE-LAW

2 CLAIMS.—Nothing in this section shall pre3 vent the attorney general of a State from 

4 bringing an action under State law for acts 

5 or practices that also violate paragraph 

6 (1). 

7 (ii) ASSERTION IN SAME CIVIL AC8 TION.—If the attorney general of a State 

9 has authority to bring an action under 

10 State law for acts or practices that also 

11 violate paragraph (1), the attorney general 

12 may assert the State-law claim and the 

13 claim for violation of such paragraph in 

14 the same civil action. 

15 (E) ACTIONS BY OTHER STATE OFFI16 CIALS.—In addition to civil actions brought by 

17 attorneys general under subparagraph (A), any 

18 other consumer protection officer of a State 

19 who is authorized by the State to do so may 

20 bring a civil action under such subparagraph, 

21 subject to the same requirements and limita22 tions that apply under this paragraph to civil 

23 actions brought by attorneys general. 

24 (4) RULEMAKING AUTHORITY.—The Commis25 sion may promulgate regulations under section 553 


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1 of title 5, United States Code, to implement para2 graph (1). 

3 (b) REPORT TO CONGRESS ON TOBACCO PRODUCT

4 ADVERTISING.— 

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

6 the date of the enactment of this Act, and annually 

7 thereafter, the Commission shall submit to Congress 

8 a report relating to each category of products de9 scribed in paragraph (2) (or a single report a por10 tion of which relates to each such category) that 

11 contains the following: 

12 (A) Information on domestic sales and ad13 vertising and promotional activity by the manu14 facturers that have the largest market shares of 

15 the product category. 

16 (B) Such recommendations for legislation 

17 as the Commission may consider appropriate. 

18 (2) PRODUCT CATEGORIES DESCRIBED.—The 

19 categories of products described in this paragraph 

20 are the following: 

21 (A) Cigarettes. 

22 (B) Cigars. 

23 (C) Smokeless tobacco. 

24 (D) Electronic nicotine delivery systems. 


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1 (c) PRESERVATION OF AUTHORITY.—Nothing in this 

2 section may be construed in any way to limit the Commis3 sion’s authority under any other provision of law. 

4 (d) DEFINITIONS.—In this section: 

5 (1) CIGAR.—The term ‘‘cigar’’ means any roll 

6 of tobacco wrapped in leaf tobacco or in any sub7 stance containing tobacco (other than any roll of to8 bacco which is a cigarette within the meaning of 

9 paragraph (2)). 

10 (2) CIGARETTE.—The term ‘‘cigarette’’ has the 

11 meaning given such term in section 900 of the Fed12 eral Food, Drug, and Cosmetic Act (21 U.S.C. 387). 

13 (3) COMMISSION.—The term ‘‘Commission’’ 

14 means the Federal Trade Commission. 

15 (4) ELECTRONIC NICOTINE DELIVERY SYS16 TEM.— 

17 (A) IN GENERAL.—The term ‘‘electronic 

18 nicotine delivery system’’ means— 

19 (i) an electronic device that— 

20 (I) converts a mixture containing 

21 nicotine or other substances into an 

22 aerosol to be inhaled by the user; and 

23 (II) is a tobacco product; or 

24 (ii) a mixture that— 


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1 (I) contains nicotine or other 

2 substances that can be aerosolized 

3 and inhaled by the user; and 

4 (II) is a tobacco product. 

5 (B) EXCLUSION.—The term ‘‘electronic 

6 nicotine delivery system’’ does not include any 

7 product that— 

8 (i) has been approved or otherwise au9 thorized by the Food and Drug Adminis10 tration for the purpose of sale as a tobacco 

11 cessation product or for other therapeutic 

12 purposes; and 

13 (ii) is marketed and sold solely for 

14 such purpose or purposes. 

15 (5) ENDORSE.—The term ‘‘endorse’’ means to 

16 communicate an advertising message (including a 

17 verbal statement, demonstration, or depiction of the 

18 name, signature, likeness, or other identifying per19 sonal characteristics of an individual or the name or 

20 seal of an organization) that consumers are likely to 

21 believe reflects the opinions, beliefs, findings, or ex22 periences of a party other than the sponsoring ad23 vertiser, even if the views expressed by such party 

24 are identical to those of the sponsoring advertiser. 


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1 (6) NICOTINE.—The term ‘‘nicotine’’ has the 

2 meaning given such term in section 900 of the Fed3 eral Food, Drug, and Cosmetic Act (21 U.S.C. 387). 

4 (7) SMOKELESS TOBACCO.—The term ‘‘smoke5 less tobacco’’ has the meaning given such term in 

6 section 900 of the Federal Food, Drug, and Cos7 metic Act (21 U.S.C. 387). 

8 (8) TOBACCO PRODUCT.—The term ‘‘tobacco 

9 product’’ has the meaning given such term in section 

10 201 of the Federal Food, Drug, and Cosmetic Act 

11 (21 U.S.C. 321). 

Æ 


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