IB 

Union Calendar No. 324 

116TH CONGRESS 

2D SESSION H. R. 2339 

[Report No. 116–402] 

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 

FEBRUARY 21, 2020 

Additional sponsors: Mr. RUSH, Ms. LEE of California, Mr. SARBANES, Ms. 

UNDERWOOD, Ms. BLUNT ROCHESTER, Ms. MUCARSEL-POWELL, Ms. 

SCHAKOWSKY, Mr. NEGUSE, Mr. QUIGLEY, Mr. SUOZZI, Mr. RYAN, Mr. 

RASKIN, Mr. TONKO, Mr. COHEN, Mr. ENGEL, Ms. SEWELL of Alabama, 

Mr. KENNEDY, Ms. PINGREE, Ms. WASSERMAN SCHULTZ, Mr. LARSEN

of Washington, Mr. CUMMINGS, Ms. NORTON, Mr. TED LIEU of California, Ms. CRAIG, Mr. KING of New York, Mrs. LOWEY, Mr. LEWIS, Ms. 

MCCOLLUM, Mrs. WATSON COLEMAN, Ms. HILL of California, Mr. COX

of California, Ms. TLAIB, Ms. SCHRIER, Mr. HASTINGS, Mrs. KIRKPATRICK, Ms. ROYBAL-ALLARD, Mr. KILMER, Ms. STEVENS, Mrs. DINGELL, Ms. KUSTER of New Hampshire, Mr. THOMPSON of Mississippi, 

Mr. PAPPAS, Mr. DEUTCH, Ms. BROWNLEY of California, Mr. FOSTER, 

Mr. HECK, Mr. ROUDA, Mrs. NAPOLITANO, Mr. KRISHNAMOORTHI, Mr. 

POCAN, Mr. DANNY K. DAVIS of Illinois, Mr. LEVIN of California, Mr. 

CISNEROS, Mrs. DAVIS of California, Ms. MENG, Mr. GOTTHEIMER, Mr. 

LAWSON of Florida, Ms. JOHNSON of Texas, Ms. PRESSLEY, Ms. 

BARRAGA ́N, Ms. PLASKETT, Mr. CARTWRIGHT, Ms. KELLY of Illinois, 

Mr. ROSE of New York, Mr. KIM, Mr. PAYNE, Mr. CASE, Mrs. HAYES, 

Mr. NORCROSS, Mr. LANGEVIN, Ms. MATSUI, Mr. RUIZ, Mr. HUFFMAN, 

Mrs. DEMINGS, Mr. KILDEE, Ms. HOULAHAN, Mr. DESAULNIER, Mr. 

BERA, Mrs. LAWRENCE, Mr. TAKANO, Mr. KHANNA, Mr. MCNERNEY, 

Mr. LUJA ́N, Mr. GARCI ́A of Illinois, Mr. SOTO, Mr. BLUMENAUER, Ms. 

JUDY CHU of California, Ms. DEAN, Ms. MOORE, Ms. LOFGREN, Ms. 

SCANLON, Mr. GRIJALVA, Mr. TRONE, Ms. PORTER, Mr. MALINOWSKI, 


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Mr. CASTEN of Illinois, Ms. SA ́NCHEZ, Mr. EVANS, Mr. CASTRO of Texas, 

Mr. SWALWELL of California, Mrs. BEATTY, Ms. SPEIER, Ms. BONAMICI, 

Mr. ESPAILLAT, Mr. SERRANO, Ms. SLOTKIN, Mr. SEAN PATRICK MALONEY of New York, Mr. JEFFRIES, Mrs. MCBATH, Miss RICE of New 

York, Mr. NADLER, Ms. GARCIA of Texas, Mr. CARSON of Indiana, Ms. 

WATERS, Mr. GOMEZ, Ms. HAALAND, Mr. THOMPSON of California, Mr. 

LARSON of Connecticut, Mr. VARGAS, Mr. CICILLINE, Mr. FITZPATRICK, 

Mr. CLAY, Mr. LEVIN of Michigan, Ms. JACKSON LEE, and Mr. PHILLIPS

FEBRUARY 21, 2020 

Reported with an amendment; committed to the Committee of the Whole 

House on the State of the Union and ordered to be printed 

[Strike out all after the enacting clause and insert the part printed in italic] 

[For text of introduced bill, see copy of bill as introduced on April 18, 2019] 

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. 


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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 To5 bacco 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. 

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

Sec. 103. Reducing child and adolescent nicotine addiction. 

Sec. 104. Prohibition against remote retail sales. 

Sec. 105. Fees applicable to all tobacco products. 

Sec. 106. Regulation of products containing synthetic nicotine. 

Sec. 107. Update to youth tobacco prevention public awareness campaigns. 

Sec. 108. Exemption from premarket approval of certain tobacco products. 

Sec. 109. Public education. 

Sec. 110. Regulations for recordkeeping concerning tracking and tracing. 

TITLE II—FEDERAL TRADE COMMISSION 

Sec. 201. Advertising of tobacco products. 

TITLE III—PUBLIC HEALTH PROGRAMS 

Sec. 301. Outreach to medically underserved communities. 

Sec. 302. Demonstration grant program to develop strategies for smoking cessation in medically underserved communities. 

TITLE IV—NICOTINE OR VAPING ACCESS PROTECTION AND 

ENFORCEMENT 

Sec. 401. Short title. 

Sec. 402. Increasing civil penalties applicable to certain violations of restrictions 

on sale and distribution of tobacco products. 

Sec. 403. Study and report on e-cigarettes. 


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1 TITLE I—FOOD AND DRUG 

2 ADMINISTRATION 

3 SEC. 101. CIGARETTE GRAPHIC HEALTH WARNINGS. 

4 (a) ISSUANCE DEADLINES.—Not later than March 15, 

5 2020, the Secretary of Health and Human Services, acting 

6 through the Commissioner of Food and Drugs, shall publish 

7 a final rule pursuant to section 4(d) of the Federal Ciga8 rette Labeling and Advertising Act (15 U.S.C. 1333(d)). If 

9 the Secretary fails to promulgate such final rule by March 

10 15, 2020, then the proposed rule titled ‘‘Tobacco Products; 

11 Required Warnings for Cigarette Packages and Advertise12 ments’’ published by the Food and Drug Administration on 

13 August 16, 2019 (84 Fed. Reg. 42754) shall be treated as 

14 a final rule beginning on March 16, 2020. 

15 (b) CONFORMING CHANGE.—The first section 4(d) of 

16 the Federal Cigarette Labeling and Advertising Act (15 

17 U.S.C. 1333(d)) (relating to graphic labeling statements) 

18 is amended by striking ‘‘Not later than 24 months after the 

19 date of enactment of the Family Smoking Prevention and 

20 Tobacco Control Act, the Secretary’’ and inserting ‘‘The 

21 Secretary’’. 

22 SEC. 102. ADVERTISING AND SALES PARITY FOR ALL 

23 DEEMED TOBACCO PRODUCTS. 

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

25 of enactment of this Act, the Secretary of Health and 


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1 Human Services, acting through the Commissioner of Food 

2 and Drugs, shall promulgate a final rule amending part 

3 1140 of subchapter K of title 21, Code of Federal Regula4 tions— 

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

6 all tobacco products, as applicable, to which chapter 

7 IX of the Federal Food, Drug, and Cosmetic Act (21 

8 U.S.C. 387a et seq.) applies pursuant to section 

9 901(b) of such Act (21 U.S.C. 387a(b)), as amended 

10 by section 103(a) of this Act; and 

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

12 for consistency with the amendments made by section 

13 103 of this Act, including by updating all references 

14 to persons younger than 18 years of age in subpart 

15 B of part 1140 of title 21, Code of Federal Regula16 tions. 

17 (b) EFFECTIVE DATE.—The final rule required by sub18 section (a) shall take effect on the date that is 2 years after 

19 the date of enactment of this Act. 

20 SEC. 103. REDUCING CHILD AND ADOLESCENT NICOTINE 

21 ADDICTION. 

22 (a) APPLICABILITY TO ALL TOBACCO PRODUCTS.— 

23 (1) IN GENERAL.—Subsection (b) of section 901 

24 of the Federal Food, Drug, and Cosmetic Act (21 

25 U.S.C. 387a) is amended to read as follows: 


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

2 tobacco products.’’. 

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

4 and the amendment made thereby shall not be con5 strued to limit the applicability of chapter IX of the 

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

7 387a et seq.) to— 

8 (A) products that were listed in section 

9 901(b) of such Act as in effect on the day before 

10 the date of enactment of this Act; and 

11 (B) products that were deemed by regula12 tion to be subject to such chapter pursuant to 

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

14 before the date of enactment of this Act. 

15 (b) MINIMUM AGE RESTRICTIONS.— 

16 (1) IN GENERAL.—Section 906(d) of the Federal 

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

18 amended by striking paragraph (3) and inserting the 

19 following: 

20 ‘‘(3) MINIMUM AGE RESTRICTIONS.— 

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

22 for any retailer, manufacturer, distributor, 

23 third-party marketplace, or any other commer24 cial entity to sell a tobacco product to any per25 son younger than 21 years of age. 


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1 ‘‘(B) AGE VERIFICATION.—To ensure com2 pliance with subparagraph (A), a retailer shall, 

3 at a minimum, verify by means of a govern4 ment-issued photographic identification the age 

5 of the individual purchasing the product as pre6 scribed in— 

7 ‘‘(i) subpart B of part 1140 of sub8 chapter K of title 21, Code of Federal Regu9 lations; and 

10 ‘‘(ii) successor regulations, including 

11 the regulation required by section 102 of the 

12 Reversing the Youth Tobacco Epidemic Act 

13 of 2019 and any applicable regulation im14 posing restrictions pursuant to paragraph 

15 (1). 

16 ‘‘(C) REGULATIONS.—Not later than 180 

17 days after the date of enactment of the Reversing 

18 the Youth Tobacco Epidemic Act of 2019, the 

19 Secretary shall promulgate a final regulation to 

20 implement and enforce subparagraphs (A) and 

21 (B). 

22 ‘‘(D) TIMING.—Subparagraphs (A) and (B) 

23 shall take effect on the date that is 180 days 

24 after the date of enactment of the Reversing the 

25 Youth Tobacco Epidemic Act of 2019, regardless 


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1 of whether the Secretary has promulgated the 

2 final regulations required by subparagraph 

3 (C).’’. 

4 (2) PRESERVATION OF STATE AND LOCAL AU5 THORITY.—Nothing in the amendment made by para6 graph (1) shall be construed to affect the preservation 

7 of State and local authority pursuant to section 916 

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

9 U.S.C. 387p). 

10 (c) PROHIBITING FLAVORING OF TOBACCO PROD11 UCTS.— 

12 (1) PROHIBITION.— 

13 (A) IN GENERAL.—Subparagraph (A) of 

14 section 907(a)(1) of the Federal Food, Drug, and 

15 Cosmetic Act (21 U.S.C. 387g(a)(1)) is amended 

16 to read as follows: 

17 ‘‘(A) SPECIAL RULES.— 

18 ‘‘(i) IN GENERAL.—Beginning on the 

19 date that is 1 year after the date of enact20 ment of the Reversing the Youth Tobacco 

21 Epidemic Act of 2019, a tobacco product 

22 (including its components, parts, and acces23 sories, including the tobacco, filter, or 

24 paper) that is not an electronic nicotine de25 livery system shall not contain, as a conVerDate Sep 11 2014 21:18 Feb 21, 2020 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6203 E:\BILLS\H2339.RH H2339

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1 stituent (including a smoke constituent) or 

2 additive, an artificial or natural flavor 

3 (other than tobacco) that is a characterizing 

4 flavor of the tobacco product or tobacco 

5 smoke or an herb or spice, including men6 thol, mint, strawberry, grape, orange, clove, 

7 cinnamon, pineapple, vanilla, coconut, lico8 rice, cocoa, chocolate, cherry, or coffee. 

9 ‘‘(ii) RULE OF CONSTRUCTION.—Noth10 ing in this subparagraph shall be construed 

11 to limit the Secretary’s authority to take ac12 tion under this section or other sections of 

13 this Act applicable to any artificial or nat14 ural flavor, herb, or spice. 

15 ‘‘(iii) APPLICABILITY TO CERTAIN IN16 DIVIDUALS.—Notwithstanding any provi17 sion of this Act, no individual who pur18 chases or possess for consumption a tobacco 

19 product that is in violation of the prohibi20 tion under this subparagraph shall be sub21 ject to any criminal penalty under this Act 

22 for such purchase or possession, nor shall it 

23 be used as a justification to stop, search, or 

24 conduct any other investigative measure 

25 against any individual.’’. 


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1 (B) SAVINGS PROVISION.—Section 907(a)(1) 

2 of the Federal Food, Drug, and Cosmetic Act (21 

3 U.S.C. 387g(a)(1)), as in effect on the date of en4 actment of this Act, shall remain in effect until 

5 the amendments made to such section 907(a)(1) 

6 by this paragraph take effect. 

7 (2) FLAVORED ELECTRONIC NICOTINE DELIVERY

8 SYSTEM.—Section 910 of the Federal Food, Drug, and 

9 Cosmetic Act (21 U.S.C. 387j) is amended by insert10 ing at the end the following: 

11 ‘‘(h) FLAVORED ELECTRONIC NICOTINE DELIVERY

12 SYSTEMS.— 

13 ‘‘(1) RESTRICTION.—Beginning on the date that 

14 is 30 days after the date of enactment of the Revers15 ing the Youth Tobacco Epidemic Act of 2019, any fla16 vored electronic nicotine delivery system that is a new 

17 tobacco product, including any liquid, solution, or 

18 other component or part or its aerosol, shall not con19 tain an artificial or natural flavor (other than to20 bacco) that is a characterizing flavor, including men21 thol, mint, strawberry, grape, orange, clove, cin22 namon, pineapple, vanilla, coconut, licorice, cocoa, 

23 chocolate, cherry, or coffee, unless the Secretary has 

24 issued a marketing order as described in paragraph 

25 (2). Nothing in this paragraph shall be construed to 


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1 limit the Secretary’s authority to take action under 

2 this section or other sections of this Act applicable to 

3 any artificial or natural flavor, herb, or spice. 

4 ‘‘(2) REVIEW.—The Secretary shall not issue a 

5 marketing order under subsection (c)(1)(A)(i) or a 

6 substantial equivalence order under subsection 

7 (a)(2)(A)(i) for any electronic nicotine delivery sys8 tem, including any liquid, solution, or other compo9 nent or part or its aerosol, that contains an artificial 

10 or natural flavor (other than tobacco) that is a char11 acterizing flavor, unless the Secretary issues an order 

12 finding that the manufacturer has demonstrated 

13 that— 

14 ‘‘(A) use of the characterizing flavor— 

15 ‘‘(i) will significantly increase the like16 lihood of smoking cessation among current 

17 users of tobacco products; and 

18 ‘‘(ii) will not increase the likelihood 

19 that individuals who do not use tobacco 

20 products, including youth, will start using 

21 any tobacco product, including an electronic 

22 nicotine delivery system; and 

23 ‘‘(B) such electronic nicotine delivery sys24 tem is not more harmful to users than an elecVerDate Sep 11 2014 21:18 Feb 21, 2020 Jkt 099200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6203 E:\BILLS\H2339.RH H2339

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1 tronic nicotine delivery system that does not con2 tain any characterizing flavors.’’. 

3 (3) DEFINITION OF ELECTRONIC NICOTINE DE4 LIVERY SYSTEM.—Section 900 of the Federal Food, 

5 Drug, and Cosmetic Act (21 U.S.C. 387) is amend6 ed— 

7 (A) by redesignating paragraphs (8) 

8 through (22) as paragraphs (9) through (23), re9 spectively; and 

10 (B) by inserting after paragraph (7) the fol11 lowing new paragraph: 

12 ‘‘(8) ELECTRONIC NICOTINE DELIVERY SYS13 TEM.—The term ‘electronic nicotine delivery sys14 tem’— 

15 ‘‘(A) means any electronic device that deliv16 ers nicotine, flavor, or another substance via an 

17 aerosolized solution to the user inhaling from the 

18 device (including e-cigarettes, e-hookah, e-cigars, 

19 vape pens, advanced refillable personal vapor20 izers, and electronic pipes) and any component, 

21 liquid, part, or accessory of such a device, wheth22 er or not sold separately; and 

23 ‘‘(B) does not include a product that— 

24 ‘‘(i) is approved by the Food and Drug 

25 Administration for sale as a tobacco cesVerDate Sep 11 2014 21:18 Feb 21, 2020 Jkt 099200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6203 E:\BILLS\H2339.RH H2339

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1 sation product or for another therapeutic 

2 purpose; and 

3 ‘‘(ii) is marketed and sold solely for a 

4 purpose described in clause (i).’’. 

5 SEC. 104. PROHIBITION AGAINST REMOTE RETAIL SALES. 

6 (a) IN GENERAL.—Paragraph (4) of section 906(d) of 

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

8 387f(d)) is amended to read as follows: 

9 ‘‘(4) PROHIBITION AGAINST REMOTE RETAIL

10 SALES.— 

11 ‘‘(A) PROHIBITION.—Not later than 18 

12 months after the date of enactment of the the Re13 versing the Youth Tobacco Epidemic Act of 2019, 

14 the Secretary shall promulgate a final regulation 

15 prohibiting the retail sale of all tobacco products 

16 other than retail sales through a direct, face-to17 face exchange between a retailer and a consumer. 

18 ‘‘(B) EXCEPTION FOR CERTAIN CIGAR TO19 BACCO PRODUCTS.— 

20 ‘‘(i) EXCEPTION.—The regulation re21 quired by subparagraph (A) shall not apply 

22 to tobacco products described in section 

23 910(a)(2)(A)(iii). 

24 ‘‘(ii) APPLICABLE REQUIREMENTS.— 

25 Not later than 18 months after the date of 


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1 enactment of the the Reversing the Youth 

2 Tobacco Epidemic Act of 2019, the Sec3 retary shall promulgate regulations regard4 ing the sale and distribution of tobacco 

5 products described in section 

6 910(a)(2)(A)(iii) that occur through means 

7 other than a direct, face-to-face exchange be8 tween a retailer and a consumer in order to 

9 prevent the sale and distribution of tobacco 

10 products described in section 

11 910(a)(2)(A)(iii) to individuals who have 

12 not attained the minimum age established 

13 by applicable law for the purchase of such 

14 products, including requirements for age 

15 verification. 

16 ‘‘(C) RELATION TO OTHER AUTHORITY.— 

17 Nothing in this paragraph— 

18 ‘‘(i) limits the authority of the Sec19 retary to take additional actions under the 

20 other paragraphs of this subsection; or 

21 ‘‘(ii) preempts the authority of a State 

22 or local government to establish restrictions 

23 on the retail sale of tobacco products that 

24 are at least as restrictive as the prohibition 

25 under subparagraph (A).’’. 


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1 (b) APPLICABILITY.—Section 906(d)(4) of the Federal 

2 Food, Drug, and Cosmetic Act, as in effect on the day before 

3 the date of enactment of this Act, shall continue to apply 

4 until the effective date of the regulations required by section 

5 906(d)(4) of such Act, as amended by subsection (a). 

6 SEC. 105. FEES APPLICABLE TO ALL TOBACCO PRODUCTS. 

7 (a) INCREASE IN TOTAL AMOUNT.—Section 919(b)(1) 

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

9 387s(b)(1)) is amended by striking subparagraph (K) and 

10 inserting the following subparagraphs: 

11 ‘‘(K) For fiscal year 2019, $712,000,000. 

12 ‘‘(L) For fiscal year 2020, $812,000,000. 

13 ‘‘(M) For each subsequent fiscal year, the 

14 amount that was applicable for the previous fis15 cal year, increased by the total percentage 

16 change that occurred in the Consumer Price 

17 Index for all urban consumers (all items; United 

18 States city average) for the 12-month period end19 ing June 30 preceding the fiscal year.’’. 

20 (b) APPLICATION OF USER FEES TO ALL CLASSES OF

21 TOBACCO PRODUCT.— 

22 (1) IN GENERAL.—Subparagraph (A) of section 

23 919(b)(2) of the Federal Food, Drug, and Cosmetic 

24 Act (21 U.S.C. 387s(b)(2)) is amended to read as fol25 lows: 


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1 ‘‘(A) IN GENERAL.— 

2 ‘‘(i) FISCAL YEARS 2020 AND 2021.—For 

3 fiscal years 2020 and 2021, user fees shall 

4 be assessed and collected under subsection 

5 (a) only with respect to the classes of to6 bacco products listed in subparagraph 

7 (B)(i), and the total such user fees with re8 spect to each such class shall be an amount 

9 that is equal to the applicable percentage of 

10 each such class for the fiscal year multiplied 

11 by the amount specified in paragraph (1) 

12 for the fiscal year. 

13 ‘‘(ii) SUBSEQUENT FISCAL YEARS.— 

14 For fiscal year 2022 and each subsequent 

15 fiscal year, user fees shall be assessed and 

16 collected under subsection (a) with respect 

17 to each class of tobacco products to which 

18 this chapter applies (including tobacco 

19 products that the Secretary by regulation 

20 deems to be subject to this chapter), and the 

21 total user fees with respect to each such 

22 class shall be— 

23 ‘‘(I) with respect to each class of 

24 tobacco products listed in subpara25 graph (B)(i), an amount that is calVerDate Sep 11 2014 21:18 Feb 21, 2020 Jkt 099200 PO 00000 Frm 00016 Fmt 6652 Sfmt 6203 E:\BILLS\H2339.RH H2339

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1 culated in the same way as the 

2 amounts calculated for fiscal years 

3 2020 and 2021 under clause (i), except 

4 that for purposes of fiscal years 2022 

5 and subsequent fiscal years, instead of 

6 multiplying the applicable percentage 

7 of each such class by ‘the amount speci8 fied in paragraph (1) for the fiscal 

9 year’, the applicable percentage shall 

10 be multiplied by— 

11 ‘‘(aa) the amount specified in 

12 paragraph (1) for the fiscal year, 

13 reduced by 

14 ‘‘(bb) the total user fees as15 sessed and collected pursuant to 

16 subclause (II) for the fiscal year; 

17 and 

18 ‘‘(II) with respect to each class of 

19 tobacco products to which this chapter 

20 applies but which is not listed in sub21 paragraph (B)(i), an amount deter22 mined pursuant to a formula under 

23 subparagraph (C).’’. 

24 (2) OTHER TOBACCO PRODUCTS.—Section 

25 919(b)(2) of the Federal Food, Drug, and Cosmetic 


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1 Act (21 U.S.C. 387s(b)(2)), as amended by paragraph 

2 (1), is further amended by adding at the end the fol3 lowing new subparagraphs: 

4 ‘‘(C) ALLOCATION FOR OTHER TOBACCO

5 PRODUCTS.— 

6 ‘‘(i) IN GENERAL.—Beginning with fis7 cal year 2022, the total user fees assessed 

8 and collected under subsection (a) each fis9 cal year with respect to each class of tobacco 

10 products not listed in subparagraph (B)(i) 

11 shall be an amount that is determined pur12 suant to a formula developed by the Sec13 retary by regulation using information re14 quired to be submitted under subparagraph 

15 (D). 

16 ‘‘(ii) ALLOCATION FOR OTHER TO17 BACCO PRODUCTS.—For each class of to18 bacco products not listed in subparagraph 

19 (B)(i), the percentage of fees under the for20 mula under clause (i) for the respective fis21 cal year shall be equal to the percentage of 

22 the gross domestic sales in the previous cal23 endar year that is attributable to such class 

24 of tobacco products in such calendar year, 

25 as determined by the Secretary. 


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1 ‘‘(iii) ALLOCATION OF ASSESSMENT

2 WITHIN EACH CLASS OF OTHER TOBACCO

3 PRODUCTS.—The percentage of the total 

4 user fee to be paid by each manufacturer or 

5 importer of tobacco products in a class not 

6 listed in subparagraph (B)(i) shall be deter7 mined by the Secretary, based on the per8 centage of the gross domestics sales of all 

9 such classes of tobacco products by all man10 ufacturers and importers in the previous 

11 calendar year that is attributable to such 

12 manufacturer or importer. 

13 ‘‘(iv) EFFECT OF FAILURE TO FINAL14 IZE FORMULA ON TIME.—If the Secretary 

15 for any reason fails to finalize by fiscal 

16 year 2022 the formula required by this sub17 paragraph for the assessment and collection 

18 of user fees for classes of tobacco products 

19 not listed in subparagraph (B)(i)— 

20 ‘‘(I) the Secretary shall continue 

21 to assess and collect fees under sub22 section (a) with respect to each class of 

23 tobacco products listed in subpara24 graph (B)(i); and 


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1 ‘‘(II) until the first fiscal year 

2 commencing after the finalization of 

3 such formula, the exception described 

4 in subparagraph (A)(ii)(I) shall not 

5 apply. 

6 ‘‘(v) REVISIONS BY REGULATION.—Any 

7 revisions to the formula promulgated pursu8 ant to this subparagraph shall be by regula9 tion. 

10 ‘‘(vi) DEFINITION.—In this subpara11 graph, the term ‘gross domestic sales’ means 

12 the total value in dollars of the sale or dis13 tribution by manufacturers and importers 

14 of tobacco products in the United States in 

15 classes not listed in subparagraph (B)(i), as 

16 determined based on the aggregation of sales 

17 data from every manufacturer and importer 

18 of tobacco products that submits sales data 

19 to the Secretary. 

20 ‘‘(D) INFORMATION REQUIRED TO BE SUB21 MITTED.—Each manufacturer or importer of 

22 any tobacco product shall submit to the Sec23 retary the information required under this sub24 paragraph by March 1, 2021, for calendar year 

25 2020, by April 1, 2021, for the period of JanuVerDate Sep 11 2014 21:18 Feb 21, 2020 Jkt 099200 PO 00000 Frm 00020 Fmt 6652 Sfmt 6203 E:\BILLS\H2339.RH H2339

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1 ary 1, 2021, through March 30, 2021, and 

2 monthly thereafter. Such information shall in3 clude— 

4 ‘‘(i) the identification of the manufac5 turer or importer; 

6 ‘‘(ii) the class or classes of tobacco 

7 products sold by the manufacturer or im8 porter; 

9 ‘‘(iii) the full listing of the finished to10 bacco products in a class not listed in sub11 paragraph (B)(i) sold or distributed by the 

12 manufacturer or importer in the United 

13 States; and 

14 ‘‘(iv) the gross domestic sales data for 

15 each class of finished tobacco products sold 

16 or distributed by the manufacturer or im17 porter in the United States.’’. 

18 (3) PROHIBITED ACT.—Section 301(q)(1)(B) of 

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

20 331(q)(1)(B)) is amended by inserting 

21 ‘‘919(b)(2)(D),’’ before ‘‘or 920’’. 

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 percentage 


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1 determined for purposes of allocations under subsections (e) 

2 through (h) of section 625 of Public Law 108–357’’ and in3 serting ‘‘shall be the percentage determined by the Sec4 retary’’. 

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

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

7 387s(b)) is amended— 

8 (1) by striking paragraph (5); 

9 (2) by redesignating paragraphs (6) and (7) as 

10 paragraphs (5) and (6), respectively; and 

11 (3) by amending paragraph (6), as redesignated, 

12 to read as follows: 

13 ‘‘(6) MEMORANDUM OF UNDERSTANDING.—The 

14 Secretary shall request the appropriate Federal agen15 cy to enter into a memorandum of understanding 

16 that provides for the regular and timely transfer from 

17 the head of such agency to the Secretary of all nec18 essary information regarding all tobacco product 

19 manufacturers and importers required to pay user 

20 fees. The Secretary shall maintain all disclosure re21 strictions established by the head of such agency re22 garding the information provided under the memo23 randum of understanding.’’. 

24 (e) APPLICABILITY.—The amendments made by sub25 sections (b), (c), and (d) apply beginning with fiscal year 


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1 2022. Subject to the amendment made by subsection (a), 

2 section 919 of the Federal Food, Drug, and Cosmetic Act 

3 (21 U.S.C. 387s), as in effect on the day before the date 

4 of enactment of this Act, shall apply with respect to fiscal 

5 years preceding fiscal year 2022. 

6 (f) REPORT.—For fiscal year 2020 and each subse7 quent fiscal year for which fees are collected under section 

8 919 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

9 387s), the Secretary of Health and Human Services, acting 

10 through the Commissioner of Food and Drugs, shall, by the 

11 end of the respective fiscal year, submit to the Congress fi12 nancial and performance reports with respect to such fees. 

13 SEC. 106. REGULATION OF PRODUCTS CONTAINING SYN14 THETIC NICOTINE. 

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

16 Human Services, acting through the Commissioner of Food 

17 and Drugs, shall— 

18 (1) not later than 1 year after the date of enact19 ment of this Act, issue an interim final rule pro20 viding for the regulation of products containing syn21 thetic nicotine under the Federal Food, Drug, and 

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

23 (2) not later than 2 years after such date of en24 actment, issue a final rule providing for such regula25 tion. 


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1 (b) SYNTHETIC NICOTINE DEFINED.—In this section, 

2 the term ‘‘synthetic nicotine’’ means nicotine that is not 

3 made or derived from tobacco. 

4 SEC. 107. UPDATE TO YOUTH TOBACCO PREVENTION PUB5 LIC AWARENESS CAMPAIGNS. 

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

7 Human Services, acting through the Commissioner of Food 

8 and Drugs, shall— 

9 (1) review all public health awareness campaigns 

10 of the Department of Health and Human Services de11 signed to educate at-risk individuals about the harm12 ful effects of tobacco use, including the use of e-ciga13 rettes and other electronic nicotine delivery systems; 

14 and 

15 (2) as applicable, modify such campaigns to in16 clude awareness and education materials designated 

17 for individuals who are 18 to 21 years of age. 

18 (b) CONSULTATION.—In carrying out subsection (a), 

19 the Secretary of Health and Human Services may consult 

20 with medical and public health associations and nonprofit 

21 organizations. 


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1 SEC. 108. EXEMPTION FROM PREMARKET APPROVAL OF 

2 CERTAIN TOBACCO PRODUCTS. 

3 (a) IN GENERAL.—Section 910(a)(2) of the Federal 

4 Food, Drug, and Cosmetic Act (21 U.S.C. 387j(a)(2)) is 

5 amended— 

6 (1) in subparagraph (A)— 

7 (A) in clause (i)(II), by striking ‘‘or’’; 

8 (B) in clause (ii), by striking the period at 

9 the end and inserting ‘‘; or’’; and 

10 (C) by adding at the end the following: 

11 ‘‘(iii) subject to subparagraph (C), for 

12 the period beginning on the date of the en13 actment of the Reversing the Youth Tobacco 

14 Epidemic Act of 2019 and ending on Sep15 tember 30, 2028, the tobacco product is a 

16 cigar and— 

17 ‘‘(I) is wrapped in whole tobacco 

18 leaf; 

19 ‘‘(II) contains a 100-percent leaf 

20 tobacco binder; 

21 ‘‘(III) contains primarily long 

22 filler tobacco; 

23 ‘‘(IV) does not have a character24 izing flavor other than tobacco; 

25 ‘‘(V) weighs more than 6 pounds 

26 per 1000 units; 


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1 ‘‘(VI) has no filter, tip, or non-to2 bacco mouthpiece; 

3 ‘‘(VII)(aa) is made by combining 

4 manually the wrapper, filler, and 

5 binder and is capped by hand; or 

6 ‘‘(bb) has a homogenized tobacco 

7 leaf binder and is made in the United 

8 States using human hands to lay the 

9 100-percent leaf tobacco binder onto 

10 only one machine that bunches, wraps, 

11 and caps each individual cigar; and 

12 ‘‘(VIII) has a retail price (after 

13 discounts or coupons) per cigar of no 

14 less than— 

15 ‘‘(aa) for calendar years 

16 2019 and 2020, $12; and 

17 ‘‘(bb) for each subsequent cal18 endar year, $12 multiplied by 

19 any percent increase in the Con20 sumer Price Index for all urban 

21 consumers (all items; U.S. city 

22 average) since calendar year 

23 2020.’’; and 

24 (2) by adding at the end the following: 

25 ‘‘(C) DETERMINATION OF APPLICABILITY.— 


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1 ‘‘(i) IN GENERAL.—The Secretary 

2 shall, notwithstanding subparagraph 

3 (A)(iii) or any determination of substantial 

4 equivalence, if any of the conditions speci5 fied in clause (ii) are met— 

6 ‘‘(I) withdraw any exemption ap7 plicable to a tobacco product or prod8 ucts described in such subparagraph; 

9 ‘‘(II) require that applications for 

10 review under this section be submitted 

11 with respect to such product or prod12 ucts; and 

13 ‘‘(III) require that manufacturers 

14 may only market such tobacco product 

15 after the issuance of an order under 

16 subsection (c)(1)(A)(i) with respect to 

17 such product or products. 

18 ‘‘(ii) CONDITIONS.—The conditions 

19 specified in this clause are that— 

20 ‘‘(I) the Secretary determines that 

21 the use of a tobacco product or prod22 ucts described in subparagraph (A)(iii) 

23 has resulted in an emerging public 

24 health threat; 


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1 ‘‘(II) data from a National Youth 

2 Tobacco Survey (or successor survey) 

3 conducted after the date of the enact4 ment of the Reversing the Youth To5 bacco Epidemic Act of 2019 identifies 

6 a rise in youth usage of tobacco prod7 ucts described in section 

8 910(a)(2)(A)(iii); or 

9 ‘‘(III) the Secretary determines 

10 that a tobacco product or products no 

11 longer meets the criteria specified in 

12 such subparagraph.’’. 

13 (b) NATIONAL ACADEMIES STUDY AND REPORT.— 

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

15 Human Services, acting through the Commissioner of 

16 Food and Drugs, shall enter into an agreement with 

17 the National Academies of Sciences, Engineering, and 

18 Medicine under which the National Academies shall 

19 conduct a study on— 

20 (A) the public health impact of having to21 bacco products described in subsection 

22 (a)(2)(A)(iii) of section 910 of the Federal Food, 

23 Drug, and Cosmetic Act (21 U.S.C. 387j(a)(2)), 

24 as amended by subsection (a), exempt from pre25 market review under such section; 


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1 (B) the youth usage of such tobacco prod2 ucts; and 

3 (C) the market share of such products. 

4 (2) REPORT.—The agreement under paragraph 

5 (1) shall include a requirement that the National 

6 Academies of Sciences, Engineering, and Medicine 

7 submit to Congress, not later than December 31, 2026, 

8 a report on the findings of the study conducted under 

9 such paragraph. 

10 SEC. 109. PUBLIC EDUCATION. 

11 Section 906 of the Federal Food, Drug, and Cosmetic 

12 Act (21 U.S.C. 387f) is amended by adding at the end the 

13 following: 

14 ‘‘(g) EDUCATION ON TOBACCO PRODUCTS.— 

15 ‘‘(1) IN GENERAL.—Not later than 6 months 

16 after the date of the enactment of the Reversing the 

17 Youth Tobacco Epidemic Act of 2019, the Secretary of 

18 Health and Human Services, acting through the Com19 missioner of Food and Drugs, shall provide edu20 cational materials for health care providers, members 

21 of the public, and law enforcement officials, regard22 ing— 

23 ‘‘(A) the authority of the Food and Drug 

24 Administration with respect to the regulation of 


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1 tobacco products (including enforcement of such 

2 regulation); 

3 ‘‘(B) the processes of the Food and Drug 

4 Administration for enforcing restrictions on the 

5 manufacture and sale of tobacco products; 

6 ‘‘(C) the prohibition on characterizing fla7 vors in tobacco products and the under section 

8 907(a)(1) and the exception from such prohibi9 tion under subparagraph (C) of such section; 

10 ‘‘(D) the public health impact of tobacco 

11 products with characterizing flavors; and 

12 ‘‘(E) other information as the Secretary de13 termines appropriate. 

14 ‘‘(2) CONTENT.—Educational materials provided 

15 under paragraph (1) may include— 

16 ‘‘(A) explanations of key statutory and reg17 ulatory terms, including the terms ‘tobacco prod18 uct,’ ‘component parts’, ‘accessories’, ‘con19 stituent’, ‘additive’, ‘tobacco product manufac20 turer’, and ‘characterizing flavor’; 

21 ‘‘(B) an explanation of the Food and Drug 

22 Administration’s jurisdiction to regulate tobacco 

23 products, including tobacco products with char24 acterizing flavors under section 907(a)(1); 


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1 ‘‘(C) information related to enforcement 

2 tools and processes used by the Food and Drug 

3 Administration for violations of the prohibition 

4 specified in section 907(a)(1); 

5 ‘‘(D) an explanation of the health effects of 

6 using tobacco products, including those with 

7 characterizing flavors; and 

8 ‘‘(E) information on resources available re9 lated to smoking cessation. 

10 ‘‘(3) FORMAT.—Educational materials provided 

11 under paragraph (1) may be— 

12 ‘‘(A) published in any format, including an 

13 Internet website, video, fact sheet, infographic, 

14 webinar, or other format, as the Secretary deter15 mines is appropriate and applicable; and 

16 ‘‘(B) tailored for the unique needs of health 

17 care providers, members of the public, law en18 forcement officers, and other audiences, as the 

19 Secretary determines appropriate.’’. 

20 SEC. 110. REGULATIONS FOR RECORDKEEPING CON21 CERNING TRACKING AND TRACING. 

22 The Secretary of Health and Human Services, acting 

23 through the Commissioner of Food and Drugs, shall pro24 mulgate the regulations required by section 920(b) of the 


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1 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387t) in 

2 accordance with the following schedule: 

3 (1) Not later than 1 year after the date of enact4 ment of this Act, the Secretary shall issue proposed 

5 regulations. 

6 (2) Not later than 2 years after the date of enact7 ment of this Act, the Secretary shall promulgate final 

8 regulations. 

9 TITLE II—FEDERAL TRADE 

10 COMMISSION 

11 SEC. 201. ADVERTISING OF TOBACCO PRODUCTS. 

12 (a) ADVERTISING OF ELECTRONIC NICOTINE DELIV13 ERY SYSTEMS.— 

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

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

16 electronic nicotine delivery system in a manner 

17 that appeals to an individual under 21 years of 

18 age; or 

19 (B) to market, advertise, promote, or en20 dorse, or to compensate any person for the mar21 keting, advertising, promotion, or endorsement 

22 of, any electronic nicotine delivery system with23 out clearly disclosing that the communication is 

24 an advertisement, unless the communication is 

25 unambiguously identifiable as an advertisement. 


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1 (2) ENFORCEMENT BY COMMISSION.— 

2 (A) UNFAIR OR DECEPTIVE ACTS OR PRAC3 TICES.—A violation of paragraph (1) shall be 

4 treated as a violation of a regulation under sec5 tion 18(a)(1)(B) of the Federal Trade Commis6 sion Act (15 U.S.C. 57a(a)(1)(B)) regarding un7 fair or deceptive acts or practices. 

8 (B) POWERS OF COMMISSION.—The Com9 mission shall enforce paragraph (1) in the same 

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

11 jurisdiction, powers, and duties as though all ap12 plicable terms and provisions of the Federal 

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

14 were incorporated into and made a part of this 

15 Act. Any person who violates such paragraph 

16 shall be subject to the penalties and entitled to 

17 the privileges and immunities provided in the 

18 Federal Trade Commission Act. 

19 (3) ENFORCEMENT BY STATE ATTORNEYS GEN20 ERAL.— 

21 (A) IN GENERAL.—If the attorney general of 

22 a State has reason to believe a violation of para23 graph (1) has occurred or is occurring, the attor24 ney general, in addition to any authority the at25 torney general may have to bring an action in 


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1 State court under the law of the State, may 

2 bring a civil action in any court of competent 

3 jurisdiction to— 

4 (i) enjoin further such violation by the 

5 defendant; 

6 (ii) enforce compliance with such para7 graph; 

8 (iii) obtain civil penalties in the same 

9 amount as may be obtained by the Commis10 sion in a civil action under section 5(m) of 

11 the Federal Trade Commission Act (15 

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

13 (iv) obtain damages, restitution, or 

14 other compensation on behalf of residents of 

15 the State. 

16 (B) NOTICE.—Before filing an action under 

17 subparagraph (A), the attorney general of a 

18 State shall provide to the Commission a written 

19 notice of such action and a copy of the complaint 

20 for such action. If the attorney general deter21 mines that it is not feasible to provide the notice 

22 described in this subparagraph before the filing 

23 of the action, the attorney general shall provide 

24 written notice of the action and a copy of the 


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1 complaint to the Commission immediately upon 

2 the filing of the action. 

3 (C) AUTHORITY OF FEDERAL TRADE COM4 MISSION.— 

5 (i) IN GENERAL.—On receiving notice 

6 under subparagraph (B) of an action under 

7 subparagraph (A), the Commission shall 

8 have the right— 

9 (I) to intervene in the action; 

10 (II) upon so intervening, to be 

11 heard on all matters arising therein; 

12 and 

13 (III) to file petitions for appeal. 

14 (ii) LIMITATION ON STATE ACTION

15 WHILE FEDERAL ACTION IS PENDING.—If 

16 the Commission has instituted a civil action 

17 for violation of paragraph (1) (referred to 

18 in this clause as the ‘‘Federal action’’), no 

19 attorney general of a State may bring an 

20 action under subparagraph (A) during the 

21 pendency of the Federal action against any 

22 defendant named in the complaint in the 

23 Federal action for any violation of such 

24 paragraph alleged in such complaint. 


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1 (D) RELATIONSHIP WITH STATE-LAW

2 CLAIMS.— 

3 (i) PRESERVATION OF STATE-LAW

4 CLAIMS.—Nothing in this section shall pre5 vent the attorney general of a State from 

6 bringing an action under State law for acts 

7 or practices that also violate paragraph (1). 

8 (ii) ASSERTION IN SAME CIVIL AC9 TION.—If the attorney general of a State 

10 has authority to bring an action under 

11 State law for acts or practices that also vio12 late paragraph (1), the attorney general 

13 may assert the State-law claim and the 

14 claim for violation of such paragraph in the 

15 same civil action. 

16 (E) ACTIONS BY OTHER STATE OFFI17 CIALS.—In addition to civil actions brought by 

18 attorneys general under subparagraph (A), any 

19 other consumer protection officer of a State who 

20 is authorized by the State to do so may bring a 

21 civil action under such subparagraph, subject to 

22 the same requirements and limitations that 

23 apply under this paragraph to civil actions 

24 brought by attorneys general. 


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1 (4) RULEMAKING AUTHORITY.—The Commission 

2 may promulgate regulations under section 553 of title 

3 5, United States Code, to implement paragraph (1). 

4 (b) REPORT TO CONGRESS ON TOBACCO PRODUCT AD5 VERTISING.— 

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

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

8 thereafter, the Commission shall submit to Congress a 

9 report relating to each category of products described 

10 in paragraph (2) (or a single report a portion of 

11 which relates to each such category) that contains the 

12 following: 

13 (A) Information on domestic sales and ad14 vertising and promotional activity by the manu15 facturers that have the largest market shares of 

16 the product category. 

17 (B) Such recommendations for legislation 

18 as the Commission may consider appropriate. 

19 (2) PRODUCT CATEGORIES DESCRIBED.—The 

20 categories of products described in this paragraph are 

21 the following: 

22 (A) Cigarettes. 

23 (B) Cigars. 

24 (C) Smokeless tobacco. 

25 (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 a tobacco 

6 product that— 

7 (A) is not a cigarette; and 

8 (B) is a roll of tobacco wrapped in leaf to9 bacco or any substance containing tobacco. 

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 SYSTEM.— 

16 The term ‘‘electronic nicotine delivery system’’— 

17 (A) means any electronic device that deliv18 ers nicotine, flavor, or another substance via an 

19 aerosolized solution to the user inhaling from the 

20 device (including e-cigarettes, e-hookah, e-cigars, 

21 vape pens, advanced refillable personal vapor22 izers, and electronic pipes) and any component, 

23 liquid, part, or accessory of such a device, wheth24 er or not sold separately; and 

25 (B) does not include a product that— 


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1 (i) is approved by the Food and Drug 

2 Administration for sale as a tobacco ces3 sation product or for another therapeutic 

4 purpose; and 

5 (ii) is marketed and sold solely for a 

6 purpose described in clause (i). 

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

8 communicate an advertising message (including a 

9 verbal statement, demonstration, or depiction of the 

10 name, signature, likeness, or other identifying per11 sonal characteristics of an individual or the name or 

12 seal of an organization) that consumers are likely to 

13 believe reflects the opinions, beliefs, findings, or expe14 riences of a party other than the sponsoring adver15 tiser, even if the views expressed by such party are 

16 identical to those of the sponsoring advertiser. 

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

18 meaning given such term in section 900 of the Fed19 eral Food, Drug, and Cosmetic Act (21 U.S.C. 387). 

20 (7) SMOKELESS TOBACCO.—The term ‘‘smokeless 

21 tobacco’’ has the meaning given such term in section 

22 900 of the Federal Food, Drug, and Cosmetic Act (21 

23 U.S.C. 387). 

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

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


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1 201 of the Federal Food, Drug, and Cosmetic Act (21 

2 U.S.C. 321). 

3 TITLE III—PUBLIC HEALTH 

4 PROGRAMS 

5 SEC. 301. OUTREACH TO MEDICALLY UNDERSERVED COM6 MUNITIES. 

7 The Secretary shall ensure that programs at the Cen8 ters for Disease Control and Prevention related to outreach 

9 to medically underserved communities, including racial 

10 and ethnic minority populations, include efforts to educate 

11 and provide guidance regarding effective evidence-based 

12 strategies— 

13 (1) to prevent tobacco, e-cigarette, and nicotine 

14 addiction; and 

15 (2) for smoking cessation and the cessation of the 

16 use of e-cigarettes and electronic nicotine delivery sys17 tems. 

18 SEC. 302. DEMONSTRATION GRANT PROGRAM TO DEVELOP 

19 STRATEGIES FOR SMOKING CESSATION IN 

20 MEDICALLY UNDERSERVED COMMUNITIES. 

21 (a) IN GENERAL.—The Secretary, acting through the 

22 Director of the Centers for Disease Control and Prevention, 

23 shall establish a demonstration program to award grants 

24 to or contract with State, local, Tribal, or territorial public 

25 health departments to support— 


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1 (1) the development of improved evidence-based 

2 strategies for smoking cessation and the cessation of 

3 the use of e-cigarettes and electronic nicotine delivery 

4 systems for populations in medically underserved 

5 communities, particularly racial and ethnic minority 

6 populations; 

7 (2) the development of improved communication 

8 and outreach tools to reach populations in medically 

9 underserved communities, particularly racial and eth10 nic minority populations, addicted to tobacco and e11 cigarette products; and 

12 (3) improved coordination, access, and referrals 

13 to services for smoking cessation and the cessation of 

14 the use of e-cigarettes and electronic nicotine delivery 

15 systems, including smoking cessation products and 

16 mental health and counseling services. 

17 (b) APPLICATION.—To be eligible to receive a grant 

18 under subsection (a), a State, local, Tribal, or territorial 

19 public health department shall submit to the Secretary an 

20 application at such time, in such manner, and containing 

21 such information as the Secretary may require. 

22 (c) AUTHORIZATION OF APPROPRIATIONS.—There are 

23 authorized to be appropriated to carry out this section, 

24 $3,000,000 for each of fiscal years 2020 through 2024. 


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1 TITLE IV—NICOTINE OR VAPING 

2 ACCESS PROTECTION AND 

3 ENFORCEMENT 

4 SECTION 401. SHORT TITLE. 

5 This title may be cited as the ‘‘Nicotine or Vaping Ac6 cess Protection and Enforcement Act of 2019’’ or the ‘‘NO 

7 VAPE Act of 2019’’. 

8 SEC. 402. INCREASING CIVIL PENALTIES APPLICABLE TO 

9 CERTAIN VIOLATIONS OF RESTRICTIONS ON 

10 SALE AND DISTRIBUTION OF TOBACCO PROD11 UCTS. 

12 (a) PENALTIES.—Subparagraph (A) of section 

13 103(q)(2) of the Family Smoking Prevention and Tobacco 

14 Control Act (21 U.S.C. 333 note) is amended to read as 

15 follows: 

16 ‘‘(A) IN GENERAL.—The amount of the civil 

17 penalty to be applied for violations of restric18 tions promulgated under section 906(d), as de19 scribed in paragraph (1), shall be as follows: 

20 ‘‘(i) With respect to a retailer with an 

21 approved training program, the amount of 

22 the civil penalty shall not exceed— 

23 ‘‘(I) in the case of the first viola24 tion, $0, together with the issuance of 

25 a warning letter to the retailer; 


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1 ‘‘(II) in the case of a second viola2 tion within a 12-month period, $500; 

3 ‘‘(III) in the case of a third viola4 tion within a 24-month period, $1,000; 

5 ‘‘(IV) in the case of a fourth viola6 tion within a 24-month period, $4,000; 

7 ‘‘(V) in the case of a fifth viola8 tion within a 36-month period, 

9 $10,000; and 

10 ‘‘(VI) in the case of a sixth or sub11 sequent violation within a 48-month 

12 period, $20,000 as determined by the 

13 Secretary on a case-by-case basis. 

14 ‘‘(ii) With respect to a retailer that 

15 does not have an approved training pro16 gram, the amount of the civil penalty shall 

17 not exceed— 

18 ‘‘(I) in the case of the first viola19 tion, $500; 

20 ‘‘(II) in the case of a second viola21 tion within a 12-month period, $1,000; 

22 ‘‘(III) in the case of a third viola23 tion within a 24-month period, $2,000; 

24 ‘‘(IV) in the case of a fourth viola25 tion within a 24-month period, $4,000; 


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1 ‘‘(V) in the case of a fifth viola2 tion within a 36-month period, 

3 $10,000; and 

4 ‘‘(VI) in the case of a sixth or sub5 sequent violation within a 48-month 

6 period, $20,000 as determined by the 

7 Secretary on a case-by-case basis.’’. 

8 (b) APPLICABILITY.—The amendment made by sub9 section (a) applies with respect to a violation of a restric10 tion promulgated under section 906(d)(1) of the Federal 

11 Food, Drug, and Cosmetic Act (21 U.S.C. 387f(d)(1)), as 

12 described in section 103(q)(1) of the Family Smoking Pre13 vention and Tobacco Control Act (21 U.S.C. 333 note), oc14 curring on or after the date that is 6 months after the enact15 ment of this Act. The penalties specified in such section 

16 103(q)(1), as in effect on the day before such date, shall 

17 continue to apply to violations occurring before such date. 

18 SEC. 403. STUDY AND REPORT ON E-CIGARETTES. 

19 Not later than 5 years after the date of enactment of 

20 this Act, the Comptroller General of the United States 

21 shall— 

22 (1) complete a study on— 

23 (A) the relationship of e-cigarettes to to24 bacco cessation; 


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1 (B) the perception of the harmful effects of 

2 e-cigarettes; and 

3 (C) the effects of secondhand exposure to 

4 smoke from e-cigarettes; and 

5 (2) submit to the Congress a report on the results 

6 of such study, including recommendations based on 

7 such results. 


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Union Calendar No. 324 

116TH CONGRESS 

2D SESSION H. R. 2339 

[Report No. 116–402] 

A BILL 

To amend the Federal Food, Drug, and Cosmetic 

bacco products, and for other purposes. Act with respect to the sale and marketing of toFEBRUARY 21, 2020 

Reported with an amendment; committed to the Comand ordered to be printed mittee of the Whole House on the State of the Union 


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