Reversing the Youth Tobacco Epidemic Act of 2020

II 116TH CONGRESS 2D SESSION S. 3174 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 SENATE OF THE UNITED STATES JANUARY 9, 2020 Mr. BROWN (for himself, Mr. MERKLEY, Mr. BLUMENTHAL, Mr. WHITE- HOUSE, Mr. MARKEY, Mr. DURBIN, Mr. REED, Mr. CARDIN, and Ms. HARRIS) 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 with respect to the sale and marketing of tobacco products, and for other purposes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Reversing the Youth 4 Tobacco Epidemic Act of 2020’’. 5 SEC. 2. TABLE OF CONTENTS. 6 The table of contents of this Act is as follows: 7 Sec. 1. Short title. Sec. 2. Table of contents. VerDate Sep 11 2014 21:26 Jan 13, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6211 E:\BILLS\S3174.IS S3174 jbell on DSKJLSW7X2PROD with BILLS 2 •S 3174 IS 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. Fees applicable to all tobacco products. Sec. 105. Regulation of products containing synthetic nicotine. Sec. 106. Update to youth tobacco prevention public awareness campaigns. Sec. 107. Public education. 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 ces- sation in medically underserved communities. TITLE IV—NICOTINE OR VAPING ACCESS PROTECTION AND ENFORCEMENT Sec. 401. Increasing civil penalties applicable to certain violations of restric- tions on sale and distribution of tobacco products. Sec. 402. Study and report on e-cigarettes. TITLE I—FOOD AND DRUG 1 ADMINISTRATION 2 SEC. 101. CIGARETTE GRAPHIC HEALTH WARNINGS. 3 (a) ISSUANCE DEADLINES.—Not later than March 4 15, 2020, the Secretary of Health and Human Services, 5 acting through the Commissioner of Food and Drugs, 6 shall publish a final rule pursuant to the first subsection 7 (d) of section 4 of the Federal Cigarette Labeling and Ad- 8 vertising Act (15 U.S.C. 1333). If the Secretary fails to 9 promulgate such final rule by March 15, 2020, the pro- 10 posed rule entitled ‘‘Tobacco Products; Required Warn- 11 ings for Cigarette Packages and Advertisements’’ (84 Fed. 12 Reg. 42754 (August 16, 2019)) shall be treated as a final 13 rule beginning on March 16, 2020. 14 VerDate Sep 11 2014 21:26 Jan 13, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S3174.IS S3174 jbell on DSKJLSW7X2PROD with BILLS 3 •S 3174 IS (b) CONFORMING CHANGE.—The first subsection (d) 1 of section 4 of the Federal Cigarette Labeling and Adver- 2 tising Act (15 U.S.C. 1333) is amended by striking ‘‘Not 3 later than 24 months after the date of enactment of the 4 Family Smoking Prevention and Tobacco Control Act, the 5 Secretary’’ and inserting ‘‘The Secretary’’. 6 SEC. 102. ADVERTISING AND SALES PARITY FOR ALL 7 DEEMED TOBACCO PRODUCTS. 8 (a) IN GENERAL.—Not later than 1 year after the 9 date of enactment of this Act, the Secretary of Health and 10 Human Services, acting through the Commissioner of 11 Food and Drugs, shall promulgate a final rule amending 12 part 1140 of subchapter K of title 21, Code of Federal 13 Regulations (or any corresponding similar regulation or 14 ruling)— 15 (1) to apply the provisions of such part 1140 16 (or any corresponding similar regulation or ruling) 17 to all tobacco products, as applicable, to which chap- 18 ter IX of the Federal Food, Drug, and Cosmetic Act 19 (21 U.S.C. 387 et seq.) applies pursuant to section 20 901(b) of such Act (21 U.S.C. 387a(b)), as amended 21 by section 103(a) of this Act; and 22 (2) to make such changes as may be necessary 23 for applicability to specific tobacco products and 24 VerDate Sep 11 2014 21:26 Jan 13, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S3174.IS S3174 jbell on DSKJLSW7X2PROD with BILLS 4 •S 3174 IS consistency with the amendments made by section 1 103 of this Act. 2 (b) EFFECTIVE DATE.—The final rule required by 3 subsection (a) shall take effect on the date that is 2 years 4 after the date of enactment of this Act. 5 SEC. 103. REDUCING CHILD AND ADOLESCENT NICOTINE 6 ADDICTION. 7 (a) APPLICABILITY TO ALL TOBACCO PRODUCTS.— 8 (1) IN GENERAL.—Subsection (b) of section 9 901 of the Federal Food, Drug, and Cosmetic Act 10 (21 U.S.C. 387a) is amended to read as follows: 11 ‘‘(b) APPLICABILITY.—This chapter shall apply to all 12 tobacco products.’’. 13 (2) RULE OF CONSTRUCTION.—Section 901(b) 14 of the Federal Food, Drug, and Cosmetic Act (21 15 U.S.C. 387a(b)), as amended by paragraph (1), shall 16 not be construed to limit the applicability of chapter 17 IX of the Federal Food, Drug, and Cosmetic Act 18 (21 U.S.C. 387 et seq.) to— 19 (A) products that were listed in section 20 901(b) of such Act as in effect on the day be- 21 fore the date of enactment of this Act; and 22 (B) products that were deemed by regula- 23 tion to be subject to such chapter pursuant to 24 VerDate Sep 11 2014 21:26 Jan 13, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S3174.IS S3174 jbell on DSKJLSW7X2PROD with BILLS 5 •S 3174 IS section 901(b) of such Act as in effect on the 1 day before the date of enactment of this Act. 2 (b) PROHIBITION AGAINST REMOTE RETAIL 3 SALES.—Paragraph (4) of section 906(d) of the Federal 4 Food, Drug, and Cosmetic Act (21 U.S.C. 387f(d)) is 5 amended to read as follows: 6 ‘‘(4) PROHIBITION AGAINST REMOTE RETAIL 7 SALES.—Not later than 2 years after the date of en- 8 actment of the Reversing the Youth Tobacco Epi- 9 demic Act of 2020, the Secretary shall promulgate 10 a final regulation under paragraph (1) prohibiting 11 the retail sale of all tobacco products and all compo- 12 nents, parts, and accessories of tobacco products, 13 other than retail sales through a direct, face-to-face 14 exchange between a retailer and a consumer.’’. 15 (c) PROHIBITING FLAVORING OF TOBACCO PROD- 16 UCTS.— 17 (1) PROHIBITION.— 18 (A) IN GENERAL.—Subparagraph (A) of 19 section 907(a)(1) of the Federal Food, Drug, 20 and Cosmetic Act (21 U.S.C. 387g(a)(1)) is 21 amended to read as follows: 22 ‘‘(A) SPECIAL RULES.— 23 ‘‘(i) IN GENERAL.—A tobacco product 24 (including its components, parts, and ac- 25 VerDate Sep 11 2014 21:26 Jan 13, 2020 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S3174.IS S3174 jbell on DSKJLSW7X2PROD with BILLS 6 •S 3174 IS cessories, including the tobacco, filter, or 1 paper) that is not an electronic nicotine de- 2 livery system shall not contain, as a con- 3 stituent (including a smoke constituent) or 4 additive, an artificial or natural flavor 5 (other than tobacco) that is a character- 6 izing flavor of the tobacco product or to- 7 bacco smoke or an herb or spice, including 8 menthol, mint, strawberry, grape, orange, 9 clove, cinnamon, pineapple, vanilla, coco- 10 nut, licorice, cocoa, chocolate, cherry, or 11 coffee. 12 ‘‘(ii) RULE OF CONSTRUCTION.— 13 Nothing in this subparagraph shall be con- 14 strued to limit the Secretary’s authority to 15 take action under this section or other sec- 16 tions of this Act applicable to any artificial 17 or natural flavor, herb, or spice. 18 ‘‘(iii) APPLICABILITY TO CERTAIN IN- 19 DIVIDUALS.—Notwithstanding any provi- 20 sion of this Act, no individual who pur- 21 chases or possess for consumption a to- 22 bacco product that is in violation of the 23 prohibition under this subparagraph shall 24 be subject to any criminal penalty under 25 VerDate Sep 11 2014 21:26 Jan 13, 2020 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S3174.IS S3174 jbell on DSKJLSW7X2PROD with BILLS 7 •S 3174 IS this Act for such purchase or possession, 1 nor shall it be used as a justification to 2 stop, search, or conduct any other inves- 3 tigative measure against any individual.’’. 4 (B) EFFECTIVE DATE.—The amendment 5 made by subparagraph (A) shall take effect 1 6 year after the date of enactment of this Act. 7 (2) FLAVORED ELECTRONIC NICOTINE DELIV- 8 ERY SYSTEM.—Section 910 of the Federal Food, 9 Drug, and Cosmetic Act (21 U.S.C. 387j) is amend- 10 ed by inserting at the end the following: 11 ‘‘(h) FLAVORED ELECTRONIC NICOTINE DELIVERY 12 SYSTEMS.— 13 ‘‘(1) RESTRICTION.—Beginning on the date 14 that is 30 days after the date of enactment of the 15 Reversing the Youth Tobacco Epidemic Act of 2020, 16 any flavored electronic nicotine delivery system that 17 is a new tobacco product, including any liquid, solu- 18 tion, or other component or part or its aerosol, shall 19 not contain an artificial or natural flavor (other than 20 tobacco) that is a characterizing flavor, including 21 menthol, mint, strawberry, grape, orange, clove, cin- 22 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 VerDate Sep 11 2014 21:26 Jan 13, 2020 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S3174.IS S3174 jbell on DSKJLSW7X2PROD with BILLS 8 •S 3174 IS (2). Nothing in this paragraph shall be construed to 1 limit the Secretary’s authority to take action under 2 this section or other sections of this Act applicable 3 to 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 sys- 8 tem, including any liquid, solution, or other compo- 9 nent or part or its aerosol, that contains an artificial 10 or natural flavor (other than tobacco) that is a char- 11 acterizing flavor, unless the Secretary issues an 12 order finding that the manufacturer has dem- 13 onstrated that— 14 ‘‘(A) use of the characterizing flavor— 15 ‘‘(i) will significantly increase the like- 16 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 elec- 22 tronic nicotine delivery system; and 23 ‘‘(B) such electronic nicotine delivery sys- 24 tem is not more harmful to users than an elec- 25 VerDate Sep 11 2014 21:26 Jan 13, 2020 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S3174.IS S3174 jbell on DSKJLSW7X2PROD with BILLS 9 •S 3174 IS tronic nicotine delivery system that does not 1 contain any characterizing flavors.’’. 2 (3) DEFINITION OF ELECTRONIC NICOTINE DE- 3 LIVERY SYSTEM.—Section 900 of the Federal Food, 4 Drug, and Cosmetic Act (21 U.S.C. 387) is amend- 5 ed— 6 (A) by redesignating paragraphs (8) 7 through (22) as paragraphs (9) through (23), 8 respectively; and 9 (B) by inserting after paragraph (7) the 10 following new paragraph: 11 ‘‘(8) ELECTRONIC NICOTINE DELIVERY SYS- 12 TEM.—The term ‘electronic nicotine delivery sys- 13 tem’— 14 ‘‘(A) means any electronic device that de- 15 livers nicotine, flavor, or another substance via 16 an aerosolized solution to the user inhaling 17 from the device (including e-cigarettes, e-hook- 18 ah, e-cigars, vape pens, advanced refillable per- 19 sonal vaporizers, and electronic pipes) and any 20 component, liquid, part, or accessory of such a 21 device, whether or not sold separately; and 22 ‘‘(B) does not include a product that— 23 ‘‘(i) is approved by the Food and 24 Drug Administration for sale as a tobacco 25 VerDate Sep 11 2014 21:26 Jan 13, 2020 Jkt 099200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S3174.IS S3174 jbell on DSKJLSW7X2PROD with BILLS 10 •S 3174 IS cessation product or for another thera- 1 peutic purpose; and 2 ‘‘(ii) is marketed and sold solely for a 3 purpose described in clause (i).’’. 4 SEC. 104. FEES APPLICABLE TO ALL TOBACCO PRODUCTS. 5 (a) INCREASE IN TOTAL AMOUNT.—Section 6 919(b)(1) of the Federal Food, Drug, and Cosmetic Act 7 (21 U.S.C. 387s(b)(1)) is amended by striking subpara- 8 graph (K) and inserting the following subparagraphs: 9 ‘‘(K) For fiscal year 2019, $712,000,000. 10 ‘‘(L) For fiscal year 2020, $812,000,000. 11 ‘‘(M) For each subsequent fiscal year, the 12 amount that was applicable for the previous fis- 13 cal year, adjusted by the total percentage 14 change that occurred in the Consumer Price 15 Index for all urban consumers (all items; 16 United States city average) for the 12-month 17 period ending June 30 preceding the fiscal 18 year.’’. 19 (b) APPLICATION OF USER FEES TO ALL CLASSES 20 OF TOBACCO PRODUCTS.— 21 (1) IN GENERAL.—Subparagraph (A) of section 22 919(b)(2) of the Federal Food, Drug, and Cosmetic 23 Act (21 U.S.C. 387s(b)(2)) is amended to read as 24 follows: 25 VerDate Sep 11 2014 21:26 Jan 13, 2020 Jkt 099200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S3174.IS S3174 jbell on DSKJLSW7X2PROD with BILLS 11 •S 3174 IS ‘‘(A) IN GENERAL.— 1 ‘‘(i) FISCAL YEARS 2020 AND 2021.— 2 For fiscal years 2020 and 2021, user fees 3 shall be assessed and collected under sub- 4 section (a) only with respect to the classes 5 of tobacco products listed in subparagraph 6 (B)(i), and the total such user fees with re- 7 spect to each such class shall be an 8 amount that is equal to the applicable per- 9 centage of each such class for the fiscal 10 year multiplied by the amount specified in 11 paragraph (1) for the fiscal year. 12 ‘‘(ii) SUBSEQUENT FISCAL YEARS.— 13 For fiscal year 2022 and each subsequent 14 fiscal year, user fees shall be assessed and 15 collected under subsection (a) with respect 16 to each class of tobacco products to which 17 this chapter applies, and the total user fees 18 with respect to each class shall be— 19 ‘‘(I) with respect to each class of 20 tobacco products listed in subpara- 21 graph (B)(i), an amount that is cal- 22 culated in the same way as the 23 amounts calculated for fiscal years 24 2020 and 2021 under clause (i), ex- 25 VerDate Sep 11 2014 21:26 Jan 13, 2020 Jkt 099200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S3174.IS S3174 jbell on DSKJLSW7X2PROD with BILLS 12 •S 3174 IS cept that for purposes of fiscal years 1 2022 and subsequent fiscal years, in- 2 stead of multiplying the applicable 3 percentage of each class by ‘the 4 amount specified in paragraph (1) for 5 the fiscal year’, the applicable percent- 6 age shall be multiplied by— 7 ‘ [Text truncated for display. 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