Protecting American Lungs and Reversing the Youth Tobacco Epidemic Act of 2020

IIB 116TH CONGRESS 2D SESSION H. R. 2339 IN THE SENATE OF THE UNITED STATES MARCH 2, 2020 Received; read twice and referred to the Committee on Finance AN ACT 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 VerDate Sep 11 2014 22:35 Mar 02, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H2339.RFS H2339 pamtmann on DSKBC07HB2PROD with BILLS 2 HR 2339 RFS SECTION 1. SHORT TITLE. 1 This Act may be cited as the ‘‘Protecting American 2 Lungs and Reversing the Youth Tobacco Epidemic Act of 3 2020’’. 4 SEC. 2. TABLE OF CONTENTS. 5 The table of contents of this Act is as follows: 6 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 alternative nicotine. Sec. 107. Update to youth tobacco prevention public awareness campaigns. Sec. 108. Exemption from premarket review 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 ces- sation in medically underserved communities. Sec. 303. Public awareness, education, and prevention campaign. Sec. 304. Tobacco cessation treatment grants to health centers. Sec. 305. Grants for research. 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 V—EXCISE TAX ON NICOTINE USED IN VAPING, ETC. Sec. 501. Imposition of tax on nicotine for use in vaping, etc. TITLE VI—FURTHER HEALTH INVESTMENTS Sec. 601. Waiving Medicare coinsurance for colorectal cancer screening tests. Sec. 602. Safe harbor for high deductible health plans without deductible for certain inhalers. VerDate Sep 11 2014 22:35 Mar 02, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6211 E:\BILLS\H2339.RFS H2339 pamtmann on DSKBC07HB2PROD with BILLS 3 HR 2339 RFS 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 section 4(d) of the 7 Federal Cigarette Labeling and Advertising Act (15 8 U.S.C. 1333(d)). If the Secretary fails to promulgate such 9 final rule by March 15, 2020, then the proposed rule titled 10 ‘‘Tobacco Products; Required Warnings for Cigarette 11 Packages and Advertisements’’ published by the Food and 12 Drug Administration on August 16, 2019 (84 Fed. Reg. 13 42754) shall be treated as a final rule beginning on March 14 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 19 the date of enactment of the Family Smoking Prevention 20 and Tobacco Control Act, the Secretary’’ and inserting 21 ‘‘The Secretary’’. 22 VerDate Sep 11 2014 22:35 Mar 02, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H2339.RFS H2339 pamtmann on DSKBC07HB2PROD with BILLS 4 HR 2339 RFS SEC. 102. ADVERTISING AND SALES PARITY FOR ALL 1 DEEMED TOBACCO PRODUCTS. 2 (a) IN GENERAL.—Not later than 1 year after the 3 date of enactment of this Act, the Secretary of Health and 4 Human Services, acting through the Commissioner of 5 Food and Drugs, shall promulgate a final rule amending 6 part 1140 of subchapter K of title 21, Code of Federal 7 Regulations, to apply the provisions of such part 1140 to 8 all tobacco products, as applicable, to which chapter IX 9 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 10 387a et seq.) applies pursuant to section 901(b) of such 11 Act (21 U.S.C. 387a(b)), as amended by section 103(a) 12 of this Act. 13 (b) EFFECTIVE DATE.—The final rule required by 14 subsection (a) shall take effect on the date that is 2 years 15 after the date of enactment of this Act. 16 SEC. 103. REDUCING CHILD AND ADOLESCENT NICOTINE 17 ADDICTION. 18 (a) APPLICABILITY TO ALL TOBACCO PRODUCTS.— 19 (1) IN GENERAL.—Subsection (b) of section 20 901 of the Federal Food, Drug, and Cosmetic Act 21 (21 U.S.C. 387a) is amended to read as follows: 22 ‘‘(b) APPLICABILITY.—This chapter shall apply to all 23 tobacco products.’’. 24 (2) RULE OF CONSTRUCTION.—Paragraph (1) 25 and the amendment made thereby shall not be con- 26 VerDate Sep 11 2014 22:35 Mar 02, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H2339.RFS H2339 pamtmann on DSKBC07HB2PROD with BILLS 5 HR 2339 RFS strued to limit the applicability of chapter IX of the 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 be- 5 fore the date of enactment of this Act; and 6 (B) products that were deemed by regula- 7 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) PROHIBITING FLAVORING OF TOBACCO PROD- 11 UCTS.— 12 (1) PROHIBITION.— 13 (A) IN GENERAL.—Subparagraph (A) of 14 section 907(a)(1) of the Federal Food, Drug, 15 and Cosmetic Act (21 U.S.C. 387g(a)(1)) is 16 amended 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 enact- 20 ment of the Protecting American Lungs 21 and Reversing the Youth Tobacco Epi- 22 demic Act of 2020, a tobacco product (in- 23 cluding its components, parts, and acces- 24 sories, including the tobacco, filter, or 25 VerDate Sep 11 2014 22:35 Mar 02, 2020 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H2339.RFS H2339 pamtmann on DSKBC07HB2PROD with BILLS 6 HR 2339 RFS paper) that is not an electronic nicotine de- 1 livery system shall not contain, as a con- 2 stituent (including a smoke constituent) or 3 additive, an artificial or natural flavor 4 (other than tobacco) that is a character- 5 izing flavor of the tobacco product or to- 6 bacco smoke or an herb or spice, including 7 menthol, mint, mango, strawberry, grape, 8 orange, clove, cinnamon, pineapple, vanilla, 9 coconut, licorice, cocoa, chocolate, cherry, 10 or coffee. 11 ‘‘(ii) RULE OF CONSTRUCTION.— 12 Nothing in this subparagraph shall be con- 13 strued to limit the Secretary’s authority to 14 take action under this section or other sec- 15 tions of this Act applicable to any artificial 16 or natural flavor, herb, or spice. 17 ‘‘(iii) APPLICABILITY TO CERTAIN IN- 18 DIVIDUALS.—Notwithstanding any provi- 19 sion of this Act, no individual who pur- 20 chases for individual consumption, pos- 21 sesses for individual consumption, or con- 22 sumes, a tobacco product that is in viola- 23 tion of the prohibition under this subpara- 24 graph, including a tobacco product that 25 VerDate Sep 11 2014 22:35 Mar 02, 2020 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H2339.RFS H2339 pamtmann on DSKBC07HB2PROD with BILLS 7 HR 2339 RFS contains a characterizing flavor of menthol, 1 shall be subject to any criminal penalty 2 under this Act for such purchase, posses- 3 sion, or consumption, nor shall such pur- 4 chase, possession, or consumption be used 5 as a justification to stop, search, or con- 6 duct any other investigative measure 7 against any individual.’’. 8 (B) SAVINGS PROVISION.—Section 9 907(a)(1) of the Federal Food, Drug, and Cos- 10 metic Act (21 U.S.C. 387g(a)(1)), as in effect 11 on the date of enactment of this Act, shall re- 12 main in effect until the amendment made to 13 such section 907(a)(1) by this paragraph takes 14 effect. 15 (2) FLAVORED ELECTRONIC NICOTINE DELIV- 16 ERY SYSTEM.—Section 910 of the Federal Food, 17 Drug, and Cosmetic Act (21 U.S.C. 387j) is amend- 18 ed by inserting at the end the following: 19 ‘‘(h) FLAVORED ELECTRONIC NICOTINE DELIVERY 20 SYSTEMS.— 21 ‘‘(1) RESTRICTION.—Beginning on the date 22 that is 30 days after the date of enactment of the 23 Protecting American Lungs and Reversing the 24 Youth Tobacco Epidemic Act of 2020, any flavored 25 VerDate Sep 11 2014 22:35 Mar 02, 2020 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H2339.RFS H2339 pamtmann on DSKBC07HB2PROD with BILLS 8 HR 2339 RFS electronic nicotine delivery system that is a new to- 1 bacco product, including any solution or other com- 2 ponent or part (such as a liquid or its aerosol) shall 3 not contain an artificial or natural flavor (other than 4 tobacco) that is a characterizing flavor, including 5 menthol, mint, mango, strawberry, grape, orange, 6 clove, cinnamon, pineapple, vanilla, coconut, licorice, 7 cocoa, chocolate, cherry, or coffee, unless the Sec- 8 retary has issued a marketing order as described in 9 paragraph (2). Nothing in this paragraph shall be 10 construed to limit the Secretary’s authority to take 11 action under this section or other sections of this 12 Act applicable to any artificial or natural flavor, 13 herb, or spice. 14 ‘‘(2) REVIEW.—The Secretary shall not issue a 15 marketing order under subsection (c)(1)(A)(i) or a 16 substantial equivalence order under subsection 17 (a)(2)(A)(i) for any electronic nicotine delivery sys- 18 tem, including any liquid, solution, or other compo- 19 nent or part or its aerosol, that contains an artificial 20 or natural flavor (other than tobacco) that is a char- 21 acterizing flavor, unless the Secretary issues an 22 order finding that the manufacturer has dem- 23 onstrated that— 24 ‘‘(A) use of the characterizing flavor— 25 VerDate Sep 11 2014 22:35 Mar 02, 2020 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H2339.RFS H2339 pamtmann on DSKBC07HB2PROD with BILLS 9 HR 2339 RFS ‘‘(i) will significantly increase the like- 1 lihood of smoking cessation among current 2 users of tobacco products; and 3 ‘‘(ii) will not increase the likelihood 4 that individuals who do not use tobacco 5 products, including youth, will start using 6 any tobacco product, including an elec- 7 tronic nicotine delivery system; and 8 ‘‘(B) such electronic nicotine delivery sys- 9 tem is not more harmful to users than an elec- 10 tronic nicotine delivery system that does not 11 contain any characterizing flavors.’’. 12 (3) DEFINITION OF ELECTRONIC NICOTINE DE- 13 LIVERY SYSTEM.—Section 900 of the Federal Food, 14 Drug, and Cosmetic Act (21 U.S.C. 387) is amend- 15 ed— 16 (A) by redesignating paragraphs (8) 17 through (22) as paragraphs (9) through (23), 18 respectively; and 19 (B) by inserting after paragraph (7) the 20 following new paragraph: 21 ‘‘(8) ELECTRONIC NICOTINE DELIVERY SYS- 22 TEM.—The term ‘electronic nicotine delivery system’ 23 means a tobacco product that is an electronic device 24 that delivers nicotine, flavor, or another substance 25 VerDate Sep 11 2014 22:35 Mar 02, 2020 Jkt 099200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H2339.RFS H2339 pamtmann on DSKBC07HB2PROD with BILLS 10 HR 2339 RFS via an aerosolized solution to the user inhaling from 1 the device (including e-cigarettes, e-hookah, e-cigars, 2 vape pens, advanced refillable personal vaporizers, 3 and electronic pipes) and any component, liquid, 4 part, or accessory of such a device, whether or not 5 sold separately.’’. 6 (4) LIMITATION ON ENFORCEMENT.—A law en- 7 forcement officer of a State or political subdivision 8 thereof may not enforce (including by making any 9 stop, search, seizure, or arrest or by pursuing any 10 prosecution, trial, or punishment) any provision of 11 section 907(a)(1)(A) or 910(h) of the Federal Food, 12 Drug, and Cosmetic Act, as amended and added by 13 this subsection. 14 SEC. 104. PROHIBITION AGAINST REMOTE RETAIL SALES. 15 (a) IN GENERAL.—Paragraph (4) of section 906(d) 16 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 17 387f(d)) is amended to read as follows: 18 ‘‘(4) PROHIBITION AGAINST REMOTE RETAIL 19 SALES.— 20 ‘‘(A) PROHIBITION.—Not later than 18 21 months after the date of enactment of the Pro- 22 tecting American Lungs and Reversing the 23 Youth Tobacco Epidemic Act of 2020, the Sec- 24 retary shall promulgate a final regulation pro- 25 VerDate Sep 11 2014 22:35 Mar 02, 2020 Jkt 099200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H2339.RFS H2339 pamtmann on DSKBC07HB2PROD with BILLS 11 HR 2339 RFS hibiting the retail sale of all tobacco products 1 other than retail sales through a direct, face-to- 2 face exchange between a retailer and a con- 3 sumer. 4 ‘‘(B) EXCEPTION FOR CERTAIN CIGAR TO- 5 BACCO PRODUCTS.— 6 ‘‘(i) EXCEPTION.—The regulation re- 7 quired by subparagraph (A) shall not apply 8 to tobacco products described in section 9 910(a)(2)(A)(iii). 10 ‘‘(ii) APPLICABLE REQUIREMENTS.— 11 Not later than 18 months after the date of 12 enactment of the Protecting American 13 Lungs and Reversing the Youth Tobacco 14 Epidemic Act of 2020, the Secretary shall 15 promulgate regulations regarding the sale 16 and distribution of tobacco products de- 17 scribed in section 910(a)(2)(A)(iii) that 18 occur through means other than a direct, 19 face-to-face exchange between a retailer 20 and a consumer in order to prevent the 21 sale and distribution of tobacco products 22 described in section 910(a)(2)(A)(iii) to in- 23 dividuals who have not attained the min- 24 imum age established by applicable law for 25 VerDate Sep 11 2014 22:35 Mar 02, 2020 Jkt 099200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H2339.RFS H2339 pamtmann on DSKBC07HB2PROD with BILLS 12 HR 2339 RFS the purchase of such products, including 1 requirements for age verification. 2 ‘‘(C) RELATION TO OTHER AUTHORITY.— 3 Nothing in this paragraph— 4 ‘‘(i) limits the authority of the Sec- 5 retary to take additional actions under 6 other provisions of this Act; or 7 ‘‘(ii) preempts the authority of a State 8 or local government to establish restric- 9 tions on the retail sale of tobacco products 10 that are in addition to, or more stringent 11 than, the prohibition under subparagraph 12 (A).’’. 13 (b) APPLICABILITY.—Sec [Text truncated for display. 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