E-Cigarette Device Standards Act of 2019

II 116TH CONGRESS 1ST SESSION S. 2536 To establish standards for the design of electronic nicotine delivery systems. IN THE SENATE OF THE UNITED STATES SEPTEMBER 24, 2019 Mr. MERKLEY (for himself, Ms. MURKOWSKI, Mr. DURBIN, Mr. BLUMENTHAL, and Mrs. SHAHEEN) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To establish standards for the design of electronic nicotine delivery systems. 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 ‘‘E-Cigarette Device 4 Standards Act of 2019’’. 5 SEC. 2. STANDARDS RELATING TO ELECTRONIC NICOTINE 6 DELIVERY SYSTEMS. 7 (a) ESTABLISHMENT OF STANDARDS.— 8 (1) IN GENERAL.—Section 907(a) of the Fed- 9 eral Food, Drug, and Cosmetic Act (21 U.S.C. 10 VerDate Sep 11 2014 03:27 Sep 25, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S2536.IS S2536 pamtmann on DSKBC07HB2PROD with BILLS 2 •S 2536 IS 387g(a)) is amended by adding at the end the fol- 1 lowing: 2 ‘‘(7) STANDARDS RELATING TO ELECTRONIC 3 NICOTINE DELIVERY SYSTEMS.—The Secretary shall 4 establish standards regarding the design of elec- 5 tronic nicotine delivery systems that, at a minimum, 6 prevent consumers from modifying or adding any 7 substances to electronic nicotine delivery systems 8 (including their components or parts) in a way that 9 is not intended by the manufacturer.’’. 10 (2) TIMING.—The Secretary of Health and 11 Human Services shall— 12 (A) not later than 180 days after the date 13 of enactment of this Act, issue proposed regula- 14 tions to carry out the amendment made by 15 paragraph (1); and 16 (B) not later than 1 year after the date of 17 enactment of this Act, issue final regulations to 18 carry out such amendment. 19 (b) DEFINITION.—Section 900 of the Federal Food, 20 Drug, and Cosmetic Act (21 U.S.C. 387) is amended— 21 (1) by redesignating paragraphs (8) through 22 (22) as paragraphs (9) through (23), respectively; 23 and 24 VerDate Sep 11 2014 03:27 Sep 25, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S2536.IS S2536 pamtmann on DSKBC07HB2PROD with BILLS 3 •S 2536 IS (2) by inserting after paragraph (7) the fol- 1 lowing: 2 ‘‘(8) ELECTRONIC NICOTINE DELIVERY SYS- 3 TEM.— 4 ‘‘(A) IN GENERAL.—The term ‘electronic 5 nicotine delivery system’ means any electronic 6 device that delivers nicotine, flavor, or another 7 substance via an aerosolized solution to the user 8 inhaling from the device (including e-cigarettes, 9 e-hookah, e-cigars, vapes, vape pens, advanced 10 refillable personal vaporizers, and electronic 11 pipes) and any component, liquid, part, or ac- 12 cessory of such a device, whether or not sold 13 separately, and includes components and parts 14 of the electronic nicotine delivery system. 15 ‘‘(B) COMPONENT OR PART.—With respect 16 to an electronic nicotine delivery system, the 17 terms ‘component’ and ‘part’— 18 ‘‘(i) mean any software or assembly of 19 materials intended or reasonably ex- 20 pected— 21 ‘‘(I) to alter or affect the tobacco 22 product’s performance, composition, 23 constituents or characteristics; or 24 VerDate Sep 11 2014 03:27 Sep 25, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S2536.IS S2536 pamtmann on DSKBC07HB2PROD with BILLS 4 •S 2536 IS ‘‘(II) to be used with or for the 1 human consumption of a tobacco 2 product; 3 ‘‘(ii) exclude anything that is an ac- 4 cessory of a tobacco product; and 5 ‘‘(iii) include e-liquids; atomizers; bat- 6 teries (with or without variable voltage); 7 cartomizers (atomizer plus replaceable 8 fluid-filled cartridge); digital display or 9 lights to adjust settings; clearomisers, tank 10 systems, flavors, vials that contain e-liq- 11 uids, and programmable software, flavor 12 enhancers and the vials in which such fla- 13 vor enhancers are contained; hose cooling 14 attachments; water filtration base additives 15 (including flavored additives); flavored 16 waterpipe tobacco charcoals and the wrap- 17 pers or boxes that contain the charcoals; 18 and bowls, valves, hoses, and heads.’’. 19 (c) CONFORMING AMENDMENT.—Section 9(1) of the 20 Comprehensive Smokeless Tobacco Health Education Act 21 of 1986 (15 U.S.C. 4408(1)) is amended by striking ‘‘sec- 22 tion 900(18)’’ and inserting ‘‘section 900(19)’’. 23 Æ VerDate Sep 11 2014 03:27 Sep 25, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6301 E:\BILLS\S2536.IS S2536 pamtmann on DSKBC07HB2PROD with BILLS