E-Cigarette Youth Protection Act

II 116TH CONGRESS 1ST SESSION S. 616 To impose user fees on manufacturers and importers of electronic nicotine delivery systems. IN THE SENATE OF THE UNITED STATES FEBRUARY 28, 2019 Mrs. SHAHEEN introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To impose user fees on manufacturers and importers 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 Youth 4 Protection Act’’. 5 SEC. 2. USER FEES RELATING TO ELECTRONIC NICOTINE 6 DELIVERY SYSTEMS. 7 (a) IN GENERAL.—Chapter IX of the Federal Food, 8 Drug, and Cosmetic Act (21 U.S.C. 387 et seq.) is amend- 9 ed by inserting after section 919 the following: 10 VerDate Sep 11 2014 03:30 Mar 07, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S616.IS S616 kjohnson on DSK79L0C42 with BILLS 2 •S 616 IS ‘‘SEC. 919A. USER FEES RELATING TO ELECTRONIC NICO- 1 TINE DELIVERY SYSTEMS. 2 ‘‘(a) ESTABLISHMENT OF QUARTERLY FEE.—Begin- 3 ning on the date of enactment of the E-Cigarette Youth 4 Protection Act, the Secretary shall in accordance with this 5 section assess user fees on, and collect such fees from, 6 each manufacturer and importer of electronic nicotine de- 7 livery systems. The fees shall be assessed and collected 8 with respect to each quarter of each fiscal year, and the 9 total amount assessed and collected for a fiscal year shall 10 be the amount specified in subsection (b)(1) for such year, 11 subject to subsection (c). 12 ‘‘(b) ASSESSMENT OF USER FEE.— 13 ‘‘(1) AMOUNT OF ASSESSMENT.—The total 14 amount of user fees authorized to be assessed and 15 collected under subsection (a) for a fiscal year is the 16 following, as applicable to the fiscal year involved: 17 ‘‘(A) For fiscal year 2020, the greater of— 18 ‘‘(i) $150,000,000; or 19 ‘‘(ii) 2 percent of the total value of 20 manufacturer sales of electronic nicotine 21 delivery systems in the United States in 22 fiscal year 2019. 23 ‘‘(B) For fiscal year 2021 and each fiscal 24 year thereafter, the greater of— 25 VerDate Sep 11 2014 03:30 Mar 07, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S616.IS S616 kjohnson on DSK79L0C42 with BILLS 3 •S 616 IS ‘‘(i) the amount described in subpara- 1 graph (A), increased by the percentage in- 2 crease in the Consumer Price Index be- 3 tween 2020 and the applicable year; or 4 ‘‘(ii) 2 percent of the total value of 5 manufacturer sales of electronic nicotine 6 delivery systems in the United States in 7 the previous fiscal year. 8 ‘‘(2) DETERMINATION OF USER FEE BY COM- 9 PANY.— 10 ‘‘(A) IN GENERAL.—The total user fee to 11 be paid by each manufacturer or importer of 12 electronic nicotine delivery systems shall be de- 13 termined for each quarter by multiplying— 14 ‘‘(i) such manufacturer’s or importer’s 15 percentage share of the total electronic nic- 16 otine delivery system market in the United 17 States; by 18 ‘‘(ii) the portion of the user fee 19 amount for the current quarter to be as- 20 sessed on all manufacturers and importers 21 under paragraph (1). 22 ‘‘(B) NO FEE IN EXCESS OF PERCENTAGE 23 SHARE.—No manufacturer or importer of elec- 24 tronic nicotine delivery systems shall be re- 25 VerDate Sep 11 2014 03:30 Mar 07, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S616.IS S616 kjohnson on DSK79L0C42 with BILLS 4 •S 616 IS quired to pay a user fee in excess of the per- 1 centage share of the total electronic nicotine de- 2 livery system market of the manufacturer or 3 importer. 4 ‘‘(3) TIMING OF ASSESSMENT.—The Secretary 5 shall notify each manufacturer and importer of elec- 6 tronic nicotine delivery systems subject to this sec- 7 tion of the amount of the quarterly assessment im- 8 posed on such manufacturer or importer under this 9 subsection for each quarter of each fiscal year. Such 10 notifications shall occur not later than 30 days prior 11 to the end of the quarter for which such assessment 12 is made, and payments of all assessments shall be 13 made by the last day of the quarter involved. 14 ‘‘(4) CALCULATION OF MARKET SHARE.—Be- 15 ginning not later than fiscal year 2020, and for each 16 subsequent fiscal year, the Secretary shall ensure 17 that the Food and Drug Administration is able to 18 determine— 19 ‘‘(A) the annual amount of total sales in 20 the electronic nicotine delivery system market of 21 the United States; and 22 ‘‘(B) the applicable percentage shares 23 under paragraph (2)(A). 24 ‘‘(c) CREDITING AND AVAILABILITY OF FEES.— 25 VerDate Sep 11 2014 03:30 Mar 07, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S616.IS S616 kjohnson on DSK79L0C42 with BILLS 5 •S 616 IS ‘‘(1) IN GENERAL.—Fees authorized under sub- 1 section (a) shall be collected and available for obliga- 2 tion only to the extent and in the amount provided 3 in advance in appropriations Acts. Such fees are au- 4 thorized to remain available until expended. Such 5 sums as may be necessary may be transferred from 6 the Food and Drug Administration salaries and ex- 7 penses appropriation account without fiscal year lim- 8 itation to such appropriation account for salaries 9 and expenses with such fiscal year limitation. 10 ‘‘(2) AUTHORIZATION OF APPROPRIATIONS.— 11 For fiscal year 2021 and each subsequent fiscal 12 year, there is authorized to be appropriated for fees 13 under this section an amount equal to the amount 14 specified in subsection (b)(1) for the fiscal year. 15 ‘‘(d) COLLECTION OF UNPAID FEES.—In any case 16 where the Secretary does not receive payment of a fee as- 17 sessed under subsection (a) within 30 days after it is due, 18 such fee shall be treated as a claim of the United States 19 Government subject to subchapter II of chapter 37 of title 20 31, United States Code. 21 ‘‘(e) APPLICABILITY TO FISCAL YEAR 2020.—If the 22 date of enactment of the E-Cigarette Youth Protection Act 23 occurs during fiscal year 2020, subject to subsection (c), 24 for the quarter following the quarter in which such date 25 VerDate Sep 11 2014 03:30 Mar 07, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S616.IS S616 kjohnson on DSK79L0C42 with BILLS 6 •S 616 IS of enactment occurs, the full quarterly fee amounts shall 1 be assessed and collected.’’. 2 (b) ENFORCEMENT.— 3 (1) IN GENERAL.—Section 902(4) of the Fed- 4 eral Food, Drug, and Cosmetic Act (21 U.S.C. 5 387b(4)) is amended by inserting ‘‘, or the manufac- 6 turer or importer of electronic nicotine delivery sys- 7 tems fails to pay a user fee assessed to such manu- 8 facturer or importer pursuant to section 919A by 9 the date specified in section 919A or by the 30th 10 day after final agency action on a resolution of any 11 dispute as to the amount of such fee’’ before the 12 semicolon. 13 (2) EFFECTIVE DATE.—The amendment made 14 by paragraph (1) shall take effect on the later of Oc- 15 tober 1, 2021, or the date of enactment of this Act. 16 (c) DEFINITION.—Section 900 of the Federal Food, 17 Drug, and Cosmetic Act (21 U.S.C. 387) is amended— 18 (1) by redesignating paragraphs (8) through 19 (22) as paragraphs (9) through (23), respectively; 20 and 21 (2) by inserting after paragraph (7) the fol- 22 lowing: 23 VerDate Sep 11 2014 03:30 Mar 07, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S616.IS S616 kjohnson on DSK79L0C42 with BILLS 7 •S 616 IS ‘‘(8) ELECTRONIC NICOTINE DELIVERY SYS- 1 TEM.—The term ‘electronic nicotine delivery sys- 2 tem’— 3 ‘‘(A) means any electronic device that de- 4 livers nicotine, flavor, or another substance via 5 an aerosolized solution to the user inhaling 6 from the device (including e-cigarettes, e-hook- 7 ah, e-cigars, vape pens, advanced refillable per- 8 sonal vaporizers, and electronic pipes) and any 9 component, liquid, part, or accessory of such a 10 device, whether or not sold separately; and 11 ‘‘(B) does not include a product that— 12 ‘‘(i) is approved by the Food and 13 Drug Administration for sale as a tobacco 14 cessation product or for another thera- 15 peutic purpose; and 16 ‘‘(ii) is marketed and sold solely for a 17 purpose described in clause (i).’’. 18 Æ VerDate Sep 11 2014 03:30 Mar 07, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6301 E:\BILLS\S616.IS S616 kjohnson on DSK79L0C42 with BILLS