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. 

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 ‘‘E-Cigarette Youth 

5 Protection Act’’. 

6 SEC. 2. USER FEES RELATING TO ELECTRONIC NICOTINE 

7 DELIVERY SYSTEMS. 

8 (a) IN GENERAL.—Chapter IX of the Federal Food, 

9 Drug, and Cosmetic Act (21 U.S.C. 387 et seq.) is amend10 ed by inserting after section 919 the following: 


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1 ‘‘SEC. 919A. USER FEES RELATING TO ELECTRONIC NICO2 TINE DELIVERY SYSTEMS. 

3 ‘‘(a) ESTABLISHMENT OF QUARTERLY FEE.—Begin4 ning on the date of enactment of the E-Cigarette Youth 

5 Protection Act, the Secretary shall in accordance with this 

6 section assess user fees on, and collect such fees from, 

7 each manufacturer and importer of electronic nicotine de8 livery systems. The fees shall be assessed and collected 

9 with respect to each quarter of each fiscal year, and the 

10 total amount assessed and collected for a fiscal year shall 

11 be the amount specified in subsection (b)(1) for such year, 

12 subject to subsection (c). 

13 ‘‘(b) ASSESSMENT OF USER FEE.— 

14 ‘‘(1) AMOUNT OF ASSESSMENT.—The total 

15 amount of user fees authorized to be assessed and 

16 collected under subsection (a) for a fiscal year is the 

17 following, as applicable to the fiscal year involved: 

18 ‘‘(A) For fiscal year 2020, the greater of— 

19 ‘‘(i) $150,000,000; or 

20 ‘‘(ii) 2 percent of the total value of 

21 manufacturer sales of electronic nicotine 

22 delivery systems in the United States in 

23 fiscal year 2019. 

24 ‘‘(B) For fiscal year 2021 and each fiscal 

25 year thereafter, the greater of— 


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1 ‘‘(i) the amount described in subpara2 graph (A), increased by the percentage in3 crease in the Consumer Price Index be4 tween 2020 and the applicable year; or 

5 ‘‘(ii) 2 percent of the total value of 

6 manufacturer sales of electronic nicotine 

7 delivery systems in the United States in 

8 the previous fiscal year. 

9 ‘‘(2) DETERMINATION OF USER FEE BY COM10 PANY.— 

11 ‘‘(A) IN GENERAL.—The total user fee to 

12 be paid by each manufacturer or importer of 

13 electronic nicotine delivery systems shall be de14 termined for each quarter by multiplying— 

15 ‘‘(i) such manufacturer’s or importer’s 

16 percentage share of the total electronic nic17 otine delivery system market in the United 

18 States; by 

19 ‘‘(ii) the portion of the user fee 

20 amount for the current quarter to be as21 sessed on all manufacturers and importers 

22 under paragraph (1). 

23 ‘‘(B) NO FEE IN EXCESS OF PERCENTAGE

24 SHARE.—No manufacturer or importer of elec25 tronic nicotine delivery systems shall be reVerDate Sep 11 2014 03:30 Mar 07, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S616.IS S616

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1 quired to pay a user fee in excess of the per2 centage share of the total electronic nicotine de3 livery system market of the manufacturer or 

4 importer. 

5 ‘‘(3) TIMING OF ASSESSMENT.—The Secretary 

6 shall notify each manufacturer and importer of elec7 tronic nicotine delivery systems subject to this sec8 tion of the amount of the quarterly assessment im9 posed on such manufacturer or importer under this 

10 subsection for each quarter of each fiscal year. Such 

11 notifications shall occur not later than 30 days prior 

12 to the end of the quarter for which such assessment 

13 is made, and payments of all assessments shall be 

14 made by the last day of the quarter involved. 

15 ‘‘(4) CALCULATION OF MARKET SHARE.—Be16 ginning not later than fiscal year 2020, and for each 

17 subsequent fiscal year, the Secretary shall ensure 

18 that the Food and Drug Administration is able to 

19 determine— 

20 ‘‘(A) the annual amount of total sales in 

21 the electronic nicotine delivery system market of 

22 the United States; and 

23 ‘‘(B) the applicable percentage shares 

24 under paragraph (2)(A). 

25 ‘‘(c) CREDITING AND AVAILABILITY OF FEES.— 


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1 ‘‘(1) IN GENERAL.—Fees authorized under sub2 section (a) shall be collected and available for obliga3 tion only to the extent and in the amount provided 

4 in advance in appropriations Acts. Such fees are au5 thorized to remain available until expended. Such 

6 sums as may be necessary may be transferred from 

7 the Food and Drug Administration salaries and ex8 penses appropriation account without fiscal year lim9 itation to such appropriation account for salaries 

10 and expenses with such fiscal year limitation. 

11 ‘‘(2) AUTHORIZATION OF APPROPRIATIONS.— 

12 For fiscal year 2021 and each subsequent fiscal 

13 year, there is authorized to be appropriated for fees 

14 under this section an amount equal to the amount 

15 specified in subsection (b)(1) for the fiscal year. 

16 ‘‘(d) COLLECTION OF UNPAID FEES.—In any case 

17 where the Secretary does not receive payment of a fee as18 sessed under subsection (a) within 30 days after it is due, 

19 such fee shall be treated as a claim of the United States 

20 Government subject to subchapter II of chapter 37 of title 

21 31, United States Code. 

22 ‘‘(e) APPLICABILITY TO FISCAL YEAR 2020.—If the 

23 date of enactment of the E-Cigarette Youth Protection Act 

24 occurs during fiscal year 2020, subject to subsection (c), 

25 for the quarter following the quarter in which such date 


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1 of enactment occurs, the full quarterly fee amounts shall 

2 be assessed and collected.’’. 

3 (b) ENFORCEMENT.— 

4 (1) IN GENERAL.—Section 902(4) of the Fed5 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

6 387b(4)) is amended by inserting ‘‘, or the manufac7 turer or importer of electronic nicotine delivery sys8 tems fails to pay a user fee assessed to such manu9 facturer or importer pursuant to section 919A by 

10 the date specified in section 919A or by the 30th 

11 day after final agency action on a resolution of any 

12 dispute as to the amount of such fee’’ before the 

13 semicolon. 

14 (2) EFFECTIVE DATE.—The amendment made 

15 by paragraph (1) shall take effect on the later of Oc16 tober 1, 2021, or the date of enactment of this Act. 

17 (c) DEFINITION.—Section 900 of the Federal Food, 

18 Drug, and Cosmetic Act (21 U.S.C. 387) is amended— 

19 (1) by redesignating paragraphs (8) through 

20 (22) as paragraphs (9) through (23), respectively; 

21 and 

22 (2) by inserting after paragraph (7) the fol23 lowing: 


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1 ‘‘(8) ELECTRONIC NICOTINE DELIVERY SYS2 TEM.—The term ‘electronic nicotine delivery sys3 tem’— 

4 ‘‘(A) means any electronic device that de5 livers nicotine, flavor, or another substance via 

6 an aerosolized solution to the user inhaling 

7 from the device (including e-cigarettes, e-hook8 ah, e-cigars, vape pens, advanced refillable per9 sonal vaporizers, and electronic pipes) and any 

10 component, liquid, part, or accessory of such a 

11 device, whether or not sold separately; and 

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

13 ‘‘(i) is approved by the Food and 

14 Drug Administration for sale as a tobacco 

15 cessation product or for another thera16 peutic purpose; and 

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

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

Æ 


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