Title: E-Cigarette Youth Protection Act
Policy area: Health

Summary:
E-Cigarette Youth Protection Act
This bill requires the Food and Drug Administration 	to assess quarterly user fees on manufacturers and importers of electronic nicotine delivery systems (e.g., e-cigarettes or vape pens).

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 616 Introduced in Senate (IS)]

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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 Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``E-Cigarette Youth Protection Act''.

SEC. 2. USER FEES RELATING TO ELECTRONIC NICOTINE DELIVERY SYSTEMS.

    (a) In General.--Chapter IX of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 387 et seq.) is amended by inserting after section 919 
the following:

``SEC. 919A. USER FEES RELATING TO ELECTRONIC NICOTINE DELIVERY 
              SYSTEMS.

    ``(a) Establishment of Quarterly Fee.--Beginning on the date of 
enactment of the E-Cigarette Youth Protection Act, the Secretary shall 
in accordance with this section assess user fees on, and collect such 
fees from, each manufacturer and importer of electronic nicotine 
delivery systems. The fees shall be assessed and collected with respect 
to each quarter of each fiscal year, and the total amount assessed and 
collected for a fiscal year shall be the amount specified in subsection 
(b)(1) for such year, subject to subsection (c).
    ``(b) Assessment of User Fee.--
            ``(1) Amount of assessment.--The total amount of user fees 
        authorized to be assessed and collected under subsection (a) 
        for a fiscal year is the following, as applicable to the fiscal 
        year involved:
                    ``(A) For fiscal year 2020, the greater of--
                            ``(i) $150,000,000; or
                            ``(ii) 2 percent of the total value of 
                        manufacturer sales of electronic nicotine 
                        delivery systems in the United States in fiscal 
                        year 2019.
                    ``(B) For fiscal year 2021 and each fiscal year 
                thereafter, the greater of--
                            ``(i) the amount described in subparagraph 
                        (A), increased by the percentage increase in 
                        the Consumer Price Index between 2020 and the 
                        applicable year; or
                            ``(ii) 2 percent of the total value of 
                        manufacturer sales of electronic nicotine 
                        delivery systems in the United States in the 
                        previous fiscal year.
            ``(2) Determination of user fee by company.--
                    ``(A) In general.--The total user fee to be paid by 
                each manufacturer or importer of electronic nicotine 
                delivery systems shall be determined for each quarter 
                by multiplying--
                            ``(i) such manufacturer's or importer's 
                        percentage share of the total electronic 
                        nicotine delivery system market in the United 
                        States; by
                            ``(ii) the portion of the user fee amount 
                        for the current quarter to be assessed on all 
                        manufacturers and importers under paragraph 
                        (1).
                    ``(B) No fee in excess of percentage share.--No 
                manufacturer or importer of electronic nicotine 
                delivery systems shall be required to pay a user fee in 
                excess of the percentage share of the total electronic 
                nicotine delivery system market of the manufacturer or 
                importer.
            ``(3) Timing of assessment.--The Secretary shall notify 
        each manufacturer and importer of electronic nicotine delivery 
        systems subject to this section of the amount of the quarterly 
        assessment imposed on such manufacturer or importer under this 
        subsection for each quarter of each fiscal year. Such 
        notifications shall occur not later than 30 days prior to the 
        end of the quarter for which such assessment is made, and 
        payments of all assessments shall be made by the last day of 
        the quarter involved.
            ``(4) Calculation of market share.--Beginning not later 
        than fiscal year 2020, and for each subsequent fiscal year, the 
        Secretary shall ensure that the Food and Drug Administration is 
        able to determine--
                    ``(A) the annual amount of total sales in the 
                electronic nicotine delivery system market of the 
                United States; and
                    ``(B) the applicable percentage shares under 
                paragraph (2)(A).
    ``(c) Crediting and Availability of Fees.--
            ``(1) In general.--Fees authorized under subsection (a) 
        shall be collected and available for obligation only to the 
        extent and in the amount provided in advance in appropriations 
        Acts. Such fees are authorized to remain available until 
        expended. Such sums as may be necessary may be transferred from 
        the Food and Drug Administration salaries and expenses 
        appropriation account without fiscal year limitation to such 
        appropriation account for salaries and expenses with such 
        fiscal year limitation.
            ``(2) Authorization of appropriations.--For fiscal year 
        2021 and each subsequent fiscal year, there is authorized to be 
        appropriated for fees under this section an amount equal to the 
        amount specified in subsection (b)(1) for the fiscal year.
    ``(d) Collection of Unpaid Fees.--In any case where the Secretary 
does not receive payment of a fee assessed under subsection (a) within 
30 days after it is due, such fee shall be treated as a claim of the 
United States Government subject to subchapter II of chapter 37 of 
title 31, United States Code.
    ``(e) Applicability to Fiscal Year 2020.--If the date of enactment 
of the E-Cigarette Youth Protection Act occurs during fiscal year 2020, 
subject to subsection (c), for the quarter following the quarter in 
which such date of enactment occurs, the full quarterly fee amounts 
shall be assessed and collected.''.
    (b) Enforcement.--
            (1) In general.--Section 902(4) of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 387b(4)) is amended by inserting 
        ``, or the manufacturer or importer of electronic nicotine 
        delivery systems fails to pay a user fee assessed to such 
        manufacturer or importer pursuant to section 919A by the date 
        specified in section 919A or by the 30th day after final agency 
        action on a resolution of any dispute as to the amount of such 
        fee'' before the semicolon.
            (2) Effective date.--The amendment made by paragraph (1) 
        shall take effect on the later of October 1, 2021, or the date 
        of enactment of this Act.
    (c) Definition.--Section 900 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 387) is amended--
            (1) by redesignating paragraphs (8) through (22) as 
        paragraphs (9) through (23), respectively; and
            (2) by inserting after paragraph (7) the following:
            ``(8) Electronic nicotine delivery system.--The term 
        `electronic nicotine delivery system'--
                    ``(A) means any electronic device that delivers 
                nicotine, flavor, or another substance via an 
                aerosolized solution to the user inhaling from the 
                device (including e-cigarettes, e-hookah, e-cigars, 
                vape pens, advanced refillable personal vaporizers, and 
                electronic pipes) and any component, liquid, part, or 
                accessory of such a device, whether or not sold 
                separately; and
                    ``(B) does not include a product that--
                            ``(i) is approved by the Food and Drug 
                        Administration for sale as a tobacco cessation 
                        product or for another therapeutic purpose; and
                            ``(ii) is marketed and sold solely for a 
                        purpose described in clause (i).''.
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