[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 4257 Introduced in Senate (IS)]
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119th CONGRESS
2d Session
S. 4257
To apply user fees with respect to tobacco products deemed subject to
the requirements of chapter IX of the Federal Food, Drug, and Cosmetic
Act.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
March 26, 2026
Mrs. Shaheen (for herself, Ms. Murkowski, Mr. Durbin, Ms. Baldwin, and
Mr. Blumenthal) introduced the following bill; which was read twice and
referred to the Committee on Health, Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To apply user fees with respect to tobacco products deemed subject to
the requirements of chapter IX of the Federal Food, Drug, and Cosmetic
Act.
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 ``Resources To Prevent Youth Vaping
Act''.
SEC. 2. USER FEES.
(a) Increase in Total Amount.--Section 919(b)(1) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 387s(b)(1)) is amended by
striking subparagraph (K) and inserting the following subparagraphs:
``(K) For each of fiscal years 2019 through 2026,
$712,000,000.
``(L) For fiscal year 2027, $826,200,000.
``(M) For fiscal year 2028 and each subsequent
fiscal year, the amount that was applicable for the
previous fiscal year, adjusted by the total percentage
change that occurred in the Consumer Price Index for
all urban consumers (all items; United States city
average) for the 12-month period ending June 30
preceding the fiscal year.''.
(b) Application of User Fees to All Classes of Tobacco Products.--
(1) In general.--Subparagraph (A) of section 919(b)(2) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387s(b)(2))
is amended to read as follows:
``(A) In general.--
``(i) Fiscal years 2027 and 2028.--For
fiscal years 2027 and 2028, user fees shall be
assessed and collected under subsection (a)
only with respect to the classes of tobacco
products listed in subparagraph (B)(i), and the
total such user fees with respect to each such
class shall be an amount that is equal to the
applicable percentage of each such class for
the fiscal year multiplied by the amount
specified in paragraph (1) for the fiscal year.
``(ii) Subsequent fiscal years.--For fiscal
year 2029 and each subsequent fiscal year, user
fees shall be assessed and collected under
subsection (a) with respect to each class of
tobacco products to which this chapter applies
(including tobacco products that the Secretary
by regulation deems to be subject to this
chapter), and the total user fees with respect
to each such class shall be--
``(I) with respect to each class of
tobacco products listed in subparagraph
(B)(i), an amount that is calculated in
the same way as the amounts calculated
for fiscal years 2027 and 2028 under
clause (i), except that for purposes of
fiscal years 2029 and subsequent fiscal
years, instead of multiplying the
applicable percentage of each such
class by `the amount specified in
paragraph (1) for the fiscal year', the
applicable percentage shall be
multiplied by--
``(aa) the amount specified
in paragraph (1) for the fiscal
year, reduced by
``(bb) the total user fees
assessed and collected pursuant
to subparagraph (C) for the
fiscal year; and
``(II) with respect to each class
of tobacco products to which this
chapter applies but which is not listed
in subparagraph (B)(i), an amount
determined pursuant to a formula under
subparagraph (C).''.
(2) Other tobacco products.--Section 919(b)(2) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387s(b)(2)), as
amended by paragraph (1), is further amended by adding at the
end the following new subparagraphs:
``(C) Allocation for other tobacco products.--
``(i) In general.--Beginning with fiscal
year 2029, the total user fees assessed and
collected under subsection (a) each fiscal year
with respect to each class of tobacco products
not listed in subparagraph (B)(i) shall be an
amount that is determined pursuant to a formula
developed by the Secretary by regulation using
information required to be submitted under
subparagraph (D).
``(ii) Allocation for other tobacco
products.--For each class of tobacco products
not listed in subparagraph (B)(i), the
percentage of fees under the formula under
clause (i) for the respective fiscal year shall
be equal to the percentage of the gross
domestic sales in the previous calendar year
that is attributable to such class of tobacco
products in such calendar year, as determined
by the Secretary.
``(iii) Allocation of assessment within
each class of other tobacco products.--The
percentage of the total user fees to be paid by
each manufacturer or importer of tobacco
products in a class not listed in subparagraph
(B)(i) shall be determined by the Secretary,
based on the percentage of the gross domestics
sales of all such classes of tobacco products
by all manufacturers and importers in the
previous calendar year that is attributable to
such manufacturer or importer.
``(iv) Effect of failure to finalize
formula on time.--If the Secretary for any
reason fails to finalize by fiscal year 2029
the formula required by this subparagraph for
the assessment and collection of user fees for
classes of tobacco products not listed in
subparagraph (B)(i)--
``(I) the Secretary shall continue
to assess and collect fees under
subsection (a) with respect to each
class of tobacco products listed in
subparagraph (B)(i); and
``(II) until the first fiscal year
commencing after the finalization of
such formula, the exception described
in subparagraph (A)(ii)(I) shall not
apply.
``(v) Revisions by regulation.--Any
revisions to the formula promulgated pursuant
to this subparagraph shall be by regulation.
``(vi) Definition.--In this subparagraph,
the term `gross domestic sales' means the total
value in dollars of the sale or distribution by
manufacturers and importers of tobacco products
in the United States in classes not listed in
subparagraph (B)(i), as determined based on the
aggregation of sales data from every
manufacturer and importer of tobacco products
that submits sales data to the Secretary.
``(D) Information required to be submitted.--Each
manufacturer or importer of any tobacco product shall
submit to the Secretary the information required under
this subparagraph by March 1, 2028, for calendar year
2027, by April 1, 2028, for the period of January 1,
2028, through March 31, 2028, and monthly thereafter.
Such information shall include--
``(i) the identification of the
manufacturer or importer;
``(ii) the class or classes of tobacco
products sold by the manufacturer or importer;
``(iii) the full listing of the finished
tobacco products in a class not listed in
subparagraph (B)(i) sold or distributed by the
manufacturer or importer in the United States;
and
``(iv) the gross domestic sales data for
each class of finished tobacco products sold or
distributed by the manufacturer or importer in
the United States.''.
(3) Prohibited act.--Section 301(q)(1)(B) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 331(q)(1)(B)) is
amended by inserting ``919(b)(2)(D),'' before ``or 920''.
(c) Allocation of Assessment Within Each Class of Tobacco
Product.--Section 919(b)(4) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 387s(b)(4)) is amended by striking ``shall be the percentage
determined for purposes of allocations under subsections (e) through
(h) of section 625 of Public Law 108-357'' and inserting ``shall be the
percentage determined by the Secretary''.
(d) Conforming Amendments.--Section 919(b) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 387s(b)) is amended--
(1) by striking paragraph (5);
(2) by redesignating paragraphs (6) and (7) as paragraphs
(5) and (6), respectively; and
(3) by amending paragraph (6), as redesignated, to read as
follows:
``(6) Memorandum of understanding.--The Secretary shall
request the appropriate Federal agency to enter into a
memorandum of understanding that provides for the regular and
timely transfer from the head of such agency to the Secretary
of all necessary information regarding all tobacco product
manufacturers and importers required to pay user fees. The
Secretary shall maintain all disclosure restrictions
established by the head of such agency regarding the
information provided under the memorandum of understanding.''.
(e) Applicability.--The amendments made by subsections (b), (c),
and (d) shall apply beginning with fiscal year 2029. Except for the
amendment made by subsection (a), section 919 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 387s), as in effect on the day before
the date of enactment of this Act, shall apply with respect to fiscal
years preceding fiscal year 2029.
SEC. 3. ANNUAL REPORTING ON TOBACCO REGULATION ACTIVITIES.
(a) In General.--Section 112(b) of division P of the Consolidated
Appropriations Act, 2022 (21 U.S.C. 387v(b)) is amended by adding at
the end the following:
``(12) A breakdown of the amount expended on activities
related to deemed tobacco products versus the amount expended
on activities related to combustible tobacco products listed in
section 919(b)(2)(B)(i) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 387s(b)(2)(B)(i)).
``(13) An explanation for how the Food and Drug
Administration ensures that the amount of user fees allocated
to public education campaigns on youth e-cigarette use and
prevention is sufficient to meet the need for education of
teens and minors on the dangers of e-cigarettes and other
Electronic Nicotine Delivery Systems (commonly referred to as
`ENDS').
``(14) When applicable, a breakdown of the amount or user
fees collected under the amendments made by this Act from
manufacturers of deemed tobacco products and the amount
collected from manufacturers of each of the original pre-
existing categories of tobacco products under section
919(b)(2)(B)(i) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 387s(b)(2)(B)(i)).''.
(b) Application.--The information described in paragraphs (12) and
(13) of subsection (b) of section 112 of division P of the Consolidated
Appropriations Act, 2022 (21 U.S.C. 387v(b)), as added by subsection
(a), shall be required to be included in reports under such section 112
for fiscal year 2027 and each subsequent fiscal year, and the
information described in paragraph (14) of such section 112, as added
by subsection (a), shall be required to be included in reports under
such section 112 for fiscal year 2029 and each subsequent fiscal year.
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