21 U.S.C. § 387s

User fees

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(a) Establishment of quarterly fee

Beginning on June 22, 2009, the Secretary shall in accordance with this section assess user fees on, and collect such fees from, each manufacturer and importer of tobacco products subject to this subchapter. 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 assessmentThe 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 2009, $85,000,000 (subject to subsection (e)).(B) For fiscal year 2010, $235,000,000.(C) For fiscal year 2011, $450,000,000.(D) For fiscal year 2012, $477,000,000.(E) For fiscal year 2013, $505,000,000.(F) For fiscal year 2014, $534,000,000.(G) For fiscal year 2015, $566,000,000.(H) For fiscal year 2016, $599,000,000.(I) For fiscal year 2017, $635,000,000.(J) For fiscal year 2018, $672,000,000.(K) For fiscal year 2019 and each subsequent fiscal year, $712,000,000.(2) Allocations of assessment by class of tobacco products(A) In general

The total user fees assessed and collected under subsection (a) each fiscal year with respect to each class of tobacco products shall be an amount that is equal to the applicable percentage of each class for the fiscal year multiplied by the amount specified in paragraph (1) for the fiscal year.

(B) Applicable percentage(i) In generalFor purposes of subparagraph (A), the applicable percentage for a fiscal year for each of the following classes of tobacco products shall be determined in accordance with clause (ii):(I) Cigarettes.(II) Cigars, including small cigars and cigars other than small cigars.(III) Snuff.(IV) Chewing tobacco.(V) Pipe tobacco.(VI) Roll-your-own tobacco.(ii) Allocations

The applicable percentage of each class of tobacco product described in clause (i) for a fiscal year shall be the percentage determined under section 518d(c) of title 7 for each such class of product for such fiscal year.

(iii) Requirement of regulations

Notwithstanding clause (ii), no user fees shall be assessed on a class of tobacco products unless such class of tobacco products is listed in section 387a(b) of this title or is deemed by the Secretary in a regulation under section 387a(b) of this title to be subject to this subchapter.

(iv) Reallocations

In the case of a class of tobacco products that is not listed in section 387a(b) of this title or deemed by the Secretary in a regulation under section 387a(b) of this title to be subject to this subchapter, the amount of user fees that would otherwise be assessed to such class of tobacco products shall be reallocated to the classes of tobacco products that are subject to this subchapter in the same manner and based on the same relative percentages otherwise determined under clause (ii).

(3) Determination of user fee by company(A) In generalThe total user fee to be paid by each manufacturer or importer of a particular class of tobacco products shall be determined for each quarter by multiplying—(i) such manufacturer’s or importer’s percentage share as determined under paragraph (4); by(ii) the portion of the user fee amount for the current quarter to be assessed on all manufacturers and importers of such class of tobacco products as determined under paragraph (2).(B) No fee in excess of percentage share

No manufacturer or importer of tobacco products shall be required to pay a user fee in excess of the percentage share of such manufacturer or importer.

(4) Allocation of assessment within each class of tobacco product

The percentage share of each manufacturer or importer of a particular class of tobacco products of the total user fee to be paid by all manufacturers or importers of that class of tobacco products shall be the percentage determined for purposes of allocations under subsections (e) through (h) of section 518d of title 7.

(5) Allocation for cigars

Notwithstanding paragraph (4), if a user fee assessment is imposed on cigars, the percentage share of each manufacturer or importer of cigars shall be based on the excise taxes paid by such manufacturer or importer during the prior fiscal year.

(6) Timing of assessment

The Secretary shall notify each manufacturer and importer of tobacco products 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.

(7) Memorandum of understanding(A) In general

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 the information described in paragraphs (2)(B)(ii) and (4) and 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.

(B) Assurances

Beginning not later than fiscal year 2015, and for each subsequent fiscal year, the Secretary shall ensure that the Food and Drug Administration is able to determine the applicable percentages described in paragraph (2) and the percentage shares described in paragraph (4). The Secretary may carry out this subparagraph by entering into a contract with the head of the Federal agency referred to in subparagraph (A) to continue to provide the necessary information.

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, subject to paragraph (2)(D). 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) Availability(A) In general

Fees appropriated under paragraph (3) are available only for the purpose of paying the costs of the activities of the Food and Drug Administration related to the regulation of tobacco products under this subchapter and the Family Smoking Prevention and Tobacco Control Act (referred to in this subsection as “tobacco regulation activities”), except that such fees may be used for the reimbursement specified in subparagraph (C).

(B) Prohibition against use of other funds(i) In general

Except as provided in clause (ii), fees collected under subsection (a) are the only funds authorized to be made available for tobacco regulation activities.

(ii) Startup costs

Clause (i) does not apply until October 1, 2009. Until such date, any amounts available to the Food and Drug Administration (excluding user fees) shall be available and allocated as needed to pay the costs of tobacco regulation activities.

Any amounts allocated for the start-up period pursuant to subparagraph (B)(ii) shall be reimbursed through any appropriated fees collected under subsection (a), in such manner as the Secretary determines appropriate to ensure that such allocation results in no net change in the total amount of funds otherwise available, for the period from October 1, 2008, through September 30, 2010, for Food and Drug Administration programs and activities (other than tobacco regulation activities) for such period.

(ii) Treatment of reimbursed amounts

Amounts reimbursed under clause (i) shall be available for the programs and activities for which funds allocated for the start-up period were available, prior to such allocation, until September 30, 2010, notwithstanding any otherwise applicable limits on amounts for such programs or activities for a fiscal year.

(D) Fee collected during start-up period

Notwithstanding the first sentence of paragraph (1), fees under subsection (a) may be collected through September 30, 2009 under subparagraph (B)(ii) and shall be available for obligation and remain available until expended. Such offsetting collections shall be credited to the salaries and expenses account of the Food and Drug Administration.

(E) Obligation of start-up costs in anticipation of available fee collections

Notwithstanding any other provision of law, following the enactment of an appropriation for fees under this section for fiscal year 2010, or any portion thereof, obligations for costs of tobacco regulation activities during the start-up period may be incurred in anticipation of the receipt of offsetting fee collections through procedures specified in section 1534 of title 31.

(3) Authorization of appropriations

For fiscal year 2009 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.

(e) Applicability to fiscal year 2009If the date of enactment of the Family Smoking Prevention and Tobacco Control Act occurs during fiscal year 2009, the following applies, subject to subsection (c):(1) The Secretary shall determine the fees that would apply for a single quarter of such fiscal year according to the application of subsection (b) to the amount specified in paragraph (1)(A) of such subsection (referred to in this subsection as the “quarterly fee amounts”).(2) For the quarter in which such date of enactment occurs, the amount of fees assessed shall be a pro rata amount, determined according to the number of days remaining in the quarter (including such date of enactment) and according to the daily equivalent of the quarterly fee amounts. Fees assessed under the preceding sentence shall not be collected until the next quarter.(3) For the quarter following the quarter to which paragraph (2) applies, the full quarterly fee amounts shall be assessed and collected, in addition to collection of the pro rata fees assessed under paragraph (2).(June 25, 1938, ch. 675, § 919, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1826.)Editorial NotesReferences in Text

The Family Smoking Prevention and Tobacco Control Act, referred to in subsec. (c)(2)(A), is div. A of Pub. L. 111–31, June 22, 2009, 123 Stat. 1776. For complete classification of this Act to the Code, see Short Title of 2009 Amendment note set out under section 301 of this title.

The date of enactment of the Family Smoking Prevention and Tobacco Control Act and such date of enactment, referred to in subsec. (e), is the date of enactment of Pub. L. 111–31, which was approved June 22, 2009.

Notes of Decisions

Cited in 11 cases (3 in the last 5 years), 2010–2025 · leading case: Cigar Ass'n of Am. v. U.S. Food & Drug Admin.

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Cigar Ass'n of Am. v. U.S. Food & Drug Admin. (2018) cadc · cites it 9× “" See 21 U.S.C. § 387s. The user fees "are available only for the purpose of paying the costs of the activities of the [FDA] related to the regulation *156 of tobacco products under .”

Cigar Association of America v. FDA (2021) cadc · cites it 4× “” 21 U.S.C. § 387s(a) (emphasis added). It sets the “total amount of user fees authorized to be assessed and collected” for each fiscal year.”

Philip Morris USA, Incorporated v. Thomas Vilsack (2013) ca4 · cites it 2× “§ 919(b)(2)(B)(ii) (codified at 21 U.S.C. § 387s (b)(2)(B)(ii)). Congress also passed the Children’s Health Insurance Program Reauthorization Act of 2009 (“CHIPRA”).”

Commonwealth Brands, Inc. v. United States (2010) kywd “Although, as they emphasize, the Act includes a transfer of funds to the Government in the form of “user fees,” § 101(b)(3) (adding 21 U.S.C. § 387s), that transfer is not the alleged “taking.”

Philip Morris USA Inc. v. Vilsack (2012) vaed · cites it 4× “21 U.S.C. § 387s. Plaintiff is correct that Congress refers to the FETRA methodology and accompanying regulations in prescribing how the FSPTCA user fees will be allocated among the various classes of tobacco products described in 21 U.”

En Fuego Tobacco Shop LLC v. U.S. Food & Drug Admin. (2019) cadc “See 21 U.S.C. § 387s ; 21 C.F.R. § 1150 . B. The Cigar Association Litigation On July 15, 2016, a group of plaintiffs, led by the Cigar Association of America, filed suit in this District Court against the FDA, the United States Department of Health and Human Services ("HHS"),…”

Cigar Association of America v. United States Food and Drug Administration (2018) dcd · cites it 9× “” See 21 U.S.C. § 387s. The user fees “are available only for the purpose of paying the costs of the activities of the [FDA] related to the regulation of tobacco products under .”

Am. Acad. of Pediatrics v. U.S. Food & Drug Admin. (2018) dcd “21 U.S.C. § 387s(a). In the 2018 fiscal year alone, the amount of user fees collected reached $ 672,000,000.”

Cigar Association of America v. FDA (2025) cadc “(citing 21 U.S.C. § 387s). As this scheme has been in place for seven years, the FDA worries that a vacatur order might necessitate the recalculation and reallocation of seven years worth of user fee payments.”

American Academy of Pediatrics v. United States Food and Drug Administration (2018) mad “21 U.S.C. § 387s(a). In the 2018 fiscal year alone, the amount of user fees collected reached $ 672,000,000.”

Cigar Association of America v. FDA (AMENDED OPINION) (2025) cadc “(citing 21 U.S.C. § 387s). As this scheme has been in place for seven years, the FDA worries that a vacatur order might necessitate the recalculation and reallocation of seven years worth of user fee payments.”

— 21 U.S.C. § 387s(a) — 5 cases

Cigar Association of America v. FDA (2021) cadc “” 21 U.S.C. § 387s(a) (emphasis added). It sets the “total amount of user fees authorized to be assessed and collected” for each fiscal year.”

Cigar Ass'n of Am. v. U.S. Food & Drug Admin. (2018) cadc “" See 21 U.S.C. § 387s. The user fees "are available only for the purpose of paying the costs of the activities of the [FDA] related to the regulation *156 of tobacco products under .”

Am. Acad. of Pediatrics v. U.S. Food & Drug Admin. (2018) dcd “21 U.S.C. § 387s(a). In the 2018 fiscal year alone, the amount of user fees collected reached $ 672,000,000.”

Cigar Association of America v. United States Food and Drug Administration (2018) dcd “” See 21 U.S.C. § 387s. The user fees “are available only for the purpose of paying the costs of the activities of the [FDA] related to the regulation of tobacco products under .”

— 21 U.S.C. § 387s(b)(1)(I) — 2 cases

— 21 U.S.C. § 387s(b)(2)(B) — 2 cases

— 21 U.S.C. § 387s(b)(2)(B)(i) — 1 case

Philip Morris USA Inc. v. Vilsack (2012) vaed “21 U.S.C. § 387s. Plaintiff is correct that Congress refers to the FETRA methodology and accompanying regulations in prescribing how the FSPTCA user fees will be allocated among the various classes of tobacco products described in 21 U.”

— 21 U.S.C. § 387s(b)(2)(B)(ii) — 2 cases

Philip Morris USA, Incorporated v. Thomas Vilsack (2013) ca4 “§ 919(b)(2)(B)(ii) (codified at 21 U.S.C. § 387s (b)(2)(B)(ii)). Congress also passed the Children’s Health Insurance Program Reauthorization Act of 2009 (“CHIPRA”).”

— 21 U.S.C. § 387s(b)(3) — 1 case

— 21 U.S.C. § 387s(b)(4) — 3 cases

— 21 U.S.C. § 387s(b)(iii) — 2 cases

— 21 U.S.C. § 387s(c)(2)(B)(i) — 1 case

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