---
kind: "section"
citation: "21 U.S.C. § 387s"
title: "21"
title_heading: "Food and Drugs"
number: "387s"
heading: "User fees"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/387s"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter IX — Tobacco Products"
---

# §387s. User fees

- (a) **Establishment of quarterly fee—** Beginning on June 22, 2009, the [Secretary](/usc/21/321.md?p=d) shall in accordance with this section assess user fees on, and collect such fees from, each [manufacturer](/usc/21/360hh.md?p=3) and importer of [tobacco products](/usc/21/321.md?p=rr-1) 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)](#b-1) for such year, subject to [subsection (c)](#c).
- (b) **Assessment of user fee—**
  - (1) **Amount of assessment—** The total amount of user fees [authorized](/usc/21/360eee.md?p=2) to be assessed and collected under [subsection (a)](#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)](#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)](#a) each fiscal year with respect to each class of [tobacco products](/usc/21/321.md?p=rr-1) 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)](#b-1) for the fiscal year.
    - (B) **Applicable percentage—**
      - (i) **In general—** For purposes of [subparagraph (A)](#b-2-A), the applicable percentage for a fiscal year for each of the following classes of [tobacco products](/usc/21/321.md?p=rr-1) shall be determined in accordance with [clause (ii)](#b-2-B-ii):
        - (I) [Cigarettes](/usc/21/387.md?p=3).
        - (II) Cigars, including small cigars and cigars other than small cigars.
        - (III) Snuff.
        - (IV) Chewing tobacco.
        - (V) Pipe tobacco.
        - (VI) [Roll-your-own tobacco](/usc/21/387.md?p=15).
      - (ii) **Allocations—** The applicable percentage of each class of [tobacco product](/usc/21/321.md?p=rr-1) described in [clause (i)](#b-2-B-i) for a fiscal year shall be the percentage determined under [section 518d(c) of title 7](/usc/7/518d.md?p=c) for each such class of [product](/usc/21/360eee.md?p=13) for such fiscal year.
      - (iii) **Requirement of regulations—** Notwithstanding [clause (ii)](#b-2-B-ii), no user fees shall be assessed on a class of [tobacco products](/usc/21/321.md?p=rr-1) unless such class of [tobacco products](/usc/21/321.md?p=rr-1) is listed in [section 387a(b) of this title](/usc/21/387a.md?p=b) or is deemed by the [Secretary](/usc/21/321.md?p=d) in a regulation under [section 387a(b) of this title](/usc/21/387a.md?p=b) to be subject to this subchapter.
      - (iv) **Reallocations—** In the case of a class of [tobacco products](/usc/21/321.md?p=rr-1) that is not listed in [section 387a(b) of this title](/usc/21/387a.md?p=b) or deemed by the [Secretary](/usc/21/321.md?p=d) in a regulation under [section 387a(b) of this title](/usc/21/387a.md?p=b) to be subject to this subchapter, the amount of user fees that would otherwise be assessed to such class of [tobacco products](/usc/21/321.md?p=rr-1) shall be reallocated to the classes of [tobacco products](/usc/21/321.md?p=rr-1) that are subject to this subchapter in the same manner and based on the same relative percentages otherwise determined under [clause (ii)](#b-2-B-ii).
  - (3) **Determination of user fee by company—**
    - (A) **In general—** The total user fee to be paid by each [manufacturer](/usc/21/360hh.md?p=3) or importer of a particular class of [tobacco products](/usc/21/321.md?p=rr-1) shall be determined for each quarter by multiplying—
      - (i) such [manufacturer](/usc/21/360hh.md?p=3)’s or importer’s percentage share as determined under [paragraph (4)](#b-4); by
      - (ii) the portion of the user fee amount for the current quarter to be assessed on all [manufacturers](/usc/21/360hh.md?p=3) and importers of such class of [tobacco products](/usc/21/321.md?p=rr-1) as determined under [paragraph (2)](#b-2).
    - (B) **No fee in excess of percentage share—** No [manufacturer](/usc/21/360hh.md?p=3) or importer of [tobacco products](/usc/21/321.md?p=rr-1) shall be required to pay a user fee in excess of the percentage share of such [manufacturer](/usc/21/360hh.md?p=3) or importer.
  - (4) **Allocation of assessment within each class of tobacco product—** The percentage share of each [manufacturer](/usc/21/360hh.md?p=3) or importer of a particular class of [tobacco products](/usc/21/321.md?p=rr-1) of the total user fee to be paid by all [manufacturers](/usc/21/360hh.md?p=3) or importers of that class of [tobacco products](/usc/21/321.md?p=rr-1) shall be the percentage determined for purposes of allocations under subsections (e) through (h) of [section 518d of title 7](/usc/7/518d.md).
  - (5) **Allocation for cigars—** Notwithstanding [paragraph (4)](#b-4), if a user fee assessment is imposed on cigars, the percentage share of each [manufacturer](/usc/21/360hh.md?p=3) or importer of cigars shall be based on the excise taxes paid by such [manufacturer](/usc/21/360hh.md?p=3) or importer during the prior fiscal year.
  - (6) **Timing of assessment—** The [Secretary](/usc/21/321.md?p=d) shall notify each [manufacturer](/usc/21/360hh.md?p=3) and importer of [tobacco products](/usc/21/321.md?p=rr-1) subject to this section of the amount of the quarterly assessment imposed on such [manufacturer](/usc/21/360hh.md?p=3) 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](/usc/21/321.md?p=d) 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](/usc/21/321.md?p=d) of the information described in paragraphs [(2)(B)(ii)](#b-2-B-ii) and [(4)](#b-4) and all necessary information regarding all [tobacco product manufacturers](/usc/21/387.md?p=20) and importers required to pay user fees. The [Secretary](/usc/21/321.md?p=d) 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](/usc/21/321.md?p=d) shall ensure that the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration is able to determine the applicable percentages described in [paragraph (2)](#b-2) and the percentage shares described in [paragraph (4)](#b-4). The [Secretary](/usc/21/321.md?p=d) may carry out this subparagraph by entering into a contract with the head of the Federal agency referred to in [subparagraph (A)](#b-7-A) to continue to provide the necessary information.
- (c) **Crediting and availability of fees—**
  - (1) **In general—** Fees [authorized](/usc/21/360eee.md?p=2) under [subsection (a)](#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)](#c-2-D). Such fees are [authorized](/usc/21/360eee.md?p=2) to remain available until expended. Such sums as may be necessary may be transferred from the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) 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)](#c-3) are available only for the purpose of paying the costs of the activities of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration related to the regulation of [tobacco products](/usc/21/321.md?p=rr-1) 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)](#c-2-C).
    - (B) **Prohibition against use of other funds—**
      - (i) **In general—** Except as provided in [clause (ii)](#c-2-B-ii), fees collected under [subsection (a)](#a) are the only funds [authorized](/usc/21/360eee.md?p=2) to be made available for tobacco regulation activities.
      - (ii) **Startup costs—** [Clause (i)](#c-2-B-i) does not apply until October 1, 2009. Until such date, any amounts available to the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration (excluding user fees) shall be available and allocated as needed to pay the costs of tobacco regulation activities.
    - (C) **Reimbursement of start-up amounts—**
      - (i) **In general—** Any amounts allocated for the start-up period pursuant to [subparagraph (B)(ii)](#c-2-B-ii) shall be reimbursed through any appropriated fees collected under [subsection (a)](#a), in such manner as the [Secretary](/usc/21/321.md?p=d) 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](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration programs and activities (other than tobacco regulation activities) for such period.
      - (ii) **Treatment of reimbursed amounts—** Amounts reimbursed under [clause (i)](#c-2-C-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)](#c-1), fees under [subsection (a)](#a) may be collected through September 30, 2009 under [subparagraph (B)(ii)](#c-2-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](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) 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](/usc/31/1534.md).
  - (3) **Authorization of appropriations—** For fiscal year 2009 and each subsequent fiscal year, there is [authorized](/usc/21/360eee.md?p=2) to be appropriated for fees under this section an amount equal to the amount specified in [subsection (b)(1)](#b-1) for the fiscal year.
- (d) **Collection of unpaid fees—** In any case where the [Secretary](/usc/21/321.md?p=d) does not receive payment of a fee assessed under [subsection (a)](#a) within 30 days after it is due, such fee shall be treated as a claim of the [United States](/usc/21/387.md?p=22) Government subject to subchapter II of chapter 37 of title 31.
- (e) **Applicability to fiscal year 2009—** If 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)](#c):
  - (1) The [Secretary](/usc/21/321.md?p=d) shall determine the fees that would apply for a single quarter of such fiscal year according to the application of [subsection (b)](#b) to the amount specified in [paragraph (1)(A)](#b-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)](#e-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)](#e-2).

## Source credit

(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.)

## Notes

### Editorial Notes

### References 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.