I 

118TH CONGRESS 

2D SESSION H. R. 9425 

To amend the Federal Food, Drug, and Cosmetic Act to authorize tobacco 

user fee assessments for all regulated tobacco products, and for other 

purposes. 

IN THE HOUSE OF REPRESENTATIVES 

AUGUST 30, 2024 

Ms. MCCLELLAN introduced the following bill; which was referred to the 

Committee on Energy and Commerce 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act to 

authorize tobacco user fee assessments for all regulated 

tobacco products, and for other purposes. 

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 ‘‘Tobacco User Fee 

5 Modernization Act of 2024’’. 

6 SEC. 2. TOBACCO PRODUCT USER FEES. 

7 (a) INCREASE IN TOTAL AMOUNT.—Section 

8 919(b)(1) of the Federal Food, Drug, and Cosmetic Act 


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1 (21 U.S.C. 387s(b)(1)) is amended by striking subpara2 graph (K) and inserting the following: 

3 ‘‘(K) For each of fiscal years 2019 through 

4 2024, $712,000,000. 

5 ‘‘(L) For fiscal year 2025, $826,200,000. 

6 ‘‘(M) For fiscal year 2026 and each subse7 quent fiscal year, the amount that was applica8 ble for the previous fiscal year, increased by the 

9 total percentage change that occurred in the 

10 Consumer Price Index for all urban consumers 

11 (all items; United States city average) for the 

12 12-month period ending June 30 preceding the 

13 fiscal year.’’. 

14 (b) APPLICATION OF USER FEES TO ALL TOBACCO

15 PRODUCTS.—Subparagraph (A) of section 919(b)(2) of 

16 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

17 387s(b)(2)) is amended to read as follows: 

18 ‘‘(A) IN GENERAL.— 

19 ‘‘(i) FISCAL YEARS 2025 THROUGH

20 2027.—For fiscal years 2025 through 

21 2027, user fees shall be assessed and col22 lected under subsection (a) only with re23 spect to the classes of tobacco products 

24 listed in subparagraph (B)(i), and the total 

25 such user fees with respect to each such 


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1 class shall be an amount that is equal to 

2 the applicable percentage of each such 

3 class for the fiscal year, as determined in 

4 accordance with subparagraph (B)(ii), mul5 tiplied by the amount specified in para6 graph (1) for the fiscal year. 

7 ‘‘(ii) SUBSEQUENT FISCAL YEARS.— 

8 Except as specified in subparagraph (C), 

9 for fiscal year 2028 and each subsequent 

10 fiscal year, user fees shall be assessed and 

11 collected under subsection (a) with respect 

12 to each class of tobacco products listed in 

13 subparagraph (B)(i) and other tobacco 

14 products as follows: 

15 ‘‘(I) For the classes of tobacco 

16 products listed in subparagraph 

17 (B)(i): 

18 ‘‘(aa) For each fiscal year, 

19 the total user fees assessed and 

20 collected for all the classes of to21 bacco products listed in subpara22 graph (B)(i) together shall be an 

23 amount that is equal to the prod24 uct obtained by multiplying— 


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1 ‘‘(AA) the total of the 

2 sum of the gross domestic 

3 sales for the classes of to4 bacco products listed in sub5 paragraph (B)(i) during the 

6 previous full calendar year, 

7 divided by the sum of the 

8 gross domestic sales for the 

9 classes of tobacco products 

10 listed in subparagraph 

11 (B)(i) and other tobacco 

12 products during such cal13 endar year; by 

14 ‘‘(BB) the amount 

15 specified in paragraph (1) 

16 for such fiscal year. 

17 ‘‘(bb) For each fiscal year, 

18 the total user fees assessed and 

19 collected for each individual class 

20 of tobacco products listed in sub21 paragraph (B)(i) shall be an 

22 amount that is equal to the prod23 uct obtained by multiplying— 

24 ‘‘(AA) the applicable 

25 percentage for each class as 


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1 determined under subpara2 graph (B)(ii); by 

3 ‘‘(BB) the amount de4 termined under subitem 

5 (aa). 

6 ‘‘(II) For other tobacco products, 

7 for each fiscal year, the total user fees 

8 assessed and collected for all such 

9 other tobacco products shall be an 

10 amount that is equal to the product 

11 obtained by multiplying— 

12 ‘‘(aa) the total of the gross 

13 domestic sales for other tobacco 

14 products during the previous full 

15 calendar year, divided by the sum 

16 of the gross domestic sales for 

17 the classes of tobacco products 

18 listed in subparagraph (B)(i) and 

19 other tobacco products during 

20 such calendar year; by 

21 ‘‘(bb) the amount specified 

22 in paragraph (1) for such fiscal 

23 year.’’. 

24 (c) OTHER TOBACCO PRODUCTS.— 


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1 (1) AMENDMENT.—Section 919(b)(2) of the 

2 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

3 387s(b)(2)) is amended by adding at the end the fol4 lowing: 

5 ‘‘(C) EFFECT OF FAILURE TO FINALIZE

6 REGULATIONS ON TIME.—The Secretary shall 

7 finalize updates to the regulations under part 

8 1150 of title 21, Code of Federal Regulations, 

9 to provide for the assessment and collection of 

10 user fees for other tobacco products beginning 

11 not later than fiscal year 2028. The Secretary 

12 shall continue to assess and collect fees under 

13 subsection (a) with respect to each class of to14 bacco products listed in subparagraph (B)(i) 

15 until the first fiscal year commencing after the 

16 effective date of the final regulation to imple17 ment provisions for assessment and collection of 

18 user fees for other tobacco products. 

19 ‘‘(D) INFORMATION TO BE SUBMITTED.— 

20 ‘‘(i) IN GENERAL.—In addition to any 

21 other reporting requirements under this 

22 Act and any implementing regulation, each 

23 manufacturer or importer of any tobacco 

24 product shall submit to the Secretary the 


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1 information required under this subpara2 graph— 

3 ‘‘(I) not later than— 

4 ‘‘(aa) March 1, 2027, for 

5 calendar year 2026; and 

6 ‘‘(bb) April 20, 2027, for 

7 the period of January 1, 2027, 

8 through March 30, 2027; and 

9 ‘‘(II) quarterly thereafter, or in 

10 accordance with such other reporting 

11 requirements as the Secretary may es12 tablish by regulation. 

13 ‘‘(ii) REQUIREMENTS.—The informa14 tion required to be submitted under this 

15 subparagraph shall consist of— 

16 ‘‘(I) the identification informa17 tion of the manufacturer or importer, 

18 to include— 

19 ‘‘(aa) the Employer Identi20 fication Number (EIN); 

21 ‘‘(bb) company name; 

22 ‘‘(cc) the phone number (in23 cluding area code); 

24 ‘‘(dd) the email address; and 


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1 ‘‘(ee) the mailing address 

2 where communications and as3 sessments from the Food and 

4 Drug Administration can be re5 ceived; 

6 ‘‘(II) the class or classes of to7 bacco products, to include the classes 

8 listed in subparagraph (B)(i) and 

9 other tobacco products, for which the 

10 manufacturer or importer has domes11 tic sales; and 

12 ‘‘(III) the gross domestic sales 

13 data, where the manufacturer or im14 porter has domestic sales, for each 

15 class of tobacco products listed in sub16 paragraph (B)(i) and other tobacco 

17 products.’’. 

18 (2) PROHIBITED ACT.—Section 301(q)(1)(B) of 

19 the Federal Food, Drug, and Cosmetic Act (21 

20 U.S.C. 331(q)(1)(B)) is amended by inserting 

21 ‘‘919(b)(2)(D),’’ before ‘‘or 920’’. 

22 (d) ALLOCATION OF ASSESSMENTS.—Paragraph (4) 

23 of section 919(b) of the Federal Food, Drug, and Cos24 metic Act (21 U.S.C. 387s(b)) is amended to read as fol25 lows: 


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1 ‘‘(4) ALLOCATION OF ASSESSMENTS.—The per2 centage share of each manufacturer or importer of 

3 a particular class of tobacco products listed in para4 graph (2)(B)(i) and other tobacco products of the 

5 total user fees to be paid by all manufacturers or 

6 importers of that class of tobacco products listed in 

7 paragraph (2)(B)(i) and other tobacco products shall 

8 be— 

9 ‘‘(A) for tobacco product classes listed in 

10 paragraph (2)(B)(i), the percentage determined 

11 for purposes of allocations under subsections (e) 

12 through (h) of section 625 of Public Law 108– 

13 357 (7 U.S.C. 518d); and 

14 ‘‘(B) for other tobacco products, the per15 centage determined by dividing— 

16 ‘‘(i) the total gross domestic sales of 

17 other tobacco products for a manufacturer 

18 or importer for the prior fiscal quarter; by 

19 ‘‘(ii) the total gross domestic sales of 

20 other tobacco products for all manufactur21 ers and importers for that same quarter.’’. 

22 (e) REALLOCATIONS.—Clause (iv) of section 

23 919(b)(2)(B) of the Federal Food, Drug, and Cosmetic 

24 Act (21 U.S.C. 387s(b)(2)(B)) is amended to read as fol25 lows: 


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1 ‘‘(iv) REALLOCATIONS.—In the case 

2 of a class or partial class of tobacco prod3 ucts that is not listed in section 901(b) or 

4 deemed by the Secretary in a regulation 

5 under section 901(b) to be subject to this 

6 chapter, the amount of user fees that 

7 would otherwise be assessed to such class 

8 or partial class of tobacco products shall be 

9 reallocated to the classes or partial classes 

10 of tobacco products that are subject to this 

11 chapter in the same manner and based on 

12 the same relative percentages otherwise de13 termined under clause (ii), adjusted as nec14 essary to reflect partial classes if any.’’. 

15 (f) LIABILITY.—Paragraph (5) of section 919(b) of 

16 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

17 387s(b)) is amended to read as follows: 

18 ‘‘(5) ASSESSMENT LIABILITY.—The quarterly 

19 assessment amount owed by a manufacturer or im20 porter of tobacco products listed in paragraph 

21 (2)(B)(i) or other tobacco products shall be— 

22 ‘‘(A) based on removals (as defined in sec23 tion 5702(j) of the Internal Revenue Code of 

24 1986) or gross domestic sales, as relevant, dur25 ing the prior fiscal period; and 


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1 ‘‘(B) remitted to the Food and Drug Ad2 ministration regardless of whether the manufac3 turer or importer meets the definition of manu4 facturer or importer in the fiscal quarter in 

5 which— 

6 ‘‘(i) the assessment is calculated; or 

7 ‘‘(ii) the manufacturer or importer re8 ceives notification of the amount of assess9 ment owed to the Food and Drug Adminis10 tration.’’. 

11 (g) CONFORMING AMENDMENTS.—Paragraph (7) of 

12 section 919(b) of the Federal Food, Drug, and Cosmetic 

13 Act (21 U.S.C. 387s(b)) is amended to read as follows: 

14 ‘‘(7) MEMORANDUM OF UNDERSTANDING.—The 

15 Secretary may request any appropriate Federal 

16 agency to enter into a memorandum of under17 standing that provides for the regular and timely 

18 transfer from the head of such agency to the Sec19 retary of information regarding any tobacco product 

20 manufacturer or importer required to pay user fees. 

21 The Secretary shall maintain all disclosure restric22 tions established by the head of such agency regard23 ing the information provided under the memo24 randum of understanding.’’. 


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1 (h) DEFINITIONS.—Section 919(b) of the Federal 

2 Food, Drug, and Cosmetic Act (21 U.S.C. 387s(b)) is 

3 amended by adding at the end the following: 

4 ‘‘(8) DEFINITIONS.—For purposes of this sub5 section: 

6 ‘‘(A) The term ‘gross domestic sales’ 

7 means the total amount in dollars, not to in8 clude taxes, duties, and fees, of the sale by 

9 manufacturers and importers of finished to10 bacco products in the United States. 

11 ‘‘(B) The term ‘other tobacco product’ 

12 means a tobacco product that is made or de13 rived from tobacco, or contains nicotine from 

14 any source, that does not fit within a product 

15 class listed in paragraph (2)(B)(i).’’. 

16 (i) INSPECTION AUTHORITY.—The fifth sentence of 

17 section 704(a)(1) of the Federal Food, Drug, and Cos18 metic Act (21 U.S.C. 374(a)(1)) is amended by striking 

19 ‘‘sales data other than shipment data, pricing data’’ and 

20 inserting ‘‘sales data (other than shipment data and, for 

21 tobacco products, sales data relating to tobacco product 

22 user fees under section 919), pricing data (other than 

23 pricing data relating to tobacco product user fees under 

24 section 919)’’. 

25 (j) APPLICABILITY.— 


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1 (1) IN GENERAL.—The amendments made by 

2 this section shall apply— 

3 (A) in the case of such amendments made 

4 by subsections (a), (e), and (i), beginning on 

5 the date of enactment of this Act; and 

6 (B) in the case of other amendments made 

7 by this section, beginning on October 1, 2027. 

8 (2) SPECIAL RULE.—If the date of enactment 

9 of this Act occurs after fiscal year 2024, then the 

10 Secretary of Health and Human Services shall as11 sess and collect the increase in total amount by tak12 ing the amount specified in subparagraph (L) or 

13 (M) of section 919(b)(1) of the Federal Food, Drug, 

14 and Cosmetic Act (21 U.S.C. 387c(b)(1)), as appro15 priate, and assessing such amount equally across 

16 each fiscal quarter for the relevant fiscal year. 

Æ 


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