II 

117TH CONGRESS 

1ST SESSION S. 2445 

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 

JULY 22, 2021 

Mrs. SHAHEEN (for herself, Ms. MURKOWSKI, Mr. DURBIN, Ms. COLLINS, Ms. 

BALDWIN, and Mr. ROMNEY) 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. 

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 ‘‘Resources To Prevent 

5 Youth Vaping Act’’. 

6 SEC. 2. USER FEES. 

7 (a) INCREASE IN TOTAL AMOUNT.—Section 

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


SSpencer on DSK126QN23PROD with BILLS
2 

•S 2445 IS

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

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

4 2021, $712,000,000. 

5 ‘‘(L) For fiscal year 2022, $812,000,000. 

6 ‘‘(M) For fiscal year 2023 and each subse7 quent fiscal year, the amount that was applica8 ble for the previous fiscal year, adjusted 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 CLASSES

15 OF TOBACCO PRODUCTS.— 

16 (1) IN GENERAL.—Subparagraph (A) of section 

17 919(b)(2) of the Federal Food, Drug, and Cosmetic 

18 Act (21 U.S.C. 387s(b)(2)) is amended to read as 

19 follows: 

20 ‘‘(A) IN GENERAL.— 

21 ‘‘(i) FISCAL YEARS 2022 AND 2023.— 

22 For fiscal years 2022 and 2023, user fees 

23 shall be assessed and collected under sub24 section (a) only with respect to the classes 

25 of tobacco products listed in subparagraph 


SSpencer on DSK126QN23PROD with BILLS
3 

•S 2445 IS

1 (B)(i), and the total such user fees with re2 spect to each such class shall be an 

3 amount that is equal to the applicable per4 centage of each such class for the fiscal 

5 year multiplied by the amount specified in 

6 paragraph (1) for the fiscal year. 

7 ‘‘(ii) SUBSEQUENT FISCAL YEARS.— 

8 For fiscal year 2024 and each subsequent 

9 fiscal year, user fees shall be assessed and 

10 collected under subsection (a) with respect 

11 to each class of tobacco products to which 

12 this chapter applies (including tobacco 

13 products that the Secretary by regulation 

14 deems to be subject to this chapter), and 

15 the total user fees with respect to each 

16 such class shall be— 

17 ‘‘(I) with respect to each class of 

18 tobacco products listed in subpara19 graph (B)(i), an amount that is cal20 culated in the same way as the 

21 amounts calculated for fiscal years 

22 2022 and 2023 under clause (i), ex23 cept that for purposes of fiscal years 

24 2024 and subsequent fiscal years, in25 stead of multiplying the applicable 


SSpencer on DSK126QN23PROD with BILLS
4 

•S 2445 IS

1 percentage of each such class by ‘the 

2 amount specified in paragraph (1) for 

3 the fiscal year’, the applicable percent4 age shall be multiplied by— 

5 ‘‘(aa) the amount specified 

6 in paragraph (1) for the fiscal 

7 year, reduced by 

8 ‘‘(bb) the total user fees as9 sessed and collected pursuant to 

10 subclause (II) for the fiscal year; 

11 and 

12 ‘‘(II) with respect to each class of 

13 tobacco products to which this chapter 

14 applies but which is not listed in sub15 paragraph (B)(i), an amount deter16 mined pursuant to a formula under 

17 subparagraph (C).’’. 

18 (2) OTHER TOBACCO PRODUCTS.—Section 

19 919(b)(2) of the Federal Food, Drug, and Cosmetic 

20 Act (21 U.S.C. 387s(b)(2)), as amended by para21 graph (1), is further amended by adding at the end 

22 the following new subparagraphs: 

23 ‘‘(C) ALLOCATION FOR OTHER TOBACCO

24 PRODUCTS.— 


SSpencer on DSK126QN23PROD with BILLS
5 

•S 2445 IS

1 ‘‘(i) IN GENERAL.—Beginning with 

2 fiscal year 2024, the total user fees as3 sessed and collected under subsection (a) 

4 each fiscal year with respect to each class 

5 of tobacco products not listed in subpara6 graph (B)(i) shall be an amount that is de7 termined pursuant to a formula developed 

8 by the Secretary by regulation using infor9 mation required to be submitted under 

10 subparagraph (D). 

11 ‘‘(ii) ALLOCATION FOR OTHER TO12 BACCO PRODUCTS.—For each class of to13 bacco products not listed in subparagraph 

14 (B)(i), the percentage of fees under the 

15 formula under clause (i) for the respective 

16 fiscal year shall be equal to the percentage 

17 of the gross domestic sales in the previous 

18 calendar year that is attributable to such 

19 class of tobacco products in such calendar 

20 year, as determined by the Secretary. 

21 ‘‘(iii) ALLOCATION OF ASSESSMENT

22 WITHIN EACH CLASS OF OTHER TOBACCO

23 PRODUCTS.—The percentage of the total 

24 user fee to be paid by each manufacturer 

25 or importer of tobacco products in a class 


SSpencer on DSK126QN23PROD with BILLS
6 

•S 2445 IS

1 not listed in subparagraph (B)(i) shall be 

2 determined by the Secretary, based on the 

3 percentage of the gross domestics sales of 

4 all such classes of tobacco products by all 

5 manufacturers and importers in the pre6 vious calendar year that is attributable to 

7 such manufacturer or importer. 

8 ‘‘(iv) EFFECT OF FAILURE TO FINAL9 IZE FORMULA ON TIME.—If the Secretary 

10 for any reason fails to finalize by fiscal 

11 year 2024 the formula required by this 

12 subparagraph for the assessment and col13 lection of user fees for classes of tobacco 

14 products not listed in subparagraph 

15 (B)(i)— 

16 ‘‘(I) the Secretary shall continue 

17 to assess and collect fees under sub18 section (a) with respect to each class 

19 of tobacco products listed in subpara20 graph (B)(i); and 

21 ‘‘(II) until the first fiscal year 

22 commencing after the finalization of 

23 such formula, the exception described 

24 in subparagraph (A)(ii)(I) shall not 

25 apply. 


SSpencer on DSK126QN23PROD with BILLS
7 

•S 2445 IS

1 ‘‘(v) REVISIONS BY REGULATION.— 

2 Any revisions to the formula promulgated 

3 pursuant to this subparagraph shall be by 

4 regulation. 

5 ‘‘(vi) DEFINITION.—In this subpara6 graph, the term ‘gross domestic sales’ 

7 means the total value in dollars of the sale 

8 or distribution by manufacturers and im9 porters of tobacco products in the United 

10 States in classes not listed in subpara11 graph (B)(i), as determined based on the 

12 aggregation of sales data from every man13 ufacturer and importer of tobacco products 

14 that submits sales data to the Secretary. 

15 ‘‘(D) INFORMATION REQUIRED TO BE SUB16 MITTED.—Each manufacturer or importer of 

17 any tobacco product shall submit to the Sec18 retary the information required under this sub19 paragraph by March 1, 2023, for calendar year 

20 2022, by April 1, 2023, for the period of Janu21 ary 1, 2023, through March 30, 2023, and 

22 monthly thereafter. Such information shall in23 clude— 

24 ‘‘(i) the identification of the manufac25 turer or importer; 


SSpencer on DSK126QN23PROD with BILLS
8 

•S 2445 IS

1 ‘‘(ii) the class or classes of tobacco 

2 products sold by the manufacturer or im3 porter; 

4 ‘‘(iii) the full listing of the finished to5 bacco products in a class not listed in sub6 paragraph (B)(i) sold or distributed by the 

7 manufacturer or importer in the United 

8 States; and 

9 ‘‘(iv) the gross domestic sales data for 

10 each class of finished tobacco products sold 

11 or distributed by the manufacturer or im12 porter in the United States.’’. 

13 (3) PROHIBITED ACT.—Section 301(q)(1)(B) of 

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

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

16 ‘‘919(b)(2)(D),’’ before ‘‘or 920’’. 

17 (c) ALLOCATION OF ASSESSMENT WITHIN EACH

18 CLASS OF TOBACCO PRODUCT.—Section 919(b)(4) of the 

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

20 387s(b)(4)) is amended by striking ‘‘shall be the percent21 age determined for purposes of allocations under sub22 sections (e) through (h) of section 625 of Public Law 108– 

23 357’’ and inserting ‘‘shall be the percentage determined 

24 by the Secretary’’. 


SSpencer on DSK126QN23PROD with BILLS
9 

•S 2445 IS

1 (d) CONFORMING AMENDMENTS.—Section 919(b) of 

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

3 387s(b)) is amended— 

4 (1) by striking paragraph (5); 

5 (2) by redesignating paragraphs (6) and (7) as 

6 paragraphs (5) and (6), respectively; and 

7 (3) by amending paragraph (6), as redesig8 nated, to read as follows: 

9 ‘‘(6) MEMORANDUM OF UNDERSTANDING.—The 

10 Secretary shall request the appropriate Federal 

11 agency to enter into a memorandum of under12 standing that provides for the regular and timely 

13 transfer from the head of such agency to the Sec14 retary of all necessary information regarding all to15 bacco product manufacturers and importers required 

16 to pay user fees. The Secretary shall maintain all 

17 disclosure restrictions established by the head of 

18 such agency regarding the information provided 

19 under the memorandum of understanding.’’. 

20 (e) APPLICABILITY.—The amendments made by sub21 sections (b), (c), and (d) apply beginning with fiscal year 

22 2024. Subject to the amendment made by subsection (a), 

23 section 919 of the Federal Food, Drug, and Cosmetic Act 

24 (21 U.S.C. 387s), as in effect on the day before the date 


SSpencer on DSK126QN23PROD with BILLS
10 

•S 2445 IS

1 of enactment of this Act, shall apply with respect to fiscal 

2 years preceding fiscal year 2024. 

3 SEC. 3. ANNUAL REPORT. 

4 (a) IN GENERAL.—For fiscal year 2022 and each 

5 subsequent fiscal year for which fees are collected under 

6 section 919 of the Federal Food, Drug, and Cosmetic Act 

7 (21 U.S.C. 387s), the Secretary of Health and Human 

8 Services, acting through the Commissioner of Food and 

9 Drugs, shall, not later than 180 days after the end of the 

10 respective fiscal year for which the report is being pre11 pared, submit to the Committee on Health, Education, 

12 Labor, and Pensions and the Committee on Appropria13 tions of the Senate, and the Committee on Energy and 

14 Commerce and Committee on Appropriations of the House 

15 of Representatives, an annual report with respect to such 

16 fees that contains the information required under sub17 section (b). 

18 (b) REQUIRED INFORMATION.—Each report sub19 mitted under subsection (a) shall contain the following in20 formation with respect to the fiscal year for which the re21 port is being submitted: 

22 (1) A breakdown of the amount expended by 

23 the Food and Drug Administration on each of the 

24 following activities: 

25 (A) Compliance and enforcement. 


SSpencer on DSK126QN23PROD with BILLS
11 

•S 2445 IS

1 (B) Public education campaigns. 

2 (C) Scientific research and research infra3 structure. 

4 (D) Communications. 

5 (E) Leadership, management, oversight, 

6 and administrative functions. 

7 (F) Related overhead activities. 

8 (G) Other activities. 

9 (2) Details on the amount expended, and the 

10 purpose of such expenditures, on each of the five 

11 largest expenditure amounts within each of the cat12 egories described in paragraph (1). 

13 (3) A breakdown of the amount expended on 

14 activities related to deemed tobacco products versus 

15 how much was expended on activities related to com16 bustible tobacco products outlined in the pre-existing 

17 categories of tobacco products under section 919 of 

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

19 U.S.C. 387s). 

20 (4) An explanation for how the Food and Drug 

21 Administration ensures that the amount of user fees 

22 allocated to public education campaigns on youth e23 cigarette use and prevention is sufficient to meet the 

24 need for education of teens and minors on the dan25 gers of e-cigarettes and other Electronic Nicotine 


SSpencer on DSK126QN23PROD with BILLS
12 

•S 2445 IS

1 Delivery Systems (commonly referred to as 

2 ‘‘ENDS’’). 

3 (5) A list of the status of submitted, pending, 

4 and approved tobacco product applications for each 

5 regulatory pathway and class of tobacco product as 

6 defined by the Family Smoking Prevention and To7 bacco Control Act (Public Law 111–31), including 

8 subsequent regulations, for the 3-fiscal year period 

9 preceding the fiscal year for which the report is 

10 being prepared. 

11 (6) When applicable, a breakdown of the 

12 amount or user fees collected under the amendments 

13 made by this Act from manufacturers of deemed to14 bacco products and the amount collected from man15 ufacturers of each of the original pre-existing cat16 egories of tobacco products under section 919 of the 

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

18 387s). 

Æ 


SSpencer on DSK126QN23PROD with BILLS