I 

117TH CONGRESS 

1ST SESSION H. R. 6286 

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

authority with respect to tobacco products containing nicotine not made 

or derived from tobacco, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

DECEMBER 14, 2021 

Ms. SHERRILL (for herself, Mr. KRISHNAMOORTHI, and Mr. STEWART) 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 

vest regulatory authority with respect to tobacco products 

containing nicotine not made or derived from tobacco, 

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 ‘‘Clarifying Authority 

5 over Nicotine Act of 2021’’. 


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1 SEC. 2. FDA AUTHORITY OVER PRODUCTS CONTAINING 

2 NICOTINE. 

3 (a) TOBACCO PRODUCT DEFINITION.—Section 

4 201(rr)(1) of the Federal Food, Drug, and Cosmetic Act 

5 (21 U.S.C. 321(rr)(1)) is amended— 

6 (1) by inserting ‘‘, or containing nicotine from 

7 any source,’’ after ‘‘from tobacco’’; and 

8 (2) by adding at the end the following: ‘‘An ar9 ticle that is a food as defined in paragraph (f) shall 

10 not be considered a tobacco product if it contains 

11 not more than trace amounts of nicotine and such 

12 nicotine is naturally occurring.’’. 

13 (b) APPLICABILITY.—Section 901(b) of the Federal 

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

15 amended to reads follows: 

16 ‘‘(b) APPLICABILITY.— 

17 ‘‘(1) IN GENERAL.—This chapter shall apply to 

18 all cigarettes, cigarette tobacco, roll-your-own to19 bacco, and smokeless tobacco and to any other to20 bacco products that the Secretary by regulation 

21 deems to be subject to this chapter. 

22 ‘‘(2) TOBACCO PRODUCTS CONTAINING NICO23 TINE NOT MADE OR DERIVED FROM TOBACCO.—Be24 ginning 30 days after the date of enactment of the 

25 Clarifying Authority over Nicotine Act of 2021, this 


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1 chapter shall apply to any tobacco product con2 taining nicotine not made or derived from tobacco.’’. 

3 (c) APPLICABILITY OF EXISTING REQUIREMENTS

4 FOR TOBACCO PRODUCTS.—Beginning on the date speci5 fied in section 901(b) of the Federal Food, Drug, and Cos6 metic Act, as amended by subsection (b), with respect to 

7 any regulation promulgated or related guidance docu8 ments issued, in whole or in part, under this Act before 

9 such date, the term ‘‘tobacco product’’ shall have the 

10 meaning of, and shall be deemed amended to reflect the 

11 meaning of, such term as defined in section 201(rr) of 

12 the Federal Food, Drug, and Cosmetic Act, as amended 

13 by subsection (a). Products that are ‘‘tobacco products’’ 

14 under such section 201(rr) shall be subject to the require15 ments of existing regulations for tobacco products. The 

16 Secretary shall publish a notice in the Federal Register 

17 to update the Code of Federal Regulations to reflect such 

18 deemed amendment to existing regulations and guidance 

19 documents. 

Æ 


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