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) intro-
duced 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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Clarifying Authority 
over Nicotine Act of 2021’’. 
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SEC. 2. FDA AUTHORITY OVER PRODUCTS CONTAINING 
NICOTINE. 
(a) 
TOBACCO
PRODUCT
DEFINITION.—Section 
201(rr)(1) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 321(rr)(1)) is amended— 
(1) by inserting ‘‘, or containing nicotine from 
any source,’’ after ‘‘from tobacco’’; and 
(2) by adding at the end the following: ‘‘An ar-
ticle that is a food as defined in paragraph (f) shall 
not be considered a tobacco product if it contains 
not more than trace amounts of nicotine and such 
nicotine is naturally occurring.’’. 
(b) APPLICABILITY.—Section 901(b) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 387a(b)) is 
amended to reads follows: 
‘‘(b) APPLICABILITY.— 
‘‘(1) IN GENERAL.—This chapter shall apply to 
all cigarettes, cigarette tobacco, roll-your-own to-
bacco, and smokeless tobacco and to any other to-
bacco products that the Secretary by regulation 
deems to be subject to this chapter. 
‘‘(2) TOBACCO
PRODUCTS
CONTAINING
NICO-
TINE NOT MADE OR DERIVED FROM TOBACCO.—Be-
ginning 30 days after the date of enactment of the 
Clarifying Authority over Nicotine Act of 2021, this 
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chapter shall apply to any tobacco product con-
taining nicotine not made or derived from tobacco.’’. 
(c) APPLICABILITY
OF EXISTING REQUIREMENTS 
FOR TOBACCO PRODUCTS.—Beginning on the date speci-
fied in section 901(b) of the Federal Food, Drug, and Cos-
metic Act, as amended by subsection (b), with respect to 
any regulation promulgated or related guidance docu-
ments issued, in whole or in part, under this Act before 
such date, the term ‘‘tobacco product’’ shall have the 
meaning of, and shall be deemed amended to reflect the 
meaning of, such term as defined in section 201(rr) of 
the Federal Food, Drug, and Cosmetic Act, as amended 
by subsection (a). Products that are ‘‘tobacco products’’ 
under such section 201(rr) shall be subject to the require-
ments of existing regulations for tobacco products. The 
Secretary shall publish a notice in the Federal Register 
to update the Code of Federal Regulations to reflect such 
deemed amendment to existing regulations and guidance 
documents. 
Æ 
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