Sec. 111. FDA AUTHORITY OVER PRODUCTS CONTAINING NICOTINE
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## SEC. 111 FDA AUTHORITY OVER PRODUCTS CONTAINING NICOTINE ###
(a)Tobacco Product Defined Section 201(rr) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(rr)) is amended— ####
(1)in subparagraph (1), by inserting “, or containing nicotine from any source,” after “from tobacco”; and ####
(2)by adding at the end the following: > > #### “(5) > > The term ‘tobacco product’ does not mean an article that is a food under paragraph (f), if such article contains no nicotine, or no more than trace amounts of naturally occurring nicotine.” > . ###
(b)Applicability to Certain Products Section 901(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387a(b)) is amended by adding at the end the following: “This chapter shall also apply to any tobacco product containing nicotine that is not made or derived from tobacco.”. ###
(c)Effective Date **[**[21 U.S.C. 321 note](/us/usc/t21/s321)**]** The amendments made by subsections
(a)and
(b)shall take effect 30 days after the date of enactment of this Act. ###
(d)Submission of Applications for Previously Marketed Products **[**[21 U.S.C. 387j note](/us/usc/t21/s387j)**]** ####
(1)Transition period for all products With respect to a tobacco product that contains nicotine from any source other than tobacco and that was being marketed in the United States within 30 days after the date of enactment of this Act, such product shall not be considered to be in violation of section 910 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387j) (relating to applications for review of certain tobacco products) during the 60-day period following the date of enactment of this Act. ####
(2)Submission of applications #####
(A)In general As a condition for continuing to market a product described in paragraph
(1)after the 60-day period specified in such paragraph, during the 30-day period beginning on the effective date specified in subsection (c), the manufacturer shall submit a new tobacco product application under section 910(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387j(b)) with respect to such product. #####
(B)Transition period Except as provided in subparagraph (C), with respect to a tobacco product for which an application is submitted as described in subparagraph (A), the manufacturer of such product may continue to market such product during the 90-day period beginning on the effective date specified in subsection (c). #####
(C)Exception If the Secretary of Health and Human Services previously denied an application under section 910(c)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387j(c)(2)), refused to file an application under section 910(b) of such Act, or withdrew an order under section 910(d) of such Act for a previous version of a tobacco product that used nicotine made or derived from tobacco, such product is not eligible for continued marketing under subparagraph (B). ####
(3)End of transition period Beginning on the date that is 90 days after the effective date specified in subsection (c), a tobacco product described in paragraph
(1)(including such a tobacco product that is the subject of a pending application under section 910 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387j)) is in violation of such section 910 if such tobacco product does not have an order in effect under subsection (c)(1)(A)(i) of such section. ###
(e)Applicability of Existing Requirements for Tobacco Products **[**[21 U.S.C. 321 note](/us/usc/t21/s321)**]** Effective 30 days after the date of enactment of this Act, with respect to any regulation promulgated or related guidance issued, in whole or part, under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) before the date that is 30 days after such date of enactment, 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 (21 U.S.C. 321(rr)), as amended by subsection (a). Products that are tobacco products under such section 201(rr), as so amended, shall be subject to all requirements of regulations for tobacco products. The Secretary of Health and Human Services 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. ###
(f)Technical Achievability Section 907(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387g(b)(1)) is amended by inserting before the period at the end the following: “, including with regard to any differences related to the technical achievability of compliance with such standard for products in the same class containing nicotine not made or derived from tobacco and products containing nicotine made or derived from tobacco”.
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Sec. 111
FDA AUTHORITY OVER PRODUCTS CONTAINING NICOTINE
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