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Code · BILL · 113th Congress · H.R. 5010 (Introduced in House) — To provide greater clarity in the regulation of electronic nicotine delivery systems, including electronic cigarettes... · Sec. 3

Sec. 3. FDA regulation of electronic nicotine delivery systems and e-liquids

762 words·~3 min read·/bill/113/hr/5010/ih/section-3

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Section 900 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 387 ) is amended— by redesignating paragraphs
(8)through
(22)as paragraphs
(10)through (24), respectively; and by inserting after paragraph
(7)the following: The term electronic nicotine delivery system — means any product, the use of which may resemble smoking, that provides an inhalable dose of nicotine by delivery of a vaporized solution, including any such product that is marketed as an electronic cigarette, cigar, cigarillo, pipe, or hookah; and includes any component, part, or paraphernalia of such a product, including cartridges, cartomizers, e-liquid, smoke juice, tips, atomizers, batteries, and chargers, whether or not the component, part, or paraphernalia is sold separately. The term e-liquid means a solution that contains nicotine, flavorings, or other chemicals that is intended to be used to produce an inhaled vapor from an electronic nicotine delivery system. . Section 901(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 387a(b) ) is amended by striking This chapter shall apply to all cigarettes, and inserting This chapter shall apply to all cigarettes, electronic nicotine delivery systems, e-liquids, . Section 3(1) of the Federal Cigarette Labeling and Advertising Act ( 15 U.S.C. 1332(1) ) is amended— in subparagraph (A), by striking and at the end; in subparagraph (B), by striking the period at the end and inserting ; and ; and by adding at the end the following: any electronic nicotine delivery system (as such term is defined in section 900 of the Federal Food, Drug, and Cosmetic Act). . By not later than one year after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall complete a study on— any purported health benefits associated with flavorings for electronic nicotine delivery systems and e-liquids, including whether any such flavorings help adults to quit smoking; and whether any such flavorings would appeal to children and increase their likelihood to use electronic nicotine delivery systems or e-liquids. Upon completion of the study under paragraph (1), the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall consider whether to adopt a tobacco product standard under section 907(a)(3) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 387g(a)(3) ) prohibiting or restricting the use of flavorings in electronic nicotine delivery systems and e-liquids. Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall promulgate a final tobacco product standard under section 907 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 387g ) requiring child-proof packaging for electronic nicotine delivery systems and e-liquids. Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs— shall promulgate a final tobacco product standard under section 907 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 387g ) establishing dosage limits for electronic nicotine delivery systems and e-liquids that are adequate for the majority of smokers using an electronic nicotine delivery system as a substitute to smoking; and may include in such tobacco product standard an exception allowing consumers to access electronic nicotine delivery systems and e-liquids containing nicotine in excess of the dosage limit established under paragraph
(1)pursuant to a prescription. Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs— shall promulgate a final tobacco product standard under section 907 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 387g ) establishing for e-liquids maximum levels for the concentration of nicotine, and establishing labeling requirements with respect to the concentration of nicotine, that are adequate for the majority of smokers using an electronic nicotine delivery system as a substitute to smoking; and may include in such tobacco product standard an exception allowing consumers to access e-liquids containing nicotine in excess of the dosage limit established under paragraph
(1)pursuant to a prescription. The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall make such changes to the final rule promulgated under section 102 of the Family Smoking Prevention and Tobacco Control Act ( 21 U.S.C. 387a–1 ) (or any successor regulation) as may be necessary to implement the provisions of this section and the amendments made by this section.
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  • 21 USC 387a–1
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cites case law
Sec. 3
FDA regulation of electronic nicotine delivery systems and e-liquids
U.S.C.§ 387
U.S.C.§ 387a
U.S.C.§ 1332
U.S.C.§ 387g
Cite21 USC 387a–1
Cites 5Cited by 0 across 0 sources
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