; (II) will not increase the likelihood of youth initiation of nicotine or tobacco products; and (III) will not increase the likelihood of harm to the person using the characterizing flavor. . (b) Definitions Section 900 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 387 ) is amended— (1) by redesignating paragraphs (8) through (22) as paragraphs (9) through (23); and (2) by inserting after paragraph (7) the following: (8) Electronic nicotine delivery system The term electronic nicotine delivery system — (A) means any electronic device that delivers nicotine, flavor, or another substance via an aerosolized solution to the user inhaling from the device (including e-cigarettes, e-hookah, e-cigars, vape pens, advanced refillable personal vaporizers, and electronic pipes) and any component, liquid, part, or accessory of such a device, whether or not sold separately; and (B) does not include a product that— (i) is approved by the Food and Drug Administration for sale as a tobacco cessation product or for another therapeutic purpose; and (ii) is marketed and sold solely for a purpose described in (i). . (c) Conforming amendment Section 9(1) of the Comprehensive Smokeless Tobacco Health Education Act of 1986 ( 15 U.S.C. 4408(1) ) is amended by striking section 900(18) and inserting section 900(19) . (d) Effective Date The amendments made by this section shall take effect 1 year after the date of enactment of this Act.