II 116th CONGRESS 1st Session S. 655 IN THE SENATE OF THE UNITED STATES March 5, 2019 Mr. Durbin (for himself and Ms. Murkowski ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To impose additional restrictions on tobacco flavors for use in e-cigarettes.

1. Short title This Act may be cited as the Stopping Appealing Flavors in E-Cigarettes for Kids Act or the SAFE Kids Act . 2. Findings Congress finds as follows: (1) Tobacco use almost always begins during adolescence and, because nicotine is addictive, most youth tobacco users continue to use tobacco as adults, even if they intended to quit. (2) According to the Surgeon General, the use of products containing nicotine in any form among youth, including e-cigarettes, is unsafe and nicotine exposure during adolescence can cause addiction and can harm the developing brain. (3) In 2018, youth e-cigarette use increased by 78 percent among high school students and by 48 percent among middle school students. More than 3,600,000 youth currently use e-cigarettes, an increase of 1,500,000 high school and middle school students in one year. (4) In 2018, 28 percent of high school e-cigarette users and 16 percent of middle school e-cigarette users reported frequent use of e-cigarettes, using e-cigarettes on at least 20 of the preceding 30 days. (5) Rising use of e-cigarettes among youth is hindering progress in reducing youth tobacco use. The use of any tobacco product increased by 38 percent among high school students and 29 percent among middle school students between 2017 and 2018. (6) Both the Surgeon General and the Commissioner of Food and Drugs have called the recent surge in youth e-cigarettes use an epidemic . (7) The Surgeon General issued an advisory in 2018 emphasizing the need to take immediate action to stem the youth e-cigarette epidemic and to protect youth from a lifetime of nicotine addiction and related health risks. (8) Youth use of cigars is a public health concern. High school boys smoke cigars at a higher rate than cigarettes (9 percent for cigars and 7.6 percent for cigarettes). (9) Flavors play a significant role in attracting youth to tobacco products and make such products easier to use by masking the harshness of tobacco products. (10) A 2017 study identified more than 15,000 unique e-cigarette flavors available online. E-cigarettes come in flavors such as gummy bear, cotton candy, and fruit loops. (11) The number of unique cigar flavor names more than doubled, from 108 to 250, between 2008 and 2015, and flavored cigars made up more than half of the convenience store cigar market in 2015. Cigars come in flavors such as chocolate, watermelon, and tropical fusion and are sold in convenience stores for as little as 3 for 99 cents. (12) Youth often begin tobacco use with a flavored product. Eighty-one percent of youth who have ever used a tobacco product started with a flavored tobacco product. (13) Flavors are a primary reason why youth use e-cigarettes and cigars. Eighty-two percent of current youth e-cigarette users and 74 percent of current youth cigar smokers said they used these products because they come in flavors I like . (14) In 2018, the Food and Drug Administration and the Federal Trade Commission took action against some deceptive e-liquid products that look like kid-friendly juice boxes, cookies, and candy. Many similar products remain on the market. (15) The American Association of Poison Control Centers reported more than 3100 calls in 2018 due to exposure to e-liquids, and the American Academy of Pediatrics has warned about the dangers of accidental poisonings because of the appeal of the packaging of flavored products. (16) Curbing the use of flavors in tobacco products will help to protect youth from nicotine addiction and tobacco-caused diseases such as cancer, heart disease, and respiratory disease. 3. Additional restrictions on use of tobacco flavors (a) Tobacco product standards Section 907(a)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 387g ) is amended— (1) by redesignating subparagraph (B) as subparagraph (C); and (2) by inserting after subparagraph (A) the following: (B) Special rule for tobacco products other than cigarettes (i) In general Except as provided in clause (ii), a tobacco product that is not a cigarette, or any component, part, or accessory of such a product, shall not contain, as a constituent (including a smoke or aerosol constituent) or additive, an artificial or natural flavor (other than tobacco) or an herb or spice (including menthol, strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, and coffee) that is a characterizing flavor of the tobacco product, tobacco smoke, or aerosol emitted from the product. Nothing in this subparagraph shall be construed to limit the Secretary’s authority to take action under this section or other provisions of this Act applicable to any artificial or natural flavor, herb, or spice not specified in this subparagraph. (ii) Exceptions An electronic nicotine delivery system component or part shall not contain or use an artificial or natural flavor (other than tobacco) that is a characterizing flavor of the product or its aerosol unless the Secretary issues an order finding that a manufacturer has demonstrated that use of the characterizing flavor— (I) will increase the likelihood of smoking cessation among current users of tobacco products; (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.