II 116th CONGRESS 1st Session S. 2519 IN THE SENATE OF THE UNITED STATES September 19, 2019 Mr. Romney (for himself and Mr. Merkley ) introduced the following bill; which was read twice and referred to the Committee on Finance A BILL To protect the public health by prohibiting non-tobacco e-cigarette flavors and ensuring electronic nicotine delivery systems are tamper-proof.

1. Short title This Act may be cited as the Ending New Nicotine Dependencies Act of 2019 or the ENND Act . 2. Findings Congress finds as follows: (1) As of September 11, 2019, the Centers for Disease Control and Prevention and the Food and Drug Administration reported 380 confirmed and probable cases of severe pulmonary disease cases associated with the widespread use of electronic cigarettes (referred to in this section as e-cigarettes ). (2) As of September 17, 2019, States have reported as many as 7 deaths nationwide associated with the use of e-cigarettes. (3) The American Medical Association has stated that e-cigarette-related lung illnesses reaffirm[s] our belief that the use of e-cigarettes and vaping is an urgent public health epidemic that must be addressed . (4) The Surgeon General has warned that the proliferation of e-cigarettes is cause for great concern , and that the use of e-cigarettes has become an epidemic among our nation’s young people . (5) Since 2014, e-cigarettes have been the most commonly used tobacco product among youth in the United States. (6) According to the Food and Drug Administration, youth consistently report product flavorings as a leading reason for using tobacco products and flavors may disguise the taste of tobacco . (7) In 2019, more than 1 in every 4 high school students reported using e-cigarettes in the past 30 days. (8) On September 9, 2019, the Food and Drug Administration sent a warning letter to one of the largest e-cigarette companies for violating Federal regulations and utilizing illegal marketing tactics. (9) E-cigarettes are not currently approved by the Food and Drug Administration as a smoking cessation aid. (10) More research is needed to evaluate the safety of e-cigarettes, including the risks associated with tampering with and altering e-cigarettes and the health implications of heating aerosolized tobacco products. 3. Restrictions on flavors in tobacco products and on device design (a) In general Section 907(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 387g(a) ) is amended— (1) in paragraph (1), by adding at the end the following: (C) Special rule for electronic nicotine delivery systems Beginning 90 days after the date of enactment of the ENND Act , an electronic nicotine delivery system or any of its components or parts (including e-liquid) shall not contain, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco) or an herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, coffee, menthol, or mint that is a characterizing flavor of the electronic nicotine delivery system or e-liquid. Nothing in this subparagraph shall be construed to limit the Secretary's authority to take action under this section or other sections of this Act applicable to any artificial or natural flavor, herb, or spice not specified in this subparagraph. ; and (2) by adding at the end the following: (7) Electronic nicotine delivery system standards Not later than 1 year after the date of enactment of the ENND Act , the Secretary shall promulgate regulations setting forth standards on the permissible design of electronic nicotine delivery systems, and issue guidance for manufacturers to implement such standards. Such standards, at a minimum, shall— (A) prohibit refillable components or parts; (B) prohibit any electronic nicotine delivery system designed to look like combustible cigarettes or commonplace, nonmedical devices, such as pens or USB flash drives; and (C) require each electronic nicotine delivery system and its components and parts to be tamper-proof. . (b) Definitions (1) In general Section 900 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 387 ) is amended— (A) by redesignating paragraphs (8) through (22) as paragraphs (10) through (24); and (B) by inserting after paragraph (7) the following: (8) Electronic nicotine delivery system (A) In general The term electronic nicotine delivery system — (i) means noncombustible tobacco products, including vapes, vaporizers, vape pens, hookah pens, electronic cigarettes (also known as e-cigarettes or e-cigs ), and e-pipes that deliver an aerosolized e-liquid that may contain nicotine, as well as varying compositions of flavorings, propylene glycol, vegetable glycerin, and other ingredients; and (ii) includes components and parts, such as e-liquids, tanks, cartridges, pods, wicks, and atomizers. (B) Components and parts The term components and parts , with respect to an electronic nicotine delivery system, means the objects intended or reasonably expected to be used with, or for, the human consumption of a tobacco product that are not accessories. (9) E-liquid The term e-liquid means liquid nicotine, nicotine containing liquids (including liquid nicotine combined with colorings, flavorings, or other ingredients), and liquids that do not contain nicotine or other material made or derived from tobacco, but that are intended or reasonably expected to be used with or for the human consumption of a tobacco product. . (2) 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(20) . 4. Monitoring of public health risks of tobacco use Not later than 1 year after the date of enactment of this Act and annually thereafter, the Secretary of Health and Human Services, in consultation with the Director of the National Institutes of Health, the Commissioner of Food and Drugs, the Director of the Centers for Disease Control and Prevention, and other heads of appropriate agencies, as the Secretary of Health and Human Services determines appropriate, shall submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives, and publicly post on an internet website, a report on the public health risks of tobacco use that includes— (1) the public health implications of the use of tobacco products, with a focus on electronic nicotine delivery systems and other alternative tobacco products; (2) emerging trends in tobacco use, including the use of tobacco flavors and new tobacco products; (3) updates on the public health awareness campaign authorized by section 6; and (4) recommendations for Congress. 5. Application of tobacco excise tax to electronic nicotine delivery systems (a) Imposition, rate, and attachment of tax Section 5701 of the Internal Revenue Code of 1986 is amended— (1) by redesignating subsection (h) as subsection (i); and (2) by inserting after subsection (g) the following new subsection: (h) Electronic nicotine delivery (1) Electronic nicotine delivery systems (A) In general On electronic nicotine delivery systems (as defined in section 900(8) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 387(8) )), manufactured in or imported into the United States, there shall be imposed a tax equal to $1.01 per electronic nicotine delivery system. (B) Exception This paragraph shall not apply to any single-use electronic nicotine delivery system. (2) E-liquid On e-liquids (as defined in section 900(9) of such Act) or single-use electronic nicotine delivery systems, manufactured in or imported into the United States, there shall be imposed a tax equal to— (A) in the case of a product which contains less than 5 percent nicotine by volume, $1.01, and (B) in the case of the product which contains a percentage of nicotine by volume which is equal to or greater than 5 percent, an amount equal to the sum of— (i) $1.01, plus, (ii) for each percentage point of nicotine by volume contained in such product which is in excess of 5 percent, 20.2 cents (and a proportionate amount at the like rate on any such percentage which is not a whole number). . (b) Definitions Section 5702 of the Internal Revenue Code of 1986 is amended— (1) in subsection (c), by striking and roll-your-own tobacco and inserting roll-your-own tobacco, electronic nicotine delivery systems, and e-liquids ; and (2) in subsection (d), by striking or roll-your-own tobacco each place it appears and inserting roll-your-own tobacco, electronic nicotine delivery systems, and e-liquids . (c) Effective date The amendments made by this section shall apply to articles removed after the date which is 90 days after the date of enactment of this Act. 6. Public awareness campaign (a) In general The Secretary of Health and Human Services (referred to in this section as the Secretary ) shall conduct a public awareness campaign to educate the public about the public health implications of using electronic nicotine delivery systems (as defined in section 900 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 387 ), as amended by section 3). (b) Funding To carry out subsection (a), for each of fiscal years 2021 through 2024, there shall be transferred to the Secretary, from the General Fund of the Treasury, the lesser of— (1) the amount equal to the amount collected under 5701(h) of the Internal Revenue Code of 1986 during the previous fiscal year; or (2) $115,000,000. 7. Implementation of excise tax (a) Transitional rule Any person who— (1) on the date of the enactment of this Act, is engaged in business as a manufacturer of electronic nicotine delivery systems or e-liquids; and (2) before the applicable date, submits an application under subchapter B of chapter 52 of the Internal Revenue Code of 1986 to engage in such business, may, notwithstanding such subchapter B, continue to engage in such business pending final action on such application. Pending such final action, all provisions of chapter 52 of such Code shall apply to such applicant in the same manner and to the same extent as if such applicant were a holder of a permit to manufacture electronic nicotine delivery systems or e-liquids under such chapter 52. (b) Floor Stocks Taxes (1) Imposition of tax On electronic nicotine delivery systems or e-liquids manufactured in or imported into the United States which are removed before the applicable date and held on such date for sale by any person, there is hereby imposed a tax in an amount equal to the tax which would be imposed under section 5701 of the Internal Revenue Code of 1986 on the article if the article had been removed on such applicable date. (2) Liability for tax and method of payment (A) Liability for tax A person holding electronic nicotine delivery systems or e-liquids on the applicable date to which any tax imposed by paragraph (1) applies shall be liable for such tax. (B) Method of payment The tax imposed by paragraph (1) shall be paid in such manner as the Secretary shall prescribe by regulations. (C) Time for payment The tax imposed by paragraph (1) shall be paid on or before the date that is 120 days after the applicable date. (3) Articles in foreign trade zones Notwithstanding the Act of June 18, 1934 (commonly known as the Foreign Trade Zone Act, 48 Stat. 998, 19 U.S.C. 81a et seq.), or any other provision of law, any article which is located in a foreign trade zone on any tax increase date shall be subject to the tax imposed by paragraph (1) if— (A) internal revenue taxes have been determined, or customs duties liquidated, with respect to such article before such date pursuant to a request made under the 1st proviso of section 3(a) of such Act; or (B) such article is held on such date under the supervision of an officer of the United States Customs and Border Protection of the Department of Homeland Security pursuant to the 2d proviso of such section 3(a). (4) Controlled groups Rules similar to the rules of section 5061(e)(3) of the Internal Revenue Code of 1986 shall apply for purposes of this subsection. (5) Other laws applicable All provisions of law, including penalties, applicable with respect to the taxes imposed by section 5701 of the Internal Revenue Code of 1986 shall, insofar as applicable and not inconsistent with the provisions of this subsection, apply to the floor stocks taxes imposed by paragraph (1), to the same extent as if such taxes were imposed by such section 5701. The Secretary may treat any person who bore the ultimate burden of the tax imposed by paragraph (1) as the person to whom a credit or refund under such provisions may be allowed or made. (c) Definitions For purposes of this section— (1) In general Any term used in this section which is also used in section 5701 or 5702 of the Internal Revenue Code of 1986 shall have the same meaning as such term has in such section. (2) Applicable date The term applicable date means the day after the date which is 90 days after the date of enactment of this Act. (3) Secretary The term Secretary means the Secretary of the Treasury or the Secretary’s delegate.