ENND Act

II 116TH CONGRESS 1ST SESSION S. 2519 To protect the public health by prohibiting non-tobacco e-cigarette flavors and ensuring electronic nicotine delivery systems are tamper-proof. 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. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Ending New Nicotine 4 Dependencies Act of 2019’’ or the ‘‘ENND Act’’. 5 SEC. 2. FINDINGS. 6 Congress finds as follows: 7 (1) As of September 11, 2019, the Centers for 8 Disease Control and Prevention and the Food and 9 Drug Administration reported 380 confirmed and 10 VerDate Sep 11 2014 20:33 Sep 23, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S2519.IS S2519 pamtmann on DSKBC07HB2PROD with BILLS 2 •S 2519 IS probable cases of severe pulmonary disease cases as- 1 sociated with the widespread use of electronic ciga- 2 rettes (referred to in this section as ‘‘e-cigarettes’’). 3 (2) As of September 17, 2019, States have re- 4 ported as many as 7 deaths nationwide associated 5 with the use of e-cigarettes. 6 (3) The American Medical Association has stat- 7 ed that e-cigarette-related lung illnesses ‘‘reaffirm[s] 8 our belief that the use of e-cigarettes and vaping is 9 an urgent public health epidemic that must be ad- 10 dressed’’. 11 (4) The Surgeon General has warned that the 12 proliferation of e-cigarettes is ‘‘cause for great con- 13 cern’’, and that the use of e-cigarettes has ‘‘become 14 an epidemic among our nation’s young people’’. 15 (5) Since 2014, e-cigarettes have been the most 16 commonly used tobacco product among youth in the 17 United States. 18 (6) According to the Food and Drug Adminis- 19 tration, ‘‘youth consistently report product flavorings 20 as a leading reason for using tobacco products’’ and 21 ‘‘flavors may disguise the taste of tobacco’’. 22 (7) In 2019, more than 1 in every 4 high school 23 students reported using e-cigarettes in the past 30 24 days. 25 VerDate Sep 11 2014 20:33 Sep 23, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S2519.IS S2519 pamtmann on DSKBC07HB2PROD with BILLS 3 •S 2519 IS (8) On September 9, 2019, the Food and Drug 1 Administration sent a warning letter to one of the 2 largest e-cigarette companies for violating Federal 3 regulations and utilizing illegal marketing tactics. 4 (9) E-cigarettes are not currently approved by 5 the Food and Drug Administration as a smoking 6 cessation aid. 7 (10) More research is needed to evaluate the 8 safety of e-cigarettes, including the risks associated 9 with tampering with and altering e-cigarettes and 10 the health implications of heating aerosolized to- 11 bacco products. 12 SEC. 3. RESTRICTIONS ON FLAVORS IN TOBACCO PROD- 13 UCTS AND ON DEVICE DESIGN. 14 (a) IN GENERAL.—Section 907(a) of the Federal 15 Food, Drug, and Cosmetic Act (21 U.S.C. 387g(a)) is 16 amended— 17 (1) in paragraph (1), by adding at the end the 18 following: 19 ‘‘(C) SPECIAL RULE FOR ELECTRONIC NIC- 20 OTINE DELIVERY SYSTEMS.—Beginning 90 21 days after the date of enactment of the ENND 22 Act, an electronic nicotine delivery system or 23 any of its components or parts (including e-liq- 24 uid) shall not contain, as a constituent (includ- 25 VerDate Sep 11 2014 20:33 Sep 23, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S2519.IS S2519 pamtmann on DSKBC07HB2PROD with BILLS 4 •S 2519 IS ing a smoke constituent) or additive, an artifi- 1 cial or natural flavor (other than tobacco) or an 2 herb or spice, including strawberry, grape, or- 3 ange, clove, cinnamon, pineapple, vanilla, coco- 4 nut, licorice, cocoa, chocolate, cherry, coffee, 5 menthol, or mint that is a characterizing flavor 6 of the electronic nicotine delivery system or e- 7 liquid. Nothing in this subparagraph shall be 8 construed to limit the Secretary’s authority to 9 take action under this section or other sections 10 of this Act applicable to any artificial or natural 11 flavor, herb, or spice not specified in this sub- 12 paragraph.’’; and 13 (2) by adding at the end the following: 14 ‘‘(7) ELECTRONIC NICOTINE DELIVERY SYSTEM 15 STANDARDS.—Not later than 1 year after the date 16 of enactment of the ENND Act, the Secretary shall 17 promulgate regulations setting forth standards on 18 the permissible design of electronic nicotine delivery 19 systems, and issue guidance for manufacturers to 20 implement such standards. Such standards, at a 21 minimum, shall— 22 ‘‘(A) prohibit refillable components or 23 parts; 24 VerDate Sep 11 2014 20:33 Sep 23, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S2519.IS S2519 pamtmann on DSKBC07HB2PROD with BILLS 5 •S 2519 IS ‘‘(B) prohibit any electronic nicotine deliv- 1 ery system designed to look like combustible 2 cigarettes or commonplace, nonmedical devices, 3 such as pens or USB flash drives; and 4 ‘‘(C) require each electronic nicotine deliv- 5 ery system and its components and parts to be 6 tamper-proof.’’. 7 (b) DEFINITIONS.— 8 (1) IN GENERAL.—Section 900 of the Federal 9 Food, Drug, and Cosmetic Act (21 U.S.C. 387) is 10 amended— 11 (A) by redesignating paragraphs (8) 12 through (22) as paragraphs (10) through (24); 13 and 14 (B) by inserting after paragraph (7) the 15 following: 16 ‘‘(8) ELECTRONIC NICOTINE DELIVERY SYS- 17 TEM.— 18 ‘‘(A) IN GENERAL.—The term ‘electronic 19 nicotine delivery system’— 20 ‘‘(i) means noncombustible tobacco 21 products, including vapes, vaporizers, vape 22 pens, hookah pens, electronic cigarettes 23 (also known as ‘e-cigarettes’ or ‘e-cigs’), 24 and e-pipes that deliver an aerosolized e- 25 VerDate Sep 11 2014 20:33 Sep 23, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S2519.IS S2519 pamtmann on DSKBC07HB2PROD with BILLS 6 •S 2519 IS liquid that may contain nicotine, as well as 1 varying compositions of flavorings, pro- 2 pylene glycol, vegetable glycerin, and other 3 ingredients; and 4 ‘‘(ii) includes components and parts, 5 such as e-liquids, tanks, cartridges, pods, 6 wicks, and atomizers. 7 ‘‘(B) COMPONENTS AND PARTS.—The 8 term ‘components and parts’, with respect to an 9 electronic nicotine delivery system, means the 10 objects intended or reasonably expected to be 11 used with, or for, the human consumption of a 12 tobacco product that are not accessories. 13 ‘‘(9) E-LIQUID.—The term ‘e-liquid’ means liq- 14 uid nicotine, nicotine containing liquids (including 15 liquid nicotine combined with colorings, flavorings, 16 or other ingredients), and liquids that do not contain 17 nicotine or other material made or derived from to- 18 bacco, but that are intended or reasonably expected 19 to be used with or for the human consumption of a 20 tobacco product.’’. 21 (2) CONFORMING AMENDMENT.—Section 9(1) 22 of the Comprehensive Smokeless Tobacco Health 23 Education Act of 1986 (15 U.S.C. 4408(1)) is 24 VerDate Sep 11 2014 20:33 Sep 23, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S2519.IS S2519 pamtmann on DSKBC07HB2PROD with BILLS 7 •S 2519 IS amended by striking ‘‘section 900(18)’’ and insert- 1 ing ‘‘section 900(20)’’. 2 SEC. 4. MONITORING OF PUBLIC HEALTH RISKS OF TO- 3 BACCO USE. 4 Not later than 1 year after the date of enactment 5 of this Act and annually thereafter, the Secretary of 6 Health and Human Services, in consultation with the Di- 7 rector of the National Institutes of Health, the Commis- 8 sioner of Food and Drugs, the Director of the Centers for 9 Disease Control and Prevention, and other heads of appro- 10 priate agencies, as the Secretary of Health and Human 11 Services determines appropriate, shall submit to the Com- 12 mittee on Health, Education, Labor, and Pensions and the 13 Committee on Appropriations of the Senate and the Com- 14 mittee on Energy and Commerce and the Committee on 15 Appropriations of the House of Representatives, and pub- 16 licly post on an internet website, a report on the public 17 health risks of tobacco use that includes— 18 (1) the public health implications of the use of 19 tobacco products, with a focus on electronic nicotine 20 delivery systems and other alternative tobacco prod- 21 ucts; 22 (2) emerging trends in tobacco use, including 23 the use of tobacco flavors and new tobacco products; 24 VerDate Sep 11 2014 20:33 Sep 23, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S2519.IS S2519 pamtmann on DSKBC07HB2PROD with BILLS 8 •S 2519 IS (3) updates on the public health awareness 1 campaign authorized by section 6; and 2 (4) recommendations for Congress. 3 SEC. 5. APPLICATION OF TOBACCO EXCISE TAX TO ELEC- 4 TRONIC NICOTINE DELIVERY SYSTEMS. 5 (a) IMPOSITION, RATE, AND ATTACHMENT OF 6 TAX.—Section 5701 of the Internal Revenue Code of 1986 7 is amended— 8 (1) by redesignating subsection (h) as sub- 9 section (i); and 10 (2) by inserting after subsection (g) the fol- 11 lowing new subsection: 12 ‘‘(h) ELECTRONIC NICOTINE DELIVERY.— 13 ‘‘(1) ELECTRONIC NICOTINE DELIVERY SYS- 14 TEMS.— 15 ‘‘(A) IN GENERAL.—On electronic nicotine 16 delivery systems (as defined in section 900(8) 17 of the Federal Food, Drug, and Cosmetic Act 18 (21 U.S.C. 387(8))), manufactured in or im- 19 ported into the United States, there shall be 20 imposed a tax equal to $1.01 per electronic nic- 21 otine delivery system. 22 ‘‘(B) EXCEPTION.—This paragraph shall 23 not apply to any single-use electronic nicotine 24 delivery system. 25 VerDate Sep 11 2014 20:33 Sep 23, 2019 Jkt 089200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S2519.IS S2519 pamtmann on DSKBC07HB2PROD with BILLS 9 •S 2519 IS ‘‘(2) E-LIQUID.—On e-liquids (as defined in 1 section 900(9) of such Act) or single-use electronic 2 nicotine delivery systems, manufactured in or im- 3 ported into the United States, there shall be imposed 4 a tax equal to— 5 ‘‘(A) in the case of a product which con- 6 tains less than 5 percent nicotine by volume, 7 $1.01, and 8 ‘‘(B) in the case of the product which con- 9 tains a percentage of nicotine by volume which 10 is equal to or greater than 5 percent, an 11 amount equal to the sum of— 12 ‘‘(i) $1.01, plus, 13 ‘‘(ii) for each percentage point of nico- 14 tine by volume contained in such product 15 which is in excess of 5 percent, 20.2 cents 16 (and a proportionate amount at the like 17 rate on any such percentage which is not 18 a whole number).’’. 19 (b) DEFINITIONS.—Section 5702 of the Internal Rev- 20 enue Code of 1986 is amended— 21 (1) in subsection (c), by striking ‘‘and roll-your- 22 own tobacco’’ and inserting ‘‘roll-your-own tobacco, 23 electronic nicotine delivery systems, and e-liquids’’; 24 and 25 VerDate Sep 11 2014 20:33 Sep 23, 2019 Jkt 089200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S2519.IS S2519 pamtmann on DSKBC07HB2PROD with BILLS 10 •S 2519 IS (2) in subsection (d), by striking ‘‘or roll-your- 1 own tobacco’’ each place it appears and inserting 2 ‘‘roll-your-own tobacco, electronic nicotine delivery 3 systems, and e-liquids’’. 4 (c) EFFECTIVE DATE.—The amendments made by 5 this section shall apply to articles removed after the date 6 which is 90 days after the date of enactment of this Act. 7 SEC. 6. PUBLIC AWARENESS CAMPAIGN. 8 (a) IN GENERAL.—The Secretary of Health and 9 Human Services (referred to in this section as the ‘‘Sec- 10 retary’’) shall conduct a public awareness campaign to 11 educate the public about the public health implications of 12 using electronic nicotine delivery systems (as defined in 13 section 900 of the Federal Food, Drug, and Cosmetic Act 14 (21 U.S.C. 387), as amended by section 3). 15 (b) FUNDING.—To carry out subsection (a), for each 16 of fiscal years 2021 through 2024, there shall be trans- 17 ferred to the Secretary, from the General Fund of the 18 Treasury, the lesser of— 19 (1) the amount equal to the amount collected 20 under 5701(h) of the Internal Revenue Code of 21 1986 during the previous fiscal year; or 22 (2) $115,000,000. 23 SEC. 7. IMPLEMENTATION OF EXCISE TAX. 24 (a) TRANSITIONAL RULE.—Any person who— 25 VerDate Sep 11 2014 20:33 Sep 23, 2019 Jkt 089200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S2519.IS S2519 pamtmann on DSKBC07HB2PROD with BILLS 11 •S 2519 IS (1) on the date of the enactment of this Act, is 1 engaged in business as a manufacturer of electronic 2 nicotine delivery systems or e-liquids; and 3 (2) before the applicable date, submits an appli- 4 cation under subchapter B of chapter 52 of the In- 5 ternal Revenue Code of 1986 to engage in such busi- 6 ness, 7 may, notwithstanding such subchapter B, continue to en- 8 gage in such business pending final action on such applica- 9 tion. Pending such final action, all provisions of chapter 10 52 of such Code shall apply to such applicant in the same 11 manner and to the same extent as if such applicant were 12 a holder of a permit to manufacture electronic nicotine 13 delivery systems or e-liquids under such chapter 52. 14 (b) FLOOR STOCKS TAXES.— 15 (1) IMPOSITION OF TAX.—On electronic nico- 16 tine delivery systems or e-liquids manufactured in or 17 imported into the United States which are removed 18 before the applicable date and held on such date for 19 sale by any person, there is hereby imposed a tax in 20 an amount equal to the tax which would be imposed 21 under section 5701 of the Internal Revenue Code of 22 1986 on the article if the article had been removed 23 on such applicable date. 24 VerDate Sep 11 2014 20:33 Sep 23, 2019 Jkt 089200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S2519.IS S2519 pamtmann on DSKBC07HB2PROD with BILLS 12 •S 2519 IS (2) LIABILITY FOR TAX AND METHOD OF PAY- 1 MENT.— 2 (A) LIABILITY FOR TAX.—A person hold- 3 ing electronic nicotine delivery systems or e-liq- 4 uids on the applicable date to which any tax im- 5 posed by paragraph (1) applies shall be liable 6 for such tax. 7 (B) METHOD OF PAYMENT.—The tax im- 8 posed by paragraph (1) shall be paid in such 9 manner as the Secretary shall prescribe by reg- 10 ulations. 11 (C) TIME FOR PAYMENT.—The tax im- 12 posed by paragraph (1) shall be paid on or be- 13 fore the date that is 120 days after the applica- 14 ble date. 15 (3) ARTICLES IN FOREIGN TRADE ZONES.— 16 Notwithstanding the Act of June 18, 1934 (com- 17 monly known as the Foreign Trade Zone Act, 48 18 Stat. 998, 19 U.S.C. 81a et seq.), or any other pro- 19 vision of law, any article which is located in a for- 20 eign trade zone on any tax increase date shall be [Text truncated for display. 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