I 116TH CONGRESS 1ST SESSION H. R. 4624 To amend the Federal Food, Drug, and Cosmetic Act to establish a tobacco product standard prohibiting any e-liquid with a concentration of nicotine higher than 20 milligrams per milliliter, and for other purposes. IN THE HOUSE OF REPRESENTATIVES OCTOBER 8, 2019 Mr. KRISHNAMOORTHI introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend the Federal Food, Drug, and Cosmetic Act to establish a tobacco product standard prohibiting any e- liquid with a concentration of nicotine higher than 20 milligrams per milliliter, and for other purposes. 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 Nicotine De- 4 pendence from Electronic Nicotine Delivery Systems Act 5 of 2019’’ or the ‘‘END ENDS Act of 2019’’. 6 SEC. 2. FINDINGS. 7 Congress finds as follows: 8 VerDate Sep 11 2014 23:06 Oct 08, 2019 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H4624.IH H4624 kjohnson on DSK79L0C42 with BILLS 2 •HR 4624 IH (1) According to the Centers for Disease Con- 1 trol and Prevention (in this section referred to as 2 the ‘‘CDC’’), the brain keeps developing until ap- 3 proximately age 25, and nicotine exposure can harm 4 the parts of the brain that control attention, learn- 5 ing, mood, and impulse control. 6 (2) Adolescent nicotine use may also increase 7 the risk of future addiction to other drugs. 8 (3) A recent CDC study found that 99 percent 9 of e-cigarettes sold in the United States contain nic- 10 otine. 11 (4) In congressional testimony before the Sub- 12 committee on Economic and Consumer Policy of the 13 Committee on Oversight and Reform of the House 14 of Representatives on September 24, 2019, CDC 15 Principal Deputy Director Anne Schuchat stated 16 that ‘‘fourth generation e-cigarette devices’’ were 17 first sold in 2015 and ‘‘use nicotine salts, which can 18 lead to much more available nicotine’’. 19 (5) According to Dr. Schuchat’s testimony, 20 fourth generation devices ‘‘can cross the blood-brain 21 barrier and lead to potentially more effects on the 22 developing brain in adolescents’’. Further, ‘‘the very 23 high levels of accessible nicotine and the discreet use 24 of the product’’ directly link the growing popularity 25 VerDate Sep 11 2014 23:06 Oct 08, 2019 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H4624.IH H4624 kjohnson on DSK79L0C42 with BILLS 3 •HR 4624 IH of fourth generation e-cigarette devices to the rise in 1 youth e-cigarette use. 2 (6) Prior to the use of nicotine salts, which are 3 now used in the e-liquids of the most popular e-ciga- 4 rettes, most e-cigarettes contained ‘‘freebase nico- 5 tine’’. Because freebase nicotine has a much harsher 6 effect on the inhaler, these e-cigarette devices con- 7 tained much less nicotine than devices which contain 8 nicotine salts. 9 (7) The most popular e-cigarette manufactured 10 and sold in the United States, which is considered 11 a ‘‘fourth generation device’’, most frequently con- 12 tains an ‘‘e-liquid’’ with 59 milligrams per milliliter 13 of nicotine. 14 (8) In response, the European Union, the 15 United Kingdom, and Israel implemented regula- 16 tions to cap the concentration of nicotine in e-ciga- 17 rette e-liquids to 20 milligrams per milliliter. 18 (9) The United Kingdom’s nicotine cap went 19 into effect on May 20, 2017. As youth use sky- 20 rocketed in the United States between 2017 and 21 2018, the percentage of youth e-cigarette users who 22 use more than once a week only rose from 1.2 per- 23 cent to 1.7 percent, and the percentage of youth who 24 VerDate Sep 11 2014 23:06 Oct 08, 2019 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H4624.IH H4624 kjohnson on DSK79L0C42 with BILLS 4 •HR 4624 IH use less than weekly decreased from 2.2 percent to 1 1.8 percent. 2 (10) E-cigarettes manufactured and sold in the 3 United States are currently not subject to any nico- 4 tine cap, and e-cigarette manufacturers are per- 5 mitted to design their products to be as addictive as 6 possible. 7 (11) According to the CDC, e-cigarette use rose 8 by 78 percent among high schoolers and 48 percent 9 among middle schoolers between 2017 and 2018. 10 (12) Preliminary results from the CDC’s an- 11 nual National Youth Tobacco Survey published in 12 September 2019 show that 27.5 percent of high 13 school students reported using an e-cigarette in the 14 previous 30 days, up from 20.8 percent in 2018. 15 (13) The CDC, the Food and Drug Administra- 16 tion, the Department of Health and Human Serv- 17 ices, the Surgeon General of the Public Health Serv- 18 ice, and various State and local health authorities 19 have determined the skyrocketing e-cigarette use 20 amongst American youth to be an ‘‘epidemic’’. 21 SEC. 3. SENSE OF CONGRESS. 22 It is the sense of the Congress that— 23 VerDate Sep 11 2014 23:06 Oct 08, 2019 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H4624.IH H4624 kjohnson on DSK79L0C42 with BILLS 5 •HR 4624 IH (1) effectively combating the youth e-cigarette 1 epidemic will require the implementation of bold and 2 enduring policy solutions; 3 (2) under the current regulatory framework, 4 American youth have easy access to highly addictive 5 ‘‘fourth generation’’ e-cigarette devices that hook 6 them into a lifelong addiction to nicotine; 7 (3) in order to significantly decrease youth e- 8 cigarette use and to reduce the dangers associated 9 with excessive nicotine inhalation, the Federal Gov- 10 ernment should regulate nicotine levels in e-ciga- 11 rettes in order to make them less addictive and less 12 harmful to youth; and 13 (4) in addition to regulating nicotine levels, the 14 Federal Government should also review other factors 15 related to the composition and function of fourth 16 generation e-cigarettes in order to make them less 17 addictive and appealing to youth, including battery 18 power and design. 19 SEC. 4. MAXIMUM NICOTINE CONTENT IN E-LIQUIDS. 20 (a) TOBACCO PRODUCT STANDARD.—Paragraph (1) 21 of section 907(a) of the Federal Food, Drug, and Cosmetic 22 Act (21 U.S.C. 387g(a)) is amended by adding at the end 23 the following new subparagraph: 24 VerDate Sep 11 2014 23:06 Oct 08, 2019 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H4624.IH H4624 kjohnson on DSK79L0C42 with BILLS 6 •HR 4624 IH ‘‘(C) NICOTINE CONTENT IN E-LIQUIDS.— 1 Beginning on the date of enactment of the End- 2 ing Nicotine Dependence from Electronic Nico- 3 tine Delivery Systems Act of 2019, an e-liquid 4 shall not have a concentration of nicotine higher 5 than— 6 ‘‘(i) 20 milligrams per milliliter; or 7 ‘‘(ii) such lower nicotine concentration 8 as is determined by the Secretary to be 9 minimally addictive or non-addictive.’’. 10 (b) DEFINITIONS.— 11 (1) IN GENERAL.—Section 900 of the Federal 12 Food, Drug, and Cosmetic Act (21 U.S.C. 387) is 13 amended— 14 (A) by redesignating paragraphs (8) 15 through (22) as paragraphs (10) through (24), 16 respectively; and 17 (B) by inserting after paragraph (7) the 18 following: 19 ‘‘(8) ELECTRONIC NICOTINE DELIVERY SYS- 20 TEM.—The term ‘electronic nicotine delivery system’ 21 means a tobacco product that is an electronic device 22 that delivers nicotine, flavor, or another substance 23 via an aerosolized solution to the user inhaling from 24 the device (including e-cigarettes, e-hookah, e-cigars, 25 VerDate Sep 11 2014 23:06 Oct 08, 2019 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H4624.IH H4624 kjohnson on DSK79L0C42 with BILLS 7 •HR 4624 IH vape pens, advanced refillable personal vaporizers, 1 and electronic pipes) and any component, liquid, 2 part, or accessory of such a device, whether or not 3 sold separately. 4 ‘‘(9) E-LIQUID.—The term ‘e-liquid’ means any 5 liquid intended for use with an electronic nicotine 6 delivery system.’’. 7 (2) CONFORMING AMENDMENT.—Section 9(1) 8 of the Comprehensive Smokeless Tobacco Health 9 Education Act of 1986 (15 U.S.C. 4408(1)) is 10 amended by striking ‘‘900(18)’’ and inserting 11 ‘‘900(20)’’. 12 Æ VerDate Sep 11 2014 23:06 Oct 08, 2019 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6301 E:\BILLS\H4624.IH H4624 kjohnson on DSK79L0C42 with BILLS