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 eliquid with a concentration of nicotine higher than 20 

milligrams per milliliter, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Ending Nicotine De5 pendence from Electronic Nicotine Delivery Systems Act 

6 of 2019’’ or the ‘‘END ENDS Act of 2019’’. 

7 SEC. 2. FINDINGS. 

8 Congress finds as follows: 


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1 (1) According to the Centers for Disease Con2 trol and Prevention (in this section referred to as 

3 the ‘‘CDC’’), the brain keeps developing until ap4 proximately age 25, and nicotine exposure can harm 

5 the parts of the brain that control attention, learn6 ing, mood, and impulse control. 

7 (2) Adolescent nicotine use may also increase 

8 the risk of future addiction to other drugs. 

9 (3) A recent CDC study found that 99 percent 

10 of e-cigarettes sold in the United States contain nic11 otine. 

12 (4) In congressional testimony before the Sub13 committee on Economic and Consumer Policy of the 

14 Committee on Oversight and Reform of the House 

15 of Representatives on September 24, 2019, CDC 

16 Principal Deputy Director Anne Schuchat stated 

17 that ‘‘fourth generation e-cigarette devices’’ were 

18 first sold in 2015 and ‘‘use nicotine salts, which can 

19 lead to much more available nicotine’’. 

20 (5) According to Dr. Schuchat’s testimony, 

21 fourth generation devices ‘‘can cross the blood-brain 

22 barrier and lead to potentially more effects on the 

23 developing brain in adolescents’’. Further, ‘‘the very 

24 high levels of accessible nicotine and the discreet use 

25 of the product’’ directly link the growing popularity 


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1 of fourth generation e-cigarette devices to the rise in 

2 youth e-cigarette use. 

3 (6) Prior to the use of nicotine salts, which are 

4 now used in the e-liquids of the most popular e-ciga5 rettes, most e-cigarettes contained ‘‘freebase nico6 tine’’. Because freebase nicotine has a much harsher 

7 effect on the inhaler, these e-cigarette devices con8 tained much less nicotine than devices which contain 

9 nicotine salts. 

10 (7) The most popular e-cigarette manufactured 

11 and sold in the United States, which is considered 

12 a ‘‘fourth generation device’’, most frequently con13 tains an ‘‘e-liquid’’ with 59 milligrams per milliliter 

14 of nicotine. 

15 (8) In response, the European Union, the 

16 United Kingdom, and Israel implemented regula17 tions to cap the concentration of nicotine in e-ciga18 rette e-liquids to 20 milligrams per milliliter. 

19 (9) The United Kingdom’s nicotine cap went 

20 into effect on May 20, 2017. As youth use sky21 rocketed in the United States between 2017 and 

22 2018, the percentage of youth e-cigarette users who 

23 use more than once a week only rose from 1.2 per24 cent to 1.7 percent, and the percentage of youth who 


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1 use less than weekly decreased from 2.2 percent to 

2 1.8 percent. 

3 (10) E-cigarettes manufactured and sold in the 

4 United States are currently not subject to any nico5 tine cap, and e-cigarette manufacturers are per6 mitted to design their products to be as addictive as 

7 possible. 

8 (11) According to the CDC, e-cigarette use rose 

9 by 78 percent among high schoolers and 48 percent 

10 among middle schoolers between 2017 and 2018. 

11 (12) Preliminary results from the CDC’s an12 nual National Youth Tobacco Survey published in 

13 September 2019 show that 27.5 percent of high 

14 school students reported using an e-cigarette in the 

15 previous 30 days, up from 20.8 percent in 2018. 

16 (13) The CDC, the Food and Drug Administra17 tion, the Department of Health and Human Serv18 ices, the Surgeon General of the Public Health Serv19 ice, and various State and local health authorities 

20 have determined the skyrocketing e-cigarette use 

21 amongst American youth to be an ‘‘epidemic’’. 

22 SEC. 3. SENSE OF CONGRESS. 

23 It is the sense of the Congress that— 


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1 (1) effectively combating the youth e-cigarette 

2 epidemic will require the implementation of bold and 

3 enduring policy solutions; 

4 (2) under the current regulatory framework, 

5 American youth have easy access to highly addictive 

6 ‘‘fourth generation’’ e-cigarette devices that hook 

7 them into a lifelong addiction to nicotine; 

8 (3) in order to significantly decrease youth e9 cigarette use and to reduce the dangers associated 

10 with excessive nicotine inhalation, the Federal Gov11 ernment should regulate nicotine levels in e-ciga12 rettes in order to make them less addictive and less 

13 harmful to youth; and 

14 (4) in addition to regulating nicotine levels, the 

15 Federal Government should also review other factors 

16 related to the composition and function of fourth 

17 generation e-cigarettes in order to make them less 

18 addictive and appealing to youth, including battery 

19 power and design. 

20 SEC. 4. MAXIMUM NICOTINE CONTENT IN E-LIQUIDS. 

21 (a) TOBACCO PRODUCT STANDARD.—Paragraph (1) 

22 of section 907(a) of the Federal Food, Drug, and Cosmetic 

23 Act (21 U.S.C. 387g(a)) is amended by adding at the end 

24 the following new subparagraph: 


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1 ‘‘(C) NICOTINE CONTENT IN E-LIQUIDS.— 

2 Beginning on the date of enactment of the End3 ing Nicotine Dependence from Electronic Nico4 tine Delivery Systems Act of 2019, an e-liquid 

5 shall not have a concentration of nicotine higher 

6 than— 

7 ‘‘(i) 20 milligrams per milliliter; or 

8 ‘‘(ii) such lower nicotine concentration 

9 as is determined by the Secretary to be 

10 minimally addictive or non-addictive.’’. 

11 (b) DEFINITIONS.— 

12 (1) IN GENERAL.—Section 900 of the Federal 

13 Food, Drug, and Cosmetic Act (21 U.S.C. 387) is 

14 amended— 

15 (A) by redesignating paragraphs (8) 

16 through (22) as paragraphs (10) through (24), 

17 respectively; and 

18 (B) by inserting after paragraph (7) the 

19 following: 

20 ‘‘(8) ELECTRONIC NICOTINE DELIVERY SYS21 TEM.—The term ‘electronic nicotine delivery system’ 

22 means a tobacco product that is an electronic device 

23 that delivers nicotine, flavor, or another substance 

24 via an aerosolized solution to the user inhaling from 

25 the device (including e-cigarettes, e-hookah, e-cigars, 


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1 vape pens, advanced refillable personal vaporizers, 

2 and electronic pipes) and any component, liquid, 

3 part, or accessory of such a device, whether or not 

4 sold separately. 

5 ‘‘(9) E-LIQUID.—The term ‘e-liquid’ means any 

6 liquid intended for use with an electronic nicotine 

7 delivery system.’’. 

8 (2) CONFORMING AMENDMENT.—Section 9(1) 

9 of the Comprehensive Smokeless Tobacco Health 

10 Education Act of 1986 (15 U.S.C. 4408(1)) is 

11 amended by striking ‘‘900(18)’’ and inserting 

12 ‘‘900(20)’’. 

Æ 


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