Regulation of e-cigarettes in the united states and its role in a youth epidemic

Children

Volumn 6, Issue 3, 2019, Pages

  Gottlieb, Mark A ^a  

^a NORTHEASTERN UNIVERSITY   (United States)

Author keywords

Addiction; Electronic cigarette; ENDS; FDA; Nicotine; Regulation; Vaping

Indexed keywords

EID: 85069742695     PISSN: None     EISSN: 22279067     Source Type: Journal    
DOI: 10.3390/children6030040     Document Type: Article

References (39)

1. Tayyarah, R.; Long, G.A. Comparison of select analytes in aerosol from e-cigarettes with smoke from conventional cigarettes and with ambient air. Regul. Toxicol. Pharmacol. 2014, 70, 704–710. [CrossRef] [PubMed]
2. Surgeon General’s Advisory on e-Cigarette Use Among Youth; U.S. Centers for Disease Control and Prevention: Atlanta, GA, USA, 2018.
3. Knopf, A. MTF: Dramatic increase in teen vaping of nicotine. Brown Univ. Child Adolesc. Behav. Lett. 2019, 35, 3–4. [CrossRef]
4. Hoffman, J. Addicted to Vaped Nicotine, Teenagers Have No Clear Path to Quitting. New York Times, 19 December 2018.
5. Hon, L. Electronic Atomization Cigarette. U.S. Patent No. 7,832,410, 16 November 2010.
6. Boseley, S. Hon Lik invented the e-cigarette to quit smoking—But now he’s a dual user. The Guardian, 19 June 2015.
7. Applications for FDA Approval to Market a New Drug; U.S. Food and Drug Administration: Silver Spring, MD, USA, 2018; Volume 21, p. 314.
8. U.S. Food and Drug Administration Import Alert 66–41. Available online: https://www.accessdata.fda. gov/cms_ia/importalert_190.html?source=govdelivery&utm_medium=email&utm_source=govdelivery (accessed on 25 January 2019).
9. Smoking Everywhere, Inc. v. U.S. Food and Drug Administration, 680 F. Supp. 2d 62, 2010. Available online: https://www.courtlistener.com/opinion/2485826/smoking-everywhere-inc-v-us-food-and-drug/(accessed on 28 January 2019).
10. Family Smoking Prevention and Tobacco Control Act, Public Law 111–31, H.R. 1256, U.S. Government Publication Office: Washington, DC, USA, 2009.
11. Sottera, Inc. v. U.S. Food and Drug Administration, 627 F.3d 891, 2010. Available online: https://www. courtlistener.com/opinion/180504/sottera-inc-v-food-drug-admin/(accessed on 28 January 2019).
12. Clarification of When Products Made or Derived from Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses” Vol. 82 FR; p. 2193. Available online: https://www.federalregister.gov/documents/2017/01/09/2016-31950/clarification-of-when-products-made-or-derived-from-tobacco-are-regulated-as-drugs-devices-or (accessed on 26 January 2019).
13. Agora Financial Electronic Cigarettes (E-Cigarettes) Dollar Sales Worldwide from 2008 to 2017 (in Million U.S. Dollars). Available online: https://www.statista.com/statistics/493214/global-e-cigarettes-dollar-sales/(accessed on 25 January 2019).
14. Deeming Tobacco Products to Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products. Vol. 79 FR p. 23141. Available online: https://www.federalregister.gov/documents/2014/04/25/2014-09491/deeming-tobacco-products-to-be-subject-to-the-federal-food-drug-and-cosmetic-act-as-amended-by-the (accessed on 25 January 2019).
15. Deeming Tobacco Products to Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products. Vol. 81 FR p. 28973. Available online: https://www.federalregister.gov/documents/2016/05/10/2016-10685/deeming-tobacco-products-to-be-subject-to-the-federal-food-drug-and-cosmetic-act-as-amended-by-the (accessed on 25 January 2019).
16. Robehmed, N. E-cigarette Sales Surpass $1 Billion As Big Tobacco Moves In. Forbes, 17 September 2017.
17. Richtel, M. A Bolder Effort by Big Tobacco on E-Cigarettes. New York Times, 19 January 2018.
18. FDA Center for Tobacco Products Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule. Available online: https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm557714.htm (accessed on 25 January 2019).
19. American Academy of Pediatrics v. Food and Drug Administration, No. 8:18-cv-883-PWG, 2018. Available online: https://www.khlaw.com/Files/36606_NGO_motion_for_summary_judgment.pdf (accessed on 28 January 2019).
20. McGinely, L. FDA chief calls youth e-cigarettes an ‘epidemic’. Washington Post, 12 September 2018.
21. Pankow, J.F.; Kim, K.; McWhirter, K.J.; Luo, W.; Escobedo, J.O.; Strongin, R.M.; Duell, A.K.; Peyton, D.H. Benzene formation in electronic cigarettes. PLoS ONE 2017, 12, e0173055. [CrossRef] [PubMed]
22. Willett, J.G.; Bennett, M.; Hair, E.C.; Xiao, H.; Greenberg, M.S.; Harvey, E.; Cantrell, J.; Vallone, D. Recognition, use and perceptions of JUUL among youth and young adults. Tob. Control 2019, 28, 115. [CrossRef] [PubMed]
23. Hiltzik, M. A tobacco company makes Juul’s founders billionaires while questions rise about their product’s safety. Los Angeles Times, 28 December 2018.
24. Kirkham, C. High-Nicotine E-Cigarettes Flood Market Despite FDA Rule; Thomson Reuters Foundation: London, UK, 2018. Available online: http://news.trust.org/item/20180924105952-riu6p/(accessed on 28 January 2019).
25. Juul Labs, Inc. v. The Unincorporated Associations Identified in Schedule A, No. 1:2018cv01516, 2018. Available online: https://law.justia.com/cases/federal/district-courts/virginia/vaedce/1:2018cv01516/400537/30/(accessed on 28 January 2019).
26. McMillen, R.C.; Gottlieb, M.A.; Winickoff, J.P. E-Cigarettes—The Roles of Regulation and Clinicians. JAMA Intern. Med. 2015, 175, 1603–1604. [CrossRef]
27. Prochaska, J.J. The public health consequences of e-cigarettes: A review by the National Academies of Sciences. A call for more research, a need for regulatory action. Addiction 2018. [CrossRef] [PubMed]
28. Jamal, A. Tobacco Use Among Middle and High School Students—United States, 2011–2016. MMWR Morb. Mortal. Wkly. Rep. 2017, 66, 597. [CrossRef] [PubMed]
29. Office of the Commissioner. FDA Announces Comprehensive Regulatory Plan to Shift Trajectory of Tobacco-Related Disease, Death. Available online: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm568923.htm (accessed on 26 January 2019).
30. Gottlieb, S. FDA’s Nicotine and Tobacco Regulation and the Key Role of Regulatory Science. Available online: https://www.fda.gov/NewsEvents/Speeches/ucm611033.htm (accessed on 26 January 2019).
31. Office of the Commissioner. FDA takes New Steps to Address Epidemic of Youth E-Cigarette Use, Including a Historic Action Against More Than 1300 Retailers and 5 Major Manufacturers for Their Roles Perpetuating Youth Access. Available online: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm620184.htm (accessed on 27 January 2019).
32. U.S. Food and Drug Administration, Submission Tracking Number (STN): RD0000476 2018. Available online: https://www.fda.gov/downloads/tobaccoproducts/labeling/rulesregulationsguidance/ucm605490.pdf (accessed on 26 January 2019).
33. Hoffman, J.F.D.A. Seizes Documents from Juul Headquarters. New York Times, 3 October 2018.
34. Center for Tobacco Products CTP Letters to Industry. Available online: https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm281784.htm (accessed on 27 January 2019).
35. Office of the Commissioner. FDA Advances Investigation into Whether More Than 40 E-Cigarette Products Are Being Illegally Marketed and outside Agency’s Compliance Policy. Available online: https://www.fda. gov/NewsEvents/Newsroom/PressAnnouncements/ucm623256.htm (accessed on 27 January 2019).
36. Kaplan, S. Altria to Stop Selling Some E-Cigarette Brands That Appeal to Youths. New York Times, 26 October 2018.
37. Commissioner Office of the Press Announcements—Statement from FDA Commissioner Scott Gottlieb, M.D., on New Steps to Address Epidemic of Youth E-Cigarette Use. Available online: https://www.fda. gov/NewsEvents/Newsroom/PressAnnouncements/ucm620185.htm (accessed on 27 January 2019).
38. Fox, M. FDA Chief Threatens to Take E-Cigarettes off the Market. Available online: https://www.nbcnews. com/health/health-news/fda-chief-threatens-take-e-cigarettes-market-n960411 (accessed on 27 January 2019).
39. Center for Tobacco Products a New Standard of Effective Regulation. Available online: https://www.fda. gov/TobaccoProducts/ucm283974.htm (accessed on 28 January 2019).