JUUL and the Youth Vaping Epidemic – FDA and President Trump Step In

September 13, 2019

On September 9, 2019, the FDA sent two warning letters to JUUL Labs, Inc., the maker of the popular JUUL e-cigarette.1  One letter focused on JUUL’s violation of federal regulations by advertising its vaping product as healthier than traditional combustible cigarettes.2  In finding that JUUL had promoted its product as “lower risk” or “less harmful,” the FDA referenced testimony from JUUL employees before a United States House of Representatives Subcommittee, documents seized from JUUL by the FDA, and JUUL’s own website.3  

The FDA was particularly concerned about JUUL’s statements that its products were “99% safer than cigarettes,” “much safer” than cigarettes, “totally safe,” and “a safer alternative than smoking cigarettes” were made directly to children in school.4  The FDA’s concern was “amplified by the epidemic rate of increase in youth use of ENDS [electronic nicotine delivery system] products, including JUUL’s products, and evidence that ENDS products contribute to youth use of, and addiction to, nicotine.”5 

The second letter focused on JUUL’s marketing to young people.6  In it, the FDA noted that:

JUUL products continue to represent a significant proportion of the overall use of ENDS products by children.  We believe you have a continuing responsibility to take action to address the epidemic of youth use of your products, some of which appears to have been a direct result of your product design and marketing campaigns….7

The FDA was particularly troubled by testimony from the subcommittee that suggested JUUL had participated in outreach to schools, churches, veterans groups, and tribes, sometimes offering free samples (in the case of one tribe) and other times offering to pay schools money in exchange for the school implementing JUUL-created anti-vaping curriculum.8

The FDA’s September 9 letters adds to the growing pile of regulatory inquiries JUUL is facing.  Currently, the FDA and CDC are investigating more than 450 people who have become sick with a vaping-related illness, which has resulted in six deaths.9  On September 7, 2019, the FDA issued a consumer update, warning consumers against the use of vaping products purchased on the street, or modifying/adding substances to any products purchased in stores.10  

In addition to lung injuries, the FDA has also issued warnings regarding seizures and vaping,11 and the Journal of the American College of Cardiology published an article linking vaping to cardiovascular disease.12

On September 11, President Trump suggested that he was considering a ban of all flavored e-cigarettes.13

 

[1] https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/juul-labs-inc-590950-09092019
[2] Id.
[3] Id.
[4] Id.
[5] Id.
[6] https://www.fda.gov/media/130604/download
[7] Id.
[8] Id.
[9] https://www.nytimes.com/2019/09/09/health/vaping-juul-e-cigarettes-fda.html
[10] https://www.fda.gov/consumers/consumer-updates/vaping-illnesses-consumers-can-help-protect-themselves-avoiding-tetrahydrocannabinol-thc-containing
[11] https://www.fda.gov/news-events/fda-brief/fda-brief-fda-encourages-continued-submission-reports-related-seizures-following-e-cigarette-use
[12] http://www.onlinejacc.org/content/73/21/2722
[13] https://www.nytimes.com/2019/09/11/health/trump-vaping.html

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