FDA Regulatory Actions Parallel Ongoing JUUL Litigation
The potential and actual dangers from e-cigarettes have certainly been well-highlighted in the news in recent years, and more and more specific evidence, analysis, and studies have been proving many of these concerns to be true. Interestingly, at the same time that one major study has described and criticized e-cigarette dangers to youth, the same federal agency that issued the report has given approval for other e-cigarettes to be marketed. Simultaneously, litigation against the biggest manufacturer of e-cigarettes — JUUL — continues forward.
The nicotine contained in tobacco products is an extraordinarily addictive substance — this has long been recognized among the adult users of tobacco, and it is becoming increasingly clear to also be the case among youth users due to the easy availability of vaping products. Research has shown that developing adolescent brains are even more susceptible to the chemical signaling that produces addictive effects than are adult brains. Sadly, this increases the e-cigarette dangers to youth.
Flavored E-Cigarettes Dominate Youth Tobacco Usage
The U.S. Food and Drug Administration (FDA) announced a report from the Centers for Disease Control on October 1, 2021 discussing the use of e-cigarettes by high school and middle school students in the United States. The report on the 2021 National Youth Tobacco Survey acknowledged prior findings (summarized in a 2016 Surgeon General’s report) that use of any type of tobacco products by youths was unsafe, because the nicotine contained in tobacco products can harm the developing adolescent brain — posing significant e-cigarette dangers to youth.
Among the significant findings in this new FDA report on youth and e-cigarettes:
- An estimated 3.6 million middle school and high school students in the U.S. are current users of e-cigarettes;
- E-cigarettes have been the most frequently used tobacco product by youth in the U.S. since 2014;
- More than 80% of current youth users reported using flavored e-cigarette products;
- Of those youth using flavored e-cigarettes, more than three-quarters preferred fruit, candy, dessert, or other “sweet” flavorings;
- Of current youth users of e-cigarettes nearly half those of high-school age reported using the products on 20 or more days in the prior month, with fully 27.6% reporting themselves to be daily users.
FDA Product Authorizations and Denials Sending Mixed Messages?
Shortly after issuing its report on e-cigarette usage among American youth, the FDA also announced approval for R.J. Reynolds Vapor Company to market an “electronic nicotine delivery system” under a new program for approval of tobacco products. The agency approved RJR’s “Vuse Solo” product to be marketed, however at the same time it denied approval for flavored versions of the same product, presumably due to the concerns noted above over widespread usage of flavored e-cigarettes by American youth. The announcement carefully noted that, “While today’s action permits the tobacco products to be sold in the U.S., it does not mean these products are safe or ‘FDA approved . . .,’” merely that the marketing of the RJR product was being permitted.
Applications for RJR’s menthol-flavored version was still under consideration, RJR’s ability to market their device in the media was limited, and the company was required to share their sales and marketing plans and data with the FDA.
Litigation Against JUUL Continues
Meanwhile, litigation against the largest player in the e-cigarette market — JUUL — continues forward. The earliest major entrant in the e-cigarette market, JUUL is also the first company against which litigation has made significant progress. Four “bellwether” trials have been placed on calendar in the upcoming year, with the first one scheduled for April 2022. Numerous lawsuits have been filed on behalf of individuals, class action groups, and government entities who have claimed harm from the JUUL products, either directly or by having to deal with the public health costs associated with their use. The federal “multi-district litigation” against JUUL alone includes some 3,000 cases. Thousands more cases are not yet included in the MDL, and the attorneys general in fourteen different states (including California) have also filed suit.
The bellwether trials scheduled for 2022 will have a major influence upon resolution of these many thousands of claims.
Products Liability Lawyers in Sacramento
I’m Ed Smith, a products liability lawyer in Sacramento for over three decades. If you’ve been injured by a defective product, take the time to contact a Sacramento personal injury law firm. To receive free and friendly case advice, please give us a call at (916) 921-6400 or (800) 404-5400 in order to speak with one of our experienced injury attorneys. If you prefer, you may use this convenient online contact form.
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Photo by Sarah J on Pixabay.
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