In accordance with a federal court order, manufacturers of electronic nicotine delivery products (ENDS), e.g., e-cigarettes and e-liquids, were to submit premarket tobacco product applications (PMTAs) to the Food and Drug Administration by September 9, 2020, to remain on the market up to a year while FDA reviewed the applications. Provisions in the Family Smoking Prevention and Tobacco Control Act require the FDA to assess whether allowing marketing of e-cigarettes and vaping products are “appropriate for the protection of the public health” based on the scientific evidence presented in the company’s application.
To date, FDA announced that it has acted on approximately 93 percent of the applications that were filed by the deadline and denied marketing of hundreds of thousands of flavored e-cigarettes. What has public health organizations up in arms about FDA actions so far is the delay in deciding on Juul products, which represent 41 percent of sales nationally and other e-cigarettes that comprise most of the market share, such as Vuse made by Reynolds American and NJOY products.
The AARC, as part of a large tobacco control public health coalition, has advocated for the elimination of all flavored e-cigarettes, including menthol-flavored products, that are widely used by today’s youth and are responsible for what has been determined to be an epidemic among middle- and high-school age youth. Based on an abundance of scientific literature, there can be no public justification for FDA to allow the continued sale of any flavored e-cigarettes. Although the FDA’s actions to date are a significant step in the right direction and they acknowledge the role these products have in attracting youth to smoke, every day these products stay on the market, the nations youth remain at jeopardy of being hooked on nicotine.
The AARC will continue work with the coalition to push FDA to act as quickly as possible to eliminate these products from the market. The FDA has issued a “Perspective Piece” which provides additional information and details about the review process, and we encourage our members to read it to gain a better understanding of the issues surrounding this important public health issue.
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