FDA’s decision to deny marketing applications for all JUUL products, including JUUL’s menthol-flavored products, represents the most significant action the FDA has taken to reverse the youth e-cigarette epidemic.
“JUUL, more than any other product or company, has been responsible for creating and fueling the youth e-cigarette epidemic. The impact of this decision will be substantial because JUULproducts continue to be widely used by youth. FDA must continue to reject all flavored e-cigarette applications, including menthol-flavored products,” stated Caroline Goncalves Jones, Director, Advocacy and Outreach, Campaign for Tobacco-Free Kids in a June 23, 2022 statement.
The AARC is part of a large tobacco control public health coalition that 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 scientific literature, there can be no public justification for the FDA to allow the continued sale of any flavored e-cigarettes.
As reported to our membership in the past, AARC has tracked the FDA delays and actions to remove JUUL and other products from the market. 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 FDA 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 the marketing of e-cigarettes and vaping products is “appropriate for the protection of the public health” based on the scientific evidence presented in the company’s application.
The delays had public health organizations up in arms because the FDA had not taken action on the JUUL products which represent 41 percent of sales in the US. “The Hill” reports that the FDA decision is a major blow to the company and a major step in a broader effort to prevent youth vaping. The FDA said JUUL must stop selling and marketing its products, and everything that’s already on the market must be removed. The agency said JUUL did not prove that keeping its products on the market “would be appropriate for the protection of the public health.”
FDA Commissioner Robert Califf in a statement said, “Today’s action is further progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards.”
JUUL in a statement said it disagrees with the FDA and intends to appeal. JUUL has not indicated if this appeal will be through the regulatory process or if they will sue the FDA.
The move is part of a broader FDA review of the vaping industry as the agency decides which products to allow on the market. FDA has authorized some e-cigarette applications in the past year, but they have not been the products with a major market share.
AARC Executive Director Daniel D. Garrett, CAE, said, “I commend the FDA for following the science and protecting our youth from lung disease.”
Read the FDA’s statement on the denials.
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