FDA Gives First Ever Authorization of Certain E-Cigarettes

 Published: October 14, 2021

By: Anne Marie Hummel

 

RCWeek20

As a follow-up to an earlier Newsroom article on the Food and Drug Administration’s actions in denying the legal marketing of certain e-cigarettes and vaping products, the agency announced on October 12 its first ever authorization of three e-cigarette products manufactured by R.J. Reynolds (RJR) Vapor Company under its Vuse Solo brand that include tobacco-flavored e-liquid pods as appropriate for the protection of public health. FDA also issued 10 marketing denial orders for other Vuse Solo brands but did not disclose the specific flavored products due to potential confidential commercial information.

For the authorized products, the FDA determined the potential benefit of the tobacco-flavored products to smokers who switch completely, or significantly reduce their cigarette use, outweighed the risk to youth because their exposure to harmful chemicals compared to users of combusted cigarettes would be reduced.

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This announcement comes shortly after the release of the 2021 National Youth Tobacco Survey (NYTS) which shows that almost 85 percent of the more than 2 million U.S. middle and high school students who used e-cigarettes used flavored products. However, the data suggest that flavors such as fruit, candy, or mint, and not tobacco flavors are what attracts youth to begin use of these products and that was one of the issues FDA considered in its decision. Nonetheless, at the same time, FDA made it clear that these products are not “FDA approved” and their decision only allows the products to be sold in the U.S, noting that “all tobacco products are harmful and addictive and those who do not use tobacco products should not start.” Given this authorization, the question remains as to what the FDA will decide given the numerous JUUL products that are currently under review, since they have one of the largest percentages of national sales of e-cigarette products in the U.S.

In the past few years, the AARC and a coalition comprised of over 50 public health organizations have strongly advocated to Congress, the Administration, and the FDA that all flavored products should be removed from the market. Thus, this authorization from FDA is extremely disappointing given the harmful effect of tobacco use and its relationship to chronic respiratory disease.

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Anne Marie Hummel is the AARC’s Associate Executive Director for Advocacy and Government Affairs where she brings her years of regulatory experience in the Federal Government to overseeing federal and state legislative and regulatory policies that impact the respiratory care profession. Check out AARC’s Advocacy menu on our website to learn more. Outside of work, Anne Marie loves interior design, tackling 1000-piece puzzles and spending time with her granddaughter.

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