FDA’s First-Ever Vaping Product Authorization Brings Mixed Feelings

    On October 12, the Food and Drug Administration (FDA) authorized the first-ever vaping product to legally be sold in the United States.

    The FDA determined that the Vuse Solo, along with two “tobacco”-flavored e-liquid cartridges, were “appropriate for the protection of public health”—meaning the agency believed that the products were more likely to help adult smokers switch to a safer alternative than to introduce a new generation to nicotine. The decision is historic, but leaves advocates on both sides of the raging vaping debate dissatisfied.

    “Today’s authorizations are an important step toward ensuring all new tobacco products undergo the FDA’s robust, scientific premarket evaluation,” Mitch Zeller, the director of the FDA’s Center for Tobacco Products (CTP), said in a press statement.The manufacturer’s data demonstrates its tobacco-flavored products could benefit addicted adult smokers who switch to these products—either completely or with a significant reduction in cigarette consumption—by reducing their exposure to harmful chemicals.”

    The FDA simultaneously issued marketing denial orders (MDOs) for Vuse Solo’s flavored products—in line with what some harm reduction advocates fear is a pattern—and said the agency “is still evaluating” Vuse Solo’s menthol-flavored products. Its manufacturer, R. J. Reynolds Vapor Company, still awaits decisions on its Vibe, Ciro and Alto lines.

    Vape companies had until last fall to file premarket tobacco product applications (PMTAs) for every single product they wished to keep selling on the US marketplace. The FDA then had until September 2021 to review the submissions—a deadline it failed to meet. The agency has issued marketing order denials (MDOs) for most of the small- to medium-sized producers and signaled that more time would be needed to look over the data and studies provided by the largest players.

    R. J. Reynolds Vapor Company is a subsidiary of the tobacco company Reynolds American, Inc., which was purchased by British American Tobacco in 2017. The company filed these PMTAs in 2019.

    “The Solo applications were filed two years ago, so it makes sense that they would be first in line for an authorization,” Greg Conley, the president of the American Vaping Association (AVA), told Filter. “While Reynolds is staffed with extremely capable scientists, ultimately the FDA’s decision probably came down more to timing than the strength of the data presented.”

    The decision, while monumentally significant, did not do much to restore faith in an agency that has frequently been lambasted by both sides of tobacco control.

    The Vuse Solo authorizations came with marketing restrictions: For example, Reynolds can only advertise its products on TV and radio programs in which 85 percent of the audience are adults over the age of 21; any “partners, influencers, bloggers, and/or brand ambassadors” must disclose their relationship to the company; and digital sales must be age-gated. A debate will probably unfold about whether or not these are restrictive enough.

    The decision, while monumentally significant, did not do much to restore faith in an agency that has frequently been lambasted by both sides of tobacco control. On the one hand, you have consumer advocates, tobacco harm reduction proponents and smaller vape industry players: All have long complained about a PMTA process so arduous, research-heavy and expensive that only large vape companies and those with ties to Big Tobacco could realistically complete it. On the other hand, you have leading public health and tobacco control nonprofits like the Campaign for Tobacco-Free Kids (CTFK) and the American Lung Association: They seemingly will not be satisfied with anything besides full-scale prohibition. (A handful of politicians who continue to be vocal about youth vaping rates also derided the FDA’s decision.)

    The first camp responded to the news, which followed so much disappointment and frustration, with muffled cheers—acknowledging that any FDA vape authorization has the potential to shift public perceptions of a demonized safer nicotine alternative, but retaining grave concerns about the restriction of the market against flavors and smaller companies.

    The prohibitionist side doubled down, despite the fact that many of them previously fought for the FDA to assert its regulatory authority: For instance, during a lawsuit with a federal court that established the PMTA deadline last September, Robert Falk, the general counsel and corporate secretary for the Truth Initiative, stated that the organization was “committed to harm reduction and would identify products that appeared to carry the least risks in its materials, but simply cannot do so without data from FDA. Nor can they say which e-cigarette products are the worst of the worst and emphasize the importance of avoiding those products.”

    You would imagine, then, that this kind of highly limited authorization would fulfill that hope.

    The FDA decision also did little to encourage consumers that flavors will one day be authorized.

    But so far, that does not appear to be the case, as anti-nicotine groups have yet again identified something to criticize: “The American Lung Association is dismayed that FDA will permit three Vuse products to remain on the market in the US,” the president and CEO of the organization, Harold Wimmer, said in a statement. He expressed disappointment that the “high nicotine” levels of the authorized products would “addict” teenagers, even though youth vaping rates dropped in 2021 and higher-nicotine vapes have been shown to better help adults quit smoking.

    The FDA decision also did little to encourage consumers that flavors will one day be authorized. Nor did it mean all that much, beyond its symbolism, to most vapers: According to data from last summer, Vuse Solo made up only 1.9 percent of vapor sales in the US from July 2019 to July 2020. (That figure included its menthol flavor as well.) “Notice too that FDA approved RJR’s Solo product, an outdated and inferior device hardly anyone uses,” read a tweet from the American Vapor Manufacturers Association. “That’d be like the Department of Transportation outlawing every motor vehicle except the Ford Pinto.”

    However, it was of course a welcome development for Reynolds.

    “While Alto awaits further review from FDA unless and until FDA directs otherwise, Reynolds can lawfully sell products for which it has submitted PMTAs, subject to FDA’s ongoing enforcement discretion,” spokesperson Kaelan Hollon told Filter. “FDA has stated it is focusing resources on reviewing products with the largest market share, though it has limited the number of applications any one manufacturer may have under review at one time. Vuse Alto PMTA was submitted nearly a year after Vuse Solo, and five months after Vuse Vibe and Ciro, and those applications share foundational science. We remain confident in the quality of our applications.”

     


     

    Photograph via Pxfuel

    The Influence Foundation, which operates Filter, has received unrestricted grants from both Reynolds American, Inc. and the American Vaping Association. Filters Editorial Independence Policy applies.

    • Alex is a staff writer at Filter. He previously worked as a reporter and copy editor at VICE, and has been published in The New York Times MagazineThe Columbia Journalism ReviewThe Nation and The Daily Beast, among other outlets. He is also a freelance editorial consultant for the Foundation for a Smoke-Free World; The Influence Foundation, which operates Filter, has received both restricted and general support grants from the Foundation for a Smoke-Free World. Alex is currently based in Phoenix, Arizona.

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