The Biggest Tobacco Harm Reduction Battles to Come in 2023

    United States tobacco control did not have an easy 2022. So much turmoil has come and gone this past year that even the most dedicated harm reductionists and critics struggled to keep up at one point or another, as separate events blurred into one big pile of dysfunction.

    The Food and Drug Administration (FDA) announced that it’s moving toward a federal menthol cigarette ban, much to the chagrin of social justice advocates. Congress granted the FDA the power to regulate synthetic nicotine, to which many small- and medium-sized vape manufacturers had switched in the hope of keeping their products on the market.

    More and more vape shops shut down as jurisdictions across the country enacted flavor bans. Even the good news was overlooked: US smoking rates—especially among teens—dropped to record lows; youth vaping rates are nowhere near their peak from just couple of years ago.

    Below are three areas that Filter will be tracking in 2023.

     

    Industry Moves

    These past 12 months have not been awash with positive developments. The FDA authorized just the second tobacco-flavored vaping product, by Japan Tobacco International’s Logic, and then another from NJOY and an outdated product by Reynold’s Vuse.

    With documents obtained through public records requests, Filter broke the story of how the FDA’s premarket tobacco product application (PMTA) process requires companies to prove their product meets standards “appropriate for the protection of public health” (APPH). Basically, that their product is more likely to transition an adult who smokes to a safer nicotine alternative, such as an e-cigarette, than it is to introduce a younger generation to nicotine dependence.

    Though mainstream attention tends to favor e-cigarettes, oral pouches—such as the Swedish Match-made Zyn—are growing in popularity, and the FDA will at some point have to rule on their PMTA as well. Meanwhile, outstanding decisions on menthol-flavored e-cigarettes and other major vaping products, like others produced by Vuse, have yet to be decided.

    Some companies have also entered strategic partnerships to distribute heat-not-burn products that are not yet on the US market, but available abroad.

     

    New FDA Leadership

    In July, FDA Commissioner Robert Califf formally requested that the Reagan-Udall Foundation, the independent nonprofit Congress has tasked with modernizing the agency, investigate the food and tobacco divisions. The December report that resulted was a familiar—yet blistering—reminder that the Center for Tobacco Products (CTP) does not have a clear or viable strategy for regulating nicotine. The suggestions amounted to mere abstractions about transparency and better communications. They also alarmed harm reductionists with War on Drugs-esque rhetoric, essentially calling for crackdowns on unauthorized vaping products. The ball is still in the FDA’s court.

    In April, CTP director Mitch Zeller retired after almost a decade in the role. He had assumed the position before CTP even had vaping regulation on its radar, and left after a youth vaping frenzy slowed any real chance of putting forth a “continuum of risk strategy”—which is to say, any real chance of educating smokers about how some nicotine products (like vapes and oral pouches) are significantly less harmful than combustible cigarettes.

    Meanwhile, CTP was rejecting countless PMTA. It made its most controversial decision in June, when it issued a marketing denial order (MDO) of Juul’s applications—triggering an immediate reversal once Juul filed a lawsuit, then intense public discussion about the agency caving to political pressure. Dozens of other lawsuits accused the FDA of acting “capriciously” and “arbitarily” in issuing many of these MDO.

    In July, Brian King stepped into the position Zeller had left. A former higher-up at the Centers for Disease Control and Prevention (CDC), he was known primarily for failing to clarify that “EVALI”a string of lung illnesses that cropped up in 2019—were caused by illicit THC cartridges and not nicotine vapes.

    Around that same time, director of CTP’s Office of Science Matthew Holman also departed. In a somewhat controversial move, he took an executive job at Philip Morris International. Holman, for his part, does seem as though his intention is to help smokers transition to safer nicotine alternatives. All the while, tobacco control lawyers, academics and economists continue to push the CDC to correct the misinformation swirling around EVALI. (No luck so far.)

    In December, Filter broke the news that King had disagreed with the Office of Science’s initial recommendation to authorize Logic’s menthol vaping products. These would have been the first flavor other than tobacco to make it past the agency’s APPH threshold.

    The day after Filters report, a federal court granted Logic a permanent stay. The company’s appeal will work its way through the legal system over the course of 2023.

     

    California and Illicit Markets

    We’ll all be watching the outcome of California’s flavored nicotine ban, as the most populous state in the union has some of the most restrictive and confusing legislation. Almost all products are off limits, including menthol cigarettes; the only exceptions are hookah and some premium cigars. 

    After a years-long legal battle between the tobacco industry and a Michael Bloomberg-funded coalition of anti-nicotine lobbying groups, voters overwhelmingly chose to enact the law in the November midterms. It does not appear to offer much leeway for consumers, barring the sale of so-called “flavor enhancers”—meaning no purchasing a nicotine-free flavored e-liquid and then adding in flavorless nicotine at home—and shutting out any flavored product the FDA authorizes.

    Though other states, like Massachusetts, have flavor bans of their own and witnessed illicit sales increase, California would probably be at a different scale. Similar prohibition in New York, as Filter previously reported, triggered a robust illicit market within months.

     


     

    Photograph courtesy of Vaping360 via Flickr/Creative Commons 2.0

    The Influence Foundation, which operates Filter, has received grants from Juul Labs, Reynolds American and Phillip Morris International. Filter’s Editorial Independence Policy applies.

    • Alex is Filter’s news editor. He previously worked as a reporter and copy editor at VICE, and has been published in The New York Times MagazineThe Columbia Journalism Review, The Los Angeles Times and The New Republic, among other outlets. He was also previously a freelance editorial consultant for the Foundation for a Smoke-Free World; The Influence Foundation, which operates Filter, has received grants from the Foundation for a Smoke-Free World. He is currently based in Los Angeles.

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