FDA Reports Largest-Ever Seizure of Unregulated Nicotine Vapes

    On October 22, the Food and Drug Administration announced what appears to be the United States government’s largest seizure of unregulated nicotine vapes to date, totaling an estimated 3 million individual products worth around $76 million. The joint operation with Customs and Border Protection (CBP) was carried out in July, following the formation of a federal interdiction task force in June.

    Only a handful of vape seizures have previously been reported by the FDA, all of them significantly smaller. The only one that approaches the same scale was reported in December 2023, involving an estimated 1.4 million vapes.

    “The FDA is on high alert and, in coordination with our federal partners, remains committed to stopping unauthorized e-cigarettes at our nation’s borders,” stated FDA Commissioner Robert M. Califf. “These products too often end up in kids’ hands, and the newly formed federal task force is well positioned to collectively combat this unscrupulous activity.”

    The joint task force announced June 10 is led by the FDA and the Department of Justice, but also spans the Bureau of Alcohol, Tobacco, Firearms and Explosives, the US Marshals Service, the US Postal Inspection Service and the Federal Trade Commission. It focuses primarily on seizures and prosecutions. Brian King, director of the FDA Center for Tobacco Products (CTP) stated that this operation “won’t be the last.”

    The FDA reported that the seized products comprised “various brands of illegal e-cigarettes, including Geek Bar and others.” They will presumably be incinerated by CBP.

     

     

    CBP, which was not mentioned in the June task force announcement, did not make any announcement of its own related to the recent seizure. Troy A. Miller, the agency’s acting commissioner, was quoted in the FDA’s October 22 press release, albeit not in a particularly specific way.

    “CBP’s trade enforcement mission places a significant emphasis on intercepting illicit products that could harm American consumers,” Miller stated. “We will continue to work with our enforcement partners to identify and seize unsafe and unlawful goods.”

    Taking its usual tack, the FDA claimed that seizures of unauthorized vapes can help make them “less accessible to youth.” Its June task force announcement made a series of misleading characterizations, claiming that nicotine “can harm the developing adolescent brain, which continues to develop until about age 25,” and implying that nicotine use is a gateway to “addiction to other drugs.”

    Ironically, the FDA has been instrumental in creating the unregulated vape market. Its onerous and opaque premarket tobacco products application (PMTA) process sets a higher bar to obtain marketing authorization for new vapes than is the case for new cigarettes. It has denied authorization to millions of vaping products, effectively ceding control of much of the market.

    The short list of FDA-authorized vaping products only recently expanded to include four that are menthol-flavored. All other non-tobacco flavors—which are central to adults’ attempts to switch from smoking—have been denied, in what tobacco harm reduction advocates view as a politicized, de facto flavor ban.

    In January, an appeals court found that the CTP had “arbitrarily and capriciously” shifted the PMTA goalposts, sending flavored-vape manufacturers on a “wild goose chase.” What’s known as the Triton case is due to be heard by the Supreme Court.

    Tobacco companies, which own all currently authorized vaping products, have backed states’ PMTA registry bills, which seek to stamp out sales of unauthorized vapes.

    Sales of unregulated vapes, particularly disposables, have nonetheless played a significant harm reduction role by replacing cigarettes in millions of people’s lives, as tobacco-industry data have shown.

     


     

    Top photograph of via United States Government Accountability Office/Customs and Border Protection. Inset photograph of vapes seized July 2024 via United States Food and Drug Administration/Flickr

    • Kastalia is Filter‘s deputy editor. She previously worked at half a dozen mainstream digital media outlets and would not recommend the drug coverage at any of them. For a while she was a syringe program peer worker in NYC, where she did outreach hep C testing and navigated participants through treatment. She also writes with Jon Kirkpatrick.

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