FDA reports largest-ever seizure of unregulated nicotine vapes

OhOn October 22, the Food and Drug Administration announced what appears to be the largest seizure of unregulated nicotine vapes ever made by the United States government, totaling approximately 3 million individual products, worth approximately $76 million. The joint operation with Customs and Border Protection (CBP) was conducted in July, following the formation of a federal interdiction task force in June.

Only a handful of vape seizures have ever been reported by the FDA, all significantly lower. The only one that comes close to the same magnitude was reported in December 2023, involving around 1.4 million vapers.

“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,” said FDA Commissioner Robert M. Califf. “These products too often end up in the hands of children, and the new 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 includes 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 foreclosures and prosecutions. Brian King, director of the FDA’s Center for Tobacco Products (CTP), said this operation “will not be the last.”

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

CBP, which was not mentioned in the June task force announcement, has made no announcement regarding the recent seizure. Troy A. Miller, the agency’s acting commissioner, was cited in the FDA’s Oct. 22 press release, but not particularly specifically.

“CBP’s trade enforcement mission places great importance on intercepting illicit products that have the potential to harm U.S. consumers,” Miller said. “We will continue to work with our law enforcement partners to identify and seize dangerous and illegal goods.”

Following its usual approach, the FDA said that seizures of unauthorized vapes may contribute to making them “less accessible to young people.” The task force’s June announcement made a series of misleading characterizations, claiming that nicotine “may harm the developing adolescent brain, which continues to develop until approximately age 25,” and implying that Nicotine consumption is a gateway to “dependence on other drugs”.

Ironically, the FDA has been instrumental in creating an unregulated vaping market. Its onerous and opaque Pre-Market Tobacco Application (PMTA) process raises the bar for obtaining marketing authorization for new vapes than is the case for new cigarettes. It has denied approval for millions of vaping products, ceding control of much of the market.

The FDA’s short list of approved vaping products was only recently expanded to include four menthol-flavored products. All other flavors other than tobacco, which are central to adults’ attempts to quit smoking, have been denied, in what tobacco harm reduction advocates see as a politicized policy, de facto flavor ban.

In January, an appeals court ruled that the CTP had “arbitrarily and capriciously” shifted the PMTA’s goals, sending flavored vape makers on a “wild goose chase.” The so-called Triton case must be heard by the Supreme Court.

Tobacco companies, which own all currently permitted vaping products, have supported state PMTA registry bills, which aim to stamp out unlicensed vape sales.

Unregulated vape sales, particularly disposable products, have nevertheless played an important role in reducing harm by replacing cigarettes in the lives of millions of people, tobacco industry data shows.

Top photograph from via U.S. Government Accountability Office/Customs and Border Protection. Inset photograph of vapes seized in July 2024 via US Food and Drug Administration/Flickr