FDA Enforcement Activity of Illicit Vapor Products Intensifies

'Illicit markets pose a threat to the responsible retail community,' executive director of the National Association of Tobacco Outlets says at hearing last month
vape device
Photograph: Shutterstock

Over the past month, there has been increased legislative and regulatory activity around vapor products and the Food and Drug Administration (FDA).

Last month, the U.S. Senate Judiciary Committee held a hearing on youth vaping and increasing enforcement against illicit e-cigarettes.

In the first portion of the hearing, senators questioned both the FDA’s Center for Tobacco Products Director Brian King and the Department of Justice’s (DOJ) Deputy Assistant Attorney General Arun Rao of the Civil Division’s Consumer Protection Branch, on why unauthorized vaping products are still widely available. Senate Majority Whip Dick Durbin (D-Illinois) and other senators implored the FDA and the DOJ to better enforce federal laws against the unlawful sale of unauthorized e-cigarette products.  In their responses, King and Rao cited the multi-agency task force that the DOJ and the FDA announced earlier that week to combat the illegal distribution and sale of e-cigarettes. The task force will bring together multiple law enforcement partners, including the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), the U.S. Marshals Service (USMS), the U.S. Postal Inspection Service (USPIS) and the Federal Trade Commission (FTC), to coordinate and streamline efforts to bring all available criminal and civil tools to bear against illicit e-cigarettes.

During the hearing, National Association of Tobacco Outlets (NATO) Executive Director David Spross testified on a panel of non-government witnesses. Other witnesses on the panel included: Yolanda Richardson, president and CEO of Campaign for Tobacco-Free Kids; Dr. Susan Walley, chief of the Division of Hospital Medicine at Children’s National Hospital; Tony Abboud, executive director of the Vapor Technology Association; and Josie Shapiro, a high school student from Seattle. 

In his testimony, Spross expressed strong support for a well-functioning regulatory system in which FDA oversight leads to accelerated reductions in underage use and tobacco-related harm as well as the need to enhance enforcement against illicit vapor products, emphasizing that illicit markets pose a threat to the responsible retail community. He added that a well-functioning regulatory system also requires a more coherent compliance framework that clearly communicates FDA’s enforcement priorities—what categories of products it wants immediately removed from the marketplace and what categories can remain on the market pending review of timely filed applications. 

NATO additionally advocated for more vapor product marketing authorizations to support the growing adult demand for smoke-free products.

Since the hearing, the FDA has announced a series of vapor-related enforcement activities. These included a seizure conducted jointly with U.S. Customs and Border Protection of more than 53,700 unauthorized vapor products from China intended for a Mississippi wholesaler worth approximately $1.08 million at the Chicago port of entry as well as a court-ordered permanent injunction against a manufacturer of unauthorized vapor products. Additionally, the FDA announced its first marketing granted orders for vapor products since June 2022. In these orders, the FDA for the first time authorized the marketing of menthol-flavored vapor products—Njoy Ace Pod Menthol 2.4%, Njoy Ace Pod Menthol 5%, Njoy Daily Menthol 4.5% and Njoy Daily Extra Menthol 6%.

As Congressional and media scrutiny of illicit vapor products increases with the summer temperatures, the industry should expect enforcement activity to continue to heat up with it.

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