Over the past year, the U.S. Food and Drug Administration (FDA) has intensified its regulatory scrutiny of illegal vaping products, with a particular focus on those marketed or otherwise appealing to children. As a continuation of these efforts, FDA recently announced a significant initiative aimed at combating the influx of illegal vape products entering the U.S.
Specifically, in a recent interview FDA Commissioner Dr. Marty Makary declared a commitment to a more stringent enforcement approach, which includes plans to confiscate and seize suspected illegal vaping products at U.S. borders, with a particular focus on those entering the U.S. market from China. In doing so, the Commissioner also stated that FDA will be issuing an announcement in the coming weeks regarding concerns surrounding vape shops and the products sold within such businesses. Additionally, Dr. Makary underscored the need for increased awareness among parents about the products available in local vape shops as approximately 85% of such vaping products sold in such businesses are considered illegal under FDA regulations.
This is not the first FDA initiative or action against e-cigarette products and manufacturers. In fact, FDA has continuously coordinated enforcement actions with other federal agencies to curb the distribution and sale of illegal e-cigarettes. For example, in October 2022, FDA and the Department of Justice (DOJ) sought permanent injunctions against six (6) e-cigarette manufacturers to prevent the production, sale, and distribution of unauthorized e-cigarette products. These cases marked the first time FDA initiated injunction proceedings to enforce the premarket review requirements established under the Federal Food, Drug, and Cosmetic Act for new tobacco products. By June 2024, FDA had filed civil money penalty complaints against more than 55 manufacturers and 140 retailers for the production and sale of unauthorized tobacco products.
Additionally, on June 10, 2024, FDA and DOJ unveiled a collaborative federal multi-agency task force dedicated to the enforcement of e-cigarette regulations. This initiative, along with other related efforts, was coordinated across federal agencies possessing relevant enforcement powers — 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 deploy all available criminal and civil measures against the sale and distribution of unlawful e-cigarettes. This includes, for example, investigating and prosecuting criminal, civil, seizure, and forfeiture actions under the Prevent All Cigarette Trafficking Act, the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act, and other authorities.
On October 22, 2024, shortly after the announcement of this federal multi-agency task force, FDA, in collaboration with U.S. Customs and Border Protection (CBP), announced the administrative seizure of unauthorized e-cigarette products with an estimated retail value of $76 million, all of which originated in China. On January 10, 2025, FDA, in concert with U.S. Homeland Security Investigations (HSI) and CBP, announced another seizure of more than 628,000 unauthorized e-cigarette products valued at more than $7 million, with some originating in China. In investigating both of these seizures, it was determined that the products had been intentionally misdeclared and also undervalued to evade duties and detection upon entry.
Recently, on May 22, 2025, FDA announced another seizure of nearly two million units of unauthorized e-cigarette products with an estimated retail value of $33.8 million, almost all of which originated in China. Again, in an apparent attempt to evade duties and the review of products for import safety concerns, many of the shipments contained vague product descriptions with incorrect values. These shipments also contained products that violated intellectual property rights due to the unauthorized use of protected trademarks.
As part of the May 2025 seizure, FDA also issued letters to 24 tobacco importers and entry filers involved in the importation of illegal e-cigarettes. These letters informed the recipients that providing false statements or entries constituted a federal offense and notified said companies that any failure to ensure that future imports contain complete and accurate information could be interpreted as a deliberate attempt to evade federal law. Additionally, FDA sought a response from said companies within 30 days containing details on the measures implemented to comply with relevant federal tobacco laws and regulations.
As the FDA ramps up its efforts to regulate illegal vaping products, all parties involved in the manufacture, sale, and distribution sectors should remain vigilant about compliance with FDA regulations to avoid potential legal ramifications.
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