DOJ and FDA Increase Enforcement on Unauthorized Vape Sales

Federal Enforcement Action in Illinois

On September 10, the US Department of Justice (DOJ), working in coordination with the Food and Drug Administration (FDA), the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) and the US Marshals Service, carried out a significant enforcement action against the distribution of unauthorized e-cigarettes across six states, targeting five distributors and nine retailers with civil enforcement action. In the largest seizure, federal agents seized more than 600,000 units of illicit vaping products from a warehouse in the Chicago suburbs.

Two Cabinet secretaries, Attorney General Pam Bondi and Health and Human Services Secretary Robert F. Kennedy Jr., traveled to Illinois for a press conference (along with FDA Commissioner Martin Makary) to showcase the government’s commitment to cracking down on illegal e-cigarette sales. AG Bondi said the raid focused on products being brought into the United States illegally and which were targeting children and young people.

Enforcement Tools

This action comes approximately one year after the DOJ and FDA’s announcement of a multi-agency task force in 2024 (under the previous Administration), which drew together enforcement resources from DOJ, FDA, the US Marshals Service, ATF, the Postal Inspection Service, and the Federal Trade Commission. That task force was designed to take a “whole-of-government” approach, using both civil and criminal enforcement mechanisms to address the surge in illegal e-cigarette distribution.

In a Senate Judiciary Committee hearing held in 2024, FDA and DOJ officials described unauthorized e-cigarettes as a significant public health risk to Americans, and emphasized that the government intends to deploy every available enforcement mechanism, including joint actions with the FDA and ATF and seizures of inventory by the US Marshals Service. The Illinois operation indicates that the current Administration is taking a similar approach.

Legal Foundation for Heightened Enforcement

The stepped-up enforcement comes on the heels of the April 2025 Supreme Court ruling that confirmed the FDA’s authority to reject marketing applications for flavored e-cigarettes. In a unanimous decision, the Court backed the FDA’s stance that safeguarding minors takes precedent over industry claims about adult demand for flavored nicotine. The decision shut down one of the legal challenges that may have contributed to delaying and complicating enforcement efforts and laid the groundwork for the FDA to increase its efforts to address the distribution and sale of flavored and unauthorized e-cigarettes.

FDA has routinely issued Warning Letters to retailers and e-tailers of illicit vape products—more than 50 in the last three months alone. However, the September 10 enforcement raids reflect a shift from warnings and administrative actions to highly visible and publicized enforcement operations aimed at disrupting larger distributors.

Implications for the Industry

The Illinois seizure sends a clear signal to manufacturers, distributors, and retailers: the federal government is prioritizing enforcement against unapproved vaping products, with particular emphasis on flavored products and those marketed to youth. Businesses in the supply chain should expect:

• Increased inspections and seizures: Distributors and retailers may face on-site enforcement actions, including product seizures by US Marshals.
• Expanded criminal liability: DOJ has signaled its readiness to pursue criminal charges under the Food, Drug, and Cosmetic Act (FDCA) and related statutes.
• Public scrutiny: Enforcement actions are increasingly accompanied by high-profile public messaging, raising reputational risks for implicated companies.

Compliance Considerations

For compliance officers and in-house counsel, key takeaways include:

• Audit product lines for FDA authorization: Companies should confirm that all e-cigarette and vaping products they manufacture, distribute, or sell have a valid FDA marketing authorization order. As of July 2025, only 39 e-cigarette products from four manufacturers have been authorized for sale in the United States. Products lacking authorization are deemed “adulterated” or “misbranded” under the FDCA, as amended by the Family Smoking Prevention and Tobacco Control Act and other authorities.
• Conduct due diligence on upstream suppliers carefully: Liability is not limited to manufacturers. Under the FDCA, it is prohibited to introduce unauthorized tobacco products into commerce (21 U.S.C. § 331(a)), to receive or deliver such products in commerce (21 U.S.C. § 331(c)), or to hold them for sale after shipment in commerce (21 U.S.C. § 331(k)). This means that distributors and retailers remain directly exposed even if violations originated earlier in the supply chain.
• Update compliance protocols and training: Ensure employees are trained on identifying unauthorized products and responding appropriately to FDA or DOJ inspections, seizures, or inquiries. Internal reporting and escalation mechanisms should be reviewed to reduce the risk of inadvertent violations.
• Monitor regulatory developments: Following the Supreme Court’s April 2025 decision affirming FDA’s authority to deny flavored e-cigarette applications, enforcement actions are expected to increase. Keeping current with FDA press releases, warning letters, and DOJ enforcement trends will help companies anticipate areas of heightened scrutiny.

Conclusion

The presence of AG Bondi and Secretary Kennedy in Illinois underscores that illegal e-cigarette sales are a top enforcement priority. Companies operating in this space should act now to strengthen compliance programs, assess legal exposure, and be prepared for heightened scrutiny.