Given the continued challenges in policing the burgeoning ENDS marketplace, as previously discussed in Part I of this article, in mid-2024 FDA and DOJ announced the establishment of a federal multi-agency task force to combat the "illegal distribution and sale of e-cigarettes." Specifically, the task force includes members from the Bureau of Alcohol, Tobacco, Firearms and Explosives; the U.S. Marshals Service; the U.S. Postal Inspection Service; the Federal Trade Commission; and potentially others. The task force aims to investigate and prosecute new criminal, civil, seizure, and forfeiture actions with respect to unauthorized, illegal ENDS products and sales.
Prioritizing enforcement of federal law and FDA's regulations for ENDS products by the new multi-agency task force should noticeably impact the importation and sale of unlawful e-cigarettes. For example, to target importers, utilizing practices such as Import Alerts allows FDA to inform the public of specific ENDS devices, which account for brand name changes, that can be detained without physical examination. Granting Customs and Border Protection (CBP) to seize smuggled products entering the U.S. has already resulted in the seizure of more than $76 million of products. To target manufacturers, FDA is ramping up inspections, resulting in violation warning letters and civil money penalties. In January 2025, FDA, CBP, and U.S. Homeland Security Investigations announced the seizure of more than 628,000 illicit e-cigarette products from one warehouse in Miami. Similar warning letters and civil money penalties are being used by FDA to tackle illegal sales at retailers.
Looking ahead, FDA has recently pledged to complete review of the over 26 million PMTA filings as efficiently as possible as well as draft formal guidance on civil money penalties for manufacturer violations related to illegal ENDS devices. With a new presidential administration now in control, and new appointees to the relevant regulatory agencies taking over, it will be interesting to see whether or how enforcement efforts change.
Due to the relative newness of the ENDS industry, companies and products continue to quickly evolve while regulatory and legal measures play catch-up. In parallel with enforcement efforts by FDA and DOJ, legal participants in the e-cigarette marketplace have also begun to pursue approaches to deter illegal sales. Notably, R.J. Reynolds filed separate complaints at the United States International Trade Commission alleging unfair trade practices and patent infringement and seeking exclusion order bans against 36 entities that import unauthorized e-cigarette products into the United States. Although proceedings are still underway and decisions are not expected until late 2025, a favorable outcome for R.J. Reynolds would establish additional paths for legitimate market participants to interdict illegally imported ENDS products.
In yet another example of the ever-transforming landscape, in December 2024, the United States Supreme Court heard arguments from e-cigarette liquid makers regarding the allegedly improper rejection of their PMTAs that had been filed in 2020. While a ruling on whether FDA followed proper legal procedures in evaluating these applications is not expected until June 2025, a Supreme Court ruling in favor of PMTA review processes may solidify FDA's efforts to fully regulate the ENDS sector of the tobacco industry.
If the multi-agency task force is successful and/or if third party intellectual property-grounded enforcement efforts are successful, importation and distribution of prohibited ENDS products may be reduced, which would limit the supply of such products to retailers, and ultimately, consumers. As a result, the use of illegal products among youth is expected to decline and consumers may transition to authorized, legal products.
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