Throughout 2024, the U.S. Food and Drug Administration (FDA) endeavored to curb sales of unauthorized electronic nicotine delivery systems (ENDS) in the U.S. In light of persistent demand for flavored ENDS — nearly all of which are unauthorized — there is little evidence that these enforcement efforts have reduced illicit sales. Indeed, some observers estimate that flavored ENDS account for more than 80% of all ENDS sales. With a new administration on the horizon, our team highlights two opportunities for FDA to step up its enforcement efforts: (1) focusing enforcement on imports and (2) authorizing premarket tobacco product applications (PMTAs) for flavored products.

In this blog post, our use of the terms “unauthorized” or “illicit” ENDS does not refer to ENDS products for which PMTAs (i) were filed timely with FDA, or (ii) are the subject of negative FDA action — marketing denial order (MDO), refuse-to-accept (RFA), or refuse-to-file (RTF) — and have received a stay or recission of this decision. See FDA, Advisory and Enforcement Actions Against Industry for Unauthorized Tobacco Products (“There are a few tobacco products that have received a marketing denial order (MDO) that are under further agency review and for which FDA has stated the Agency does not intend to pursue enforcement action during the pendency of the re-review. In addition, in a very limited number of instances, some courts have granted stays of MDOs pending judicial review in order to maintain the status quo, or FDA has administratively stayed MDOs. In those particular instances, FDA does not intend to take enforcement action.”).

(1) Focus Enforcement on Imports

On the supply side, FDA could focus more of its enforcement efforts on importation. Much of the agency’s 2024 enforcement efforts involved warning letters and civil money penalty complaints toward retailers or other domestic actors dealing in illicit products. Although these letters warn that continued dealing in such products will beget further enforcement action, FDA appears capable of targeting only a handful of dealers at a time (usually fewer than 100). FDA’s recent activity may suggest it understands the benefit of focusing on importation.

For instance, in August, FDA issued a proposed rule that would require importers of ENDS to provide an FDA-issued submission tracking number (STN) to U.S. Customs and Border Protection (CBP) for imports of such products. FDA generally issues STNs upon a manufacturer’s submission of PMTAs. Thus, the rule could result in the denial of entry for ENDS imports for which the manufacturer has not submitted a PMTA to FDA — i.e., unauthorized ENDS. For more on the proposed STN rule, see our prior coverage here.

FDA also periodically publishes import alerts regarding the importation of unauthorized ENDS. These alerts include a “Red List” of manufacturers and their unauthorized ENDS, which are subject to detention by CBP upon entry. Given the plethora of unauthorized products imported into the U.S., FDA could further expand the Red List to account for current conditions.

A recent notable collaboration between FDA and CBP was similarly import-focused. In October, FDA announced the administrative seizure of approximately three million units (roughly $76 million retail value) of unauthorized ENDS in conjunction with CBP. Rather than targeting domestic dealers, FDA and CBP monitored shipping invoices and examined suspicious incoming shipments from China. The seizure represents the latest public action by the multiagency task force formed by FDA and the U.S. Department of Justice to combat the distribution and sale of illicit ENDS.

(2) Authorize PMTAs for Flavored Products

On the demand side, FDA could authorize many more PMTAs for flavored ENDS than it has to date, allowing those products to be marketed by compliant companies. Although FDA has remained oppositional toward flavored ENDS, consumers overwhelmingly prefer flavored products — all of which are currently unauthorized with the exception of four menthol ENDS products. Consumers therefore lack a selection of authorized flavored ENDS products, and most elect to use illicit products instead.

FDA could facilitate a transfer of market demand from noncompliant manufacturers’ illicit products to compliant manufacturers’ authorized products by authorizing the marketing of more flavored ENDS. This would allow compliant players to compete in the flavored ENDS marketplace, potentially working to drive out illicit industry, while providing smokers less harmful options to combustible cigarettes that are FDA-authorized.

Why It Matters

The persistent prevalence of flavored ENDS raises fundamental questions about the effectiveness of FDA’s current approach toward the illicit market. FDA’s inability to control illicit sales creates conditions in which legitimate industry is crowded out by actors with no interest in compliance. With new leadership, FDA has an opportunity to focus on attacking the problem at its supply-side source, while giving American consumers authorized options for the flavored ENDS they demand.

A change in administration will entail shifting priorities, attitudes, and strategies at FDA in the ENDS space and beyond. If you have questions about how potential policy shifts at FDA will impact your business, our team is ready to assist.

For more of our team’s thoughts on what to expect more broadly from the tobacco and nicotine regulatory landscape in 2025, listen to our recent podcast episode here.