In the first half of 2024, the U.S. Food and Drug Administration (FDA) continued ramping up efforts to limit sales of unauthorized electronic nicotine delivery systems (ENDS). We previously reported on FDA’s heightened enforcement against sellers of unauthorized ENDS in 2023 and predicted that this pattern of enforcement would continue. A year-to-date review of 2024 shows that FDA is placing a high priority on action against unauthorized ENDS. 

Please note that by “unauthorized ENDS” we do not mean ENDS products for which premarket tobacco product applications (i) were filed timely with FDA, or (ii) are the subject of negative FDA action (marketing denied order, refuse-to-accept or refuse-to-file) and have received a stay or rescission 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.”). 

FDA Unauthorized ENDS Enforcement Generally

FDA typically starts enforcement actions by issuing warning letters to retailers or others dealing in illicit ENDS. These warning letters generally indicate to the target entity that continued violations (i.e., continued sales of unauthorized products) will beget further enforcement action. If, upon a follow-up inspection, FDA finds that illicit product sales continue to occur, the agency may file civil money penalty (CMP) complaints against the noncompliant dealers. In some cases, the agency may seek injunctions or product seizures in lieu of or in addition to CMPs.

With respect to which unauthorized products garner the most regulatory attention, the accompanying FDA press releases routinely highlight the perceived youth appeal of certain brands—often based on the results of 2023 National Youth Tobacco Survey. On the whole, these products tend to be disposable and/or flavored.

Enforcement Activity in 2024 Thus Far

• January: FDA issued CMP complaints against 21 brick-and-mortar retailers for their alleged sale of unauthorized ENDS. FDA previously issued warning letters to each of these retailers, but follow-up inspections revealed that the violations continued. The CMP complaints sought the maximum penalty amount of $20,678 for a single violation from each retailer.

• February: FDA issued both warning letters and CMP complaints related to unauthorized ENDS. The warning letters came in two batches. First, warning letters were sent to 14 online retailers for their alleged sale of unauthorized ENDS. Later in the month, FDA warned five more online retailers for the same alleged behavior. Regarding CMP complaints, the agency made filings against 20 brick-and-mortar retailers—again seeking the maximum penalty amount of $20,678 for a single violation from each retailer.

• March: FDA issued another large batch of warning letters. The agency sent warning letters to 61 brick-and-mortar retailers for their alleged sale of unauthorized ENDS.

• April: FDA issued further CMP complaints and collaborated with the Department of Justice (DOJ) to execute a seizure of products. The agency issued CMP complaints against 20 brick-and-mortar retailers and two online retailers for their alleged sale of unauthorized ENDS, seeking the maximum penalty of $20,678 for a single violation from each retailer. In a notable first-time collaboration with the U.S. Marshals Service, FDA  and DOJ seized more than 45,000 unauthorized ENDS valued at approximately $703,000 from a warehouse in California. Consistent with prior enforcement action in this space, FDA first issued a warning letter to the target entity and subsequently conducted a follow-up inspection. This action is particularly significant in that it demonstrates FDA’s willingness to remove unauthorized products from the supply chain at multiple levels.

• May: FDA issued warning letters, CMP complaints, and an import alert related to unauthorized ENDS. The warning letters were sent to 14 online retailers for their alleged sale of unauthorized ENDS. Later in the month, FDA filed CMP complaints against nine brick-and-mortar retailers and one online retailer for their alleged illicit ENDS sales. The agency similarly sought the maximum penalty of $20,678 from each retailer. FDA also issued an import alert to block the importation of multiple popular unauthorized ENDS brands. However, reports suggest that foreign manufacturers may be able to skirt such importation bans by simply renaming products and changing shipping addresses.

• June: FDA and DOJ formed a multi-agency task force aimed at combatting the distribution and sale of illicit ENDS. Participating agencies include the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), the U.S. Marshals Service (USMS), the U.S. Postal Inspection Service (USPIS), the Federal Trade Commission (FTC), and U.S. Customs and Border Protection (CBP). According to FDA’s press release, the agencies will coordinate civil and criminal enforcement efforts against the distribution and sale of illicit ENDS. Coordinated efforts appear to be underway. In late June, FDA and CBP announced the seizure of 53,700 unauthorized ENDS valued at approximately $1,080,000 from a port of entry in Chicago.

Why It Matters

FDA’s intensified attention to unauthorized ENDS in 2024 reflects a solidification of the agency’s relatively new focus on this area since the latter half of 2023. For some perspective, between January 2021 and June 2023, FDA issued just 13 CMP complaints for the sale of illicit ENDS products.

This activity may stem from increased public pressure on the agency from both pro- and anti-nicotine forces. For instance, at an April hearing, members of the U.S. House Oversight and Accountability Committee pressed FDA Commissioner Robert Califf regarding the harms of illicit products on legitimate industry stakeholders. These concerns reflect the broader sentiment of the industry establishment: FDA’s enforcement against illicit products has been insufficient. Representing a more industry-skeptical perspective, U.S. Senate Judiciary Committee Chairman Dick Durban has long pushed for stricter FDA regulation of tobacco and nicotine products generally—both legitimate and illicit. In a January open letter, Chairman Durban described the agency’s reactive approach to illicit ENDS enforcement as “granting a free pass to scores of vaping products that are harming the health of children in our country.” FDA appears responsive to this pressure. The June announcement of a multi-agency task force came just days before FDA officials were questioned in a hearing before Chairman Durbin’s committee titled, “Combatting the Youth Vaping Epidemic by Enhancing Enforcement Against Illegal E-Cigarettes.”

The growing pressure on FDA for an effective solution to unauthorized ENDS raises fundamental questions about the agency’s regulatory purpose. To the extent FDA cannot control illicit ENDS sales, it creates market conditions in which legitimate industry is squeezed out by actors with no interest in compliance. Although FDA’s multi-agency task force is a significant development, it remains to be seen whether this latest ramp-up is adequate to address the illicit products’ sizeable market share. These questions surely remain on state regulators’ minds, as evidenced by multiple states (with encouragement from industry establishment) moving to establish ENDS directories and empower their own attorneys general to curb the illicit market.

The steady churn of warning letters and enforcement actions indicates that this current enforcement posture may be here to stay. As we have noted in prior coverage, this regulatory attention is consistent with FDA’s stated objectives in its strategic plan for 2024. There, the agency articulated a commitment to “aggressive enforcement of the law and pursuing enforcement actions against manufacturers, distributors, importers, and retailers for violating the law.”