[co-author: Zie Alere]*
In September, the U.S. Food and Drug Administration (FDA) issued two new rounds of warning letters to online retailers, manufacturers, and distributors for reportedly selling or distributing unauthorized e-cigarette products. Notably, FDA’s most recent letters target several popular disposable flavored products, including Elf Bar, EB Design, Lava, Cali, Bang, and Kangertech, which FDA states are particularly appealing to youth. FDA also sought civil money penalties against 22 retailers for failing to comply with prior warning letters and, for the first time, sought the maximum penalty allowed by law.
Concerns of youth appeal continue to guide FDA’s enforcement priorities, and the agency is expanding its surveillance capabilities to monitor youth use. In an FDA press release accompanying the issuance of its September 14 warnings, FDA indicated that it is relying on “nimble surveillance tools” that draw on “[r]etail sales data, emerging internal data from surveys of youth, as well as other data sources” to “proactively identify and swiftly stave off emerging threats, particularly those affecting our nation’s youth.” In addition, FDA and the National Institutes of Health (NIH) funded the creation of a research consortium in June called the Center for Rapid Surveillance of Tobacco (CRST). FDA expects CRST to help it understand the tobacco product market broadly, giving regulators insights on use patterns.
Increasingly, action follows FDA’s warnings. In a September 28 press release, the agency announced complaints seeking civil money penalties against 22 brick-and-mortar retailers for the illegal sale of Elf Bar/EB Design disposable flavored e-cigarettes. To put this into perspective, FDA only issued 13 civil money penalties from January 2021 through June 2023. The warning letters are a follow up to the warning letters FDA previously issued to the same retailers regarding the sale of such products. According to the press release, the agency seeks “the maximum civil money penalty of $19,192 for a single violation from each retailer” — marking the first time FDA has requested the maximum amount for a violation of this nature. Signaling ongoing scrutiny of flavored disposable products, the agency also announced the issuance of 168 additional warning letters to brick-and-mortar retailers regarding their alleged sale of Elf Bar/EB Design products.
These actions come in the wake of pressure on the agency to do more. On August 29, a bipartisan coalition of 33 state attorneys general (AGs) signed a letter to FDA, urging the agency “to swiftly formulate and implement a strategic plan that adequately protects public health form the glut of child-friendly flavored disposable Electronic Nicotine Delivery Systems (ENDS) currently on the market.” In particular, the coalition pointed to what it called a “disposables loophole” rooted in FDA’s 2020 enforcement priorities. Among those enforcement priorities, in 2020 FDA called out flavored, cartridge-based ENDS products (other than tobacco and menthol), as the ENDS products most attractive to youth. The state AGs’ letter states that today this is no longer the case, citing statistics that indicate that more than half of youth ENDS users reported using disposables in 2022 compared to a quarter that reported using pod or cartridge-based products.
The recent round of FDA warning letters regarding disposable flavored products appears to reflect the agency’s responsiveness to such pressure, and we anticipate the agency will continue to place enforcement resources in this area.
*Associate with Troutman Pepper, not admitted to practice law in any jurisdiction