FDA Issues More Massive Fines to Elf Bar Retailers

The FDA announced a "new wave of enforcement actions" against stores selling unlicensed disposable vapes Tuesday, coinciding with the announcement of the 2023 National Youth Tobacco Survey findings. The FDA proceedings were directed at dealers of Elf Bar , which was also recognized as the top brand choice by the diminishing number of school-age vapers polled in this year's NYTS.

Despite NYTS results showing the lowest high school vaping prevalence since 2013—and the lowest youth smoking rate since the government began tracking it—FDA Center for Tobacco Products (CTP) Director Brian King says the agency "cannot and will not let our guard down on this issue," and "will not stand by as bad actors place profit over the health of our nation's youth."

FDA Is Not Only Sending Warning Letters Anymore.

The "bad actors" discovered yesterday include 20 small brick-and-mortar businesses from 10 states that have all received civil money penalty (CMP) complaints for selling Elf Bar (or EBDESIGN ) goods. CMP complaints are a further stage in FDA enforcement after warning letters. According to the FDA, these merchants had previously received warning letters but were determined to be selling the infringing items during later inspections.

The FDA can seek CMPs of up to $19,192 for each tobacco infraction under the Food, Drug, and Cosmetic Act (which includes the Tobacco Control Act). Businesses charged with CMP breaches can pay the whole sum immediately, enter into a settlement agreement with the FDA, request an extension to respond to the complaint or request a hearing. They have 30 days to respond or face a default order with the entire penalty.

The establishments mentioned yesterday include two that might be specialized vape shops. However, the remaining 18 were either gas stations, convenience stores, or smoke shops, which are typical targets for FDA enforcement efforts.

In September, the FDA sought civil money penalties from 22 merchants who sold Elf Bar products. The agency stated at the time that it was pursuing the maximum fines available for small firms, and it stated again Tuesday that it was seeking "similar amounts" in the second round of cases.

FDA: Elf Bar Is Public Enemy No. 1.

Elf Bar has been a main target of the FDA's odd assault on disposable vaping devices. As cigarette smoking drops among adults and kids, the FDA is under continual pressure from a strange alliance of tobacco control organizations, Democratic politicians, and tobacco firms to crack down on disposable vape devices, which are now the most popular among individuals who have quit smoking.

In May, the FDA directed US import inspectors to halt Elf Bar imports from China. Since then, the agency has pursued many proceedings against Elf Bar merchants, both in-store and online, as well as distributors of Elf and other throwaway products.

Last month, the United States' two largest tobacco firms filed lawsuits against disposable vape producers, distributors, and retailers. R.J. Reynolds petitioned the International Trade Commission to prohibit imports of Breeze, Elf Bar, Esco Bar, Hyde, Puff Bar, and R&M disposables, which Reynolds (the producer of Newport and Camel cigarettes) said were "intentionally and systematically marketed to youth."

Just a few days later, vape manufacturer NJOY and its parent company Altria (the maker of Marlboro cigarettes) filed a federal lawsuit against companies associated with disposable brands Breeze, Elf Bar, Esco Bar, Flum, Juice Box, Lava Plus, Loon, Lost Mary, Mr. Fog, and Puff Bar, seeking an injunction to prevent their import and sale, as well as compensatory and punitive damages paid to NJOY.