FDA Levies More Huge Fines Against Elf Bar Retailers

The FDA used the release of 2023 National Youth Tobacco Survey results yesterday as an occasion to announce a “new wave of enforcement actions” against retailers selling unauthorized disposable vapes. The FDA actions were targeted at sellers of Elf Bar—which was also the top brand choice named by the dwindling number of school-age vapers surveyed 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 just sending warning letters anymore

The “bad actors” identified yesterday are 20 small brick-and-mortar retailers from 10 states, all issued civil money penalty (CMP) complaints for selling Elf Bar (or EBDESIGN) products. CMP complaints are an FDA enforcement step beyond warning letters. The FDA says these retailers had already received warning letters, and were discovered during subsequent inspections to have continued selling the offending products.

The FDA can seek CMPs of up to $19,192 for each tobacco violation of the Food, Drug, & Cosmetic Act (of which the Tobacco Control Act is a part). Businesses charged with violations punishable by CMPs can pay the full amount immediately, reach a settlement agreement with the FDA, ask for an extension to answer the complaint, or answer with a request for a hearing. They have 30 days to respond or risk a default order imposing the full penalty.

The stores cited yesterday include two that may be dedicated vape shops. But the other 18 were either gas stations, convenience stores or smoke shops—the usual targets for FDA enforcement actions.

The FDA also sought civil money penalties from 22 retailers in September—also for selling Elf Bar products. The agency said then it was seeking the largest possible penalties for the small businesses, and said yesterday it was seeking “similar amounts” in the second wave of actions.

FDA: Elf Bar is Public Enemy #1

Elf Bar has been a primary target of the FDA’s bizarre war on disposable vapes. As cigarette smoking declines among adults and youth, the agency is constantly pressured by a weird coalition of tobacco control groups, Democratic lawmakers and tobacco companies to crack down on the disposable vape products that are now the most popular among those who have quit smoking.

In May, the FDA ordered its import inspectors to detain Elf Bar shipments from China. Since then, the agency has taken multiple actions against both brick-and-mortar and online Elf Bar retailers, and distributors of Elf and other disposables.

Last month, the two largest U.S. tobacco companies launched legal actions against disposable vape manufacturers, distributors and retailers. R.J. Reynolds asked the International Trade Commission to block imports of Breeze, Elf Bar, Esco Bar, Hyde, Puff Bar, and R&M disposables, which Reynolds (maker of Newport and Camel cigarettes) accused of “intentionally and systematically market[ing] to youth.”

Just a few days later, vape manufacturer NJOY and its parent company Altria (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, asking for an injunction that would prevent their import and sale, and compensatory and punitive damages paid to NJOY.