The Food and Drug Administration (FDA) announced that it is seeking civil money penalties (CMPs) from 10 retailers for the sale of unauthorized Elf Bar e-cigarettes.
The FDA had previously issued warning letters to the retailers, however during follow-up inspections the agency reported that they had not corrected their violations. Therefore, the FDA is now seeking a CMP of $20,678 from each retailer.
The agency cited the 2023 National Youth Tobacco Survey, in which Elf Bar was reportedly a commonly used brand among middle and high school students who reported using e-cigarettes in the past 30 days.
The $20,678 CMP sought from each retailer is consistent with similar CMPs sought against retailers for the sale of unauthorized Elf Bar products over the last few months, including February and April of this year. The retailers can pay the penalty, enter into a settlement agreement, request an extension to respond or request a hearing.
The FDA noted that retailers that do not take action within 30 days after receiving a complaint risk a default order imposing the full penalty amount.
“To date, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices. These are the only e-cigarette products that currently may be lawfully marketed and sold in the U.S,” the agency stated. “Further information on tobacco products that may be legally marketed in the U.S. is available in FDA’s new Searchable Tobacco Products Database.”