The Food and Drug Administration has issued civil money complaints (CMPs) against 20 brick and mortar retailers and two online retailers for the sale of unauthorized e-cigarettes and tobacco products. The CMPs were geared specifically to retailers selling Elf Bar products.
The FDA previously issued warning letters against the retailers and deemed that they had not properly corrected their violations.
The agency cited the 2023 National Youth Tobacco Survey, which alleged that Elf Bar was the most commonly used brand among middle and high school students.
“The approximately $20,000 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 in September, November, December and February,” according to the FDA.
As a result, 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.
“Today’s CMP actions continue the comprehensive effort by FDA to take action across the supply chain to remove unauthorized e-cigarettes, particularly those that are popular among youth, from the marketplace,” the FDA continued in a statement.
As of April 2024, the agency has issued more than 550 warning letters and 108 CMPs to retailers, including brick and mortar and online retailers, for selling unauthorized tobacco products.
In addition to actions involving retailers, FDA has issued more than 670 warning letters to manufacturers, importers and distributors for illegally selling and/or distributing unauthorized new tobacco products, including e-cigarettes.
The agency has also filed civil money penalty complaints against 55 e-cigarette firms for manufacturing unauthorized products and sought injunctions in coordination with the U.S. Department of Justice against seven manufacturers of unauthorized e-cigarette products.
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.; further information on tobacco products that may be legally marketed in the U.S. is available in FDA’s new Searchable Tobacco Products Database.