On Dec. 5, 2023, FDA announced the filing of civil money penalty (CMP) complaints against 25 brick and mortar and online retailers for the illegal sale of unauthorized Elf Bar, EB Design and other e-cigarette products. FDA previously warned each retailer in the form of a warning letter to stop selling unauthorized tobacco products. During follow-up inspections, FDA observed the retailers had not corrected the violations, resulting in these civil money penalty actions.
The e-cigarette products that were the focus of these complaints are especially popular among youth. Findings from the 2023 National Youth Tobacco Survey found that Elf Bar was the most commonly used brand among middle and high school students who reported using e-cigarettes (56.7%).
The complaints seek the maximum civil money penalty of $19,192 for a single violation from each retailer. The retailers can pay the penalty, enter into a settlement agreement based on mitigation factors, request an extension of time to file an answer to the complaint, or file an answer and request a hearing. Retailers that do not take action within 30 days after receiving the complaint risk a default order imposing the full penalty amount.
Today’s actions bring the total number of CMPs filed against retailers for the sale of unauthorized e-cigarettes up to 67. Previously, in September, and then again in November, FDA sought CMPs for similar amounts against 42 brick and mortar retailers across 18 states for the sale of unauthorized Elf Bar products. Today’s actions include retailers from 14 states and, for the first time, include cases against online retailers.
FDA will continue to take actions across the supply chain to remove unauthorized e-cigarettes from the marketplace, particularly those that are popular among youth. As of Dec. 5, 2023, FDA has issued more than 400 warning letters 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 630 warning letters to firms for illegally manufacturing and/or distributing unauthorized new tobacco products, including e-cigarettes. The agency has also filed civil money penalty complaints against 36 e-cigarette manufacturers for manufacturing unauthorized products, and sought injunctions in coordination with the U.S. Department of Justice against seven manufacturers of unauthorized e-cigarette products.