January 30, 2024
FDA has issued complaints for civil money penalties (CMPs) against 21 brick and mortar retailers for the sale of unauthorized Esco Bars e-cigarettes, a popular youth-appealing brand. FDA previously issued each retailer a warning letter for their sale of unauthorized tobacco products. However, follow-up inspections revealed that the retailers had failed to correct the violations, and the agency is now seeking the maximum penalty amount of $20,678 from each retailer.
The complaints announced today represent the first set of CMPs FDA has filed for the sale of unauthorized Esco Bars e-cigarettes. Data indicate these products are appealing to U.S. youth. According to the 2023 National Youth Tobacco Survey, Esco Bars were the second most commonly used brand among youth e-cigarette users; among middle and high school students who reported using e-cigarettes in the past 30 days, about 1 in 5 said they used Esco Bars products during that period.
“These retailers were duly warned of what could happen if they continued selling these unauthorized e-cigarettes,” said Brian King, Ph.D., M.P.H., director of FDA’s Center for Tobacco Products. “They should have acted responsibly to correct the violations, but they chose not to do so and now must face the consequences of that decision. FDA won’t sit back and tolerate inaction to comply with the law.”
Currently, $20,678 is the maximum civil money penalty amount FDA can seek for a single violation from each retailer, which is consistent with similar CMPs sought against retailers for the sale of unauthorized Elf Bar products in Sept., Nov., and Dec. of 2023. 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 a complaint risk a default order imposing the full penalty amount.
Today’s CMP actions are just the latest in the continued, comprehensive push by FDA to take action across the supply chain to remove unauthorized e-cigarettes, particularly those that are popular among youth, from the marketplace. As of Jan. 30, 2024, FDA has issued more than 440 warning letters and 88 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 660 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 48 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.
FDA will continue to take compliance and enforcement action against those making, distributing, importing, or selling unauthorized e-cigarette products, including seeking CMPs against retailers who violate the law. To date, 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. When e-cigarettes lack a marketing authorization order from FDA, selling or distributing them to consumers in the U.S. is prohibited under the Federal Food, Drug, and Cosmetic Act.