FDA fines 21 offline retailers selling Esco Bars, up to $20,000 each

  21 brick-and-mortar retailers are facing FDA civil penalty complaints for selling unauthorized Esco Bars e-cigarettes, with each retailer potentially facing fines of up to $20,678.

Breaking news, January 30 U.S. Pacific Time: The U.S. Food and Drug Administration (FDA) said in a post on its Center for Tobacco Products news page that it has issued civil money penalty complaints against 21 brick-and-mortar retailers for selling unauthorized Esco Bars e-cigarettes, a brand popular among young people. The FDA had previously sent warning letters to each retailer, alleging that they were selling unauthorized tobacco products. However, follow-up inspections showed that these retailers failed to correct the violations, and the agency is now seeking fines of up to $20,678 against each retailer.
 

Today’s complaints represent the FDA’s first civil money penalties involving the sale of unauthorized Esco Bars e-cigarettes. Data show that these products appeal to U.S. youth. According to the 2023 National Youth Tobacco Survey, Esco Bars was the second most commonly used brand among youth e-cigarette users; among middle and high school students who used e-cigarettes in the past 30 days, about one in five said they had used Esco Bars products during that period.

Brian King, Ph.D., director of the FDA’s Center for Tobacco Products, said: “These retailers were warned about what could happen if they continued selling these unauthorized e-cigarettes.” They should have acted responsibly to correct the violations, but they chose not to do so and must now face the consequences of that decision. The FDA will not stand by and tolerate noncompliance with the law.

At present, $20,678 is the maximum civil money penalty the FDA may seek against each retailer for a single violation. This is consistent with similar fines the FDA sought in September, November, and December 2023 over the sale of unauthorized Elf Bar products. Retailers may pay the fine, reach a settlement agreement based on mitigating factors, request an extension of time to respond, or file an answer and request a hearing. Retailers that fail to act within 30 days of receiving the complaint may be subject to a default order imposing the full penalty.

Today’s civil penalty action is just the latest step in the FDA’s broader effort across the supply chain to remove unauthorized e-cigarettes, especially products popular among youth. As of January 30, 2024, the FDA had issued more than 440 warning letters and 88 civil money penalty complaints to retailers, including both physical stores and online retailers, for selling unauthorized tobacco products. In addition to retailer-focused actions, the FDA has also sent warning letters to more than 660 companies for illegally manufacturing and/or distributing unauthorized new tobacco products, including e-cigarettes. The agency has also filed civil money penalty complaints against 48 vaping companies for manufacturing unauthorized products and, in coordination with the U.S. Department of Justice, has filed injunction actions against 7 unauthorized vaping product manufacturers.

The FDA said it will continue taking compliance and enforcement actions against the manufacture, distribution, importation, or sale of unauthorized e-cigarette products, including filing civil money penalty complaints against retailers that violate the law. To date, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices. These are currently the only e-cigarette products legally marketed and sold in the United States. E-cigarettes sold or distributed in the U.S. without FDA marketing authorization are in violation of the Federal Food, Drug, and Cosmetic Act.