FDA Issues Civil Penalty Notices to 21 Retailers Selling Unauthorized Esco Bars
On January 30, in Pacific Standard Time, the Food and Drug Administration (FDA) Tobacco News Center released a statement announcing that civil penalty notices have been issued to 21 physical retailers for selling unauthorized Esco Barse-cigarettes, a popular brand among young people. Earlier, the FDA had sent warning letters to each retailer accusing them of selling unauthorized tobacco products. However, subsequent inspections revealed that these retailers failed to rectify their non-compliant actions, leading the agency to seek penalties of up to $20,678 for each retailer.
Today, the FDA announced its first ever civil penalties against the unauthorized sale of Esco Barse-cigarettes, following complaints. Data indicates that these products are attractive to American teenagers. According to the 2023 National Youth Tobacco Survey, Esco Bars is the second most popular brand among adolescent e-cigarette users. Approximately one-fifth of middle and high school students who have used e-cigarettes in the past 30 days reported using Esco Bars during that period.
Dr. Brian King, director of the FDA Center for Tobacco Products, has stated that these retailers have been warned about the potential consequences if they continue to sell unauthorized e-cigarettes. They were supposed to responsibly address their violations, but they have chosen not to do so and must now face the repercussions of their decision. The FDA will not stand idly by and tolerate non-compliance with the law.
Currently, $20,678 is the maximum civil penalty amount that the FDA can seek from each retailer for a single violation, which aligns with similar fines sought by the FDA in September, November, and December 2023 for the sale of unauthorized Elf Bar products. Retailers have the option to pay the fine, reach a settlement agreement based on mitigating factors, request an extension for their defense, or present a defense and request a hearing. Retailers who fail to take action within 30 days of receiving a complaint will face default orders, resulting in full penalties being imposed.
Today's civil fines action is just the latest move by the FDA in its efforts to rid the entire supply chain of unauthorized e-cigarettes, especially those popular among young people. As of January 30, 2024, the FDA has issued over 440 warning letters and 88 civil penalty notices to retailers, including brick-and-mortar stores and online retailers, accusing them of selling unauthorized tobacco products. In addition to actions involving retailers, the FDA has also sent warning letters to over 660 companies for illegal manufacturing and/or distribution of unauthorized novel tobacco products, including e-cigarettes. The agency has also filed civil penalty complaints against 48 e-cigarette companies, accusing them of manufacturing unauthorized products, and has sought injunctions against seven unauthorized e-cigarette product manufacturers in coordination with the U.S. Department of Justice.
The FDA will continue its compliance and enforcement actions against the manufacturing, distribution, importation, or sale of unauthorized e-cigarette products, including imposing civil penalties on retailers found in violation of the law. As of now, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices, which are the only legally sold e-cigarette products in the United States. Selling or distributing e-cigarettes without FDA market authorization is a violation of the Federal Food, Drug, and Cosmetic Act.
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