WARNING: This product contains nicotine, nicotine is an addictive chemical.
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On January 30th, the Tobacco News Center of the U.S. Food and Drug Administration (FDA) issued a document. It stats that it has issued civil penalty notices to 21 offline vape retailers for selling unauthorized Esco Bars vapes. Esco Bars is a vape brand popular among young people.
The FDA has already issued warning letters to these retailer, accusing them of selling unauthorized tobacco products. But, subsequent inspections revealed that the retailers failed to correct the violations. So the agency is now seeking fines of up to $20,678 per retailer.
The complaint is the first civil penalty brought by the FDA about unauthorized sales of Esco Bars vapes. Data shows the appeal of these products to American teenagers. According to the 2023 National Youth Tobacco Survey, Esco Bars are the second most commonly used vape brand among teen vape users. About 1/5 middle and high school students who used vapes in the past 30 days reported using Esco Bars during that period.
“These retailers were duly warned of what could happen if they continued selling these unauthorized e-cigarettes.” said Dr. Brian King, director of the 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 penalty amount the FDA can seek per retailer for a single violation. This is consistent with similar penalties the FDA sought in 9, 11, and 12, 2023 for the sale of unauthorized Elf Bar products.
Retailers can pay a fine, enter into a settlement based on mitigating factors, request an extension of time to plead, or file a plea and request a hearing. Retailers fail to take action within 30 days of receiving complaints will face default orders, which will impose full fines.
Today’s civil penalty action is just the latest step in the FDA’s move across the supply chain. Aiming at remove unauthorized vapes, especially those popular among young people. By Jan. 30, 2024, the FDA has issued more than 440 warning letters and 88 civil penalty notices to retailers. These retailers include both brick-and-mortar and online retailers. The FDA accuse them of selling unauthorized tobacco products.
Besides, the FDA has issued warning letters to more than 660 vape companies. It accuse them for illegally manufacturing and/or distributing unauthorized new tobacco products, including vapes.
The agency also filed civil penalty complaints against 48 vape companies. The complaints accuse them of manufacturing unauthorized products. And, while coordinating with the U.S. Department of Justice, FDA filed injunctions against 7 unauthorized vape manufacturers.
FDA will continue to take compliance and enforcement actions. It will keep on against those who manufacture, distribute, import, or sell unauthorized vape products. The action also include pursuing civil penalties against retailers who violate the law. So far, the FDA has authorized 23 tobacco-flavored vape products and devices. These are the only vape products currently sold legally in the United States. When vapes lack an FDA marketing authorization, selling or distributing them in the US would be illegal. Otherwise it will violate the Federal Food, Drug, and Cosmetic Act.