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Earlier this year, FDA announced that it has issued complaints for civil money penalties (CMPs) against twenty-one (21) brick and mortar retailers for selling unauthorized Esco Bars e-cigarettes. This action follows previous warnings to these retailers about the sale of unauthorized tobacco products, which they failed to correct. As a result, FDA is seeking the maximum penalty of $20,678 from each retailer.
This marks the first set of CMPs filed for the sale of unauthorized Esco Bars e-cigarettes, a brand particularly popular among youth. Data from the 2023 National Youth Tobacco Survey shows Esco Bars were the second most common brand among youth e-cigarette users. Among middle and high school students who reported using e-cigarettes in the past 30 days, approximately 1 in 5 used Esco Bars products during that period.
Dr. Brian King, director of FDA’s Center for Tobacco Products, emphasized the seriousness of these violations. He stated, “These retailers were duly warned of 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 now must face the consequences of that decision. FDA won’t sit back and tolerate inaction to comply with the law.”
The maximum penalty amount of $20,678 per violation is consistent with similar CMPs sought against retailers for unauthorized Elf Bar products in late 2023. Retailers have several options: they can pay the penalty, enter into a settlement agreement, request an extension to file an answer, or file an answer and request a hearing. Failure to act within thirty (30) days can result in a default order imposing the full penalty amount.
This move by FDA is part of an ongoing effort to remove unauthorized e-cigarettes, particularly those appealing to youth, from the market. Our firm understands the complexities and challenges that businesses face in navigating regulatory compliance. If your business is affected by these recent FDA actions or if you need guidance on compliance with federal regulations, we are here to help.
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