According to an announcement on the official website of the US Food and Drug Administration (FDA) on April 23, the FDA has issued civil fines (CMPs) to 20 brick-and-mortar retailers and 2 online retailers for selling unauthorized e-cigarettes, including the popular brand "ELFBAR" among young people.
The FDA has previously issued warnings to these retailers, stating that their sale of unauthorized tobacco products is in violation of regulations. However, subsequent inspections have revealed that these retailers have failed to correct these violations. Therefore, the FDA is now seeking to fine each retailer $20,000.
According to the 2023 National Youth Tobacco Survey, ELFBAR is the most commonly used brand among middle and high school students. 56.7% of youth e-cigarette users in the past 30 days reported using ELFBAR, with approximately one-third (31.1%) stating it is their "regular" brand.
The FDA is currently seeking civil penalties of approximately $20,000 from each retailer, consistent with civil penalties sought in recent months for selling unauthorized ELFBAR products, including in September, November, December, and February. These retailers have the option to pay the fine, reach a settlement agreement, apply for an extension of the response period, or request a hearing. If the retailers take no action within 30 days of receiving the complaint, they may default and be required to pay the full amount of the penalty.
The FDA's unauthorized civil fine action against e-cigarettes will continue to take comprehensive actions against the supply chain, particularly targeting products popular among young people for removal. As of April 2024, the FDA has issued over 550 warning letters and 108 civil fines to retailers (including brick-and-mortar and online retailers) selling unauthorized tobacco products.
In addition to actions targeting retailers, the FDA has also issued warning letters to over 670 manufacturers, importers, and distributors of e-cigarettes for illegally selling and/or distributing unauthorized new tobacco products. The agency has also initiated civil monetary complaints against 55 e-cigarette companies for illegally manufacturing unauthorized products, and has filed injunctions with the Department of Justice against 7 unauthorized e-cigarette product manufacturers.
The FDA has authorized 23 tobacco-flavored e-cigarette products and devices, which are currently the only e-cigarette products legally available for sale in the United States. Further information about which tobacco products can be legally marketed in the US can be found in the FDA's new searchable tobacco product database.
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