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This action represents the first occurrence of the FDA pursuing civil money penalties for the maximum amount against e-cigarette retailers for such an offense.
The US Food and Drug Administration (FDA) announced its filing of civil money penalty (CMP) complaints against 22 retailers as a result of their reported illegal sale of Elf Bar/EB Design e-cigarettes, an e-cigarette brand known to strongly appeal to youth.1
The retailers given CMP complaints had each been sent warning letters by the agency previously, with the messages urging them to end their sale of tobacco products deemed to be unauthorized. Upon the FDA’s re-inspection, officials noted that the retailers had not responded correctly to their violations, leading to the new fines.
Ann Simoneau, JD, MBA, the director of the Office of Compliance and Enforcement for the Center for Tobacco Products at the FDA, commented on the actions the agency was compelled to take against the sellers.
"We continue to monitor closely all those in the supply chain, including retailers, for compliance with federal law,” Simoneau said in a statement. “This includes follow-up inspections and surveillance of those who have received a warning letter, and taking additional action, as appropriate, to enforce the law.”
The agency’s complaints demand a maximum civil money penalty of $19,192 per violation from each of the retailers, a move considered a first for the FDA in pursuing CMPs for the maximum amount. The sellers in question are permitted to either pay the required penalty, submit an extension request to respond to the CMP, take part in a settlement agreement, or fully respond to the CMP and ask for a hearing.
The FDA’s announcement featured a reminder that retailers refusing to take action within a 30 day time frame following their receipt of the CMP will risk a default order imposing the full penalty.
On the same day as the actions were taken against these 22 sellers, the agency disclosed 168 letters of warning to brick-and-mortar retailers as a result of unlawful sales of Elf Bar/EB Design products. These letters were the result of a retailer inspection effort occurring around the US that was carried out in August.
Those given warning letters are allowed to receive 15 working days to answer with the corrective measures taken to comply with the law, and failure to address the issues acknowledged may lead to further actions by the FDA such as seizures, injunctions, or further civil money penalties.
“The FDA has been abundantly clear that we are committed to using the full scope of our authorities, as appropriate, to hold those who break the law accountable,” Brian King, PhD, MPH, director of the FDA’s Center for Tobacco Products, said in a statement. “These retailers were duly warned of what could happen if they failed to correct their violations. They chose inaction and will now face the consequences.”
These combined actions by the agency demonstrate the FDA's consistent goal of eliminating illegal e-cigarettes from the market in the US, especially ones seen to appeal to younger people. As of September 19, 2023, the agency has given out over 400 warning letters to online and in-person sellers of e-cigarettes for selling unauthorized products with tobacco.