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The US Food and Drug Administration (FDA) has recently announced it is seeking civil money penalties (CMPs) of $20,678 from ten retailers. The nine physical shops and one online are accused of selling Elf Bar e-cigarettes after previously receiving FDA warning letters for sales of unauthorised products.
These CMP actions are the latest in the continued push by the federal agency to take action across the supply chain to remove unauthorised e-cigarettes from the marketplace, particularly those that are popular among youth.
The FDA said: “The $20,678 CMP sought from each retailer is consistent with similar CMPs sought against retailers for the sale of unauthorised Elf Bar products over the last few months, including February and April of this year.”
The agency said that the retailers have options to pay the penalty, enter into a settlement agreement, request an extension to respond, or request a hearing. Retailers that do not take action within 30 days after receiving a complaint risk a default order imposing the full penalty amount.
In April, the FDA issued a similar action against 20 bricks-and-mortar and 2 online retailers for the sale of unauthorised e-cigarettes, including Elf Bar. In February, the agency issued more than 440 warning letters to and filed 100 CMP actions against retailers, including physcial and online retailers, for selling unauthorised tobacco products. In addition to actions involving retailers, the FDA has issued more than 660 warning letters to manufacturers, importers and distributors for illegally selling and distributing unauthorised new tobacco products, including e-cigarettes.
Elf Bar is ‘the usual’ for schoolkids
The agency also filed CMP complaints against 50 e-cigarette firms for manufacturing unauthorised products and sought injunctions in coordination with the US Department of Justice against 7 manufacturers of unauthorised e-cigarette products. Similar CMPs were sought against retailers for selling unauthorised Elf Bar products in September, November and December of 2023.
According to the 2023 National Youth Tobacco Survey, Elf Bar was the most commonly used brand among middle- and high-school students who reported using e-cigarettes. Data found that 56.7% of e-cigarette users in this age group reported current use of Elf Bar, and 31.1% reported it was their “usual” brand.
To date, the FDA has authorised 23 tobacco-flavoured e-cigarette products and devices. These are the only e-cigarette products that currently may be lawfully marketed and sold in the US.
Last month, the federal agency issued an import alert, which seems to very specifically target Elf Bar, following a few others issued this year. However, when ECigIntelligence asked the FDA, a spokesperson from the agency said these products have been on this import alert list since May 2023 with no recent change.
– Antonia Di Lorenzo ECigIntelligence staff
Photo: John Cameron
