Russ WareThe FDA has announced that it has filed complaints against 20 brick-and-mortar retailers, seeking the maximum penalty of $20,678 for each violation. The violations in each of the 20 cases pertain to the sale of unauthorized Elf Bar disposable vapes.
The issuing of the Civil Money Penalty complaints (CMPs) in these cases follow warning letters relating to the sale of unauthorized e-cigarettes. Follow-up inspections, which usually take place 15 days from the date of the letter, showed that these retailers had failed to heed the warning. To date, more than 440 warning letters have been sent out to stores that continue to sell anything other than the 23 vapes that have so far been given marketing approval.
This is not the first time retailers of unauthorized Elf Bars have been targeted by the FDA, either in the form of warning letters or fines. Such actions were taken most recently in September, November, and December of 2023. This latest round of fines comes just a month after similar penalties were handed to 21 Esco Bar retailers.
The total number of CMP complaints issued to brick-and-mortar and online retailers of vapes that do not have agreed Pre-Market Tobacco Applications (PMTAs) has now risen to well beyond 100. As with all previous complaints, these latest retailers can pay the penalty, argue mitigating factors for failure to comply, request an extension of time to file an answer to the complaint, or file an answer and request a hearing.
Commenting on these new fines, Ele Ibarra-Pratt, M.P.H., the FDA’s acting director of the Office of Compliance and Enforcement, said:
“We closely monitor the entire supply chain, including retailers, for compliance with the law. This includes follow-up inspections and surveillance of those who have received a warning letter, and taking enforcement actions, including filing civil money penalty complaints and seeking seizures and injunctions, as appropriate.”
The Elf Bar products identified in the CMPs mainly appear to be the BC5000 disposables, in flavors ranging from Tobacco and Clear to Blueberry Energize, Summer Peach Ice, and Tropical Rainbow Blast. And it is the availability of exactly flavors like these that the FDA and other opponents of vaping say has led to the increase in youth vaping.
The Elf Bar brand has come under fire regularly in recent years after being highlighted as the one most popular and often used by teens and other underage vapers. The 2023 National Youth Tobacco Survey suggested that 56% of the 2.13 million students who currently use e-cigarettes chose Elf Bar over any other.
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