As the Food and Drug Administration (FDA) continues to crack down on retailers and vape manufacturers, the administration has now filed complaints for civil money penalties (CMPs) against 20 retailers for the sale of Elf Bar e-cigarettes.
The FDA previously issued each retailer a warning letter for the sale of unauthorized e-cigarettes. However, the administration’s follow-up inspections revealed that the retailers had failed to correct the violations, and the agency is now seeking the maximum penalty amount of $20,678 for a single violation from each retailer.
FDA’s Recent Enforcement
As of Feb. 15, the FDA has filed more than 440 warning letters and 100 CMP complaints against retailers, mainly for the illegal sale of Elf Bar e-cigarettes and like brands, which the administration describes as “appealing to youth.”
Elf Bar was cited as the most popular brand among youth, according to the 2023 National Youth Tobacco Survey, reported the National Association of Tobacco Outlets (NATO).
“Today’s CMP actions are the latest in the continued, comprehensive push by FDA to take action across the supply chain to remove unauthorized e-cigarettes, particularly those that are popular among youth, from the marketplace,” the FDA noted in a statement.
The agency has also filed CMP complaints against 50 e-cigarette firms for manufacturing unauthorized products and sought injunctions against seven manufacturers.
In addition to actions involving retailers, the FDA has issued more than 660 warning letters to manufacturers, importers and distributors for illegally selling and/or distributing unauthorized new tobacco products, including e-cigarettes.
“These retailers have not adequately addressed the violations noted in previous warnings from FDA regarding the sale of unauthorized e-cigarettes,” said Brian King, director of FDA’s Center for Tobacco Products. “Their continued failure to comply with the law is inexcusable, and as is evidenced by today’s actions, we’re committed to holding them accountable for it.”
Currently, $20,678 is the maximum civil money penalty amount FDA can seek for a single violation from each retailer, which is consistent with similar CMPs sought against retailers in September, November and December of 2023. The retailers can pay the penalty, enter into a settlement agreement based on mitigating factors, request an extension of time to file an answer to the complaint or file an answer and 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.
Marketing Denial Orders
In addition to the FDA’s CMPs and warning letters, the administration has also been vigilant with its marketing denial orders (MDOs).
The most recent target was Bidi Vapor, after the administration stated the company’s Classic e-cigarette product allegedly “does not meet the necessary public health standard.”
The FDA noted that evidence submitted by Bidi Vapor did not “demonstrate an overall net benefit to people who use tobacco products and lacked sufficient evidence to address health risks,” leading to the denial of its premarket tobacco product application (PMTA) — a message that the administration has emphasized for hundreds of products on the market today.
Since 2020, the FDA has received PMTAs for more than 26 million tobacco products, the vast majority of which are e-cigarettes, and has made determinations on 99% of these applications. To date, FDA has only authorized 23 tobacco-flavored e-cigarette products and devices.
“We closely monitor the entire supply chain, including retailers, for compliance with the law,” said Ele Ibarra-Pratt, acting director of the Office of Compliance and Enforcement in the FDA’s Center for Tobacco Products. “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 administration’s recent actions “reflect FDA’s acceleration of its efforts to address illicit e-cigarettes products in the marketplace,” NATO noted in a statement.
“Earlier this month, 21 brick and mortar retailers received maximum CMP complaints for selling Esco Bar flavored disposable vapor products, which the FDA noted were the second most commonly used brand among youth e-cigarette users,” the statement continued.
The FDA is expected to continue the vigilant surveillance and enforcement of tobacco products, namely e-cigarette products.