The U.S. Food and Drug Administration has warned 189 retailers against unauthorized sales of two of the most popular disposable e-cigarettes in the U.S., specifically Elf Bar and Esco Bars brand e-cigarettes. These two flavored brands have high youth appeal for its unique flavors such as bubblegum and cotton candy.
Following a nationwide retailer inspection blitz over the past several weeks, the FDA has issued warning letters to 189 retailers amid cracking down on the sale of these unauthorized e-cigarettes.
“We are committed to a multipronged approach using regulation, compliance and enforcement action and education to protect our nation’s youth,” said FDA Commissioner Robert Califf.
The agency has been continuously monitoring the marketplace and took these actions as emerging marketplace data led to concerns over their appeal and risks to young people. The ongoing surveillance efforts helped FDA identify Elf Bar and Esco Bars as being among the most popular brands in the U.S.
According to the agency, Elf Bar and Esco Bars brand disposable e-cigarettes were two of the most commonly reported brands used by youth e-cigarette users in 2022. Last month, the FDA issued import alerts for all products under both the Elf Bar and Esco Bars brands to help prevent these products from illegally entering the marketplace.
Elf Bar and Esco Bars products do not have the required marketing authorization from the FDA. To date, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices that may be lawfully sold in the U.S.
Selling or distributing e-cigarettes that lack a marketing authorization order to consumers in the U.S. is prohibited under the Federal Food, Drug, and Cosmetic Act.
From January 2021 through May 2023, the agency has already issued more than 570 warning letters to firms for manufacturing, selling and/or distributing illegal tobacco products, including e-cigarettes, and filed civil money penalty complaints against 12 e-cigarette manufacturers.
Last month, the FDA conducted a nationwide blitz to crack down on the sale of unauthorized e-cigarettes popular with youth, specifically Puff and Hyde products, which resulted in warning letters to more than 30 retailers and one distributor. A majority of companies corrected the stated violations.
However, failure to promptly correct the violations can result in additional FDA actions such as injunction, seizure and/or civil money penalties. The retailers will get 15 working days to respond with the steps they will take to correct the violation and to prevent future violations.
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