C-Store Retailers Receive Warning Letters for Elf Bar, Esco Bars Products

Over half of 189 retailers on FDA list from convenience channel

WASHINGTON, D.C. – More than half of the 189 retailers targeted, vaping-related warning letters from the U.S. Food and Drug Administration (FDA) for selling noncompliant products were convenience stores, according to a list provided by the agency.

Many of the stores appeared to be independently operated locations, so-called “mom-and-pop” sites, but most had major oil fuel brands, including Amoco, BP, Chevron, Conoco, Exxon, Phillips and Shell.

In late June, the FDA announced that it had issued warning letters to 189 retailers for selling unauthorized tobacco products, specifically Elf Bar and Esco Bars vaping devices. Both brands are disposable e-cigarettes that come in flavors like bubble gum and cotton candy, known to appeal to youth, the agency said.

In a press release, the FDA said it continuously monitors the marketplace and took these actions as emerging data led to concerns over their appeal and risks to young people. More specifically, the agency’s ongoing surveillance efforts helped FDA identify Elf Bar and Esco Bars as being among the most popular brands in the United States and having high youth appeal.

“All players in the supply chain—including retailers—have a role in keeping illegal e-cigarettes off the shelves,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products (CTP). “This latest blitz should be a wake-up call for retailers of Elf Bar and Esco Bars products nationwide. If they’re waiting for a personal invitation to comply with the law, they might just get it in the form of a warning letter or other action from the FDA.”

Earlier in the spring, the FDA issued import alerts for all products under both the Elf Bar and Esco Bars brands. An import alert places these tobacco products on the red list, which makes them subject to “Detention Without Physical Examination” and allows the FDA to detain a product without physically examining it at the time of entry.

The distribution or sale of unlawfully marketed products is subject to compliance and enforcement action. The FDA generally sends warning letters the first time an inspection or investigation reveals a violation of the law, and recipients are given 15 working days to respond with the steps they’ll take to correct the violation and to prevent future violations.

As of June 16, the FDA has 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. In October 2022, the first complaints for permanent injunctions were filed against six e-cigarette manufacturers. In May 2023, the FDA issued warning letters to the firms responsible for two brands of unauthorized flavored, disposable e-cigarette products: Shenzhen Innokin Technology Co. Ltd. for Esco Bars products and Breeze Smoke, LLC for Breeze products. Also, in May of 2023, 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. Failure to promptly correct the violations can result in additional FDA actions such as injunction, seizure and/or civil money penalties.

To further expand surveillance capabilities of the dynamic tobacco landscape, the FDA and the National Institutes of Health announced earlier this month that funding was awarded for a new Center for Rapid Surveillance of Tobacco (CRST). This specialized center will complement CTP’s internal surveillance efforts by providing additional rapid information about changes in the tobacco product marketplace and tobacco use patterns.

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