The U.S. Food and Drug Administration (FDA) has issued warning letters to 189 retailers for selling unauthorized tobacco products, specifically Elf Bar and Esco Bars products. Both brands are disposable e-cigarettes that come in flavors known to appeal to youth, such as bubblegum and cotton candy. The FDA is committed to using all of its authorities to keep these illegal and youth-appealing products out of the hands of children.
The warning letters were a result of a nationwide retailer inspection blitz targeting the sale of unauthorized e-cigarettes. The FDA took action based on emerging marketplace data which raised concerns about the appeal and risks of these products to young people. Elf Bar and Esco Bars were identified as popular brands with high youth appeal.
Two studies published by the Centers for Disease Control and Prevention (CDC) reinforce concerns about the risks of Elf Bar products among young people. One study found that Elf Bar was the most popular disposable e-cigarette sold in the U.S. in December 2022. Another study showed thousands of e-cigarette exposure cases reported to U.S. poison centers in the past year, with Elf Bar being cited more than all other brands combined.
The FDA emphasizes that all players in the supply chain, including retailers, have a responsibility to keep illegal e-cigarettes off the shelves. The import of Elf Bar and Esco Bars products has been placed on the red list through import alerts issued by the FDA. This allows the FDA to detain these tobacco products without physically examining them at the time of entry.
Elf Bar and Esco Bars products do not have the required marketing authorization from the FDA. Only 23 tobacco-flavored e-cigarette products and devices have been authorized by the FDA for lawful sale in the U.S. The distribution or sale of unlawfully marketed products is subject to compliance and enforcement action.
The FDA has issued over 570 warning letters to firms for manufacturing, selling, and/or distributing illegal tobacco products, including e-cigarettes. Civil money penalty complaints have been filed against 12 e-cigarette manufacturers, and complaints for permanent injunctions have been filed against six e-cigarette manufacturers.
To enhance surveillance capabilities of the tobacco landscape, the FDA and the National Institutes of Health have announced funding for a new Center for Rapid Surveillance of Tobacco (CRST). This center will provide rapid information about changes in the tobacco product marketplace and tobacco use patterns.
Overall, the FDA is taking aggressive action to address e-cigarettes with a high appeal to youth, including flavored disposable products. The FDA is committed to protecting the nation’s youth through regulation, compliance, and enforcement actions, as well as education.
