According to a statement from the U.S. Food and Drug Administration (FDA) on March 26th, the FDA has issued warning letters to 61 retail entities for selling unauthorized e-cigarette products. The warning letters specifically mention the sale of disposable e-cigarette products under the Elf Bar/EB Design and Lava brands.
The FDA stated that these warning letters are the result of long-term monitoring of multiple surveillance systems and their findings, with the aim of identifying products commonly used or popular among adolescents. Research results from the 2023 national youth tobacco survey showed that over 50% of adolescent e-cigarette users reported using the Elf Bar brand; in 2023, the manufacturer of Elf Bar began marketing their products under the name "EB Design". Furthermore, after reviewing retail sales data and recent youth survey data, the FDA has identified the Lava brand as popular among adolescents.
These retailers who received warning letters are selling or distributing e-cigarette products in the United States without FDA authorization, which violates the Federal Food, Drug, and Cosmetic Act. The recipients of the warning letters have been given 15 business days to respond, correct the violations, and prevent future violations. Failure to promptly correct the violations may result in the FDA taking further action, such as injunctions, seizure, and/or civil penalties.
These warning letters are part of the FDA's ongoing efforts to address the marketing and sales of unauthorized e-cigarettes targeting youth, including previous warning letters sent to online retailers selling similar unauthorized e-cigarettes.
So far, the FDA has issued more than 550 warning letters to retailers selling unauthorized e-cigarettes and has taken over 100 civil penalty actions.
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