U.S. FDA's Center for Tobacco Products Issues Warning Letter on Unauthorized Products

U.S. FDA's Center for Tobacco Products Issues Warning Letter on Unauthorized Products

On December 13, the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) issued warning letters to 11 online retailers, known as Lost Mary, Funky Republic/Funky Lands, Elf Bar/EB Design, Kangvape, Cali Brands such as and Breeze sell unauthorized e-cigarette products. Those who receive a warning letter have 15 business days to respond with steps they will take to correct the violations discussed in the warning letter and prevent future violations. Failure to promptly correct violations may result in FDA enforcement actions such as injunctions, seizures, and/or civil penalties.

"It is illegal to sell, import, distribute, or offer for sale or distribute to U.S. consumers any e-cigarette that is not authorized by the FDA," CTP Director Brian King said in a statement. "These warning letters refer to The product is on the market without authorization. For products for which an application has been submitted and is under review, we can issue a warning letter, and a warning letter has been issued. For unauthorized tobacco products, the pendency of the application will not prevent the sale of the product. products create any safe harbor.”

As of December 2023, the FDA has issued more than 400 warning letters to retailers for selling unauthorized e-cigarettes and filed civil penalty lawsuits against more than 65 retailers and manufacturers, accusing them of producing or selling unauthorized e-cigarettes. Authorized Products.

So far, the FDA has approved 23 e-cigarette devices and tobacco-flavored e-cigarette products.
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