FDA WARNING_LETTER - virginiavapes.com - November 01, 2025
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The FDA issued a Warning Letter to virginiavapes.com on November 26, 2025, following a review of its website. The agency found that the company is unlawfully selling and distributing specific electronic nicotine delivery system (ENDS) products, namely Juice Head 30K 5% Disposable - Cherry Apple and Grape Pop, to customers in the United States. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended in 2022 to include nicotine from any source, these products are classified as "new tobacco products" and require premarket authorization from the FDA. The primary violation is the absence of these required marketing authorization orders. Consequently, the products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to lacking necessary premarket review. Virginiavapes.com is mandated to provide a written response within 15 working days. This response must detail the actions taken to cease the unlawful sale and distribution of these unauthorized tobacco products and outline a comprehensive plan to ensure ongoing compliance with the FD&C Act. Failure to address these violations may lead to significant enforcement actions, including civil money penalties, product seizure, or injunctions.
ID · c938b1f7-1066-4fae-a354-91ad9399aa31
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