FDA WARNING_LETTER - Mr. Vape USA LLC - November 04, 2025

On November 12, 2025, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to Mr. Vape USA LLC, following a review of inspection records. The FDA determined that Mr. Vape USA LLC sells and distributes e-liquid products, which are regulated as tobacco products under the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they contain nicotine. The primary violation identified is the marketing of new tobacco products, specifically "FRUISION JUICE CO SWEET APPLE SUGAR BABY 100ML 6MG," without the required premarket authorization order. Under the FD&C Act, any tobacco product not commercially marketed in the U.S. as of February 15, 2007, requires an FDA marketing authorization. Lacking this authorization, the product is considered both "adulterated" and "misbranded" under the FD&C Act. Mr. Vape USA LLC is required to immediately cease the sale and distribution of all unauthorized products and submit a written response to the FDA within 15 working days. This response must detail the actions taken to address the violations and outline a comprehensive plan to maintain compliance with the FD&C Act. Failure to comply may lead to further regulatory actions, including civil money penalties or product seizure.