FDA WARNING_LETTER - Tobacco Vapor Zone - October 01, 2025

The FDA issued a Warning Letter to Tobacco Vapor Zone on October 2, 2025, following a review of inspection records, indicating the company"s sale and distribution of unauthorized tobacco products. The primary violation concerns the marketing of Electronic Nicotine Delivery System (ENDS) products, specifically "NEXA ULTRA Pink n Blue 50 mg/ml," which the FDA deems a "new tobacco product" under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Under the FD&C Act, as amended to include products containing nicotine from any source, new tobacco products require premarket authorization from the FDA to be legally marketed in the United States. Tobacco Vapor Zone failed to obtain the necessary marketing order for the identified ENDS product, which was not commercially available before February 15, 2007, and is not otherwise exempt. Consequently, the product is considered both adulterated and misbranded by the FDA.

The FDA mandates that Tobacco Vapor Zone take prompt action to address these violations. The company must submit a written response within 15 working days detailing the steps taken to discontinue the violative sale and distribution of the unauthorized product and outlining a plan for future compliance with the FD&C Act. Failure to rectify these issues could result in further regulatory actions, including civil money penalties, product seizure, or injunctions. This letter serves as a formal notification and an opportunity for the company to demonstrate compliance.