FDA WARNING_LETTER - Vapor Forrest LLC, d/b/a Vapor Forrest #3

The FDA issued a Warning Letter to Vapor Forrest LLC, operating as Vapor Forrest #3, on September 18, 2025, following an inspection by the Center for Tobacco Products. The inspection revealed that the company sells and distributes electronic nicotine delivery system (ENDS) products in the U.S. without the necessary marketing authorization, violating the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Key violations include the sale of ENDS products, such as Hyppe Max Air Naked Unflavored 5% NIC Salt 13ml, which lack premarket authorization as required under section 910(c)(1)(A)(i) of the FD&C Act. These products are considered "new tobacco products" because they were not commercially available in the U.S. before February 15, 2007, and do not have the required FDA marketing authorization. Consequently, these products are deemed adulterated and misbranded under sections 902(6)(A) and 903(a)(6) of the FD&C Act, respectively.

The FDA mandates that Vapor Forrest LLC immediately cease the sale and distribution of these unauthorized products and submit a written response within 15 working days detailing corrective actions taken. The response should include the cessation dates of the violative sales and a compliance plan. Failure to comply may result in regulatory actions, including civil penalties, seizure, or injunction. The company is urged to ensure all products and related marketing comply with the FD&C Act and FDA regulations.