FDA WARNING_LETTER - 911 Vapor Inc - August 28, 2025

The FDA"s Center for Tobacco Products issued a warning letter to 911 Vapor Inc, located at 860 South Main Street, Jacksonville, IL, on August 28, 2025. The letter follows an inspection that revealed the company sells e-liquid products in the U.S. without the necessary premarket authorization, as required by the Federal Food, Drug, and Cosmetic Act (FD&C Act). These products, including MRKT PLCE ELIQUID ICED Grapefruit Citrus Sugarberry 100ML 3MG, are classified as new tobacco products because they were not marketed in the U.S. before February 15, 2007.

The FDA"s regulatory framework mandates that new tobacco products must have a marketing authorization order unless they meet specific exemption criteria. The products in question are deemed adulterated and misbranded under sections 902(6)(A) and 903(a)(6) of the FD&C Act, respectively, due to the absence of required authorization and notification.

911 Vapor Inc is required to address these violations promptly. The company must submit a written response within 15 working days, detailing actions taken to comply with the FD&C Act, including ceasing the sale and distribution of non-compliant products. Failure to comply may result in regulatory actions such as civil penalties, seizure, or injunction. The FDA emphasizes the importance of ensuring all tobacco products and related marketing comply with applicable laws and regulations.