FDA WARNING_LETTER - A-Z Tobacco Inc, d/b/a A-Z Tobacco - May 01, 2025

The FDA Center for Tobacco Products issued a Warning Letter to A-Z Tobacco Inc, d/b/a A-Z Vapor, regarding the manufacture, sale, and distribution of e-liquid products, specifically "Rainbow Drips." The letter clarifies that these products are considered "tobacco products" under the FD&C Act, including those containing nicotine from any source, following recent legislative amendments. The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization order, as mandated by section 910(a) of the FD&C Act. The FDA determined that "Rainbow Drips" e-liquid was not commercially marketed as of February 15, 2007, and lacks the necessary marketing authorization. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the failure to provide required notice under section 905(j). The firm is instructed to submit a written response within 15 working days detailing actions taken to address these violations, including discontinuing violative sales and outlining a compliance plan. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction, and imported products may be detained.