FDA WARNING_LETTER - A-Z Tobacco Inc, d/b/a A-Z Tobacco - February 18, 2025

The FDA's Center for Tobacco Products issued a Warning Letter to A-Z Tobacco Inc d/b/a A-Z Tobacco and Vapor, identifying violations related to the marketing of e-liquid products. The letter, dated February 14, 2025, states that A-Z Tobacco Inc manufactures, sells, and/or distributes e-liquid products, which are classified as tobacco products under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, to include nicotine from any source.

The primary violation is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the product "Adam’s Downfall" e-liquid was identified as a new tobacco product not commercially marketed in the U.S. as of February 15, 2007, and lacking FDA marketing authorization. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required notice or information under section 905(j).

A-Z Tobacco Inc is required to submit a written response within 15 working days, detailing actions taken to address the violations, including discontinuation dates for violative sales and distribution, and a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil