FDA WARNING_LETTER - A-Z Tobacco Inc, d/b/a A-Z Tobacco - March 13, 2025

On March 13, 2025, the FDA Center for Tobacco Products issued a Warning Letter to A-Z Tobacco Inc, d/b/a A-Z Tobacco, following a review of inspection records. The FDA determined that A-Z Tobacco Inc manufactures, sells, and/or distributes e-liquid products, including "Berry Crunch," which are considered tobacco products under section 201(rr) of the FD&C Act.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization order. These products are deemed "new tobacco products" because they were not commercially marketed in the United States as of February 15, 2007, and lack FDA marketing authorization orders under section 910(c)(1)(A)(i) of the FD&C Act, nor are they exempt.

Consequently, these products are adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) of the FD&C Act, as required notice or information under section 905(j) was not provided.

A-Z Tobacco Inc is required to submit a written response within 15 working days from receipt of the letter, detailing actions taken to address the violations, including dates of discontinued sales/distribution and a plan for maintaining compliance. Failure to comply may result in regulatory actions