Azure Tobacco, Inc. – FDA Warning Letter, Mar 2, 2023

On March 2, 2023, the FDA issued a Warning Letter to AZURE TOBACCO, INC. for manufacturing and distributing waterpipe tobacco products without required marketing authorization. The FDA determined that Azure Premium Hookah Tobacco Gold Line Berrymania 250g and Azure Premium Hookah Tobacco Gold Line Winter Rose 250g are "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders or exemptions.

These products are deemed adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) for failing to provide required information under section 905(j). The introduction of adulterated or misbranded tobacco products into interstate commerce, and the failure to provide required reports, are prohibited acts under sections 301(a) and 301(p) of the FD&C Act, respectively.

The FDA requires AZURE TOBACCO, INC. to submit a written response within 15 working days detailing actions taken to address violations, including discontinuing the sale and distribution of the non-compliant products and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.