FDA WARNING_LETTER - E Cig Zone Inc - December 01, 2021

On December 1, 2021, the FDA issued a Warning Letter to E Cig Zone Inc. for manufacturing and distributing e-liquid products, specifically "Straw-Mazing 3mg 60ml e-liquid," without the required premarket authorization. The FDA determined that this product is a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption.

This renders the product adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) for failure to provide required information under section 905(j). The letter states that manufacturing, selling, or distributing such products is a prohibited act under section 301(k) and failure to provide required reports is a prohibited act under section 301(p).

E Cig Zone Inc. is a registered manufacturer with over 4,400 listed products. The FDA emphasizes that all new tobacco products marketed without premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and/or injunction. The company must submit a written response within 15 working days detailing corrective actions, including discontinuation of violative sales and a plan for future compliance.