FDA WARNING_LETTER - Breezesmokes LLC - March 15, 2023

The FDA issued a Warning Letter to Breezesmokes LLC on March 15, 2023, following a review of submissions and inspection records. The FDA determined that Breezesmokes LLC manufactures, imports, and distributes e-liquid products, which are classified as tobacco products under the FD&C Act.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, Breezesmokes Cinnamon 11mg 30ml and Breezesmokes USA Tobacco 3mg 50ml e-liquid products were found to be commercially marketed without FDA marketing authorization orders or exemptions. These products are considered "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007.

Consequently, these products are deemed adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) of the FD&C Act due to the lack of required premarket notification (section 905(j)). The failure to provide such reports is a prohibited act under section 301(p) of the FD&C Act, and any act resulting in adulterated or misbranded products held for sale after interstate shipment is prohibited under section 301(k).

Breezesmokes LLC is required to submit a written response