FDA WARNING_LETTER - Gorilla Vapes of Egg Harbor - September 14, 2023

On September 14, 2023, the FDA issued a Warning Letter to Gorilla Vapes of Egg Harbor, identifying violations related to the manufacture and distribution of e-liquid products. The FDA determined that Gorilla Vapes' e-liquid products, specifically "COFFEE," are "new tobacco products" under section 201(rr) of the FD&C Act because they contain nicotine and were not commercially marketed in the U.S. as of February 15, 2007.

The primary violation is the marketing of these new tobacco products without the required premarket authorization, as mandated by section 910(a) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) because the required notice or information under section 905(j) was not provided. Prohibited acts include holding for sale after shipment in interstate commerce resulting in adulteration or misbranding (section 301(k)) and failure to provide a required report (section 301(p)).

Gorilla Vapes must submit a written response within 15 working days detailing actions to address these violations, including dates of discontinued sales/distribution and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.