FDA WARNING_LETTER - Gorilla Vapes of Vineland - January 07, 2021

On January 7, 2021, the FDA issued a Warning Letter to Gorilla Vapes of Vineland, identifying that their "Gorilla Vapes Vineland Plain 50 ml e-liquid product" is a "new tobacco product" lacking the required premarket authorization. This product, deemed a tobacco product under section 201(rr) of the FD&C Act, was not commercially marketed in the U.S. as of February 15, 2007, and therefore requires an FDA marketing authorization order under section 910(c)(1)(A)(i) or an exemption.

The FDA determined that the company manufactures, sells, and/or distributes this e-liquid without the necessary marketing authorization, rendering it adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the lack of a required notice or information under section 905(j). Prohibited acts include any action resulting in an adulterated or misbranded product held for sale after interstate commerce shipment (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 corrective actions, including discontinuation dates for the violative product and a plan for compliance. Failure to address these violations could lead to