FDA WARNING_LETTER - Gorilla Vapes of East Brunswick - February 14, 2025

On February 14, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to Gorilla Vapes LLC, identifying that the company manufactures, sells, and/or distributes e-liquid products, including "Captain Crunch," to customers in the United States. These products are classified as tobacco products under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, due to containing nicotine from any source and being intended for human consumption.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization order, as mandated by section 910(a) of the FD&C Act. "Captain Crunch" e-liquid was determined to be a new tobacco product because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks the necessary FDA marketing authorization or exemption. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

Gorilla Vapes LLC is required to submit a written response within 15 working days from the receipt of the letter. The response must detail actions taken to address the violations, including dates of discontinued sales and distribution of the violative products, and a plan for maintaining compliance with the FD&