FDA WARNING_LETTER - Gorilla Vapes LLC - October 08, 2024

On September 19, 2024, the FDA's Center for Tobacco Products issued a Warning Letter to Russel Jurczyk regarding e-liquid products sold on gorillavapes.com. The FDA determined these products are tobacco products under section 201(rr) of the FD&C Act, as amended on March 15, 2022, to include nicotine from any source.

The primary violation is the marketing of "new tobacco products" without required premarket authorization, as per section 910(a) of the FD&C Act. Specifically, the e-liquid products "Brewed Awakening Classic Salt Nicotine 30ml by CCC," "Lucid by CCC," "UFOhm Encounter 30ml Nic Salt by CCC," "Breakfast All Day French Toast by CCC," and "UFOhm Encounter Ice 30ml Nic Salt by CCC" were identified as new tobacco products not commercially marketed before February 15, 2007, and lacking FDA marketing authorization orders or exemptions.

Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The letter requires a written response within 15 working days detailing actions to address violations, including discontinuing sales and a plan for future compliance. Failure to comply may result in regulatory actions such as