FDA WARNING_LETTER - K2 Distro LLC, d/b/a K2 Distribution - June 27, 2024

The FDA's Center for Tobacco Products issued a Warning Letter to K2 Distro LLC, d/b/a K2 Distribution, on June 27, 2024, based on a review of inspection records. The letter states that K2 Distro sells and/or distributes Electronic Nicotine Delivery System (ENDS) products, which are considered tobacco products under the FD&C Act, including those containing nicotine from any source as per the Consolidated Appropriations Act, 2022.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the products "DRIIIZY SMOKE X2 15000 Puffs BLUE RAZZ ICE 50mg/ml 30ml" and "Lost Mary MT15000 TURBO WATERMELON ICE 50mg/ml 16ml" were cited. These products are deemed "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders or exemptions.

Consequently, these products are considered adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required notice or information was not provided. K2 Distro is required to submit a written response within 15 working days detailing