FDA WARNING_LETTER - unclelarrysmokes.com

The FDA issued a Warning Letter to Uncle Larry"s Smokes, located at 4785 NW 167 ST, Miami Gardens, FL, following a review of their website offering electronic nicotine delivery system (ENDS) products for sale in the U.S. The inspection, conducted by the Center for Tobacco Products, identified violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, the products Fume x Nicky Jam 15k – Blue Miami and HQD Cuvie Plus – Cotton Candy were found to be marketed without the necessary premarket authorization, rendering them adulterated and misbranded under sections 902(6)(A) and 903(a)(6) of the FD&C Act.

The regulatory framework requires that new tobacco products, defined as those not commercially marketed in the U.S. as of February 15, 2007, must have a marketing authorization order. The FDA"s jurisdiction extends to products containing nicotine from any source, as amended by the Consolidated Appropriations Act, 2022.

Uncle Larry"s Smokes must take immediate action to address these violations, including ceasing the sale and distribution of the non-compliant products and ensuring all products meet FD&C Act requirements. A written response detailing corrective actions must be submitted within 15 working days. Failure to comply may result in enforcement actions such as civil penalties or product seizure. The company is advised to review the FDA"s searchable database for authorized products and ensure all marketing complies with regulatory standards.