FDA WARNING_LETTER - Up N Smoke Shop - July 24, 2025

The FDA"s Center for Tobacco Products issued a warning letter to Up N Smoke Shop, located at 5194 Highway 100, Suite 100, Lyles, TN, on July 24, 2025. The inspection revealed that the company sells electronic nicotine delivery system (ENDS) products, specifically the VIHO Turbo Watermelon Berries, without the necessary premarket authorization, violating the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Under the FD&C Act, products containing nicotine from any source are classified as tobacco products and must comply with FDA regulations. The legislation, amended by the Consolidated Appropriations Act, 2022, requires new tobacco products, those not marketed before February 15, 2007, to have a marketing authorization order. The absence of such authorization renders the products adulterated and misbranded.

Up N Smoke Shop must cease the sale and distribution of the non-compliant products and submit a written response within 15 working days detailing corrective actions, including discontinuation dates and future compliance plans. Failure to comply may result in enforcement actions, such as civil penalties or product seizure. The letter serves as a notification of violations and an opportunity for the company to address them. For further guidance, the company is directed to the FDA"s website and instructed to reference ER2501250 in their response.