Rollin Vapor LLC – FDA Warning Letter, Aug 11, 2025

The FDA issued a Warning Letter to Rollin Vapor, located at 5412 South Mingo Road, Suite A, Tulsa, OK, on August 7, 2025, following an inspection by the Center for Tobacco Products. The inspection revealed that Rollin Vapor sells electronic nicotine delivery system (ENDS) products, which are classified as tobacco products under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The company was found to be distributing products, specifically the FOGER SWITCH PRO KIT STRAWBERRY ICE 5% Nicotine, 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 premarket authorization order. Rollin Vapor"s failure to obtain this authorization means their products are marketed unlawfully, subject to potential enforcement actions such as civil penalties, seizure, or injunction.

The FDA has requested that Rollin Vapor take immediate corrective actions to comply with the FD&C Act, including ceasing the sale and distribution of the violative products and submitting a written response within 15 working days outlining their compliance plan. The company is advised to ensure all products and related marketing adhere to FDA regulations to avoid further regulatory actions.