FDA WARNING_LETTER - Cordova Tobacco & Vape - September 11, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Cordova Tobacco & Vape, located at 1204 North Houston Levee Road, Suite 113, Cordova, TN, on September 11, 2025. The FDA"s Center for Tobacco Products conducted a review of the company"s operations and identified violations related to the sale and distribution of electronic nicotine delivery system (ENDS) products. These products fall under the regulatory framework of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Consolidated Appropriations Act, 2022, which extends FDA jurisdiction to all nicotine-containing products, regardless of their source.

The main violation identified was the marketing of the "Fasta Burrst 35000 Frozen Strawberry Banana 5% nicotine" product without the required premarket authorization. This product is considered a "new tobacco product" as it was not commercially available in the U.S. before February 15, 2007, and lacks a marketing authorization order, rendering it adulterated and misbranded under the FD&C Act.

The FDA requires Cordova Tobacco & Vape to 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 detailing their compliance plan. Failure to comply may result in enforcement actions such as civil penalties, product seizure, or injunctions. The company is urged to ensure that all tobacco products and related marketing comply with FDA regulations.