FDA WARNING_LETTER - North Texas Vapor Shop - October 15, 2019

On September 27, 2019, the FDA issued a Warning Letter to Jeremy Speight regarding e-liquid products sold on bigtexvaporshop.com. The FDA determined these e-liquids are tobacco products under the FD&C Act.

The primary violation identified is that several e-liquid products, including Bavarian Cream, Gummy Bear, Candy Apple Rancher, Cinna-Bomb, and Banana Nut Bread, are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)). This is because their website advertising fails to include the required nicotine warning statement: "WARNING: This product contains nicotine. Nicotine is an addictive chemical," as mandated by 21 C.F.R. § 1143.3(b).

The letter emphasizes that it is unlawful for manufacturers, packagers, importers, distributors, or retailers to advertise covered tobacco products without this warning. Failure to comply with the FD&C Act may result in further FDA action, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction.

The company is required to submit a written response within 15 working days detailing corrective actions, including dates of discontinued violative activities and a plan for maintaining compliance. The response should be sent to the FDA Center for