FDA WARNING_LETTER - bigtexanvapor.com

The U.S. Food and Drug Administration (FDA) issued a warning letter to Big Texan Vape, LLC, located at 2661 Midway Road, Suite 200, Carrollton, TX, on September 12, 2025. The FDA"s Center for Tobacco Products conducted a review of the company"s website, https://bigtexanvapor.com, and found that electronic nicotine delivery system (ENDS) products were being sold or distributed in the United States without the necessary premarket authorization. The products in question include the Lost Mary MO5000 by EBDesign and Raz TN9000, both of which are considered new tobacco products under the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they were not marketed in the U.S. before February 15, 2007.

These products are deemed adulterated and misbranded as they lack the required marketing authorization and necessary notifications under sections 902(6)(A) and 903(a)(6) of the FD&C Act. The FDA requires Big Texan Vape to take immediate action to address these violations by discontinuing the sale and distribution of these products and ensuring compliance with all applicable regulations. The company must submit a written response within 15 working days detailing the corrective actions taken, including the cessation of violative sales and a plan for ongoing compliance.

Failure to comply may result in enforcement actions such as civil penalties, seizure, or injunction. The FDA emphasizes that this letter serves as a formal notification of the violations and an opportunity for the company to rectify them.