FDA WARNING_LETTER - Ferrum City Liquid - August 02, 2022

The FDA Center for Tobacco Products reviewed ferrumcityliquid.com and determined that e-liquid products, including "Angry Graham Bears" and "Angry Pink Lemonade," are manufactured and sold without required marketing authorization. These products are considered "new tobacco products" under section 201(rr) of the FD&C Act, as they were not commercially marketed in the U.S. before February 15, 2007, and contain nicotine from any source, falling under FDA jurisdiction.

The identified e-liquid products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because they lack the necessary premarket authorization order or exemption. The FDA has not received an application for marketing authorization for these products.

The company must submit a written response within 15 working days detailing actions taken to address violations, including discontinuing sales and distribution of non-compliant products, and outlining a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction. The letter also notes that imported non-compliant products may be detained or refused admission.