ECigMafia LLC – FDA Warning Letter, Jun 22, 2023

On June 7, 2023, the FDA's Center for Tobacco Products issued a Warning Letter to Daniel Bradford regarding electronic nicotine delivery system (ENDS) products sold on ecigmafia.com. The FDA determined that products listed on the website are offered for sale or distribution in the United States and are considered tobacco products under section 201(rr) of the FD&C Act, as they contain nicotine from any source and are intended for human consumption.

The key violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the products Elf Bar EB BC5000 – Gumi, Elf Bar EB BC5000 – Honeydew Pineapple Orange, and Esco Bar 2500 Puffs – Cotton Candy were found to be new tobacco products not commercially marketed in the U.S. as of February 15, 2007, and lacking an FDA marketing authorization order or exemption. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The letter requires a written response within 15 working days detailing actions taken to address the violations, including discontinuing the sale/distribution of the non-compliant products and a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction