FDA WARNING_LETTER - EC Vapor LLC - November 15, 2022

On November 4, 2022, the FDA issued a Warning Letter to Thomas Trainor regarding e-liquid products sold on ecsmokes.com. The FDA determined these e-liquids are tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The primary violation is the sale and distribution of "new tobacco products" without required premarket authorization. Specifically, EC Vapor Asteroid, EC Vapor Diesel, and EC Vapor Mint Candy e-liquids were identified as new tobacco products not commercially marketed before February 15, 2007, and lacking FDA marketing authorization orders or exemptions. This renders the products 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 violations, including discontinuing the sale and distribution of non-compliant products, and 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 products appearing adulterated or misbranded may be detained or refused admission.