FDA WARNING_LETTER - Illumivaption Inc. d/b/a Nashville Vapor - October 07, 2021

The FDA Center for Tobacco Products issued a Warning Letter to David Pellicane regarding e-liquid products sold on nashvillevapor.com. The FDA determined that products like Sancia Tiger Blood 30ml and Sancia Banana Nut Bread 30ml are "new tobacco products" under section 201(rr) of the FD&C Act, subject to FDA jurisdiction.

These products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket authorization order or exemption. The firm, a registered manufacturer with over 800 products listed with FDA, had a Premarket Tobacco Product Application (PMTA) (STN PM0003569) for 771 products, which received a Marketing Denial Order on September 3, 2021.

The FDA emphasizes that all new tobacco products on the market without premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and/or injunction. The company must submit a written response within 15 working days detailing actions taken to address violations, including discontinuing sales and a plan for future compliance.