FDA WARNING_LETTER - E-Cig POD USA LLC d/b/a e-cig POD - August 24, 2021

The FDA Center for Tobacco Products issued a Warning Letter to Tom and Rachel Madden regarding e-liquid products sold on ecigpod.com. The FDA determined that "E-Cig POD The Darkness" and "E-Cig POD Lumberjack" e-liquid products are "new tobacco products" under section 910(a) of the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007.

These products are being offered for sale without the required premarket authorization order from the FDA, as mandated by section 910(c)(1)(A)(i) of the FD&C Act. Consequently, the products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as no notice or information was provided per section 905(j).

The firm, a registered manufacturer with over 600 products listed with the FDA, is responsible for ensuring compliance with the FD&C Act and FDA regulations. Failure to address these violations may result in regulatory actions including civil money penalties, no-tobacco-sale orders, seizure, and/or injunction. The company must submit a written response within 15 working days detailing corrective actions, including discontinuation of violative sales and a plan for future compliance.