FDA WARNING_LETTER - Average Joes Juice LLC - January 29, 2021

On January 29, 2021, the FDA issued a Warning Letter to Joseph Fennen regarding e-liquid products sold on avgjoesjuice.com. The FDA determined that products like B-52 Ice Avg Joes and Fuji-Man Ice Avg Joes are tobacco products under section 201(rr) of the FD&C Act and are subject to FDA regulation.

The primary violation is the marketing of "new tobacco products" without required premarket authorization. These e-liquids were not commercially marketed in the U.S. as of February 15, 2007, and lack an FDA marketing authorization order, making them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The letter emphasizes that the firm, a registered manufacturer with over 2,400 listed products, is responsible for ensuring compliance across all sales and advertising platforms. Failure to correct these violations may result in regulatory actions, including civil money penalties, seizure, and/or injunction. The FDA requires a written response within 15 working days detailing corrective actions, including discontinuation of violative sales and a plan for future compliance.