FDA WARNING_LETTER - Walker Trading Company, Inc. - February 15, 2022

The FDA Center for Tobacco Products issued a Warning Letter to Bryan Walker regarding e-liquid products sold on vapedojo.com. The FDA determined that products like "Vape Dojo Poseidon’s Punch" and "Charlie Noble Coconut Lime" are tobacco products under section 201(rr) of the FD&C Act and are subject to FDA regulation.

These e-liquid products are classified as "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007. The FDA found that these products are being sold without the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act, rendering them adulterated under section 902(6)(A) and misbranded under section 903(a)(6).

Although the firm is a registered manufacturer with over 930 products listed, their Premarket Tobacco Product Application (PMTA) STN PM0003869, covering 66 products, received a Refuse to Accept determination on December 7, 2021. The FDA emphasizes that all new tobacco products on the market without statutory premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and injunction.

The company must submit a written response within 15 working days detailing actions taken to address violations, including discontinuing