FDA WARNING_LETTER - Walker Trading Co. Inc. d/b/a Vape Dojo - August 02, 2022

The FDA Center for Tobacco Products issued a Warning Letter to (b)(6) regarding e-liquid products sold on vapedojo.com. The FDA determined these products, including Vape Dojo - Eden"s Beach, Charlie Noble - Spiced Mango Slush, and Charlie Noble - Blue Razz Slush, are "tobacco products" under section 201(rr) of the FD&C Act, especially with recent legislation expanding the definition to include nicotine from any source. The primary violation is the manufacturing and offering for sale of these "new tobacco products" without the required premarket authorization order, as mandated by section 910(a) and 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the lack of required notice under section 905(j). The firm must respond within 15 working days, detailing corrective actions, dates of discontinuance for violative activities, and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, product seizure, injunctions, or detention of imported products.