FDA WARNING_LETTER - Legend Vapor, Inc. d/b/a Legend Vapor - April 13, 2021

The FDA's Center for Tobacco Products issued a Warning Letter to Donal Bush concerning e-liquid products, specifically Dragon King Dew eLiquid and Dragon King Apple Candy eLiquid, offered for sale on legendvapor.com. The FDA determined these products are "new tobacco products" under section 201(rr) of the FD&C Act and are subject to FDA regulation (21 C.F.R. § 1100.1). The firm was found to be manufacturing and selling these products without the required premarket marketing authorization order, as mandated by section 910(c)(1)(A)(i) of the FD&C Act for new tobacco products not commercially marketed before February 15, 2007. Consequently, these e-liquid products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required notice or information under section 905(j). The firm, a registered manufacturer, must ensure compliance with all applicable provisions. The FDA requires a written response within 15 working days detailing actions to address violations, including discontinuing violative activities and a plan for maintaining compliance. Failure to comply may lead to regulatory actions such as civil money penalties, seizure, or injunction, and imported products may be detained or refused admission.