FDA WARNING_LETTER - Jaded Vapors LLC - April 05, 2022

The FDA issued a Warning Letter to Toby Gooch, Charlotte Wilbanks, and John Sumrall of Jaded Vapor on January 7, 2022, following a review of their website, https://jadedvapor.com. The FDA determined that the firm manufactures and offers e-liquid products, including Apple Jolly and Capt Crunch, for sale in the U.S. These products are classified as tobacco products under section 201(rr) of the FD&C Act and 21 C.F.R. § 1100.1. The primary violation identified is the marketing of these "new tobacco products" without the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act, as they were not commercially marketed before February 15, 2007. 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 absence of required notice under section 905(j). The firm is a registered manufacturer, and a Premarket Tobacco Product Application (STN PM0003599) covering 5,087 products received a Marketing Denial Order on September 8, 2021. The FDA prioritizes enforcement against products marketed without authorization, especially those with MDOs. The letter mandates a written response within 15 working days detailing corrective actions, discontinuation of violative activities, and a plan for sustained compliance, warning of potential regulatory actions such as civil money penalties, seizure, or injunction for non-compliance.