FDA WARNING_LETTER - The Vapor Gypsy, LLC - May 17, 2022

The FDA's Center for Tobacco Products reviewed The Vapor Gypsy's website, https://www.thevaporgypsy.com, and determined that the firm is manufacturing and offering e-liquid products, specifically "Vapor Gypsy Unflavored," for sale in the U.S. These e-liquids are considered tobacco products under section 201(rr) of the FD&C Act and are subject to FDA regulation. The FDA found that "Vapor Gypsy Unflavored" is a "new tobacco product" because it was not commercially marketed before February 15, 2007, and lacks the required premarket marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, this product is 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 information under section 905(j). The FDA requires a written response within 15 working days detailing corrective actions, including discontinuing violative sales and a plan for future compliance, to avoid further regulatory actions such as civil money penalties, seizure, or injunction.