FDA WARNING_LETTER - Capitol Hill Vapor Co. - May 27, 2021

The FDA issued a Warning Letter to Alexander Barnes-Tamari of CapHill Vapor Co. on May 21, 2021, after reviewing their website, https://www.caphillvapor.com. The review determined that the firm manufactures and sells e-liquid products, specifically Capitol Hill Vapor Co. e-liquids: Highlander Extended Steamboat and Highlander Extended Molly Brown, which are considered "new tobacco products" under section 910(a) of the FD&C Act as they were not commercially marketed before February 15, 2007. The primary violation 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. 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 failure to provide required notices under section 905(j). The letter stresses the firm's responsibility to ensure all tobacco products and advertising comply with the FD&C Act and FDA regulations. A written response is required within 15 working days, detailing corrective actions, including discontinuing violative activities and a plan for future compliance. Non-compliance may lead to civil money penalties, seizure, injunction, or detention of imported products.