FDA WARNING_LETTER - The Tiki Hut Vapes - March 07, 2025

The FDA Center for Tobacco Products issued a Warning Letter to The Tiki Hut Vapes on March 6, 2025, following a review of inspection records. The company manufactures, sells, and/or distributes e-liquid products, which are classified as tobacco products under the FD&C Act, including those containing nicotine from any source, effective March 15, 2022.

The primary violation identified is the marketing of "new tobacco products" without required premarket authorization. Specifically, the product "Tiki Cookie" was cited as a new tobacco product that was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption. This renders the product 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 letter emphasizes the company's responsibility to ensure all tobacco products and related advertising comply with the FD&C Act and FDA regulations. Failure to address these violations may result in regulatory actions such as civil money penalties, seizure, and/or injunction. The company is required to submit a written response within 15 working days detailing actions taken to address violations, including discontinuation of violative sales and a plan for future compliance.