FDA WARNING_LETTER - Flavor Concepts LLC - April 13, 2021

The FDA Center for Tobacco Products issued a Warning Letter to Susannah VanWinkle of Concepts in Flavor on April 9, 2021, following a review of their website, https://conceptsinflavor.com. The review determined that the company manufactures and sells e-liquid products, which are deemed tobacco products under the FD&C Act and subject to FDA regulation.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization order. Specifically, Cloud Maker Vapor Company e-liquids, including Red Cowboy, Alien Bomb Sauce, and Strawberries & Cream, were found to be new tobacco products not commercially marketed before February 15, 2007, and lacking FDA marketing authorization. This renders these products adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required notice or information was not provided.

The letter emphasizes the firm's responsibility, as a registered manufacturer with over 300 listed products, to ensure compliance with all applicable FD&C Act provisions 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 corrective actions, including discontinuing the violative sale and distribution, and a plan for future compliance.