FDA WARNING_LETTER - Take Off Corp - February 12, 2021

On February 12, 2021, the FDA Center for Tobacco Products issued a Warning Letter to Ghazi Mustafa regarding e-liquid products sold on takeoffeliquid.com. The FDA determined that products like "Take Off Land of Clouds Lemon-Lime," "Mango," and "Strawberry Lemonade" are tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The primary violation is the marketing of "new tobacco products" without required premarket authorization. These e-liquids were not commercially marketed in the U.S. as of February 15, 2007, and lack an FDA marketing authorization order, rendering them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The letter emphasizes the firm's responsibility, as a registered manufacturer with over 30 listed products, to ensure compliance across all advertising and sales channels. Failure to address these violations may result in civil money penalties, seizure, and/or injunction. The FDA requires a written response within 15 working days detailing corrective actions, including discontinuation of violative sales and a plan for future compliance.