FDA WARNING_LETTER - VAPE 911 LLC - March 12, 2021

The FDA issued a Warning Letter to David Lemke and Tanner Thomas of Vape911.com on March 12, 2021, after reviewing their website and determining they manufacture and sell e-liquid products in the U.S. These e-liquids, including "Vanilla Bean Ice Cream," "Lemonade," and "Jaw Breaker," are considered tobacco products under the FD&C Act.

The primary violation is marketing "new tobacco products" without required premarket authorization. These products were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders or exemptions. Consequently, they are 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.

Vape911.com, a registered manufacturer with over 5,800 listed products, is responsible for ensuring compliance across all sales and advertising platforms. 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 activities and a plan for future compliance.