The Vaping Dragon, LLC – FDA Warning Letter, Sep 28, 2023

The FDA issued a Warning Letter to The Vaping Dragon, LLC on September 28, 2023, following a review of inspection records. The company manufactures and distributes e-liquid products, including "Why So Cereal," which are considered tobacco products under the FD&C Act, as amended to include products with nicotine from any source.

The primary violation is the marketing of "new tobacco products" without required premarket authorization. "Why So Cereal" was not commercially marketed in the U.S. as of February 15, 2007, and lacks FDA marketing authorization, substantial equivalence, or exemption. 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 information under section 905(j).

The FDA has not received a marketing authorization application for these products. The company is engaging in prohibited acts under sections 301(k) and 301(p) of the FD&C Act. Failure to address these violations may result in regulatory actions such as civil money penalties, seizure, and/or injunction. The Vaping Dragon, LLC must submit a written response within 15 working days detailing corrective actions, including discontinuation of violative sales and a plan for maintaining compliance.