FDA WARNING_LETTER - Vape Dojo Corporate Headquarters - December 15, 2023

On December 15, 2023, an FDA inspection of Vape Dojo at 721 Hanover Pike, Suite 123, Hampstead, MD 21074, revealed a violation of federal tobacco laws. The establishment offered for sale a "Vape Dojo Berry Smoothie 120 ML 0.6% e-liquid product" which is a "new tobacco product" lacking the required premarket authorization.

Under Section 910(a) of the FD&C Act, a "new tobacco product" is defined as any tobacco product not commercially marketed in the U.S. as of February 15, 2007, or any modified tobacco product marketed after this date. Such products generally require a marketing authorization order under Section 910(c)(1)(A)(i) of the FD&C Act, unless found substantially equivalent to a predicate product or covered by exemptions. Since the Vape Dojo product was not commercially marketed by February 15, 2007, and lacks FDA marketing authorization, it is deemed "adulterated" under Section 902(6)(A) and "misbranded" under Section 903(a)(6) of the FD&C Act.

The FDA requires a response within 15 working days, outlining the plan to address the violation and prevent future occurrences. Failure to comply may lead to regulatory actions,