FDA WARNING_LETTER - Toe Toe Inc d/b/a Juana Vape - November 09, 2023

On November 9, 2023, the FDA issued a Warning Letter to Toe Toe Inc d/b/a Juana Vape, following a review of inspection records. The FDA determined that the company manufactures and distributes e-liquid products, including "Peppermint," which are considered tobacco products under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. The FDA states that "Peppermint" e-liquid was not commercially marketed in the U.S. as of February 15, 2007, and lacks FDA marketing authorization 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 absence of required premarket notification (section 905(j)).

The letter emphasizes that marketing such products is a prohibited act under sections 301(k) and 301(p) of the FD&C Act. Toe Toe Inc is required to submit a written response within 15 working days, detailing actions taken to address violations, including discontinuing sales and distribution of non-compliant products, and outlining a plan for future compliance. Failure to comply may result in regulatory actions such