FDA WARNING_LETTER - Liquivape - February 02, 2023

On February 2, 2023, the FDA issued a Warning Letter to Liquivape, identifying violations related to the manufacturing and distribution of e-liquid products. The FDA determined that Liquivape's e-liquid products, specifically "Gummi Bearz e-liquid products," are tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The primary violation is that these products are "new tobacco products" as they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required notices or information under section 905(j) were not provided.

The FDA states that marketing these products without authorization is unlawful and a prohibited act under sections 301(k) and 301(p) of the FD&C Act. Liquivape is required to submit a written response within 15 working days detailing actions taken to address these violations, including discontinuing sales and distribution of the non-compliant products, and outlining a plan for maintaining compliance. Failure