FDA WARNING_LETTER - wise vice llc - August 17, 2023

On August 17, 2023, the FDA issued a Warning Letter to Wise Vice LLC d/b/a Wise Vice Vapors, following a review of inspection records. The FDA determined that Wise Vice LLC manufactures and distributes e-liquid products, including "Aloha," which are considered tobacco products under section 201(rr) of the FD&C Act, as they contain nicotine and are intended for human consumption.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. "Aloha" and other e-liquid products were found to be new tobacco products because they were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders or exemptions. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required notice or information was not provided per section 905(j).

The FDA cited prohibited acts under section 301(k) for holding for sale adulterated or misbranded products, and section 301(p) for failing to provide required reports. Wise Vice LLC 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 a plan for maintaining