FDA WARNING_LETTER - wise vice llc - August 03, 2023

The FDA issued a Warning Letter to Wise Vice LLC d/b/a Wise Vice Vapors on August 3, 2023, following a review of inspection records. The company manufactures and distributes e-liquid products, which are classified as tobacco products under the FD&C Act, including those containing nicotine from any source.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the e-liquid product "Aloha" was found to be a new tobacco product, as it was not commercially marketed in the U.S. as of February 15, 2007, and lacks FDA marketing authorization. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required notice or information under section 905(j).

These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act. The FDA has not received a marketing authorization application from Wise Vice LLC for the listed products. The letter warns that failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction. Wise Vice LLC must submit a written response within 15 working days detailing corrective actions, including discontinuation of violative sales and a plan for future compliance.