FDA WARNING_LETTER - VaVaVape - March 02, 2023

The FDA issued a Warning Letter to VaVaVape on March 2, 2023, following a review of submissions and inspection records. The FDA determined that VaVaVape manufactures and distributes e-liquid products, specifically "Strawberry Fields e-liquid products," for commercial distribution in the United States. These products are classified as tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. The "Strawberry Fields e-liquid products" were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders or exemptions. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The failure to provide a required report under section 905(j) is also cited as a prohibited act.

VaVaVape is required to submit a written response within 15 working days detailing actions taken to address the violations, including dates of discontinued sales/distribution and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.