FDA WARNING_LETTER - Vapes Gone Wild Juice, LLC - February 12, 2021

On February 12, 2021, the FDA issued a Warning Letter to Trent Struck regarding e-liquid products sold on vapesgonewild.com. The FDA determined that products like "Vapes Gone Wild Leprechaun Juice" and "Vapes Gone Wild Sour Rainbow" are tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The key violation is that these e-liquid 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 because the required notice or information under section 905(j) was not provided.

The FDA requires a written response within 15 working days detailing actions taken to address the violations, including discontinuing the sale and distribution of the non-compliant products and a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.