FDA WARNING_LETTER - Vapor City Plus, LLC - February 26, 2021

The FDA Center for Tobacco Products issued a Warning Letter to Gene Crane regarding e-liquids sold on https://vaporcityplus.com. The FDA determined that e-liquids, including "Vapor City Plus Alien Sauce" and "Vapor City Plus Banana Cream Pie," are tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The primary violation is the marketing of "new tobacco products" without required premarket authorization. A "new tobacco product" is defined as any tobacco product not commercially marketed in the U.S. as of February 15, 2007, or any modified product marketed after this date. The listed e-liquids were not commercially marketed by the specified date and lack an FDA marketing authorization order, making them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The letter emphasizes the firm's responsibility, as a registered manufacturer with over 2,400 listed products, to ensure compliance with the FD&C Act and FDA regulations (21 C.F.R. Parts 1140, 1141, and 1143). Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction. The firm must submit a written response within 15 working