Vaping Xtreme, LLC – FDA Warning Letter, Feb 12, 2021

The FDA issued a Warning Letter to Mark Goddard, operating VapingXtreme.com, on February 12, 2021, for manufacturing and selling unapproved new tobacco products. The FDA's review of VapingXtreme.com identified e-liquid products, specifically "Xtreme Juice Arctic Bay" and "Xtreme Juice Iceberg," as tobacco products under the FD&C Act.

These products are considered "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket authorization order from the FDA under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these e-liquids are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as no notice or information was provided per section 905(j).

The letter emphasizes the firm's responsibility, as a registered manufacturer with over 2,200 listed products, to ensure compliance with all applicable FD&C Act provisions and FDA regulations (21 C.F.R. Parts 1140, 1141, and 1143). Failure to correct these violations may result in regulatory actions, including civil money penalties, seizure, and/or