FuZion Vapor LLC – FDA Warning Letter, Apr 20, 2023

On April 20, 2023, the FDA issued a Warning Letter to Fuzion Vapor LLC, identifying violations related to the manufacture and distribution of e-liquid products. The FDA determined that Fuzion Vapor LLC's e-liquid products, specifically "FUZION VAPOR RED SKY," are "new tobacco products" under section 201(rr) of the FD&C Act because they contain nicotine and were not commercially marketed in the U.S. as of February 15, 2007.

The primary violation is that these products are being marketed without the required premarket authorization from the FDA, as mandated by section 910(a) of the FD&C Act. Consequently, the products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, due to the lack of required notice or information under section 905(j). The failure to provide such a report is also a prohibited act under section 301(p).

The FDA requires Fuzion Vapor LLC to submit 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 outlining a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure,