Singing Hawk LLC d/b/a Sin City Vapor – FDA Warning Letter, Sep 8, 2022

On September 8, 2022, the FDA issued a Warning Letter to Singing Hawk LLC d/b/a Sin City Vapor for manufacturing and distributing e-liquid products, specifically "BrushFire e-liquid products," without required marketing authorization. These products are considered "new tobacco products" under section 201(rr) of the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007, and contain nicotine.

The FDA determined that these products are adulterated under section 902(6)(A) of the FD&C Act because they lack the necessary marketing authorization order under section 910(c)(1)(A)(i) and are not otherwise exempt. Furthermore, they are misbranded under section 903(a)(6) of the FD&C Act due to the failure to provide 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 letter requires a written response within 15 working days detailing actions taken to address the violations, including dates of discontinued sale/distribution and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.