FDA WARNING_LETTER - Singing Hawk LLC d/b/a Sin City Vapor III - January 12, 2022

On January 12, 2022, the FDA issued a Warning Letter to Singing Hawk LLC d/b/a Sin City Vapor II, identifying violations related to the manufacture and distribution of e-liquid products. The FDA determined that e-liquid products, including "Sin City Vapor Brushfire 3mg 30ml," "Sin City Vapor Pimpin Pineapple 9mg 30ml," and "Sin City Vapor Berry Cakes 18mg 30ml," are "new tobacco products" under the FD&C Act.

These products were found to be adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007, and lacked the required FDA marketing authorization order under section 910(c)(1)(A)(i). The firm's Premarket Tobacco Product Application (PMTA), STN PM0003455, submitted on September 8, 2020, received a Marketing Denial Order on September 16, 2021, covering 717 products.

The FDA emphasized that marketing new tobacco products without premarket authorization is unlawful and subject to enforcement. The letter requires a written response within 15 working days detailing corrective actions, including dates