FDA WARNING_LETTER - Singing Hawk LLC d/b/a Sin City Vapor III - September 01, 2022

The FDA issued a Warning Letter to Singing Hawk LLC d/b/a Sin City Vapor III on September 1, 2022, following a review of submissions and inspection records. The company manufactures and distributes e-liquid products, including "Hazelnut Heaven," which are classified as tobacco products under the FD&C Act, as amended to include nicotine from any source.

The primary violation is the marketing of "Hazelnut Heaven" e-liquid products as "new tobacco products" without the required premarket authorization order from the FDA. These products were not commercially marketed in the U.S. as of February 15, 2007, and lack the necessary marketing authorization or exemption. This renders the products adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The failure to provide a required report under section 905(j) is also a prohibited act under section 301(p).

The FDA requires Singing Hawk LLC to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing the sale and distribution of non-compliant products and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.