Singing Hawk LLC d/b/a Sin City Vapor III

Warning LetterOpen

Thomas Harmon Owner Singing Hawk LLC d/b/a Sin City Vapor III 90 South Stephanie Street, Suite 160 Henderson , NV 89012 United States info@sincityvapor.comFEI 3019874580Issued Sep 1, 2022Center for Tobacco Products

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3019874580.

Violations1

Issue DateSep 1, 2022

Product TypeTobacco

StatusOpen

Letter Details

Firm: Singing Hawk LLC d/b/a Sin City Vapor III
Location: Thomas Harmon Owner Singing Hawk LLC d/b/a Sin City Vapor III 90 South Stephanie Street, Suite 160 Henderson , NV 89012 United States info@sincityvapor.com
FEI Number: 3019874580
Country: United States
Issue Date: September 01, 2022
Issuing Office: Center for Tobacco Products
Product Type: Tobacco
Status: Open

Summary

Singing Hawk LLC d/b/a Sin City Vapor III, a Nevada-based e-liquid manufacturer, was warned that its nicotine-containing vaping products constitute tobacco products under FDA jurisdiction and require premarket authorization to be legally marketed in the United States. The company had manufactured and distributed e-liquid products without obtaining required premarket authorization orders, violating the Federal Food, Drug, and Cosmetic Act's new tobacco product requirements. The warning came following FDA review of the company's submissions and inspection records, and notably referenced the March 2022 legislative expansion of FDA's tobacco product definition to include products containing nicotine from any source, not just tobacco-derived nicotine.

Singing Hawk LLC d/b/a Sin City Vapor III FDA Warning Letter, September 1, 2022