Toro Imports, LLC Warning Letter Details

Summary

Toro Imports, LLC was warned for importing, selling, and distributing electronic nicotine delivery system (ENDS) products without required FDA premarket authorization. The company's ENDS products, which contain nicotine and fall under FDA tobacco product jurisdiction, were not in compliance with Federal Food, Drug, and Cosmetic Act requirements, particularly the mandate that "new tobacco products" obtain marketing authorization orders before being legally sold in the United States. The FDA's Center for Tobacco Products determined that the company's products were subject to FDA oversight under expanded tobacco product definitions that include any products containing nicotine from any source, effective April 14, 2022.