Cavalry Industries d/b/a Select Vape Warning Letter Details

Summary

Cavalry Industries d/b/a Select Vape was cited for offering electronic nicotine delivery system (ENDS) products for sale without required premarket authorization, violating the Federal Food, Drug, and Cosmetic Act. The company failed to comply with FDA tobacco product regulations applicable to ENDS products containing nicotine from any source, which fall under FDA jurisdiction as of the March 2022 legislative amendment expanding tobacco product definitions. The FDA determined through review of the company's website that these products were being distributed in the United States without the legally mandated premarket authorization order required for new tobacco products.