Walker Enterprises, LLC d/b/a MaddCatt Vapor Warning Letter Details

Summary

Walker Enterprises, LLC d/b/a MaddCatt Vapor manufactured and distributed e-liquid tobacco products containing nicotine that lacked required premarket authorization orders for new tobacco products as mandated by the Federal Food, Drug, and Cosmetic Act. The company's e-liquid products, which fall under FDA's Center for Tobacco Products jurisdiction—including those containing nicotine from non-tobacco sources under 2022 legislation—were not in compliance with FDA requirements for legally marketing new tobacco products in the United States.