JVS Vapor Inc d/b/a Jacks Vapor Warning Letter Details

Summary

JVS Vapor Inc d/b/a Jacks Vapor manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization from the FDA, violating the Family Smoking Prevention and Tobacco Control Act. The company's e-liquid products, which fall under FDA jurisdiction as electronic nicotine delivery systems, were deemed tobacco products subject to FDA regulation as of August 8, 2016, but lacked the necessary "new tobacco product" premarket authorization required under section 910 of the Federal Food, Drug, and Cosmetic Act.