E-Vaperz Spring Hill Location LLC Warning Letter Details

Summary

E-Vaperz Spring Hill Location LLC 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, classified as newly deemed tobacco products subject to FDA jurisdiction as of August 8, 2016, lacked the required marketing authorization order under section 910 of the Federal Food, Drug, and Cosmetic Act that applies to new tobacco products not commercially marketed before February 15, 2007.