D & C Beckley, Inc d/b/a Kickin’ Ash Vapors Warning Letter Details

Summary

D & C Beckley, Inc d/b/a Kickin' Ash Vapors manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization from the FDA. The company's e-liquid products, which are electronic nicotine delivery systems subject to FDA jurisdiction under the Family Smoking Prevention and Tobacco Control Act, were marketed as "new tobacco products" without the necessary marketing authorization orders. The Center for Tobacco Products determined that the company failed to comply with section 910 of the Federal Food, Drug, and Cosmetic Act, which requires premarket approval before distributing newly deemed tobacco products to consumers in the United States.