21 Century Smoking, Inc. Warning Letter Details

Summary

21 Century Smoking, Inc. was warned for manufacturing and selling e-liquid tobacco products without required premarket authorization. The FDA determined that e-liquids sold through the company's website are deemed tobacco products subject to FDA jurisdiction under the Family Smoking Prevention and Tobacco Control Act, and as "new tobacco products" not commercially marketed before February 15, 2007, they require premarket approval orders to be legally marketed in the United States. The company was found to be in violation of the Federal Food, Drug, and Cosmetic Act for offering these products for sale and distribution without obtaining the necessary marketing authorization.