Moor Vapes USA Inc., d/b/a Aqua Glass Works Warning Letter Details

Summary

Moor Vapes USA Inc., d/b/a Aqua Glass Works was cited for selling electronic nicotine delivery system (ENDS) products without required premarket authorization under the Family Smoking Prevention and Tobacco Control Act. The company's vaping products, which contain nicotine from any source, are subject to FDA jurisdiction as tobacco products and must comply with Federal Food, Drug, and Cosmetic Act requirements, including obtaining a premarket authorization order before legally marketing "new tobacco products" in the United States. The FDA's inspection determined the company was distributing these products without the mandatory premarket approval required for tobacco products that were not commercially marketed in the U.S. prior to February 15, 2007.