MR FOG d/b/a MR FOG Officials Warning Letter Details

Summary

MR FOG Officials was cited for offering electronic nicotine delivery system (ENDS) products for sale in the United States without required premarket authorization, in violation of the Federal Food, Drug, and Cosmetic Act. The company's website listed nicotine-containing tobacco products that lacked the necessary premarket approval required for "new tobacco products" under FDA regulations. The violation encompasses both traditional tobacco-derived nicotine products and those containing nicotine from non-tobacco sources, which fall under FDA's expanded jurisdiction effective April 14, 2022.