Loading…
Smart Toothpicks LLC manufactured and distributed nicotine toothpick products without required premarket authorization, in violation of the Federal Food, Drug, and Cosmetic Act. The Center for Tobacco Products determined that these products qualify as tobacco products subject to FDA jurisdiction under section 901(b) of the FD&C Act, particularly following the March 2022 expansion of FDA authority to cover products containing nicotine from any source, not just tobacco-derived nicotine. The company failed to obtain the legally required marketing authorization order before selling these "new tobacco products" in the United States.