FDA's CTP Regulation of Tobacco Products: Premarket Review
The Family Smoking Prevention and Tobacco Control Act (TCA) requires manufacturers of all new tobacco products to submit an application to the Food and Drug Administration’s Center for Tobacco Products (CTP) for premarket review to prove that the sale of their product is “appropriate for the protection of public health” prior to going on to the market. This is one of the most important provisions of the TCA, and was intended to prevent new, harmful tobacco products from ever being sold. Unfortunately, the premarket review of all new tobacco products has never taken full effect due to lack of enforcement by the agency, the tobacco industry continuing to sell new products without CTP authorization and implementation disruptions.