The Food and Drug Administration (FDA) held a one-day public hearing on December 17th to seek input on FDA’s consideration of applicable approval mechanisms and additional indications for nicotine replacement therapies (NRTs), and on a report to Congress examining the regulation and development of innovative products and treatments for tobacco dependence. The questions are related to the implementation of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act).