Today, FDA announced in the Federal Register a proposed rule entitled “Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses.” This proposed rule describes the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This action is intended to provide direction to regulated industry and to help avoid consumer confusion.

The proposed rule was developed in accordance with regulatory guidance and will be available for comment starting tomorrow, Friday, September 25, 2015, until Tuesday, November 24, 2015.