On January 9, 2017, the U.S. Food and Drug Administration (FDA) published in the Federal Register a final rule [Docket No. FDA–2015–N–2002] to describe 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.

This rule is effective February 8, 2017.