Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”; Partial Delay of Effective Date

The Food and Drug Administration (FDA, the Agency, or we) is issuing this final rule to delay the effective date of amendments to the existing medical product "intended use" regulations, contained in the final rule published January 9, 2017, until further notice. This final rule delays the effective date of the amendments to allow further consideration of the substantive issues raised in the comments received regarding the amendments. This action does not delay the effective date of the portions of the January 9, 2017, final rule that 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 (FD&C Act), which remains March 19, 2018.