In the Federal Register of January 9, 2017 (82 FR 2193), the Food and Drug Administration (FDA) issued a final 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 final rule creates a new regulation that 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 (FD&C Act).  The final rule also amended FDA’s existing regulations describing the types of evidence that may be considered in determining a medical product’s intended uses (21 CFR 201.128 (drugs) and 21 CFR 801.4 (devices)).  FDA subsequently delayed the rule from going into effect until March 19, 2018, and re-opened the docket to invite additional public comment due to concerns from stakeholders with the discrete intended use part of the rule. In March 2018, we delayed the effective date of the intended use amendments until further notice, to allow for further consideration of the substantive issues raised in the comments received.

FDA is seeking to amend the Agency’s existing regulations describing the types of evidence that may be considered in determining a medical product’s intended uses (see 21 CFR 201.128 (drugs) and 21 CFR 801.4 (devices)). To provide clarity to regulated industry, FDA is seeking to clarify the definition of intended use.