In a Federal Register Notice to be published on March 20, 2017 the Food and Drug Administration (FDA) will announce a delayed effective date to a previously issued federal register notice regarding “Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ‘Intended Uses.’”

FDA made the decision to delay the effective date due to a petition received from the trade and affected parties, who issued questions regarding amendments contained in the regulation, in particular, concerning “intended uses”. The FDA is seeking public comments concerning, “the important substantive issues raised by the petition and to allow additional time to fully evaluate these issues and any other issues raised in response to this request for comments.”

The revised effective date will be March 19, 2018. Public comments will be received for 60 days after publication in the Federal Register.

The notice can be accessed at:

https://s3.amazonaws.com/public-inspection.federalregister.gov/2017-05526.pdf