FDA Delays for 1 Year Intended Use Final Rule

Federal Register Notice: FDA has delayed until 3/19/2018 the effective date of its final rule on “Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ‘Intended Uses,’” which published on 1/9. FDA has received a petition (see story) from industry that questions the agency’s unexpected decision to revise the definitions of “intended use” to include a new “totality of the evidence” standard that they contend was not communicated to the public prior to publication, depriving stakeholders of fair notice and an opportunity to be heard in violation of the Administrative Procedure Act. FDA’s new notice invites public comment on the important substantive issues raised by the petition and provides additional time to fully evaluate these issues and any other issues raised in response to this request for comments. To view the notice, click here.