FDA deadlines guidance

| May 11, 2017

The US Food and Drug Administration has issued its guidance on the Three-Month Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule. The extension applies only to dates set for May 10 or later.

In a press note, the FDA’s Center for Tobacco Products said the extension was first communicated in legal filings in federal court on May 1, and was then shared with stakeholders. It was announced also that the FDA intended to issue the latest guidance document.

‘As announced, and under the guidance being released today, all provisions with compliance dates that have already occurred – such as mandatory age and photo-ID checks to prevent illegal sales to minors – will remain in effect,’ the note said. ‘The FDA will continue to enforce such requirements.

‘For all future compliance dates related to the final deeming rule, the FDA is deferring its enforcement for an additional three months. Provisions for which this extension will apply include, but are not limited to:

  • Submission of cigar rotational warning plans
  • Registration and listing
  • Ingredient listing
  • Health documents
  • Substantial Equivalence (SE) exemption requests
  • Substantial Equivalence (SE) applications
  • Premarket tobacco product applications (PMTAs)
  • Harmful and potentially harmful constituent (HPHC) reports.’

The guidance is at https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm557714.htm?source=govdelivery&utm_campaign=ctp-compliancedeadlines&utm_content=guidance&utm_medium=email&utm_source=govdelivery.

Tags:

Category: Breaking News, Regulation

Comments are closed.