Focus on Flavored E-Cigarette Review, Filing Prioritization, and Environmental Assessment Criteria
The U.S. Food and Drug Administration (FDA) has posted thirteen new regulatory science policy memos outlining key methodologies and criteria for the review of premarket tobacco product applications (PMTAs). These memos, developed between 2020 and 2023, provide insight into the agency’s approach to reviewing PMTAs, with particular focus on flavored e-cigarettes, filing prioritization, and environmental assessment requirements.
The newly released memos, spanning critical areas of tobacco product regulation, include:
- February 20, 2020: To Support the Efficient Filing Review of Premarket Tobacco Product Applications (PMTAs)
- June 30, 2021: Updated Prioritization of PMTA Filing Reviews (with an addendum from July 28, 2021)
- July 9, 2021: ENDS Containing Non-Tobacco Flavored E-Liquid: Approach to PMTAs Not in Substantive Scientific Review (Phase III) (plus five addendums from 2021–2023)
- July 16, 2020: Environmental Assessment Criteria to Support Refuse to Accept or Refuse to File Actions on Premarket Applications (with an addendum from May 27, 2021)
The memos also highlight filing prioritization criteria for PMTAs submitted between September 10, 2020, and November 3, 2021, ensuring that resources are directed efficiently toward high-priority applications.
In line with FDA’s commitment to transparency, these memos reflect the agency’s regulatory perspective at the time of issuance. FDA underscores that these documents are not intended as guidelines for application preparation but as snapshots of scientific policy and decision-making processes. Applicants are encouraged to refer to official regulations, including the PMTA final rule, and to consult FDA’s resources, such as guidance documents and webinars, for comprehensive information on submission requirements.
This marks the fourth batch of memos released in 2024, bringing the total number of regulatory science policy memos shared to 26. This initiative builds upon the December 2022 recommendations of an independent expert panel facilitated by the Reagan-Udall Foundation, aiming to enhance the transparency and efficiency of the Center for Tobacco Products (CTP).
The FDA invites stakeholders to explore the memos and other resources on its website for a deeper understanding of its regulatory science policies and processes.
For additional information and to view the memos, visit the FDA’s website.
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