On November 21st, U.S. Food and Drug Administration (FDA) released additional regulatory science policy memos concerning its review of premarket applications. These memos aim to provide clarity on the agency’s methods and processes for evaluating applications.
The release includes thirteen memos developed between 2020 and 2023 and details FDA's approach to filing and reviewing PMTAs for flavored e-cigarettes and other products, including the criteria for prioritization. The memos also outline the agency's rationale for actions related to environmental assessments.
The memos posted today include:
- Feb. 20, 2020: To Support the Efficient Filing Review of Premarket Tobacco Product Applications (PMTAs)
- June 30, 2021: Updated Prioritization of PMTA Filing Reviews (includes an addendum from July 28, 2021)
- Jan. 21, 2022: Filing Prioritization for PMTAs Received between Sep. 10, 2020, to Nov. 3, 2021 (with an addendum from Feb. 28, 2022)
- July 9, 2021: ENDS Containing Non-Tobacco Flavored E-Liquid: Approach to PMTAs Not in Substantive Scientific Review (Phase III) (and five addendums from July 28, 2021, Aug. 18, 2021, Nov. 22, 2022, Dec. 7, 2022, and April 27, 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)
FDA notes that these science policy memos provide snapshots of its perspectives at specific times. Consequently, the information may evolve with changes in policies, regulatory frameworks, or regulatory science.
FDA reviews tobacco product applications based on the specific facts provided in each submission, with findings documented accordingly. As such, the regulatory science policy memos are not intended to serve as tools, guides, or manuals for preparing or submitting applications to FDA.
To support applicants seeking to market new tobacco products, FDA has issued final regulations, including the PMTA final rule. This rule specifies the required content, format, and review procedures for PMTAs and is supplemented by additional guidance documents. FDA also offers resources such as webinars and application tips, which are regularly updated on the CTP's website and social media platforms.
In April 2024, FDA resumed the publication of regulatory science policy memos. With the latest batch released today, the agency has published four sets of memos this year, totaling 26 memos in 2024.
