U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Tobacco Products
  3. CTP Newsroom
  4. FDA Posts Regulatory Science Policy Memos Related to the Agency’s Review of Premarket Applications
  1. CTP Newsroom

FDA Posts Regulatory Science Policy Memos Related to the Agency’s Review of Premarket Applications

Memos focus on premarket application review prioritization, flavored e-cigarette review, and environmental assessment criteria.

November 21, 2024

Today, FDA posted additional regulatory science policy memos related to the agency’s review of premarket applications. This release includes thirteen memos developed between 2020 and 2023 that describe the process and prioritization methods used to conduct filing and review of PMTAs for flavored e-cigarettes and other PMTAs, as well as the bases to support specific 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 (and an addendum from July 28, 2021)
  • Jan. 21, 2022: Filing Prioritization for PMTAs Received between Sep. 10, 2020, to Nov. 3, 2021 (and 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 (and an addendum from May 27, 2021)

In general, the science policy memos provide a snapshot of the center’s perspective on a specific topic at a certain point in time. Therefore, the information contained in the memos is subject to change, for example, based on changes in policy, the regulatory framework, or regulatory science.

FDA’s review of tobacco product applications is based on the specific facts presented in each application and is documented in reviews particular to each application. The memos posted today should not be used as a tool, guide, or manual for the preparation of applications or submissions to FDA. For applicants seeking to market new tobacco products, FDA has issued final regulations, such as the PMTA final rule that describes the required content, format, and review procedures for PMTAs, as well as guidance documents. FDA also regularly posts additional resources, such as webinars and application tips, on CTP’s website and social media.

In April, FDA resumed the posting of regulatory science policy memos. This is now the fourth batch of released memos in 2024, and including those posted today, FDA has released a total of 26 memos. The release of these latest memos reflects the center’s commitment to enhance transparency consistent with the December 2022 evaluation of the center by an independent expert panel facilitated by the Reagan-Udall Foundation. Visit the FDA website to read more about FDA’s actions in response to the evaluation.

Back to Top