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FDA Posts Additional Regulatory Science Policy Memos

May 14, 2024

Today, FDA posted additional regulatory science policy memos focused on internal roles, responsibilities, and processes related to premarket tobacco product application (PMTA) review. 

This release includes five memos, developed between 2020 and 2022. The memos describe the internal roles and responsibilities for the review of scientific disciplines and marketing information. One of the memos also discusses FDA’s approach to Acceptance and Filing Review at the time it was developed, including discussion of the prioritization of certain applications received for non-tobacco nicotine products as of November 4, 2021.

The five memos released today are:

  • August 3, 2020: Guidelines for Office of Health Communication and Education Consult for Marketing Plan Review and Evaluation
  • March 04, 2021: Clarification of PMTA Review Responsibilities Regarding Harmful and Potentially Harmful Constituent (HPHC) Aerosol and Smoke Yields and Clinical Biomarkers of Exposure (BOE)Data Among Division of Individual Health Science (DIHS), Division of Product Science (DPS), and Division of Nonclinical Science (DNCS)
  • March 30, 2022: Clarification of PMTA Review Responsibilities between Division of Population Health Science and Division of Individual Health Science
  • May 2, 2022: Addendum to Guidelines for Office of Health Communication and Education Consult for PMTA Marketing Information Review and Evaluation
  • June 01, 2022: Process for implementing new Acceptance and Filing Reviews for PMTAs based on new requirements under 21 CFR 1114

In general, the science policy memos provide a snapshot of the center’s internal thinking 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.  

Last month, FDA resumed the posting of regulatory science policy memos with the release of six memos on the premarket review process. The release of these memos is consistent with commitments made by CTP to post scientific policy memos and reviewer guides as appropriate, and reflects the center’s commitment to enhance transparency consistent with the Reagan-Udall Foundation’s (RUF) operational evaluation of CTP.

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