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FDA Resumes Posting Regulatory Science Policy Memos on Premarket Review Process

Newly released memos focus on toxicology and chemistry related considerations.

April 2, 2024

Today, FDA is releasing several scientific review policy memoranda that provide a snapshot of FDA’s internal thinking on certain topics within the premarket tobacco review process. This action is consistent with commitments made by CTP to post scientific policy memos and reviewer guides, as appropriate, in response to the 2022 Reagan-Udall Foundation’s operational evaluation of the center. 

“We’ve heard loud and clear from stakeholders that opportunities exist to enhance the center’s transparency,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products. “Consistent with our commitment to do so, FDA is making previously internal memos available to the public to provide further clarity on the premarket review process. We intend to continue posting batches of memos like these on a rolling basis, as appropriate, moving forward." 

The memos provide additional transparency regarding the considerations that different regulatory science disciplines take into account when reviewing a tobacco product application. These are the first of several sets of memos that FDA plans to release as part of these resumed postings. This release includes six memos, developed between 2019 and 2023, covering topics pertaining to chemistry and toxicology within the tobacco product application program and review processes.   

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.  

The memos being released today are the following:

Chemistry

  • Considerations for Tobacco Specific Nitrosamines (TSNAs) In Cigar Filler, Wrapper and Binder, and Mainstream Smoke During Premarket Application Product Review
  • E-liquid Manufacturing Evaluation Responsibilities of Chemistry in the PMTA and MRTPA Review Program
  • Recommended Approaches for Reviewing Nicotine Dissolution Profile Differences for Smokeless Tobacco Products and Other Orally Placed Tobacco Products in Pre-Market Tobacco Applications
  • Approaches to the Evaluation of Extractables and Leachables in Tobacco Product Application Review

Toxicology

  • Normalization of HPHC Yields Between New and Comparison Products in ENDS PMTAs
  • Use of Reference Values in the Toxicological Evaluation of Inhaled Tobacco Products

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 premarket tobacco product application (PMTA) final rule that describes the required content, format, and review procedures of 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.  

The release of these memos is an action step to respond to Recommendation #6 of the Reagan-Udall Foundation’s operational evaluation of CTP. Visit the FDA website to read more about actions that FDA is and has been taking in response to the RUF evaluations, and to read these newly posted memos.

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