On November 21, the U.S. Food and Drug Administration (FDA) issued other regulatory science policy memoranda related to the review of premarket applications. This memorandum includes thirteen memoranda developed between 2020 and 2023, which describe the process and priority approach used for filing and reviewing flavored vapes and other PMTAs, as well as the basis for supporting specific actions related to environmental assessments.
The memorandums include:
- February 20, 2020: Supporting Efficient Review of Premarket Tobacco Product Applications (PMTAs)
- June 30, 2021: Updated Priorities for Review of PMTA Applications (and Addendum dated July 28, 2021)
- January 21, 2022: Prioritization of PMTA Applications Received Between September 10, 2020 and November 3, 2021 (and Addendum dated February 28, 2022)
- July 9, 2021: vapes with Non-Tobacco Flavored Liquids: Approach for PMTAs Not Entering Substantive Scientific Review (Phase III) (and Addendums dated July 28, 2021, August 18, 2021, November 22, 2022, December 7, 2022, and 2023) Five Addenda from April 27)
- July 16, 2020: Environmental Assessment Criteria to Support Denial of Acceptance or Refusal of Prosecution of Premarket Applications (and Addenda from May 27, 2021)
FDA states that science policy memoranda provide a snapshot of the Center’s thinking on a particular topic at a point in time. Therefore, the information contained in the memorandum is subject to change, for example, in response to changes in policy, regulatory framework, or regulatory science.
FDA’s review of tobacco product applications is based on the specific facts provided in each application and documented in the specific review of each application.
FDA emphasizes that the memorandums published should not be used as tools, guides, or manuals for preparing applications or submitting documents to FDA.
For applicants seeking to market new tobacco products, FDA has published final regulations, such as the PMTA Final Rule, which describe the required content, format, and review process for PMTAs, as well as guidance documents. FDA also periodically publishes additional resources, such as webinars and application tips, on the CTP’s website and social media.
In April, FDA resumed publishing regulatory science policy memoranda. This is the fourth batch of memoranda issued in 2024, and including the memoranda issued today, the FDA has issued a total of 26 memoranda.
In the latest news, the U.S. Food and Drug Administration (FDA) issued 13 regulatory science policy memoranda focusing on the review approach for flavored vapes. This move has attracted widespread attention in the vape industry, and Veehoo, as a company committed to providing safe and healthy vape products, will also be affected.
As a company actively involved in the development of the vape industry, Veehoo is closely following these regulatory policy changes. The FDA emphasizes that the memorandum provides a snapshot of the views on a specific topic at a specific point in time, so the information may change. For applicants seeking to sell new tobacco products, the FDA has issued final regulations, such as the PMTA final rule, describing the required content, format, and review procedures.
As the FDA continues to issue regulatory science policy memoranda, including the 13 memoranda released this time, Veehoo and other vape companies will face a changing regulatory environment. By actively adapting and complying with regulatory policies, Veehoo has the opportunity to set an example in the industry, provide consumers with more reliable vape products, and promote the sustainable development of the industry.
Tags: US FDA Regulatory Science Policy，US FDA focuses on flavored vape review，veehoo vape
