On August 5th, the U.S. Food and Drug Administration (FDA) released two regulatory science policy memoranda regarding Pre-Market Tobacco Product Applications (PMTAs) for new e-cigarette products.
Two memorandums were published on June 3rd of this year, titled "Genotoxicity hazard identification and carcinogenicity stratification of components in tobacco products intended for sale of electronic nicotine delivery systems (ENDS)" and "Calculation of excessive lifetime cancer risk in tobacco products intended for sale of ENDS
Overall, these scientific policy memoranda provide an internal overview of the FDA's thoughts on a specific topic at a particular point in time. As policies, regulatory frameworks, or the science of regulation evolve, the information in the memoranda may change, and the memoranda are continuously being updated.
The FDA's review of tobacco product applications is based on specific facts within each application and documented in each application's specific review. Therefore, the two memos released today should not be used as tools, guides, or manuals for preparing or submitting applications to the FDA.
For applicants seeking approval for new tobacco products in the market, the FDA has released final regulations, such as the PMTA final rule, which specifically describes the content, format, review process and guidance documents required for PMTAs. Additionally, the FDA regularly posts more related resources on its website and social media platforms in its Center for Tobacco Products (CTP), such as webinars and application tips.
It has been reported that in April of this year, the FDA resumed issuing regulatory science policy memoranda, and released another in May. The latest memorandum reflects CTP's commitment to enhancing regulatory transparency.
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