US FDA issues two new e-cigarette PMTA regulatory science policy memoranda

US FDA issues two new e-cigarette PMTA regulatory science policy memoranda

The U.S. Food and Drug Administration (FDA) today issued two regulatory science policy memoranda on premarket tobacco product applications (PMTAs) for new e-cigarette products. The two memoranda are titled "Genotoxic Hazard Identification and Carcinogenicity Stratification of Ingredients in

Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (ENDS)" and "Calculating Excess Lifetime Cancer Risk in Premarket Tobacco Product Applications for ENDS". The information in the memoranda may change as policies, regulatory frameworks, or regulatory science change, and the memoranda are constantly updated.

On August 5, the U.S. Food and Drug Administration (FDA) issued two regulatory science policy memoranda on premarket tobacco product applications (PMTAs) for new e-cigarette products.

Both memoranda were issued on June 3 of this year and are titled "Genotoxic Hazard Identification and Carcinogenicity Stratification of Ingredients in Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (ENDS)" and "Calculating Excess Lifetime Cancer Risk in Premarket Tobacco Product Applications for ENDS"

Overall, these science policy memoranda provide an overview of the FDA's internal thinking on a topic at a specific point in time. The information in the memorandum may change as policies, regulatory frameworks, or regulatory science change, and the memorandum information is continuously updated.

The FDA's review of tobacco product applications is based on the specific facts in each application and is recorded in the specific review of each application. Therefore, the two memoranda released today should not be used as tools, guides, or manuals for preparing or submitting FDA applications.

For applicants who want to market new tobacco products, the FDA has issued final regulations, such as the PMTA final rule, which specifically describes the content, format, review procedures, and guidance documents required for PMTAs. In addition, the FDA regularly publishes more relevant resources, such as webinars and application tips, on the website and social media of its Center for Tobacco Products (CTP).

It is reported that in April this year, the FDA resumed publishing regulatory science policy memoranda and released them again in May. The latest memorandum released this time reflects CTP's consistent commitment to enhancing regulatory transparency.