August 5, 2024
The U.S. Food and Drug Administration (FDA) announced the release of two significant regulatory science policy memos. These memos pertain to the agency’s evaluation of premarket tobacco product applications (PMTAs) for new e-cigarette products. The documents, dated June 3, 2024, cover the following topics:
- Genotoxicity Hazard Identification and Carcinogenicity Tiering of Constituents in ENDS Premarket Tobacco Product Applications
- Calculating Excess Lifetime Cancer Risk in ENDS Premarket Tobacco Product Applications
These memos offer insights into the FDA’s current perspectives on these specific issues. However, the information is subject to change as policies, regulatory frameworks, and scientific understanding evolve.
The FDA’s assessment process for tobacco product applications is tailored to the unique facts of each submission. Consequently, these memos should not be construed as definitive guides for preparing applications or submissions to the agency. Instead, they reflect the FDA’s internal considerations at a particular time.
For those planning to introduce new tobacco products to the market, the FDA has established final regulations. These include the PMTA final rule, which outlines the essential content, format, and review procedures for PMTAs. Additionally, the FDA provides guidance documents that further detail the expectations and requirements for these applications.
To support applicants, the FDA regularly updates its resources, including webinars and application tips. These materials are accessible on the Center for Tobacco Products (CTP) website and through their social media channels.
