Key Points
- FDA identified product characterization as the foundational basis for ENDS PMTA review and APPH determinations.
- PMTA submissions must include complete product information and product-specific validation or verification of test methods.
- FDA highlighted the role of tobacco product master files (TPMFs) in supporting complex or proprietary ingredients and related testing procedures.
2Firsts, February 10, 2026
U.S. Food and Drug Administration (FDA) officials on Monday emphasized that product characterization is a foundational and critical element of premarket tobacco product application (PMTA) reviews, as the agency continues its roundtable discussion with small manufacturers of electronic nicotine delivery systems (ENDS).
Speaking during a session that has just concluded at the FDA’s PMTA roundtable, Matthew Walters, PhD, MPH, Deputy Director of the Division of Product Science in the Office of Science at FDA’s Center for Tobacco Products (CTP), said that a clear understanding of a product’s physical characteristics is the first step in determining whether a product meets the statutory standard of being appropriate for the protection of public health.
According to key points presented during the session, FDA expects PMTA submissions to include complete product identifying information, such as ingredients, harmful and potentially harmful constituents (HPHCs), design specifications, and product shelf life, to allow regulators to fully understand a product’s physical properties.
FDA also underscored that all test methods used to support a PMTA are expected to be validated and/or verified on the specific product type intended for authorization, rather than relying solely on generalized or non-product-specific data.
For products involving complex or proprietary components, FDA reiterated the usefulness of tobacco product master files (TPMFs), particularly for product characterization related to proprietary ingredients, such as flavor formulations, as well as for validation and verification procedures for analytical and microbiological test methods.
In addition, FDA encouraged applicants to clearly explain the “story” of their product in PMTA submissions, enabling reviewers to understand the complete composition, design, and physical characteristics of the product rather than assessing isolated data points.
The roundtable, which is limited to manufacturers with fewer than 350 employees, is being held in a hybrid format and remains ongoing. FDA has indicated that a transcript and recording of the meeting will be made available to the public after the discussion concludes.
2Firsts will continue to follow the meeting and provide the latest updates.
