FDA Issues Final Guidance on Analytical Testing for Industry Use in Tobacco Product Applications

January 6, 2025

Today, FDA issued “Validation and Verification of Analytical Testing Methods Used for Tobacco Products,” a final guidance providing tobacco manufacturers with information and recommendations to aid tobacco product application submissions. The guidance explains how manufacturers can provide FDA with validated and verified data for the analytical procedures and test methods used in application submissions to the agency – including premarket tobacco product applications, substantial equivalence reports, and modified risk tobacco product applications.

To legally market a new tobacco product or a modified risk tobacco product in the United States, a company must first submit an application to – and receive authorization from – the FDA. These applications often have data and information supporting the analytical methods used for the testing of tobacco products, and this guidance is intended to help manufacturers and laboratories assemble and present scientifically valid information.

The principles described in the guidance may also be useful for the reporting of harmful and potentially harmful constituents in tobacco products, which is required of tobacco product manufacturers and importers.

A draft version of this guidance was previously issued in 2021, at which time the public was given the opportunity to comment on the content. FDA considered comments, and changes from the draft to the final guidance include updating the definition of “tobacco product” to include non-tobacco nicotine, revising to reflect provisions from the final PMTA and SE rules, and updating and adding definitions to several terms. The final guidance also includes updated examples for alternative validation approaches.

The recommendations are non-binding and do not establish legally enforceable responsibilities. Additionally, FDA acknowledges there are other validation procedures that may differ from the recommendations in this guidance. For example, there may be alternative approaches to matters such as statistical tests. 

For applicants seeking to market new tobacco products, FDA remains committed to providing information and resources, including this latest guidance. FDA has issued final regulations, such as the PMTA final rule, and regularly posts additional resources, such as application tips and webinars, on its website and social media.