FDA issues final guidance on testing for industrial use in tobacco product applications

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The Food and Drug Administration released a tobacco industry guide on Monday titled Validation and verification of analytical test methods for tobacco products.

This is a definitive guide that provides tobacco manufacturers with information and recommendations to assist with application submission, the agency says on its website.

The guidance explains how manufacturers can provide the FDA with validated and verified data for the analytical procedures and test methods used Application Submissions to the agency, including premarket applications for tobacco products (PMTA), substantial equivalence reports and applications for modified risk tobacco products, the agency said.

To legally market a new or modified-risk tobacco product in the United States, a company must first submit an application to and receive approval from the FDA.

“The principles described in the guidance may also be useful for the reporting of harmful and potentially harmful components in tobacco products, which is required of manufacturers and importers of tobacco products,” the FDA said in a statement.

The updated guidance completes the draft version issued in 2021. Changes from draft to final guidance include updating the definition of “tobacco product” to include the following Non-tobacco nicotineRevised to reflect the provisions of the final version PMTA and Essential Equivalence Rules (SE), as well as updating and adding definitions to several terms. The final guidance also includes updated examples of alternative validation approaches, the agency said.

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