The Food and Drug Administration on Monday issued a guidance for the tobacco industry entitled Validation and Verification of Analytical Testing Methods Used for Tobacco Products.
This is a final guidance providing tobacco manufacturers with information and recommendations to aid application submissions, the agency said 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 in application submissions to the agency, including premarket tobacco product applications (PMTA), substantial equivalence reports and modified risk tobacco product applications, the agency said.
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.
“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,” the FDA said in a statement.
The updated guidance concludes the draft version issued in 2021. 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 substantial equivalence (SE) rules, and updating and adding definitions to several terms. The final guidance also includes updated examples for alternative validation approaches, the agency said.
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