FDA Releases Draft Guidance on Validation of Test Methods

The U.S. Food and Drug Administration on Dec. 21 announced the availability of a draft guidance for the industry titled “Validation and Verification of Analytical Testing Methods Used for Tobacco Products” and is requesting comments, including scientific and other information, concerning the recommendations set forth in the draft guidance. The comment period will continue through Feb. 22, 2022.

The draft guidance, when finalized, would provide information and recommendations related to the validation and verification of analytical test methods, including analytical testing of tobacco product constituents, ingredients and additives as well as stability testing of tobacco products. This draft guidance would help the industry produce more consistent and reliable analytical data used to support regulatory submissions for finished tobacco products.