FDA Issues Draft Guidance on Validation and Verification of Analytical Testing Methods Used for Tobacco Products

On Dec. 21, FDA issued draft guidance for industry entitled “Validation and Verification of Analytical Testing Methods Used for Tobacco Products.”

The draft guidance, when finalized, would provide information and recommendations related to the validation and verification of analytical test methods, including analytical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 This draft guidance would help industry produce more consistent and reliable analytical data used to support regulatory submissions for tobacco products, such as premarket tobacco product applications (PMTAs) and substantial equivalence (SE) reports.

FDA requests comments beginning tomorrow (Dec. 22) through Feb. 22, 2022, including scientific and other information, concerning the recommendations set forth in the draft guidance.