📊FDA Guidance on Analytical Testing Methods for Tobacco Products
Validation and Verification of Analytical Testing Methods Used for Tobacco Products; Guidance for Industry; Availability
Summary
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry entitled "Validation and Verification of Analytical Testing Methods Used for Tobacco Products." The guidance provides 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 guidance is intended to help industry produce more consistent and reliable analytical data used to support regulatory submissions for finished tobacco products. This guidance finalizes the draft guidance of the same title issued in December 2021.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The guidance outlines compliance requirements for analytical testing methods for tobacco products, significantly affecting manufacturers and regulators. Sections detailing validation, verification, and data reliability highlight mandatory standards essential for regulatory submissions, thus impacting operational practices and financial planning for affected businesses.