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GUIDANCE DOCUMENT

Validation and Verification of Analytical Testing Methods Used for Tobacco Products January 2025

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2021-D-0756
Issued by:
Guidance Issuing Office
Center for Tobacco Products

This is a final guidance providing tobacco manufacturers with information and recommendations to aid application submissions. The guidance explains how manufacturers can provide 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, substantial equivalence reports, and modified risk tobacco product applications.

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2021-D-0756.

Questions?

Contact Point
Contact CTP
Center for Tobacco Products
Food and Drug Administration
Document Control Center
10903 New Hampshire Avenue
Building 71, Room G335
Silver Spring, MD 20993-0002
AskCTP@fda.hhs.gov
(9 a.m. - 4 p.m. Eastern) 1-877-CTP-1373 (1-877-287-1373)
Twitter: https://twitter.com/FDATobacco
FDA Tobacco Education Resource Library: https://digitalmedia.hhs.gov/tobacco
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