Docket Number:
FDA-2021-D-0756
Issued by:
Guidance Issuing Office
Center for Tobacco Products

The Food and Drug Administration is announcing the availability of a draft guidance for industry entitled "Validation and Verification of Analytical Testing Methods Used for Tobacco Products" and requesting comments, including scientific and other information, concerning the recommendations set forth in the draft guidance. The draft guidance, when finalized, would provide information and recommendations related to the validation and verification of analytical test methods, including analytical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 This draft guidance would help industry produce more consistent and reliable analytical data used to support regulatory submissions for finished tobacco products.

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
Exchange Lab: https://digitalmedia.hhs.gov/tobacco