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GUIDANCE DOCUMENT

Tobacco Health Document Submission (Revised) Guidance for Industry March 2023

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2009-D-0600
Issued by:
Guidance Issuing Office
Center for Tobacco Products

This guidance describes FDA’s current thinking regarding the submission of health-related documents required by section 904(a)(4) of the Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 387d(a)(4)). This guidance is intended for manufacturers and importers of cigarettes, cigarette tobacco, roll your own tobacco (RYO), smokeless tobacco and those tobacco products subject to FDA’s final rule, Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act (81 FR 28974) (the deeming rule).

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-2009-D-0600.

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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