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GUIDANCE DOCUMENT

Tobacco Health Document Submission Guidance for Industry October 2017

Final

This guidance is being distributed for comment purposes only.

Issued by:
Guidance Issuing Office
Center for Tobacco Products

October 2017

pdf icon small Guidance for Industry: Health Document Submission Requirements for Tobacco Products (Revised) *

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 on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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 comments should be identified with the title of the guidance.

Questions?

Contact Point
Contact CTP
Document Control Center
Center for Tobacco Products
Food and Drug Administration
10903 New Hampshire Ave WO71-G335
Silver Spring, MD 20993-002
AskCTP@fda.hhs.gov
(877) 287-1373 (9am EST-4pm EST)