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GUIDANCE DOCUMENT

Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products Guidance for Industry and Food and Drug Administration Staff January 2011

Final

This guidance is being distributed for comment purposes only.

Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products

Issued by:
Guidance Issuing Office
Center for Tobacco Products

January 2011

pdf icon small Guidance for Industry and Food and Drug Administration Staff: Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products

This guidance provides information for those submitting reports concerning substantial equivalence under section 905(j) of the FD&C Act, including FDA’s interpretation of the statutory sections related to substantial equivalence and recommendations on the form and content of section 905(j) reports.  


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:

Division of Dockets Management (HFA- 305)
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)