Tobacco Products

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

January 2011

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.  


 

Contact FDA

1-877-CTP-1373
1-877-287-1373
(9am EST-4pm EST)
Tobacco

For General Inquiries:
AskCTP@fda.hhs.gov

Center for Tobacco Products Food and Drug Administration

10903 New Hampshire Avenue

Building 71, Room G335

Silver Spring, MD 20993-0002

Page Last Updated: 03/30/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.