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U.S. Department of Health and Human Services

Tobacco Products

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

 

January 2011 

 

PDF

 

 

 

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

Silver Spring, MD 20993-0002