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Specializing in FDA Regulatory Matters

FDA Issues Final Guidance to Frequently Asked Questions on Demonstrating the Substantial Equivalence of a New Tobacco Product

On March 4, 2015 FDA issued a final GuidanceDemonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions, that provides responses to frequently asked questions the agency received from manufacturers and others about demonstrating substantial equivalence (SE) for a new tobacco product. The questions relate to: label changes, product quantity changes, additives/specifications, and general questions about SE reports. The Guidance also explains the circumstances under which a manufacturer may submit streamlined SE reports for tobacco products that have certain modifications to labels and changes to product quantity. For more information on this final guidance, please visit our Guidance web page.

FDA will be hosting an upcoming webinar to discuss this Guidance. To submit questions about the Guidance that you would like addressed during the webinar, send them to with the subject line “SE Webinar.”