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Guidance on Tobacco Products Document Submission


Federal Register Notice: FDA is making available a revised draft guidance for industry entitled Health Document Submission Requirements for Tobacco Products. It is intended to assist persons making certain document submissions to FDA as required by the Family Smoking Prevention and Tobacco Control Act. The revised draft guidance includes guidance for manufacturers or importers of products that are newly deemed as tobacco products that are subject to Chapter IX of the FD&C Act. To download this guidance, click here. To view this notice, click here.