Health Document Submission Requirements for Tobacco Products; Guidance for Industry; Availability

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The Food and Drug Administration (FDA or we) is announcing the availability of a revised guidance for industry entitled "Health Document Submission Requirements for Tobacco Products." The guidance provides information to assist persons making health document submissions to FDA as required by the Family Smoking Prevention and Tobacco Control Act. We received several comments to the draft guidance, and those comments were considered as the guidance was finalized.