New Dietary Ingredient Notification Master Files for Dietary Supplements; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Comment Request
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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled "New Dietary Ingredient Notification Master Files for Dietary Supplements." The draft guidance, when finalized, will provide recommendations to the dietary supplement industry on Master Files for new dietary ingredients. The purpose of this draft guidance, when finalized, will be to help industry comply more easily with the new dietary ingredient notification requirement by providing recommendations on the submission and use of Master Files that contain identity, manufacturing, or safety data that can be used to support a new dietary ingredient notification. New dietary ingredient Master Files are submitted solely at the discretion of the Master File owner and are not required by statute or regulation.
Abstract as published in the Federal Register.
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