FDA Issues Supplement Safety Notification Guidance

Law360, New York (July 5, 2011, 10:37 PM EDT) -- The U.S. Food and Drug Administration on Tuesday published long-awaited draft guidance for dietary supplement makers, detailing how and when manufacturers need to submit a safety notification for products containing new ingredients.

The new guidelines aim to assist manufacturers in meeting a 1994 federal law requiring premarket notification for supplements with new dietary ingredients, or NDI. The guidance fills in the gaps created in the Dietary Supplement Health and Education Act of 1994, which for instance does not specify the type or amount of data needed...
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