FDA Updates Guidance on Premarket Safety for Dietary Supplements

FDA Updates Guidance on Premarket Safety for Dietary Supplements

"This revised draft guidance is an important step forward in the agency's work to protect public health from potentially dangerous new dietary ingredients," said Steven Tave, acting director of FDA's Office of Dietary Supplement Programs.

The U.S. Food and Drug Administration released revised draft guidance on dietary supplement companies' new dietary ingredient (NDI) premarket safety notifications to the agency. Now, the manufacturer or distributor must notify the FDA at least 75 days before beginning to market a dietary supplement that contains a new dietary ingredient unless the NDI is used in the food supply without chemical alteration.

The agency estimates that 5,560 dietary supplement products are introduced to the market each year, with more than 55,600 available now. The revisions have been introduced in order to clarify points that were misunderstood initially when the guidance was issued in 2011.

"This revised draft guidance is an important step forward in the agency's work to protect public health from potentially dangerous new dietary ingredients," said Steven Tave, acting director of FDA's Office of Dietary Supplement Programs. "Notification of new dietary ingredients is the only pre-market opportunity the agency has to identify unsafe supplements before they are available to consumers. The revised draft guidance is intended to improve the quality of industry's new dietary ingredient reporting so the FDA can more effectively monitor the safety of dietary supplements."

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