FDA Drafts Rules on Dietary Supplements

The Food and Drug Administration is requesting public comment on a series of safety rules for dietary supplements, clarifying when and how manufacturers need to notify regulators about new ingredients. The new guidelines are meant to help clarify a 1994 law regulating new dietary ingredients in tablets, powders, liquids, and other supplements.

According to the 1994 law, manufacturers need to file a safety notification with the FDA before marketing dietary ingredients not on the market when the law passed. But the FDA has only received 700 notifications of dietary ingredients in the last 16 years. The agency believes that over 55,000 dietary supplement products are currently available.

The guidelines answer questions manufacturers might have about the law, like whether an ingredient used in food (but not marketed as a dietary ingredient) needs a safety notification. The FDA says it does, and the guidelines provide a template for filing notices.

The safety rules are the result of a food safety reform law passed in January that gave the FDA six months to offer draft guidelines for when to file a new dietary ingredient notification (NDI).

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