FDA Issues Final Guidance on New Dietary Ingredient Notifications: Clarifying the Identity and Safety Information Supplement Filings Should Include
The U.S. Food and Drug Administration (FDA) has announced the availability of a final guidance, "New Dietary Ingredient (NDI) Notifications and Related Issues: Identity and Safety Information About the NDI," in a Federal Register notice dated October 20, 2026. The guidance addresses frequently asked questions about NDI notifications and sets out the agency's recommendations on the identity and safety information that should be included in a notification.
Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), a manufacturer or distributor must notify the FDA before marketing a dietary supplement containing a new dietary ingredient, identifying the ingredient and providing the basis for concluding it is reasonably expected to be safe; unlike drugs, dietary supplements are not approved by the FDA before marketing. The final guidance focuses on that notification step, covering how firms should describe an ingredient's identity, manufacturing and specifications, and what safety information should accompany the filing.
The FDA said the guidance is intended to give industry a clearer, more predictable framework for preparing notifications, in a market with tens of thousands of supplement products where the NDI notification is the central premarket filing.
As with other FDA guidance documents, the final guidance represents the agency's current thinking on the topic. Firms may use the approach described in the guidance or an alternative approach, provided the alternative satisfies the requirements of the applicable statutes and regulations.
Published by GSM · USA (original Chinese edition)
Photo: 各类维生素与膳食补充剂片剂（资料图）。照片：Raysonho 摄，CC0，经维基共享资源。 / File photo: assorted vitamin and dietary supplement tablets. Photo by Raysonho, CC0, via Wikimedia Commons.
