NDI (New Dietary Ingredient)
RegulatoryAlso known as: New Dietary Ingredient Notification, NDIN, NDI notification
An ingredient not marketed in the US before October 15, 1994, requiring FDA notification before sale.
What It Means
Under DSHEA, any dietary ingredient not marketed in the US before Oct 15, 1994 is considered a New Dietary Ingredient. Manufacturers must notify FDA at least 75 days before marketing products containing an NDI, providing evidence of reasonable expectation of safety. This is the closest thing to pre-market review in the supplement space.
What It Is Not
NDI notification is NOT FDA approval. FDA reviews the notification and may object, but lack of objection is not the same as approval. Many companies market NDIs without proper notification — enforcement is inconsistent.
Evidence and References
- guidanceFDA NDI guidance
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