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. FDA notification is generally required before sale unless the ingredient qualifies for the food-supply exception.
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 generally notify FDA at least 75 days before marketing products containing an NDI, providing evidence of reasonable expectation of safety — UNLESS the ingredient has been present in the food supply as an article used for food in a form in which the food has not been chemically altered (FD&C Act section 413(a)(1)). Being an NDI and requiring an NDI notification are not the same thing. The notification pathway 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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