What Is New Dietary Ingredient?
A dietary ingredient that was not marketed in the United States before October 15, 1994. Manufacturers must submit a pre-market safety notification (NDI notification) to the FDA at least 75 days before marketing a supplement containing an NDI.
Why It Matters for Supplement Brands
If your product contains an ingredient that wasn't sold as a supplement before DSHEA's enactment date, you're legally required to file an NDI notification. Failure to do so can result in FDA warning letters and product seizures — even if the ingredient is perfectly safe.
How It Works
The NDI notification process requires:
1. **Determination**: Establish whether your ingredient qualifies as 'new' (not marketed before October 15, 1994). 2. **Safety evidence**: Compile evidence demonstrating the ingredient is 'reasonably expected to be safe' at the proposed dose. 3. **75-day notification**: Submit the notification to the FDA at least 75 days before first marketing. 4. **FDA response**: The FDA may object, request more data, or allow the 75-day period to expire without objection.
The FDA maintains a public database of all NDI notifications and their responses, which can be a useful research tool for brands evaluating new ingredients.
Common Mistakes to Avoid
- ✗Not checking whether your ingredient qualifies as an NDI before launching
- ✗Relying on a supplier's claim that 'no NDI notification is needed' without independent verification
- ✗Submitting insufficient safety evidence, leading to FDA objection
- ✗Confusing GRAS (Generally Recognized as Safe) status for food with NDI requirements for supplements
Related Terms
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