If you’re working on a supplement that includes a new compound or botanical extract, chances are you’ve come across the term new dietary ingredient, or NDI. It’s not just another bit of industry jargon—it’s a critical part of FDA compliance.
Getting it right can help your product move smoothly into the market. Getting it wrong can lead to delays, warning letters, or even product recalls. So let’s unpack what an NDI really is, when it applies, and what your next steps should be if you’re introducing one.
What Is a New Dietary Ingredient?
A new dietary ingredient is exactly what it sounds like. It’s a substance that qualifies as a dietary ingredient under the law—but wasn’t marketed in the U.S. before October 15, 1994. That cutoff date is part of the Dietary Supplement Health and Education Act (DSHEA), which created the current regulatory framework for supplements.
If your ingredient was used in supplements and sold in the U.S. before that date, it’s considered “grandfathered in.” You don’t need to notify the FDA before marketing it. But if your ingredient is new—or if you can’t prove it was marketed before 1994—you may need to submit a New Dietary Ingredient Notification, or NDIN, to the FDA.
The goal is simple. The FDA wants to make sure new ingredients in supplements are reasonably expected to be safe before they hit store shelves.
Why the NDI Rule Matters
Many companies assume that if their ingredient is natural, or if it’s already used in foods, they’re automatically in the clear. That’s not always true.
NDI rules apply to ingredients used specifically in dietary supplements. Even if the ingredient is in food, if you’re using it in a capsule, tablet, or powder and marketing it as a supplement, the rules change.
Failing to file an NDIN when it’s required can lead to serious consequences. The FDA can declare your product adulterated. That means it’s technically illegal to sell. They can issue a warning letter, seize your product, or require you to reformulate. That’s the last thing any brand wants after investing time and money into development.
So understanding whether your ingredient qualifies as an NDI—and whether a notification is required—is a big deal.
Do You Need to File an NDI Notification?
This is the key question. Here’s the simple version.
You need to file an NDI notification if:
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Your ingredient meets the legal definition of a dietary ingredient, and
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It wasn’t marketed in the U.S. in a supplement before October 15, 1994.
It doesn’t matter if it’s used in Europe, Asia, or even in U.S. foods. What matters is documented evidence of use in U.S. dietary supplements before 1994. If you can’t prove that, then the FDA considers it new—and that triggers the requirement.
There are a few exceptions. For example, if your ingredient is the same as an existing one but manufactured differently, you might not need to file. Or if the ingredient is already the subject of an existing NDIN that’s still valid, you might be able to reference that. But those are narrow cases, and the burden of proof is still on you.
When in doubt, get a regulatory opinion. The risk of skipping this step is simply too high.
What Does the NDI Notification Involve?
Filing an NDI notification isn’t a five-minute form. It’s a detailed scientific document that shows your ingredient is reasonably expected to be safe under its intended conditions of use.
You’ll need to include:
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A full description of the ingredient and how it’s made
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Proposed usage levels
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Target populations
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Any history of use
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Toxicology data
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Human safety studies, if available
It’s not a formal approval process. The FDA doesn’t “approve” ingredients in the way it does for food additives. But if they don’t object to your submission, you can move forward with more confidence.
Still, don’t treat it lightly. If the FDA finds gaps or weaknesses in your data, they can reject the notification. That puts your product launch on pause—and you may have to redo part of the process.
How Long Does It Take?
The FDA generally responds to an NDI notification within 75 days. But preparing the notification itself can take several months, especially if you need to generate new safety data or conduct studies.
This is why early planning is critical. If your ingredient may be considered new, you need to build the NDI timeline into your product development plan. Don’t treat it as an afterthought.
Companies that succeed with NDIs tend to do two things right:
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They start thinking about NDI status early, even before formulation is final.
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They involve scientific and regulatory experts who understand what the FDA expects.
Common Mistakes to Avoid
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Assuming it’s not “new” because it’s in food
Being in food is not enough. If it hasn’t been in supplements before 1994, it might still be an NDI. -
Lack of documentation
You need real evidence of pre-1994 supplement use in the U.S. Anecdotes or international sales don’t count. -
Weak safety data
The FDA wants strong, peer-reviewed evidence or well-run studies. Not just theoretical safety or traditional use. -
Delaying the process
Waiting until just before launch to think about NDI compliance can derail your whole schedule.
Final Thoughts
If you’re working with a new dietary ingredient, the key is to understand your regulatory obligations from the beginning. The NDI notification process can feel technical and time-consuming, but it’s there for a reason—to make sure new ingredients entering the supplement market are safe for consumers.
Don’t let the regulatory side slow you down. Use it as a tool to build a better, more trusted product. A solid NDI strategy helps you launch smarter, with fewer surprises.
If you’re unsure whether your ingredient needs an NDI notification, get a qualified opinion early. That small step can save you months of delay—and possibly save your product altogether.
