If your supplement includes a novel ingredient, there’s one step you can’t afford to overlook—the NDI application.
NDI stands for New Dietary Ingredient. Filing an application with the FDA is often a necessary part of bringing that ingredient to market in the U.S. It’s not just a formality. It’s a legal requirement that protects your product, your consumers, and your brand.
The process can sound complicated, especially if you’re hearing about it for the first time. But with the right preparation, it becomes a manageable (and smart) part of product development.
Here’s what you need to know.
What Is an NDI Application?
The NDI application—officially called a New Dietary Ingredient Notification (NDIN)—is a document submitted to the FDA when your supplement contains an ingredient that wasn’t marketed in the U.S. before October 15, 1994.
That date is important. It’s the cutoff under the Dietary Supplement Health and Education Act (DSHEA). Ingredients sold in supplements before then are considered established. Anything introduced afterward is considered new and requires FDA notification—before you can sell the product.
An NDI application isn’t about getting approval. It’s about notifying the FDA and demonstrating, with scientific support, that your ingredient is reasonably expected to be safe under its intended use.
Why the NDI Process Matters
Skipping the NDI step can create major problems. The FDA can label your product as adulterated, which means it’s not legally allowed on the market. That can result in warning letters, removals, or forced reformulations.
Beyond compliance, submitting an NDI application sends a message to your partners and customers: you’ve done your due diligence. It strengthens your credibility, improves your risk profile, and supports long-term growth.
NDI filings are not just for regulatory peace of mind—they’re also smart business.
Do You Need an NDI Application?
The basic test is simple: Was your ingredient already marketed in U.S. dietary supplements before October 15, 1994? If not—or if you can’t prove it—then it’s likely considered a new dietary ingredient, and a notification is required.
Even if your ingredient is common in foods, cosmetics, or traditional medicine, that’s not enough. The FDA is only interested in documented use in U.S. supplements before the cutoff date.
If your ingredient is extracted or manufactured differently than it was in the past, or used at significantly higher levels, the FDA may still consider it new—even if the ingredient itself has some history of use.
When there’s uncertainty, it’s better to get a professional opinion early on.
What Goes Into an NDI Application?
An NDI application is a scientific submission. It includes detailed data and documentation to back up the safety of your ingredient. Most applications include:
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A full profile of the ingredient’s identity and composition
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A description of the manufacturing process
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Proposed use levels, dose, and target populations
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A safety narrative, including toxicology data and published studies
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Any evidence of prior use, whether in supplements or food
The FDA isn’t looking for guesses. They expect a clear and supported case showing that your ingredient won’t pose harm under its intended conditions of use.
What Happens After You Submit?
Once submitted, the FDA has 75 calendar days to review your NDI application. Their response might be:
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A letter stating they have no objections
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A request for clarification or additional data
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An objection if they find the safety data lacking or incomplete
If the FDA raises objections, you’ll need to address them before going to market. If you receive no objections within the 75-day period, you can generally proceed—but only if your submission was complete and met all requirements.
Common Mistakes to Avoid
Several missteps can delay or derail an NDI application:
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Underestimating the data requirements
Claims of natural or traditional use aren’t substitutes for toxicology or human data. -
Unclear ingredient identity
You must clearly define what the ingredient is, how it’s made, and what’s in it. -
Weak or missing documentation of historical use
Unsupported claims won’t satisfy FDA requirements. -
Waiting too long to start
Remember: the FDA needs 75 days to review your submission before launch. Filing late can delay your entire timeline.
Strategic Benefits of Filing
The NDI application isn’t just a legal formality. It’s a strategic asset. Filing it can help:
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Build retailer and investor confidence
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Improve your brand’s regulatory credibility
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Protect your product from future challenges
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Support claim substantiation and safety transparency
Companies that treat this process seriously tend to move faster and with more confidence once they’re on the market.
Final Thoughts
If your supplement includes a new dietary ingredient, then filing an NDI application is more than a regulatory checkbox—it’s a smart and necessary step.
Start early. Know your ingredient. Build a strong, science-backed case. And if you’re unsure whether a notification is required, don’t guess—get a regulatory expert involved.
The payoff is worth it: a clean, compliant product that’s ready for market and built on a foundation of safety.
