WHAT IS A NEW DIETARY INGREDIENT NOTIFICATION AND WHY DOES IT MATTER?

What Is a New Dietary Ingredient Notification and Why Does It Matter?

What Is a New Dietary Ingredient Notification and Why Does It Matter?

Blog Article

If you're in the supplement industry—or thinking about launching your own health product—there's one term you absolutely need to understand: new dietary ingredient notification.


This FDA-required process is essential if you're using ingredients in your dietary supplement that weren’t marketed in the United States before October 15, 1994. Whether you’re formulating a new vitamin, herbal extract, or functional blend, this rule helps ensure that anything new hitting the shelves is also safe for consumers.


Let’s break it down.



What Is a New Dietary Ingredient (NDI)?


A new dietary ingredient, or NDI, refers to any dietary substance that hasn’t been previously sold in the U.S. before the 1994 cutoff date. This could include a newly discovered plant extract, a synthetic version of a known compound, or a purified active from a traditional food source.


The new dietary ingredient notification process is how you tell the FDA, “Hey, here’s this new ingredient we want to use—and here’s the evidence that it’s safe.”



Why Is This Notification Required?


Simple: consumer safety.


The FDA doesn’t require pre-approval for most supplements, but when you’re introducing a new ingredient, the agency wants proof that it won’t harm anyone. Through the new dietary ingredient notification, you provide key information like:





  • What the ingredient is and where it comes from




  • How much will be used and how it's taken (capsule, powder, etc.)




  • Scientific evidence and research showing it’s safe




This isn’t just paperwork—it’s about building a trustworthy product backed by solid science.



What Happens If You Skip It?


Not good. If you market a supplement with an NDI and don’t file the proper notification, the FDA can pull your product from the market or take enforcement actions. Even worse, you risk damaging your brand’s reputation.


Following the new dietary ingredient notification process isn’t just about compliance—it’s also about credibility. Consumers are increasingly looking for brands that are transparent and responsible.



Final Thoughts


The new dietary ingredient notification may seem like just another regulatory hurdle, but in reality, it’s a vital checkpoint for ensuring quality and safety in the supplement industry. If you’re launching a new product with a novel ingredient, make this process a priority.


It not only keeps you on the right side of the law—it also helps build trust with your customers.





Report this page