CRN on why FDA needs to enforce NDINs if they want compliance

The U.S. Food and Drug Administration (FDA) recently published its first of many final guidance documents for New Dietary Ingredient Notifications (NDIN). Nutritional Outlook caught up with the president and CEO of the Council for Responsible Nutrition (CRN; Washington, D.C.) at Natural Products Expo West 2024, and he told us his takeaways from the document.

Excerpt below:

"One thing that did catch our attention is FDA's continued insistence that the NDI provision in the law requires every single product covered by the NDI to have its own notification. Now they do give themselves a little bit of a wiggle room, but but it's clear that they really want finished products as well as the ingredient suppliers filing notifications. And yet what strikes us is that we've had numerous conversations with them. If they expect industry to do this, they've got to create either carrots or sticks for industry to do it and they have not shown any proclivity to enforce the law against piggyback companies that will ride on somebody else's NDI notification even though they are making the ingredient from scratch on their own. And they're not notifying the agency how it's being made-up.

That is a problem because there's there is always the chance that somebody is making the ingredient in a way that's not safe....Every ingredient needs to have an NDIN, and FDA needs to enforce the law and bring some kind of, you know, landmark investigations to send that message to the industry. If they don't do that, if they're not willing to do that, this is all just wasted breath for FDA because companies have no incentive to file the NDIN if they feel like there's no consequence."