FDA last week released its long-awaited draft guidance on New Dietary Ingredient (NDI) notifications. CRN staff alerted its members immediately and has begun review of the draft and will discuss details with the Regulatory Affairs Committee, preparing comments to the draft within 60 days of the Aug. 12 official release. CRN also announced an NDI webinar this fall (date to be determined), presented in partnership with Informa Exhibitions.

FDA has dropped the previous requirement that companies submit separate notifications for each single finished product on the market containing an NDI, as CRN President & CEO Steve Mister told Nutritional Outlook, “I think this absolutely is a place where FDA is trying to move to common ground. They certainly heard our concerns from the marketplace side that what was in the first guidance was not workable.” CRN had proposed the master-file concept over many meetings with FDA.

As noted in the Nutritional Outlook article, there is much for stakeholders to review in the draft, including the agency’s view on “grandfathered” ingredients, manufacturing processes, synthetic botanicals, probiotics, investigational new drugs and GRAS notifications. But, as Mr. Mister noted, “...just having the guidance out is a win for the industry. It’s taken us four years since [FDA] promised to give us a new draft, and I think the fact that we have it at all is going to do a lot towards giving more transparency and more certainty in the industry. It gives the industry a clear roadmap as to what FDA expects.” He added, “Even if we don’t always agree with everything that FDA says, it’s a big victory just to know what the agency’s interpretation is, with clarity. And I think we’re getting that today.”

See CRN in the News for more.

 

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