I have quickly reviewed the document, which is to be commended for its brevity (9 pages). I strongly recommend that your relevant staff charged with NDI compliance read this notification and provide me with any comments or questions that we can then forward to FDA. There is a 60-day comment period that opens today and will close on June 3, 2024.
BACKGROUND: The concept of NDI master files was first raised at least 7-8 years ago by members of our industry to provide a mechanism whereby an NDI holder can “license” the use of the NDI ingredient to third parties, which would provide insights to FDA about what brands contain one or more master file authorized ingredients. This would provide a regulatory confirmation that such an ingredient is being lawfully sold.
FDA previously proposed a master file process to which industry had a number of concerns and objections.
Today’s document is a slimmed-down and modified version of the previous master file guidance. I would draw two points to your attention:
Confidential Information. FDA makes it clear that it is up to the NDI notifier to clearly indicate what information is a trade secret or Confidential Commercial Information (CCI). FDA will work on the basis that unless you explicitly lay out what you believe is confidential, it is not. So please read that section carefully.
The other key issue which is unaddressed here is, what is the status of a non-authorized ingredient that is identical to or very similar to an ingredient under master file authorization? In other words, since FDA will know what NDI ingredients are being sold in the market, will there be a new risk for parties selling other identical or very similar ingredients not authorized under an NDI master file?
We have long discussed the growing problem of borrowed science or the failure to respect NDI intellectual property. I would very much like your comments on this issue.
We will convene a discussion call shortly after the upcoming ICSB conference at Ole Miss where I believe this subject will be a point of discussion, and I will share any related news coming out of ICSB.
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