IRVINE, Calif., Aug. 19, 2024 /PRNewswire/ — Nutraland USA, Inc., a pioneer in innovative, plant-based nutritional solutions, today announced an exclusive partnership with Biowell NutriScience Corp.,
Dear Colleagues,
This morning at 9:00 am (ET), FDA released the attached document titled, “Draft Guidance for Industry: New Dietary Ingredient Notification Master Files for Dietary Supplements.” (Relevant links are also included at the end of this memo.)
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:
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.
Happy reading.
Kind regards,
LDI
Draft Guidance for Industry – New Dietary Ingredient Notification Master Files for Dietary Supplements
Constituent Update – FDA Issues Draft Guidance on New Dietary Ingredient Notification Master Files for Dietary Supplements
IRVINE, Calif., Aug. 19, 2024 /PRNewswire/ — Nutraland USA, Inc., a pioneer in innovative, plant-based nutritional solutions, today announced an exclusive partnership with Biowell NutriScience Corp.,
July 30, 2024, Salt Lake City, UT: The United Natural Products Alliance, a leading trade association for the dietary supplement industry, has joined