UNPA UPDATE: FDA Issues Final Guidance on NDI Notification Procedures and Timelines / March 5, 2024
Mar 5, 2024
Dear Colleagues,
This morning, FDA’s Office of Dietary Supplement Programs announced the availability of a final guidance for industry titled, “Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry.”
This 102 page document is the first in a series of final guidance intended to provide industry with greater clarity and direction on key elements of the NDI process. This all began in 2011 when FDA issued an initial NDI notification draft guidance, which was not well received by industry. FDA tried again in 2016, and that document was even less well received by industry. This led to discussions between FDA and several trade associations, including UNPA, where we offered suggestions as to how FDA could simplify, clarify, and streamline the NDI Guidance.
Today is that day, everyone. FDA has now issued the first of what will be a series of guidance documents. This one is on “procedures and timeframes” to file an NDI notification. Please see all links pertaining to today’s announcement below:
Constituent Update – FDA Issues Final Guidance on New Dietary Ingredient Notification Procedures and Timeframes
In my leisure time I will give this a thorough read and provide further comments. We will no doubt convene an all-member webinar to further discuss and receive your comments, which we will then share with FDA.
To those of you who are going to read the whole thing, God bless you.
Loren Israelsen visits with Mike Kauffman, President of Facilities Consulting NW, and discusses the importance of facility design in achieving GMP compliance. Mike
The U.S. Food and Drug Administration (FDA) published a draft guidance on the submission of new dietary ingredient notification (NDIN) master files. The
