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 This all began in 2011 when FDA issued an initial NDI notification draft guidance, which was not well received by industry.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:

Federal Register notice on display

Guidance for Industry: New Dietary Ingredient Notification Procedures and Timeframes

Revised Draft NDIN Guidance (with redacted sections to indicate which content was finalized)

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.

Kind regards,