FDA issues final guidance on NDIN procedures, timeframes

05-Mar-2024 - Last updated on 06-Mar-2024 at 14:38 GMT

The Food and Drug Administration (FDA) has finalized guidance for industry titled “Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry".

Published this morning, this new guidance focuses on frequently asked questions about the NDIN submission and review process.

NDI notifications

Under DSHEA (Dietary Supplement Health and Education Act of 1994), a manufacturer of a New Dietary Ingredient—i.e., one that was not marketed as a dietary ingredient prior to Oct. 15, 1994—is required to file a notification with FDA 75 days before putting the ingredient on the market. The dossier is supposed to provide scientific backing to prove that the ingredient can be ‘reasonably expected to be safe’ under the conditions of use.

Within that time frame, FDA is supposed to respond with a letter, either concurring with the assertion of safety or raising objections. (FDA never puts itself in the position of ‘approving’ ingredients.)

First issued in 2011, the initial NDI draft guidance was met with significant industry backlash, which led to the Agency to admitting that it was going to take the document back to the drawing board. Five years later, a revised draft guidance was released. That revised version was described as “more positive than negative” by Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), when it was released in 2016, but some stakeholders still voiced concerns that the Agency’s approach would dampen innovation.

Since that time, the Agency has adopted more of a piecemeal approach to the NDIN guidance, stating that it is working “expeditiously” to finalize sections as and where it can.

One of those sections, Section V (“NDI Notification Procedures and Timeframes”), has now been finalized, in addition to several related questions from other sections of the draft guidance, said the Agency.

“This approach of separating the 2016 revised draft guidance into discrete sections for ease of use is responsive to comments received on the draft guidance,” stated FDA in a Constituent Update.

“The FDA understands the importance of providing the agency’s thinking on the topic of NDINs and related issues and plans to prioritize finalizing other parts of the 2016 revised draft guidance as the agency completes its review and analysis of those sections.”

The new guidance provides information in a questions and answers format about the NDIN submission and review process, including:

- Who needs to submit an NDIN?
- How should the information be organized and presented?
- Where should an NDIN be submitted?
- What happens after an NDIN is submitted?

The full guidance can be viewed HERE.

The public may submit comments related to this final guidance at any time via Regulations.gov with the docket number: FDA-2023-D-5280.

CRN welcomes progress

In an email to NutraIngredients-USA, CRN welcomed the FDA’s announcement today. "It has been nearly eight years since FDA published the last Draft Guidance, and we welcome any progress toward gaining clarity of FDA’s expectations for these NDI notifications," said the association.

"CRN has previously communicated various concerns and recommendations to the FDA regarding the New Dietary Ingredient (NDI) notification process. Today’s release appears to follow CRN’s earlier recommendation to split up the earlier 2016 Draft Guidance into separate parts and release them individually rather than trying to address all aspects of the NDI process at once.

"Throughout our communications, CRN has consistently advocated for a more collaborative approach with the FDA to develop changes to the NDI notification process, suggesting that the industry could serve as a valuable resource in decision-making. We will be examining this Guidance with our Regulatory Affairs Committee and responding to FDA as appropriate."

Amnesty

The Agency claims to have received only about 1,200 NDI notifications since the passage of DSHEA, but that represents only a fraction of the total NDIs launched on the market over that time. FDA estimates that more than 4,600 notifications should have been submitted and were not.

In a six-page draft guidance released in 2022, FDA proposed granting an amnesty period of sorts so that the missing notifications can be filed without fear of having products that are technically adulterated pulled from the market.

This is breaking news - NutraIngredients-USA will update this article with reaction from industry stakeholders.