FDA releases draft guidance on new dietary notification for dietary supplements

04 Apr 2024 --- The US Food and Drug Administration (FDA) has unveiled a new draft guidance for the dietary supplement industry, presenting not-yet-binding recommendations concerning new dietary ingredients (NDI) and superseding the 2016 revised draft guidance.

The aim of the draft guidance is to assist supplement and ingredient manufacturers and distributors in determining whether or not to submit premarket safety notifications to the FDA when a new product contains NDI. The guidance sets out to streamline the process and ensure the safety of dietary supplements for consumers.

Steve Mister, president and CEO of the US Council for Responsible Nutrition (CRN), comments: “It’s a positive development to see the FDA moving ahead with this draft guidance.”

“In 2020, CRN developed an NDI master file framework for dietary supplements to protect our members’ investments and intellectual property, and this is clearly a step in the right direction, incorporating many of the elements we put forward.”

The new guidance
The newly released document details what qualifies as an NDI, when an NDI notification is required, the procedures for submitting a notification is necessary, recommendations on the data and information to consider during the safety evaluation, as well as advice on the contents of an NDI notification. 

The document further provides detailed recommendations on what information should be included when establishing master files for new dietary ingredient notifications (NDINs).

It defines the FDA’s role in reviewing NDIN master files, emphasizing the importance of communication between the FDA, notifiers and master file owners during the review process. 

Mister continues: “As we have previously stated, meaningful enforcement alongside guidance is crucial in supporting responsible companies desiring to innovate, to protect investment while doing so, and to fairly compete. FDA must deter bad actors who circumvent the law, thereby posing a risk to public safety.”

“So, while we welcome this draft guidance, we, at the same time, strongly urge the FDA to publicly announce its resolve to enforce the proper use of master files,” he concludes.

The document builds upon the FDA’s guidance on the procedures and deadlines for NDINs, released last month. 

By Milana Nikolova