The Food and Drug Administration on Tuesday announced the availability of a final guidance pertaining to procedures and timeframes for new dietary ingredient notifications (NDINs).

The guidance is intended to help distributors and manufacturers prepare and submit NDINs to FDA, according to a constituent update from the Center for Food Safety and Applied Nutrition (CFSAN).

These pre-market notifications are a fundamental requirement intended to ensure that novel substances marketed in supplements meet a safety standard in the Dietary Supplement Health and Education Act of 1994 (DSHEA). Since 1994, FDA has received approximately 1,300 notifications.

The last NDI guidance, a draft guidance, was issued in 2016 and spanned 102 pages.

The new 16-page guidance covers such topics as who must submit an ingredient notification, how information should be organized and presented, where an NDIN should be submitted and what happens following submission of a notification, according to FDA.

“The guidance finalizes Section V (‘NDI Notification Procedures and Timeframes’) of the 2016 revised draft guidance in addition to several related questions from other sections of the draft guidance,” the constituent update added. “This approach of separating the 2016 revised draft guidance into discrete sections for ease of use is responsive to comments received on the draft guidance. 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thinking on the topic of NDINs and related issues and plans to prioritize finalizing other parts of the 2016 revised draft guidance as the agency completes its review and analysis of those sections.”

Related:FDA NDI guidance: Five key takeaways

Even though in final form, the guidance only represents FDA's thinking on the topics and is not binding on the agency or the public.

"You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations," the agency said in the final guidance.

The public can comment to FDA on the final guidance electronically or in written comments.

Starting Wednesday, upon publication of the guidance in the Federal Register, public comments can be submitted electronically to regulations.gov with the docket number FDA-2023-D-5280. FDA requested written comments be identified with the docket number FDA-2023-D-5280 and the title of the guidance document and submitted to the following:
Dockets Management Staff (HFA-305),
Food and Drug Administration
5630 Fishers Lane, Rm.1061
Rockville, MD 20852.

Editor's note: This is breaking news, so stay tuned for follow-up coverage on reaction from industry.

Related:‘GRAS loophole’ rears head in FDA supplements letter