Josh Long, Associate editorial director, Natural Products Insider

March 5, 2024

2 Min Read

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The last NDI guidance, a draft guidance, was issued in 2016 and spanned 102 pages.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“The guidance finalizes Section V (‘NDI Notification Procedures and Timeframes’) of the 2016 revised draft guidance in addition to several related questions from other sections of the draft guidance,” the constituent update added. “This approach of separating the 2016 revised draft guidance into discrete sections for ease of use is responsive to comments received on the draft guidance.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thinking on the topic of NDINs and related issues and plans to prioritize finalizing other parts of the 2016 revised draft guidance as the agency completes its review and analysis of those sections.”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 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

About the Author(s)

Josh Long

Associate editorial director, Natural Products Insider, Informa Markets Health and Nutrition

Josh Long directs the online news, feature and op-ed coverage at Natural Products Insider, which targets the health and wellness industry. He has been reporting on developments in the dietary supplement industry for over a decade, with a focus on regulatory issues, including at the Food and Drug Administration.

He has moderated and/or presented at industry trade shows, including SupplySide East, SupplySide West, Natural Products Expo West, NBJ Summit and the annual Dietary Supplement Regulatory Summit.

Connect with Josh on LinkedIn and ping him with story ideas at [email protected]

Education and previous experience

Josh majored in journalism and graduated from Arizona State University the same year "Jake the Snake" Plummer led the Sun Devils to the Rose Bowl against the Ohio State Buckeyes. He also holds a J.D. from the University of Wyoming College of Law, was admitted in 2008 to practice law in the state of Colorado and spent a year clerking for a state district court judge.

Over more than a quarter century, he’s written on various topics for newspapers and business-to-business publications – from the Yavapai in Arizona and a controversial plan for a nuclear-waste incinerator in Idaho to nuanced issues, including FDA enforcement of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

Since the late 1990s, his articles have been published in a variety of media, including but not limited to, the Cape Cod Times (in Massachusetts), Sedona Red Rock News (in Arizona), Denver Post (in Colorado), Casper Star-Tribune (in Wyoming), now-defunct Jackson Hole Guide (in Wyoming), Colorado Lawyer (published by the Colorado Bar Association) and Nutrition Business Journal.

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