UNPA’s Israelsen: ‘We’ve really got to get this NDI issue resolved’

26-Mar-2024 - Last updated on 01-Apr-2024 at 18:50 GMT

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Loren Israelsen, president of the United Natural Products Alliance (UNPA) and one of the key architects of the Dietary Supplement Health and Education Act (DSHEA), is urging the Food and Drug Administration (FDA) to “move along as quickly as they can” to finalize any outstanding sections of the New Dietary Ingredient guidance.

Under DSHEA, 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First issued in 2011, the initial NDI draft guidance was met with significant industry backlash, which led to the Agency to go back to the drawing board. Five years later, a revised draft guidance was released.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, 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.

The FDA recently finalized Section V (“NDI Notification Procedures and Timeframes”) of the NDI guidance, which focuses on frequently asked questions about the NDIN submission and review process. Industry reaction was mixed, but most saw the announcement as progress and an important first step.

“It’s good to have anything,” Israelsen told NutraIngredients-USA. “It’s been a long time. And this is the appetizer, all the meaty parts are yet to come.

“It was a restatement in more clear terms with a couple of templates that people could use, so it’s an indication of progress and also, I think, a thoughtful process that they [FDA] are going through. The obvious question is, how soon can we expect the next pieces and the hard parts?”

A FDA spokesperson told NutraIngredients-USA earlier this month that the Agency does not have an anticipated timeline for other parts of the guidance but said that it is "prioritizing finalization of additional sections as the Agency completes its review and analysis in light of competing priorities."

Thirty years…

One industry source told us this week that he thinks the industry will not have to wait too long for additional sections to be finalized over the course of 2024, and Israelsen said the whole NDI issue needs to be resolved.

“I don’t think FDA can expect the industry to increase notifications until there’s clarity of process and agreement on some of the fundamentals,” he told us during the recent Expo West in Anaheim. “I am really hopeful we get there. We need to get over this. [It’s been] 30 years [since the passage of DSHEA]. We need to move on.

“I would encourage FDA to move along as quickly as they can. I do understand they are resource constrained, terribly, but given how important they feel this is and we think it is, it needs to move on.”

DSHEA Summit

Israelsen also discussed the upcoming DSHEA Summit, hosted by NutraIngredients-USA and supported by UNPA, that will bring together the architects of the law, key industry stakeholders and former and current FDA officials to discuss the past, present and future of the U.S. dietary supplements industry.

The DSHEA Summit will take place at the Hyatt Regency, Salt Lake City on Monday, June 10, 2024, from 8:30 a.m to 2 p.m.

Confirmed speakers include:

Scott Bass, Partner, Global Life Sciences, Sidley Austin
Christine Burdick-Bell, EVP & General Counsel, Pharmavite
Robert Durkin, Partner, Arnall Golden Gregory LLP & former acting Director and Deputy Director, Office of Dietary Supplement Programs (ODSP), FDA
Jim Emme, CEO, NOW Health Group
Loren Israelsen, President and Founder, United Natural Products Alliance (UNPA)
Patricia Knight, Senior Political Advisor, UNPA & former Chief of Staff to Senator Orrin Hatch, R-Utah
George Paraskevakos, Executive Director, International Probiotics Association (IPA)
Peter Reinecke, Senior Political Advisor, UNPA & former Chief of Staff to Senator Tom Harkin, D-Iowa
Dr. Cara Welch, Director, Office of Dietary Supplements Programs, FDA