FDA Has No Objections to One in Four NDI Notifications

FDA acknowledges approximately one out of every four new dietary ingredient (NDI) notifications companies submit these days, according to the American Herbal Products Association (AHPA; Silver Spring, MD). AHPA observed these recent numbers as the association made updates to its AHPA NDI database-namely, it added partial data on 40 new NDI notifications companies sent to FDA between November 2012 and February 2014.

AHPA’s subscription-access NDI database now includes information on 710 NDI notifications filed with FDA since 1995, including such information as company name, ingredient, and FDA responses (objections and no objections).

Of the 40 recent NDI notifications added to the AHPA database, FDA acknowledged 10 of them without objection. “The fact that one in four NDI notifications were acknowledged by FDA without objection demonstrates that companies are effectively navigating the NDI system in order to meet consumer demand for innovative and safe dietary supplement ingredients,” said Merle Zimmermann, PhD, AHPA’s chief information analyst and manager of the AHPA NDI database, in a press release.

AHPA hopes that industry members can use the information collected in its NDI database to learn from other companies’ notification mistakes and “avoid common pitfalls that can result in FDA objections,” Zimmermann said.

Why might FDA reject an NDI notification? According to AHPA, the reasons can vary from something as minor as missing technical data (such as a company’s name, etc.) to something more serious, such as safety concerns based on notification information or the fact that an ingredient does not meet the definition of a dietary supplement under current regulations. Under the Dietary Supplement Health and Education Act (DSHEA) of 1994, companies are required to notify FDA within 75 days before introducing to market an ingredient that was not in the U.S. market prior to October 15, 1994, via a NDI notification.

If FDA initially objects to a notification, companies can re-file the notification after addressing and clearing up any concerns that FDA had with the initial notification.

AHPA’s president Michael McGuffin will participate in a panel discussing strategies for successfully filing NDI notifications on Wednesday, June 18, at the American Conference Institute (ACI).

“There is a false impression in the supplement industry that the NDI notification system is a bound-to-fail effort for most companies,” McGuffin noted via press release. “In fact, more than half of submissions that are in full compliance with the current NDI regulations are filed by FDA without substantive objections on the initial submission, and this rate increases with attentive re-submissions when needed.”

Jennifer Grebow
Editor-in-Chief
Nutritional Outlook magazine jennifer.grebow@ubm.com