FDA Had No Objections to 25% of Recent NDI Notifications, AHPA Reports

Mar 31, 2017

Nearly one-quarter of the 59 new dietary ingredient (NDI) notifications companies submitted to FDA between November 2015 and October 2016 were acknowledged without objection by FDA. The American Herbal Products Association (AHPA; Silver Spring, MD) shared these numbers from its AHPA NDI Database, which tracks NDI notifications as well as FDA’s responses.

Of those 15 NDI notifications that FDA received without objection during that time frame, several were from companies resubmitting a notification after FDA expressed concerns about an original submission. And of the 59 NDI notifications submitted to FDA between November 2015 and October 2016, FDA flagged 18 of them as incomplete, for reasons including a failure to translate information into English and failure to identify the ingredient.

“Data from the latest NDI notifications confirm that companies can successfully navigate this system to bring new dietary ingredients to market,” commented Merle Zimmerman, PhD, AHPA’s chief information analyst. “The data also show that companies are having success when they resubmit notifications that address FDA observations about previous submissions.”

Zimmerman also said there is still a need to educate companies on what factors will cause FDA to flag a notification as incomplete “so they can avoid common pitfalls,” noting that his association offers several resources to assist firms, including the NDI Database (from which companies can learn what FDA objected to), as well as webcasts and association guidance documents.


Also read:

Everything you Need to Know about FDA's NDI Draft Guidance. Click here to access Nutritional Outlook's free NDI Draft Guidance E-Book.


Jennifer Grebow
Nutritional Outlook magazine
[email protected]