FDA acknowledged over half of NDI notices in FY21

Over half of FDA’s responses last year to premarket notifications for novel ingredients in supplements did not object to the identity and safety data presented.

Of its responses to 49 new dietary ingredient notifications (NDINs), FDA acknowledged 27 submissions without an objection, Natural Products Insider has learned.

FDA officials have stressed the premarket notifications are crucial because they represent the agency’s only chance to review the safety of ingredients in supplements before they are marketed to consumers. Old dietary ingredients—those marketed in the U.S. before Oct. 15, 1994—are exempt from the notification requirement.

The acknowledgment (AKL) rate, 55%, is the highest it’s been since FY98, according to an FDA spreadsheet obtained by Natural Products Insider, via a Freedom of Information Act (FOIA) request. The rate of acknowledgement letters has averaged 39% over the last quarter century.

While the agency did not draw any conclusions from the acknowledgement rate in FY21, an FDA spokesperson said, "We are however, encouraged by the increase in the AKL rate and hope it is a reflection of ODSP [Office of Dietary Supplement Programs] outreach, notifiers receiving helpful feedback in their pre-NDIN meetings and notifiers’ commitment to submitting comprehensive notifications."

"The FDA remains committed to improving the quality of NDINs by supporting notifiers and making the NDIN process as straightforward as possible," the spokesperson added in an email.

Among some of the firms that received acknowledgement letters: Ana Bio Research & Development JSC for an NDI in a supplement product to be marketed under the trade name, “LiveSPO COLON”; Cantech Pharma Inc. for an NDI in a supplement product to be marketed under the trade name, “Cantech Pharma ImmuneBooster”; and Greenyn Biotechnology Inc. for an NDI called "GreenynAntrodia cinnamomea Mycelia" intended to be marketed as a bulk ingredient for use in supplement products.

In many instances, notifiers that receive an acknowledgement letter had provided additional documents to FDA following the original filing, FDA records show. For instance, FDA received Greenyn Biotechnology’s NDIN in August 2020, followed by additional information in October, November and December of the same year. Likewise, Ana Bio Research & Development JSC provided FDA additional documents in October, November and December of last year following its original submission in July 2020.

Even when FDA acknowledges a notification, it considers such acceptance a “procedural matter” and reserves the right to take action against a product containing an NDI if it is “unsafe, adulterated or misbranded.”

FDA objected to 27 NDINs in FY21. Eleven letters were related to identity and safety concerns, four responses alleged the submissions were incomplete, and seven responses reflected FDA’s position that the substance was not a dietary ingredient.

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FY21 data regarding NDINs

NDINs submitted: 45 

FDA responses to NDINs: 47 (two responses were to NDIDs submitted in FY20)

Acknowledgement letters w/out objections (AKL): 27 (55%)

Not dietary ingredient/dietary supplement (NDL): 7 (14%)

Inadequate safety/identity (IAL): 11 (22%)

Incomplete (ICL): 4 (8%)

Source: FDA, via FOIA request

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It’s unclear what criteria FDA uses for data-collection purposes in identifying a specific objection because the agency often raises multiple concerns in its objection letters. For example, in letters to Charlotte’s Web and Irwin Naturals, FDA asserted CBD was excluded from the definition of a dietary supplement, and the agency also raised safety concerns regarding the ingredients.

FDA’s responses in FY21 covered NDIN numbers 1167 through 1214—most of which are now available for review on the public docket.