Most NDI notifications to FDA receive good day letter in FY23

The Food and Drug Administration in FY23 acknowledged 61% of premarket notifications for new dietary ingredients (NDIs), marking the third year in a row that over half of the notices received a so-called good day letter, Natural Products Insider has learned.

The notices are a requirement under the Dietary Supplement Health and Education Act of 1994 (DSHEA) to demonstrate the safety of NDIs in supplements, a marketplace that has exploded over the last three decades based on annual sales and the breadth of products.

Of its 44 responses in the fiscal year that ended on Sept. 30, FDA acknowledged 27 NDI notifications (NDINs). The agency objected to the remainder of notifications because they were either incomplete, did not meet the definition of a dietary ingredient, or FDA had identity or safety concerns.

FDA officials have stressed the premarket notifications are crucial because they represent the agency’s only chance to review the safety of ingredients in dietary 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, as are NDIs in the food supply in a non-chemically-altered form.

Companies in FY23 submitted a total of 47 NDINs to FDA.

Related:Supplements sector achieves record-high rate of successful ingredient notifications

“The FDA typically reviews and responds to fewer than 50 notifications each year, so these numbers aren’t generally enough to demonstrate a trend; that said, we are pleased to see a second year for a strong majority of acknowledged NDI notifications,” FDA spokeswoman Lindsay Haake said.

…

FY23 data regarding NDINs

FDA responses to NDINs: 44

Acknowledgement letters w/out objections (AKL): 27 (61%)

Not dietary ingredient: (NDL): 3 (7%)

Inadequate safety/identity (IAL): 7 (16%)

Incomplete (ICL): 7 (16%)

Source: FDA, via Freedom of Information Act (FOIA) request

…

In FY21, the acknowledgement rate was 55%, the highest on record at the time since FY98, according to an FDA spreadsheet obtained in 2021 by Natural Products Insider, via a FOIA request. At that time, the rate of acknowledgement letters had averaged 39% over the last quarter century.

In FY22, FDA acknowledged 7 out of 10 premarket ingredient notifications submitted to the agency to establish the safety of NDIs in supplements. Of the 42 NDINs that received a response in FY22, FDA acknowledged 30 of them, or 71%, without objection, according to FDA data.

“NDI notifications are integral to a strong dietary supplement regulatory program, providing valuable information about the safety of dietary supplements and ingredients,” Haake said. “We appreciate the efforts of the many responsible firms who put together comprehensive premarket notifications to demonstrate the safety of their product, and we remain committed to working with firms to help them understand and navigate the NDI notification process.”

Related:FDA acknowledged over half of NDI notices in FY21