FDA working ‘expeditiously’ to finalize NDI draft guidance sections

By Stephen Daniells

- Last updated on GMT

© bankrx / Getty Images
© bankrx / Getty Images

Related tags Ndi Ndi draft guidance Ndi notification Fda Dietary supplements Probiotics

The US Food & Drug Administration intends to release multiple draft guidance documents to the industry as smaller, discreet topics relating to New Dietary Ingredients (NDI), a senior figure said recently.

The comments were made by Dr Betsy Jean Yakes, PhD, Acting Director of FDA’s Division of Research & Evaluation, during a round table discussion at the recent IPA World Congress + Probiota Americas in Washington, D.C.

When FDA was asked to elaborate, a spokesperson told NutraIngredients-USA: “The FDA has expressed our desire to move toward finalizing those parts of the guidance that we can. We are working on this expeditiously.

“In fact, we’ve announced our intent to finalize the “NDI Notification Procedures and Timeframes” sections of this guidance in the Foods Program Guidance Under Development, which lists guidance topics the FDA Foods Program is considering.”

NDI notifications

Under DSHEA (Dietary Supplement Health and Education Act of 1994), 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.)

The Agency claims to have received only about 1,200 NDI notifications since the passage of DSHEA, but that represents only a fraction of the total NDIs launched on the market over that time. FDA estimates that more than 4,600 notifications should have been submitted and were not.

In a six-page guidance released recently​, FDA said it is granting an amnesty period of sorts so that the missing notifications can be filed without fear of having products that are technically adulterated pulled from the market.

Having said that, there are parts of the NDI draft guidance that are awaiting finalization, and the agency has stated it will do so, where it can.

Commenting on the impending NDI draft guidance documents, George Paraskevakos, executive director of the International Probiotics Association (IPA), said: “Future draft guidance documents from the Agency on NDIs are critical to our probiotic industry members.

“IPA has maintained a dialog with the Agency over the course of the prior two NDI draft guidance’s, and we anticipate many issues will remain unresolved in upcoming NDI guidance documents. Our issues and concerns are unique to probiotics, as we have stated in previous stakeholder comments, and IPA’s request for a public meeting, is intended to ensure that FDA has all of the information it needs to address these complex topics”

Town Hall

Also during the IPA World Congress + Probiota Americas event, IPA announced it will formally request that FDA host a public meeting  to give interested stakeholders an opportunity to discuss the unique issues related to FDA’s regulation of probiotics in dietary supplements, such as issues concerning NDI notification and the labeling of the quantity of ingredients in a dietary supplement. 

“CBD captured the Agency’s attention for many years, and FDA decided to host a meeting specific to CBD,” ​said Dr Corey Hilmas, KGK’s Chief Scientific Affairs and Regulatory Officer and IPA US Regulatory Task Force Leader.

“We believe a focused town hall, led by IPA in collaboration with other groups, to address ongoing, unresolved issues related to probiotic NDIs, labeling, and a host of other topics is long overdue. A town hall would be a mutually beneficial process and dialog to have between the probiotic industry and the Agency over lingering issues that could not be resolved in any other manner.”

The Agency confirmed to NutraIngredients-USA that it has received the IPA’s request for a public meeting and is “currently considering this request”.



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