New Dietary Ingredient Notifications (NDIs)

Recent updates:

JUNE 3, 2024: CRN submitted comments on FDA’s final guidance for Industry on New Dietary Ingredient Notification Procedures and Timeframes - Dietary Supplements and new draft guidance on New Dietary Ingredient Notification (NDIN) Master Files for dietary supplements:

  • CRN’s comments on FDA’s Guidance on New Dietary Ingredient Notification Procedures and Timeframes urge the agency to expedite the release of other final guidance sections on New Dietary Ingredient Notifications (NDINs) that have been pending since 2016, and to reconsider its overreaching interpretations that impose unnecessary burdens on the dietary supplement industry without enhancing consumer safety. They also emphasize that NDINs should only include essential safety information and should not require separate notifications for each dietary supplement containing a New Dietary Ingredient (NDI), unless specific conditions altering safety are met.

  • CRN comments on FDA’s Draft Guidance on New Dietary Ingredient Notification Master Files ask the agency to clarify the process for submitting master files for previously notified New Dietary Ingredients (NDIs) to encourage more submissions. They also emphasize the need for strict FDA enforcement against non-compliance to enhance public safety.

MARCH 5, 2024: FDA on March 5 released a Final Guidance for Industry, New Dietary Ingredient Notification Procedures and Timeframes—Dietary Supplements. The release appears to follow CRN’s earlier recommendation to split up the earlier 2016 Draft Guidance into separate parts and release them individually rather than trying to address all aspects of the NDI process at once.

JULY 21, 2022: CRN comments on FDA’s NDI draft guidance call out the agency's failure to address major concerns expressed by industry related to earlier guidance issued in 2016 that remains "draft"—read more in this unlocked edition of the CRN Daily Supplement.

MAY 19, 2022: CRN Responds to FDA’s NDI Announcement

As of 2022, industry continues to await a final guidance for New Dietary Ingredients (NDIs), after more than 10 years since the first draft.

CRN most recently called for action on NDIs, applauding the confirmation of Dr. Robert M. Califf as FDA Commissioner, urging the agency to issue final guidance for new dietary ingredients, along with an official list of pre-DSHEA dietary ingredients that are “grandfathered” under the 1994 law.

As noted in CRN's 2021 annual reportCRN conducted meetings in May 2021 with FDA Acting Commissioner Janet Woodcock and her team, encouraging the advancement of top supplement issues, with final NDI guidance on the agenda.

CRN NDI Notification comments timeline:












More on NDI notifications:

Mister on New Dietary Ingredients: Will FDA protect consumers from pirates and piggybackers?

Public safety is inherently intertwined with NDI requirements, CRN President & CEO Steve Mister observed in a guest article for NutraIngredients-USA. So, why is it so hard to get FDA to enforce the law when it comes to NDIs? Mister noted that NDI notifications and master files represent a way to give consumers an assurance of safety in these ingredients. Citing CBD as an example, he advised, "It's time FDA takes the safety issues with NDIs as seriously as it does the safety issues is raises for CBD." Read more.

Integrating master files in the NDI notification process to facilitate innovation in dietary supplements

This article in RAPS by CRN's Haiuyen Nguyen discusses the application of master files to the new dietary ingredient notification process to protect intellectual property of ingredient manufacturers and incentivize submission of NDI notifications. The author describes an NDI master file model, based on the US drug master file, as a proposal for consideration by the US Food and Drug Administration.

Questions? Contact Haiuyen Nguyen.