New Dietary Ingredient Notifications (NDIs)

Recent updates:

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 The release appears to follow CRN’s earlier recommendation to split up the earlier 2016 Draft Guidance into separate parts and release them individually rather than trying to address all aspects of the NDI process at once.

• Learn more in coverage from NutraIngredients-USA and WholeFoods Magazine. 

JULY 21, 2022: CRN comments on FDA’s NDI draft guidance call out the agency's failure to address major concerns expressed by industry related to earlier guidance issued in 2016 that remains "draft"—read more in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

• See additional coverage in NutraIngredients and Nutritional Outlook. 

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 report, CRN 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:

2023:

• CRN letter to FDA on planned master file Draft Guidance

2022:

• CRN comments on NDI Enforcement Discretion Draft Guidance

2020:

• CRN submits NDI master file framework proposal to FDA

2019:

• CRN gives feedback on FDA Responsible Innovations Dietary Supplements meeting

2017:

• CRN comments on the development of ODI list

2016:

• CRN comments on revised NDI Notifications Draft Guidance (2016)

2015:

• CRN letter supporting separate guidance on ingredient identification

2013:

• CRN comments on "chemically altered"
• CRN letter supporting AHPA's follow-up comments on NDI Notification Draft Guidance

2012:

• CRN comments on synthetic botanical constituents 
  • FDA's response to CRN's comments
    • CRN's counter-response to FDA

2011:

• CRN comments on NDI Notification Draft Guidance (2011)
  • Appendix A to comments
• CRN comments on Homotaurine

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.