On October 19, 2026, the U.S. Food and Drug Administration (FDA) issued final guidance (the “Final Guidance”) on identity and safety information for New Dietary Ingredient Notifications (NDINs).
FDA’s New Dietary Ingredient (NDI) Notifications and Related Issues; Identity and Safety Information About the NDI finalizes the identity, history of use, and safety summary sections of FDA’s 2016 revised Draft Guidance.[1] For companies preparing to bring a new ingredient to market, it is the most concrete statement yet of what FDA expects to see in a notification. Industry has long asked for that clarity, and this release is a meaningful step toward it. However, the Final Guidance still fails to address fundamental questions regarding when an NDIN is even required, leaving the industry still a bit perplexed on how to navigate the field.
The Final Guidance is organized as a set of questions and answers, which makes it useful as a practical checklist. Manufacturers, ingredient suppliers, and distributors can use it to prepare an NDIN and to audit the files they already have for gaps in information now expected to be required in such an application.
On identity, the FDA recommends that companies establish specifications for the NDI, and for those components of the NDI and dietary supplement that are relevant to establishing the basis for the safety of the dietary supplement. This includes how the “acceptance criteria” was reached based on the results of each test, check, or measurement used to develop the specification. The FDA further advises that NDINs should include a detailed description of the identity specifications in table form and gives concrete examples in the guidance of the information it expects to be included in the submission. Importantly, the FDA advises that the acceptance criteria—the numerical limits, ranges, or other criteria for the tests described—which are included in the specification, be specific. Likewise, analytical methods that are included in specifications should be detailed, covering all steps from preparing the test sample to reporting the results.
The Final Guidance also addresses discrete chemical entities, botanicals, extracts, fermentation-derived ingredients, live microbial dietary ingredients, and other types of NDIs, describing the information FDA will look for in each case. For instance, if your NDI is a botanical or is derived from a botanical, the botanical’s Latin binomial name must be included in the submission. The FDA also sets forth additional information that it recommends be included such as details regarding the part of the plant from which the ingredient is derived, descriptions of specific tests or examinations used to ensure correct taxonomic identity, conditions of propagation and cultivation, and periods during which the botanical is cultivated or harvested among others.
On safety, the FDA also offers instructive guidance. It recognizes the value of historical use data and scientific research, and it explains how to bridge gaps between historical use and proposed conditions of use through additional evidence. FDA sets 25 years of widespread use as a general benchmark for relying on history of use alone for safety, but it also acknowledges that shorter histories can be supported with additional information, which is especially relevant for new ingredients. Examples of documentation of an NDI’s history of use in food and history of safe use may include:
- published data and information, such as peer-reviewed scientific literature;
- reports from an authoritative body or source;
- survey data on food or nutrient composition and consumption, such as the National Health and Nutrition Examination Survey (NHANES), FDA Total Diet Study, or other federal agency-sponsored studies;
- advertisements or other published promotional material describing the composition of products; published agricultural or food production data;
- cookbooks or other published recipes documenting the use of an ingredient to prepare conventional foods;
- survey or consumption data from non-Federal agency sources;
- product sales or production data such as records, commercial invoices, and production runs;
- product labels; and
- compositional analysis, such as liquid or gas chromatography, mass spectrometry, infrared spectroscopy, and nuclear magnetic resonance spectroscopy.
Further, regarding safety, the FDA states that it will consider new alternative methods (NAMs) to animal testing to support risk or safety assessment for FDA-regulated products, a welcome signal for companies looking to reduce animal testing. Companies that choose to include NAMs in their NDINs to demonstrate other evidence of safety should include information demonstrating that the NAM is scientifically valid, fit-for-purpose, reliable and appropriate for use in the dietary supplement context.
Though the FDA’s Final Guidance is substantial with regards to identity and safety, it does not resolve all the open questions still pending from the 2016 Draft Guidance, limiting its commentary to only the identity and safety sections of the 2016 version. This is now in addition to FDA’s final guidance regarding NDIN procedures and timeframes released in March 2024 (Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry)that companies must consider when planning a submission. Several fundamental questions remain open and are still in draft, including when an ingredient is considered new, when a notification is required, and what qualifies as a dietary ingredient. Until all sections are finalized, companies will have to work from a mix of final and draft material to prepare their NDINs.
Companies should review the guidance now and evaluate their current and planned NDINs against the Final Guidance. FDA continues to review stakeholder comments and to develop guidance on master files and other outstanding issues. Stakeholders can submit comments at any time under docket number FDA-2025-D-6501 on Regulations.gov, and pre-NDIN meetings are available for companies that are unsure how FDA will view their data.
If you have any questions regarding NDIN strategy, identity and safety documentation, file audits, and preparing a NDIN under the new guidance, please contact the authors of this blog post.
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If you have questions, please reach out to the author(s).
The Health Law Advisor blog is currently edited by Emily Chi Fogler.
ENDNOTES
[1] FDA’s guidance on New Dietary Ingredient Notifications has been revised multiple times since it was first issued in July 2011, each time focusing on a different section of the guidance: revised August 2016; revised March 2024; revised April 2024; and revised October 2026.
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