FDA Finalizes NDI Guidance on Identity and Safety Information, Leaving Some Industry Concerns Open

FDA has issued final guidance on the identity and safety information that should accompany a new dietary ingredient notification (NDIN) and a notice of availability published in the Federal Register on Oct. 20.^1,2 The question-and-answer document, filed under docket FDA-2025-D-6501, finalizes Sections VI.A, VI.B, and VI.C of the agency's 2016 revised draft guidance, according to FDA.³ The guidance is nonbinding, and FDA says it will finalize the remaining sections of the draft one at a time.³

What Does the Final Guidance Recommend?

On identity, the guidance asks notifiers to describe an ingredient well enough to show what it is and how it relates to the materials supporting its safety.¹ Recommendations vary by ingredient type. For botanicals, FDA points to taxonomic verification, plant part, processing, voucher specimens, and exclusion of adulterants. For extracts, it calls for details on solvents, ratios, marker substances, and standardization. It also recommends stability data to support expiration dating.¹

On safety, FDA recommends a safety narrative: an objective evaluation that includes total daily intake estimates, toxicity concerns, effects on vulnerable groups, and the role of non-dietary ingredients.^1,2 Notifiers relying on history of use alone should generally show about 25 years of widespread use, and historical intake should equal or exceed the proposed intake, the agency says. When proposed use differs from history, FDA recommends adding animal, human, or alternative-method data.¹ For products containing multiple new dietary ingredients, notifiers can submit data on the combination, or data on each ingredient plus an explanation of why the combination raises no new concerns.¹

How Are AHPA and CRN Responding?

AHPA President and CEO Graham Rigby said the final guidance contains useful refinements but leaves key questions open.

"While the newly finalized guidance introduces some constructive refinements — such as removing language that recommended submitting separate notifications for every product formulation and clarifying how notifiers can present safety data for multi-ingredient mixtures — it leaves several longstanding industry concerns unaddressed,” Rigby said in a statement to Nutritional Outlook. “The guidance maintains existing positions on finished product safety expectations, specification details, and stability standards while deferring broader questions regarding the statutory scope of chemical alteration. For example, the guidance suggests that botanical extract manufacturers relying on a history of safe use will still need to carefully navigate these evolving expectations on a case-by-case basis.”

The Council for Responsible Nutrition (CRN) struck a more welcoming tone on several points. In a statement, the trade group said the final guidance gives manufacturers greater flexibility in demonstrating safety, recognizes the value of historical use and existing scientific evidence, and sets clearer expectations. CRN added that several of the improvements reflect recommendations it had previously submitted to FDA.

However, CRN also voiced disappointment on two points. It said FDA retained its generally recommended 25-year benchmark for establishing a history of safe use, although the agency clarified that shorter periods may be supported by additional evidence. CRN also noted that the guidance continues to recommend that notifications include safety information about other dietary and non-dietary ingredients in finished supplements, an approach the group has urged FDA to reconsider.

"More broadly, important regulatory questions remain unresolved, particularly regarding what qualifies as a dietary ingredient, when an ingredient is considered new, and when a notification is required. CRN urges FDA to prioritize addressing these fundamental issues to provide the regulatory certainty necessary to support responsible innovation and consumer access to safe dietary supplements," the group said.

What Does This Mean for Nutraceutical Professionals?

For regulatory and quality teams, the identity section works as a documentation checklist. Specifications, manufacturing process descriptions, analytical methods, and stability data all feature in the recommendations, so gaps in an ingredient's file are likely to surface while preparing a notification.¹

Botanical extract suppliers face the issue Rigby raised most directly. Under the guidance, history of safe use must match the proposed intake, and FDA gives examples in which food-based history does not support concentrated extracts.¹ Suppliers should expect to compare an extract's composition and daily intake against the historical material, and to plan for additional data where the two diverge.¹ The 25-year benchmark remains, but because FDA acknowledges that shorter histories can be supported by additional evidence, newer ingredients with limited history may still have a path if the supporting data are strong.

Formulators of multi-ingredient products have more clarity on how to present safety data, as Rigby noted, though FDA says it prefers combination data when most of the evidence concerns the combination.¹ Both trade groups noted that finished-product expectations remain in place, so brand owners and contract manufacturers should plan to document the other dietary and non-dietary ingredients in a formula. The agency also offers pre-NDIN meetings for questions about differences from historical use, and it accepts comments on the guidance at any time.^1,2

Where Does This Leave the NDI Landscape?

The guidance is the latest step in a piecemeal process that Nutritional Outlook has followed for years. When FDA released its 2016 revised draft, industry welcomed a master-file option in place of per-product notifications and a safety standard more closely tied to the statute's "reasonably expected to be safe" language.⁴ In March 2024, FDA finalized the procedures-and-timeframes section and signaled more to come,⁵ and in 2025 it listed NDIN guidance on its Human Foods Program agenda.⁶ This year, industry groups urged FDA to take a broader view of which substances qualify as dietary supplement ingredients.⁷

With the identity and safety sections now final, attention shifts to the sections still in draft and to the questions the trade groups say remain open. Rigby pointed to the statutory scope of chemical alteration, while CRN cited what qualifies as a dietary ingredient, when an ingredient is considered new, and when a notification is required. Until FDA settles those, notifiers will be building files against guidance that is partly final and partly draft, and for botanical extracts, outcomes may continue to turn on case-by-case review.

References

1. Guidance for Industry: New Dietary Ingredient (NDI) Notifications and Related Issues; Identity and Safety Information About the NDI. US Food and Drug Administration; October 2026. Accessed October 20, 2026. https://www.fda.gov/media/195770/download
2. New Dietary Ingredient (NDI) Notifications and Related Issues; Identity and Safety Information About the NDI; Guidance for Industry; Availability. Federal Register. 91 FR 66336. Published October 20, 2026. Accessed October 20, 2026. https://www.federalregister.gov/documents/2026/10/20/2026-21453/new-dietary-ingredient-ndi-notifications-and-related-issues-identity-and-safety-information-about
3. FDA issues guidance on identity and safety information for new dietary ingredient notifications. Constituent update. US Food and Drug Administration; October 19, 2026. Accessed October 20, 2026. https://www.fda.gov/food/hfp-constituent-updates/fda-issues-guidance-identity-and-safety-information-new-dietary-ingredient-notifications
4. Grebow J. 2 big wins for supplement industry in FDA's new NDI draft guidance. Nutritional Outlook. August 11, 2016. Accessed October 20, 2026. https://www.nutritionaloutlook.com/view/2-big-wins-supplement-industry-fdas-new-ndi-draft-guidance
5. FDA publishes final guidance on NDIN procedures and timeframes, with more to follow. Nutritional Outlook. March 6, 2024. Accessed October 20, 2026. https://www.nutritionaloutlook.com/view/fda-publishes-final-guidance-on-ndin-procedures-and-timeframes-with-more-to-follow
6. FDA releases guidance agenda for the Human Foods Program that includes NDIN guidance. Nutritional Outlook. July 1, 2025. Accessed October 20, 2026. https://www.nutritionaloutlook.com/view/fda-releases-guidance-agenda-for-human-foods-program-that-includes-ndin-guidance
7. Industry groups urge FDA to broaden definition of dietary supplement ingredients. Nutritional Outlook. May 5, 2026. Accessed October 20, 2026. https://www.nutritionaloutlook.com/view/industry-groups-urge-fda-to-broaden-definition-of-dietary-supplement-ingredients