Published yesterday, the guidance aims to help companies demonstrate that new dietary ingredients can reasonably be expected to be safe under their intended conditions of use before products reach consumers.
The document, New Dietary Ingredient (NDI) Notifications and Related Issues; Identity and Safety Information About the NDI, finalises three sections of the FDA’s revised 2016 draft guidance.
These cover ingredient and dietary supplement identity, history of use or other evidence of safety and a summary of the basis for a company’s safety conclusion.
Clarifying evidence requirements
The guidance addresses frequently asked questions about NDIN submissions, including the types of identity and safety information companies should provide and when the agency recommends submitting different types of studies.
For ingredient suppliers and supplement manufacturers, the recommendations clarify how to prepare the scientific evidence underpinning a notification, supporting regulatory planning and pre-market safety assessments.
Under the Federal Food, Drug, and Cosmetic Act, manufacturers or distributors generally must notify the FDA at least 75 days before introducing a dietary supplement containing an applicable NDI into interstate commerce.
The notification must include the information supporting their conclusion that the ingredient will reasonably be expected to be safe under the proposed conditions of use.
An NDI is generally an ingredient that was not marketed in the US in a dietary supplement before 15th October 1994.
Not every ingredient introduced after that date necessarily requires a notification, as statutory exceptions apply.
The FDA emphasised that the notification process gives the agency an opportunity to evaluate the safety information submitted before an applicable new ingredient enters the market.
Further guidance under development
The latest document forms part of the FDA’s phased approach to finalising its broader 2016 revised draft guidance on new dietary ingredient notifications. The agency said it would continue reviewing and analysing the remaining sections, updating the draft to identify which recommendations have become final.
The guidance provides recommendations rather than independently establishing legally enforceable obligations; underlying statutory and regulatory requirements remain applicable.
Industry stakeholders can submit comments on the final guidance at any time through Regulations.gov, using docket number FDA-2025-D-6501.
