FDA releases guidance agenda for the Human Foods Program that includes NDIN guidance

The U.S. Food and Drug Administration (FDA) has published its 2025 Human Foods Program Guidance Agenda, highlighting priorities for completion in 2025. Among the topics highlighted by the agenda was “New Dietary Ingredient Notifications and Related Issues: Identity, and Safety Information About the NDI: Guidance for Industry.”

Final guidance on the new dietary ingredient notification (NDIN) process has been a long time in the making. The agency released its NDI draft guidance in 2016, and only began releasing final guidance on NDINs in March of 2024 with final guidance on procedures and timeframes. FDA’s strategy for final guidance was to separate the guidance into discrete sections for ease of use, based on suggestions from commenters on the 2016 draft guidance. In April of 2024, FDA published a draft guidance for the submission of NDIN master files. Master files allow manufacturers submitting NDINs to create a master file for its ingredient, authorizing clients to refer to the master file in their own NDIN submissions. In a June 11 constituent update, FDA released educational materials on the NDIN process, including two educational videos and a fact sheet.

Another topic on the guidance agenda is “Food Colors Derived from Natural Sources: Fruit Juice and Vegetable Juice as Color Additives in Food; Draft Guidance for Industry.” This guidance is in line with efforts by HHS to phase out petroleum-based synthetic dyes, authorize natural color additives and accelerate the review and approval of further natural color additives. FDA has, so far, granted three color additive petitions for ingredients made from natural source. Major consumer packaged goods companies are already committing to divesting from synthetic color additives in response to the HHS announcement, including Kraft Heinz, General Mills, Nestle, and Conagra.

The full list of guidance topics under development can be viewed here.