The U.S. Food and Drug Administration (FDA)’s Human Foods Program proposed its 2025 guidance agenda, which includes a list of topics for which it either plans to create new guidance documents or revise existing ones.

Guidance documents reflect FDA’s current thinking on a specific topic, and the information can help stakeholders plan for potential changes, though guidance documents themselves aren’t considered legally enforceable requirements.

New topics will include guidance documents on New Dietary Ingredient Notifications (NDINs), food colors derived from natural sources, and the action level for opiate alkaloids in poppy seeds.

FDA also intends to revise existing guidance documents on the following topics:

• Action levels for cadmium in food intended for babies and young children
• Action levels for inorganic arsenic in food intended for babies and young children
• Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 12: Preventive Controls for Chemical Hazards
• The Food Traceability Rule: Questions and Answers; Draft Guidance for Industry

Clarity on NDINs

Observers have long criticized the agency for not providing a clear enough framework when it comes to navigating the complicated and controversial process of choosing the right pathway to market for a new ingredient in foods, beverages, and supplements.  

Today, companies can introduce a new ingredient to the food supply through the self-affirmed GRAS (Generally Recognized as Safe) pathway if their ingredient is widely accepted as safe for intended uses, and notifying the FDA is not mandatory. However, for ingredients that are designated as New Dietary Ingredients, pre-market notification to FDA is required.  

In recent years, many ingredients that were introduced to the marketplace through the GRAS (Generally Recognized as Safe) pathway have been targeted in warning letters from FDA, with the agency expressing that the ingredients should have gone through the NDIN pathway, and are therefore considered unapproved new drugs. This has impacted a wide range of ingredients including NAC, NMN, and more.

FDA had twice attempted to issue a draft guidance on the NDIN procedure in 2011 and 2016, before again attempting to release a final multi-sectional guidance document on NDINs in early 2024, which has stalled.

In March, Health and Human Services Secretary Robert F. Kennedy, Jr. directed the FDA to explore potential rulemaking to revise its final rule and guidance document to eliminate the self-affirmed GRAS pathway, in an effort to “enhanced the FDA’s oversight of ingredients considered to be GRAS and bring transparency to American consumers.”

Natural Food Colors

While FDA hasn’t provided great detail on precisely what it intends to accomplish on the front of natural food colors, industry observers have long critiqued current FDA thinking on how natural food colors can be marketed on a product label.

After fast-tracking the approval of three new natural food colors in May, and announcing earlier that it would work with the food industry on a voluntary basis to phase out synthetic dyes, it seems likely that the agency intends to facilitate the use of natural food colors by all means.

Current FDA rulemaking makes it rather difficult for brands to advertise the use of natural food colors on labels. Even if a color additive comes from a natural source, current rulemaking precludes it from being labeled as ‘natural’ if it would not normally be a part of that food, or if it was processed in some way. While FDA hasn’t actively enforced this guidance, it has been the subject of class action lawsuits.

Public comments on all existing agenda topics can be submitted here.