New FDA guidance in the works for 2025

The FDA has published its proposed agenda for 2025 guidance, including new topics such as food colorings.

Topics on the agenda are a priority for the Food and Drug Administration’s Human Foods Program to complete during 2025. New topics include:

• Action Level for Opiate Alkaloids on Poppy Seeds: Draft Guidance for Industry;
• Food Colors Derived from Natural Sources: Fruit Juice and Vegetable Juice as Color Additives in Food; Draft Guidance for Industry; and
• New Dietary Ingredient Notifications and Related Issues: Identity and Safety Information About the NDI: Guidance for Industry

The complete list can be found at Foods Program Guidance Under Development | FDA. The FDA may also issue additional guidance that is not on the list.

Public comments on the list of human food and cosmetic guidance topics, including suggestions for alternatives or recommendations on the topics the FDA is considering, can be submitted to https://www.regulations.gov/, using Docket FDA-2022-D-2088.

Guidance documents represent the FDA’s current thinking on a specific topic. The information can help stakeholders plan for potential changes that may impact their businesses and organizations. Guidance documents do not impose legally enforceable requirements. 

The list of guidance topics is just one of several resources the FDA’s Human Foods Program routinely shares with stakeholders and partners to inform them of agency priorities. Most proposed and final rules are on the “Unified Agenda of Regulatory and Deregulatory Actions,” which is published by the Office of Information and Regulatory Affairs in the Office of Management and Budget. 

The Unified Agenda is updated twice a year and reports planned actions by federal departments and agencies government wide. A list of those FDA regulations and guidance documents under administration review is available on the Office of Management and Budget website.

Additional information about FDA guidance can be found on the following websites: