Earlier this year, the FDA released the draft and final guidance topics that are a priority for the agency’s Foods Program to complete during 2024. Since January, the FDA has issued the following guidances that were on the list:
- New Dietary Ingredient (NDI) Notifications and Related Issues: NDI Notification Procedures and Timeframes: Guidance for Industry
- New Dietary Ingredient Notification Master Files for Dietary Supplements; Draft Guidance for Industry
- Foods Derived from Plants Produced Using Genome Editing; Guidance for Industry
- Recommendations for Collecting Representative Samples for Food Testing Used as Evidence for Release of Certain Fish and Fishery Products Subject to Detention Without Physical Examination (DWPE) and Removal of a Foreign Manufacturer’s Goods from DWPE: Guidance for Industry
- Hazard Analysis and Risk-Based Preventive Controls for Human Food; Appendix 1: Potential Hazards for Foods and Processes; Draft Guidance for Industry
Guidance documents represent the FDA’s current thinking on a specific topic and the information can help stakeholders plan for potential changes that may impact their businesses and organizations. Guidance documents do not impose legally enforceable requirements.
Although the FDA’s intent is to publish all draft and final guidance topics on the list, modifications in plans may be needed to support emerging issues and Administration priorities. We also may issue additional guidances that are 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.
The FDA’s list of guidance topics is just one of several resources that the 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.
The guidance documents that have issued so far in 2024 have been removed, and an updated list can be found at Foods Program Guidance Under Development.
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Posted in Dietary Supplements, FDA and USDA Regulatory Update, Foods.