July 6, 2023
Today, the U.S. Food and Drug Administration’s Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR) released an updated list of draft and final guidance topics that are a priority for the FDA Foods Program to complete during 2023. The list updates the guidance agenda released in February 2023 and focuses on Level 1 draft and final guidances.
The following guidance topics have been added to the agenda:
- Draft Guidance on Dietary Supplement Master Files
- Draft Guidance on Low-Moisture Ready to Eat Foods (including infant formula)
- Draft Guidance on Action Levels for Arsenic in Food Intended for Babies and Young Children
- Draft Guidance on Action Levels for Cadmium in Food Intended for Babies and Young Children
- Amendment to the Menu Labeling Supplemental Guidance
- Guidance on Protein Efficiency Ratio (PER) Rat Bioassay Studies to Demonstrate that a New Infant Formula Supports the Quality Factor of Sufficient Biological Quality of Protein.
Since the release of the agenda in February 2023, the FDA has issued the following guidances that were on the list:
- Draft Guidance for Industry: Questions and Answers About Dietary Guidance Statements in Food Labeling Sec. 555.250
- Major Food Allergen Labeling and Cross-contact Draft Compliance Policy Guide - Guidance for FDA Staff
- Guidance for Industry: Action Level for Inorganic Arsenic in Apple Juice
- Draft Guidance for Industry: Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination
The FDA is taking this action to provide continued transparency for stakeholders regarding foods program priorities. 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 www.regulations.gov, using Docket ID: FDA - 2021-N-0553.
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.
For More Information:
- Foods Program Guidance Under Development
- Fact Sheet: FDA Good Guidance Practices
- What Does FDA Regulate