The U.S. Food and Drug Administration’s Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR) offered an updated list of draft and final guidance topics considered to be a priority for the FDA Foods Program to complete in 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• Draft Guidance on Dietary Supplement Master Files
• Draft Guidance on Low-Moisture Ready to Eat Foods (including infant formula)
• Draft Guidance on Action Levels for Arsenic in Food Intended for Babies and Young Children
• Draft Guidance on Action Levels for Cadmium in Food Intended for Babies and Young Children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• Draft Guidance for Industry: Questions and Answers About Dietary Guidance Statements in Food Labeling Sec. 555.250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• Draft Guidance for Industry: Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination

Guidance documents represent the FDA’s current thinking on a specific, but do not impose legally enforceable requirements.

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.