- On July 6, the FDA published an updated list of draft and final guidance topics that are a priority 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 topics were added:
- Draft Guidance on Dietary Supplement Master Files
- Draft Guidance on Low-Moisture Ready to Eat Foods (including infant formula)
- Draft Guidance on Action Levels for Arsenic in Food Intended for Babies and Young Children
- Draft Guidance on Action Levels for Cadmium in Food Intended for Babies and Young Children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.
- The FDA has issued the following guidance documents since publishing the February 2023 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- Draft Guidance for Industry: Questions and Answers About Dietary Guidance Statements in Food Labeling Sec. 555.250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- Draft Guidance for Industry: Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination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 noted in their press release that although it is the Agency’s intent to publish all guidance documents included in the list, modifications may be needed. Stakeholders may submit comments on the list of guidance topics to www.regulations.gov, using Docket ID: FDA – 2021-N-0553. Please feel free to contact Keller and Heckman at fooddrug@khlaw.com for assistance providing FDA comments.