The U.S. Food and Drug Administration’s (FDA’s) Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR) released a list of draft and final guidance topics that are a priority for the FDA Foods Program to complete within the next 12 months.
The agency anticipates it will publish many of the documents on the list by January 2024. The list focuses on Level 1 draft and final guidances. Documents on the list related to foods include:
- Guidance for industry: Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 5)
- Draft guidance for FDA staff: Compliance Policy Guide Sec. 555.250 Major Food Allergen Labeling and Cross-Contact
- Guidance for FDA staff and stakeholders: Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act
- Draft guidance for industry: Preparation of Premarket Submission for Food Contact Substances (Chemistry Recommendations)
- Draft guidance for industry: Premarket Consultation on Cultured Animal Cell Foods: Draft Guidance for Industry
- Draft guidance for industry: Foods Derived from Plants Produced Using Genome Editing
- Draft guidance for industry: Inorganic Arsenic in Apple Juice: Action Level
- Draft guidance for industry: Detention Without Physical Examination (DWPE) of Fish and Fishery Products Due to the Appearance of Adulteration by Bacterial Pathogens, Unlawful Animal Drugs, Scombrotoxin (Histamine), or Decomposition—Evidence Recommended for Release of Goods Subject to DWPE and Removal of a Foreign Manufacturer's Goods from DWPE
- Draft guidance for FDA staff: Compliance Policy Guide Sec. 555.320 Listeria monocytogenes in Human Food
- Draft guidance for industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food, Appendix 1: “Potential Hazards for Foods and Processes”
- Draft guidance for industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 11: “Food Allergen Controls,” Chapter 16: “Validation of Process Controls,” Chapter 17: “Classifying Food as Ready-To-Eat or Not Ready- to-Eat,” and Chapter 18: “Acidified Foods”
- Guidance for industry: Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption for Sprout Operations
- Draft guidance for industry: Labeling of Plant-Based Alternatives to Animal-Derived Foods
- Draft guidance for industry: Questions and Answers About Dietary Guidance Statements in Food Labeling
- Draft guidance for industry: Use of Nutrient Content Claims for Added Sugars in the Labeling of Human Food Products
Although 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.
Public comments on the list of priority guidance topics, including suggestions for alternatives or recommendations on the topics FDA should consider, can be submitted to www.regulations.gov, using Docket ID: FDA-2021-N-0553.