The FDA Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR) has released a list of draft and final guidance topics that are a priority for the FDA Foods Program to complete during the next 12 months.

The guidance documents do not impose legally enforceable requirements, but they can help stakeholders plan for potential changes that may impact their businesses and organizations. The agency anticipates it will publish many of the listed documents by January 2024.

The priority list of draft and final guidance topics include (by category):

Allergens

• Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 5); Guidance for Industry
• Compliance Policy Guide Sec. 555.250 Major Food Allergen Labeling and Cross-contact; Draft Guidance for FDA Staff
• Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act; Guidance for FDA Staff and Stakeholders

Food Additives

• Preparation of Premarket Submission for Food Contact Substances (Chemistry Recommendations): Draft Guidance for Industry
• Premarket Consultation on Cultured Animal Cell Foods: Draft Guidance for Industry

Food Safety

• Foods Derived from Plants Produced Using Genome Editing; Draft Guidance for Industry
• Inorganic Arsenic in Apple Juice: Action Level; Draft Guidance for Industry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– Evidence Recommended for Release of Goods Subject to DWPE and Removal of a Foreign Manufacturer’s Goods from DWPE; Draft Guidance for Industry
• Compliance Policy Guide Sec. 555.320 Listeria monocytogenes in Human Food; Draft Guidance for FDA Staff

FSMA

• 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Analysis and Risk-Based Preventive Controls for Human Food; Appendix 1: Potential Hazards for Foods and Processes; Draft Guidance for Industry
• Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 11: Food Allergen Controls; Draft Guidance for Industry
• Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 16: Validation of Process Controls; Draft Guidance for Industry
• Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 17: Classifying Food as Ready-To-Eat or Not Ready- to-Eat; Draft Guidance for Industry
• Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 18: Acidified Foods; Draft 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: Guidance for Industry

Labeling

• 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: Draft Guidance for Industry

Public comments on the list of 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.