The U.S. Food and Drug Administration (FDA) recently released an updated list of priority draft and final guidance documents related to foods and dietary supplements that the agency intends to publish by the end of this year.
FDA last updated this list in January 2022.1 The updated list2 omits seven guidance documents that the agency published in the first half of the year and adds one new draft guidance document, related to preparation of premarket submissions for food contact substances. The food and dietary supplement items on the list are as follows:
Title of Guidance
Category
Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 5); Draft Guidance for Industry
Allergens
Policy Regarding N-acetyl-L-cysteine; Guidance for Industry
Dietary Supplements
New Dietary Ingredient (NDI) Notifications and Related Issues: NDI Notification Procedures and Timeframes; Guidance for Industry
Best Practices for Convening a GRAS Panel; Guidance for Industry
Food Additives
Premarket Consultation on Cultured Animal Cell Foods: Draft Guidance for Industry
Preparation of Premarket Submission for Food Contact Substances (Chemistry Recommendations): Draft Guidance for Industry
Foods Derived from Plants Produced Using Genome Editing; Draft Guidance for Industry
Food Safety
Inorganic Arsenic in Apple Juice: Action Level; Draft Guidance for Industry
Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry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– Evidence Recommended for Release of Goods Subject to DWPE and Removal of a Foreign Manufacturer's Goods from DWPE; Draft Guidance for Industry
Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation (Layers with Access to Areas Outside the Poultry House): Questions and Answers Regarding the Final Rule; Guidance for Industry
Compliance Policy Guide Sec. 555.320 Listeria monocytogenes in Human Food; Draft Guidance for FDA Staff
Hazard Analysis and Risk-Based Preventive Controls for Human Food; Appendix 1: Potential Hazards for Foods and Processes; Draft Guidance for Industry
FSMA
Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 11: Food Allergen Controls; Draft Guidance for Industry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
Refusal of Inspection by a Foreign Food Establishment or Foreign Government; Guidance for Industry
Foreign Supplier Verification Programs for Importers of Food for Humans and Animals; 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 of Plant-based Milk Alternatives; Draft 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
Protein Efficiency Ratio (PER) Rat Bioassay Studies to Demonstrate that a New Infant Formula Supports the Quality Factor of Sufficient Biological Quality of Protein; Draft Guidance for Industry
Nutrition
FDA plans to update the list every six months. The ambitious agenda signals FDA’s commitment to the food program and continuing efforts to expand the use of guidance.
We will continue to monitor the FDA’s issuance of guidance documents affecting the food and dietary supplement industries. Please do not hesitate to contact us with any questions.
Authored by Maile Gradison and Connie Potter.
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