FDA releases updated priority list of food guidance documents intended for publication by January 2023

03 February 2022

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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 an updated list of priority draft and final guidance documents related to foods and dietary supplements that the agency intends to publish in the next year.

Index

Newly-Announced Guidance Documents
Complete List of Planned Guidance Documents to Be Published by January 2023
Next steps

The FDA had previously released in June 2021 a list of draft and final guidance documents it intended to publish over the next year and noted that it would release an update to the list every six months.¹The updated list² released this week includes six new proposed guidance documents.

Newly-Announced Guidance Documents

The following proposed guidance documents have been added to the FDA’s list. The new items include draft and final guidance documents related to pre-market activities for cell-cultured products, foods derived via gene editing, labelling of plant-based foods (in addition to the previously-announced forthcoming guidance on plant-based milks), and notifications for new dietary ingredients.

Food Additives
- Premarket Consultation on Cultured Animal Cell Foods: Draft Guidance for Industry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- Foods Derived from Plants Produced Using Genome Editing; Draft Guidance for Industry
- Reconditioning of Fish and Fishery Products by Segregation; Guidance for Industry
Labeling
- Labeling of Plant-Based Alternatives to Animal-Derived Foods; Draft Guidance for Industry
Dietary Supplements
- New Dietary Ingredient (NDI) Notifications and Related Issues: NDI Notification Procedures and Timeframes; Guidance for Industry

Complete List of Planned Guidance Documents to Be Published by January 2023

Title of Guidance	Category
Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Defined in the Federal Food, Drug, and Cosmetic Act; Draft Guidance for FDA Staff and Stakeholders	Allergens
Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 5); Draft Guidance for Industry	Allergens
Testing Methods for Asbestos in Cosmetic Products Containing Talc; Draft Guidance for Industry	Cosmetics
Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-market Notifications; Draft Guidance for Industry	Dietary Supplements
New Dietary Ingredient (NDI) Notifications and Related Issues: NDI Notification Procedures and Timeframes; Guidance for Industry	Dietary Supplements
Best Practices for Convening a GRAS Panel; Guidance for Industry	Food Additives
Premarket Consultation on Cultured Animal Cell Foods: Draft Guidance for Industry	Food Additives
Foods Derived from Plants Produced Using Genome Editing; Draft Guidance for Industry	Food Safety
Action Levels for Lead in Juice; Draft Guidance for Industry	Food Safety
Inorganic Arsenic in Apple Juice: Action Level; Guidance for Industry	Food Safety
Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry	Food Safety
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	Food Safety
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	Food Safety
Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting; Guidance for Industry	Food Safety
Compliance Policy Guide Sec. 555.320 Listeria monocytogenes in Human Food; Draft Guidance for FDA Staff	Food Safety
Reconditioning of Fish and Fishery Products by Segregation; Guidance for Industry	Food Safety
Current Good Manufacturing Practice and Preventive Controls, Foreign Supplier Verification Programs, Intentional Adulteration, and/or Produce Safety Regulations: Enforcement Policy Regarding Certain Provisions; Guidance for Industry	FSMA
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	FSMA
Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 16: Validation of Process Controls; Draft Guidance for Industry	FSMA
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	FSMA
Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 18: Acidified Foods; Draft Guidance for Industry	FSMA
Questions and Answers Regarding the Accredited Third-Party Certification Program: Draft Guidance for Industry	FSMA
Refusal of Inspection by a Foreign Food Establishment or Foreign Government; Guidance for Industry	FSMA
Foreign Supplier Verification Programs for Importers of Food for Humans and Animals; Guidance for Industry	FSMA
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	FSMA
Labeling of Plant-based Milk Alternatives; Draft Guidance for Industry	Labeling
Labeling of Plant-Based Alternatives to Animal-Derived Foods; Draft Guidance for Industry	Labeling
Questions and Answers About Dietary Guidance Statements in Food Labeling; Draft Guidance for Industry	Labeling
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

Next steps

The planned guidance initiatives could have a significant impact on the food industry, and the ambitious agenda signals a busy year ahead at the FDA. 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 about FDA guidance documents in development.

References

1 FDA releases priority list of food guidance documents FDA intends to publish by June 2022, Hogan Lovells Engage (June 30, 2021) https://www.engage.hoganlovells.com/knowledgeservices/news/fda-releases-priority-list-of-food-guidance-documents-fda-intends-to-publish-by-june-2022.

2 Foods Program Guidance Under Development, FDA, https://www.fda.gov/food/guidance-documents-regulatory-information-topic-food-and-dietary-supplements/foods-program-guidance-under-development (last visited Feb. 1, 2022).

Authored by Martin Hahn, Veronica Colas, and Connie Potter.

Contacts

Martin Hahn
Partner
Washington, D.C.

Veronica Colas
Counsel
Washington, D.C.

Connie Potter
Associate
Washington, D.C.

Index

Newly-Announced Guidance Documents
Complete List of Planned Guidance Documents to Be Published by January 2023
Next steps

Keywords FDA, Guidance Document, FSMA

Languages English

Topics Dietary Supplements and Medical Foods, Emerging Food Technology and New Product Development, Food Compliance, Enforcement, and Litigation, Food Legislation and Regulatory Policy Development, FSMA and Food Safety Regulation, Food Labeling, Food Advertising and Claims Substantiation, Premarket Authorizations, Food Additives, Food Contact, and GRAS

Countries United States