FDA Releases Updated Priority List of Food Guidance Documents Targeted for Release by January 2023 | Hogan Lovells
The U.S. Food and Drug Administration’s (FDA) Center for Food Safety and Applied Nutrition (CFSAN) and the Office of Food Policy and Response (OFPR) have released an updated list of interim guidance documents and final priorities for foods and dietary supplements that the agency intends to publish next year.
The FDA previously released a list of draft and final guidance documents in June 2021 that it intended to publish over the next year and indicated that it would post an updated list every six months.1 The updated list2 released this week includes six proposed new guidance documents.
Recently announced guidance documents
The following proposed guidance documents have been added to the FDA list. New material includes draft and final guidance documents related to pre-market activities for products derived from cell cultures, foods derived from gene editing, labeling of foods of plant origin (in addition to upcoming guidance previously announced on plant-based milks), and notifications for new food ingredients.
- Food additives
- Pre-market consultation on foods made from cultured animal cells: draft guidance for industry
- Food safety
- Foods derived from plants produced using genome editing; Draft guidelines for industry
- Repackaging of fish and fish products by segregation; Industry Tips
- Labeling
- Labeling of plant-based alternatives to foods of animal origin; Draft guidelines for industry
- Food supplements
- Novel Food Ingredient (NDI) Notifications and Related Issues: NDI notification procedures and timelines; Industry Tips
Full list of guidance documents planned to be published by January 2023
|
Orientation title |
Category |
|
Assessment of the public health significance of food allergens other than the main food allergens defined in the Federal Food, Drug and Cosmetic Act; Draft Guidance for FDA Staff and Stakeholders |
Allergens |
|
Food Allergen Questions and Answers, including the Food Allergen Labeling and Consumer Protection Act 2004 (Edition 5); Draft guidelines for industry |
Allergens |
|
Test methods for asbestos in cosmetic products containing talc; Draft guidelines for industry |
Beauty products |
|
Policy regarding certain new food ingredients and food supplements subject to the requirement of pre-marketing notifications; Draft guidelines for industry |
Food supplements |
|
Novel Food Ingredient (NDI) Notifications and Related Issues: NDI notification procedures and timelines; Industry Tips |
Food supplements |
|
Best practices for convening a GRAS panel; Industry Tips |
Food additives |
|
Pre-market consultation on foods made from cultured animal cells: draft guidance for industry |
Food additives |
|
Foods derived from plants produced using genome editing; Draft guidelines for industry |
Food safety |
|
Action levels for lead in juice; Draft guidelines for industry |
Food safety |
|
Inorganic arsenic in apple juice: level of action; Industry tips |
Food safety |
|
action levels for lead in foods for babies and young children; Draft guidelines for industry |
Food safety |
|
Detention Without Physical Examination (DWPE) of Fish and Fish Products Due to Appearance of Adulteration by Bacterial Pathogens, Illegal Animal Drugs, Scombrotoxin (Histamine), or Decomposition – Recommended Evidence for Release of Goods subject to DWPE and removal of goods from a foreign manufacturer from DWPE; Draft guidelines for industry |
Food safety |
|
Prevention of Salmonella Enteritidis in shell eggs during production, storage and transport (layers with access to areas outside the barn): questions and answers regarding the final rule; Industry Tips |
Food safety |
|
Reduction of microbial risks for food safety in the production of seeds for germination; Industry tips |
Food safety |
|
Compliance Policy Guide Sec. 555.320 Listeria monocytogenes in human food; Draft FDA Staff Guidelines |
Food safety |
|
Repackaging of fish and fish products by segregation; Industry Tips |
Food safety |
|
Current Good Manufacturing Practices and Preventive Controls, Foreign Supplier Verification Programs, Intentional Tampering and/or Product Safety Regulations: Enforcement Policy Regarding Certain Provisions; Industry Tips |
FSMA |
|
hazard analysis and preventive controls based on food hazards; Appendix 1: Potential Food and Process Hazards; Draft guidelines for industry |
FSMA |
|
hazard analysis and preventive controls based on food hazards; Chapter 11: Food Allergen Controls; Draft guidelines for industry |
FSMA |
|
hazard analysis and preventive controls based on food hazards; Chapter 16: Validation of Process Controls; Draft guidelines for industry |
FSMA |
|
hazard analysis and preventive controls based on food hazards; Chapter 17: Classification of foods as ready-to-eat or non-ready-to-eat; Draft guidelines for industry |
FSMA |
|
hazard analysis and preventive controls based on food hazards; Chapter 18: Acidified Foods; Draft guidelines for industry |
FSMA |
|
Questions and Answers Regarding the Accredited Third-Party Certification Program: Draft Guidelines for Industry |
FSMA |
|
Refusal of inspection by a foreign food establishment or foreign government; Industry Tips |
FSMA |
|
Foreign supplier verification programs for importers of food and feed; Industry Tips |
FSMA |
|
Compliance and recommendations for the implementation of the Standards for the cultivation, harvesting, packaging and preservation of products intended for human consumption for sprouting operations: Guidance for industry |
FSMA |
|
Labeling of milk substitutes of plant origin; Draft guidelines for industry |
Labeling |
|
Labeling of plant-based alternatives to foods of animal origin; Draft guidelines for industry |
Labeling |
|
Questions and Answers on Dietary Guidance Statements in Food Labelling; Draft guidelines for industry |
Labeling |
|
Protein Efficacy Ratio (PER) Biological studies in rats to demonstrate that a new infant formula supports the quality factor of biologically sufficient protein quality; Draft guidelines for industry |
Nutrition |
Next steps
The planned guidance initiatives could have a significant impact on the food industry, and the ambitious program promises a busy year at the FDA. We will continue to monitor the FDA’s release of guidance documents relevant to the food and dietary supplement industries.
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