Foods Program Guidance Under Development
(Expected to publish as drafts or finals by the end of December 2023.)
Introduction
The following list of guidance topics includes possible new topics for guidance documents or revisions to existing guidance documents that the FDA Foods Program is considering.[1] We currently intend to develop guidance on each topic; however, the FDA Foods Program is neither bound by this list of topics, nor required to issue every guidance document on this list. Several factors may impact FDA’s ability to issue the listed guidances, including, for example, new Administration priorities, emerging public health issues, or other extenuating circumstances. We are not precluded from issuing guidance documents on topics not on this list.
You may submit comments on the guidance topics at www.regulations.gov in Docket FDA-2022-D-2088.
| Title of Guidance | Category |
|---|---|
| Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 5); Guidance for Industry | Allergens |
| Compliance Policy Guide Sec. 555.250 Major Food Allergen Labeling and Cross-contact; Draft Guidance for FDA Staff | Allergens |
| 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 | Allergens |
| Insanitary Conditions at Tattoo Ink Manufacturing and Distribution Facilities; Draft Guidance for Industry | Cosmetics |
| New Dietary Ingredient (NDI) Notifications and Related Issues: NDI Notification Procedures and Timeframes; Guidance for Industry | Dietary Supplements |
| Preparation of Premarket Submission for Food Contact Substances (Chemistry Recommendations): Draft Guidance for Industry | Food Additives |
| Premarket Consultation on Cultured Animal Cell Foods: Draft Guidance for Industry | Food Additives |
| Foods Derived from Plants Produced Using Genome Editing; Draft Guidance for Industry | Food Safety |
| Inorganic Arsenic in Apple Juice: Action Level; Draft Guidance for Industry | Food Safety |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– Evidence Recommended for Release of Goods Subject to DWPE and Removal of a Foreign Manufacturer's Goods from DWPE; Draft Guidance for Industry | Food Safety |
| Compliance Policy Guide Sec. 555.320 Listeria monocytogenes in Human Food; Draft Guidance for FDA Staff | Food Safety |
| 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 |
| 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 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 |
| Use of Nutrient Content Claims for Added Sugars in the Labeling of Human Food Products: Draft Guidance for Industry | Labeling |
[1] Veterinary Medicine also has published a list of Guidances Under Development for 2023.