FDA is responsible for ensuring that the nation's seafood supply, both domestic and imported, is safe, sanitary, wholesome, and honestly labeled. This page provides access to content about seafood, including fish and shellfish, from across the Food section of FDA.gov. Grouped according to target audiences, these links include access to up-to-date consumer information and advice, guidance documents, regulation, and science and research content.
- How to Report Seafood-Related Toxin and Scombrotoxin Fish Poisoning Illnesses
- FDA Moves into Second Phase of AI Imported Seafood Pilot Program
- Use of The Seafood List to Determine Acceptable Seafood Names Final Compliance Policy Guide Sec. 540.750
Guidance for Industry
Publication of updated sections of the Fish and Fishery Products-Hazards and Controls Guidance. The following sections of the Guide have been updated as of June 2021.
- Cover Page
- Table of Contents
- Guidance for Industry: Fish and Fishery Products Hazards and Controls Guidance
- Chapter 3: Potential Species-Related and Process-Related Hazards
- Chapter 11: Aquaculture Drugs
- Appendix 1: Forms
- Appendix 2: Product Flow Diagram - Example
- Appendix 3: Critical Control Point Decision Tree
- Appendix 5: FDA and EPA Safety Levels in Regulations and Guidance
- Appendix 8: Procedures for Safe and Sanitary Processing and Importing of Fish and Fishery Products
- Appendix 11: Approved Animal Drugs for Aquaculture Use
- Appendix 12: Unapproved Animal Drugs for Aquaculture
- Addendum 1: Fish and Fishery Products (21 CFR 123) and Control of Communicable Diseases (21 CFR 1240.60)
- Addendum 2: Current Good Manufacturing Practices (cGMP)
This section provides updates and information about seafood safety for consumers.
This section provides about seafood guidance, regulations imports and exports.
- The Seafood List (Fish Naming)
- Seafood Regulation & Guidance
- Seafood HACCP
- Seafood HACCP Video Series
- Hazards & Controls Guidance
- National Shellfish Sanitation Program
- Interstate Certified Shellfish Shippers List
- Imports & Exports
- FDA DNA Testing
- Gulf of Mexico Oil Spill
- Nutrition Information for Seafood - Retail Store Posters
- Shellfish Equivalence
- Labeling of Foods Comprised of or Containing Cultured Seafood Cells
FDA is inviting public comment in a Federal Register notice on a proposed determination that the European Union (EU) food safety control system for raw bivalve molluscan shellfish intended for export into the U.S. is equivalent to the U.S. system because it provides at least the same level of sanitary protection as the U.S. system.
Public Health Officials and Healthcare Providers
How to Report Seafood-Related Toxin and Scombrotoxin Fish Poisoning Illnesses
To help FDA effectively investigate, remove unsafe seafood products from the market, and develop new prevention strategies, the FDA relies on illness reporting from public health officials and healthcare providers. While most foodborne outbreaks are tracked through the FDA’s Coordinated Outbreak Response and Evaluation (CORE) network, seafood-related illnesses caused by natural toxins have a unique reporting mechanism. This web page provides information on commonly occurring seafood-related illnesses and how to report them to the FDA. To report an illness from raw bivalve molluscan shellfish, email the FDA at email@example.com.