Food Defense Guidance Documents & Regulatory Information
Guidance documents contain nonbinding recommendations.
General
- Draft Supplemental Mitigation Strategies to Protect Food Against Intentional Adulteration (February 2020)
- Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration (March 2019)
- Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration - What You Need to Know About the FDA Regulation: Small Entity Compliance Guide (August 2017)
- Draft Guidance for Industry: Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities (August 2016)
- FSMA Final Rule on Mitigation Strategies to Protect Food Against Intentional Adulteration (May 2016)
Importers & Prior Notice of Imported Foods
- See Imports & Exports Guidance Documents & Regulatory Information
- View More on Importing Food Products into the United States
Registration
Establishment and Maintenance of Records
In February 2012, FDA published an Interim Final Rule amending FDA’s regulation on the record availability requires in section 1.361 (21 CFR 1.361) as part of its implementation of the amendments to the Federal Food, Drug, and Cosmetic Act made by the FDA Food Safety Modernization Act.
FDA Actions on the Food Safety Modernization Act of 2011:
- What You Need to Know About Establishment and Maintenance of Records (December 2004; April 2014)
- FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act (April 2014)
- Final Rule: Record Availability Requirements: Establishment, Maintenance, and Availability of Records (April 2014)
- Questions and Answers Regarding Establishment and Maintenance of Records By Persons Who Manufacture, Process, Pack, Transport, Distribute, Receive, Hold, or Import Food (Edition 5) (February 2012)
FDA Actions on the Bioterroism Act of 2002:
- Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (November 2005)
- Fact Sheet on Establishment and Maintenance of Records Under the Bioterrorism Preparedness and Response Act of 2002 (November 2005)
Administrative Detention
FDA Actions on the Food Safety Modernization Act of 2011:
- What You Need to Know About Administrative Detention of Foods; Small Entity Compliance Guide (November 2004; October 2011; March 2013)
- Final Rule: Criteria Used to Order Administrative Detention of Food for Human or Animal Consumption (February 2013)
FDA Actions on the Bioterroism Act of 2002:
- Final Rule: Administrative Detention of Food for Human or Animal Consumption Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (June 2004)
- Fact Sheet: FDA's New Food Bioterrorism Regulation Final Rule: Administrative Detention (May 2004)
Recalls
FDA Actions on the Food Safety Modernization Act of 2011:
Fees
- Implementation of the Fee Provisions of Section 107 of the FDA Food Safety Modernization Act (September 2011)
ALERT
- Letter to Industry, State and Local Food Regulators and Inspectors Regarding Web-based ALERT Training (February 22, 2007)
Food and Cosmetic Security Preventive Measures Guidance
- DRAFT UPDATE ISSUED - Importers and Filers: Food Security Preventive Measures Guidance (October 2007); See Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration (March 2019)
- DRAFT UPDATE ISSUED - Food Producers, Processors, and Transporters: Food Security Preventive Measures Guidance (October 2007); See Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration (March 2019)
- Dairy Farms, Bulk Milk Transporters, Bulk Milk Transfer Stations and Fluid Milk Processors Food Security Preventive Measures Guidance (October 2007) Available in multiple languages.
- Retail Food Stores and Food Service Establishments: Food Security Preventive Measures Guidance (October 2007)