Food Defense Guidance Documents & Regulatory Information

Guidance documents contain nonbinding recommendations.

Food Defense 

• Final Rule: Mitigation Strategies to Protect Food Against Intentional Adulteration (May 2016)
• Supplemental Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration (February 2020)
• Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration (March 2019)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: Current Good Manufacturing Practice and Preventive Controls, Foreign Supplier Verification Programs, Intentional Adulteration, and Produce Safety Regulations: Enforcement Policy Regarding Certain Provisions (March 2022)
• Small Entity Compliance Guidance: Mitigation Strategies to Protect Food Against Intentional Adulteration (August 2017)
• Preventive Measures Guidance - Dairy Farms, Bulk Milk Transporters, Bulk Milk Transfer Stations and Fluid Milk Processors (October 2007) Available in multiple languages.
• Preventive Measures Guidance - Retail Food Stores and Food Service Establishments (October 2007)
• Guidance for Industry: Notice to Growers, Food Manufacturers, Food Warehouse Managers, and Transporters of Food Products on Decontamination of Transport Vehicles (November 2005)

General & Related Information

Importers & Prior Notice of Imported Foods

• See Imports & Exports Guidance Documents & Regulatory Information
• View More on Importing Food Products into the United States

Registration

• See Registration of Food Facilities  

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 Bioterrorism 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)

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 Bioterrorism 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)

Recalls

FDA Actions on the Food Safety Modernization Act of 2011:

• Questions and Answers Regarding Mandatory Food Recalls (May 2015) 

Fees

• Implementation of the Fee Provisions of Section 107 of the FDA Food Safety Modernization Act (September 2011)

Other Food Defense Historical/Archived Information

• Importers and Filers: Food Security Preventive Measures Guidance (October 2007); See current Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration (March 2019)
• Food Producers, Processors, and Transporters: Food Security Preventive Measures Guidance (October 2007); See current Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration (March 2019)
• Letter to Industry, State and Local Food Regulators and Inspectors Regarding Web-based ALERT Training (February 22, 2007) – See updated updated trainings aligned with the provisions of the Final Rule: Mitigation Strategies to Protect Food Against Intentional Adulteration (May 2016)
• Fact Sheet on Establishment and Maintenance of Records Under the Bioterrorism Preparedness and Response Act of 2002 (November 2005) 
• Fact Sheet: FDA's New Food Bioterrorism Regulation Final Rule: Administrative Detention (May 2004) 

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For general food defense information, please email fooddefense@fda.hhs.gov.