FSMA Overview
For the first time, FDA has a legislative mandate to require comprehensive, prevention-based controls across the food supply. FSMA enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. The law also provides FDA with new enforcement authorities designed to achieve higher rates of compliance with prevention- and risk-based food safety standards and to better respond to and contain problems when they do occur. The law also gives FDA important new tools to hold imported foods to the same standards as domestic foods and directs FDA to build an integrated national food safety system in partnership with state and local authorities.
FSMA Resources
Use these FSMA resources to learn more about the rules and for guidance.
Disclaimer: The materials on this website are provided for informational purposes only and do not constitute legal advice. IFT does not advise on the application of law to an individual’s or company’s specific circumstances.
Final Status: May 27, 2016
This rule is intended to protect food from intentional acts of adulteration where there is an intent to cause wide scale public health harm. This rule applies to both domestic and foreign facilities that are required to register under section 415 of the FD&C Act.
Sanitary Transportation of Human and Animal Food (Sanitary Transportation)
Final Status: April 6, 2016
This rule is intended to establish requirements for shippers, loaders, carriers by motor vehicle and rail vehicle, and receivers engaged in the transportation of food, including food for animals, to use sanitary transportation practices to ensure the safety of the food they transport.
Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and To Issue Certifications (Accredited Third-Party Certification)
Final Status: November 27, 2015
This rule is intended to provide for accreditation of third-party certification bodies to conduct food safety audits of foreign food entities, including registered foreign food facilities, and to issue food and facility certifications, under the FDA Food Safety Modernization Act (FSMA).
Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (Foreign Supplier Verification Programs (FSVP)
Final Status: November 27, 2015
This rule is intended to require importers to verify that food they import into the United States Is produced in compliance with the hazard analysis and risk-based preventive controls and standards for produce safety provisions of the Federal Food, Drug, and Cosmetic Act (the FDA&C Act), is not adulterated, and is not misbranded with respect to food allergen labeling.
Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Produce Safety)
Final Status: November 27, 2015
This rule is intended to minimize the risk of serious adverse health consequences or death from consumption of contaminated produce, by establishing science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption.
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food (Preventive Controls for Human Food)
Final Status: September 17, 2015
The rule is intended to modernize requirements for current good manufacturing practices (cGMPs) and for domestic and foreign facilities that are subject to Registration of Food Facilities to establish and implement hazard analysis and risk-based preventive controls for human food.
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (Preventive Controls for Food for Animals)
Final Status: September 17, 2015
This rule is intended to establish requirements for the current good manufacturing practice (cGMP) for food for animals and for certain domestic and foreign animal food facilities to establish and implement hazard analysis and risk-based preventive controls for food for animals.
For the comprehensive list of FDA issued Guidance Documents, see the FDA's FSMA Rules & Guidance for Industry web page.
Full Text of the Food Safety Modernization Act (FSMA)
The full text of 111 Congress Public Law 353, Food Safety Modernization Act (FSMA), as provided by the FDA.
FDA Food Safety Modernization Act (FSMA) Main Page
FDA published information about FSMA. Includes up-to-date announcements and implementation activity.
Background on the FDA Food Safety Modernization Act (FSMA)
FDA background document on purpose and history of the FSMA. Available in multi-language translation and PDF.
Operational Strategy for Implementing the FDA Food Safety Modernization Act (FSMA)
This strategy document is intended to guide the next phase of FSMA implementation by outlining broadly the drivers of change in FDA’s approach to food safety and the operational strategy for implementing that change, as mandated and empowered by FSMA.
FSMA Training
Training and outreach programs to assist companies in complying with the FSMA rules.
Frequently Asked Questions on Food Safety Modernization Act (FSMA)
This page addresses questions related to FSMA.
For the comprehensive list of Final Rules, see the Food Safety Modernization Act Homepage.