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Regulation & Compliance

FSMA (Food Safety Modernization Act)

The landmark 2011 law that shifted FDA food regulation from reacting to contamination to preventing it.

What It Means

The FDA Food Safety Modernization Act (FSMA), signed into law by President Obama on January 4, 2011, is the most sweeping reform of U.S. food safety laws in more than 70 years. FSMA fundamentally shifted the FDA's approach to food safety from responding to contamination after it occurs to preventing it in the first place. The law established a series of rules and requirements that apply to food facilities, farms, and importers. Key provisions include the Preventive Controls for Human Food rule, which requires food facilities to implement written food safety plans with hazard analysis and risk-based preventive controls; the Produce Safety rule, which establishes science-based standards for growing, harvesting, packing, and holding produce on farms; the Foreign Supplier Verification Program, which requires importers to verify that food imported into the U.S. meets domestic safety standards; and the Intentional Adulteration rule, which requires facilities to address vulnerabilities to intentional contamination. FSMA also gave the FDA new enforcement tools, including mandatory recall authority for the first time in the agency's history, enhanced inspection authority, and the ability to suspend a facility's food registration. The implementation of FSMA has been phased in over several years, with different compliance dates for businesses of different sizes.

Related Terms

Frequently Asked Questions

What does FSMA (Food Safety Modernization Act) mean?

The landmark 2011 law that shifted FDA food regulation from reacting to contamination to preventing it.

Why is FSMA (Food Safety Modernization Act) important for food safety?

The FDA Food Safety Modernization Act (FSMA), signed into law by President Obama on January 4, 2011, is the most sweeping reform of U.S. food safety laws in more than 70 years. FSMA fundamentally shifted the FDA's approach to food safety from responding to contamination after it occurs to preventing...

this entity is one of the U.S. FDA food, drug, and device recalls concepts that recurs across this site. The definition above is the technical answer; the paragraphs below add the practical context for how the concept connects to the the FDA openFDA enforcement-report API data behind every per-entity page on the site.

In the the FDA openFDA enforcement-report API data, this concept shapes one or more of the fields that drive the per-entity grades and rankings on this site. The methodology page describes which fields feed into which output; this glossary entry documents the underlying term.

Source: FDA Recalls, Market Withdrawals and Safety Alerts, 2026.