Enforcing the Food Safety Modernization Act

Center for Food Safety successfully sued FDA to enforce key food safety protections required by the Food Safety Modernization Act, helping improve food traceability, outbreak response, and consumer protection.

What Is the Food Safety Modernization Act?

Enacted in 2011, the Food Safety Modernization Act (FSMA) was the United States’ first major food safety legislation since 1938. It strengthens the nation’s food safety system and seeks to prevent foodborne illness outbreaks before they occur.

The law requires FDA to establish modern food safety measures, including improved food traceability, outbreak response systems, and protections for foods that pose higher risks of contamination.

FSMA Litigation

Center for Food Safety has repeatedly sued FDA to enforce critical food safety protections required by the Food Safety Modernization Act (FSMA).

From 2012 to 2014, CFS successfully litigated the first-ever FSMA lawsuit over FDA’s failure to comply with FSMA’s required timelines for issuing new regulations on food production, transport, and imports. That case resulted in FDA’s enactment of those regulations based on new Court-set deadlines.

From 2018-2019, CFS successfully litigated the second FSMA lawsuit over FDA’s failure to designate and establish reporting requirements for foods that are at “high-risk” of causing foodborne illness outbreaks. That case resulted in FDA agreeing to designate and establish reporting requirements for “high-risk” foods by a Court-ordered deadline.

In 2020, CFS’s third successful litigation resulted in FDA agreeing to establish a new program for the testing of food by accredited laboratories. FSMA required FDA to establish the laboratory accreditation program in 2013. After years of delay, CFS sued FDA in 2019 for failing to establish the new program.

The resulting food safety protections we won in court from our three successful cases help reduce the risk of widespread outbreaks and strengthen consumer confidence in the safety of the food supply.

Food Safety and Our Work

Foodborne illness affects millions of Americans each year and can result in hospitalization, long-term health impacts, and death.

Rapid identification of contaminated foods helps prevent additional illnesses and allows faster recalls.

Congress required FDA to identify high-risk foods and establish traceability requirements under FSMA. Despite these mandates, FDA failed to meet important deadlines, delaying protections intended to reduce foodborne illness outbreaks.

FDA’s failure to meet the deadlines required by law prompted Center for Food Safety to file multiple lawsuits to ensure FDA complies with the Food Safety Modernization Act. These cases have helped force implementation of key food safety protections Congress required more than a decade ago.

Through our successful lawsuits, we have improved recordkeeping and food traceability requirements that help FDA identify contamination sources more quickly, improving outbreak response and protecting public health.