“Today’s final rule on intentional adulteration will further strengthen the safety of an increasingly global and complex food supply,” says Stephen Ostroff, incoming deputy commissioner for foods and veterinary medicine, FDA. “The rule will work in concert with other components of FSMA by preventing food safety problems before they occur.”

Food manufacturers are required to comply with the new regulation within three to five years after publication of the final rule, depending on the size of the business.

With this announcement, FDA has finalized all of the seven major rules that implement the core of FSMA. Signed into law by President Barack Obama in 2011, FSMA is a sweeping reform of the nation’s food safety laws. These changes are built upon a foundation of seven new major rules that aim to ensure the US food supply is safe by shifting focus from responding to contamination to preventing it. The Intentional Adulteration final rule builds on the Preventive Controls rules for human food and animal food, the Produce Safety rule, Foreign Supplier Verification Program rule, Accreditation of Third-Party Certification rule and the rule on Sanitary Transportation of Human and Animal Food. These seven rules will work together to systemically strengthen the food safety system and better protect public health, FDA says.