October 27, 2016

FDA Issues Final Food Defense Regulation

The FDA released the Food Safety Modernization Act (FSMA) final rule for mitigation strategies to protect food against intentional adulteration last week. This rule is intended to prevent public harm by requiring companies in the U.S. and abroad to take steps to prevent adulteration of the food supply.

Tamper Resistant

These facilities are required to complete and maintain a written food defense plan that assesses their potential vulnerabilities to deliberate contamination. They must also establish food defense monitoring procedures and corrective actions, verify that the system is working, and ensure that personnel assigned to these areas receive training and maintain records.

Before 1982, most food and drug products did not have tamper-proof packaging or tamper-resistant seals. In 1982, seven people died when they consumed Tylenol in gel capsule form that had been laced with cyanide. Those responsible have never been found. Congress passed and the FDA has enacted anti-product tampering legislation after these tragic deaths.

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

FDA is going to provide industry with tools to make compliance with the rule easier, such as training courses, guidance, and a technical assistance center. The press releases stated “while such acts are unlikely to occur, the new rule advances mitigation strategies to further protect the food supply.”

This rule is the seventh major rule of FSMA and the last one to be finalized. The other rules are Preventive Controls rules for human food, rules for 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. FSMA was signed into law in January 2011. It has taken more than five years to finalize all of its rules.


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