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May 26, 2016: FDA Issues Final Food Defense FSMA Regulation

On May 26, 2016, the U.S. Food and Drug Administration (FDA) finished the creation of the FDA Food Safety Modernization Act (FSMA). This action was marked by the completion of the seventh final piece of regulation.

FSMA Regulation Finalized

This new rule signifies the completion of the FDA Food Safety Modernization Act (FSMA). The new food safety rule under the FDA Food Safety Modernization Act (FSMA) aims to prevent wide-scale risks to public health by requiring national and international companies to take steps to prevent intentional adulteration of the food supply.
The FDA Food Safety Modernization Act (FSMA), the most sweeping reform of our food safety laws in more than 70 years, was signed into law by President Obama on January 4, 2011. The new regulation was established in order to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it.

FDA Issues New FSMA Regulation

Stephen Ostroff, M.D., incoming deputy commissioner for foods and veterinary medicine, FDA, explains the need for this new regulation. “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.”

The New FSMA Regulation Details According to the FDA Press Release

In establishing this unprecedented oversight, the FDA requires domestic and foreign food facilities to complete and maintain a written food defense plan that assesses their potential vulnerabilities to deliberate contamination where the intent is to cause wide-scale public health harm.

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. The rule was proposed in December 2013 and takes into consideration more than 200 comments submitted by the food industry, government regulatory partners, consumer advocates and others.


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