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When ‘Reason to Believe’ Halts Food Production

Sloppy record-keeping could trigger the FDA’s administrative detention

Cathy Crawford
Mon, 08/22/2011 - 13:35
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As of July 3, 2011, the Food and Drug Administration (FDA) has increased authority to use administrative detention as an enforcement tool. For this reason, companies that manufacture, prepare, pack, or hold food should ensure strong record-keeping practices.

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Under the current criteria of the Food, Drug and Cosmetics Act, the FDA may order the detention of human or animal food where there is credible evidence or information indicating an article of food presents a threat of serious adverse health consequences or death to humans or animals.

This new rule, which is amended under the Food Safety Modernization Act (FSMA), changes the Food Drug and Cosmetics Act criteria to allow the FDA to order detention if there is reason to believe an article of food is adulterated or misbranded. Foods can be detained for 20 calendar days with a possible 10 calendar-day extension, if needed.

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