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FDA Finalizes Rule on Detention of Food

WASHINGTON—The U.S. Food and Drug Administration (FDA) on Monday announced a final rule that allows the agency to administratively detain food that it believes is "adulterated" or "misbranded".

FDA noted it can keep the products out of the marketplace for up to 30 days while deciding whether to take further enforcement action, such as seizing the food.

"Under the new criteria, FDA can order an administrative detention if there is reason to believe that an article of food is adulterated or misbranded," the rule states.

FDA, however, declined to elaborate on the circumstances in which it would make such a finding, saying in the final rule its decisions would be made on a case-by-case basis. "Because such decisions are fact specific, FDA has not, therefore, amended the regulation to provide additional explanation of the criteria for ordering administrative detention."

The rule reflects the intent of the FDA Food Safety Modernization Act (FSMA): to prevent foodborne illnesses in a country where 3,000 people die each year from such diseases, according to estimates from the Centers for Prevention and Disease Control.

"Before the passage of FSMA, FDA was able to detain a food product only when it had credible evidence that a food product presented a threat of serious adverse health consequences or death to humans or animals," FDA explained in a press release.

The final rule — "Criteria Used to Order Administrative Detention of Food for Human or Animal Consumption"  — incorporates an interim final rule that became effective in July 2011.

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