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FDA Issues Interim Final Rules Related to Food Safety Act

May 11, 2011

The Food and Drug Administration last week issued two interim final rules on specific action that is required by the Food Safety Modernization Act. One expands FDA's authority for detaining products to include foods the agency believes are adulterated or misbranded. The other amends existing regulation on prior notice of imported foods. The rules will take effect July 3, 2011.

The rule on administrative detention of food and feed products aims to shift FDA's primary focus to preventing food safety problems before they occur, in addition to reacting to them once they occur. Previously, the agency had the authority to detain food only if inspectors found evidence that the product presented "a threat of serious adverse health conditions or death to humans or animals." The new rule allows the agency to detain the food for 20 days with a possible 10-day extension if there is reason to believe the product is adulterated or misbranded.

"This is a huge downward change, theoretically giving FDA a free hand to apply it to products with small inconsistencies, such as the wrong typeface on a label," said Clay Detlefsen, IDFA vice president of regulatory affairs. "In reality, though, we expect FDA to be judicious in using it."

The rule on prior notice, issued jointly with U.S. Customs and Border Protection, requires importers to notify government officials if the products to be imported have been refused entry by other countries. The rule will allow FDA to make better-informed decisions about potential safety risks from imported foods, including food for animals, and will eliminate "port shopping." IDFA supports this rule.

IDFA plans to submit comments to both of these rules before the comment periods end August 3, 2011.

For more information, members may contact Detlefsen at



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