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July 1, 2004
By: Sean Moloughney
Editor, Nutraceuticals World
In late May, FDA issued a final rule establishing procedures for administrative detention of food under the authority of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act). This new authority applies to food for which the agency has credible evidence or information that it presents a threat of serious adverse health consequences or death to humans and animals. According to Health and Human Services (HHS) Secretary Tommy Thompson, this will provide an additional layer of protection to the U.S.’s defense against bioterrorism and strengthen the security of the food supply by enabling FDA to act more quickly and effectively to prevent potentially contaminated food from reaching consumers. Additionally, acting FDA commissioner Lester Crawford said, “The rule describes how the FDA can hold food in place while it initiates legal action in court to seize it and permanently remove it from commerce. Alternately, our experts can determine that the food is safe and the detention order may be terminated.” Either way, he said, consumers are protected. Under the final rule, FDA may detain an article of food on the strength of credible evidence or information resulting from an inspection, examination or investigation. The rule requires a detention order to be approved by the FDA district director of the district where the detained article of food is located, or by a higher official. A copy of the detention order would be given to the owner, operator and/or agent in charge of the place where the article of food is located, and to the owner of the food provided the owner’s identity can be determined readily. If FDA issues a detention order for an article of food located in a vehicle or other carrier, the agency also must provide a copy of the detention order to the shipper of record and the owner and operator of the vehicle or other carrier provided the owner’s identity can be determined readily. The final rule requires detained articles of food to be held in secure locations, as determined by FDA. The food may not be transferred from the place where it has been ordered detained, or from the place where the detained article has been removed without FDA approval, until FDA terminates the detention order or the detention period expires. A detention may not exceed 30 days, and violation of a detention order is a prohibited act.
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