Guidance on Administrative Detention of Foods Now Available from FDA
The Food and Drug Administration has made available on its Web site a new guidance document for industry that provides information on FDA’s authority to order the administrative detention of food for human or animal consumption under the Federal Food, Drug and Cosmetic Act, as amended by the FDA Food Safety Modernization Act. Among other things, this guidance specifies the following.
• FDA may order the detention of any article of food (except food regulated exclusively by the Department of Agriculture) that is found during an inspection, examination or investigation under the FFDCA if the officer or qualified employee has reason to believe that it is adulterated or misbranded.
• FDA may detain an article of food for a reasonable period, not to exceed 20 calendar days, after the detention order is issued, although this period may be extended 10 additional calendar days if required to institute a seizure or injunction action.
• The following information must be included in an administrative detention order: detention order number, hour and date of the order, identification of the detained article of food, detention period, statement that the article of food identified is detained for the period shown, brief and general statement of the reasons for the detention, address and location where the article of food is to be detained and the appropriate storage and transportation conditions, a statement that the article of food is not to be consumed, moved, altered or tampered with in any manner during the detention period (unless the detention order is first modified under 21 CFR 1.381(c)), and the name and title of the authorized FDA representative who approved the detention order.
• Administrative detention orders may, but not do not have to, require that the detained article of food be labeled or marked as detained.
• Transferring an article of food subject to an administrative detention order and/or altering or removing any mark or label that identifies an article of food as administratively detained is prohibited, although there can be exceptions for detained food moved under FDA supervision and control.
• FDA may approve a request for modification of an administrative detention order to allow for the destruction of the article of food or its movement to a secure facility, to maintain or preserve the integrity or quality of the article of food, or for any other purpose that the authorized FDA representative believes is appropriate.
• FDA will issue the administrative detention order to the owner, operator or agent in charge of the location where the article of food is being detained. If the owner of the article of food is different from the owner, operator or agent in charge of the place where the article of food is detained, FDA will also provide a copy of the order to the owner if its identity can be readily determined. If FDA issues an administrative detention order for an article of food located within a vehicle or other carrier used to transport the food, it must also provide a copy to the shipper of record and the owner and operator of the vehicle or other carrier if their identities can be readily determined.
• FDA’s authority to administratively detain food is separate and distinct from its authority to refuse admission of imported food. When a food offered for import is detained, FDA provides the importer with a Notice of Detention and Hearing, which gives the importer an opportunity for an informal hearing and a minimum of 10 working days to provide evidence or testimony for the hearing. To appeal an administrative detention order, however, the individual who owns the food should submit a written request to the FDA district director who approved the administrative detention.
• If FDA terminates an administrative detention order or the detention period expires, an authorized FDA representative will issue a termination notice to any person who received the order (or that person’s representative), releasing the article of food. If FDA fails to issue a termination notice and the detention period expires, the order is deemed to be terminated.