FDA Releases Guidance Document on Administrative Detention Under FSMA

Date: Oct 26, 2011

On October 25, 2011, the Food and Drug Administration (FDA) published a guidance document entitled "Guidance for Industry: What You Need to Know About Administrative Detention of Foods."1 The guidance provides nineteen questions and answers covering a range of administrative detention topics, including the length of detentions, labeling of detained foods, and appeals to administrative detentions.

The guidance document states that FDA may detain any article of food, either offered for import or in domestic commerce, where an FDA agent has "reason to believe that the article of food is adulterated or misbranded." During an administrative detention, food may not be moved (although FDA can grant exceptions) and FDA may label the food as detained, but the detention period must be reasonable (not to exceed 30 days). Administrative detentions are subject to appeal, which if granted will be held within two days after the appeal is filed.

FDA's administrative detention authority was established in the Bioterrorism Act of 2002 and was amended in January 2011 with the Food Safety Modernization Act (FSAMA). Pursuant to FSMA, in May 20011, FDA issued an interim final rule amending administrative detention regulations that went into effect in July 2004 under the Bioterrorism Act.2

1 Guidance for Industry: What You Need to Know About Administrative Detention of Foods, available at, http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/

2 76 Fed. Reg. 25538 (May 5, 2011), available at, http://www.gpo.gov/fdsys/pkg/FR-2011-05-05/pdf/2011-10953.pdf