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FDA Adopts Final Rule Authorizing Broad Authority to Detain Food

February 7, 2013

On February 5, 2013, the U.S. Food and Drug Administration's final rule amending the criteria for ordering administrative detention of human and animal food went into effect. The final rule adopts changes made by an interim rule that has been in effect since July 3, 2011. Under the now-final rule, an FDA officer or qualified employee can order the detention of any article of food if the officer or qualified employee has "reason to believe that the article of food is adulterated or misbranded." The agency may detain food for 20 days, and in some cases, up to 30 days. Prior to the interim rule, administrative detention was only allowed if FDA had "credible evidence or information indicating that [the] article present[ed] a threat of serious adverse health consequences or death to humans or animals."

Although FDA received numerous comments on the interim rule requesting that the agency limit the scope of its detention authority, or at least clarify when it could be invoked, FDA declined all suggestions. Instead, it retained the broad and flexible authority permitted under the interim rule. For instance, the agency declined to clarify the new "reason to believe" standard, stating that detention decisions are made on a case-by-case basis. It also declined to centralize authority to issue detention orders, expressing confidence that regional offices would apply consistent standards across the country.

Stakeholders can appeal detention orders through an agency administrative process, but they must move quickly. An appellant only has two calendar days to appeal a detention of perishable goods, and ten days to appeal a detention of nonperishable goods. If an appellant seeks a hearing, it must make that request within four days. If FDA grants a hearing request, the hearing will occur within two days.

Although FDA was first authorized to detain food in 2002, with the broader authority afforded by the now-final rule, FDA says it is "more likely to use administrative detention," even in Class II-like recall situations where a product may cause temporary adverse health consequences, or where the possibility of serious adverse health consequences is remote.

By promulgating this final rule, FDA continues to execute steps required by the 2011 Food Safety Modernization Act (FSMA). This latest move comes on the heels of the agency's issuance of two proposed rules on preventive controls and produce. The agency is expected to release additional proposed rules shortly on imported food and preventive controls for animal food.

For more information, please contact the professional(s) listed below, or your regular Crowell & Moring contact.

John Fuson
Partner – Washington, D.C.
Phone: +1.202.624.2910
Cheryl A. Falvey
Partner – Washington, D.C.
Phone: +1.202.624.2675
John B. Brew
Partner – Washington, D.C.
Phone: +1.202.624.2720