FOOD & DRUG LAW

Detentions & Refusals

FDA Releases Administrative Detention Final Rule
Why this BTA Regulation Is Actually Necessary
05/06

The new administrative detention rule implements one of four Bioterrorism Act (“BTA”) requirements that were designed with the intent to ensure the safety and security of food. Unlike some of the BTA requirements, which many justifiably regard as doing little or nothing to promote public health and safety, the administrative detention regulation is a necessary authority that will enable the FDA to respond quickly to serious health and safety threats. A summary of the new regulation is available at:  http://www.cfsan.fda.gov/~dms/fsbtac21.html.

FDA’s newest authority to detain food administratively under section 304(h) of the Federal Food, Drug, and Cosmetic Act (“FFDCA”) is separate and distinct from the traditional FDA authority to refuse admission of imported food under section 801(a) of the FFDCA. FDA reports that it does not foresee using administrative detention under section 304(h) to control the movement of imported food subject to section 801. Historically, FDA has utilized Customs seizure authority under Title 19 § 1595a to gain “control” over products that posed a serious health threat at the time of importation.

Section 304(h) authority may, however, prove to be a useful enforcement tool to control the movement of imported food under section 801(a). The majority of FDA imported foods are almost always conditionally released to the importer’s premises. This means that the products are “immediately” delivered to the importer of record or consignee on the condition that the terms of the Customs bond will be honored. Prior notice can never assume that the FDA will become aware of “credible evidence” during the prior notice screening, which would lead to an FDA hold or 801 (m) refusal under the prior notice requirements. (Prior notice hold and refusal requirements also provide for secured storage of products posing serious health threats). The FDA needs to be able to respond immediately to those food imports that pose a “credible threat” and are not detected during prior notice review.

The most significant need for administrative detention arises primarily because the FDA lacks necessary risk related information about foreign manufactured goods. The FDA’s ability to assess risk is limited in large part to information received through other government agencies. Further, the FDA currently conducts physical inspections of significantly less than 2 percent of all food imports. The chance that a food product, posing a serious adverse health threat, will enter U.S. commerce is extremely high. On a positive note, however, the FDA is pursuing risk based initiatives such as the FDA’s Import Strategic Plan (“ISP”). The ISP is designed to capture and integrate product information to better enable the FDA to access risk. Until the FDA is able to gain better control over risk assessment, a proactive approach, it is at least helpful to note that there is an efficient reactive approach available to the FDA.