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FDA Finalizes Rule on New Administrative Detention Regulation

Today, FDA issued a new final rule amending its regulations on administrative detention as required by the Food Safety Modernization Act (“FSMA”).

Under FSMA and the new final rule, FDA can order administrative detention if there is reason to believe that an article of food is adulterated or misbranded.  See 21 U.S.C. § 334(h)(1)(A); 21 C.F.R. § 1.378.  Prior to FSMA, FDA could only detain food if it had credible evidence or information indicating that an article of food presents a threat of serious adverse health consequences or death to humans or animals.

Although FDA can now detain food if it poses no threat to consumer health or safety, FDA indicated in the preamble to the final rule that it “intends to use administrative detention in a manner that is consistent with and furthers the prevention-based goals of FSMA and the Agency’s public health mission.”  78 Fed. Reg. 7994, 7995 (Feb. 5, 2013).  It indicated that it will continue to use Warning Letters and untitled letters to achieve voluntary compliance and voluntary corrective action.  Id.  Thus, where detention is unlikely to prevent illnesses or deaths, FDA will likely continue to rely on letters when an article of food is misbranded or adulterated.

FDA ignored comments requesting that it clarify the criteria for ordering administrative detention, particularly the circumstances under which it will decide that it has “reason to believe” that a food is adulterated or misbranded.   Id.  FDA said that such a determination is fact specific and will be made on a case-by-case basis.  Id.

FDA can administratively detain food for up to 30 days while it decides if it should take further enforcement action.

Administrative detention of food should not be mistaken with the term “detention” as it is used during the import process to describe a product that may be subject to refusal of admission and is being held pending testimony regarding its admissibility.  When FDA detains an article of food, it will clarify which type of detention is at issue.

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