In comments filed Monday, IDFA supported the Food and Drug Administration's amendments to the administrative detention of food for humans or animals, which were required under the Food Safety Modernization Act (FSMA). Because the act gives FDA broader authority to order administrative detention, IDFA asked the agency to consider developing clear criteria and guidance regarding when FDA would use the authority and when it wouldn't.
Under the interim final rule, which became effective July 3, 2011, FDA has the authority to order administrative detention for food that is adulterated or misbranded. Previously, this authority was limited to situations where the food presented a serious adverse health consequence or threat of death to humans or animals.
"IDFA notes that while there has been concern within the regulated community that the revised administrative detention authority could be overused, or even misused, IDFA is confident, given FDA's history and procedures, that that is unlikely," the comments stated.
The comments reference the Bioterrorism Act and subsequent FDA regulations that allow only the Commissioner or official designated by the Commissioner to approve a detention order, which was created as a mechanism to allow FDA to pursue seizures or injunctions. IDFA is pleased that this "well-reasoned approach" will be maintained in the new interim final rule.
Agreeing with an FDA example that applied the authority to Class II recall situations, IDFA asked for clarification regarding what, if any, other types of incidents would trigger it.
"Extending the exercise of this authority to other situations that are not likely to cause adverse health consequences, such as Class III recalls or misbranding situations, though permitted by FSMA, would be unsound," the comments stated.
For more information, contact Clay Detlefsen, IDFA vice president of regulatory affairs, at cdetlefsen@idfa.org.