FDA's 2013 Annual Report To Congress On The Use Of Mandatory Recall Authority
FDA issued its 2013 Annual Report to Congress on the Use of Mandatory Recall Authority, which is required by the FDA Food Safety Modernization Act (FSMA). This is the first annual report FDA has issued on this topic.
As background, FSMA provided FDA with authority to issue a mandatory recall order for any food, other than infant formula, for which FDA determines there is a “reasonable probability” that the food is adulterated or misbranded due to the presence of undeclared allergens and that the use of or exposure to that food will cause serious adverse health consequences or death to humans or animals. In order to issue such a mandatory recall order, FDA must first provide the responsible party with the opportunity to cease distribution and to conduct a voluntary recall of the article of food in question. If the responsible party refuses to, or does not voluntarily, cease distribution or recall such food within the time and in the manner prescribed by FDA, FDA may proceed under the mandatory recall authority.
The report explains that from fiscal year 2011 through fiscal year 2013, FDA “initiated one enforcement action” under the mandatory recall authority that involved Kasel Associates Industries, a pet treat manufacturer. Notably, FDA did not actually go so far as to mandate a recall by Kasel because the issue was resolved after FDA provided the company the opportunity conduct a voluntary recall.
To meet the statutory prerequisite notification requirement, FDA issued Kasel a letter entitled “Notification of Opportunity to Initiate a Voluntary Recall.” The letter notified Kasel that FDA was providing them two business days to inform the agency whether the company would conduct a recall voluntarily and threatened further action to mandate a recall in the absence of voluntary action. In response to the notification letter, Kasel issued a press release announcing the voluntary recall of all pet treats at issue. Accordingly, because Kasel took advantage of the “opportunity to initiate a voluntary recall,” FDA did not need to take the next step to exercise its mandatory recall authority.