FDA Uses New Recall Power For First Time


More than two years ago, the Food Safety Modernization Act authorized, for the first time, the FDA to force a company to conduct a food recall. Prior to that, all food recalls (with the exceptions of baby formula) were voluntarily conducted by the food manufacturer. Sure, the FDA could exert significant pressure, but ultimately, it did not have the authority to order a mandatory recall. That all changed with FSMA.  

Under FSMA, FDA now has the power to order a mandatory recall of food for which there is "a reasonable probability" that the food is "adulterated … or misbranded … and the use or of exposure to such article(s) will cause serious adverse health consequences or death to humans or animals." However, two years passed and FDA never used this new power. Until now. In mid-February 2013, the FDA issued a Notification of Opportunity to Initiate a Voluntary Recall to Kasel Associates Industries, Inc for that company's pet treats. FDA and state inspectors had conducted numerous product tests and environmental sampling – which came back positive for Salmonella – and had cited the facility for sanitation and cleanliness issues last fall. In response, Kasel conducted a voluntary recall. However, a second agency inspection in February alleged ongoing extensive noncompliance, a failure to properly conduct a recall, and widespread Salmonella contamination. Thus, FDA issued the Notification – which is the first step in mandatory recall process. The Notice provided Kasel a two-day window (which is the requirement under FSMA before FDA can proceed with ordering the mandatory recall) within which to conduct the recall voluntarily.  Kasel did so, which means we haven't yet seen a situation where FDA follows through the whole mandatory recall process. Nonetheless, it is significant that FDA took this action.  And it, together the relatively recent suspension of Sunland's registration and the very recent indictment of PCA employees, are clear indicators to industry that the FDA is serious about food safety.  

If you have questions about how this FDA action and others may affect your company's risk profile, please don't hesitate to contact me at sskluting@varnumlaw.com or 616-336-6569 or on my cell at 616-822-4613.


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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