May 12, 2015
Authored by: Brandon Neuschafer
One key element of the 2011 Food Safety Modernization Act was the Act’s grant to FDA of powers to force a product recall. Prior to FSMA, FDA had no such authority, and was required to use other authorities to “lean” on companies to conduct a recall. Now, FDA may force a recall where it finds that there is a reasonable probability that food is adulterated or misbranded and the use of or exposure to the food will cause serious adverse health consequences or death to humans or animals. In addition to satisfying this fairly substantial threshold, the responsible party must refuse to voluntarily conduct a recall. The result is that FDA has initiated its mandatory recall authority only a couple of times, notably with respect to Kasel Associates Industries, Inc.’s pet treats and dietary supplements manufactured by USPLabs.
FDA recently issued draft nonbinding guidance regarding its mandatory recall authority. The draft