• As our readership is well aware, the Food Safety Modernization Act (FSMA) equips the FDA with mandatory recall authority to remove a potentially dangerous food product from the marketplace when a company does not voluntarily cease distribution and initiate a recall. But the Agency has very rarely used this authority. In practice, the FDA most often works with companies to bring about voluntary recalls, with the goal of getting the product out of the marketplace as quickly and efficiently as possible.
  • A recent report by the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services concludes that FDA’s current recall process can be too slow and puts consumers at risk. This report follows on an “early alert” released by the OIG on June 8, 2016 finding that FDA did not have a process in place to ensure that regulated companies initiated food recalls promptly.
  • In preparing the December 2017 report, the OIG reviewed documentation from a sample of 30 voluntary food recalls initiated from October 1, 2012 to May 4, 2015 to analyze FDA’s oversight of companies’ initiation of recalls, as well as the Agency’s monitoring of firm-initiated recalls, and the Agency’s maintenance of data in an electronic recall data system.
  • In response to the OIG report, FDA Commissioner Scott Gottlieb issued a statement contending that FDA’s recall protocol is generally quite effective, noting, for example, that on average voluntary recalls are initiated within four calendar days of when a problem is discovered. At the same time, Commissioner Gottlieb acknowledged that there is room for improvement and stated that the Agency intends “to say more in early 2018 on additional policy steps [the Agency will] take as part of a broader action plan to improve [its] oversight of food safety and how [it] implements the recall process.” According to Commissioner Gottlieb, FDA is currently looking at ways to improve the timeliness and scope of information the Agency provides to the public about recalls of FDA regulated foods.
  • It remains to be seen whether this latest OIG report will prompt FDA to consider utilizing its mandatory recall authority on a greater scale.