FDA Has Yet to Issue Any Mandatory Recall of Food Products, Report States
The Food and Drug Administration has made available the first annual report to Congress on its use of the mandatory recall authority granted by the Food Safety Modernization Act. FSMA also requires the FDA to report annually on its public health advisories that advise against the consumption of an article of food on the grounds that it is adulterated and poses an imminent danger to health, but the FDA is still considering which of its public communications meet this criterion and will include any such advisories in future reports.
Under FSMA, the FDA may issue a mandatory recall order for any FDA-regulated food, other than infant formula, for which it determines that (a) there is a reasonable probability that the food is adulterated or misbranded and (b) the use of or exposure to that food will cause serious adverse health consequences or death to humans or animals. Before issuing such an order, the FDA must first provide the responsible party with the opportunity to cease distribution and conduct a voluntary recall. If that party refuses to do so or does not do so voluntarily, the FDA may order it to cease distribution and give notice to other persons in the distribution chain. In such case the responsible party may request a hearing to be held within two days to contest the order and convince the FDA that the product should not be recalled.
The report notes that from fiscal year 2011 through FY 2013 the FDA initiated only one enforcement action under its mandatory recall authority. The FDA found more than ten different species of Salmonella in dog treat products and the Colorado facility where they were manufactured and also observed problems with that facility’s general sanitation, cleanliness and state of repair. The producer conducted several voluntary recalls for specific lots of dog treat products but refused to recall others until the FDA signaled its intent to issue a mandatory recall.