OIG issues alert on FDA recall process
June 9, 2016
by Erica Shaffer
WASHINGTON – Consumers are at risk for illness or death because the Food and Drug Administration does not have an efficient process to ensure voluntary recalls are initiated promptly, the Office of the Inspector General (OIG) of the Dept. of Health and Human Services said in an early alert issued to the FDA.
The OIG’s preliminary findings are the result of an ongoing audit of FDA’s monitoring of food recalls. Specifically, the OIG found that consumers remained at risk for foodborne illnesses for several weeks after FDA had evidence of a contaminated food product in the supply chain.
FDA generally relies on food companies to voluntarily recall potentially hazardous food items. However, under the Food Safety and Modernization Act (FSMA), the agency has the authority to order a recall of certain food products after FDA determines that the product is adulterated or misbranded and can cause illness or death in humans or animals. OIG noted that FDA has used this authority twice — for a recall of pet food in September 2012 and second time for a recall of dietary supplements in September 2013.
But the OIG also found instances in which a recall came several months after FDA became aware of a potentially hazardous food product in the supply chain. In a nut butter recall, at least 14 people were sickened by a strain of Salmonella indistinguishable from or linked to the strain found at the firm’s manufacturing facility. But 165 days passed from the date FDA identified the product and the date the firm initiated a voluntary food recall.
In a second incident, at least nine people were sickened from Listeria monocytogenes, 10 including one infant who died. FDA records showed the Atlanta-based Centers for Disease Control and Prevention also linked two fetal losses to these illnesses. But 81 days passed from the date FDA became aware of the adulterated product and the date the firm launched a recall of all affected products.
“We suggest that FDA revise its policies and procedures to instruct recall staff to establish set timeframes for FDA to request that firms voluntarily recall their products and firms to initiate voluntary food recalls,” OIG said.
In a statement, FDA said that during the OIG’s nearly three-year audit, the FDA oversaw thousands of food recalls with an average recall initiation of less than week. However, FDA acknowledged that a “small number of these recalls fell outside of that average” even though companies were notified about a problem as soon FDA had evidence.
“These delays are unacceptable,” FDA said in a statement. “While some food recalls are more complicated than others due to the nature of the product(s), contamination, and investigation, the recall process should be as swift as possible and the FDA is already taking concrete steps to address the OIG’s concerns. These steps include the establishment of a rapid-response team made up of agency leaders, and the introduction of new technologies to make the process even swifter.”
And in a blog post on the FDA website, FDA Deputy Commissioner for Foods and Veterinary Medicine Stephen Ostroff, MD and Howard Sklamberg, Deputy Commissioner for Global Regulatory Operations and Policy, emphasized that the agency is currently expediting changes that will strengthen FDA’s compliance and enforcement capabilities.
“To consumers hearing about the OIG alert, we want to be clear that the FDA is totally committed to its public health mission of ensuring the safety of the food supply,” Ostroff and Sklamberg wrote. “The United States has one of the world’s safest food supplies. The work we do—performing facility and site inspections, conducting surveillance sampling both domestically and at the border, and using laboratory and other analyses to help determine prevalence of food-borne risks—contributes to its safety each and every day.”
Click here to read the OIG’s memorandum.