That’s the finding of the U.S. Department of Health and Human Services’ Office of the Inspector General as part of its ongoing audit of the FDA’s food recall program.
The FDA doesn’t have policies and procedures to ensure that companies responsible initiate voluntary food recalls promptly, the OIG said in a report released Thursday.
“This issue is a significant matter and requires FDA’s immediate attention,” Daniel R. Levinson, inspector general, said.
The OIG suggests that the FDA update its policies and procedures to instruct its recall staff to establish set timeframes for:
- The FDA to request that firms voluntarily recall their products.
- Firms to initiate voluntary food recalls.
The OIG selected 30 samples of voluntary food recalls between Oct. 1, 2012, and May 4, 2015. It found the FDA didn’t prescribe a timeline for each company to initiate a recall. For two recalls, the companies didn’t initiate the recall until 165 and 81 days after the FDA became aware of the potential contaminations.
- In a recall involving nut butter, at least 14 people became ill with a strain of Salmonella linked to the strain found at a company’s manufacturing facility. One-hundred-sixty-five days passed from the date the FDA identified the potentially adulterated product and the date the company initiated a voluntary food recall.
- In a series of cheese recalls, at least nine people became ill from Listeria monocytogens, including one infant who died. Two fetal losses also were linked to these illnesses, according to the FDA and the Centers for Disease Control and Prevention. Eighty-one days passed from the date the FDA became aware of the adulterated product and the date the company had voluntarily recalled all affected products.
Levinson said consumers remained at risk of illness or death for several weeks after the FDA was aware of a potentially hazardous food in the supply chain due to the lack of timelines for recalls.
The FDA said during the nearly three-year period reviewed by the OIG, it oversaw thousands of food recalls, with an average time for recall initiation of less than a week.
“A small number of these recalls fell well outside of that average, with months passing before all impacted products were taken off shelves, even though the FDA notified the companies involved of a contamination as soon as it had evidence,” the FDA said in a statement.
Calling the delays referred to in the inspector general’s report unacceptable, the FDA said it’s already taking steps to address the inspector general’s concerns. They 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.
“News that the FDA does not have policies or procedures to ensure swift voluntary recalls during cases of foodborne illness outbreaks is mind-boggling,” said Rep. Rosa DeLauro, D-Connecticut, a member on the subcommittee responsible for FDA funding.
DeLauro said a salmonella outbreak in cucumbers last year sickened nearly 900 people, hospitalized 191, and killed six. The outbreak began in July, but it took until September before producers started recalling the cucumbers.
"Delays like this one – and others found in the report – are completely unacceptable and leave American consumers at risk for illness and death," she said.
DeLauro said the FDA must make the OIG’s recommendations a top priority and act on them immediately.
The Food Safety Modernization Act, passed in 2011, allows the FDA to launch a mandatory recall if a company won’t issue a voluntary one. The agency has used it twice since it became law.