The Food and Drug Administration (FDA) is often far too slow to get food companies to recall tainted products, says an audit report by the Department of Health and Human Services (HHS), citing cases in which firms waited months before recalling contaminated nut and cheese products that caused multiple illnesses.
"FDA does not have adequate policies and procedures to ensure that firms take prompt and effective action in initiating voluntary food recalls," the HHS Office of Inspector General (OIG) said in the Jun 8 report. "As a result, consumers remained at risk of illness or death for several weeks after FDA was aware of a potentially hazardous food in the supply chain."
In response, FDA officials said that most recalls are launched less than a week after a problem is identified and that the agency recently set up a committee whose duties include reviewing slow-moving cases in an effort to spur faster responses.
OIG wants 'immediate' action'
The OIG report, labeled an "early alert," said the problem requires the FDA's immediate attention. It calls on the agency to set time frames for requesting that food companies voluntarily recall tainted products and for firms to actually carry out the recalls.
The OIG said the report follows up on a 2011 report in which the OIG said the FDA's recall program was inadequate because the agency lacked the authority to order food recalls and did not always follow its own procedures for monitoring recalls.
Since then, the report notes, the Food Safety Modernization Act (FSMA) has empowered the FDA to order recalls of unsafe food if a company declines to act voluntarily. The agency has used that authority twice.
30 recalls reviewed
The report says the OIG looked at a "judgmental sample" of 30 voluntary human food recalls reported to the FDA between Oct 1, 2012, and May 4, 2015. They were chosen on the basis of risk and how long it took for the FDA to classify the recall and for the company to issue the recall.
The review showed that the FDA did not have policies and procedures for prescribing "a time and a manner in which to initiate the voluntary recall" or for ensuring that companies issued recalls promptly. The agency did not prescribe a recall timeline in any of the 30 cases.
One of the two cases specifically described in the report involved Salmonella-contaminated almond and peanut butter made by nSpired Natural Foods Inc., which was linked to at least 14 illnesses in 11 states.
It took 165 days from when the FDA found Salmonella in environmental samples from the company's facility until the voluntary recalled was issued (Mar 7 to Aug 19, 2014), according to the report. The agency learned on Mar 24, 2014, that two Salmonella isolates from patients matched the strain found in the company plant, and whole-genome sequencing in May showed that isolates from some patients were indistinguishable from the environmental sample isolates.
The other case involved nine Listeria monocytogenes infections that were linked to various cheese products made by Oasis Brands Inc., according to the OIG. One infant died of the illness, and two miscarriages were also tied to the outbreak.
The OIG found that 81 days elapsed between when the FDA learned of a contaminated product and when the company voluntarily recalled all potentially tainted products (Jul 28 to Oct 17, 2014).
Virginia officials first notified the FDA on Jul 28 that Listeria had been found in one cheese product, which led the company on Jul 31 to recall that product with a specific expiration date, the report shows. Subsequent inspections by the FDA and a private lab confirmed the presence of Listeria in the facility and products. Despite this, the company shipped "3,332 potentially adulterated units" in late September.
FDA says new task force will help
In response to the report, the FDA said it recently established a special team of food safety experts whose duties include reviewing foodborne outbreak cases that seem to be moving slowly. The move was described yesterday in an FDA Voice blog post by Stephen Ostroff, MD, deputy commissioner for foods and veterinary medicine, and Howard Sklamberg, JD, deputy commissioner for global regulatory operations and policy.
"We have established the Strategic Coordinated Outbreak Response and Evaluation (SCORE) team, a decision-making body of key senior leaders that will be co-chaired by those responsible for directing compliance and enforcement activities in the foods program and field operations," the pair wrote.
The SCORE team will review cases that raise complex policy questions, those in which additional expert help is needed, and ones in which "response timelines have not been met," the post states. Ostroff said the group will review slow-moving cases weekly, according to an Associated Press (AP) report yesterday.
Ostroff also told the AP that the cases cited by the OIG were "outliers" and "a very select sample" in which recalls did not proceed in a matter of days. The blog post says that in the 3-year period covered by the OIG report, the FDA worked with food companies to effect thousands of recalls, with an "average recall initiation time of less than a week."
Jun 8 OIG report landing page
Full OIG report
Jun 9 FDA Voice blog post
Jun 9 AP story