Inspector General: FDA Still Takes Too Long To Recall Tainted Food Products

Image courtesy of Natasha L.

Five years ago, the Food Safety Modernization Act granted the Food and Drug Administration the statutory authority to compel food producers to recall tainted products. However, a new report from a federal investigator shows that people are falling ill while the FDA sometimes takes months to issue recalls, even after it has evidence of contamination.

The preliminary report [PDF] comes from the Inspector General for the Department of Health and Human Services, whose office is auditing the FDA’s recall processes to determine whether the agency has an efficient and effective method for initiating food recalls “that helps ensure the safety of the Nation’s food supply.”

While the FSMA gives the FDA the authority to mandate food recalls, the agency must first provide food companies with the opportunity to issue “voluntary” recalls of tainted food; and almost all food recalls eventually fall under that voluntary umbrella.

In fact, according to the Inspector General’s report, the FDA has only used its authority to force two recalls: First, in Feb. 2013, to take salmonella-tainted pet food off the market; then in Nov. 2013, with a forced recall of adulterated dietary supplements. In both cases, it was months between the FDA learning of the adulteration and the recalls being issued.

Inspectors from Levinson’s office audited 30 voluntary recalls of human food from between Oct. 2012 and May 2015, and found that FDA policies and procedures provide no guidance for recall staff in terms of giving food companies a proper timeframe or manner in which to initiate a voluntary recall.

The report points to two examples of voluntary recalls in which the FDA identified potentially dangerous contamination in food products but waited months for finally pushing for a voluntary recall.

The first example involves the voluntary Aug. 2014 recall of various nut butters from a company called nSpired.

According to the Inspector General’s timeline (see image at left), FDA inspected the company’s facility in late Feb. 2014, and confirmed the presence of salmonella on March 7. Seventeen days later, the agency learned that this strain of salmonella matched samples taken from two people who had previously fallen ill.

In May 2014, the FDA found that samples from patients were “indistinguishable” from the samples found in the nut butter facility, yet no recall was issued.

It wasn’t until late Aug. 2014, after the FDA had considered using its authority to compel a recall, that a voluntary recall was initiated. In the 165 days between the FDA identifying the pathogen and the recall announcement, at least four people fell ill from consuming the tainted product.

The second delayed recall cited in the Inspector General’s report involves cheese products from a company called Oasis Brands.

In July 2014, Virginia state officials notified the FDA that they had found listeria in an Oasis product, and that it had been linked to previous illnesses. Later that month, the company recalled the specific product, and subsequent FDA inspections in Aug. 2014 turned up bacteria samples that were indistinguishable from those found by Virginia authorities in the recalled product, indicating a likelihood of further contamination.

Then in Sept. 2014, an outside lab hired by Oasis also turned up listeria samples in cheese. A local recall was announced, but only for one product produced during a very limited timeframe.

It wasn’t until mid/late-October that a full-scale recall of all potentially contaminated products was initiated. In the nearly three months between the time when Virginia confirmed the tainted cheese was linked to earlier illnesses and that voluntary recall was announced, six illnesses — including the loss of two fetuses — were linked to these tainted cheeses.

“FDA does not have adequate policies and procedures to ensure that firms take prompt and effective action in initiating voluntary food recalls,” concludes the Inspector General’s 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 to the report, the FDA claims the instances cited by the Inspector General are outliers representing a “very selective sample.”

Deputy Commissioner Stephen Ostroff tells the AP that the FDA now has a group that meets weekly to review slow-moving recall cases.

“That way we will be able to take action much more quickly in circumstances where there seems to be some reluctance at the firm,” explains Ostroff.