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FDA chasing after voluntary recalls, but doesn’t often take mandatory route

Timely and efficient food recalls would cut down on foodborne illnesses, but the U.S. Food and Drug Administration has yet to figure out to do it.

That’s the bottom line of another report on FDA food recalls by the Office of the Inspector General for the federal Health and Human Services Department. The OIG put out an “early alert” on the work last June.

Titled “FDA’s Food-Recall Process Did Not Always Ensure the Safety of the Nation’s Food Supply,” the latest OIG report was an audit of the documentation “for 30 voluntary food recalls judgmentally selected from the 1,557 food recalls reported to FDA between Oct. 1, 2012, to May 4, 2015.”

The performance audit looked at FDA’s oversight of food businesses initiating recalls, monitoring of the recalls, and maintenance of food recall data. FDA is not always timely in evaluating health hazards, or efficient in handling audit checks or their assignments. And it’s status reports are not still complete or timely nor its data accurate.

FDA Commissioner Scott Gottlieb personally responded to the report on Dec. 26, saying he takes the agency’s food recall obligations “very seriously.” He said since the “early alert,” FDA has been working to improve its recall system.

The gap between FDA recall warnings and removing unsafe products from store shelves can take up to 10 months.

“FDA generally relies on firms to protect public health by voluntarily recalling food products that present a risk of injury or gross deception or are otherwise defective,” according to the OIG. “FDA monitors and assesses the adequacy of a firm’s recall efforts. According to FDA, recalls should be evaluated on a case-by-case basis because some recalls are more challenging or complex than others.”

Since the Food Safety Modernization Act (FSMA) was signed into law seven years ago, FDA has had the power to order firms to recall food, but it has only twice used that authority. FDA has to determine there is a “reasonable probability” of food adulteration before it orders a recall.

Food recalls undertaken by a business without an FDA order are monitored by the agency’s district offices. FDA and state agencies may conduct audit checks to make sure recalled products are removed from the market. FDA uses the Recall Enterprise System (RES) to document the progress of recalls.

The OIG says its “early alert” review concerns have been “catalysts to major changes in FDA’s oversight of the process.” It says FDA has “expedited changes to improve voluntary recall oversight and strengthen its enforcement strategies, including its ability to use its mandatory recall authority.”

Six findings by the OIG conclude FDA did not always:

  • evaluate health hazards promptly (initiation).
  • issue audit check assignments at the appropriate level (monitoring).
  • complete audit checks by its procedures (monitoring).
  • collect timely and comprehensive status reports from recalling firms (monitoring).
  • track key recall date in the RES (data system), and
  • maintain accurate recall data in the RES (data system).

“FDA could not always ensure that firms initiated recalls promptly; therefore, some consumers became ill, and others were at risk of illness, or in some cases, death,” the OIG reports says. “FDA relies primarily on voluntary recalls, which makes the timeliness of the recalls largely dependent on the firm’s willingness to take action.”

The report found it took from a median of 29 days to an average of 57 days for a business to issue a recall after FDA learned that a product was potentially hazardous. The time from discovery to recall ranged from nine to 303 days for the 30 voluntary recalls reviewed.

FDA also did not correctly monitor other recalls and failed to obtain complete or accurate data for others. Timely and comprehensive status reports also weren’t kept.

“Making sure the FDA has effective recall practices in place, and that we take immediate action to address unsafe foods, are high priorities of mine,” the FDA commissioner said. “Our recall authorities – and how we deploy them – are a cornerstone of our vital, consumer protection mission.”

Since last year, FDA has used its Strategic Coordinated Oversight of Recall Execution (SCORE) to set timeframes, expedite decision-making and get recalled processed.

FDA bureaucracy could spell opportunity for others.

Michael Lucas, CEO of i3 Brands and an expert in “track and trace” technologies, says his company’s patented mobile protection platform may be a better solution for “ultimately bridging the divide between the recall process and customer safety.”

i3 Brands is beta testing “WatchOut,” which will identify any defective or recalled products held within the perimeter of a retailer’s premises.

© Food Safety News