FDA’s flimsy recall power for food imports puts public at risk, watchdog says

Introduction

The Food and Drug Administration’s watchdog is warning that changes must be made to ensure the safety of American consumers when tainted food imports are recalled.

“Because FDA’s food recall guidance is nonbinding on the industry,” the inspector general concluded in a report, “FDA cannot compel firms to follow it and therefore FDA cannot ensure the safety of the Nation’s food supply.”

“It’s pretty damning,” says Tony Corbo of Food and Water Watch. He told iWatch News that the report should be a “wakeup call” for the FDA to take action quickly.

While the U.S. Agriculture Department oversees the safety of imported beef, chicken and pork, the FDA is responsible for the safety of virtually all other foods served on American dining tables.

Imported cheeses from Mexico and Italy, tainted with salmonella and listeria monocytogenes respectively, are among the 17 food recalls in 2007-08 that were reviewed by the FDA inspector general. The United States imported 356 million pounds of cheese in 2009, according to the International Dairy Foods Association, compared to more than 10 billion pounds produced domestically that year.

The report coincided with a special FDA report detailing the long-term challenges facing the agency in regulating imports of food, drugs and medical devices over the coming decade. Already, more than 10 percent of all food consumed by American households is imported, the FDA said, and nearly two-thirds of fruits and vegetables on the U.S. dinner plate are imported.

The special report concluded that the FDA must “substantially change its operating model” to handle the challenges it may face in the future when dealing a steady rise in imported food and drugs.

The FDA had lacked the power to initiate a food recall until January, when President Barack Obama signed into law the FDA Food Safety Modernization Act. Previously, all recalls had to be initiated by the company involved. But under the new law, the FDA can initiate a mandatory recall after first asking the company to voluntarily remove the product from shelves.

The inspector general’s office analyzed 17 of the 40 Class I recalls — a designation for recalls posing the greatest health hazard — that occurred in 2007 and 2008. An FDA spokesman told iWatch News that 2007-08 was selected because the audit began during that time period.

In addition to cheese, the reviewed products included cantaloupes from Honduras (salmonella) and dried fish from China (clostridium botulinim). Also included was a recall of Chinese beverage pitchers that had unacceptably high levels of lead.

Among the problems found were companies failing to promptly launch a recall; companies not submitting their recall plans to the FDA to check for adequacy; and companies failing to issue accurate information to their consignees about contaminated products.

In one case, the inspector general said a recall of contaminated mussel meat from New Zealand was not issued until 102 days after the FDA was first notified of the health hazard. The lack of communication went the other way as well, according to the report, which said the “FDA did not always follow its own procedures to ensure that the recall process operated efficiently and effectively.”

Corbo, of Food and Water Watch, says he is particularly disturbed by the fact that the FDA’s guidelines for recalls of imported food were not clear, calling it “inexcusable.”

In 14 of the 17 cases studied by the inspector general, the FDA failed to obtain complete information about the contaminated products. In 5 of the 17 cases, the FDA did not conduct any audits on the recall; in the remaining 12 situations the audits were “untimely and incomplete.”

The watchdog’s report ended with two simple conclusions: the FDA needs to include the results of their audit when considering how to implement the Food Safety Modernization Act, and the FDA needs to follow its own procedures when monitoring future recalls.

In a response to the audit, the FDA insisted that recalls initiated under the voluntary system have been “successful in removing these products from use and preventing harm to the public.” However, the agency also said it was conducting a study to “examine the current process and ensure that it protects the public health.”

These reports aren’t the first to convey concern about how the government regulates the food Americans consume.

Earlier this year, iWatch News reported a U.S. Agriculture Department watchdog warned about flawed E.coli testing in ground beef. That report concluded that the USDA’s method to screen for E.coli samples “is not designed to yield the statistical precision that is reasonable for food safety or to verify that plant controls or interventions are working as intended.”

Another USDA watchdog report, released after the nuclear disaster in Japan, suggested that the government may not be prepared to handle a similar widespread contamination of U.S. food.