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FDA takes too long to remove contaminated food from shelves, investigators say

REUTERS/Jim Young
The FDA is responsible for recalling almost all harmful foods, including processed foods, from stores and food service locations.

The Food and Drug Administration (FDA) is taking too long — in some cases, up to 10 months — to get contaminated food products off store shelves, according to a report released last week by the Office of Inspector General (OIG) of the Department of Health and Human Services.

That delay puts consumers’ health at risk. An estimated 48 million people get ill from foodborne diseases each year in the United States. Of those, 128,000 are hospitalized and 3,000 die.

The FDA is responsible for recalling almost all harmful foods, including processed foods, from stores and food service locations. The exceptions are cases involving meat and poultry, which are under the jurisdiction of the Department of Agriculture. 

Food recalls are almost always voluntary. As the FDA explains on its website, “Sometimes a company discovers a problem and recalls a product on its own. Other times a company recalls a product after FDA raises concerns. Only in rare cases will FDA request a recall.”

Taking too long

In 2011, President Obama signed into law the Food Safety Modernization Act, which gave the FDA the power to require companies to recall unsafe foods. But the agency has used that authority only twice.

The new report was done, according to the inspector general’s office, “to determine whether FDA is fulfilling its responsibility now that it has mandatory recall authority.”

The OIG researchers looked at 30 of the 1,557 cases of food products that were recalled by the FDA between 2012-2015. They found it took an average of 57 days after the FDA learned that those products were contaminated for companies to recall them.

Twenty-three of the 30 cases involved Class I recalls, which meant that there was “a reasonable probability” that eating the food would “cause serious adverse health consequences or death.” The other seven cases involved Class II recalls, which meant that there was still a probability that eating the food would lead to adverse health consequences, but not permanent ones.

“Our review found that FDA does not have adequate policies and procedures to ensure that firms take prompt and effective action in initiating voluntary food recalls,” said George Nedder, the report’s lead author and an assistant regional inspector general at HHS, in an audio statement. “This means that dangerous food products may have remained in our nation’s food supply for weeks after FDA was aware of the contamination.”

“In one case, a baby died, and nine others became ill, all from consuming cheese that contained listeria,” he added. “Eighty-one days passed from when FDA learned of the adulterated product, to when the firm initiated the recall.” (The owner of that company was sentenced to 15 months in prison for not immediately halting distribution of the cheese after the FDA informed him that it was contaminated.) 

In another case, involving a dietary supplement, it took 10 months after receiving a warning letter from the FDA for the company to pull the product off the shelf.

Acknowledging a need for improvement

In response to the report, the FDA commissioner, Dr. Scott Gottlieb, said the agency fixed many of its recall policies and procedures in 2016 and 2017, after the OIG released a preliminary version of its report. He acknowledged, however, that the agency still has more work to do to improve its food-recall processes.

"I want to do even more to make sure that consumers have the information they need to avoid hazardous products that are the subject of recalls, or to seek assistance if they may have been exposed to a recalled food product," he said in a released statement. "The FDA is exploring various ways to better accomplish this goal. Among other steps, the agency will issue guidance on recall communications in the first half of 2018."

One possibility — advocated by many food safety experts — is to disclose to consumers the names of stores or food service locations that may have sold or distributed a potentially unsafe food, he said.

Gottlieb appears to take issue, however, with some of the details in the report. He says, for example, that most FDA recalls occur, on average, "within four calendar days of the problem being discovered." 

The OIG authors do not agree. As Nedder told USA Today reporter Jayne O’Donnell, the report found that in 36 percent of its recall cases, the FDA inaccurately reported the day the recall started — and by an average of 16 days.

It's also not clear what effects the Trump admininistration's proposed budget cuts to the FDA will have on the food-recall process.

FMI: You can read the inspector general’s report on the agency’s website. For information about how you can protect yourself and your family from foodborne illnesses in your home, go to the “Foodborne Illness” section of the Minnesota Department of Health’s website. State health officials encourage Minnesotans to report suspected cases of foodborne illnesses to them through their hotline (1-877-FOOD-ILL) or via email (health.foodill@state.mn.us). (Typical symptoms include abdominal cramps, nausea, fever, joint/back aches, and fatigue — what many people often call “the stomach flu.”) “Your call to the hotline helps us identify foodborne and waterborne illness outbreaks in Minnesota and prevent the spread of illness to others,” they say.

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