Inspector general report: FDA food recalls dangerously slow, procedures deeply flawed

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Much has changed since the recalls between 2012 and 2015 that were analyzed by the inspector general, says Food and Drug Administration Commissioner Scott Gottlieb.

“Delay is deeply concerning to me as well,” Gottlieb, a physician, said in an interview. “I think it’s working a lot better now.”

FDA is in charge of all food recalls except for meat and poultry, which the Agriculture Department handles.

FDA must evaluate health hazards in food and diet supplements, such as vitamins, more quickly to force reluctant companies to do recalls, the report recommended. FDA’s electronic tracking system also needs to improve, the report said, along with its process for monitoring recalls.

The recalls studied were worrisome enough the inspector general issued an “early alert” about them in June 2016. That prompted the FDA to establish a team to speed up processes. Gottlieb, a Trump appointee, noted this new team helped block two facilities’ ability to distribute food.

More will change soon, he says, including its own look at what else can be done to improve recalls, Gottlieb says.

FDA will also release guidance in the first half of 2018 on what information it can release about where recalled food and diet supplements were sold. A coalition of safety advocates urged Gottlieb in August to release the names of the stores that sell recalled food items, which FDA has claimed is confidential business information. The Agriculture Department releases it, as do other agencies including the Consumer Product Safety Commission.

If FDA doesn’t have enough authority, Gottlieb says he will ask Congress for it.

Of the 30 recalls reviewed by the inspector general, 23 were class 1 recalls, which report author George Nedder says means they could cause death, irreversible health problems like kidney failure. The other seven were Class 2 which could cause reversible issues that could require up to months-long hospital stays, he says.

Of these recalls, it took a median of 29 days and an average of 57 days for the recall to start after FDA became aware of the hazardous condition. Eskin says the seriousness levels of the slow recalls is “very concerning.”

One infant and two fetuses died in the recalls examined between October 2012 and May 2015 and multiple illnesses were reported. Hazards included Hepatitis A in pomegranate seeds, cadmium in frozen spinach and listeria in pistachios.

FDA relies primarily on voluntary recalls, which makes timeliness, oversight and its own system of assessing risk critical, notes Nedder, an HHS assistant regional inspector general based in Boston. It also is required to do “health hazard evaluations,” which determines the severity of the risk to the public and gives FDA the power to mandate recalls.

Source: wbir