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June 10, 2016

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FDA draws flak for tainted-food recall delay

UNITED States federal health officials failed to force a recall of peanut butter and almond products for three months after advanced DNA testing confirmed salmonella contamination, government investigators reported yesterday.

Despite new legal powers to compel recalls and sophisticated technology to fingerprint pathogens, the Food and Drug Administration allowed some food-safety investigations to drag on, placing consumers at risk of death or serious illness, according to the inspector general’s office at the Department of Health and Human Services.

In an unusual urgent warning called an “early alert,” the internal watchdog said the FDA needs to pay “immediate attention” to the problem and follow clear procedures to get manufacturers to promptly recall tainted foods.

“Months and weeks when peoples’ lives are on the line?” asked lead investigator George Nedder. “It needs to be done faster.”

Responding to the findings, the FDA’s top food safety official said the cases singled out by investigators were “outliers,” a “very selective sample” in which recalls did not proceed quickly and efficiently.

Nonetheless, Deputy Commissioner Stephen Ostroff said the FDA has set up a group of food safety officials to review cases on a weekly basis that don’t seem to be moving. “That way we will be able to take action much more quickly in circumstances where there seems to be some reluctance at the firm.”

Food safety has long been a weakness for the FDA, an agency thinly stretched to oversee about 80 percent of the US’ food supply, including seafood, dairy, fruits and vegetables.

The FDA traditionally has relied on voluntary recalls to remove tainted products from the market, saying that’s the fastest route. But a 2011 law gave FDA power to order recalls in cases that have the potential for serious harm.

It didn’t seem to make much difference in at least one case from 2014 that was examined by the inspector general. It is part of a review of 30 recalls from 2012 to 2015.

The inspector general said it involved peanut butter and almond products voluntarily recalled by nSpired Natural Foods Inc on August 19, 2014. That recall came 165 days after the FDA first discovered salmonella in samples from a company manufacturing plant, and a little more than three months after DNA mapping concluded that the salmonella from the facility was “indistinguishable” from samples taken from patients.

Salmonella is a bacterial illness that can cause serious and potentially fatal infections in young children, older adults, and people with compromised immune systems. Most patients develop diarrhea, fever and abdominal cramps and usually recover without treatment.

At least 14 people in 11 states were sickened in the outbreak.




 

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