FDA building

FDA Recall Process Comes Under Fire

The U.S. Food and Drug Administration (FDA) recently came under fire regarding its substandard food recall process. On June 8, 2016, the Office of Inspector General for the U.S. Department of Health and Human Services issued a report revealing some disturbing procedural issues within the FDA when it comes to recalling dangerous food products. In 2011 the FDA was given the ability to require companies and manufacturers to recall products if it believes potential harm may be caused to consumers and no voluntary recall is initiated. Despite this power, the Inspector General’s report evaluating 30 different recalls in 2014 found that the speed of FDA food recalls is far from acceptable, making the following suggestion:

“We suggest that FDA revise its policies and procedures to instruct its recall staff to establish set timeframes for (1) FDA to request that firms voluntarily recall their products and (2) firms to initiate voluntary food recalls.” – Office of Inspector General (June 8, 2016)

Out of all 30 recalls studied, not a single recall included a timeline that would ensure the timely execution of the recall, whether either voluntarily by the responsible parties or as a mandate from the FDA.

In one recall studied, salmonella was found in the manufacturing facility of a nut butter company. The FDA made this discovery on March 7, 2014, but it wasn’t until August 19, 2014, that the manufacturer finally initiated a recall. During those 165 days, 14 people became severely sick from the contaminated nut butter.

In another recall, listeria monocytogenes was found in a series of cheese products. The FDA was notified of the contamination on July 28, 2014, but a voluntary recall of all potentially adulterated products didn’t occur until October 17, 2014, a whopping 81 days later. During that time, at least nine people became ill. This included the death of an infant and two fetal losses that the Centers for Disease Control and Prevention (CDC) linked to the listeria monocytogenes contamination of the cheese products.

According to a recent article written by Rosalie Chan for TIME Magazine:

“The FDA said it is already taking steps to address . . . the report’s concerns, including establishing a rapid-response team of agency leaders and introducing new technologies to make the process even swifter.”

The attorneys at GoldenbergLaw are monitoring this situation closely. We hope the FDA acts swiftly and implements these new procedures and technologies before more innocent citizens are injured or killed due to flaws in agency procedure.


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