How FDA's recall system fails consumers
Story Date: 7/6/2018

 

Source: POLITICO'S MORNING AGRICULTURE, 7/5/18

As the FDA prepares to update its food-recall system, your host spent the past several months speaking to the many victims who fell ill from E. coli after eating soy-nut butter.

The product — I.M. Healthy Original Creamy SoyNut Butter — was a favorite for people with food allergies and compromised immune systems. But the product it contained a type of E.coli so dangerous that food safety experts said these were some of the sickest victims they had ever witnessed in their careers.

The problem outbreak sickened 32 people in 12 states last year. To this day, some of the victims and relatives who POLITICO interviewed have not returned to work and continue to undergo surgeries.

All in the timing: Peter Ebb, a Boston-based lawyer, has long been pretty health conscious, especially because he has Crohn's disease. One morning, he ate his usual gluten-free English muffin smeared with soy nut butter — three days after FDA had announced it was recalling the company's products. That same morning, he received a recall notice from Amazon warning him about the product, but downplaying the medical dangers.

Six days later, Ebb was hospitalized and developed a deadly type of kidney failure called hemolytic uremic syndrome. Doctors told his wife to send for their children in case they needed to bid him a last goodbye.

"If I had heard about the problem even one week earlier and stopped then, I might have been able to avoid the disease completely, and life today would be very different," Ebb told POLITICO.

What FDA could have done differently: Unlike USDA, FDA does not publicly disclose information about which retailers had sold a recalled product because the agency has considered it trade secret information. It's especially confounding because the USDA, which is responsible for the safety of meat and poultry but not other types of food, changed its own policy nearly a decade ago to require such disclosures. Last month, the Trump administration, seeking to improve safety standards, proposed shifting the recall function to USDA as part of a broader reorganization that would require congressional approval. But few observers expect any action in the near term.

A long time coming: The weaknesses in the nation's food-safety system were all the more notable because they came 8 1/2 months after the FDA's inspector general declared that it lacked adequate procedures for handling food outbreaks. "We found that the FDA did not have an efficient and effective food recall initiation process that helps ensure the safety of the nation's food supply,"

Inspector General Daniel Levinson wrote on June 8, 2016. "This issue is a significant matter and requires the FDA's immediate attention."

How it kept getting sold: Even though FDA started to recall versions of the nut butter with certain sell by dates starting on March 3, 2017, retailers took days to inform customers. And six months after FDA had ordered its original recall, Amazon continued to sell the contaminated product through third-party sellers who emerged after the earlier product had been recalled.

What's next for FDA: Commissioner Scott Gottlieb, who took office shortly after the nut butter recall, said in a statement that the agency is committed to improve its oversight and "ensure that all food recalls are initiated, overseen, and completed quickly and effectively to best protect consumers." He pledged that the new steps will "increase transparency, empower consumers and ultimately lead to fewer potential recall situations with less people getting sick from contaminated food."

























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