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Lead-Tainted Applesauce Marketed for Children Bypasses Overstretched FDA Testing Protocols

Posted  March 1, 2024

The NY Times reports that hundreds of children were poisoned last year from cinnamon-flavored applesauce pouches that were traced to the Ecuadorian company Negasmart, which supplies to Austrofood and distributes the product under the name Wanabana.  The FDA, working with Ecuadorean investigators, traced the contamination of the Sri Lankan imported cinnamon to a spice grinder in Ecuador that likely intentionally contaminated the cinnamon with lead chromate, a powder that is illegally used to bulk up spices.  Millions of applesauce pouches were recalled from retail and dollar stores across America, including Dollar Tree and private label versions at Schnucks and Weis grocery markets.  Panicked families in 44 states are left monitoring their children for short-term and long-term effects of lead poisoning including damage to the brain and nervous system, stunted developmental growth, learning and behavior problems, and hearing and speech deficits.

Whistleblowers Nicole Peterson and Thomas Duong were instrumental in uncovering this threat to public health and child-safety. They were alarmed by spiking blood-lead levels in their children during a routine screening and follow-up visit.  The parents, working with local health department officials in North Carolina, searched the home and day care without identifying a source.  When the parents blood tests came back normal, they identified the only food source that they could think of that their children consumed and they did not – the foil pouches of cinnamon applesauce they bought at Dollar Tree.   The CDC estimated the median test results on the tainted applesauce were six times the level found in the lead pipers found during the water crisis in Flint, Michigan, albeit they were caught faster and thus long-term effects will hopefully be less sustained.

An expose conducted by the NY Times in conjunction with the nonprofit health newsroom The Examination, revealed that Austrofood never tested the cinnamon or the applesauce before shipping it to the United States, relying instead on a certificate from a supplier that said it was virtually lead free.   They also revealed that American inspectors had not visited Austrofood for inspections in five years. While the FDA says it lacks authority to investigate that far down the international supply chain, safety audits commissioned by American importers are supposed to provide an additional layer of protection and it is unclear whether any of the importers even considered lead a risk they were testing for.  Records showed one auditor even gave the applesauce an A+ safety rating during the very time children were ingesting the lead poisoned applesauce.  Neil Fortin, director of the Institute for Food Laws and Regulations at Michigan State University described the situation as a “catastrophic failure” of a “food supply regulatory system [that is largely] based on an honor system.”

Records showed that the FDA visited less than 1 percent of FDA registered international food makers last year.   When the Government Accountability Office flagged problems back in 2015, the FDA questioned the utility of conducting so many inspections.   The lack of resources led Sara Sorscher, director of regulatory affairs for the Center for Science in the Public Interest to suggest the need for a “totally independent regulatory agency” to be added into the mix to check on process and do proper inspections.

Whistleblowers like Ms. Peterson and Mr. Duong play a vital role in safeguarding our communities, especially when regulatory bodies are stretched too thin or when systems fail. This incident serves as a powerful reminder of the importance of whistleblowers in holding companies and regulatory agencies accountable. It highlights the need for stronger protections for those who speak out and for a more aggressive regulatory action that can prevent such oversights from happening in the first place.

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