In late October, Miami Shores-based WanaBana recalled its apple cinnamon purée pouches after North Carolina health officials detected "extremely high concentrations of lead" in product samples and determined the purée was the source of alarming lead levels in the blood of several children, according to the U.S. Food and Drug Administration (FDA). The company expanded the recall on November 9 to include products distributed under supermarket chains Schnucks' and Weis's in-house brands.
The WanaBana applesauce was sold across the country through online and retail stores. In one product sample from Dollar Tree, investigators detected lead levels 200 times greater than the action level the FDA proposed in draft guidance for fruit purées made for babies and young children.
As of December 5, there had been 64 reports of children with illnesses and "adverse events" potentially linked to the lead-contaminated applesauce, according to data collected by the FDA. Those affected have ranged from infants to children as old as 5 years. Reports of child sicknesses attributed to the contamination have been growing steadily in recent weeks.
In the wake of the recall, parents of children who were allegedly poisoned have started to file claims against the company, with the first civil cases in Miami-Dade County beginning to flow in last month.The child "was losing weight at an alarming rate" and "would cry uncontrollably."
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One of the initial claimants, Mustafa Al-Khaled of Norfolk, Nebraska, claims he began noticing grave changes in his 17-month-old son's demeanor and health in October. He notes his son, referred to in the complaint by the initials A.A., had been eating the apple purée since August.
"A.A. was losing weight at an alarming rate, would cry uncontrollably, and on multiple occasions passed white stool," the lawsuit states.
As his son's symptoms persisted, the lawsuit alleges, Al-Khaled took him to a medical center in November, where lab results showed he had very high levels of lead in his blood at 15.3 micrograms per deciliter. The Centers for Disease Control and Prevention uses a blood-lead reference value of 3.5 micrograms per deciliter to help determine toxic levels of lead.
In a separate Miami-Dade lawsuit, Sarah Callahan and Ricky Callahan Jr. of Maryland say their one-year-old son tested positive for elevated lead levels in August after consuming the contaminated applesauce for months. They say they had been feeding the child the purée since May when he was 9 months old to help transition him from breast milk to solid foods.
To determine the source of their son's lead poisoning, the Callahans say, they placed him "on an elimination diet whereby he only consumed a limited number of whole foods that were prepared at home." They claim his blood-lead levels began to decrease as the applesauce was eliminated from his diet.
Around October 30, the pair saw the FDA's public health alert about the products and concluded the purée was the cause of their son's elevated lead levels.
The Callahans say WanaBana had marketed its items as high-quality, all-natural snacks with the all-caps slogan, "I AM ONLY FRUIT."
"Our products not only maintain the fruit’s organoleptic and nutritional characteristics, but also carry a production line with the highest standards in the market, evidenced in the certifications obtained year after year," the company's website stated.
Following the FDA's public health notice, WanaBana said in a statement the company is working closely with the FDA to investigate the source of contamination. Based on its ongoing investigation, the agency says that cinnamon in the applesauce is the likely culprit as similar products without cinnamon have not shown high levels of lead.
Wanabana USA said the cinnamon in the recalled products had been supplied by Negocios Asociados Mayoristas S.A., doing business as Negasmart, a distribution company located in Ecuador.
"The FDA is continuing to work with Ecuadorian authorities to investigate the source of the contamination and to determine if the cinnamon in the recalled products was used in other products or distributed as a raw ingredient to other countries. FDA has confirmed that Negasmart does not import cinnamon directly into the U.S.," the agency said.
Lead exposure can lead to severe health problems in children, including developmental delays, behavioral issues, and damage to the brain and nervous system, according to the Centers for Disease Control and Prevention.
In an interview with NBC News, Sarah Callahan said her son is exhibiting signs of speech delays and undergoing periodic blood tests.
"It’s really sad to see him sitting there...knowing especially that the lead poisoning wasn’t the baby’s fault and it wasn’t our fault," she said.
In addition to the South Florida cases, a class action was filed in October against WanaBana in North Carolina federal court over the lead contamination.
The Florida Department of Health notes that lead can taint spices, including cinnamon, through a variety of pathways. Accidental contamination can stem from improper storage or old production equipment. Intentional adulteration by introducing lead or lead compounds to add weight to a shipment or enhance product color has also been documented.
