Officials in Ecuador have named a ground cinnamon processor as the likely source of lead contamination in applesauce products linked with hundreds of illnesses among children in the US, the US Food and Drug Administration said Tuesday.
The processor, Carlos Aguilera, is no longer in operation, the agency said. The Ecuadorian health agency also sampled unprocessed cinnamon sticks that were sourced in Sri Lanka and found no lead contamination, but its investigation is ongoing.
“The FDA has limited authority over foreign ingredient suppliers who do not directly ship product to the U.S.,” the agency said in an update on the lead investigation. “This is because their food undergoes further manufacturing/processing prior to export. Thus, the FDA cannot take direct action with Negasmart or Carlos Aguilera.” Negasmart supplied the ground cinnamon from Carlos Aguilera to applesauce manufacturer Austrofoods.
As of Friday, the US Centers for Disease Control and Prevention has received reports of 413 cases of elevated blood lead levels in children in 43 states who consumed certain cinnamon applesauce products. FDA testing has also found high levels of chromium, a naturally occurring element, in some of the products.
Reports emerged in October of children with elevated blood lead levels, indicating potential acute lead toxicity, that was associated with cinnamon applesauce products sold in the United States under the brands WanaBana, Weis and Schnucks.
In November, manufacturer Austrofood and Wanabana USA, distributor of WanaBana products in the United States, said in a statement that the cinnamon in the products was the source of the elevated lead levels.
Wanabana recalled its apple cinnamon fruit puree pouches. Cinnamon applesauce pouches from the other brands, Schnucks and Weis, are also subject to recall.
“People who ate recalled products, especially if they had elevated blood lead levels, may have been exposed to chromium and should inform their healthcare provider so they can monitor health and provide supportive care, as needed,” the FDA said.
The health effects of chromium in this case are “difficult to predict,” according to the CDC. Yet “we know that there is no safe level of lead. CDC recommends discarding all affected products and not eating any of them. Anyone who may have eaten the affected products should talk with their healthcare provider.”
Lead exposure can cause developmental delays in children, as well as head, stomach and muscle aches, vomiting, anemia, irritability, fatigue and weight loss.
An FDA official told Politico in December that the lead contamination in cinnamon applesauce pouches may have been an “intentional act.”
Jim Jones, the FDA’s deputy commissioner for human foods, said in that interview that the agency is still investigating the lead-tainted cinnamon applesauce pouches, “but so far all of the signals we’re getting lead to an intentional act on the part of someone in the supply chain and we’re trying to sort of figure that out.”
Contaminated spices are “incredibly common,” Dr. Diane Calello, executive and medical director of the New Jersey Poison Control Center, said last month. Some contamination occurs in natural products, including rice and apples, because they’re grown in soil that contains metals.
“But then we do sometimes see intentionally contaminated products that are sold by weight. And the best way to make something heavy is to put metal in it, right?” she said. “So that’s why I think we frequently hear, maybe on the order of once or twice a month, about a product – for some reason, it’s often turmeric – but a spice that’s contaminated with lead.”
Calello emphasized the importance of regular lead screening for children at 1 and 2 years of age at their pediatrician’s office, noting that because of the Covid-19 pandemic, some routines may have fallen behind.
Austrofood and Wanabana USA said they have established a program to reimburse consumers of the recalled products who may have documented out-of-pocket costs for health care provider visits and blood testing up to a total amount of $150 for a lead test.
CNN’s Jacqueline Howard, Jamie Gumbrecht and Meg Tirrell contributed to this report.
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