Cinnamon processor in Ecuador is culprit behind lead-tainted applesauce, FDA says

A company in Ecuador that processed the cinnamon used in flavored applesauce pouches destined for the American market is the likely source of lead contamination in those products, U.S. investigators said.

In an update to its investigation into recalled WanaBana, Weis and Schnucks brand cinnamon-flavored applesauce pouches, the U.S. Food and Drug Administration said a now-defunct Ecuadorian company called Carlos Aguilera is to blame for high amounts of lead in the product.

Carlos Aguilera processed raw cinnamon sticks originating in Sri Lanka, the FDA explained.

However, Ecuadorian officials analyzed the unprocessed cinnamon sticks, which were "found to have no lead contamination" before being processed.

Lead contamination appears to have been introduced during processing at Carlos Aguilera, according to the FDA. Carlos Aguilera then sent the cinnamon to another company, Negasmart, which in turn sold it to Austrofoods, the manufacturer of the recalled applesauce pouches.

The investigation reveals the complex international web of food suppliers, processors and manufacturers which makes FDA oversight of imported products sold in American supermarkets very tough, the agency said. Legally, the FDA's hands are tied.

"The FDA has limited authority over foreign ingredient suppliers who do not directly ship product to the U.S.," the agency explained in its statement. "This is because their food undergoes further manufacturing/processing prior to export. Thus, the FDA cannot take direct action with Negasmart or Carlos Aguilera."

Investigations by Ecuadorian authorities "to determine ultimate responsibility for the contamination are still ongoing," the FDA said.

No new cases

One piece of good news: "FDA has no indication that this issue extends beyond these recalled products and does not have any confirmed reports of illnesses or elevated blood lead level adverse events reported for other cinnamon-containing products or cinnamon," the agency said.

As for the current case, "as of February 5, 2024, FDA has not received any additional confirmed complaints/reports of adverse events potentially linked to recalled product."

As of Feb. 2, the U.S. Centers for Disease Control and Prevention has received reports of a total of 413 cases of confirmed, probable or suspected lead poisonings linked to the recalled applesauce from 43 states.

Most of the cases involve very young kids: The median age for cases in the investigation "is nearly 2 years old," a CDC spokesperson told CBS News, though reports have come in for children as old as 9.

Federal officials have urged state health departments to seek out cases of lead poisoning, which could be missed if children who ate lead-tainted applesauce don't get blood tests from their doctor for the toxic metal.

AustroFoods has said that it will reimburse customers up to $150 for lead tests.

In early December, FDA said the tainted fruit puree pouches were found to contain levels of toxic lead that were 2,000 times higher than proposed standards.

Tests conducted at an Ecuadorean facility run by Austrofoods found that cinnamon supplied to the plant by another company, Negasmart, contained "extremely high levels of lead contamination, 5110 parts per million (ppm) and 2270 ppm," the FDA said.

To put that into context, an international body charged with setting lead limits in bark-sourced spices such as cinnamon "is considering adopting a maximum level of 2.5 ppm for lead in bark spices," the FDA said.

Advice to parents

So far, sample analysis of WanaBana, Weis and Schnucks fruit puree pouches that do not contain cinnamon and are not part of the recall have not shown elevated levels of lead.

In its initial alert on the recall issued in late October, the FDA said four children in North Carolina were the first to be found to have high levels of lead in their blood that was linked to the WanaBana products.

The FDA has warned families not to eat or serve these products and encourages them to throw out the pouches or return them to the store where they were purchased for a refund.

Caregivers should take any children who may have eaten these products to have blood tests to check for lead exposure, the CDC added.

Lead is toxic to humans, particularly children, and there is no safe level of exposure, the CDC says. Exposure can cause developmental delays in children. Initial symptoms of lead poisoning may include head, stomach and muscle aches, vomiting, anemia, irritability, fatigue and weight loss.

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