The company behind an outbreak of high lead levels in children who ate certain cinnamon applesauce has named the supplier of the cinnamon.

Austrofood, along with Wanabana USA, has named Negocios Asociados Mayoristas S.A., operating as Negasmart, a third-party distribution company located in Ecuador, as the cinnamon supplier.

based on its investigation, the U.S. Food and Drug Administration had already concluded that the cinnamon in certain applesauce products was the source of the lead. After conducting its investigation, Austrofood has come to the same conclusion. FDA testing has shown the implicated applesauce has 200 times the acceptable lead level.

“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.,” according to an updat from the FDA.

As of Nov. 30, 57 children aged less than 1 to 5 years old have been confirmed with high levels of lead in their blood after eating cinnamon applesauce. The children are spread across 22 states. Three brands of cinnamon applesauce pouches have been recalled. They are Wanabana, sold in stores nationwide and on the internet, and Schnucks and Weis store brands sold at those regional grocery chains. The Schnucks cinnamon applesauce is sold individually and in a variety of packs.

“At this time, the FDA has no indication that this issue extends beyond these recalled products, but to further protect public health, the FDA is screening incoming shipments of cinnamon from multiple countries for lead contamination. As of Nov. 30, 2023, no screening results have tested positive for higher levels of lead,” according to the FDA update. 

“Separately, Austrofood CIA LDA’s apple cinnamon fruit puree pouch products exported to the U.S. were added to import alert 99-42, detention without physical examination of foods due to heavy metal (toxic element) contamination.” 

Lead is toxic to humans and can affect people of any age or health status, but children are particularly susceptible to lead toxicity. Lead poisoning can result in several long-term problems, including developmental disorders and brain damage.

“These products have a long shelf life. Consumers should check their homes and discard these products. Most children have no obvious immediate symptoms of lead exposure,” according to the FDA’s alert. “If there’s suspicion that a child may have been exposed to lead, parents should talk to their child’s healthcare provider about getting a blood test.”

Short-term exposure to lead can result in the following symptoms: headache, abdominal pain/colic, vomiting, and anemia. Longer-term exposure could result in additional symptoms: irritability, lethargy, fatigue, muscle aches or muscle prickling/burning, constipation, difficulty concentrating/muscular weakness, tremors, and weight loss.

Investigation background
The FDA first became aware of the problem when state public health authorities reported children with elevated lead levels in mid-October.

On Oct. 18, the FDA received information about an investigation by the North Carolina Department of Health and Human Services. 

On Oct. 24, North Carolina officials notified the FDA of additional information that included four children with elevated blood lead levels. 

On Oct. 25, the FDA began receiving analytical worksheets from the North Carolina Health Department for the samples of applesauce with cinnamon pouches with elevated lead levels. 

On Oct. 27, the FDA completed an “accelerated” review of the analytical findings the North Carolina officials provided and notified Wanabana LLC regarding the levels detected in their analysis. 

On Oct. 28, the FDA discussed the analytical findings with Wanabana LLC and issued a safety alert warning consumers not to use WanaBana Apple Cinnamon Fruit Puree products. Wanabana LLC agreed to recall the WanaBana Apple Cinnamon Fruit Puree products the same day.

The FDA relies on self-reported information submitted by healthcare providers, consumers, and some state partners who submitted an adverse event report to the FDA as an initial step in determining if a product is a potential shared source of exposure amongst complainants. 

“While our total reports included in this advisory represent complaints that have been reported to the FDA, we recognize there are other avenues for reporting of elevated lead levels. For example, through case reporting from the state health departments to CDC, which is routinely done for cases of childhood lead exposure,” according to the FDA statement. 

“Because these different avenues for reporting represent two different data collection mechanisms, we are currently not including them in our advisory. However, we are working with our state partners and CDC to gather and evaluate as much data as possible while recognizing different mechanisms are being leveraged.”