Officials from the FDA have closed their investigation into the Ecuadoran company that supplied lead-tainted cinnamon applesauce products to the United States after finding that the lead content was thousands of times higher than recommended levels.

The applesauce, sold in pouches packaged for children, has been found to have a lead content of 5110 parts per million (ppm) and 2270 ppm. The international Codex body is considering adopting a maximum level of 2.5 ppm for lead in bark spices, including cinnamon.

Sold under the brands Wanabana, Schnucks, and Weis, the applesauce was made at an Austrofoods facility in Ecuador using cinnamon from Negasmart.

The FDA’s deputy commissioner for its Human Foods Program, Jim Jones, has said that he believes the cinnamon was intentionally contaminated with lead. Lead can increase the weight of foods.

To date, the FDA has received reports of 65 children across the country with high levels of lead in their blood. All are 6 years or younger, and all have eaten applesauce from one of the three recalled brands. The Wanabana brand was sold nationwide in stores and online. Those regional grocery chains sold the Schnucks and Weis brands.

“At this time, the FDA is still relying on officials in Ecuador to support the investigation into Negasmart. To date, the FDA has confirmed that Negasmart does not ship product directly to the U.S. and that, of Negasmart’s direct customers, only Austrofoods ships product to the U.S.,” according to an update from the Food and Drug Administration.

“The FDA has limited authority over foreign ingredient suppliers who do not directly ship product to the U.S. This is because their food undergoes further manufacturing/processing before export. Thus, the FDA cannot take direct action with Negasmart. However, we continue to work closely with Ecuadorian officials, as they are conducting their own rapidly evolving investigations into the source of contamination.”

Although the FDA has concluded its inspection of the Ecuadoran companies, it continues to investigate lead levels in other foods.

The FDA has tested multiple products, and based on the current evidence, no further products are being added to the recall. The FDA and state partners tested 136 samples of non-cinnamon-containing products, and all have been negative for elevated lead levels. Of those 136 non-cinnamon-containing samples, 11 are the Smoothie Mango Passionfruit Banana flavor of WanaBana purees. Three of these samples are of the same lot that the Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (ARCSA) in Ecuador initially reported as positive for lead. FDA results were negative for elevated lead for all samples. In addition, the FDA collected samples of WanaBana Organic Mango Puree at import, with negative sample results for elevated lead levels.

“While our information at this time indicates that in the U.S., the contaminated cinnamon is limited to only the applesauce products that have already been recalled, the FDA is still investigating whether the cinnamon in the recalled products was used in other products exported to the U.S. Increasing screening for imported cinnamon from certain countries remains in place. The FDA does not indicate that this issue extends beyond these recalled products,” according to the agency’s Dec. 18 update.

Officials in Ecuador report that Negasmart does not ship products outside Ecuador. They also told the FDA that their testing thus far of raw cinnamon from all cinnamon importers in Ecuador does not appear to be contaminated with lead. In contrast, the ground or powdered cinnamon from Negasmart is contaminated. The Ecuadorian processor used by Negasmart is not currently operating.

About lead poisoning

Parents and caretakers should consult a healthcare provider if they suspect a child may have been exposed to lead. 

Short-term exposure to lead could 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. 

Permanent consequences can lead to developmental delays and brain damage.

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