As many as 125 children poisoned by lead in applesauce

FDA is conducting an onsite inspection at the Austrofoods facility located in Ecuador. Cinnamon samples collected from the lots used in recalled products will undergo laboratory analysis. FDA will update this advisory to share the sample results once the analysis is complete. 

To date, the FDA has worked with Ecuadorian authorities to gather information about Negasmart, the supplier of cinnamon to Austrofoods, including whether the cinnamon in the recalled products was used in other products exported to the United States. Working together with Ecuadorian authorities, the FDA has confirmed that, of Negasmart’s direct customers, only Austrofoods ships product to the US. In addition, the FDA has confirmed that Negasmart does not directly export products to the US. 

As of December 11, 2023, FDA has received 65 reports of adverse events potentially linked to recalled product. To date, confirmed complainants, or people for whom an adverse event was submitted, are under 6 years of age. 

CDC’s National Center for Environmental Health is conducting case finding efforts in collaboration with state and local health departments. CDC’s case definition for state partners includes a blood lead level of 3.5 µg/dL or higher measured within 3 months after consuming a recalled WanaBana, Schnucks, or Weis brand fruit puree product after November 2022. As of December 8, CDC has received reports of 46 confirmed cases, 68 probable cases, and 11 suspected cases for a total of 125 cases from 22 different states through their reporting structure. For more information, please visit CDC’s page to review their case reporting methodology and findings.

CDC and FDA have different data sources, so the counts reported by each agency will not directly correspond. In addition, some people who were affected by the contaminated product might be reflected in both the numbers reported by the FDA and the numbers reported by CDC, so the numbers should not be added together.

FDA’s investigation is ongoing to determine the point of contamination and whether additional products are linked to illnesses. FDA will update the advisory as information becomes available.

FDA, along with CDC and state and local partners, is investigating reports of elevated blood lead levels in individuals with reported exposure to Apple Cinnamon Fruit Puree pouches manufactured in Ecuador and sold under WanaBana, Weis, and Schnucks brands.

• WanaBana apple cinnamon fruit puree pouches are sold nationally and are available through multiple retailers including Amazon, Dollar Tree, and other online outlets.
• FDA is aware that recalled WanaBana Apple Cinnamon Puree is still on the shelves at several Dollar Tree stores in multiples states. This product should not be available and consumers should not purchase this product.
• Schnucks-brand cinnamon-flavored applesauce pouches and variety pack are sold at Schnucks and Eatwell Markets grocery stores.
• Weis-brand cinnamon applesauce pouches are sold at Weis grocery stores.

FDA is aware that recalled WanaBana Apple Cinnamon Puree is still on the shelves at several Dollar Tree stores in multiple states. FDA is working with the firm to ensure an effective recall. This product should not be available for sale and consumers should not purchase or consume this product as it is potentially contaminated with lead, which can be harmful to health, particularly for children.

To properly discard the product, consumers and retailers should carefully open the pouch and empty the content into a trash can before discarding the packaging to prevent others from salvaging recalled product from the trash. Clean up any spills after discarding the product then wash your hands. 

FDA’s investigation is ongoing to determine the point of contamination and whether additional products are linked to illnesses. At this time, the FDA is not aware of any other reports of illnesses or elevated blood lead level adverse events reported for other cinnamon-containing products or cinnamon.

FDA and other state partners collected and analyzed additional product samples of fruit puree and applesauce pouches. FDA detected elevated levels of lead in one finished product sample of WanaBana Apple Cinnamon Puree collected from Dollar Tree. The level detected in the FDA sample of WanaBana apple cinnamon puree is 2.18 parts per million (ppm), which, for context, is more than 200 times greater than the action level the FDA has proposed in draft guidance for fruit purees and similar products intended for babies and young children. 

FDA’s leading hypothesis is that cinnamon used in these recalled pouches is the likely source of contamination for these products; however, the FDA has not yet been able to collect and test samples of the cinnamon used in the recalled products. The FDA is continuing to work with Ecuadorian authorities to investigate the source of the cinnamon. At this time, FDA has no indication that this issue extends beyond these recalled products, but to further protect public health, FDA is screening incoming shipments of cinnamon from multiple countries for lead contamination. 

In addition to determining the source of cinnamon, FDA’s investigation is ongoing to determine the point of contamination and whether additional products are linked to illnesses. At this time, the FDA is not aware of any other reports of illnesses or elevated blood lead level adverse events reported for other cinnamon-containing products or cinnamon.

The FDA also reminds industry that it is the legal responsibility of companies distributing food products that are sold in the U.S., to comply with applicable requirements in the Federal Food, Drug, and Cosmetic Act and FDA’s regulations. 

By law, food manufacturers have a responsibility to significantly minimize or prevent chemical hazards when needed. This includes putting in place any needed preventive controls to reduce or eliminate the presence of lead in their products. Most food manufacturers and processors are covered by the preventive control provisions of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule. The preventive control provisions require industry to implement controls to significantly minimize or prevent any identified chemical hazards, such as lead, requiring a control. In addition, some manufacturers may conduct verification activities like testing the final product. 

For more information please see FDA’s Draft Guidance for Industry on Hazard Analysis and Risk-Based Preventive Controls for Human Food.

Republished with permission from Bill Marler and Marler Clark. Copyright (c) Marler Clark LLP, PS. All rights reserved.