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. As of November 16, there have been 34 reports of illness potentially linked to recalled product submitted to FDA, most of whom they agency says are children. The company announced a recall of the products in early November.
The agency and other state partners collected and analyzed additional product samples of fruit puree and applesauce pouches and detected elevated levels of lead in one finished product sample of WanaBana apple cinnamon puree collected from Dollar Tree. The level detected in the sample is 2.18 parts per million, which is more than 200 times greater than the action level the FDA has proposed in draft guidance for fruit purees and similar products intended for babies and young children.
To date, 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.
FDA’s leading theory is that cinnamon used in these recalled pouches is the likely source of contamination; however, the agency has not yet been able to collect and test samples of the cinnamon used in the recalled products. It continues to work with Ecuadorian authorities to investigate the source of the cinnamon. At this time, while FDA has no indication that this issue extends beyond these recalled products, it 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. As of November 17, the agency says it is not aware of any other reports of illnesses or elevated blood lead level adverse events reported for other cinnamon or cinnamon-containing products.
Food Quality & Safety will update this advisory as information becomes available.
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