FDA has confirmed that lead and chromium detected in the cinnamon in applesauce pouches imported from Ecuador are from lead chromate. Three brands of applesauce pouches, manufactured in Ecuador and sold under WanaBana, Weis, and Schnucks brands, were recalled last November due to lead contamination.

Historically, lead chromate has been illegally added to certain spices increase to their weight and enhance their color, which increases the monetary value of the adulterated spices, the agency said in a February 29 statement. FDA’s leading hypothesis remains that this was likely an act of economically motivated adulteration.

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 prior to export. Therefore, FDA has limited ability to take direct action with Negasmart, the supplier of cinnamon to Austrofoods, or Carlos Aguilera, the processor of the cinnamon sticks.

Ecuadorian officials in Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (ARCSA) have reported that Carlos Aguilera of Ecuador, is the likely source of contamination and is not in operation at this time.

The CDC has identified 468 total cases of contamination in 44 states. The investigation is ongoing.  

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FDA is providing additional context about the amount of lead in testing results from cinnamon used as an ingredient in the recalled applesauce pouches and in testing results of the recalled pouches. As of December 26, the agency has received 82 confirmed complaints/reports of adverse events potentially linked to recalled product, up from 69 complaints as of December 19. Those impacted are between zero and 53 years of age.

In an interview published on December 14 in Politico, Jim Jones, FDA’s deputy commissioner for human foods, said the agency is still investigating the lead-tainted cinnamon applesauce pouches, but adds that, “so far all of the signals we’re getting lead to an intentional act on the part of someone in the supply chain and we’re trying to sort of figure that out.” The agency’s investigation into how the lead was added is ongoing, and it has not given a conclusion as of December 28.

FDA tested samples of the cinnamon collected from the Austrofoods manufacturing facility in Ecuador and used in the recalled applesauce pouches. The highest result was 5,110 parts per million (ppm), which was more than 2,000 times the level of 2.5 ppm being considered for bark spices.

In addition, the testing results previously reported for the sample of recalled WanaBana cinnamon apple puree pouch collected from Dollar Tree had a lead concentration of 2.18 ppm which, for context, is more than 200 times greater than the action level of 0.01 ppm that the FDA has proposed in draft guidance for fruit purees and similar products intended for babies and young children.

FDA and state partners have tested at least 136 samples of non-cinnamon containing products and all have been negative for elevated lead levels. Of those, 11 are the Smoothie Mango Passionfruit Banana flavor of WanaBana purees, three of these samples are of the same lot that ARCSA originally reported as positive for lead, and FDA results were negative for elevated lead for all samples. In addition, FDA collected a sample of WanaBana Organic Mango Puree at import and sample results are negative for elevated levels of lead.

The CDC is working in collaboration with state and local health department to investigate the situation as well. 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 22, CDC has received reports of 73 confirmed cases, 157 probable cases, and 21 suspected cases for a total of 251 cases from 34 different states through their reporting structure. CDC and FDA have different data sources, so the counts reported by each agency will not directly correspond.

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Austrofood and Wanabana USA, distributors behind recalled applesauce pouches, say that cinnamon used to manufacture the products was supplied by Negocios Asociados Mayoristas S.A., operating as Negasmart, a third-party distribution company located in Ecuador.

FDA is continuing to work with Ecuadorian authorities to investigate the source of the contamination and to determine whether 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.

As of November 30, there have been 57 reports of adverse events potentially linked to recalled product submitted to FDA. To date, those who have been confirmed to be impacted are younger than 5 years old.

FDA relies on self-reported information submitted by healthcare providers, consumers, and some state partners who submitted an adverse event report to FDA as an initial step in determining whether a product is a potential shared source of exposure amongst complainants. Unlike outbreaks of foodborne illnesses that are genetically linked to pathogens, there is no method to link lead exposure to a specific source, which can make establishing a causal relationship complicated. 

FDA’s investigation is ongoing to determine the point of contamination and whether additional products are linked to illnesses. At this time, the agency 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 and, as of November 30, there have been no screening results that have tested positive for higher levels of lead.

The list of recalled products can be found on FDA’s website.

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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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