"FDA’s onsite inspection of the Austrofoods facility in Ecuador has ended. However, the FDA investigation of the elevated lead levels in recalled cinnamon applesauce pouches continues. During the inspection, investigators collected samples of cinnamon supplied by Negasmart to Austrofoods. These samples have undergone analysis and results show extremely high levels of lead contamination, 5110 parts per million (ppm) and 2270 ppm. For context, the international standard-setting body, Codex Alimentarius Commission (Codex)External Link Disclaimer is considering adopting a maximum level of 2.5 ppm for lead in bark spices, including cinnamon, in 2024."
CDC has received the following reports from state and local health departments:
This contamination issue, according to FDA, is likely due to adulteration. "Spices such as turmeric, cinnamon and paprika have been known to be mixed with lead chromate or lead oxide, compounds that mirror the spices' colors, said Karen Everstine, technical director for FoodchainID, a company that tracks food supply chains." “The intent is not to make people sick. Nobody wants to do that because then they get caught,” Everstine said. “What they want to do is make money.”
The import of this product does fall under regulation. The foreign company manufacturing the product would be operating under Preventive Controls for Human Foods, and the importer would have to comply with the Foreign Supplier Verification program. Most of this however, focuses on known hazards. Intentional adulteration can be more difficult to control, especially when it occurs at a foreign manufacturer using an ingredient from a foreign source that does not enter the US.
Investigation of Elevated Lead Levels: Cinnamon Applesauce Pouches (November 2023)
Do not eat, sell, or serve multiple brands of recalled apple cinnamon fruit pouches. FDA’s investigation is ongoing.
Content current as of: 12/19/2023
Current Update
December 19, 2023
- Total Cases: 205
- Confirmed Cases: 67
- Probable Cases: 122
- Suspect Cases: 16
- States: (33 total) AL, AR, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, ME, MI, MN, MO, MT, NC, ND, NE, NH, NY, OH, OK, OR, PA, TN, TX, VA, WA, WI, WV
- Recall: Yes
This contamination issue, according to FDA, is likely due to adulteration. "Spices such as turmeric, cinnamon and paprika have been known to be mixed with lead chromate or lead oxide, compounds that mirror the spices' colors, said Karen Everstine, technical director for FoodchainID, a company that tracks food supply chains." “The intent is not to make people sick. Nobody wants to do that because then they get caught,” Everstine said. “What they want to do is make money.”
The import of this product does fall under regulation. The foreign company manufacturing the product would be operating under Preventive Controls for Human Foods, and the importer would have to comply with the Foreign Supplier Verification program. Most of this however, focuses on known hazards. Intentional adulteration can be more difficult to control, especially when it occurs at a foreign manufacturer using an ingredient from a foreign source that does not enter the US.
Investigation of Elevated Lead Levels: Cinnamon Applesauce Pouches (November 2023)
Do not eat, sell, or serve multiple brands of recalled apple cinnamon fruit pouches. FDA’s investigation is ongoing.
Content current as of: 12/19/2023
Current Update
December 19, 2023
As of December 19, 2023, FDA has received 69 complaints/reports of adverse events potentially linked to recalled product. To date, confirmed complainants, or people for whom a complaint or 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 15, CDC has received reports of 67 confirmed cases, 122 probable cases, and 16 suspected cases for a total of 205 cases from 33 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.
You can find previous updates not captured by the initial timeline below in the Previous Updates section. FDA will update the advisory as information becomes available.
https://www.cdc.gov/nceh/lead/news/lead-poisoning-outbreak-linked-to-cinnamon-applesauce-pouches.html
Lead Poisoning Outbreak Linked to Cinnamon Applesauce Pouches
Apple Cinnamon Fruit Puree Pouches & Cinnamon Apple Sauce
On October 31, 2023, WanaBana recalled all WanaBana apple cinnamon fruit puree pouches regardless of expiration date and lot code as part of an ongoing FDA investigation into lead-contaminated food products. On November 9, 2023, WanaBana expanded their recall. Two additional brands of products are also subject to recall: 1) certain Schnucks cinnamon-flavored applesauce pouches and variety packs and 2) certain Weis cinnamon applesauce pouches.
CDC has received the following reports from state and local health departments:
Total Cases: 205
Confirmed Cases: 67
Probable Cases: 122
Suspect Cases: 16
States: (33 total) AL, AR, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, ME, MI, MN, MO, MT, NC, ND, NE, NH, NY, OH, OK, OR, PA, TN, TX, VA, WA, WI, WV
Recall: Yes
Investigation status: Active
Cases are reported to the CDC through state health departments. State health departments receive reports of potential cases from various sources, and then follow up to determine whether the case definition is met. In order to be considered in CDC’s case count, the person must have had a blood lead level of 3.5 ug/dL or higher measured within 3 months after consuming a recalled WanaBana, Schnucks, or Weis brand fruit purée product after November 2022. Based on the amount of information available, CDC asks states to further classify cases as “suspect”, “probable”, and “confirmed”. As the investigation progresses, cases might be assigned to different case categories.
ABC News
https://abcnews.go.com/Health/wireStory/parents-children-sickened-lead-linked-tainted-fruit-pouches-105806558
Parents of children sickened by lead linked to tainted fruit pouches fear for kids' future
Parents of children who posted sky-high blood lead levels after eating potentially tainted apple cinnamon fruit puree pouches are worried about their kids' futures
ByJONEL ALECCIA AP health writer
December 20, 2023, 9:28 AM
When Cora Dibert went for a routine blood test in October, the toddler brought along her favorite new snack: a squeeze pouch of WanaBana cinnamon-flavored apple puree.
“She sucked them dry,” recalls her 26-year-old mother, Morgan Shurtleff, of Elgin, Oklahoma.
Within a week, the family got an alarming call. The test showed that the 1-year-old had lead poisoning, with nearly four times as much lead as the level that raises concern. Only later did Shurtleff learn that that the fruit puree Cora’s grandmother bought at a Dollar Tree store may have been the cause.
“That was the scariest thing that ever happened to me,” Shurtleff says.
Cora is among dozens of young kids across the U.S. poisoned by lead linked to tainted pouches of the cinnamon-and-fruit puree.
The exact number of affected children is unclear. The Centers for Disease Control and Prevention reports at least 205 confirmed, probable or suspected cases from 33 states. Using a different reporting method, the Food and Drug Administration counts at least 69 kids ages 6 and younger sickened in 28 states as of Dec. 14.
Tests show victims had blood lead readings up to eight times higher than the federal reference level of concern, health officials said. Samples of the puree showed lead contamination more than 200 times higher than the FDA allows.
The pouches were sold under three brands — WanaBana, Schnucks and Weis. The products were produced at a plant in Ecuador and first imported to the U.S. in November 2022, the officials said.
Testing of cinnamon samples supplied to the factory showed “extremely high” levels of lead — more than 2,000 times higher than a proposed FDA maximum, the agency said.
FDA officials have raised the prospect that the contamination was intentional. One possibility is that the cinnamon was contaminated for economic reasons, the agency said. That could mean an ingredient such as lead may have been added to boost the value of the cinnamon.
Spices such as turmeric, cinnamon and paprika have been known to be mixed with lead chromate or lead oxide, compounds that mirror the spices' colors, said Karen Everstine, technical director for FoodchainID, a company that tracks food supply chains.
“The intent is not to make people sick. Nobody wants to do that because then they get caught,” Everstine said. “What they want to do is make money.”
https://abcnews.go.com/Health/wireStory/parents-children-sickened-lead-linked-tainted-fruit-pouches-105806558
Previous Updates
December 18, 2023
FDA’s onsite inspection of the Austrofoods facility in Ecuador has ended. However, the FDA investigation of the elevated lead levels in recalled cinnamon applesauce pouches continues. During the inspection, investigators collected samples of cinnamon supplied by Negasmart to Austrofoods. These samples have undergone analysis and results show extremely high levels of lead contamination, 5110 parts per million (ppm) and 2270 ppm. For context, the international standard-setting body, Codex Alimentarius Commission (Codex)External Link Disclaimer is considering adopting a maximum level of 2.5 ppm for lead in bark spices, including cinnamon, in 2024.
The FDA has tested multiple products and, based on the current evidence, there are no further products being added to the recall at this time. Additionally, 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, 136 non-cinnamon containing samples, eleven 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) originally reported as positive for lead, and FDA results were negative for elevated lead for all samples. In addition, FDA collected samples of WanaBana Organic Mango Puree at import and sample results are negative for elevated levels of lead.
At this time, FDA is still relying on officials in Ecuador to support the investigation into Negasmart. To date, 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.
Further, Ecuadorian officials from ARCSA report that Negasmart does not ship product outside Ecuador. ARCSA also reports that in their testing thus far, raw/unprocessed cinnamon from cinnamon importers in Ecuador do not appear to be contaminated with lead, whereas the ground or powdered cinnamon from Negasmart is contaminated. The Ecuadorian processor used by Negasmart is not currently operating.
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. To date, increased screening for imported cinnamon from certain countries remains in place and FDA has no indication that this issue extends beyond these recalled products.
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 prior to export. Thus, the FDA cannot take direct action with Negasmart. However, we are continuing to work closely with Ecuadorian officials, as they are conducting their own rapidly evolving investigations into the source of contamination. FDA is actively assessing information received, using all available resources to further protect public health.
In addition to coordinating with Ecuadorian officials, FDA also is continuing to take steps to make other countries aware of the ongoing investigation into elevated lead levels in cinnamon applesauce pouches manufactured by Austrofoods. As part of this effort, FDA sends updates of the FDA public health advisory to other countries through the World Health Organization (WHO) International Food Safety Authority Network (INFOSAN), which includes more than 200 partner countries.
Finally, we understand there is heightened awareness and interest in this incident, especially for families with small children. For that reason, in addition to continuing to provide timely updates on our investigation, FDA is also providing a timeline detailing the early stages of our investigation in an effort to be as transparent and forthcoming with information as possible.
December 12, 2023
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.
https://www.cdc.gov/nceh/lead/news/lead-poisoning-outbreak-linked-to-cinnamon-applesauce-pouches.html
Lead Poisoning Outbreak Linked to Cinnamon Applesauce Pouches
Apple Cinnamon Fruit Puree Pouches & Cinnamon Apple Sauce
On October 31, 2023, WanaBana recalled all WanaBana apple cinnamon fruit puree pouches regardless of expiration date and lot code as part of an ongoing FDA investigation into lead-contaminated food products. On November 9, 2023, WanaBana expanded their recall. Two additional brands of products are also subject to recall: 1) certain Schnucks cinnamon-flavored applesauce pouches and variety packs and 2) certain Weis cinnamon applesauce pouches.
CDC has received the following reports from state and local health departments:
Total Cases: 205
Confirmed Cases: 67
Probable Cases: 122
Suspect Cases: 16
States: (33 total) AL, AR, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, ME, MI, MN, MO, MT, NC, ND, NE, NH, NY, OH, OK, OR, PA, TN, TX, VA, WA, WI, WV
Recall: Yes
Investigation status: Active
Cases are reported to the CDC through state health departments. State health departments receive reports of potential cases from various sources, and then follow up to determine whether the case definition is met. In order to be considered in CDC’s case count, the person must have had a blood lead level of 3.5 ug/dL or higher measured within 3 months after consuming a recalled WanaBana, Schnucks, or Weis brand fruit purée product after November 2022. Based on the amount of information available, CDC asks states to further classify cases as “suspect”, “probable”, and “confirmed”. As the investigation progresses, cases might be assigned to different case categories.
ABC News
https://abcnews.go.com/Health/wireStory/parents-children-sickened-lead-linked-tainted-fruit-pouches-105806558
Parents of children sickened by lead linked to tainted fruit pouches fear for kids' future
Parents of children who posted sky-high blood lead levels after eating potentially tainted apple cinnamon fruit puree pouches are worried about their kids' futures
ByJONEL ALECCIA AP health writer
December 20, 2023, 9:28 AM
When Cora Dibert went for a routine blood test in October, the toddler brought along her favorite new snack: a squeeze pouch of WanaBana cinnamon-flavored apple puree.
“She sucked them dry,” recalls her 26-year-old mother, Morgan Shurtleff, of Elgin, Oklahoma.
Within a week, the family got an alarming call. The test showed that the 1-year-old had lead poisoning, with nearly four times as much lead as the level that raises concern. Only later did Shurtleff learn that that the fruit puree Cora’s grandmother bought at a Dollar Tree store may have been the cause.
“That was the scariest thing that ever happened to me,” Shurtleff says.
Cora is among dozens of young kids across the U.S. poisoned by lead linked to tainted pouches of the cinnamon-and-fruit puree.
The exact number of affected children is unclear. The Centers for Disease Control and Prevention reports at least 205 confirmed, probable or suspected cases from 33 states. Using a different reporting method, the Food and Drug Administration counts at least 69 kids ages 6 and younger sickened in 28 states as of Dec. 14.
Tests show victims had blood lead readings up to eight times higher than the federal reference level of concern, health officials said. Samples of the puree showed lead contamination more than 200 times higher than the FDA allows.
The pouches were sold under three brands — WanaBana, Schnucks and Weis. The products were produced at a plant in Ecuador and first imported to the U.S. in November 2022, the officials said.
Testing of cinnamon samples supplied to the factory showed “extremely high” levels of lead — more than 2,000 times higher than a proposed FDA maximum, the agency said.
FDA officials have raised the prospect that the contamination was intentional. One possibility is that the cinnamon was contaminated for economic reasons, the agency said. That could mean an ingredient such as lead may have been added to boost the value of the cinnamon.
Spices such as turmeric, cinnamon and paprika have been known to be mixed with lead chromate or lead oxide, compounds that mirror the spices' colors, said Karen Everstine, technical director for FoodchainID, a company that tracks food supply chains.
“The intent is not to make people sick. Nobody wants to do that because then they get caught,” Everstine said. “What they want to do is make money.”
https://abcnews.go.com/Health/wireStory/parents-children-sickened-lead-linked-tainted-fruit-pouches-105806558
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