Announcement

**Pathfinder** · December 15, 2023, 12:45 PM

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.
en español (Spanish) Product

Recalled cinnamon apple puree and applesauce products. Information on lot codes and UPCs can be found in the firm's recall announcement.

Recalled WanaBana apple cinnamon fruit puree pouches – including three packs
Recalled Schnucks-brand cinnamon-flavored applesauce pouches and variety pack
Recalled Weis-brand cinnamon applesauce pouches

Symptoms of Lead Toxicity

Lead is toxic to humans and can affect people of any age or health status. Protecting children from exposure to lead is particularly important because they are more susceptible to lead toxicity. Most children have no obvious immediate symptoms. Parents and caretakers should consult a healthcare provider if you 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; anemia. Longer term exposure could result in the following additional symptoms: irritability; lethargy; fatigue; muscle aches or muscle prickling/burning; constipation; difficulty concentrating/muscular weakness; tremor; weight loss.

Stores Affected

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, as of December 7, recalled WanaBana Apple Cinnamon Puree product (including recalled three packs) was still on the shelves at several Dollar Tree stores in multiple states. This product should not be available for sale 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.

Status

Ongoing; updates to this advisory will be provided as they become available.

Recommendation

Consumers should not eat, sell, or serve recalled WanaBana, Schnucks, or Weis-brand apple cinnamon pouches and should discard them.
These products have a long shelf life. Consumers should check their homes and discard these products.
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.
Most children have no obvious immediate symptoms of lead exposure. If there’s suspicion that a child may have been exposed to lead, parents should talk to their child’s healthcare provider about getting a blood test.
Contact your healthcare provider if you think you may have symptoms of lead toxicity after eating recalled fruit pouches.
If you or your child have symptoms or exposure to this product, you can also file a complaint or adverse event report (illness or serious allergic reaction).

Current Update

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.

Previous updates on this investigation are available below.

Adverse Event Overview

Total FDA Adverse Events: 65*
Report Date Ranges: October 17, 2023 – December 8, 2023
States with Adverse Illness Events: AL (1), AR (1), CA (1), CT (1), FL (1), GA (2), IA (1), IL (3), KY (3), LA (4), MA (3), MD (6), MI (3), MO (1), NC (5), NE (2), NH (1), NM (1), NY (8), OH (3), PA (1), SC (2), TN (1), TX(3), VA(2), WA (3), WI (1), Unknown (1)
Product Distribution: Nationwide

*Estimate based on Consumer Complaint and CFSAN Adverse Event Reporting System (CAERS) reports received by the FDA. Useful Links

Product Images

Recalled Product

In response to this investigation, Wanabana has voluntarily recalled all WanaBana Apple Cinnamon Fruit Puree Pouches regardless of expiration date and lot code. Two additional brands of products are also subject to recall: certain Schnucks cinnamon-flavored applesauce pouches and variety pack and certain Weis cinnamon applesauce pouches.

International Distribution for Recalled Products

The recall impacts markets outside of the United States. Customer information provided by the firm shows that product was also distributed to Cuba and the United Arab Emirates.

Previous Updates

December 5, 2023

FDA has initiated an onsite inspection at the Austrofoods facility located in Ecuador. Ingredient sample collection is underway.

The FDA is continuing to coordinate with Ecuadorian authorities on the investigation of the source of elevated lead levels in cinnamon apple pouches. In addition, the Ecuadorian authorities report that Negasmart's cinnamon had higher levels of lead than allowed by Ecuador and that Negasmart, the supplier of cinnamon to Austrofoods, is currently under an Ecuadorian administrative sanctions process to determine the responsible party for the contamination.

As of December 5, 2023, FDA has received 64 reports of adverse events potentially linked to recalled product. To date, confirmed complainants, or people who an adverse event was submitted for, are under 6 years of age.

To date, the FDA has included adverse event reports submitted directly to the FDA that note blood lead levels at or above 3.5 micrograms of lead per deciliter of whole blood (µg /dL) within 3 months after consuming recalled product. The FDA is continuing to evaluate incoming adverse reports of illnesses. For background, the Centers for Disease Control and Prevention’s (CDC) blood reference level of 3.5 µg /dL is the level at which the CDC recommends clinical monitoring of lead exposure in children.

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 1, CDC has received reports of 18 confirmed cases, 30 probable cases, and 4 suspected cases from 13 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.

The 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 if a product is a potential shared source of exposure amongst complainants. Unlike outbreaks of foodborne illnesses that are genetically linked to pathogens, lead exposure in an individual can result from several sources. There is no established method to link lead exposure in an individual to a specific source, which can make establishing a causal relationship difficult.

While our total reports included in this advisory represent adverse event reports that have been submitted to FDA, we acknowledge that there are other avenues for reporting of lead exposure. However, we are working with our state partners and CDC to gather and evaluate as much data as possible, while recognizing there are different mechanisms being leveraged.

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.

November 30, 2023

On November 30, 2023, Austrofood, along with Wanabana USA, the distributor of WanaBana products in the United States, released a statement that reports that Wanabana has conducted a root cause investigation. Based on this investigation, the firm’s leading hypothesis to date is that the cinnamon is the source of the elevated lead levels in the recalled products. The statement released today by Wanabana USA and Austrofood states that the cinnamon used to manufacture the recalled products was supplied by Negocios Asociados Mayoristas S.A., operating as Negasmart, a third-party distribution company located in Ecuador.

The FDA is continuing to work with Ecuadorian authorities to investigate the source of the contamination and to determine if 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, 2023, there have been 57 reports of adverse events potentially linked to recalled product submitted to FDA. To date, confirmed complainants are less than 1 to 5 years of age.

The 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 if 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.

While our total reports included in this advisory represent complaints that have been reported to FDA, we recognize there are other avenues for reporting of elevated lead levels. For example, through case reporting from the state health departments to CDC which is routinely done for cases of childhood lead exposure. Because these different avenues for reporting represent two different mechanisms of collecting data, we are currently not including them in our advisory. However, we are working with our state partners and CDC to gather and evaluate as much data as possible, while recognizing there are different mechanisms being leveraged.

FDA’s investigation is ongoing to determine the point of contamination and whether additional products are linked to illnesses. 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. As of November 30, 2023, there have been no screening results that have tested positive for higher levels of lead. Separately, Austrofood CIA LDA’s apple cinnamon fruit puree pouch products exported to the U.S. were added to Import Alert 99-42, detention without physical examination of foods due to heavy metal (toxic element) contamination.

FDA will update the advisory as information becomes available.

November 22, 2023

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 22, 2023, there have been 52 reports of adverse events potentially linked to recalled product submitted to FDA. To date, confirmed complainants are less than 1 to 4 years of age. FDA is continuing to evaluate incoming adverse event reports.

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 will update the advisory as information becomes available.

November 16, 2023

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, 2023, there have been 34 reports of illness potentially linked to recalled product submitted to FDA. FDA is continuing to evaluate incoming adverse reports of illnesses.

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.

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 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.

FDA will update this advisory as information becomes available.

November 13, 2023

As reported in a safety alert issued by FDA on October 28, 2023, the FDA, along with the North Carolina Department of Health and Human Services (NCDHHS) and the North Carolina Department of Agriculture & Consumer Services (NCDA&CS) are investigating reports of four children with elevated blood lead levels, indicating potential acute lead toxicity. The NCDHHS investigation identified WanaBana Apple Cinnamon Fruit Puree pouches as a potential shared source of exposure. As part of their investigation, NCDHHS analyzed multiple lots of WanaBana Apple Cinnamon Fruit Puree, detecting extremely high concentrations of lead. The FDA has reviewed and supports NCDHHS’s analytical findings and determined that levels of lead found in the analyzed pouches could result in acute lead toxicity.

As of November 13, 2023, there have been 22 reports of illness potentially linked to recalled product submitted to FDA. As part of this investigation, FDA and state partners are collecting and analyzing additional product samples of fruit puree and applesauce pouches. At this time, sample analyses have not shown elevated levels of lead in any non-recalled products.

On October 31, 2023, Wanabana LLC initiated a voluntary recall of all WanaBana Apple Cinnamon Fruit Puree Pouches. On November 9, 2023, Wanabana LLC expanded their recall announcement to include information on recalled Schnucks and Weis cinnamon applesauce pouches.

The recall impacts markets outside of the United States. Customer information provided by the firm shows that product was also distributed to Cuba and the United Arab Emirates.

Since the first alert was issued this investigation has been transferred to FDA’s Coordinated Outbreak Response & Evaluation (CORE) Network for additional follow up, in collaboration with the Centers for Disease Control and Prevention (CDC) and state and local partners. Two additional brands of products are also subject to recall: certain Schnucks cinnamon-flavored applesauce pouches and variety pack and certain Weis cinnamon applesauce pouches.

FDA is continuing to evaluate incoming reports of illnesses. FDA’s investigation is ongoing to determine the source of lead contamination and whether additional products are linked to illnesses. FDA will update this advisory as information becomes available.

November 3, 2023

As reported in a safety alert issued by FDA on October 28, 2023, the FDA, along with the North Carolina Department of Health and Human Services (NCDHHS) and the North Carolina Department of Agriculture & Consumer Services (NCDA&CS) are investigating reports of four children with elevated blood lead levels, indicating potential acute lead toxicity. The NCDHHS investigation identified WanaBana Apple Cinnamon Fruit Puree pouches as a potential shared source of exposure. As part of their investigation, NCDHHS analyzed multiple lots of WanaBana Apple Cinnamon Fruit Puree, detecting extremely high concentrations of lead.

The FDA has reviewed and supports NCDHHS’s analytical findings and found that analytical results at this level could result in acute toxicity. The FDA has shared the results with the firm and on October 31, 2023, Wanabana LLC initiated a voluntary recall of all WanaBana Apple Cinnamon Fruit Puree Pouches.

Since the first alert was issued this investigation has been transferred to FDA’s Coordinated Outbreak Response & Evaluation (CORE) Network for additional follow up, in collaboration with the Centers for Disease Control and Prevention (CDC) and state and local partners. Two additional brands of products are also subject to recall: certain Schnucks cinnamon-flavored applesauce pouches and variety pack and certain Weis cinnamon applesauce pouches.

FDA has received additional reports of illnesses and is working to evaluate those complaints. FDA’s investigation is ongoing to determine the source of lead contamination and whether additional products are linked to illnesses. FDA will update this advisory as information becomes available.

October 28, 2023

The FDA was recently made aware of a developing investigation by the North Carolina Department of Health and Human Services (NCDHHS) and the North Carolina Department of Agriculture & Consumer Services (NCDA&CS) regarding four children with elevated blood lead levels, indicating potential acute lead toxicity. The NCDHHS investigation identified WanaBana apple cinnamon fruit puree pouches as a potential shared source of exposure. As part of their investigation, NCDHHS analyzed multiple lots of WanaBana apple cinnamon fruit puree, detecting extremely high concentrations of lead. The FDA has reviewed and supports NCDHHS’s analytical findings and found that analytical results at this level could result in acute toxicity. The FDA has shared the results with the firm whose representatives are cooperating with the FDA and have agreed to voluntarily recall all WanaBana apple cinnamon fruit puree pouches regardless of expiration.

The FDA is issuing this public health alert advising parents and caregivers not to purchase or feed WanaBana apple cinnamon fruit puree pouches to toddlers and young children because they may contain elevated levels of lead. The FDA is continuing to work with state officials and the firm, collecting additional information, and taking steps to remove all contaminated product from the market.

Investigation of Elevated Lead & Chromium Levels: Cinnamon Applesauce

https://www.fda.gov/food/outbreaks-foodborne-illness/investigation-elevated-lead-levels-cinnamon-applesauce-pouches-november-2023

FDA issues Warning Letter and leverages Import Alerts.

**Pathfinder** · December 15, 2023, 12:52 PM

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.

Fast Facts

Data updated on December 8, 2023.

CDC has received the following reports from state and local health departments:

Total Cases: 125
- Confirmed Cases: 46
- Probable Cases: 68
- Suspect Cases: 11
States: CA, CO, FL, IA, ID, IL, IN, KS, KY, LA, MN, NC, NE, NH, NY, OH, OK, OR, TN, TX, 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.

What You Should Do

Do not eat any recalled apple cinnamon fruit puree pouches. Throw them away or return them to where you bought them.
Call your healthcare provider about getting a blood test for lead if you or your children may have consumed recalled products.

What Businesses Should Do

Do not sell or serve recalled apple cinnamon fruit puree pouches.
To properly discard the product, retailers should carefully open the pouch and empty the content into a trash can before discarding the packaging to prevent others from salvaging recalled products from the trash.
Clean up any spills after discarding the product, and then wash your hands.

CDC Case Definition

CDC asks states to classify cases as “suspect,” “probable,” or “confirmed” based on several factors. CDC accepts the state’s classification.

CDC defines a person with a “suspect” case as anyone with a blood lead level of 3.5 μg/dL or higher detected through capillary or unspecified testing (not yet confirmed through venous blood testing) within three months of consuming a recalled product. Capillary and venous testing are both commonly used to test blood for lead levels. However, capillary testing might give a falsely high result. Venous testing is more accurate.

CDC defines a person with a “probable” case as anyone with a blood lead level of 3.5 μg/dL or higher detected through venous testing within three months of consuming a recalled product. People with a “probable” case:

might not have had a follow-up assessment to rule out other potential sources of lead exposure or
might have had a follow-up assessment completed, but the results indicated there were other potential sources of lead exposure (for example., lead-based paint).

CDC defines a person with a “confirmed case” as anyone with a blood lead level of 3.5 μg/dL or higher:

Detected through venous testing within three months of consuming a recalled product and
must have had a follow-up assessment that ruled out other potential sources as the likely cause of lead exposure.

Please note that as the investigation progresses, cases might move to different case categories. For example, a state may initially classify a case as “suspect,” but later determine that the case meets the criteria for being a “confirmed” case. In addition, these simplified definitions might not capture all the nuances of the case definition. We ask that states use our official case definition when classifying cases submitted to CDC. For more information, see CDC’s Lead Poisoning Outbreak Linked to Cinnamon Applesauce Pouches – Case Definition.

Please note that CDC and FDA have different data sources, so the counts reported by each agency might not match. In addition, some people who were affected by the contaminated product might be counted in numbers reported by both FDA and CDC, so the numbers should not be added together. FDA relies on self-reported information submitted by healthcare providers, consumers, and some state partners who submitted an adverse event report to FDA. The reports were submitted as an initial step in determining if a product is a potential shared source of exposure amongst complainants.

Symptoms of Lead Exposure

Children with lead exposure may have no apparent acute symptoms. However, even low levels of lead have been associated with learning and behavior problems, hearing and speech problems, and slowed growth and development. This can show up as lower IQ, decreased ability to pay attention, and underperformance in school. Children who are exposed to large amounts of lead may develop symptoms of acute lead poisoning, including

Abdominal pain, constipation, and nausea
Anemia
Weakness and fatigue
Severe neurological symptoms (including seizures, encephalopathy, and coma)

If parents suspect that a child may have been exposed to lead, they should talk to their child’s healthcare provider about getting a blood lead test. Healthcare providers and most local health departments can test for lead in the blood. Many private insurance policies cover the cost of testing for lead in the blood. The cost of blood lead testing for children enrolled in Medicaid is covered by the Centers for Medicare & Medicaid Services.

The health effects of exposure are more harmful to children less than six years of age because their bodies are still developing and growing rapidly. Young children also tend to put their hands or other objects, which may be contaminated with lead dust, into their mouths, so they are more likely to be exposed to lead than older children.

See Also

Last Reviewed: December 14, 2023

Page Not Found | CDC

https://www.cdc.gov/nceh/lead/news/lead-poisoning-outbreak-linked-to-cinnamon-applesauce-pouches.html

Page Not Found | CDC

**Pathfinder** · December 15, 2023, 01:04 PM

Applesauce pouches may have been contaminated on purpose, FDA foods chief says
...
By MARCIA BROWN and MEREDITH LEE HILL
12/14/2023 01:29 PM EST

Tainted cinnamon applesauce pouches that have sickened scores of children in the U.S. may have been purposefully contaminated with lead, according to FDA’s Deputy Commissioner for Human Foods Jim Jones.

“We’re still in the midst of our investigation. But 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,” Jones said in an exclusive interview. The pouches found to be contaminated were sold under three brands — Weis, WanaBana and Schnucks — that are all linked to a manufacturing facility in Ecuador. The FDA says it’s conducting an inspection of that facility.

“My instinct is they didn’t think this product was going to end up in a country with a robust regulatory process,” Jones said. “They thought it was going to end up in places that did not have the ability to detect something like this.”

The FDA continues to investigate a number of theories for how the pouches became contaminated, and has not drawn any conclusions about the way the lead was added, why or by whom. The FDA says it currently believes the adulteration is “economically motivated.” That generally refers to ingredients being altered in order to make products appear higher in value, often so companies can produce a cheaper item and sell it at an elevated price.
...
“We’re going to chase that data and find whoever was responsible and hold them accountable,” Jones said.

Just a moment...

https://www.politico.com/news/2023/12/14/applesauce-pouches-may-have-been-contaminated-on-purpose-fda-foods-chief-says-00131797

**Pathfinder** · December 19, 2023, 11:39 AM

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.
en español (Spanish)
...

Current Update

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 all 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.

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.

...

Investigation of Elevated Lead & Chromium Levels: Cinnamon Applesauce

https://www.fda.gov/food/outbreaks-foodborne-illness/investigation-elevated-lead-levels-cinnamon-applesauce-pouches-november-2023

FDA issues Warning Letter and leverages Import Alerts.

**Pathfinder** · January 2, 2024, 10:56 AM

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:
12/26/2023

...

Stores Affected

WanaBana apple cinnamon fruit puree pouches are sold nationally and have been available through multiple retailers, including Amazon, Dollar Tree, Family Dollar/Dollar Tree combination stores, and other online outlets.
- FDA is aware that, as of December 13, recalled WanaBana Apple Cinnamon Puree product (including recalled three packs) was still on the shelves at several Dollar Tree stores in multiple states. As of December 19, FDA also received a report that recalled WanaBana Apple Cinnamon Puree product (including recalled three packs) may still be on shelves at Family Dollar/Dollar Tree combination stores. This product should not be available for sale 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.

...

Current Update

December 26, 2023

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 recently reported, 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 (including cinnamon) by the international standard-setting body, Codex Alimentarius Commission (Codex)External Link Disclaimer.

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.

Although there are proposed action levels for lead used for comparison, it is important to underscore that the FDA does not need an action level or guidance to take action when food contains a harmful substance, such as lead, that may render the food injurious to health.

As previously reported on December 18, 2023, 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 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.

As of December 26, 2023, FDA has received 82 confirmed 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 and met FDA’s complainant definition, are between zero and 53 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 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. 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.
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Investigation of Elevated Lead & Chromium Levels: Cinnamon Applesauce

https://www.fda.gov/food/outbreaks-foodborne-illness/investigation-elevated-lead-levels-cinnamon-applesauce-pouches-november-2023

FDA issues Warning Letter and leverages Import Alerts.

**Pathfinder** · January 6, 2024, 10:30 AM

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.
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Current Update

January 5, 2024

In FDA’s testing of the recalled products and the cinnamon collected from the Austrofoods facility, the agency has found chromium. People who ate recalled products, especially if they had elevated blood lead levels, may have been exposed to chromium and should inform their healthcare provider so they can monitor health and provide supportive care, as needed. Healthcare providers can refer to CDC’s Clinician Outreach and Communication Activity (COCA Now) announcement for information for additional guidance.

Chromium is a naturally occurring element. It is an essential trace nutrient important to the diet that exists predominantly in two forms, chromium (III) and chromium (VI). Chromium (VI) is more toxic than chromium (III). Due to limitations in available testing methods, FDA was not able to definitively determine the form of chromium in the cinnamon apple puree sample (i.e., whether the chromium present is chromium (III) or chromium (VI)). The lead-to-chromium ratio in the cinnamon apple puree sample is consistent with that of lead chromate (PbCrO₄) (which contains chromium (VI)), but this is not a definitive indicator that lead chromate or chromium (VI) (the more toxic form of chromium) was present. Information on the health effects of eating food contaminated with chromium (VI) are limited. The chromium in lead chromate may also be converted to chromium (III) (the less toxic form of chromium) due to the acidity of the applesauce and the stomach.

Additional FDA Laboratory Results Indicate Chromium Contamination:

After additional analysis of both recalled cinnamon apple products and the cinnamon collected from the manufacturer in Ecuador, FDA has determined that, in addition to lead, the cinnamon and recalled products also contained a high level of chromium. The level of chromium detected in the two samples of cinnamon yielded 1201 and 531 parts per million (ppm). Because of the limited amount of cinnamon used in the finished product, the level of chromium detected in the reanalysis of FDA samples of the recalled WanaBana Cinnamon Apple Puree product yielded 0.590 and 0.566 ppm.

FDA also conducted testing for arsenic and cadmium, but those elements were not detected above trace levels in the cinnamon collected from the Austrofoods facility in Ecuador or in the recalled product. As part of this investigation, some state partners also conducted testing for toxic elements and only detected elevated levels of lead and chromium.

Health Implications & Recommendations:

The health effects of eating food contaminated with chromium (VI), as a constituent of lead chromate, are not well understood. Symptoms of chromium exposure from eating contaminated food may be nonspecific. Some people might not experience any symptoms. Symptoms for children are likely similar to those of adults. Acute ingestion of chromium exceeding dietary recommendations may result in abdominal pain, nausea, vomiting, diarrhea, anemia, renal and hepatic dysfunction.

Consumers should contact their healthcare providers if they are experiencing any symptoms following the consumption of recalled product. Consumers should also inform their healthcare provider that they may have been exposed to high levels of chromium and lead if recalled products were consumed so their provider can monitor and potentially address any adverse health effects.

Healthcare providers can refer to CDC’s COCA Now announcement for information for additional guidance.

FDA’s investigation is ongoing to determine the point of contamination and whether additional products are linked to illnesses. Previous updates not captured by the initial timeline are below in the Previous Updates section. FDA will update the advisory as information becomes available.

FDA Complaint/Adverse Event Report Overview

Total Complaint/Adverse Event Report: 82*
Report Date Ranges: October 17, 2023 – December 20, 2023
States with Complaint/Report: AL (1), AR (1), CA (1), CT (1), FL (1), GA (2), IA (1), IL (5), IN (1), KY (3), LA (4), MA (3), MD (6), MI (7), MO (2), NC (5), NE (2), NH (1), NJ (1), NM (1), NY (8), OH (3), PA (2), SC (2), TN (3), TX (3), VA (2), WA (4), WI (2), WV (1), Unknown (3)
Product Distribution: Nationwide

*Estimate based on Consumer Complaint and CFSAN Adverse Event Reporting System (CAERS) reports received by the FDA.

...

Investigation of Elevated Lead & Chromium Levels: Cinnamon Applesauce

https://www.fda.gov/food/outbreaks-foodborne-illness/investigation-elevated-lead-levels-cinnamon-applesauce-pouches-november-2023

FDA issues Warning Letter and leverages Import Alerts.

**Pathfinder** · March 7, 2024, 09:20 AM

FDA Takes Steps to Ensure Safety of Cinnamon Products Sold in the US

Following Testing, FDA Recommends Consumers Do Not Buy or Eat Recalled Ground Cinnamon

For Immediate Release: March 06, 2024

Español

The U.S. Food and Drug Administration is taking several additional steps to address concerns about elevated lead levels in cinnamon following the recent incident associated with certain cinnamon apple sauce pouches that resulted in lead poisoning in young children. Today, the agency sent a letter to all cinnamon manufacturers, processors, distributors and facility operators in the U.S., reminding them of the requirement to implement controls to prevent contamination from potential chemical hazards in food, including ground cinnamon products. The agency is also recommending the voluntary recall of certain ground cinnamon products sold by a number of brands at six different retail chains that were found to contain elevated levels of lead.

The agency notified the distributors and manufacturers of products found to contain elevated levels of lead and recommended that the manufacturers voluntarily recall these products because prolonged exposure to them may be unsafe. The products were identified during an FDA-initiated sampling and testing effort to assess cinnamon sold across numerous retail stores. No illnesses or adverse events have been reported to date related to the ground cinnamon products listed below, but the FDA is concerned that, because of the elevated lead levels in these products, continued and prolonged use of the products may be unsafe.

The FDA is advising consumers to throw away and not to buy the ground cinnamon products with the lot codes listed below because samples of these products were found to contain elevated levels of lead. Consumers can find lot codes listed on the product’s label. The FDA is working with the firms listed below to voluntarily recall the products, with the exception of the MTCI cinnamon. The FDA has been unable to reach MTCI to share its findings and request that the company initiate a recall. The FDA will update its Safety Alert with new information as it becomes available.

La Fiesta Food Products La Miranda, CA	La Superior SuperMercados	25033
Marcum, Moran Foods, LLC Saint Ann, MO	Save A Lot	Best By: 10/16/25 10 D8; 04/06/25 0400B1
MTCI Santa Fe Springs, CA	SF Supermarket	No codes
SWAD, Raja Foods LLC Skokie, IL	Patel Brothers	KX21223 Best Before: July 2026
Supreme Tradition, Greenbriar International, Inc. Chesapeake, VA	Dollar Tree Family Dollar	Best By: 09/29/25 09E8; 04/17/25 04E11; 12/19/25 12C2; 04/12/25 04ECB12; 08/24/25 08A_ _; 04/21/25 04E5; and 2025-09-22 09E20
El Chilar Apopka, FL	La Joya Morelense, Baltimore, MD	F275EX1026; D300EX1024

It is important to note that the lead levels found in the ground cinnamon products listed above are significantly lower than lead levels in cinnamon in the recalled apple sauce pouches removed from the market this past fall. The products currently recommended for recall contain lead levels ranging from 2.03 to 3.4 parts per million (ppm) lead. The levels of lead in the ground cinnamon recommended for recall is approximately 2,000 ppm to nearly 5,000 ppm lower than the levels of lead associated with the cinnamon in recalled apple puree and apple sauce products. Therefore, these ground cinnamon products do not pose the same level of risk to human health as the apple sauce pouches but could be unsafe for prolonged use.

“Today’s actions serve as a signal to industry that more needs to be done to prevent elevated levels of contaminants from entering our food supply,” said Deputy Commissioner for Human Foods Jim Jones. “Food growers, manufacturers, importers and retailers share a responsibility for ensuring the safety of the foods that reach store shelves. The levels of lead we found in some ground cinnamon products are too high and we must do better to protect those most vulnerable to the negative health outcomes of exposure to elevated levels of lead.”

In the letter sent to the cinnamon industry today, the FDA reminds manufacturers, processors, distributors and facility operators to follow the requirements of the rule Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food, including the requirement to consider chemical hazards that may be present in foods when conducting hazard analyses required by this rule. While the agency continues to emphasize the importance of the cinnamon industry’s responsibility to take measures to prevent potential chemical hazards in its products, the letter to industry and recent recalls highlight how the FDA will request the removal of unsafe cinnamon products from the market.

In the meantime, the FDA has continued to make notable progress in reducing exposure to environmental contaminants from foods through its Closer to Zero initiative. For example, the FDA’s work establishing action levels to reduce levels of inorganic arsenic in infant rice cereals has resulted in close to a 30% reduction since 2020. The agency is continuing the cycle of improvement for arsenic, lead, cadmium and mercury by evaluating the science and other relevant data; proposing draft action levels, as appropriate; consulting with stakeholders on feasibility, achievability and other issues; and adjusting, as needed, and finalizing action levels. While working towards issuing final guidance for lead action levels in food intended for infants and young children remains a priority, today’s recalls and letter to industry underscore that the FDA does not need action levels or guidance to take action when the level of a contaminant, such as lead, is unsafe.

As part of Closer to Zero, the FDA continues to pursue additional authorities from Congress to require manufacturers to test ingredients or final products marketed for consumption by infants and young children for contaminants before products enter the U.S. market. Under current federal law, there is no explicit requirement for manufacturers to conduct such testing. The President’s FY2024 Budget contains legislative proposals to explicitly require industry to conduct this testing, maintain testing results for FDA inspection and provide the FDA remote access to test results. Having such requirements would help the FDA understand levels of contaminants in foods, allow the FDA to monitor industry progress in reducing levels over time and identify where the FDA should devote more time and resources. In addition, such requirements may prevent products with elevated lead levels from entering the U.S. market in the first instance.

The agency is also working with Centers for Disease Control and Prevention as well as state and local partners to investigate elevated lead and chromium levels in individuals with reported exposure to apple cinnamon fruit puree pouches manufactured in Ecuador and sold in the U.S. under WanaBana, Weis and Schnucks brands. This work led to a voluntary recall of these products in October 2023.

The FDA and industry share a common goal of ensuring the safety of food, but more can and must be done. Until these additional authorities are granted, the FDA will continue using all currently available tools to conduct additional sampling and testing of foods with known hazards, including cinnamon and cinnamon-containing foods consumed by babies and young children, and looking at samples collected both domestically and at import.

Related Information

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https://www.fda.gov/news-events/pres...oducts-sold-us

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FDA Alert Concerning Certain Cinnamon Products Due to Presence of Elevated Levels of Lead

March 6, 2024

Audience

All consumers
All retailers

What is the problem?

Through product testing, the FDA has determined that the ground cinnamon products listed in the table below contain elevated levels of lead and that prolonged exposure to these products may be unsafe.

The FDA is advising consumers to throw away and not to buy these ground cinnamon products. The FDA has recommended that the firms voluntarily recall these products, with the exception of the MTCI cinnamon. The FDA has been unable to reach MTCI to share our findings and request that the company initiate a recall. The FDA will update this notice with the communications from firms that voluntarily agree to recall as we receive them.

Products

La Fiesta Food Products La Miranda, CA	La Superior SuperMercados	La Fiesta	25033	2.73
Moran Foods, LLC Saint Ann, MO	Save A Lot	Marcum	Best By: 10/16/25 10DB 04/06/25 0400B1	3.20 2.70
MTCI Santa Fe Springs, CA	SF Supermarket	MK	No codes	2.99
Raja Foods LLC Skokie, IL	Patel Brothers	Swad	KX21223	2.12
Greenbriar International, Inc. Chesapeake, VA	Dollar Tree Family Dollar	Supreme Tradition	Best By: 09/29/25 09E8 04/17/25 04E11 12/19/25 12C2 04/12/25 04ECB12 08/24/25 08A_ _ 04/21/25 04E5 04/21/25 04E5 2025-09-22 09E20 (Missouri)	3.37 2.26 2.03 2.34 3.14 3.12 2.88 3.13
El Chilar Apopka, FL	La Joya Morelense (Baltimore, MD)	El Chilar	F275EX1026 (Maryland) D300EX1024 (Maryland)	3.40 2.93

Recommendations for consumers

The FDA is advising consumers to stop using and dispose of these products.
Consumers should not eat, sell, or serve ground cinnamon products listed in the table above and should discard them.
These products have a long shelf life. Consumers should check their homes and discard these products.
If there’s suspicion that someone has been exposed to elevated levels of lead, talk to your healthcare provider. Most people have no obvious immediate symptoms of lead exposure.

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Safety Alert

https://www.fda.gov/food/alerts-advisories-safety-information/fda-alert-concerning-certain-cinnamon-products-due-presence-elevated-levels-lead

The FDA is advising consumers to throw away and not to buy the ground cinnamon products listed above because samples of these products were found to contain elevated levels of lead.

**sharon sanders** · March 8, 2024, 08:49 AM

bump this

Announcement

CDC Health Alert - High Blood Lead Levels in Children Consuming Recalled Cinnamon Applesauce Pouches - November 13, 2023

CDC Health Alert - High Blood Lead Levels in Children Consuming Recalled Cinnamon Applesauce Pouches - November 13, 2023

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