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  5. Post-Incident Response Activities: Elevated Lead and Chromium Levels in Cinnamon Applesauce Pouches
  1. Outbreaks of Foodborne Illness

Post-Incident Response Activities: Elevated Lead and Chromium Levels in Cinnamon Applesauce Pouches

Investigation of Elevated Lead & Chromium Levels: Cinnamon Applesauce Pouches

Public Health Alerts for Ground Cinnamon

Investigation Summary

In October 2023, the FDA, in collaboration with state and local partners, initiated an investigation into reports of children with elevated blood lead levels, indicating potential acute lead toxicity. The investigation led to the FDA issuing a public health alert and a firm – WanaBana – initiating a recall of their Apple Cinnamon Fruit Puree products in late October 2023. In November 2023, WanaBana expanded their recall announcement to include additional brands of products. Also subject to recall were: 1) certain Schnucks cinnamon-flavored applesauce pouches and variety packs and 2) certain Weis cinnamon applesauce pouches.

To determine the source of the lead contamination, the FDA led an investigation, which is detailed here: Investigation of Elevated Lead and Chromium Levels: Cinnamon Applesauce Pouches and Chromium Levels: Cinnamon Applesauce Pouches. 

Through FDA’s processes for incident response and investigation, and in conjunction with our regulatory partners and industry, we identified the source of the lead contamination and ensured that the unsafe product was removed from the U.S. market. As a result of our investigation, the FDA’s leading hypothesis is that this contamination event was the result of economically motivated adulteration of the cinnamon used in the applesauce. Economically motivated adulteration (EMA) occurs when someone intentionally leaves out, takes out, or substitutes a valuable ingredient or part of a food, or when a substance is added to a food to make it appear better or of greater value. In some cases, EMA can result in negative health impacts for those who consume the adulterated product. 

The FDA has transitioned from its initial response activities to contain the event so that no additional illnesses occurred and to identify the source of the issue. The agency is now focused on post-incident response actions and activities, which may include additional surveillance, as well as prevention and compliance activities. The FDA will continue to update this page with additional actions that occur related to this incident.

FDA Complaint/Adverse Event Report Overview

As of March 2024, the FDA has received over 200 reports of adverse events potentially related to the cinnamon apple sauce pouches in the CFSAN Adverse Event Reporting System (CAERS); however, the agency has only been able to confirm 90 as of January 31, 2024, as noted in the investigation page. For reference, the FDA defined confirmed complaints as those reports submitted directly to the FDA that note elevated blood lead levels of 3.5 µg/dL or higher, detected through laboratory testing in a person within three months after consuming apple cinnamon puree pouches manufactured by Austrofood S.A.S (Ecuador) after November 2022.

Both healthcare providers and consumers may submit reports voluntarily to CAERS. While the FDA reviews every report submitted, at times there may not be enough information to follow up or to confirm the source or scope of the issue. The agency will continue to work with the Centers for Disease Control and Prevention (CDC), which is also tracking reports related to this incident. 

FDA Post-Incident Response Activities and Actions

On March 6, 2024, the FDA issued a public health alert advising consumers not to buy or eat certain ground cinnamon products because samples of these products were found to contain elevated levels of lead and because prolonged exposure to these products may be unsafe and could contribute to elevated levels of lead in the blood. The alert followed FDA’s targeted lead analysis survey that focused on ground cinnamon products from discount retail stores, and additional testing by states under the Laboratory Flexible Funding Model Cooperative Agreement (LFFM). The FDA initiated this testing to evaluate the presence of lead in cinnamon following the October 2023 voluntary recall of cinnamon apple puree and applesauce products due to elevated lead levels linked to the cinnamon in those products and the concern for lead toxicity in children.

As part of our response to the findings in the retail sampling assignment, the FDA also sent a letter to 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 in ground cinnamon products. The FDA will continue to work with firms to ensure they are meeting their responsibilities under provisions of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule.  

Public Health Alerts for Ground Cinnamon:  

State Sampling

For the last several years, including prior to the recall of WanaBana apple puree and applesauce products containing elevated levels of lead and chromium, FDA has supported state testing of ground cinnamon and other spices. Following the FDA’s targeted assessment of ground cinnamon products for lead and chromium and the March 6, 2024 FDA public health alert, states continue to provide the FDA with sampling data for samples of ground cinnamon.

The New York State Department of Agriculture and Markets (NYSAGM) partnered with FDA to follow up on information provided to the FDA by the New York City Department of Health. As part of their follow-up, NYSAGM collected a sample containing 20 ppm lead and provided that sample for FDA review. On July 25, 2024, the FDA issued a public health alert on El Servidor brand ground cinnamon and recommended the product for voluntary recall due to concern that it could contribute to elevated levels of lead in the blood, especially in babies and young children. Protecting children from exposure to lead is particularly important because they are more susceptible to lead toxicity.

In addition, several states continue to provide the FDA with sampling data for samples of ground cinnamon collected through the LFFM. The LFFM is a cooperative agreement with states to help investigate, monitor and remove adulterated foods from commerce and aid regulatory programs. California, Maryland, Missouri, Connecticut, and Virginia collected ground cinnamon samples through the LFFM, in addition to samples collected outside the LFFM from the New York State Department of Agriculture and Markets, all of which are included in the July 30, 2024 public health alert.

The FDA is continuing to analyze cinnamon and review sample results received from state partners who have been continuously sampling ground cinnamon at retail for the presence of lead. Previous public health alerts on ground cinnamon may be updated as necessary if the FDA finds that additional products contain elevated levels of lead and that exposure to these products may be unsafe.

Additional Activities

The FDA is continuing work to optimize oversight of foreign suppliers and imported foods, including through increased and more targeted import screening. The agency will continue to explore additional surveillance, as well as prevention and compliance activities.

The FDA has issued several warning letters as part of the agency’s ongoing efforts to enhance the safety of cinnamon, ground spices, and other foods, particularly those consumed by babies and young children.

  • In November and December 2024, the FDA issued warning letters to three importers of apple cinnamon fruit puree from Austrofood: WanaBana USA LLC, Purcell International, and Caribbean Produce Exchange, LLC. The warning letters outlined violations of the FDA’s Foreign Supplier Verification Program (FSVP). The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the U.S. has been produced in a manner that meets applicable U.S. food safety standards.
  • On August 9, 2024, the FDA issued a warning letter to AUSTROFOOD S.A.S. (Austrofood), the foreign manufacturer of the apple cinnamon fruit puree pouches. The warning letter cites Austrofood for violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule. The warning letter also states that the presence of the levels of lead in the apple cinnamon fruit puree pouches causes these products to be adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they bear or contain an added poisonous or deleterious substance which may render them injurious to health.
  • The FDA issued a warning letter in June 2024 to Dollar Tree, Inc., because, at the time of the recall, the company failed to adequately remove recalled WanaBana apple cinnamon fruit puree pouches from its store shelves. When a food is recalled, retailers play a crucial role in carrying out the recall by ensuring that recalled products are not available to consumers at their stores.

In addition to continued work with manufacturers, distributors, and retailers to remove unsafe products from the market and further investigation into the sources of lead contamination, the FDA is also continuing to sample food through its Toxic Elements monitoring program, targeted assignments, and through testing by states. This testing of a variety of foods includes colored spices offered for sale in the U.S. Imported foods with levels of toxic elements that may be unsafe can be placed on Import Alert 99-42 and detained without physical examination. In addition, our previous and ongoing sampling at import has prevented some cinnamon with elevated lead levels from entering U.S. commerce; however, like all of our surveillance activities, these monitoring programs only evaluate a small subset of the commodity being imported. Ultimately, it is the responsibility of the manufacturers and the importers to ensure the safety of the products entering the U.S. market. The FDA also works on several fronts to combat economically motivated adulteration, especially adulteration that leads to food safety hazards. Our efforts include signals monitoring, risk prioritization, surveillance, and enforcement actions.

The FDA is working with the spice industry to provide awareness about these findings so that the spice industry can make informed decisions that help ensure the safety of their products. FDA staff participated in an international Codex Alimentarius (Codex) Commission meeting in the spring of 2024 to work toward development of a recommended international maximum level (ML) for lead in bark spices like cinnamon. This work will continue in 2025 after more data are gathered. The purpose of Codex is to protect the health of consumers and promote fair trade practices by adopting scientifically based standards, guidelines, and codes of practice across all areas of food safety and quality. The FDA will follow up on these findings as well as continue our surveillance activities concerning imported spices to prevent unsafe cinnamon from reaching consumers in the U.S., including adding firms and products to import alerts such as Import Alert 99-42 where appropriate.

In June 2024, the agency placed Negasmart, the foreign distributor of the cinnamon used in the contaminated apple cinnamon fruit puree products, on multiple import alerts. Those include Import Alert 99-47 regarding products that appear to be adulterated for economic gain after the FDA determined lead chromate was present in sampled cinnamon intended for production, and Import Alert 99-42 for products that are contaminated with heavy metals and appear to be adulterated under section 402(a)(1) of the FD&C Act.

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