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. The agency sent a letter to all cinnamon manufacturers, processors, distributors and facility operators in the United States, 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.

Fhe 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 United States 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.

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