FOOD SAFETY: FDA ENSURES INTEGRITY OF CINNAMON PRODUCTS SOLD IN THE UNITED STATES

The United States Food and Drug Administration (FDA) is taking further steps to address concerns regarding elevated levels of lead in cinnamon, following a recent incident associated with certain packets of cinnamon apple sauce that caused lead poisoning in young children. Today, the agency sent a letter to all cinnamon manufacturers, processors, distributors, and facility operators in the United States, reminding them of the obligation to implement controls to prevent contamination from potential chemical hazards in foods, including products containing ground cinnamon. Additionally, the agency recommends the voluntary recall of certain cinnamon-based products sold by various brands at six different retail chains that have been found to contain elevated levels of lead.

The agency has informed distributors and manufacturers of products found to contain elevated levels of lead and has recommended that manufacturers voluntarily recall these products because prolonged exposure to them may be dangerous. The products were identified during a sampling and testing effort initiated by the FDA to assess cinnamon sold in numerous retail stores. As of today, there have been no reported cases of illnesses or adverse events related to the listed ground cinnamon products, but the FDA is concerned that, due to the elevated levels of lead in these products, continued and prolonged use of the products may be unsafe.

The FDA advises consumers to discard and not purchase 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 the listed lot codes on the product label. The FDA is working with the companies listed below to voluntarily recall the products, except for MTCI cinnamon. The FDA was unable to contact 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.

Summary Table of At-Risk Ground Cinnamon Products:

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

Deputy Commissioner for Human Foods Jim Jones stated, "Today's actions serve as a signal to the industry that more must be done to prevent elevated levels of contaminants from entering our food chain. Growers, manufacturers, importers, and food retailers share the responsibility to ensure the safety of foods that reach store shelves. The levels of lead we found in some cinnamon-based products are too high, and we must do better to protect those who are most vulnerable to the adverse health outcomes of exposure to elevated levels of lead."

The FDA, in the communication sent to the cinnamon industry today, reminds manufacturers, processors, distributors, and facility operators to follow the requirements of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation, including the requirement to consider chemical hazards that may be present in foods during the hazard analysis required by this regulation. 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 the industry and recent recalls highlight how the FDA will require the withdrawal from the market of unsafe cinnamon-based products.

Meanwhile, the FDA has continued to make significant progress in reducing exposure to environmental contaminants from foods through its Closer to Zero initiative. For example, the FDA's work in establishing action levels to reduce levels of inorganic arsenic in infant rice cereals has resulted in a nearly 30% reduction since 2020. The agency is continuing the improvement cycle for arsenic, lead, cadmium, and mercury by assessing science and other relevant data; proposing preliminary action levels, if appropriate; consulting with stakeholders on feasibility, achievability, and other issues; and adjusting, if necessary, and finalizing the action levels. While working to issue definitive guidance for lead action levels in foods intended for infants and young children, today's recalls and the letter to the industry underscore that the FDA does not need action levels or guidance to act when the level of a contaminant, such as lead, is unsafe.

Under Closer to Zero, the FDA continues to seek additional authorizations from Congress to require manufacturers to test ingredients or final products intended for consumption by infants and young children for contaminants before the 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 the industry to conduct these tests, maintain the test results for FDA inspection, and provide the FDA with remote access to the test results. Such requirements would help the FDA understand contaminant levels in foods, enable the FDA to monitor industry progress in reducing levels over time, and identify where the FDA should devote more time and resources. Additionally, such requirements can prevent products with elevated levels of lead from entering the U.S. market in the first place.

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

The FDA and the industry share a common goal of ensuring food safety, but more can and must be done. Until these additional authorizations are granted, the FDA will continue to use all currently available tools to conduct additional sampling and testing of foods with known hazards, including cinnamon and cinnamon-containing foods consumed by infants and young children, and to monitor samples collected both nationally and from imports.

Glossary

• FDA: The U.S. government agency for food and drug regulation, responsible for food and drug safety.
• Food Safety: A concept concerning the management, control, and prevention of food risks to ensure that foods are safe for human consumption.
• Cinnamon: A spice obtained from the inner bark of trees belonging to the genus Cinnamomum, commonly used in cooking.
• Lead: A toxic heavy metal that can cause serious health issues if ingested in excessive amounts.
• Recall: The action of withdrawing a product from the market due to safety or compliance concerns.
• Contaminants: Unwanted or harmful substances present in foods that may pose a health risk.
• Public Health: The discipline concerned with protecting and improving the health of communities and populations.
• Toxicity: The quality of being toxic or harmful to health.
• Action Levels: Standards or limits established to regulate the levels of certain substances in specific products.
• Initiative: An action or plan undertaken to achieve a specific goal.
• Test: Procedures or experiments conducted to assess the presence of unwanted substances or to verify compliance with certain standards.
• Exposure: The condition of being exposed to a substance or external agent.
• Children: Individuals in the childhood stage, typically from infants to 12 years old.
• Regulations: Official rules or provisions established to regulate a specific activity or sector.
• Food Industry: The economic sector involving the production, distribution, and marketing of food.

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