FDA issues warning to producer of lead tainted applesauce

The U.S. Food and Drug Administration has issued a stern warning to Austrofoods, the Ecuador-based manufacturer of apple cinnamon fruit puree pouches recalled last year after being found to contain dangerously high levels of lead and chromium.

The Aug. 9, 2024, warning letter just released by the FDA is part of the agency’s ongoing efforts to ensure the safety of cinnamon and other spices, particularly in products consumed by babies and young children.

The FDA’s investigation, conducted in collaboration with state health and agriculture departments in North Carolina, Maryland and Pennsylvania, began in the fall of 2023 after harmful levels of lead and chromium were detected in the apple cinnamon puree pouches. These pouches, manufactured at Austrofood’s facility in Ecuador, were distributed in the United States by WanaBana USA LLC. The FDA’s leading hypothesis is that the contamination resulted from economically motivated adulteration of the cinnamon used in the product.

“Protecting our food supply, especially foods intended for babies and young children, is an agency priority,” said Jim Jones, Deputy Commissioner for Human Foods at the FDA. “The safety of cinnamon and other spices in our food supply is something we take very seriously, and we are committed to working with our state partners and industry to ensure these products do not pose a risk to public health.”

Outbreak linked to lead-contaminated applesauce
The contamination found in Austrofood’s apple cinnamon fruit puree pouches was not just a regulatory concern; it resulted in a significant public health crisis. The outbreak of lead poisonings in the fall and winter of 2023 sickened at least 519 children across 44 states, according to the Centers for Disease Control and Prevention.

Three brands of cinnamon applesauces sold in pouches and marketed for children were implicated in the recall: WanaBana, Schnucks and Weis. All the affected products contained cinnamon contaminated with lead. The FDA was first notified about the lead contamination in mid-September 2023 by public health officials in North Carolina, who had identified the tainted applesauce as a common factor among children with elevated blood lead levels.

On Oct. 28, 2023, the FDA formally alerted U.S. consumers about the contamination after discussing analytical findings with Austrofood. The agency urged consumers to avoid the recalled products, which included WanaBana apple cinnamon fruit puree pouches, Schnucks-brand cinnamon-flavored applesauce pouches and Weis-brand cinnamon applesauce pouches.

Violations of federal food safety regulations
The warning letter to Austrofood cited multiple violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (PC Human Food Rule). Before the recall, Austrofood failed to conduct an appropriate hazard analysis to identify and evaluate lead in cinnamon as a potential risk that required a preventive control. This oversight is particularly concerning given the known prevalence of lead in spices and the vulnerability of young children to the negative health effects of lead exposure.

The FDA’s letter emphasized that the presence of lead at the levels detected in the apple cinnamon puree pouches rendered these products adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act). By shipping these contaminated products to the U.S., Austrofood violated section 301(a) of the FD&C Act, which prohibits the introduction of adulterated food into interstate commerce.

Ongoing efforts and industry responsibilities
As part of its broader efforts to enhance food safety, the FDA has initiated targeted sampling and testing of cinnamon sold at discount retail stores. This initiative led to recalls of certain ground cinnamon products found to contain elevated levels of lead. The FDA has also placed Negasmart, the distributor of the contaminated cinnamon used in Austrofood’s products, on multiple import alerts, including those related to economic adulteration and contamination with heavy metals.

The FDA is also seeking new authorities from Congress to establish binding contamination limits in foods, particularly those consumed by infants and young children. This would allow the FDA to mandate recalls more swiftly and update limits as new scientific information becomes available. Additionally, the agency is asking for the authority to require industry to test final products for contaminants and to maintain records that the FDA could remotely access and review.

“Our work in this space is also focused on implementing a strategic, long-term iterative approach to reducing childhood dietary exposure to lead, arsenic, cadmium, and mercury through the FDA’s Closer to Zero initiative,” said Jones. “We’re focused on reducing dietary exposure to environmental contaminants to as low as possible while maintaining access to nutritious foods.”

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