FDA Issues Warning Letter to Manufacturer of Apple Cinnamon Fruit Puree Products Containing Elevated Levels of Lead and Chromium
Constituent Update
August 15, 2024
On August 9, 2024, the U.S. Food and Drug Administration issued a Warning Letter to AUSTROFOOD S.A.S. (Austrofood), the manufacturer of the apple cinnamon fruit puree pouches that were recalled last year and that were found to contain elevated levels of lead and chromium. The letter is 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.
As part of a multistate investigation including the FDA, the North Carolina Department of Health and Human Services, the North Carolina Department of Agriculture & Consumer Services, the Maryland Department of Health, and the Pennsylvania Department of Agriculture, laboratory analysis of multiple lots of the apple cinnamon fruit puree pouches detected extremely high concentrations of lead in the pouches. The presence of these levels of lead causes these products, manufactured at the Austrofood facility in Ecuador, 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. By shipping the apple cinnamon fruit puree pouches to the U.S., Austrofood caused the introduction or delivery for introduction into interstate commerce of adulterated food in violation of section 301(a) of the FD&C Act.
In addition, the FDA issued this warning letter to Austrofood because, following inspection of the company’s facility in Ecuador, FDA investigators identified serious violation of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation. Before the recall, Austrofood did not appropriately conduct a hazard analysis to identify and evaluate a known or reasonably foreseeable hazard; in this case, lead, for the fruit puree pouches to determine whether that hazard required a preventive control. The rule requires food manufacturers to conduct hazard analyses to identify and evaluate known or reasonably foreseeable hazards to determine whether there are any hazards requiring a preventive control. Austrofood used cinnamon powder as an ingredient in the apple cinnamon fruit puree pouches, a product intended for young children, including infants as young as six months old. Lead is often found in spices, including cinnamon, from the environment where it is grown or processed, and oral exposure to elevated levels of lead can pose health risks to humans, especially babies and young children. Therefore, the warning letter states that lead in the cinnamon ingredient is a known or reasonably foreseeable hazard for which children are especially sensitive. Considering the known prevalence of lead in spices such as cinnamon and the intended audience of the apple cinnamon fruit puree finished product, including the particular susceptibility of young children to the negative health effects of lead exposure, the warning letter states that a knowledgeable person at the Austrofood facility manufacturing/processing foods intended for young children would identify lead in this cinnamon ingredient as a hazard requiring a preventive control. In the past, the FDA has found several occurrences of lead compounds (lead chromate and lead oxide) intentionally added to spices, including turmeric, paprika, and cinnamon powder, that have caused illness and/or death.
The FDA has asked Austrofood to respond within 15 days of receipt of the warning letter stating the specific steps they are taking or have taken to correct the deviation found at their facility, including explanation of how they plan to prevent the violation or similar violations from occurring again, or provide their reasoning and supporting information as to why the company believes their facility or their products are not in violation of the FD&C Act.
In addition to this warning letter, the FDA continues to work with state partners on sampling ground cinnamon at retail for levels of lead. The agency recently issued two public health alerts concerning ground cinnamon products containing elevated levels of lead in July 2024, following an initial alert in March 2024. The ground cinnamon in the public health alerts contain levels of lead that are significantly lower than the levels of lead associated with the apple cinnamon fruit puree pouches manufactured by Austrofood, which had between 2,270 ppm to 5,110 ppm lead in the cinnamon. Those alerts and other post-incident response activities and actions following the investigation of lead and chromium in apple cinnamon fruit puree pouches last fall are detailed on the Post-Incident Response Activities: Elevated Lead and Chromium Levels in Cinnamon Applesauce Pouches webpage.