The U.S. Food and Drug Administration (FDA) has issued a warning letter to Ecuadorian company Austrofood S.A.S., the manufacturer of the apple cinnamon fruit puree pouches that gave hundreds of children across the U.S. lead poisoning in late 2023.

Laboratory analysis of multiple lots of the apple cinnamon fruit puree pouches, which were manufactured at the Austrofood facility in Ecuador, showed extremely high concentrations of lead, rendering the products to be adulterated under the Federal Food, Drug, and Cosmetic Act (FFDC). 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 FFDC.

In addition to violating FFDC, another reason FDA issued the warning letter to Austrofood is that, 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 in cinnamon—for the fruit puree pouches to determine whether the hazard required a preventive control. Considering the widely understood prevalence of lead in spices like cinnamon, and because children are known to be the majority of consumers of the apple cinnamon fruit puree finished product, the warning letter states that a knowledgeable person at the Austrofood facility should have identified lead in cinnamon as a hazard requiring a preventive control.

FDA has asked Austrofood to respond within 15 days of receipt of the warning letter stating the specific steps it is taking or has taken to correct the issues found at their facility, including an explanation of how the company plans to prevent the violation or similar violations from occurring again, or its reasoning and supporting information as to why the company believes its facility or products are not in violation of FFDC.

The cover story from the August/September 2024 issue of Food Safety Magazine explores how this lead chromate contamination incident in cinnamon applesauce pouches has underscored critical gaps in the U.S. national food recall system, and illustrates the urgent need to modernize food recall processes and enhance data-sharing among food safety and public health agencies. Read the article here.