FDA Implements Further Measures After Investigating High Lead and Chromium Levels in Apple Cinnamon Puree Products

DA Implements Further Actions After Investigating High Lead and Chromium Levels in Apple Cinnamon Puree Products

In response to the investigation into elevated lead and chromium levels found in apple cinnamon fruit puree pouches last fall, the U.S. Food and Drug Administration (FDA) continues to take decisive actions. Prompted by reports of increased blood lead levels in children, initial response efforts focused on identifying the contamination source and preventing further health risks. Now, the FDA emphasizes ongoing measures encompassing prevention, compliance, and surveillance activities.

A crucial post-response action includes emphasizing retailers’ responsibility in executing recalls effectively. The FDA issued a warning letter to Dollar Tree, Inc. due to its failure to promptly remove recalled WanaBana apple cinnamon fruit puree pouches from store shelves during the recall period. Despite the manufacturer’s voluntary recall, reports from public health officials across several states indicated the continued presence of recalled products in Dollar Tree stores. This warning letter forms part of the FDA’s persistent efforts following the incident.

According to the FDA, retailers play a pivotal role in recall execution by ensuring that recalled products are swiftly removed from consumer access. The agency expressed concern over Dollar Tree’s ability to promptly withdraw unsafe products from shelves during public health threats like recalls. In response, the FDA has requested Dollar Tree to respond within 15 days, detailing corrective actions taken to address violations and prevent their recurrence, or providing justification if it believes it has not violated regulations.

Furthermore, the FDA maintains oversight over foreign firms and imported foods through enhanced and targeted import screening. Consequently, Negasmart, also known as Sanchez Obando Alexander Ricardo, the distributor linked to the contaminated cinnamon in the applesauce products, has been placed on multiple import alerts. These include Import Alert 99-47 for products potentially adulterated for economic gain and Import Alert 99-42 for products contaminated with heavy metals, deemed adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Import alerts enable the FDA to detain products without physical examination if evidence suggests FD&C Act violations. While the FDA has no current indication of import attempts by Negasmart/Sanchez Obando Alexander Ricardo, these alerts serve as preventive measures to flag any potential shipments for FDA review before reaching U.S. consumers. Following the WanaBana apple cinnamon fruit puree pouch recall and FDA investigation, Austrofood S.A.S., the manufacturer, has also been added to Import Alert 99-42.

These actions underscore the FDA’s commitment to safeguarding public health and ensuring compliance with food safety standards amidst ongoing regulatory scrutiny and oversight.