FDA Takes Additional Steps Following Investigation of Elevated Lead and Chromium Levels in Apple Cinnamon Puree Products

The U.S. Food and Drug Administration (FDA) is continuing to take steps following the investigation of lead and chromium in apple cinnamon fruit puree pouches this past fall that was prompted by findings of elevated blood lead levels in children. While initial response activities to investigate the source of the contamination and prevent additional illnesses are completed, the agency said it is continuing to explore prevention, compliance and surveillance activities going forward.

One key post-response activity is highlighting the important responsibility that retailers have in effectuating a recall. The FDA issued a warning letter to Dollar Tree, Inc., because, at the time of the recall, the company failed to adequately remove recalled WanaBana apple cinnamon fruit puree pouches from its store shelves. In the weeks and months that followed the manufacturer’s voluntary recall of apple cinnamon fruit puree pouches, public health officials across many states reported continuing to see recalled WanaBana apple cinnamon fruit puree pouches on Dollar Tree store shelves. This warning letter is part of the Agency’s ongoing post-incident response activities.

When a food is recalled, retailers play a crucial role in carrying out the recall by ensuring that recalled products are not available to consumers at their stores, said FDA. The agency said it is concerned with Dollar Tree’s capability to quickly remove unsafe products from its store shelves as necessary and as required during a public health threat such as a recall. The FDA has asked the company to respond within 15 days of receipt of the warning letter stating the specific steps it has taken to address any violations and prevent the recurrence of violations or providing its reasoning and supporting information as to why the company believes it is not in violation of the law.

In addition, the FDA is continuing oversight of foreign firms and imported foods, including through increased and more targeted import screening. As such, the agency has also placed Negasmart, doing business as Sanchez Obando Alexander Ricardo, the distributor of the cinnamon used in the contaminated applesauce products, on multiple import alerts, including Import Alert 99-47 regarding products that appear to be adulterated for economic gain and Import Alert- 99-42 for products that are contaminated with heavy metals and appear to be adulterated under section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Import alerts are tools the FDA uses when the agency has enough evidence to allow for Detention Without Physical Examination of products that appear to be in violation of the FD&C Act. While the FDA has no indication that Negasmart/Sanchez Obando Alexander Ricardo is attempting to import products, the import alerts will help ensure that any attempt by the firm to import products will be flagged for FDA reviewers prior to any shipments entering the U.S. and reaching consumers. Following the WanaBana apple cinnamon fruit puree pouch recall and FDA’s investigation, the FDA also added Austrofood S.A.S., the manufacturer of the apple cinnamon fruit puree pouches, to Import Alert 99-42.