FDA Issues Warning Letter to Dollar Tree for Failure to Recall Lead-Tainted Cinnamon Fruit Puree Pouches that Sickened Children
Image credit: FDA
Following a national lead poisoning outbreak linked to adulterated cinnamon fruit puree pouches that affected hundreds of children in late 2023, the U.S. Food and Drug Administration (FDA) is conducting post-response prevention, compliance, and surveillance activities.
First, FDA is highlighting the critical responsibility that retailers have in effectuating a recall. On June 11, 2024, the agency issued a warning letter to Dollar Tree, Inc. due to the company’s failure to adequately remove recalled WanaBana apple cinnamon fruit puree pouches from 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. In its warning letter, FDA asked Dollar Tree to respond within 15 days to report the specific steps it has taken to address any violations and prevent the recurrence of violations, or to provide reasoning and supporting information as to why the company believes it is not in violation of the law.
FDA is also continuing to increase its oversight of foreign firms and improve targeted screening of imported foods. Specifically, FDA has 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 (FFDC). FDA also added Austrofood S.A.S., the manufacturer of the apple cinnamon fruit puree pouches, to Import Alert 99-42. Import alerts are tools 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 FFDC.
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