FDA continues investigation of elevated lead in cinnamon applesauce pouches

On Nov. 17, FDA emailed an update on recalls for elevated lead related to applesauce products. As of Nov. 16, 34 reports of illness have been potentially linked to recalled products produced by Wanabana, LLC and submitted to FDA. The recalled products—WanaBana Apple Cinnamon Fruit Puree, Schnucks Apple Sauce with Cinnamon and Weis Cinnamon Apple Sauce—are all packaged in kid-friendly pouches, as illustrated in FDA’s Nov. 3 website post.

FDA revealed on Nov. 17 that the fruit pouches were manufactured in Ecuador. The FDA’s leading hypothesis is that cinnamon is the probable cause of contamination; however, the source of the cinnamon has yet to be identified. Ecuadorian authorities are assisting in the investigation of cinnamon. A sample of WanaBana Apple Cinnamon Puree obtained from Dollar Tree was tested with 2.18 parts per million (ppm) detected. This is more than 200 times greater the proposed action levels in FDA’s draft guidance for fruit purees for babies and young children.

As FDA continues its investigation, FDA and state partners are collecting and analyzing additional product samples of fruit puree and applesauce pouches. The agency is continuing to evaluate incoming adverse reports of illnesses. The source of the contamination and whether additional products are linked to illnesses are currently under investigation.

“At this time, sample analyses have not shown elevated levels of lead in any non-recalled products,” a spokesperson from FDA said.

The trouble began in late October when the North Carolina Department of Agriculture & Consumer Services received reports of four children with elevated blood lead levels indicating potential acute lead toxicity. WanaBana’s branded product was implicated. The recall was later expanded to include private label products produced by the company.

“At this time, sample analyses have not shown elevated levels of lead in any non-recalled products,” FDA said.

As FDA continues its investigation, FDA and state partners are collecting and analyzing additional product samples of fruit puree and applesauce pouches. The agency is continuing to evaluate incoming adverse reports of illnesses. The source of the contamination and whether additional products are linked to illnesses are currently under investigation.

The recall is particularly complex because of several factors. The applesauce pouches are shelf-stable, so their longevity in pantries and distribution centers is enhanced. Moreover, WanaBana’s sales channels include Amazon and other online outlets. According to information provided to FDA by WanaBana, the products were distributed outside the United States, namely Cuba and the United Arab Emirates.

Most children have no obvious immediate symptoms of lead exposure. Short-term exposure could result in headaches, abdominal pain, vomiting and anemia. Longer-term exposure could result in lethargy fatigue, muscle aches or muscle prickling/burning, occasional abdominal discomfort, constipation, difficulty concentrating, muscular exhaustibility, headaches, tremors and weight loss. Clinical testing is the only way to diagnose lead poisoning.