Lead in Recalled Apple Cinnamon Fruit Pouches Traced Back to Foreign Processor: FDA

The FDA has limited authority to take action against a foreign supplier believed to be the source of lead contamination in recalled apple cinnamon fruit pouches.

Federal regulators have identified the likely source of lead contamination in recalled WanaBana, Weis, and Schnucks apple cinnamon fruit pouches, which have been linked to hundreds of lead poisoning cases across dozens of states.

In an apple sauce lead investigation update issued on February 6, the U.S. Food and Drug Administration (FDA) indicates the agency has traced the probable source of lead in recalled cinnamon-flavored fruit puree products to the processor of the ground cinnamon used to manufacture them.

Officials indicate Ecuadorian regulators in Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (ARCSA) tested samples of unprocessed cinnamon sticks sourced from the supplier but did not find lead contamination. The ARCSA believes the ground cinnamon processor, Carlos Aguilera of Ecuador, may be responsible for the dangerously high lead levels found in recalled applesauce pouches.

According to the latest lead poisoning outbreak update issued by the U.S. Centers for Disease Control and Prevention (CDC) on February 2, there are currently 100 confirmed lead poisoning cases, 277 probably cases, and 36 suspected cases spread across 43 states.

Apple Sauce Lead Poisoning Investigation

FDA officials began looking into the contaminated applesauce pouches following an investigation led by North Carolina health officials, who identified them as the potential source of lead poisoning for four children. After confirming the products could cause lead poisoning if consumed, the agency issued a consumer warning on October 28, 2023.

After sample testing identified elevated lead concentrations in several batches of the cinnamon-flavored variety, a WanaBana fruit pouch recall was announced on October 31, 2023. The applesauce recall was expanded on November 9 to include additional products distributed under Weis and Schnucks brands, after investigators also identified elevated lead levels in those cinnamon-flavored fruit pouches.

Sample testing only identified elevated levels in products that contained cinnamon, leading officials to suspect the cinnamon used in them could be the lead source. Investigators found high lead levels in sample testing of ground cinnamon supplied by a third-party distribution company, Negasmart, located in Ecuador, leading them to suspect the contamination may have been intentional.

Last month, investigators also identified high levels of chromium in the recalled applesauce pouches. While the FDA was unable to determine what form of chromium was present, officials indicate the levels of lead and chromium found are consistent with those seen in lead chromate. Some manufacturers have been known to add lead chromate that contains toxic chromium (VI) to give spices a brighter color and appear to be higher in quality than they really are.

No Lead Found Before Cinnamon was Processed

In the latest update, the FDA confirms the unprocessed cinnamon sourced from Sri Lanka was not contaminated with lead, but exceptionally high levels were found in the ground cinnamon. Officials traced the contamination back to Carlos Aguilera of Ecuador, who processed the ground cinnamon supplied by Negasmart, before it was added to the applesauce. The single processor is not currently operating at this time, according to Ecuadorian authorities.

While the investigation is still ongoing, the FDA indicates it cannot take direct action against Negasmart or Carlos Aguilera, and has limited authority over the issue because the cinnamon was supplied by a foreign country. The FDA does not have authority over foreign ingredient suppliers because they do not directly ship products to the U.S. and they undergo further manufacturing and processing before they are exported.

The ARCSA continues to investigate and indicates it will take legal action to determine who is ultimately responsible for the lead contamination.

WanaBana Lead Poisoning Lawsuits

A growing number of WanaBana contamination lawsuits are now being pursued by families of children nationwide who suffered from lead poisoning after they consumed the toxic applesauce pouches.

A Wanabana lawsuit was filed in December 2023 in the U.S. District Court for the Southern District of New York, seeking class action status on behalf of consumers who purchased the recalled fruit pouches found to contain dangerous levels of lead. While the plaintiff did not claim any injury related to the lead contamination, the lawsuit indicated the plaintiff and other consumers were financially harmed by purchasing dangerous products that could not be consumed.

Another lawsuit was filed last month in the U.S. District Court for the Southern District of Florida, also seeking class action status to pursue damages against WanaBana on behalf of all consumers who purchased lead-tainted products and may need further medical monitoring for lead poisoning.

One plaintiff claimed her one-year-old child suffered lead poisoning and elevated blood lead levels nearly three times higher than the CDC’s recommended level for clinical monitoring of lead poisoning. Another plaintiff alleges her daughter did not develop lead poisoning, but was also exposed to serious health risks due to the toxic levels of lead and chromium.

On February 2, another WanaBana lead poisoning lawsuit was filed in the state court for Miami-Dade County, Florida, by the parents of two children who developed lead poisoning and other long-term injuries after they consumed the products. The parents claimed their children, who were one and three years-old at the time, had extremely high lead levels after consuming multiple products throughout the course of several months.

Both children required extensive medical treatment to remove the toxic lead from their bloodstreams, and will need developmental delay monitoring throughout their lives due to their young lead exposure age, the lawsuit claims.