Report Outlines How Lead-Tainted Apple Sauce Fruit Pouches Reached U.S. Consumers

Lead contamination in apple sauce products marketed for children went untested and unnoticed for months, according to a report that highlights serious gaps in food safety regulations.

Serious flaws in the U.S. food supply regulatory system may have allowed lead-tainted apple cinnamon fruit pouches to reach American children, causing hundreds of lead poisoning cases across dozens of states, according to a new investigation.

A report published on February 27 by The Examination, in collaboration with The New York Times, indicates federal and international regulators failed to test or discover contaminated cinnamon used in children’s apple sauce pouches, which were recalled late last year.

Investigators reviewed documents and conducted interviews with government and company officials in several countries, finding that the U.S. Food and Drug Administration (FDA) failed to oversee inspections or testing of imported cinnamon used in recalled WanaBana, Weis, and Schnucks apple sauce, or in the finished product once it arrived to the U.S.

The report also revealed that current regulations prevented the FDA from taking action once the lead contamination was found. In addition, although Ecuadorian authorities had the authority to take action, they did not have the capacity to conduct lead testing themselves, which combined to allow lead-tainted products to reach U.S. consumers.

Apple Sauce Lead Poisoning Investigation and Recalls

North Carolina health officials initially identified contamination in the apple sauce pouches during an investigation into at least four lead poisoning cases among children. As a result of those findings, the FDA issued a consumer warning on October 28, 2023, after confirming the products contained so much lead that they could cause lead poisoning if consumed.

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

During the investigation, officials indicated the contamination may have been intentional, as sample testing only identified lead in products containing cinnamon, and revealed high lead levels in ground cinnamon supplied by Negasmart, a third-party distribution company located in Ecuador.

In January, investigators also identified high levels of chromium in the recalled fruit pouches, indicating the levels of lead and chromium found were consistent with those seen in toxic lead chromate, which some manufactures have been known to add to spices to make them appear brighter in color and higher in quality than they really are.

Earlier this month, sample testing revealed high lead levels in packaged cinnamon from customers of the cinnamon processor, but did not find lead in unprocessed cinnamon sticks, leading officials to rule out the supplier. The FDA traced the probable source of contamination to the processor of the ground cinnamon, Carlos Aguilera of Ecuador, who had already halted operations. However, the agency has limited authority in Ecuador because the cinnamon was supplied by a foreign country, leaving it unable to take direct action.

Report Finds Regulatory Failures

In the latest report, investigators indicate the tainted cinnamon went untested and undiscovered for months before a recall was finally issued. The cinnamon originated in Sri Lanka, and was then ground in Ecuador, before it was sold, bagged, and then sold again to Austrofood, which blended it into the recalled pouches.

The report revealed Austrofoods failed to test the cinnamon or the finished apple sauce products before shipping them to the U.S. The company indicated it relied on a certificate from Negasmart saying it was lead-free, and Negasmart indicated in a statement given to investigators that it complied with all regulations, but did not discuss the certification. While Austrofood was not legally required to conduct lead testing, it is required to identify potential safety hazards and the FDA cited it for failing to identify lead as a hazard.

The FDA does not have the ability to investigate international supply chains, but it does have the authority to inspect oversea food shipments to the U.S., and is required by law to conduct 19,000 international food inspections a year. Investigators found the agency failed to test the apple sauce pouches when they arrived at U.S. ports and had only conducted about 1,200 inspections last year, visiting less than 1% of FDA-registered international food manufacturers.

The report notes that Ecuadorian authorities had the authority to test for lead but did not have the capacity to do so, as regulators there had never tested cinnamon for toxins before, and nearly half of their lab equipment was out of service when the FDA asked for help in its investigation.

FDA Apple Sauce Food Inspection Limitations

Safety auditors are supposed to inspect food imported into the U.S., but only inspect for hazards they can identify themselves. In reviewing documents, investigators found they did not consider lead as a risk for testing or inspect the apple sauce before it was imported. According to the documents, one auditor even gave the apple sauce maker an A+ safety rating in December, well after the apple sauce recalls, and lead poisoning cases were found.

U.S. officials inspected Austrofood in 2019 and did not find any problems, but they failed to indicate what testing they conducted in their report. The records show the facility was not inspected again until the lead poisoning issue was discovered, nearly five years later. The FDA never inspected the original source of the cinnamon, though the company conducted its own lead testing, and did not have authority to inspect other companies in the cinnamon supply chain because they do not directly ship to the U.S.

The FDA indicates it will review the incident and seek new authority powers from Congress to prevent future outbreaks. In 2022, it asked Congress to give it authority to set heavy-metal limits and testing requirements for baby-food products that may have prevented the widespread lead poisonings, but Congress did not act.

Child Lead Poisoning Risks

Childhood exposure to lead can result in a wide range of serious health conditions because their brains and organs are still developing, which increases their risk of developing lifelong health or behavioral conditions. Studies have shown lead lowers structural brain integrity later in life, and associated lead exposure in childhood to lower IQ scores.

In 2020, researchers found that infants and young children absorb nearly five times the amount of lead that enters their body than adults, increasing their risk of adverse health effects.

The American Academy of Pediatrics warns there is no safe level of lead exposure among children. Even exposure to low lead levels increases risk of early death, and causes more than 400,000 deaths in the U.S. every year.

WanaBana Lead Contamination Lawsuits

WanaBana faces several lawsuits over the high levels of lead contaminations found in its recalled cinnamon apple sauce pouches. The parents of four children in North Carolina that suffered lead poisoning and prompted the extensive investigation filed the first lawsuit against WanaBana, Austrofoods, and Dollar Tree, where they purchased the products.

A WanaBana class action lawsuit was filed on December 21, 2023 in the U.S. District Court for the Southern District of New York, alleging that deceptive and misleading practices placed consumers, particularly children, at an increased risk of lead poisoning. The plaintiff claimed she and others were financially harmed and lost money buying products that were useless and dangerous.

Another WanaBana lawsuit seeking class action status was filed on January 12 in the U.S. District Court for the Southern District of Florida, by families of children who also suffered from food poisoning after consuming the pouches. In that filing, one family indicated that their children had elevated lead levels nearly three times higher than it was supposed to be, and were exposed to serious health risks due to toxic levels of lead and chromium in the products. Another family sought financial compensation for economic damages they have suffered, and coverage for future medical monitoring of their child for lead poisoning.

Just weeks later, the parents of two children diagnosed with lead poisoning filed a lawsuit against WanaBana on January 25, in the Circuit Court of the Eleventh Judicial Circuit in and for Miami-Dade County, Florida. The parents alleged their children suffered from catastrophic long-term injuries, including lead poisoning, after they consumed several contaminated apple sauce pouches between March and August 2023.

Both children required extensive treatment to remove the toxic lead from their bloodstreams, and need to see physicians regularly for lead-removal treatments, as well as routine blood lead level and developmental testing throughout their lives