Toxic Lead in Cinnamon Apple Sauce Pouches Was Likely Added By Ingredient Supplier To Increase Profit: FDA

Federal regulators suspect toxic heavy metals were intentionally added to recalled apple sauce pouches by an ingredient supplier to increase the value of the cinnamon, which has now been linked to hundreds of lead poisoning cases across dozens of states.

In an apple sauce contamination investigation update released on February 29, the U.S. Food and Drug Administration (FDA) indicates that further analysis of cinnamon samples taken from the manufacturer, Austrofoods, located in Ecuador, has confirmed that lead and chromium contamination identified in the final products originated from lead chromate.

The agency notes that, historically, some manufacturers have been known to add lead chromate to certain spices to enhance their color and increase their weight, making them appear higher in quality than they really are, and increasing their value. The FDA suspects that the Ecuadorian cinnamon processor, Carlos Aguilera, likely contaminated the ingredient intentionally by adding toxic lead chromate to boost profits before selling the ground cinnamon to the apple sauce manufacturer.

Apple Sauce Lead Poisoning Investigation and Recalls

The recalled apple sauce pouches were originally identified as contaminated during an investigation into at least four child lead poisoning cases by North Carolina health officials. As a result of the investigation’s findings, the FDA conducted sample testing and issued a consumer warning on October 28, 2023, indicating the products contained so much lead that they could cause lead poisoning if consumed.

On October 31, a WanaBana fruit pouch recall was issued, after sample testing identified high lead concentrations in several batches of the cinnamon-flavored variety. The 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.

Early in the investigation, officials suspected 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 also located in Ecuador.

In January, investigators also identified high levels of chromium, indicating the levels of lead and chromium found in the recalled fruit pouches were consistent with those seen in toxic lead chromate. However, testing method limitations at the time left the FDA unable to determine what form of chromium was used in the products until recently.

FDA Response to Foreign Lead Poisoning Legally Limited

Last month, the FDA traced the probable source of contamination to the processor of the ground cinnamon after sample testing revealed high lead levels in packaged cinnamon. Lead was not identified in unprocessed cinnamon sticks, leading officials to rule out the original supplier. While the processor has already halted operations, the FDA indicated it has limited authority in Ecuador to take further action because the cinnamon was supplied by a foreign country.

An investigation led by the Examination, in collaboration with the New York Times, uncovered serious flaws in the U.S. food supply regulatory system, which may have allowed the lead and chromium-tainted products to reach American children, resulting in the widespread lead poisoning outbreak.

The report revealed that the FDA failed to oversee inspections or testing of the imported cinnamon, failed to test the finished products once when they arrived at U.S. ports, and had not inspected the Austrofood manufacturing facility since 2019. Records show the facility was not inspected again until after the contamination was found, nearly five year later, and one safety auditor even gave the facility an A+ safety rating in December, well after the recalls and lead poisoning cases were found.

Officials warn those who consumed the recalled products, especially those who have suffered from elevated blood lead levels, may have also been exposed to toxic chromium found in lead chromate. Consumers who may have consumed the products should inform their healthcare provider immediately for health monitoring and supportive care, if needed.

As of February 23, the U.S. Centers for Disease Control and Prevention have identified a total of 468 cases of lead exposure linked to the recalled apple sauce pouches across 44 states, including 111 confirmed cases, 320 probable cases and 37 suspected cases.

Lead Poisoning Risks

Lead is a toxic heavy metal that can cause permanent brain damage, nervous system injuries, cognitive impairment, physical disabilities, or other long-term health consequences. Children are particularly vulnerable to lead exposure, as they are still developing and do not usually show exposure signs or symptoms.

While short-term exposure can cause headaches, abdominal pain, headaches, vomiting, or other minor symptoms, longer exposure may result in more severe symptoms, including lethargy, muscular weakness, confusion, or tremors.

According to pediatricians, there is no safe lead exposure level for children, and any exposure may increase the risk of developing serious or permanent injuries, or even death.