• Posted December 19, 2023

Cinnamon Tied to Tainted Applesauce Had Lead Levels 2,000 Times Higher Than Proposed Standards, FDA Says

Cinnamon samples gathered at a facility in Ecuador linked to tainted applesauce pouches were found to contain levels of toxic lead that were 2,000 times higher than proposed standards, according to U.S. Food and Drug Administration inspectors.

Tests conducted at an Ecuadorean facility run by Austrofoods (maker of the recalled applesauce) found that cinnamon supplied to the plant by another company, Negasmart, contained "extremely high levels of lead contamination, 5110 parts per million (ppm) and 2270 ppm," the FDA said in its latest update.

To put that into context, an international body charged with setting lead limits in bark-sourced spices such as cinnamon "is considering adopting a maximum level of 2.5 ppm for lead in bark spices," the FDA said.

As of Dec. 18, 65 children under 6 years of age have been diagnosed with symptoms of lead poisoning tied to various brands of recalled applesauce.

Last week, a source at the U.S. Food and Drug Administration said that the cinnamon used in the recalled applesauce may have been deliberately tainted with the toxic element.

"We're still in the midst of our investigation," Jim Jones, the FDA's deputy commissioner for human foods, told Politico. "But so far all of the signals we're getting lead to an intentional act on the part of someone in the supply chain and we're trying to sort of figure that out."

The applesauce pouches under recall so far are from three brands -- Weis, WanaBana and Schnucks. Each is tied to the same manufacturing facility in Ecuador, which the FDA said it is now inspecting.

"My instinct is they didn't think this product was going to end up in a country with a robust regulatory process,"Jones said. "They thought it was going to end up in places that did not have the ability to detect something like this."

According to Politico, the FDA suspect the deliberate adulteration of cinnamon included in the applesauce products was "economically motivated." Typically, that involves boosting the perceived quality of a product while producing it at a cheaper price.

U.S. and Ecuadorian authorities are cooperating and have traced the cinnamon to Negasmart, which supplies the spice to Austrofoods, which manufactures the applesauce pouches in Ecuador.

The FDA said Negasmart is now operating under an "Ecuadorian administrative sanctions process."

Jones told Politico that food adulteration outside the U.S. "is always going to be tricky to absolutely stop, if somebody has intent to purposefully do something like this."

An FDA spokesperson also told Politico: "We have limited authority over foreign ingredient suppliers that do not directly ship product to the U.S. because their food undergoes further manufacturing/processing prior to export."

Still, he said, "we're going to chase that data and find whoever was responsible and hold them accountable."

In November, FDA said health officials detected very high levels of lead in one product sample of WanaBana Apple Cinnamon Puree collected from Dollar Tree. The level then detected was 2.18 parts per million, which is more than 200 times greater than the action level the FDA has proposed in draft guidance for fruit purees and similar products intended for babies and young children.

So far, sample analysis of WanaBana, Weis and Schnucks fruit puree pouches that do not contain cinnamon and are not part of the recall have not shown elevated levels of lead

In its initial alert on the recall issued in late October, the FDA said four children in North Carolina were the first to be found to have high levels of lead in their blood that was linked to the WanaBana products.

Cases of high blood lead levels in children have now been reported in 27 states: Alabama, Arkansas, California, Connecticut, Florida, Georgia, Iowa, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, Nebraska, New Hampshire, New Mexico, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin.

By law, food manufacturers have a responsibility to prevent chemical hazards when needed, the FDA noted. This includes measures to lower or eliminate the presence of lead in their products.

The FDA has warned families not to eat or serve these products and encourages them to throw out the pouches or return them to the store where they bought them for a refund.

Caregivers should take any children who may have eaten these products to have blood tests to check for lead exposure, the CDC added.

Lead is toxic to humans, particularly children, and there is no safe level of exposure, the CDC says. Exposure can cause developmental delays in children. Initial symptoms of lead poisoning may include head, stomach and muscle aches, vomiting, anemia, irritability, fatigue and weight loss.

More information

Visit the CDC for more on the dangers of lead exposure.

SOURCES: Politico, Dec. 14, 2023, U.S. Food and Drug Administration, health alerts, Dec. 18 and Nov. 17, 2023