The cinnamon applesauce pouches that sickened 60 or more children in recent weeks may have been intentionally contaminated with lead, FDA’s Deputy Commissioner for Human Foods told Politico.
“We’re still in the midst of our investigation. 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,” Deputy Commissioner Jim Jones said in an exclusive interview with the news organization.
The motive may be economic adulteration of the cinnamon that was added to the applesauce in a production plant in Ecuador. Even a small amount of lead would have increased the weight of the cinnamon sold as an ingredient.
The pouches found to be contaminated were sold under the Weis, WanaBana and Schnucks brands, and all were made at Austrofoods, a food processor in Ecuador. But the FDA’s initial investigation quickly focused on lead in the cinnamon, which came from Negasmart, an ingredient supplier also in Ecuador.
Ecuadorian authorities say Negasmart’s cinnamon exceeded the country’s allowed levels of lead. Jones told Politico Negasmart is under an “Ecuadorian administrative sanctions process.”
FDA itself inspected the Negasmart facility, and cinnamon samples taken showed “extremely high levels of lead contamination, 5110 parts per million (ppm) and 2270 ppm. For context, the international standard-setting body, Codex Alimentarius Commission, is considering adopting a maximum level of 2.5 ppm for lead in bark spices, including cinnamon, in 2024,” the FDA said in its own report, released today (Dec. 18).
Ecuadorian officials said Negasmart does not ship product outside Ecuador, and among Negasmart’s direct customers, only Austrofoods ships product to the U.S. The FDA is still investigating whether Negasmart cinnamon was used in other products exported to the U.S.
“The FDA has limited authority over foreign ingredient suppliers who do not directly ship product to the U.S. This is because their food undergoes further manufacturing/processing prior to export,” today’s FDA statement said. “Thus, the FDA cannot take direct action with Negasmart. However, we are continuing to work closely with Ecuadorian officials, as they are conducting their own rapidly evolving investigations into the source of contamination.”
“My instinct is they didn’t think this product was going to end up in a country with a robust regulatory process,” Jones told Politico. “They thought it was going to end up in places that did not have the ability to detect something like this.”
More than 60 U.S. children under the age of 6 have tested positive for lead poisoning after consuming the pouches — some at levels more than 500 times the acceptable threshold for lead, according to The Washington Post.
State and local officials first noticed elevated levels of lead in children during standard blood screenings, which the CDC recommends to help reduce lead exposure in kids under age 6, typically from sources like paint or water, said the Politico story. Federal officials are now working with state and local health departments to find all the cases of lead poisoning linked to the contaminated applesauce products.