WASHINGTON — The Food and Drug Administration (FDA) has identified the source of lead contamination in applesauce pouches manufactured by Austrofood, Sangolquí, Ecuador – Negasmart SA, Quito, Ecuador, the supplier of cinnamon to Austrofood.

The FDA said Dec. 18 samples of cinnamon taken from Negasmart had “extremely high” levels of lead, in the range of 2,270 parts per million (ppm) to 5,110 (ppm). For context, the agency said 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.

“While our information at this time indicates that in the US the contaminated cinnamon is limited to only the applesauce products that have already been recalled, the FDA is still investigating whether the cinnamon in the recalled products was used in other products exported to the US,” the FDA said. “To date, increased screening for imported cinnamon from certain countries remains in place and FDA has no indication that this issue extends beyond these recalled products.”

The FDA also has confirmed that Negasmart does not ship product directly to the United States and, of the company’s direct customers, only Austrofoods ships product to the United States.

“The FDA has limited authority over foreign ingredient suppliers who do not directly ship product to the US,” the agency said. “This is because their food undergoes further manufacturing/processing prior to export. 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. FDA is actively assessing information received, using all available resources to further protect public health.”