FDA finds ‘extremely high’ levels of lead in cinnamon-tainted applesauce pouches

Samples of cinnamon obtained during an FDA inspection of the facility that produced the recently recalled applesauce tested “extremely high” for levels of lead. Results of analysis show 5110 ppm and 2270 ppm. Just 2.5 ppm for lead in bark spices such as cinnamon is considered the maximum acceptable level, as proposed by the international standard-setting body, Codex Alimentarius Commission (Codex) in 2024.

The tainted applesauce was produced by Austrofood in Ecuador. FDA announced the conclusion of the investigation on Dec. 18 and the test results of cinnamon samples that were supplied by Negasmart to Austrafood.

FDA Deputy Commissioner for Human Foods Jim Jones recently 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.”

Sen. Richard Blumenthal expressed his concern in a Dec. 18 letter to FDA Commissioner Robert Califf: “I am further alarmed at the possibility that they may have been contaminated on purpose,” he wrote. “While the U.S. food supply is among the safest in the world, overdue action from FDA continues to threaten consumers. If the apple sauce pouches were indeed purposefully contaminated, we need to ensure that our regulatory and inspection mechanisms are fortified and able to handle intentional acts.

“After the infant formula crisis last year, I was encouraged to see the FDA take necessary steps to address internal issues by creating a new Human Foods Program to improve coordination and oversight of our nation’s food supply,” he continued. “However, this new crisis is yet another example highlighting the need for urgent action. I have long supported the agency’s efforts to reduce exposure to environmental contaminants in foods through the Closer to Zero campaign, but the progress to finalize the objectives has been slow—leaving consumers at risk. To begin addressing these concerns, the agency should issue regulations that establish action levels, increase targeted compliance and enforcement activities and monitor levels of contaminants over time to determine necessary adjustments. Moving swiftly can help prevent this from happening again, saving lives.”

FDA learned of the problem on Oct. 28 when the agency was informed of an investigation conducted by state agencies in North Carolina following reports of four children with elevated blood lead levels. Since then, multiple brands of cinnamon applesauce have been recalled, including WanaBana, Weis and Schnucks.

As of the most recent update of adverse events on Jan. 12, 2024, CDC reports 354 total cases. Of these, 93 cases are confirmed, 233 cases are considered probable and 28 are suspected. All cases involve people aged 0 to 53 in 41 states. To be considered in the case count, CDC looks for blood lead levels of 3.5 ug/dL or higher measured within three months after consuming one of the recalled products. There is a lag in reporting, as cases are reported to CDC through state health departments.

Early on, FDA proposed a hypothesis that cinnamon was the source of the lead toxicity. Besides confirming their hypothesis, the agency also confirmed that Negasmart does not directly import products to the United States. Ecuadorian officials confirmed that Negasmart does not ship product outside of Ecuador. Further, testing thus far indicates that cinnamon from all cinnamon importers in Ecuador do not appear to be contaminated with lead. Negasmart, which supplied the contaminated cinnamon, is not currently operating.

As a precaution, FDA increased screening for imported cinnamon from certain countries. FDA is still investigating whether the cinnamon in the recalled products was used in other products exported to the U.S. While the investigation is ongoing, current information indicates that the contaminated cinnamon was limited to the applesauce products.