In response to the problem with elevated levels of lead in cinnamon in children’s applesauce and recalls of products in the fall of 2023, the FDA initiated a review of ground cinnamon and has issued warnings.

During the review the Food and Drug Administration found elevated levels of lead in several products. The products are not targeted toward children, but are used as ingredients in foods that consumers may make and serve to children.

“Consistent with the agency’s Closer to Zero initiative, which focuses on reducing childhood exposure to lead, the agency is recommending voluntary recall of the products listed below because prolonged exposure to the products may be unsafe. Removing the ground cinnamon products in this alert from the market will prevent them from contributing elevated amounts of lead to the diets of children,” according to the FDA warning.

The FDA’s targeted survey checked ground cinnamon products from discount retail stores and analyzed the samples for chromium as well as lead.

The ground cinnamon products subject to the FDA’s warning are:

The FDA is advising consumers to throw away and to not buy these ground cinnamon products. The FDA has recommended that the firms voluntarily recall these products, with the exception of the MTCI cinnamon. The FDA has been unable to reach MTCI to share test findings and therefore has been unable to request that the company initiate a recall. The FDA will post updates with communications from firms that voluntarily agree to recalls.

Contamination thought to be intentional
This past week the FDA confirmed that lead chromate is the source of lead and chromium in cinnamon applesauce marketed for children and imported from Ecuador.

Leaders at the FDA continue to believe the contamination was intentional.

The Food and Drug Administration had already confirmed that applesauce samples had as much as 2,000 times the amount of lead considered safe.

Three brands of cinnamon applesauce pouches were recalled in November of 2023 because of lead contamination: Wanabana, Schnucks, and Weis. The FDA also found elevated levels of chromium in the recalled applesauce.

“People who ate recalled products, especially if they had elevated blood lead levels, may have been exposed to chromium and should inform their healthcare provider so they can monitor health and provide supportive care, as needed,” according to the FDA.

“Historically, lead chromate has been illegally added to certain spices to increase their weight and color, increasing the monetary value of the adulterated spices. FDA’s leading hypothesis remains that this was likely an act of economically motivated adulteration.”

The FDA has limited regulatory power over foreign ingredient suppliers who do not directly ship their products to the United States. Consequently, the FDA cannot take direct action against Negasmart, the supplier of the cinnamon to the Ecuadorean applesauce manufacturer Austrofoods, or Carlos Aguilera, the processor of the cinnamon sticks. 

“Ecuadorian officials in Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (ARCSA) have reported that Carlos Aguilera of Ecuador is the likely source of contamination and is not in operation at this time,” according to the U.S. FDA.

Children impacted by cinnamon applesauce with elevated levels of lead
According to the Centers for Disease Control and Prevention there are now 468 patients spread across 44 states.

The implicated cinnamon applesauce products — Wanabana, Schnucks and Weis — were recalled in the fall of 2023. They have long shelf life and consumers may still have them on hand, so FDA continues to urge people to check their homes for these products.

“Cases are reported to the CDC through state health departments. State health departments receive reports of potential cases from various sources, and then follow up to determine whether the case definition is met. In order to be considered in CDC’s case count, the person must have had a blood lead level of 3.5 ug/dL or higher measured within 3 months after consuming a recalled WanaBana, Schnucks, or Weis brand fruit purée product after November 2022,” according to the CDC’s outbreak update.

The Food and Drug Administration is also logging patients in the outbreak. As of Feb. 27 the FDA was reporting that its patient count was holding steady at 90. The FDA and CDC use different ways of tracking patients, so there may be some overlap with the counts. The FDA reports that the vast majority of the patients are 1 year old or younger.

The investigation
The FDA and officials in Ecuador — wher the applesauce was produced — continue to investigate the situation. Some of the tests of cinnamon used to make the implicated applesauce showed 2,000 times the amount of lead considered safe.

Earlier this month, the U.S. Food and Drug Administration revealed the name of the company that supplied tainted cinnamon used to make applesauce marketed for young children in the United States. On Feb. 6, officials in Ecuador reported to the FDA that Carlos Aguilera of Ecuador was the processor of ground cinnamon used in making applesauce sold in pouches in the United States.

The cinnamon supplier sold the tainted spice to Negasmart, which sold the cinnamon to Austrofoods, the end producer of the applesauce. The FDA’s investigation is ongoing to determine the point of contamination and whether additional products are linked to illnesses.

According to the U.S. Food and Drug Administration, the cinnamon supplier is currently not in business. The FDA’s deputy commissioner for human foods, Jim Jones, has said he believes the cinnamon was intentionally contaminated. Adding lead to spices and other products can increase the product’s weight and, therefore, its value.

“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 before export. Thus, the FDA cannot take direct action with Negasmart or Carlos Aguilera,” according to a statement from the agency.

“FDA does not indicate that this issue extends beyond these recalled products and does not have any confirmed reports of illnesses or elevated blood lead level adverse events reported for other cinnamon-containing products or cinnamon.”

According to health officials in Ecuador, unprocessed cinnamon sticks used in recalled products were sourced from Sri Lanka. They were sampled by Ecuadoran officials and found to have no lead contamination.

about lead poisoning
Parents and caretakers should consult a healthcare provider and ask for blood tests if they suspect a child may have been exposed to the recalled cinnamon applesauce products. 

Short-term exposure to lead could result in the following symptoms: headache, abdominal pain/colic, vomiting, and anemia. 

Longer-term exposure could result in additional symptoms: irritability, lethargy, fatigue, muscle aches or muscle prickling/burning, constipation, difficulty concentrating/muscular weakness, tremors, and weight loss. 

Permanent consequences can lead to developmental delays and brain damage.