FDA Traces WanaBana Lead Contamination Incident to Single Cinnamon Processor

Last fall, dozens of children across the United States began experiencing symptoms such as headaches, nausea, anemia, and fatigue. Parents were shocked to discover that the applesauce pouches their children consumed daily had caused lead poisoning.

On October 31, WanaBana USA, a well-known applesauce pouch manufacturer, voluntarily recalled all apple cinnamon fruit puree productsdue to excessive lead levels found in some of its products.。

The recall eventually covered three brands—WanaBana, Schnucks, and Weis—all produced by food manufacturer Austrofoods. According to data from the U.S. Centers for Disease Control and Prevention, as of February 9, these products had caused 422 cases of lead poisoning across 44 states.

In the months since the initial voluntary recall, the U.S. Food and Drug Administration (FDA) traced the source of contamination to a factory in Ecuador that produced these fruit puree pouches. On February 6, the agency announced that Ecuadorian officials had identified a cinnamon processor in the country as the likelysource of contamination。

The FDA's months-long investigation not only involved infant food production practices and supply chain issues, but also revealed the agency's challenges in regulating overseas factories that produce goods for the U.S. market.

Timeline of contamination

WanaBana's voluntary recall initially stemmed from reports in October from the North Carolina Department of Health and Human Services and the North Carolina Department of Agriculture and Consumer Services regardingelevated blood lead levels in four children. At the time of the recall, WanaBana stated it was working to determine the source of contamination.

On November 9, two additional products were recalled: Schnucks apple cinnamon puree and Weis cinnamon applesauce, both produced by WanaBana USA.

On November 16, the FDA tested a pouch of WanaBana applesauce collected from a Dollar Tree store and found its lead levels were more than 200 times higher than thestandard the FDA considers safe for fruit purees and similar products intended for infants and young children.

On December 5, the FDA conducted an on-site inspection of the Austrofoods facility in Ecuador that produces WanaBana products. According to itsLinkedInprofile, Austrofoods was founded in 2008 and has only one facility located in Pichincha, Ecuador.

The agency also investigated Negasmart, an Ecuadorian third-party distribution company responsible for supplying cinnamon to Austrofoods.

According to a notice dated January 5, 2024, the FDA also discovered chromium in the fruit puree pouches while testing the recalled products and cinnamon.

According to the U.S. Centers for Disease Control and Prevention,lead and chromium are both toxic at elevated levels, especially for children.

On February 6, Ecuadorian officials identified cinnamon processing company Carlos Aguilera as the "likely source of contamination" for the fruit puree pouches. Carlos Aguilera sourced cinnamon sticks from Sri Lanka, which, according to Ecuadorian officials, were not contaminated with lead before processing.

According to the FDA update on February 6, Carlos Aguilera is currently not operating.

However, the FDA has limited authority to intervene with the foreign suppliers and manufacturers involved, because Negasmart and Carlos Aguilera did not ship directly to the U.S., and their products underwent further processing before export, the agency stated in the update.

WanaBana did not respond to requests for comment.

What does this case mean for U.S. food production?

The FDA confirmed it is exploring a theory that the cinnamon contamination may have resulted from economically motivated adulteration. According to the agency, such incidents refer to cases where someone intentionally omits, removes, or substitutes valuable ingredients or components in food.

"The current elevated lead levels in cinnamon applesauce pouches are highly unusual," an FDA spokesperson said in an email to Manufacturing Dive.

Because the lead levels far exceeded the FDA's draft guidance levels and could pose health risks, these products are considered adulterated under the Federal Food, Drug, and Cosmetic Act, the spokesperson added.

Every stage of the infant food production process is strictly monitored by the FDA. The spokesperson stated that manufacturers of foods for infants and young children must implement controls to test for toxins such as arsenic, cadmium, lead, chromium, or mercury, in order to significantly reduce or prevent any chemical hazards from entering products.

The FDA also launched theCloser to Zero programin 2021, focusing on reducing children's exposure to these contaminants through research, regulation, and consultation. In January 2023, the agency proposed setting new, lower action levels for contaminants in fruits, vegetables, and other foods.The draft action level is 10 ppb or lower, which would apply to fruit puree pouches like WanaBana products.

FDA found WanaBana cinnamon apple pouches had lead levels 200 times higher than guideline allows

Some experts consider the program insufficient, such as Jane Houlihan, research director at the food safety advocacy group Healthy Babies Bright Futures. She noted that the FDA's proposed action levels for lead in baby food would only reduce lead exposure in infants' diets by 3% to 4%. This is because the FDA data does not include infant formula, ingredients for homemade baby food, and other store-bought foods, the advocacy group stated.

"We want the FDA to set action levels that are more health-protective," Houlihan said. "The standards they set are easily achievable by industry but offer little benefit to infant health, and their priorities for action under the Closer to Zero program are misaligned."

The Closer to Zero program is still in the draft guidance stage. The FDA hopes to issue final guidance on action levels for lead in foods for infants and young children by December 2024.

"We want the FDA to set action levels that are more health-protective. The standards they set are easily achievable by industry but offer little benefit to infant health, and their priorities for action under the Closer to Zero program are misaligned."

—Jane Houlihan, Research Director, Healthy Babies Bright Futures

Due to the current lack of regulation, Houlihan said manufacturers can only comply with internal standards, leaving room for elevated contaminant levels.

"We want them to truly ramp up the program and take more actions that provide real benefits for infants," Houlihan said. "Setting action levels involves a lot of bureaucratic process and scientific analysis, and it is disappointing that the program's first major action level—the lead action level—has such minimal benefit to children's health."

She hopes to see mandatory federal testing of supplier ingredients and finished products.

"Most baby food companies want to sell foods that are beneficial to infant health. So, if there are federal guidance levels, they would be interested in paying attention," Houlihan stated.

Due to the recent WanaBana investigation, the FDA spokesperson said the agency expects to conduct additional testing of cinnamon and cinnamon-containing foods consumed by infants and young children. The agency will examine samples collected domestically and internationally, and will consider conducting more inspections of facilities that use cinnamon as a finished ingredient.

Both domestic and foreign manufacturers have a responsibility to ensure that products entering the U.S. market are safe, the spokesperson added.

"The FDA's oversight of the food supply is always consistent and vigilant," the spokesperson said. "Based on the information obtained from this investigation, we expect to continue inspecting other businesses and conducting investigations to ensure similar incidents do not recur."