The US Food and Drug Administration has found “extremely high” lead levels in cinnamon samples at a plant in Ecuador that made apple sauce pouches linked to a multi-state recall.

The FDA has completed an inspection of the Austrofood manufacturing plant following ever-increasing reports of “adverse events” from recalled cinnamon apple sauce products in the US.

Following analysis of an undisclosed number of cinnamon samples at the site, the agency said it found “extremely high levels of lead contamination”.

It recorded 5,510 parts per million in one sample, while another is said to have contained 2,270 ppm.

“For context, the international standard-setting body, Codex Alimentarius Commission (Codex) is considering adopting a maximum level of 2.5 ppm for lead in bark spices, including cinnamon, in 2024,” the FDA said in its update released earlier this week.

The food safety regulator said it also tested 136 samples of cinnamon-free products that did not register high lead levels.

Out of these samples that tested negative for elevated lead, 11 were from WanaBana’s Smoothie Mango Passionfruit Banana fruit purees. Three of those samples were said to have come from the same batch that was initially reported as positive for high levels of lead by Ecuador’s National Agency for Health Regulation, Control and Surveillance.

The FDA also examined samples of the WanaBana Organic Mango Puree product “at import”, which also showed no signs of extortionate lead levels.

Products affected by the recall include apple sauce pouches from brands WanaBana, Schnucks and Weis, which have all been found to contain cinnamon contaminated with lead.

US and Ecuadorian authorities traced the contaminated spice back to Negasmart, which supplies Austrofood with the ingredient.

Reports from Politico last week said that the supplier was now under an “Ecuadorian administrative sanctions process.”

FDA deputy commissioner for human foods Jim Jones told Politico that “all of the signals” are indicating that this contamination was an “intentional act” from someone in the supply chain.

In a statement yesterday (19 December), the FDA said it was “still relying on officials in Ecuador to support the ongoing investigation into Negasmart.”

Some 69 reports of illness potentially connected to the recalled product have now been recorded by the group, with the majority coming from children under the age of six.

An FDA spokesperson told Just Food that it is still considering the notion that the tainted apple sauce pouches were potentially linked to an "economically motivated adulteration."

"As this is an ongoing investigation, the FDA can only confirm this is one of the theories at this time,” they said.

“Additional investigation needs to occur before FDA reaches any conclusions. The FDA will continue to keep the public updated as the investigation unfolds.”

It is unclear yet when the investigation is expected to close.

The product recall also affects products outside the US, according to the FDA, with customer details from Negasmart showing its cinnamon has also been shipped to Cuba and the United Arab Emirates.