The manufacturer behind now-recalled cinnamon applesauce pouches failed to ever test its product for heavy metals, the Food and Drug Administration found in a recent inspection, among several shortfalls by the plant now linked to hundreds of lead poisonings nationwide.
The FDA's citation, outlined in a document obtained by CBS News through a freedom of information request, comes from a December inspection of a fruit puree factory in Ecuador run by Austrofood S.A.S.
Austrofood is the company behind the WanaBana brand cinnamon applesauce, as well as batches from store brands Weis and Schnucks that were also recalled, which the Centers for Disease Control and Prevention now says has been linked by state and local health authorities to at least 385 cases of lead poisonings across the U.S.
Many cases have been in very young children, who are especially vulnerable to the long-lasting developmental delays caused by lead poisoning, the CDC has said.
A total of 42 states have now reported at least one case of lead poisoning in someone who recently consumed one of the recalled products. Cases have continued to mount in recent weeks, as health departments have linked previous lead poisonings dating back to last year with the product.
"The increase in case counts reflects newly reported cases, for which the time of applesauce consumption varies. There is still ongoing outreach to find new cases at this time, and communication efforts to spread awareness of the dangers of these products are focused on preventing future exposures," a CDC spokesperson said in a Jan. 19 statement.
The FDA says the company failed twice, when analyzing the process for producing its applesauce products, to draw up plans to mitigate the risk that the cinnamon it was buying might end up contaminating its products.
"In addition, you did not sample and test the raw material or the finished product for heavy metals. Furthermore, sampling conducted by FDA in the United States identified [a] high level of lead in finished products," the agency's inspectors said.
Other issues the FDA found at the plant included shortfalls in its pasteurization and sanitation procedures. Austrofood was also cited for "numerous rough edges, chipped, and pitted areas" on one of its equipment that could break loose and end up in its products.
The FDA previously inspected the plant once before in 2019, FDA records show, which at the time did not result in any citations to the company.
A spokesperson for WanaBana did not immediately respond to a request for comment.
While health officials have worried for years over the risk of higher-than-optimal lead levels making its way into baby food, the FDA said last year that the "extremely high" lead levels found in WanaBana's cinnamon applesauce products was on a different scale. Concentrations of lead found by investigators in North Carolina from testing of the applesauce "could result in acute lead toxicity."
Another potential worrying metal — chromium — was also reported earlier this month in testing of Austrofood's cinnamon and the recalled pouches.
That could be the result of lead chromate, the CDC and FDA said. Lead chromate has been used by manufacturers in other countries to hide quality issues with their spices, leading to both chromium and lead poisoning.
The agency said last year it was investigating whether the lead was intentionally added to the cinnamon supplied to Austrofood for economic gain, but has stopped short of confirming this was the cause.
An FDA spokesperson was not able to immediately respond to CBS News' request for comment, when asked why the FDA has so far been unable to conclude whether the cinnamon was intentionally contaminated.
Officials have previously cited limits to their jurisdiction in their investigation of the lead contamination in Ecuador.
While the agency was able to conduct an inspection at Austrofood's factory, probing others in the supply chain — like the distributor and supplier suspected to be behind the lead contamination — required the help of authorities in Ecuador.
The FDA has also previously disputed statements by Ecuador's health authorities about the recall, after the country suggested other not-recalled WanaBana products might also be contaminated.
"FDA has no indication 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," the FDA said in an update published Jan. 23.
Alexander Tin is a digital reporter for CBS News based in the Washington, D.C. bureau. He covers the Biden administration's public health agencies, including the federal response to infectious disease outbreaks like COVID-19.
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