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Sixty-four children ages 6 and under may have lead poisoning after consuming tainted pouches of cinnamon apple puree from several manufacturers, according to the U.S. Food and Drug Administration (FDA), which on Wednesday said it is “continuing to evaluate incoming adverse reports of illnesses.”

The FDA’s report cited three products: WanaBana apple cinnamon fruit puree pouches, sold through Amazon, Dollar Tree, and other online outlets; Schnucks-brand cinnamon-flavored applesauce pouches and variety pack, sold at Schnucks and Eatwell Markets grocery stores; and Weis-brand cinnamon applesauce pouches sold at Weis grocery stores.

Blood lead levels in the 64 children were at or above 3.5 micrograms of lead per deciliter (µg/dL). The Centers for Disease Control and Prevention (CDC) recommends clinical monitoring of lead exposure in children with a blood reference level of 3.5 µg/dL, the FDA said.

There is no safe level of lead for children, according to the CDC. Research published recently showed lead exposure in kids under 5 is linked to IQ loss and heart disease deaths.

According to the FDA, short-term exposure to lead may result in symptoms including headache, abdominal pain/colic, vomiting and anemia. Symptoms associated with longer-term exposure include irritability, lethargy, fatigue, muscle aches or muscle prickling/burning, constipation, difficulty concentrating, muscle weakness, tremor and weight loss.

The FDA’s report comes as Rising Pharmaceuticals — a drugmaker that sells a generic lead poisoning antidote — came under fire for its recent decision to charge $32,000 per treatment, CNN reported.

The price is 10 times more than a version of the same drug imported from France and approved by the FDA for use during the domestic supply shortage.

U.S. Sen. Amy Klobuchar (D-Minn.) on Dec. 7 asked Rising Pharmaceuticals’ president and CEO how the company reached that price. In a letter, she wrote:

“The U.S. Food and Drug Administration gave Rising Pharmaceuticals approval to manufacture and commercially produce this drug to alleviate a shortage of this critical treatment.

“Rising’s decision to price this generic injectable at ten times the price of the imported version from France is leading to avoidable and dangerous delays in patient treatment and compromising patient care.”

Klobuchar asked the company to disclose “the biggest factors” that influenced its decision.

Cases reported in 27 states

Meanwhile, the number of children reported to be experiencing lead poisoning symptoms after eating packaged cinnamon and apple-based products appears to be on the rise, according to the FDA, which reported seven additional cases between Nov. 30 and Dec. 5.

The FDA’s Dec. 5 report was an update to the agency’s investigation, initiated more than a month ago, into the source of lead contamination in packaged apple-based products.

The agency launched the investigation in late October after the North Carolina Department of Health and Human Services found four cases of child lead poisoning linked to consumption of WanaBana apple cinnamon fruit puree that contained “extremely high concentrations of lead.”

On Oct. 30, WanaBana issued a nationwide recall of the product, the FDA said.

On Nov. 9, the company extended the recall to apply to other products WanaBana sells under other brand names, including Schnucks applesauce pouches with cinnamon and Weis cinnamon applesauce.

Since then, child lead poisoning cases linked to the products have been reported in 27 states: Alabama, Arkansas, California, Connecticut, Florida, Georgia, Iowa, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, Nebraska, New Hampshire, New Mexico, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin, NBC News reported.

Is it the cinnamon?

Although the FDA’s investigation is ongoing, authorities have tentatively traced the contamination to WanaBana’s cinnamon-sourcing plant in Ecuador.

The FDA said it “has initiated an onsite inspection at the Austrofoods facility located in Ecuador. Ingredient sample collection is underway.”

The agency also said Ecuadorian authorities found Austrofoods’ supplier, Negasmart, had lead levels in its cinnamon higher than what the country allows.

“Negasmart … is currently under an Ecuadorian administrative sanctions process to determine the responsible party for the contamination,” the FDA said.

WanaBana did not immediately respond to The Defender’s request for comment on the FDA’s investigation, nor did Schnucks or Weis.

Although the amount of lead detected in WanaBana’s products exceeded FDA limits, the agency is aware that even small amounts of lead are problematic for kids’ health.

Earlier this year the FDA released new draft guidance proposing limits on lead in processed baby food and foods — including mashed fruits — intended for children under age 2.

However, critics questioned the proposals, arguing that no amount of lead in foods is safe and that the limits should apply to other heavy metals, and other foods for the general population.

The FDA’s proposed limits have yet to go into effect.