The Food and Drug Administration said there have been at least 90 confirmed reports of sickened people connected to lead-contaminated cinnamon applesauce pouches that were recalled last year.
Those who experienced adverse effects from the products were between 0 and 53 years of age, with a median age of 1 year old, the FDA said.
In addition to the FDA’s ongoing investigation, the Centers for Disease Control and Prevention’s National Center for Environmental Health has received reports of 126 confirmed cases, 336 probable cases and 37 suspected cases for a total of 499 cases from 44 different states, as of March 8.
The cases tracked by the CDC all measured a blood lead level of three micrograms per deciliter or higher within three months after consuming the tainted WanaBana, Schnucks or Weis brand fruit puree products.
The numbers provided by the FDA and the CDC differ since the agencies use different data sources. There may also be duplicates in their reports, the FDA said.
An investigation into the source of the lead contamination in the applesauce pouches, which are primarily marketed to children, has been ongoing since the FDA’s initial safety alert last October.
During an onsite inspection of the Austrofoods facility in Ecuador where the applesauce pouches were produced before being sold in the U.S., the agency tested cinnamon samples supplied to Austrofoods from the companies Negasmart and Carlos Aguilera.
An extremely high amount of lead, thousands of times more than an international proposed limit, was discovered in the samples, the FDA said. There were also notable amounts of chromium found.
Later the FDA confirmed the lead and chromium were from lead chromate — an inorganic compound that, historically, has been illegally added to certain spices to increase their weight and enhance their color, therefore increasing their monetary value.
The FDA’s leading hypothesis remains that this was likely an act of economically motivated adulteration, it said.
Since the FDA has limited authority over foreign ingredient suppliers who do not directly ship products to the U.S., it has limited ability to take action with Negasmart or Carlos Aguilera.
However, Ecuadorian officials reported that Carlos Aguilera is the likely source of contamination and is not in operation at this time.
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