The FDA is investigating an outbreak of “adverse events” related to a frozen food that was recalled, but the notice of investigation does not identify a specific product.
As of June 29, 107 people had reported what the Food and Drug Administration calls adverse events. On-site tracing, testing and inspections are ongoing in addition to the product recall.
All the facts — including a statement from the company’s CEO — point to the product being Daily Harvest brand frozen French lentil + leek crumbles.
“We have spent the past ten days working with the FDA, state agencies and several independent laboratories, as well as microbiology, food safety and toxicology experts to perform testing. These tests cover common foodborne pathogens, toxins and allergens,” said Rachel Drori, founder and CEO of Daily Harvest, in a written statement released June 27.
She said the company used an ISO 17025-certified third-party lab to test for various bacteria and other pathogens in the product.
“At this point, despite consulting with numerous experts, cooperating with the FDA investigation, collaborating with our supply chain, and conducting extensive testing, we have not yet identified a cause.” she declared.
Over 470 people have reported through various channels that they fell ill after eating French Lentil + Leek Crumbles. They have similar symptoms, including elevated liver values and rapid onset pain consistent with gallbladder problems.
A lawyer who represents 125 of the sick people says there is “no doubt that the product is the cause of the illnesses”. That attorney, Bill Marler of Seattle-based Marler Clark LLP, says it’s not yet known which ingredient or chemical is the culprit.
Marler said if it weren’t for gallbladder patients, the symptoms would be consistent with hepatitis infection. Virtually all of his clients have had yellowing of the skin and eyes and dark urine in addition to poor liver blood test results. Some patients were hospitalized. He said 20 of them had had their gallbladders removed.
“We are testing over 40 crumb samples from both opened and unopened packages,” Marler said.
He said it was unusual for the FDA to receive more than 100 complaints in such a short time regarding an individual product. Whether the company issued a recall is also an important factor.
Of the patients who retained Marler, the vast majority are between the ages of 25 and 45, and most are women. All ate the French Lentil + Leek Crumbles, which just became available to the public in May.
In its outbreak announcement, the FDA did not say where the sick people live or indicate their age range. The agency did not say what it is testing or when testing began.
The CEO of Daily Harvest said the FDA and the state Department of Agriculture each inspected the facility where the French lentil + leek crumbles were made.
“We are confident that this issue is limited to our French Lentil + Leek crumbles and does not affect any of our other 100 menu items. We continue to eat and feed our families with all of our other products,” according to the CEO’s statement.
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