Theoutbreak began in April 2022 and the last person to become ill developed symptoms in September 2022, according to the FDA. Symptoms included a variety of gastrointestinal issues and liver problems. About 30 people had to have their gallbladders removed. According to government figures, 393 people from 39 states were involved.
It has been known since early summer 2022 that tara protein flour was unique to Daily Harvest products. It was added to the recipe for frozen French Lentil & Leek Crumbles in mid-spring this past year. Tara flour, the suspect ingredient in the crumbles, comes from the seeds of the tara plant grown in the higher altitudes of Peru.
The crumbles product also included sacha inchi powder, but that ingredient was also used in other Daily Harvest products. Consumers did not report illnesses related to the products with sacha inchi powder, except for the French Lentil & Leek Crumbles.
In the spring of this past year, the Daily Harvest company started receiving complaints of illnesses from customers who had eaten the crumbles. In response to those reports, the company recalled, on June 23, 2022, its French Lentil and Leek Crumbles product. Some consumers may have had the product in their freezers and been unaware of the recall, thus continuing to use the crumbles.
Following the initial reports of the illnesses, the FDA began a joint inspection with the Minnesota Department of Agriculture (MDA) at Stone Gate Foods dba Second Bite Foods Inc. in Shakopee, MN. No significant observations were noted, according to the FDA report.
It was unable to be determined which regions, countries, or fields the tara protein flour lot codes used in the Daily Harvest Lentil and Leek Crumbles products were sourced from, the agency reported.
There were other products suspected to be linked to some illnesses, but the FDA said it does not find any definitive issues. Those products included smoothies of various flavors, including but not limited to, Strawberry Peach and Mint cacao.
The Minnesota Department of Health conducted an epidemiologic investigation related to adverse illness events reported after consumption of Daily Harvest products from April 1 to July 20, 2022. Multiple analytical studies were conducted, including a case-control study at the category, product, and ingredient levels. French Lentils & Leek Crumbles were statistically associated with illness. Ingredient-level analyses did not statistically implicate tara protein flour or sacha inchi powder but did find a statistical association between (b)(4) and illness, though analyses were limited by the small number of cases. The investigation provides further evidence that the French Lentil and Leek Crumbles were the sources of illness, according to the FDA report.
The FDA tested individual ingredients, including tara flour, for the crumbles and found toxic metals. The toxic metals screen included the following metals above the reporting limit (200 ng/g): vanadium, chromium, cobalt, nickel, arsenic, selenium, cadmium, mercury, thallium, and lead.
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