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Image credit: Impossible Foods

Brief: Lawsuit challenges US regulatory approval of heme in Impossible Foods’ ‘bleeding’ burger

February 4, 2021

  • The Center for Food Safety (CFS) has filed suit [PDF brief here] in the US Court of Appeals for the Ninth Circuit, arguing the US Food & Drug Administration (FDA) erred in its 2019 decision to approve soy leghemoglobin — a key ingredient in Impossible Foods‘ plant-based meat analogs — for human consumption.
  • The CFS claims the decision wasn’t based on ‘convincing evidence’ as required by the FDA’s approval process. The agency “approved soy leghemoglobin even though it conducted none of the long-term animal studies [needed] to determine whether or not it harms human health,” said Bill Freese, CFS science policy analyst, according to Food Safety News.
  • Freese claimed “a number of potential adverse effects” were detected in a short-term trial involving rats, including “disruption of reproductive cycles and reduced uterine weight [and] biomarkers of anemia, reduced clotting ability, and kidney problems.”

Why it matters:

Soy leghemoglobin — commonly referred to by the generic term heme — is a colorant and flavorant synthesized by extracting DNA from soybean roots, where heme is naturally produced in small quantities, and adding it to genetically engineered yeast.

Impossible Foods developed the substance to impart an umami taste, and mimic the appearance of blood, in its products in a way that’s reminiscent of actual animal-derived meat.

“Based on our own extensive studies as well as a comprehensive review of previous published studies, we concluded [soy leghemoglobin] is completely and unequivocally safe for human consumption,” the company states on its website.

Ryan Talbott, CFS staff attorney, said the FDA’s approval “must be revoked, unless and until truly convincing evidence proves it to be safe.”

The CFS previously garnered attention for advocacy and legal action targeting regulatory approval of genetically modified crop varieties, including several developed by Monsanto.

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