The Center for Food Safety filed a reply brief on Thursday in its Ninth Circuit lawsuit challenging the red food coloring additive placed in some of Impossible Foods’ meat products to cause the appearance of “bleeding” helping the product resemble actual meat. The plaintiff argued in the lawsuit that the Food and Drug Administration (FDA) did not sufficiently test the additive, soy leghemoglobin, or heme, before approving the product.
The lawsuit was filed against the FDA, and Impossible Foods intervened as a respondent. The Center for Food Safety argued in its brief that the FDA did not “apply the convincing evidence standard” when approving the color additive and that its decision to approve the additive was not sufficiently supported. It asked the Ninth Circuit to vacate the FDA’s decision to approve the product and to conduct further tests before approving the product.
According to the plaintiff, soy leghemoglobin is relatively new in food products and should have merited “rigorous testing” by the FDA. The brief cited a rat-feeding study completed by Impossible Foods, which the plaintiff claimed did not meet minimum requirements under the FDA for a subchronic toxicity study. The plaintiff said it is “not remotely clear” which standard the FDA did apply when approving heme, and argued that because color additives do not add nutritional value, they should be held to a more strict standard.
Impossible Foods reportedly argued that the Center for Food Safety did not have standing because it did not assert a specific injury. The brief explained that “the injury is that consumer safety consequences might be overlooked by the agency.”
In a press release, the plaintiff explained that heme is produced using genetically engineered yeast, and that the Impossible Burger contains “substantial quantities” of the additive, which is new to the human diet. Although the Center for Food Safety explained that it supports plant-based foods, it said the foods should not be used as an excuse to breach food safety laws.
“FDA approved soy leghemoglobin even though it conducted none of the long-term animal studies that are needed to determine whether or not it harms human health,” said Bill Freese, science policy analyst at Center for Food Safety. “We find this to be all the more troubling because a number of potential adverse effects were detected in a short-term rat trial: disruption of reproductive cycles and reduced uterine weights in females, and biomarkers of anemia, reduced clotting ability, and kidney problems.”
The Center for Food Safety is represented by its own lawyers, the FDA is represented by the Department of Justice, and Impossible Foods is represented by Hogan Lovells.