Lawsuit Challenges FDA Approval of Additive in Impossible Burgers
The Center for Food Safety (CFS) filed a legal brief on Jan. 28, challenging the U.S. Food and Drug Administration’s (FDA) approval in 2019 of soy leghemoglobin (“heme”), a color additive used to make Impossible Foods’ Impossible Burger appear to “bleed” like real meat.
"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,” Bill Freese, science policy analyst at Center for Food Safety, said in a release. “This includes studies for cancer, reproductive impairment, and other adverse effects called for by FDA’s Redbook, the Bible of food and color additive testing. 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 heme colorant is produced in genetically engineered yeast and is modeled on a protein that is found in the roots of soybean. CFS claims the FDA should have required more extensive safety testing before approving its use as a color additive as required by law.
A "clear law" on color additives
Because they offer no substantive benefits, and add only aesthetic appeal, Congress and FDA established an extremely high bar for approval. The agency’s “convincing evidence” standard means that a color additive cannot be approved without the strongest possible evidence of safety, a higher bar than for other food additives, CFS explained in a release.
Impossible Foods products containing genetically engineered (GE) heme are now widely available in supermarkets across the country due to FDA’s unlawful approval of GE heme as a color additive, CFS said.
Ryan Talbott, staff attorney at CFS, said, “The approval of soy leghemoglobin must be revoked, unless and until truly convincing evidence proves it to be safe.”
CFS added that “enthusiasm for meatless products cannot be used as an excuse to skirt food safety laws.” This introduction of Impossible Foods products highlights a troubling deregulatory trend which prioritizes corporate profit over public health and safety, CFS noted.