The Center For Food Safety recently filed a legal brief, challenging the U.S. Food and Drug Administration’s (FDA) 2019 approval of soy leghemoglobin, otherwise known as “heme.”
Heme is a food coloring produced in genetically-engineered yeast. It’s used to give the meat-free “Impossible Burger,” made by Impossible Brands, the appearance that it’s “bleeding” just like a juicy, dripping real burger patty.
The challenge to the FDA approval of heme centers around the fact that heme, because it is genetically engineered and new to the human diet, should have been extensively studied for safety by the FDA, as required by law, before being approved as a color additive.
In a press release by The Center For Food Safety (CFS), that organization’s science policy analyst, Bill Freese, said, “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.”
Freese added, “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. [CFS] find[s] 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 FDA and Congress are supposed to have a high bar for approving food colorings, because the only benefit to them is aesthetic value rather than health benefits. According to the CFS, the FDA’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.
Impossible Foods’ products, including the Impossible Burger, are ubiquitous in supermarkets throughout the U.S., despite the fact that heme has not had rigorous safety tests, making the approval by the FDA unlawful, suggests CFS.
An attorney with CFS, Ryan Talbott, said in the press release, “FDA’s failure to require Impossible Foods to conduct long-term tests called for in the agency’s own authoritative guidelines means it does not have ‘convincing evidence’ that this color additive, consumed by millions, is safe.”
Talbott added, “The approval of soy leghemoglobin must be revoked, unless and until truly convincing evidence proves it to be safe.”
Plant-based diets are becoming increasingly popular, however, CFS says that “enthusiasm for meatless products cannot be used as an excuse to skirt food safety laws.”
CFS describes the approval of heme by the FDA as a “dereliction of duty,” which has resulted in the “premature introduction of heme [which] highlights a troubling deregulatory trend which prioritizes corporate profit over public health and safety.”