The FDA Faces a Lawsuit Over Untested Color Additives in Impossible Burgers

The Center for Food Safety (CFS) filed a lawsuit against the U.S. Food and Drug Administration (FDA) regarding its approval of a colorant and flavorant used in plant-based protein company Impossible Foods, despite allegations that no long-term studies were conducted to test the colorant’s effect on human health.

Soy leghemoglobin or “heme” is a genetically engineered ingredient used to make Impossible Burgers appear to “bleed”.

The official brief is quick to point out that for soy leghemoglobin, generically referred to as “heme”, there is “no history of knowledge of human dietary exposure”. This would imply that without thorough long-term studies, it is impossible to know how the human body will be affected by this new genetically engineered ingredient. Additionally, the amount of this color additive used in the Impossible Burgers allegedly places it in the FDA’s “highest probable risk to human health” category, and should have triggered extensive toxicity testing before gaining the FDA’s approval.

Ingredients that may pose a risk to human health are generally required to undergo long-term subchronic, chronic, carcinogenicity, and reproductive testing.

The FDA is responsible for requiring food manufacturers to conduct certain studies regarding any previously untested ingredients in their products. In fact, in regard to colorants in particular, the FDA has previously had relatively high standards regarding safety testing and approval. In the past, the FDA has required food manufacturers to show “convincing evidence” of safety regarding color additives before the food can go to market; CFS argues that no convincing evidence was submitted for heme. CFS further alleges that Impossible Foods was not required to conduct long-term tests, putting the health of millions of consumers at risk.

The lawsuit points out potential adverse effects that were detected in short-term trials.

Short-term trials of heme conducted with rats revealed possible adverse effects including disruption of reproductive cycles, reduced uterine weight, and signs of blood and kidney problems. These effects could be indicative of serious health concerns for human consumers, and generally require extensive long-term testing before being approved by the FDA. Currently, the burgers with heme color additives are sold in both grocery stores and restaurants across the country, without any explicit warnings of the untested nature of one of its most significant ingredients.

The lawsuit is seeking for the FDA to vacate its approval of the additive.

The brief points out the FDA’s core duty is to ensure that color additives are safe before they are sold by requiring companies to conduct adequate tests. CFS is requesting that the FDA retract its approval of heme as a color additive until thorough long-term testing has been completed to determine any negative effects on human health. Additionally, they are requesting that heme only continue to be used as a color additive if it is proven to be largely non-harmful to humans on a long-term basis, something critics of the ingredient suspect will not be the case.