By now, most of us have seen plant-based “meat” in supermarkets and restaurants.  For one of those plant-based meat substitutes, ImpossibleTM Burger, a lawsuit is underway challenging the FDA’s approval of the compound used to simulate blood in the “meat.”  In order to simulate blood, as in ground beef, ImpossibleTM Foods, the maker of ImpossibleTM Burger, developed a genetically engineered soy protein called soy leghemoglobin. It was created by taking DNA from the roots of soybeans and inserting the DNA into genetically modified yeast which produce the soy leghemoglobin.  

At the heart of the dispute is the standard applied by the FDA in its approval of soy leghemoglobin and whether adequate testing was done to demonstrate its safety.  The issues are whether the compound that simulates the blood should have been evaluated as a color additive and whether soy leghemoglobin has been proven to be safe for human consumption.  (“Safe means that there is convincing evidence that establishes with reasonable certainty that no harm will result from the intended use of the color additive.”  21 C.F.R. § 70.3(i)).

In seeking FDA approval for the use of soy leghemoglobin, ImpossibleTM Foods said that it should be “generally recognized as safe for use to optimize flavor in ground beef analogue products intended to be cooked.”  In its initial approval of ImpossibleTM Foods’ use of soy leghemoglobin, the FDA said “we have no questions at this time regarding Impossible Foods’ conclusion that soy leghemoglobin preparation is GRAS under its intended conditions of use to optimize flavor in ground beef analogue products intended to be cooked.”  While acknowledging that soy leghemoglobin has a “red/brown” color, the FDA specifically did not, at that time, evaluate soy leghemoglobin as a color additive.  (“Our response to GRN 000737 is not an approval for use as a color additive . . . .”)  The FDA later amended its regulations to exempt soy leghemoglobin from its color additive regulations as long as the soy leghemoglobin did not exceed .80 of the uncooked weight of the uncooked “beef analogue.”  21 CFR § 73.520.  The Center for Food Safety objected to the regulatory amendment on several grounds, including the assertion that soy leghemoglobin should be labeled as a color additive and that it should not be approved without further testing to establish its safety.

After the FDA denied its objections and request for a hearing, the Center for Food Safety filed suit against the FDA, alleging that the FDA applied an incorrect standard in permitting the use of soy leghemoglobin.  The Center for Food Safety argues that the FDA should have evaluated soy leghemoglobin under the standard for a color additive and that the studies submitted to the FDA on behalf of soy leghemoglobin did not meet the “convincing evidence” standard for color additives.  Specifically, the Center for Food Safety claims that the animal studies conducted on soy leghemoglobin were inadequate and demonstrated adverse effects, including decreases in weight gain, possible indicia of anemia, kidney problems, inflammatory disease, and decreased blood clotting.  On behalf of soy leghemoglobin, ImpossibleTM Foods claims that the research is adequate and shows that soy leghemoglobin is safe for human consumption.

The Petition for Review filed by the Center for Food Safety from the FDA’s decision is currently pending before the Ninth Circuit Court of Appeals.  The outcome of this lawsuit has significant implications for makers of other plant-based meat substitutes.