9th Circuit Denies Request to Review FDA Approval of Impossible Foods Color Additive

In a memorandum filed Monday, the Ninth Circuit denied a petition asking for a review of a Food and Drug Administration (FDA) order allowing Impossible Foods Inc., which produces meat substitutes, to include a genetically engineered color additive in its products. 

The plaintiff, Center for Food Safety, alleged in its January brief that the FDA’s approval of soy leghemoglobin, used to give the appearance that meat was bleeding so it more closely resembled meat, was not sufficiently tested and that the FDA did not use the appropriate standards when approving the substance. The product is reportedly produced using genetically engineered yeast. The plaintiff alleged that, since it is a new product that has not previously been approved for consumption, it should be held to a higher standard of testing. 

The Ninth Circuit, however, determined that the FDA used the correct standards under the Federal Food, Drug, and Cosmetic Act when approving the product and that there was sufficient evidence that the additive would not cause harm, denying the plaintiff’s requests for further analysis. The court determined that the FDA gave sufficient justification for its decision and did additional assessments rather than relying on Impossible Foods’ study claiming that the substance was safe. 

“It is clear from reading the FDA’s decision as a whole that the FDA performed the appropriate analysis,” the Ninth Circuit found. “Isolated instances in which the FDA phrased the safety standard differently do not establish that the agency used the wrong standard.”

The Center for Food Safety issued a statement on the decision, explaining that although the approval of soy leghemoglobin was affirmed by the court, consumers still can challenge this determination. 

“We are disappointed by the court’s ruling today, which will allow Impossible Burger and other meatless burgers to be made with a novel genetically engineered chemical without conducting any long-term health studies,” Center for Food Safety counsel Sylvia Wu said. “FDA is supposed to protect consumers from unsafe novel chemicals in our food supply, instead now consumers bear the burden of avoiding these GMO plant-based burgers.”

All three judges on the Ninth Circuit panel, Judges Susan P. Graber, Consuelo Maria Callahan, and Diarmuid F. O’Scannlain, agreed that the petition should be denied. Judge O’Scannlain, however, filed a dissent to the majority’s reasoning, arguing that the petition cannot be considered because the petitioner “lacks constitutional standing”; thus, the federal court does not have jurisdiction and should not entertain the petition, according to Judge O’Scannlain. He further claimed that the Ninth Circuit should examine the Article III standing of the Center for Food Safety before evaluating the request for a review and consider the standing based on documents the plaintiff submits.

“We must not cut to the chase, so to speak, even when it may promote judicial convenience or efficiency to gloss over jurisdictional prerequisites,” O’Scannlain said.

The Center for Food Safety is represented by internal counsel, the FDA is represented by the Department of Justice, and intervenor Impossible Foods is represented by Hogan Lovells.