Well Done


A US Court of Appeals for the Ninth Circuit panel recently affirmed a decision by the US Food and Drug Administration (FDA) approving soy leghemoglobin (also known as “heme”), a soy protein, as a color additive. Ctr. for Food Safety v. U.S. Food & Drug Admin., No. 20-70747, 2021 WL 1739920 (9th Cir. May 3, 2021). Heme is produced using a novel genetically engineered yeast strain that makes Impossible Foods' plant-based burger appear to "bleed."

Impossible Foods originally received correspondence from FDA in 2018 determining that the agency would not challenge the company’s determination that its heme is generally recognized as safe (GRAS). The letter also noted that heme could be considered a color additive under certain conditions, resulting in Impossible Foods’ submission of a color additive petition, which was approved in 2019. 21 CFR § 73.520.

The nonprofit Center for Food Safety (CFS) originally filed a lawsuit in March 2020 challenging FDA’s approval of Impossible Foods’ color additive petition. CFS argued that FDA used a lower safety standard than required when it approved genetically engineered heme as a color additive. Color additive approval generally requires convincing evidence that establishes with reasonable certainty that no harm will result from the intended use of the color additive. 21 CFR § 70.3(i). CFS claimed that FDA failed to review the petition using this standard of review. CFS further asserted that genetically modified heme requires additional testing to ensure that it does not cause any health problems in consumers because it is a new product that has not previously been approved for consumption.

The Ninth Circuit panel majority found CFS’s objections to be "unavailing," holding that FDA applied the correct review standard and performed sufficient assessments to determine heme’s safety. “It is clear from reading the FDA’s decision as a whole that the FDA performed the appropriate analysis,” the court held. “Isolated instances in which the FDA phrased the safety standard differently do not establish that the agency used the wrong standard.”

The Ninth Circuit’s holding affirms FDA’s approval process for color additives and allows food companies to use novel techniques, such as creating genetically engineered yeast, to produce chemicals for use in alternative food products.

In a dissenting opinion, Judge Diarmuid O’Scannlain opposed the majority’s reasoning, arguing that the petition should not have been considered because CFS lacked constitutional standing; thus, the court did not have jurisdiction and should not have entertained the petition. CFS issued a statement following the decision, explaining that although the approval of heme was affirmed by the court, the decision to hear the case showed that consumers have the right to seek judicial review of FDA's determinations. The nonprofit is separately challenging FDA’s GRAS rule, seeking a ruling that FDA is required to enforce the GRAS provision through a mandatory premarket notification mechanism. Ctr. for Food Safety v. Price, No. 17-CV-3833 (VSB), 2018 WL 4356730 (S.D.N.Y. Sept. 12, 2018).