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Center for Food Safety Filed Lawsuit Against FDA Challenging Decision to Approve Genetically Engineered Soy Protein Found in the Impossible Burger

FDA's Decision Not Based on "Convincing Evidence" that Regulation Requires

March 18, 2020
Center for Food Safety


(Washington, D.C.) Yesterday, Center for Food Safety (CFS) filed a lawsuit against the U.S. Food and Drug Administration (FDA) for its decision to decline the advocacy group's objections to the agency's approval of a genetically engineered (GE) soy protein used in the Impossible Burger. Also referred to as genetically engineered "heme," soy leghemoglobin is the color additive Impossible Foods uses to make its plant-based burger appear to "bleed."

CFS's lawsuit asserts that FDA used the wrong legal standard when it reviewed and approved GE heme to be used in raw Impossible Burgers sold in grocery stores. Instead of using the color additive safety standard that specifies "convincing evidence that establishes with reasonable certainty that no harm will result from the intended use of the color additive," FDA conflated that standard with the food additive safety standard, which does not specify that there must be "convincing evidence."

"By treating these two standards as 'the same,' FDA ignored the 'convincing evidence' requirement out of its color additive safety standard, which the agency isn't legally allowed to do," said Ryan Talbott, staff attorney at CFS. "This isn't just a problem with FDA's review and approval of soy leghemoglobin, but how the agency consistently ignores the "convincing evidence" standard in its review of all color additives that are added to our food." 

In order to make this GMO heme, Impossible Foods uses the process of synthetic biology (or synbio) to extract DNA from the roots of soy plants—where a small amount of heme is produced—and inserts the DNA into genetically engineered yeast where it is fermented to mass-produce this genetically engineered heme.

"This heme produced using synbio has never been consumed before. FDA should have required additional independent testing to make sure that this new substance does not cause allergic reactions or other health problems in people," said Jaydee Hanson, Center for Food Safety's policy director. "But instead of following its own guidelines for 90-day studies, the agency allowed the company to conduct a 28-day study to evaluate the safety of its own product."

CFS filed an objection to FDA's approval of the GE heme in uncooked Impossible Burgers in October 2019. This objection should have halted Impossible Burger sales in grocery stores, but several chains including Wegmans, Gelson's, and Fairway Market started selling Impossible Burgers illegally before FDA responded to CFS's objection.

While CFS avidly supports plant-based eating, the lack of transparency in getting the GE Impossible Burger in restaurants and retail stores highlights a troubling deregulatory trend which prioritizes corporate profit over public health and safety.

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