08/25/2019
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Dear Robert,
Following an “unusually rapid” approval process, the Food and Drug Administration (FDA) just approved soy leghemoglobin or “heme”—the color additive that Impossible Foods uses to make its GMO Impossible Burger appear to “bleed.”
This is the first time that people have consumed “heme.” In this situation, FDA is supposed to require testing to make sure that this new substance does not cause allergic reactions in people, but the agency did not do so.
Tell FDA to stop its approval of “heme” until independent testing shows this new additive to be safe!
Center for Food Safety (CFS) avidly supports plant-based eating, but the lack of transparency in getting the GMO Impossible Burger in restaurants and retail stores highlights a troubling deregulatory trend which prioritizes corporate profit over public health and safety.
Impossible Foods makes “heme” through a brand-new genetic engineering process called synthetic biology or “synbio,” which uses yeast that has been genetically engineered to contain the gene for soy leghemoglobin. Through the synbio process, new compounds including proteins may be created that have never been consumed by humans before, and thus the impact of these compounds on our gut and our overall health is unknown.
FDA’s approval is especially troubling because the first time Impossible Foods submitted data on the allergenicity of its “heme,” FDA found it to be inadequate and came back to the company with clarifying questions. Instead of answering them, Impossible Foods responded by withdrawing its application in order to redo its research. Although the FDA now says that it has "no questions" about Impossible Foods' latest research on the safety of "heme," the agency itself has not affirmatively declared that "heme" produced in genetically engineered yeast is safe for human consumption. FDA also warned Impossible Foods that it cannot claim its “heme” is a source of iron based on this review and that it must label its product as a potential allergen.
Instead of requiring Impossible Foods to file a new food additive petition before the company could sell its GMO burgers in restaurants, FDA allowed the company to use a weak regulatory process called “Generally Recognized As Safe” (GRAS) in which Impossible Foods does its own research and chooses its own reviewers to self-certify that the product is safe for human consumption.
However, before Impossible Foods could sell its GMO Impossible Burger in grocery stores, the company had to file a color additive petition with FDA. The speed with which FDA approved “heme” suggests that the agency accepted Impossible Foods’ claims from last year’s flawed process at face value rather than conducting its own independent testing.
Tell FDA to stop its approval of “heme” until independent testing shows this new color additive to be safe!
Contrary to what Impossible Foods claims on its website, there is no evidence that shows Impossible Burger customers would have purchased a meat burger if not for the option of getting a GMO Impossible Burger. It’s not a coincidence that the companies entering the GMO “meat” market are often the same companies that have been producing meat—unsustainably—for generations.
CFS has a lawsuit challenging the GRAS food additive loophole that the GMO Impossible Burger was able to slip through. By challenging the irresponsible GRAS approval process, we at CFS are trying to prevent a domino effect of “synbio” additives making their way into products on the market without proper, independent testing.
Tell FDA to stop its approval of “heme” until independent testing shows this new color additive to be safe!
