Tell Congress: Fake Meat Needs Safety-Testing, Just Like All GMOs!

Whether you’re excited about new meat alternatives, or you’d rather eat regenerative and organic grass-fed beef, we can all agree on one thing: Fake meat, like all foods made with genetic engineering and synthetic biology, should be safety-tested before we start eating it.

TAKE ACTION: Tell Congress to press the U.S. Food & Drug Administration to safety test the GMO Impossible Burger!

man eating a hamburger on a bun

The FDA has let consumers become guinea pigs in the Big Impossible Burger GMO Experiment.

Here’s why. The Impossible Burger contains a GMO ingredient called soy leghemoglobin (heme). It is the color additive Impossible Foods uses to make its plant-based burger appear to “bleed” as if it were beef. 

The novel “heme” colorant is a product of genetic engineering and synthetic biology. Its DNA is extracted from the roots of soy plants which contain a small amount of heme. That DNA is inserted into genetically engineered yeast that mass-produces the genetically engineered heme. The final product contains more than a dozen yeast proteins.

Impossible Food’s genetically engineered synthetic heme is new to the human diet and substantial quantities of it are added to the Impossible Burger.

Eating something humans have never eaten before can expose us to new toxins or allergens and trigger immune responses or cause digestive problems. (For more on this, watch Robyn O’Brien’s excellent TEDx Talk.) 

The best way to safety-test new GMOs is to conduct long-term studies on human volunteers, before the GMOs are released into the market. 

Yet this isn’t required by regulators—even though the few studies that have been conducted on humans show problems, including immune responses, allergic reactions and the transfer of GMO proteins to human gut bacteria.

Without pre-market safety testing, we’ve all become part of the big GMO experiment. In 1989, a dietary supplement, L-tryptophan, produced using genetically modified bacteria, was found to be toxic. L-tryptophan killed 37 people and disabled more than 1500 others.

In 2000, StarLink, a variety of genetically modified Bt corn that wasn’t approved for human consumption, accidentally entered the food supply. The corn caused severe allergic reactions, including anaphylactic shock.

In the cases of L-tryptophan and StarLink, regulators were able to trace health disasters back to the specific GMOs that caused them. But it’s been far more difficult to prove that the introduction of GMOs into the food supply has caused a corresponding rise in allergies. 

A recent review found “evidence that genetic modification, in some instances, resulted in the product having decreased IgE binding capacity in subjects with allergy compared with its conventional counterpart, which could indicate hypo-allergenicity.” 

The FDA could have regulated heme as a Food Additive—but didn’t. Instead it allowed the ingredient to go through the Generally Recognized As Safe (GRAS) process, which is voluntary. In the GRAS process, the FDA makes no conclusions of its own about an ingredient’s safety. It simply chooses to ask more questions of the company, or not. 

The FDA had a lot of questions for Impossible Foods, the Silicon-Valley-based maker of the Impossible Burger. The agency was especially concerned about the potential of the more than 40 proteins contained within GMO soy leghemoglobin to be allergens. 

The FDA reportedly told Impossible Foods:

“F.D.A. believes the arguments presented, individually and collectively, do not establish the safety of soy leghemoglobin for consumption nor do they point to a general recognition of safety.”

So what happened? This: Impossible Foods responded to the FDA by supplying statements asserting that, based on the company’s own research, the ingredient contained no known allergens or toxins. 

The FDA then ended the GRAS process by sending the company a “no questions” letter

End of story? No, the FDA also had to review the Impossible Burger’s GMO heme as a color additive. 

The FDA accepted Impossible Burger’s color additive petition, clearing the company to sell raw Impossible Burgers in the meat case at grocery stores.

The Center for Food Safety is challenging the FDA’s approval, because the agency’s decision was not based on “convincing evidence” as required by regulation.

“FDA approved soy leghemoglobin even though it conducted none of the long-term animal studies that are needed to determine whether or not it harms human health,” said Bill Freese, CFS science policy analyst. 

“This includes studies for cancer, reproductive impairment and other adverse effects called for by FDA’s Redbook, the Bible of food and color additive testing. We find this to be all the more troubling because a number of potential adverse effects were detected in a short-term rat trial: disruption of reproductive cycles and reduced uterine weights in females and biomarkers of anemia, reduced clotting ability and kidney problems.”

“FDA’s failure to require Impossible Foods to conduct long-term tests called for in the agency’s own authoritative guidelines means it does not have ‘convincing evidence’ that this color additive, consumed by millions, is safe,” said Ryan Talbott, staff attorney at CFS. 

“The approval of soy leghemoglobin must be revoked, unless and until truly convincing evidence proves it to be safe.”

The FDA is supposed to have an extremely high bar for approval for color additives in food. The agency’s “convincing evidence” standard means that a color additive cannot be approved without the strongest possible evidence of safety, a higher bar than for other food additives. 

However, Impossible Foods’ products containing genetically engineered heme are now widely available in supermarkets across the country because of the FDA’s unlawful approval.

The full legal brief can be viewed here.

It shouldn’t have to be this hard. Congress should require the Impossible Burger and all GMO foods to undergo rigorous third-party pre-market safety testing, post-market regulatory oversight and mandatory labels. 

Tell Congress to press the U.S. Food & Drug Administration to safety test the GMO Impossible Burger!

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