By Beth Kowitt
July 24, 2018

Impossible Foods had a simple idea for convincing meat eaters to give up their beef burgers in exchange for plant-based ones. Its burger had to trick not just consumers’ taste receptors into thinking they were experiencing meat, but all of the other senses, too.

Impossible Foods found the answer in heme, the iron-rich molecule in blood that carries oxygen and is responsible for the deep-red color. It’s this “plant blood” that helps the Impossible Burger look, taste, and behave like meat.

Convincing the U.S. Food and Drug Administration of heme’s magical properties proved to be more challenging. But yesterday—nearly four years after Impossible Foods voluntarily went to the FDA for review—the company received a “no questions” letter from the regulator that deemed soy leghemoglobin, the protein that carries the heme, as “generally recognized as safe,” or GRAS, for the purpose of optimizing “flavor in ground beef analogue products intended to be cooked.”

“This is proof-positive for many outside the company that we are not just obviously safe to eat,” says Impossible Foods COO and CFO David Lee, “but that we’re ready for primetime.”

Impossible Foods didn’t need the FDA’s approval to make its burgers in the U.S., but in an effort to be transparent with consumers it still asked the regulator to confirm soy leghemoglobin as GRAS. “This particular heme protein is new to the food system,” says Impossible Foods CEO and founder Pat Brown. “That’s why we felt that it’s important to us to do the safety testing.”

But the FDA came back to the company with some follow up questions, and Impossible Foods withdrew its GRAS submission in November 2015, before refiling it last year with with additional safety data. “Obviously we wish it would have happened a lot faster,” says Brown.

Heme is found in the roots of plants like legumes, which turn nitrogen into fertilizer, but Impossible Foods makes it by fermenting genetically engineered yeast, which it says is a more economically feasible and environmentally friendly path.

The nod of approval from the FDA is also a boost for Impossible Foods in pushing back against Friends of the Earth, a vocal nonprofit group, which has called into the question the regulatory oversight and safety testing of this new generation of alternative meat.

Impossible Foods is one of several startups attempting to make meat without animals, either through making plants taste more like meat or by growing meat from cells. These companies, which have attracted a lot of attention from the tech community, say that their processes require fewer resources than animal agriculture, and are therefore a more sustainable alternative.

“If we’re going to solve this urgent environmental problem we need a scalable, sustainable way of producing heme,” says Brown. “This, after a lot of research, is the most readily scalable and is far more sustainable than covering the earth with cows.”

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