One of the chief selling points of the Impossible Burger, a much ballyhooed plant-based burger patty, is its resemblance to meat, right down to the taste and beeflike “blood.”
Those qualities, from an ingredient produced by a genetically engineered yeast, have made the burger a darling among high-end restaurants like Momofuku Nishi in New York and Jardinière in San Francisco, and have attracted more than $250 million in investment for the company behind it, Impossible Foods.
Now, its secret sauce — soy leghemoglobin, a substance found in nature in the roots of soybean plants that the company makes in its laboratory — has raised regulatory questions.
Impossible Foods wants the Food and Drug Administration to confirm that the ingredient is safe to eat. But the agency has expressed concern that it has never been consumed by humans and may be an allergen, according to documents obtained under a Freedom of Information request by the ETC Group as well as other environmental and consumer organizations and shared with The New York Times.
“F.D.A. believes the arguments presented, individually and collectively, do not establish the safety of soy leghemoglobin for consumption,” agency officials wrote in a memo they prepared for a phone conversation with the company on Aug. 3, 2015, “nor do they point to a general recognition of safety.”
Impossible Foods can still sell its burger despite the F.D.A. findings, which did not conclude soy leghemoglobin was unsafe. The company plans to resubmit its petition to the agency.
Impossible Foods is finding out what happens when a fast-moving venture capital business runs headlong into the staid world of government regulation.
Investors like Bill Gates and Khosla Ventures have poured money into a variety of so-called alt meat companies. Silicon Valley has noble goals, applying technological solutions to address major issues like climate change, farm animal welfare and food security.
But food is not an app. It is far more heavily regulated by governments and much more heavily freighted with cultural and emotional baggage.
“This rush to market is the Silicon Valley mind-set,” said Michael Hansen, a food safety expert who is the senior staff scientist at Consumers Union, an advocacy group. “They think because they’re doing something disruptive, the regulations that apply to other companies don’t apply to them.”