The meatless, “bleeding” burger known as the Impossible Burger has been a roaring success in the food tech startup world: It’s raked in more than $250 million from investors (including Bill Gates) and is now served at some of the nation’s most acclaimed restaurants, including David Chang’s Momofuku Nishi in New York and Underbelly in Houston.
But the company perhaps isn’t having quite as much success when it comes to dealing with the Food and Drug Administration, thanks to the high-tech ingredient that makes its product so meat-like. Impossible Foods has asked the FDA to declare its product safe to eat, but the agency has expressed some reservations about the ingredient, soy leghemoglobin, according to the New York Times.
Soy leghemoglobin gives the Impossible Burger its meaty taste and texture and is also responsible for making the burger “bleed” like a real meat patty. Though the substance is found in nature — it comes from the roots of soybean plants, the Times notes — Impossible Foods uses genetically engineered yeast to produce it in a lab setting. But the FDA has refused to declare the substance as safe, noting that soy leghemoglobin hasn’t previously been consumed by humans and saying that the company has not done sufficient testing to determine whether the ingredient could be an allergen.
Not coincidentally, Impossible Foods pushed out a press release this morning — clearly timed to the publication of the Times story — reaffirming the safety of its product, noting that soy leghemoglobin has now been declared safe by two panels of food safety and allergy experts after “extensive testing” and insisting that it “has a very low potential for allergenicity.” Simultaneously, the environmental lobbying group Friends of the Earth put out its own press release which asserts that the Impossible Burger ought to be pulled off shelves “until safety can be established by the FDA.”
Impossible Foods has also directly responded to the Times article calling it “cynical” and “inaccurate,” releasing a statement today that reads in part:
The article fails to detail the extensive safety testing and investigation that the Impossible Burger and its key ingredient, soy leghemoglobin, have undergone. In particular, a panel of food safety experts from three universities has agreed multiple times that the product is safe.
In addition, Impossible Foods provided the reporter with details about a rat feeding study in which rats consumed the equivalent of more than 200 times the amount of heme, in the form of soy leghemoglobin, that the average American consumes daily from ground beef. In addition to daily observations of overall health, growth and behavior, a meticulous examination of every organ found no evidence of any adverse effect from even massive overconsumption of soy leghemoglobin -- yet these results were not mentioned in the article.
It’s important to note that food manufacturers do not have to seek FDA approval for new ingredients; as the Times points out, “Companies can hire consultants to run tests [on new ingredients], and they have no obligation to inform the agency of their findings, a process known as self-affirmation.” This has led some to worry that the FDA is too lax when it comes to policing food additives — though the agency could force Impossible Foods to yank the Impossible Burger from the market if it truly believed it posed a risk to public health.
Update: This story has been updated to include a statement from Impossible Foods.
• Impossible Burger’s ‘Secret Sauce’ Highlights Challenges of Food Tech [NY Times]
• Impossible Foods Passes Extensive Safety Testing [Press Release]