WASHINGTON, D.C. – Creators of a fake-meat burger made with a high-profile genetically engineered ingredient may have landed their experimental industry in a sizzling food safety mess, casting doubt on a Silicon Valley foodtech investor bubble.

As reported on in today’s New York Times, recently obtained documents from the U.S. Food and Drug Administration (FDA) reveal that Impossible Foods, maker of the Impossible Burger, the meatless burger that supposedly “bleeds,” was told by FDA officials that it hadn’t provided adequate proof of safety for a genetically engineered protein that gives the burger its meat-like taste and color. Impossible Foods put the genetically engineered product on the market for public consumption even though the company privately admitted to the FDA that it had not conducted or designed safety tests. The FOIA-produced documents state that the “FDA believes that the arguments presented, individually and collectively, do not establish the safety of SLH for consumption, nor do they point to a general recognition of safety.”

“The FDA told Impossible Foods that its burger was not going to meet government safety standards, and the company admitted it didn’t know all of its constituents. Yet it sold it anyway to thousands of unwitting consumers. Responsible food companies don’t treat customers this way,” said Jim Thomas of ETC Group. “Impossible Foods should pull the burgers from the market unless and until safety can be established by the FDA and apologize to those whose safety it may have risked.”

“Under no circumstances should any food company ignore FDA safety warnings and put consumers’ health at risk,” Dana Perls, senior food and technology campaigner at Friends of the Earth. “The FDA must be the authority when it comes to determining food safety, and that means overhauling the broken regulatory process so that companies like Impossible Foods cannot self-regulate and rubber stamp their products as safe.”

The FDA’s safety designation of “generally recognized as safe” (GRAS) allows a manufacturer, like Impossible Foods, to decide for itself, without FDA input, whether or not a product is safe. The self-determination does not require notice to the public or the FDA, and may apply to food chemicals regardless of industry conflicts of interest, or whether the chemicals are new or not widely studied.

U.S. government documents, obtained by ETC Group and Friends of the Earth U.S. through the Freedom of Information Act, reveal that Impossible Foods was warned by FDA officials that its key genetically engineered ingredient, “soy leghemeglobin” (SLH), would not meet the basic FDA GRAS status. SLH, or “heme,” is a bio-engineered protein additive that adds meat-like taste and color. Impossible Foods recognizes that SLH has never been widespread in the human diet in its natural or genetically engineered form. Despite touting the color properties of the engineered “heme,” Impossible Foods did not seek FDA approval as a color additive, which has stricter safety regulations.

In discussion with FDA, Impossible Foods also admitted that up to a quarter of its “heme” ingredient was composed of 46 “unexpected” additional proteins, some of which are unidentified and none of which were assessed for safety in the dossier.

The case of Impossible Burger raises concerns that surpass this one patty and implicates the extreme genetic engineering field of synthetic biology, particularly the new high-tech investor trend of “vat-itarian” foods (meat, dairy, and other animal proteins grown in a biotech vat instead of from an animal). While Impossible Burger is the poster child for this vat-grown approach, other companies such as Perfect Day (synthetic biology cow milk) and Clara Foods (synthetic biology egg whites) appear also to be racing to market. Just as biofuels were pitched as a “clean tech” fix to climate change a decade ago, the vat-itarian venture capitalists are now attempting to capitalize on animal welfare concerns through “molecular farming.”

While the health and environmental damage caused by large-scale industrial livestock production should not be minimized, the success of non-animal burgers like the non-GMO Beyond Burger demonstrates that plant-based animal substitutes can succeed without resorting to genetic engineering.

A 2013 US National Survey by Hart Research found that 61% of respondents felt negative about synthetic biology-produced food additives. Polls also show that consumers increasingly want GMOs to be labeled as such, but so far, most companies selling products with synthetic biology ingredients, including Impossible Foods, are not labeling on the products or menus.

Friends of the Earth and ETC Group reached out last week to Impossible Foods, inviting the company to a discussion on the safety of the Impossible Burger.

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Impossible Burger FOIA documents are available here.

For further information and analysis see ETC Group’s on-line searchable database of synthetic biology derived ingredients, including Impossible Food’s “heme”.

See Friends of the Earth’s blog on synthetic biology animal replacement products “Is ‘Food-Tech’ the Future of Food?” and website for additional information on synthetic biology’s risks to our health and environment.