Quantcast
GMO
Impossible Foods

FDA Questions Safety of Impossible Burger's Key GMO Ingredient

The U.S. Food and Drug Administration (FDA) told the manufacturer of the meat-like Impossible Burger that the company hadn't demonstrated the safety of the product's key genetically engineered ingredient, according to internal FDA documents. Despite FDA's concerns, Impossible Foods put its GMO-derived burger on the market for public consumption.


GMO Ingredient Gives Product Meat-Like Taste and Red Blood-Like Color

The Impossible Burger is made using a genetically engineered form of a protein called soy leghemoglobin (SLH) or "heme" that is found in the root nodules of soybean plants. Impossible Foods adds a SLH gene to a yeast strain, which is then grown in vats using a fermentation process. The SLH or heme is then isolated from the yeast and added to the Impossible Burger. Heme gives the Impossible Burger its meat-like taste and red blood-like color.

Impossible Foods claims its product "uses about 75 percent less water, generates about 87 percent fewer greenhouse gases and requires around 95 percent less land than conventional ground beef from cows. It's produced without hormones, antibiotics, cholesterol or artificial flavors."

The GMO-derived Impossible Burger is sold in 43 restaurants nationwide, including several burger chains, and Impossible Foods has attracted significant funding from investors such as Bill Gates.

FDA: Arguments "Do Not Establish Safety of SLH for Consumption"

According to documents obtained by ETC Group and Friends of the Earth U.S. through the Freedom of Information Act (FOIA), Impossible Foods submitted an application to seek GRAS (generally recognized as safe) status for SLH from the FDA in 2014. The FDA's 1997 GRAS notification policy allows a manufacturer, like Impossible Foods, to decide for itself, without FDA input, whether or not a product is safe.

But the FDA warned Impossible Foods that SLH would not meet the basic GRAS status. 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."

According to Michael Hansen, senior scientist at Consumers Union, Impossible Foods claimed that the engineered SLH/heme was identical to the SLH that has been in the food supply but the company had no safety testing data to back that claim.

"You are taking something that has never been in the food supply before and you come to the FDA, say it is GRAS, and you have no safety data, particularly from feeding studies," Hansen said. "Their argument has literally come down to saying this is exactly identical to the heme we've always been eating, but it's not true."

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.

"It's only 73 percent pure, the other 27 percent is from proteins from the genetically engineered yeast that produces it, and these have an unknown function," Hansen said.

According to the FOIA documents, Impossible Foods withdrew its GRAS application in November of 2015.

Despite the FDA's warnings, Impossible Foods went ahead and started selling the Impossible Burger in 2016.

"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."

David Bronner: "Totally Unethical to Market and Feed an Untested Protein"

A recent New York Times article by Stephanie Strom brought the controversy over the Impossible Burger to light.

In response to the article, Impossible Foods issued a press release attesting to the safety of its product. The company said that "a panel of food safety and allergy experts at three universities unanimously reaffirmed last week that soy leghemoglobin is generally recognized as safe."

Impossible Foods also said it will voluntarily provide the results of a study feeding rats SLH and "additional data to the U.S. Food and Drug Administration."

Yet, Impossible Foods is submitting feeding study results to the FDA after the product has been on the market for a year.

"It's very troubling that Impossible Foods has put this product on the market and, more than one year later, still has not submitted requested safety data, including a rat feeding study, to FDA," Hansen said.

David Bronner, president of Dr. Bronner's Magic Soaps and plant-based foods advocate, had earlier expressed support for the Impossible Burger as a solution to environmental problems caused by industrial meat production. But the recent revelations have changed Bronner's opinion.

"While there is great potential good that the Impossible Burger could do, it's totally unethical to market and feed an untested protein to people and claim that it is identical to what we already eat," he said.

Major Loopholes in FDA Food Safety Regulations

The fact that companies like Impossible Foods can request GRAS status, then withdraw the application when the FDA raises concerns, and yet still put a product on the market shows major loopholes in FDA food safety regulations, according to Hansen.

"The GRAS process is so broken. It's perfectly legal for a company to say whatever compound they want to use is determined to be safe, and then put it in the food supply, and not even tell the FDA."

Another major loophole is that, while FDA conducts reviews of genetically engineered plants and animals, the agency doesn't review products made using genetically engineered microorganisms like the Impossible Burger's heme.

"The FDA doesn't even request safety data," Hansen said.

Hansen believes the GMO heme should be regulated as a color additive because Impossible Foods promotes heme's ability to give the burger a blood-red color like meat. The FDA requires safety assessments of color additives.

"If it affects color and marketability, it meets the definition of a color additive and should be regulated as such," he said.

Show Comments ()

EcoWatch Daily Newsletter

Sponsored
Health
"From 1992 to 2016, heat killed 783 workers in the U.S. and seriously injured nearly 70,000, according to a new report on heat risks." InsideClimateNews / USDA

Protect Workers From Extreme Heat, Advocates Urge OSHA

A broad coalition of worker advocacy, public health and environmental groups on Tuesday called on the federal Occupational Safety and Health Administration (OSHA) to create a workplace standard for heat stress.

Keep reading... Show less
Animals
Emilie Chen / Flickr / CC BY-ND 2.0

Against All Odds, Mountain Gorilla Numbers Are on the Rise

By Jason Bittel

The news coming out of East Africa's Virunga Mountains these days would have made the late (and legendary) conservationist Dian Fossey very happy. According to the most recent census, the mountain gorillas introduced to the world in Gorillas in the Mist, Fossey's book and the film about her work, have grown their ranks from 480 animals in 2010 to 604 as of June 2016. Add another couple hundred apes living in scattered habitats to the south, and their population as a whole totals more than 1,000. Believe it or not, this makes the mountain gorilla subspecies the only great apes known to be increasing in number.

Keep reading... Show less
Health
San Cristóbal de las Casas, in the Mexican state of Chiapas. Tjeerd Wiersma from Amsterdam, The Netherlands / CC BY 2.0

How Coca-Cola and Climate Change Created a Public Health Crisis in a Mexican Town

A lack of drinking water and a surplus of Coca-Cola are causing a public health crisis in the Mexican town of San Cristóbal de las Casas, The New York Times reported Saturday.

Some neighborhoods in the town only get running water a few times a week, so residents turn to soda, drinking more than half a gallon a day on average.

Keep reading... Show less
Animals
Plastic trash isn't safe for kids, whether human or bear. Kevin Morgans Wildlife Photography

Even Polar Bear Cubs Can’t Escape Plastic Pollution

By Allison Guy

Plastic bags are often stamped with an all-caps warning: This bag is not a toy. Unfortunately, polar bear moms don't have much control over their kids' playthings.

Keep reading... Show less
Sponsored
Insights
Sea level rise is a natural consequence of the warming of our planet. NASA Goddard Space Flight Center

We Can’t Hide From Global Warming’s Consequences

Over the past few months, heat records have broken worldwide.

In early July, the temperature in Ouargla, Algeria, reached 51.3°C (124.34°F), the highest ever recorded in Africa! Temperatures in the eastern and southwestern U.S. and southeastern Canada have also hit record highs. In Montreal, people sweltered under temperatures of 36.6°C (97.88°F), the highest ever recorded there, as well as record-breaking extreme midnight heat and humidity, an unpleasant experience shared by people in Ottawa. Dozens of people have died from heat-related causes in Quebec alone.

Keep reading... Show less
Health
Stacey_newman / Getty Images

More Than a Third of Schools Tested Have ‘Elevated Levels’ of Lead in Drinking Water

A troubling new report by the U.S. Government Accountability Office (GAO) found that more than a third of the nation's schools that tested their water for lead found "elevated levels" of the neurotoxin. But despite heightened concern in recent years about lead in drinking water, more than 40 percent of schools surveyed conducted no lead testing in 2016.

Keep reading... Show less
Sponsored
Popular
Bill Pugliano / Stringer / Getty Images

Can Elon Musk Fix Flint’s Water?

By Fiona E. McNeill

The Michigan community of Flint has become a byword for lead poisoning. Elon Musk recently entered the fray. He tweeted a promise to pay to fix the water in any house in Flint that had water contamination above acceptable levels set by the U.S. Food and Drug Administration.

Keep reading... Show less
Popular
A researcher at Oregon State University examines creeping bentgrass. Oregon State University / Flickr / Tiffany Woods

You Need to Be Paying Attention to GMO Grass

By Dan Nosowitz

Creeping bentgrass doesn't get as much attention as other genetically modified plants. But this plant tells us an awful lot—emphasis on the "awful"—about how GMO plants are regulated and monitored.

Keep reading... Show less
Sponsored

mail-copy

The best of EcoWatch, right in your inbox. Sign up for our email newsletter!