By Rachel Konrad, Chief Communications Officer, Impossible Foods
Update: On May 3, 2021, the US Court of Appeals for the Ninth Circuit upheld the FDA’s decision to approve soy leghemoglobin (“heme”) as a color additive(opens in a new tab), and denied the Center for Food Safety’s petition to overturn that decision. The court determined that the FDA “applied the correct standard for evaluating the safety of soy leghemoglobin as a color additive” and that “substantial evidence” supports the FDA’s decision to approve it. One judge argued separately that the petition should have been dismissed earlier on the basis that “the Center for Food Safety lacks constitutional standing.”
We applaud the court's decision to recognize and uphold the FDA’s assessment of the abundant evidence supporting the safety of our product and to deny the meritless petition of the Center for Food Safety.
Monday, February 8th, 2021
The Center for Food Safety (CFS), an anti-genetic engineering pressure group, has been spreading lies about Impossible Foods in a years-long disinformation campaign. As part of the organization’s ongoing lawsuit against the US Food and Drug Administration, CFS filed a legal brief Jan. 28, 2021, alleging that Impossible Foods’ products are not safe and not backed up by scientific research.
The claims are patently false; in fact, Impossible products are among the most rigorously tested and safety-verified in the history of the US FDA -- supported by publicly accessible, peer-reviewed scientific data, expert testimony and further validated by regulatory authorities globally.
The FDA has determined multiple times that the Impossible Burger’s key ingredient is safe to eat. Impossible Foods’ products have undergone rigorous safety testing and meet or exceed all relevant federal requirements. We’ve gone far above and beyond all regulatory requirements:
Impossible Foods has worked closely with the FDA, the nation’s food-safety guardian, and has shared both extensive test data and commercial plans with the government body, the world’s gold standard for food safety and security.
The FDA is fully aware of Impossible Foods’ growth, both in the United States and worldwide.
Impossible Foods also engages with federal food-safety agencies everywhere we sell or intend to sell products. (In addition to the US FDA, the national food-safety agencies in Singapore, Canada, Australia and New Zealand have independently confirmed the safety of soy leghemoglobin during their regulatory review processes.)
Impossible Foods meets or exceeds all food-safety regulations and is entirely legal everywhere we sell the product.
Soy leghemoglobin: Thoroughly scrutinized, vetted and validated
Soy leghemoglobin is the special ingredient that makes the Impossible Burger uniquely meaty and craveable. In fact, Soy leghemoglobin(opens in a new tab) is one of the most highly publicized and thoroughly scrutinized ingredients in modern history, and the FDA, food safety experts, and the public have been able to read and analyze extensive safety testing and other data in full transparency.
As far back as 2014 (well before Impossible Burger’s commercial debut in 2016), a panel of America’s top food-safety experts reviewed extensive test data and unanimously concluded that soy leghemoglobin is “generally recognized as safe” (GRAS). In December 2017, the FDA published Impossible Foods’ extensive test data online(opens in a new tab) so that scientists and the public could fully scrutinize and understand soy leghemoglobin.
In July 2018, after this thorough, time-consuming, independent and public review, the FDA itself stated that it had no remaining questions about our key ingredient’s safety.(opens in a new tab) In July 2019, the FDA further authorized(opens in a new tab) soy leghemoglobin as a color additive after the government again scrutinized the extensive safety data. (Federal regulations require color additive approval on all ingredients, with limited exceptions, used to impart color to food — from synthetic substances to fruit extracts.)
In addition to the recognition of safety by the FDA, the respected academic publication International Journal of Toxicology published this peer-reviewed study on safety of soy leghemoglobin(opens in a new tab). Another respected academic publication, Molecular Nutrition and Food Research, published this peer-reviewed study on potential risks of allergy and toxicity of soy leghemoglobin(opens in a new tab).
When we were looking for the heme protein to put into our plant-based meat, we wanted something that was totally safe and sustainable and that would closely mimic all the sensory properties of beef, which gets its characteristic taste, smell and cooking attributes, as well as its highly bioavailable iron, from the heme protein myoglobin. Thousands of different heme proteins are commonly consumed in the human diet; none have ever shown toxicity. We analyzed soy leghemoglobin to determine if it shared any meaningful similarities with known allergens; it does not. We performed numerous tests (including tests on digestion, heat sensitivity and acid sensitivity) to make sure it was safe.
Rigorous test results showed(opens in a new tab) no adverse effects from consumption of our heme protein at levels far in excess of what could ever be consumed by humans eating our product. Our studies established no observed adverse effect at a level of 750 mg/kg/d of soy leghemoglobin, which is more than 100 times greater than the 90th percentile estimated daily intake, if our product were to replace all animal-derived ground beef in the American diet.
Heme is one of the most studied molecules in science. Indeed, in multiple studies published by others, rodents were fed doses of heme that, adjusted for body weight, vastly exceed what any human would or could possibly consume — the equivalent of between 30 and 300 pounds of burgers per day. Even at these enormous doses, heme had no observable harmful effect on any tissue or organ, no overall ill health effects, no cancers, and no reproducible effects that might be related to cancer or any other disease — an extraordinary record of safety.
Heme: The “magic” ingredient that just might save civilization
The destructive impact of animal agriculture on the global environment far exceeds that of any other technology on Earth. The greenhouse gas footprint of animal agriculture rivals that of every car, truck, bus, ship, airplane, and rocketship(opens in a new tab) combined. Animal agriculture pollutes(opens in a new tab) more and consumes more water than any other industry(opens in a new tab).
Raising animals for food makes up the vast majority of the land footprint of humanity. All the buildings, roads and paved surfaces in the world occupy less than one percent of Earth’s land surface(opens in a new tab), while more than 45% of the land surface of Earth(opens in a new tab) is currently in use as land for grazing or growing feed crops for livestock. Animal agriculture is responsible for as much greenhouse gas emissions as every form of powered transportation combined(opens in a new tab).
More worrisome, livestock is the primary driver of the existential threat of biodiversity collapse(opens in a new tab). Since 1970, total populations of mammals, birds, reptiles, amphibians, and fish living on earth today have collapsed by about 70%. Almost single-handedly, livestock’s vast land footprint and the effects of overfishing have diminished the average populations of Earth’s wild animal species to less than a third of their numbers just 50 years ago.
Unless we act quickly to eliminate the use of animals in the food system, we are racing toward ecological disaster. Impossible Foods’ essential mission(opens in a new tab) is to avert an impending global environmental catastrophe by satisfying the global demand for meat, from plants.
Our approach to doing so is market-based: to achieve our mission we need to create products that outperform today’s animal-derived products in delivering pleasure, nutrition and affordability to the world’s consumers. And our heme protein is the “magic” ingredient that makes the Impossible Burger the first true plant-based meat. Heme is what makes meat taste like meat — essential for the flavor and aroma profile that meat-lovers crave. So the ability to produce a heme protein safely and sustainably at scale is critical for the future of our planet.
Mission matters most
Given our mission to halt biodiversity collapse and turn back the clock of climate change(opens in a new tab), we’re not surprised by CFS’ campaign to spread fear about Impossible Foods. The goal of this staunchly anti-GMO organization — a 501c3 litigating and regulatory activist group — is to thwart progress toward a safer, healthier and more sustainable food system and restrict the choices available to farmers and consumers. (CFS regularly floods the FDA(opens in a new tab) with auto-generated appeals for stricter regulation of genetic engineering in its quest to “oppose industrial agriculture and food production technologies.” - conveniently ignoring the fact that today’s animal-based food system is the apotheosis of industrial agriculture)
Bottom line: CFS’ lawsuit against the FDA is a cynical disinformation campaign. Impossible Foods complies with all food-safety laws everywhere it’s sold and works with government bodies that regulate food. There is abundant evidence supporting the safety of soy leghemoglobin and no evidence whatsoever of any health risks from the Impossible Burger — and in particular there is no evidence whatsoever of any health risks from heme.
Quite the contrary: Heme is the molecule that carries oxygen in your blood, and it’s an essential component of the system that burns calories for energy in every cell; without heme, we die. Heme is essential for life on Earth -- and its use by Impossible Foods is our best chance to halt a late-stage biodiversity crisis.