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.
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By Bob Jacobs
Hanako, a female Asian elephant, lived in a tiny concrete enclosure at Japan's Inokashira Park Zoo for more than 60 years, often in chains, with no stimulation. In the wild, elephants live in herds, with close family ties. Hanako was solitary for the last decade of her life.
Hanako, an Asian elephant kept at Japan's Inokashira Park Zoo; and Kiska, an orca that lives at Marineland Canada. One image depicts Kiska's damaged teeth. Elephants in Japan (left image), Ontario Captive Animal Watch (right image), CC BY-ND
Affecting Health and Altering Behavior<p>It is easy to observe the overall health and psychological consequences of life in captivity for these animals. Many captive elephants suffer from arthritis, obesity or skin problems. Both <a href="https://doi.org/10.11609/JoTT.o2620.1826-36" target="_blank">elephants</a> and orcas often have severe dental problems. Captive orcas are plagued by <a href="https://doi.org/10.1016/j.jveb.2019.05.005" target="_blank">pneumonia, kidney disease, gastrointestinal illnesses and infections</a>.</p><p>Many animals <a href="https://doi.org/10.1016/j.neubiorev.2017.09.010" target="_blank">try to cope</a> with captivity by adopting abnormal behaviors. Some develop "<a href="https://doi.org/10.1016/j.applanim.2017.05.003" target="_blank" rel="noopener noreferrer">stereotypies</a>," which are repetitive, purposeless habits such as constantly bobbing their heads, swaying incessantly or chewing on the bars of their cages. Others, especially big cats, pace their enclosures. Elephants rub or break their tusks.</p>
Changing Brain Structure<p>Neuroscientific research indicates that living in an impoverished, stressful captive environment <a href="https://doi.org/10.1016/j.jveb.2019.05.005" target="_blank" rel="noopener noreferrer">physically damages the brain</a>. These changes have been documented in many <a href="https://doi.org/10.1002/cne.903270108" target="_blank" rel="noopener noreferrer">species</a>, including rodents, rabbits, cats and <a href="https://doi.org/10.1006/nimg.2001.0917" target="_blank" rel="noopener noreferrer">humans</a>.</p><p>Although researchers have directly studied some animal brains, most of what we know comes from observing animal behavior, analyzing stress hormone levels in the blood and applying knowledge gained from a half-century of neuroscience research. Laboratory research also suggests that mammals in a zoo or aquarium have compromised brain function.</p>
This illustration shows differences in the brain's cerebral cortex in animals held in impoverished (captive) and enriched (natural) environments. Impoverishment results in thinning of the cortex, a decreased blood supply, less support for neurons and decreased connectivity among neurons. Arnold B. Scheibel, CC BY-ND<p>Subsisting in confined, barren quarters that lack intellectual stimulation or appropriate social contact seems to <a href="https://doi.org/10.1590/S0001-37652001000200006" target="_blank" rel="noopener noreferrer">thin the cerebral cortex</a> – the part of the brain involved in voluntary movement and higher cognitive function, including memory, planning and decision-making.</p><p>There are other consequences. Capillaries shrink, depriving the brain of the oxygen-rich blood it needs to survive. Neurons become smaller, and their dendrites – the branches that form connections with other neurons – become less complex, impairing communication within the brain. As a result, the cortical neurons in captive animals <a href="https://doi.org/10.1002/cne.901230110" target="_blank">process information less efficiently</a> than those living in <a href="https://doi.org/10.1002/dev.420020208" target="_blank">enriched, more natural environments</a>.</p>
An actual cortical neuron in a wild African elephant living in its natural habitat compared with a hypothesized cortical neuron from a captive elephant. Bob Jacobs, CC BY-ND<p>Brain health is also affected by living in small quarters that <a href="https://doi.org/10.3233/BPL-160040" target="_blank">don't allow for needed exercise</a>. Physical activity increases the flow of blood to the brain, which requires large amounts of oxygen. Exercise increases the production of new connections and <a href="http://dx.doi.org/10.1126/science.aaw2622" target="_blank">enhances cognitive abilities</a>.</p><p>In their native habits these animals must move to survive, covering great distances to forage or find a mate. Elephants typically travel anywhere from <a href="https://www.elephantsforafrica.org/elephant-facts/#:%7E:text=How%20far%20do%20elephants%20walk,km%20on%20a%20daily%20basis." target="_blank">15 to 120 miles per day</a>. In a zoo, they average <a href="https://doi.org/10.1371/journal.pone.0150331" target="_blank" rel="noopener noreferrer">three miles daily</a>, often walking back and forth in small enclosures. One free orca studied in Canada swam <a href="https://doi.org/10.1007/s00300-010-0958-x" target="_blank" rel="noopener noreferrer">up to 156 miles a day</a>; meanwhile, an average orca tank is about 10,000 times smaller than its <a href="https://www.cascadiaresearch.org/projects/killer-whales/using-dtags-study-acoustics-and-behavior-southern" target="_blank" rel="noopener noreferrer">natural home range</a>.</p>
Disrupting Brain Chemistry and Killing Cells<p>Living in enclosures that restrict or prevent normal behavior creates chronic frustration and boredom. In the wild, an animal's stress-response system helps it escape from danger. But captivity traps animals with <a href="https://doi.org/10.1073/pnas.1215502109" target="_blank">almost no control</a> over their environment.</p><p>These situations foster <a href="https://doi.org/10.1037/rev0000033" target="_blank">learned helplessness</a>, negatively impacting the <a href="https://doi.org/10.1155/2016/6391686" target="_blank" rel="noopener noreferrer">hippocampus</a>, which handles memory functions, and the <a href="https://doi.org/10.1016/j.neuropharm.2011.02.024" target="_blank" rel="noopener noreferrer">amygdala</a>, which processes emotions. Prolonged stress <a href="https://doi.org/10.3109/10253899609001092" target="_blank" rel="noopener noreferrer">elevates stress hormones</a> and <a href="https://doi.org/10.1523/JNEUROSCI.10-09-02897.1990" target="_blank" rel="noopener noreferrer">damages or even kills neurons</a> in both brain regions. It also disrupts the <a href="https://doi.org/10.1016/j.neubiorev.2005.03.021" target="_blank" rel="noopener noreferrer">delicate balance of serotonin</a>, a neurotransmitter that stabilizes mood, among other functions.</p><p>In humans, <a href="https://doi.org/10.1006/nimg.2001.0917" target="_blank" rel="noopener noreferrer">deprivation</a> can trigger <a href="https://doi.org/10.3389/fnins.2018.00367" target="_blank" rel="noopener noreferrer">psychiatric issues</a>, including depression, anxiety, <a href="https://doi.org/10.3389/fnins.2018.00367" target="_blank" rel="noopener noreferrer">mood disorders</a> or <a href="https://doi.org/10.1177/1073858409333072" target="_blank" rel="noopener noreferrer">post-traumatic stress disorder</a>. <a href="https://doi.org/10.1007/s00429-010-0288-3" target="_blank" rel="noopener noreferrer">Elephants</a>, <a href="https://doi.org/10.1371/journal.pbio.0050139" target="_blank" rel="noopener noreferrer">orcas</a> and other animals with large brains are likely to react in similar ways to life in a severely stressful environment.</p>
Damaged Wiring<p>Captivity can damage the brain's complex circuitry, including the basal ganglia. This group of neurons communicates with the cerebral cortex along two networks: a direct pathway that enhances movement and behavior, and an indirect pathway that inhibits them.</p><p>The repetitive, <a href="http://dx.doi.org/10.1016/j.bbr.2014.05.057" target="_blank">stereotypic behaviors</a> that many animals adopt in captivity are caused by an imbalance of two neurotransmitters, dopamine and <a href="https://doi.org/10.1016/j.neubiorev.2010.02.004" target="_blank" rel="noopener noreferrer">serotonin</a>. This impairs the indirect pathway's ability to modulate movement, a condition documented in species from chickens, cows, sheep and horses to primates and big cats.</p>
The cerebral cortex, hippocampus and amygdala are physically altered by captivity, along with brain circuitry that involves the basal ganglia. Bob Jacobs, CC BY-ND<p>Evolution has constructed animal brains to be exquisitely responsive to their environment. Those reactions can affect neural function by <a href="https://www.penguinrandomhouse.com/books/311787/behave-by-robert-m-sapolsky/" target="_blank">turning different genes on or off</a>. Living in inappropriate or abusive circumstance alters biochemical processes: It disrupts the synthesis of proteins that build connections between brain cells and the neurotransmitters that facilitate communication among them.</p><p>There is strong evidence that <a href="https://doi.org/10.1523/JNEUROSCI.0577-11.2011" target="_blank">enrichment</a>, social contact and appropriate space in more natural habitats are <a href="https://doi.org/10.1111/j.1748-1090.2003.tb02071.x" target="_blank" rel="noopener noreferrer">necessary</a> for long-lived animals with large brains such as <a href="https://doi.org/10.1371/journal.pone.0152490" target="_blank" rel="noopener noreferrer">elephants</a> and <a href="https://doi.org/10.1080/13880292.2017.1309858" target="_blank" rel="noopener noreferrer">cetaceans</a>. Better conditions <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5543669/" target="_blank" rel="noopener noreferrer">reduce disturbing sterotypical behaviors</a>, improve connections in the brain, and <a href="https://doi.org/10.1038/cdd.2009.193" target="_blank" rel="noopener noreferrer">trigger neurochemical changes</a> that enhance learning and memory.</p>