Impossible Foods' Rebuttal to Accusations of Illegal Sales Distorts the Truth
BACKGROUND: On September 3, 2019, Center for Food Safety (CFS) filed legal objections regarding the Food and Drug Administration's (FDA) approval of Impossible Foods' color additive petition for its genetically engineered soy leghemoglobin (also known as GMO "heme"). This is the new coloring additive Impossible Foods uses to make Impossible Burgers appear to "bleed."
Impossible Foods makes this GMO "heme" through a new kind of genetic engineering process called synthetic biology (or "synbio") in which the company takes DNA from the roots of soy plants, where a small amount of "heme" is produced, and inserts it into genetically engineered yeast that is then fermented to mass-produce GMO "heme." This substance has never been consumed before.
CFS objects to the approval of the new color additive petition for GMO "heme" because (1) FDA did not require testing of the raw product or the genetically engineered yeast; (2) FDA's approval will allow GMO "heme" to be used in new cell-based products without additional testing; (3) the product is not properly labeled; and (4) FDA failed to satisfy the "convincing evidence" standard that applies for approval of new color additives. The law states that until FDA responds to our objections, uncooked Impossible Burgers cannot be sold in grocery stores.
Nevertheless, several grocery stores have started selling uncooked Impossible Burgers anyway.
CFS responded by sending a letter to FDA explaining why these sales are unlawful and requesting the agency to take action against grocery stores that are unlawfully selling uncooked Impossible Burgers.
Impossible Foods attacked CFS and unleashed a torrent of falsehoods and misleading statements that cannot go unanswered.
Here are a few things that Impossible Foods got wrong in that rebuttal.
MYTH #1: "CFS' claim that stores are selling the Impossible Burger 'illegally' is an egregious, deliberate, cynical lie."
TRUTH: When CFS objected to FDA's approval of soy leghemoglobin as a color additive, by law that approval is on hold until the agency responds to our objections[i] (see citation in the U.S. Code of Laws for the legal reference).
Nowhere in Impossible Foods' response does it refute the fact that it is unlawful for grocery stores to be selling uncooked Impossible Burgers without a valid color additive regulation. This is quite telling.
MYTH #2: "In 2014, 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)."
TRUTH: What Impossible Foods failed to mention is that the "experts" on the panel were selected by none other than the company itself!
Impossible Foods selected Joseph Borzelleca, Michael Pariza, and Stephen Taylor to review the test data. All three fought for Big Tobacco as members of the Phillip Morris Scientific Advisory Board. All three are now frequently used by the food industry to sit on sketchy ingredient approval panels like these.
Maybe that's why Impossible Foods calls them "top food-safety experts," but we agree with Center for Public Integrity's description of the trio as a "standing panel of industry hired guns."
MYTH #3: "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. Another respected academic publication, Molecular Nutrition and Food Research, published this peer-reviewed study on potential risks of allergy and toxicity of soy leghemoglobin."
TRUTH: Both of the studies Impossible Foods cites were authored by Impossible Foods' employees.
Three of the five authors of the first study work for Impossible Foods. In the second study, one of the authors works for Impossible Foods while another author, who used to work for Monsanto, is currently paid to be a consultant for Impossible Foods.
Other studies that Impossible Foods submitted for FDA review suffer from similar conflicts. One study from 2017 lists the "principal investigator" for the "conduct and reporting of the analysis of the neat test substance and all dietary preparations" as Rachel Fraser, who is employed as the director of research at Impossible Foods.
Considering the financial conflicts-of-interests of those who authored and reviewed these studies, CFS does not consider these to be truly independent peer-reviewed studies.
MYTH #4: "The FDA has acknowledged multiple times that the Impossible Burger's key ingredient is safe to eat…We've gone far above and beyond all regulatory requirements."
TRUTH: FDA has not acknowledged that soy leghemoglobin is safe to eat "multiple times." Impossible Foods chose to go through a legal loophole to get its GMO "heme" served in restaurants. FDA relied on that unreliable, biased data when it responded to Impossible Foods' petition to serve products with GMO "heme" in grocery stores.
The GMO "heme" in Impossible Burgers was first introduced to consumers in restaurants through a fast-track legal loophole that food companies exploit in order to market products with substances that they believe should be "generally recognized as safe" (GRAS). In this flawed process, companies like Impossible Foods get to decide for themselves whether or not a new substance added to our food should be reviewed by FDA or is safe for human consumption.
As you might expect, conflicts of interest run rampant when companies get to decide their own food safety review process, which is why CFS has joined other organizations in suing FDA over this broken GRAS system.
In July 2018, FDA issued a "no questions" letter in response to Impossible Foods' notification to the agency that the company had self-determined that soy leghemoglobin to be GRAS. But FDA specified that this "no questions" letter "is not an affirmation that soy leghemoglobin preparation is GRAS under 21 CFR 170.35." Contrary to Impossible Foods' statement, FDA explicitly stated that this "no questions" letter is not an acknowledgement by the agency of the safety of soy leghemoglobin.
While it is true that FDA approved Impossible Foods' color additive petition for GMO "heme" earlier this year, that is the only time that FDA has affirmatively made a decision on safety regarding this GMO "heme."
The color additive approval process to sell GMO "heme" in grocery stores was further tainted by the fact that FDA — instead of requiring independent testing — just relied on Impossible Foods' previous GRAS filings, which is insufficient to satisfy the "convincing evidence" standard for color additives[ii] (see citation in Code of Federal Regulations for the legal reference).
Impossible Foods claims to care about transparency in its statement, but in relying on the broken GRAS process to get its burgers into restaurants, the company chose the least-transparent review process available. Impossible Foods can't claim that it went "far above and beyond all regulatory requirements" in a "very public review" when it's been relying on GRAS' self-determined approval loophole in which there is no opportunity for public comment or appeals.
MYTH #5: "CFS regularly floods the FDA with auto-generated appeals for stricter regulation of genetic engineering in its quest to 'oppose industrial agriculture and food production technologies.'"
TRUTH: Center for Food Safety submits scientific and legal comments to FDA. Like many consumer advocacy non-profits, we share this information with our members who have voluntarily elected to receive opportunities to submit comments to regulatory agencies or to send emails to companies, at their own discretion, in hopes of building a safer and healthier food system.
Notably, the "its quest" link referred to in Impossible Foods' response takes you to a website called "Left Exposed," which is described as a "free-market think tank" run by The Heartland Institute, a staunch climate change denier and defender of global warming skeptics. One wonders why Impossible Foods — a company that claims that its burgers are "poised to provide a major wedge in the fight against climate change" — is using climate change deniers to attack CFS. It is almost impossible to believe.
[i] See 21 U.S.C. § 379e(d); 21 U.S.C. § 371(e)(2) ("Until final action upon such objections is taken . . . the filing of such objections shall operate to stay the effectiveness of those provisions of the order to which the objections are made.").
[ii] See 21 C.F.R. § 70.3(i)("Safe means that there is convincing evidence that establishes with reasonable certainty that no harm will result from the intended use of the color additive.").