Frankenfoods v2: Exploiting the Bioequivalence Principle

Powerful forces are trying to shift our food system away from the soil-based farming systems and towards genetically engineered, lab-grown food. We can’t let them succeed.

THE TOPLINE

• Bored Cow, a cow and animal free whey-containing, cultured milk, is one of a growing number of foods being produced through synthetic biology and ‘precision fermentation’—the health risks of which are largely unknown.
• We’re told products like Bored Cow are fine—even desirable—because they’re biologically the same as their natural counterparts without the toll on the environment purportedly caused by livestock and dairy farming.
• Yet the evidence indicates that these products are far from biologically equivalent, but regulators don’t seem to care.

Got Milk GE-yeast-fermented-whey-protein drink?

You may have heard about the new “animal-free dairy milk” called Bored Cow. It’s being billed as a more animal and environmentally friendly option to traditional milk that comes from a ruminant’s udders. It all sounds great until you dig a bit deeper to learn that it is produced using synthetic biology (synbio), using genetically engineered (GE) yeast that is then put into a so-called ‘precision fermentation’ system. While the whey protein in it is the same as that found in cow’s milk, that’s only a small part of the overall story. Emerging data from some scientists, like John Fagan from the Health Research Institute (HRI), says the fermentation isn’t as precise as claimed, and there’s a lot of other compounds in the milk, some of which have never been recorded by science before. That might mean that drinking Bored Cow ‘milk’ on a daily basis could have unknown and potentially dangerous human health implications. This might just be one product, but it matters because powerful special interests are working to make synbio the tech platform of our food system moving forward—where farms are replaced with fermentation tanks—in the name of protecting the environment.

What’s happening here is an effort to get consumers to believe they can enjoy all the flavor, mouth feel, and nutrition of real cow’s milk…without the involvement of any cows (hence the “Bored Cow” name). Bored Cow is made with whey protein produced through a process called “precision fermentation,” a form of synbio. This involves taking a gene for whey protein and inserting it into a GE yeast. The yeast is put into fermentation tanks with other nutrients to help it grow. At the end the GE yeast is supposed to be filtered out, leaving only the milk protein. Bored Cow takes this protein and adds vitamins, minerals, and other ingredients to mimic the taste, consistency, and nutritional content of real cow’s milk.

Far from ‘bioequivalent’

The marketing hype behind Bored Cow starts falling apart when you learn that it’s not even close to being equivalent to real milk from pasture. HRI’s independent testing found 92 unknown compounds in this synbio milk. Fagan, HRI’s chief scientist, said these compounds are “completely novel to our food…They are nutritional dark matter.”

The FDA must be on top of this, right? Wrong. Bored Cow has not undergone safety testing at the FDA. Perfect Day, the manufacturer of the synbio whey protein, determined it was “generally recognized as safe” (GRAS) and voluntarily notified the FDA of this determination; in response the FDA said it had no questions. Given how rife the GRAS process is with conflicts of interest, this is akin to taking the company’s word for it that its novel synbio whey protein is safe.

Nor is it very likely that Bored Cow is nutritionally equivalent to real milk. Just as meat is more than just protein, milk is far more than a simple combination of whey and various vitamins and minerals. Milkfat contains 400 different fatty acids. Milk has two types of proteins, whey and casein—and there are several different types of these two proteins contained in milk, and a whole bundle of other compounds like lactoferrin and bioactive peptides that help prime the immune system.

Does synbio milk have this nutritional complexity? It doesn’t seem like it, as casein, to use just one example, which comprises 80 percent of the protein in cow’s milk, isn’t listed as an ingredient. Further, according to HRI’s tests, the amino acid composition of Bored Cow is “strikingly different” than that of milk.

Laws not fit to purpose

Bored Cow is representative of a whole new generation of GE foods that are in development, some of which we’ve written about previously. Older genetically modified (GM) foods were created by modifying the genome of a living plant by inserting, for example, an herbicide-resistance trait. That was nothing compared to what’s going on now. GE yeast or fungi are being used as little factories to manufacture food components that regulators say are biologically equivalent to their natural counterparts, so, they say, no additional testing is required because the foods have been shown to be safe through their long history of consumption. But, as we’ve seen, getting a yeast to make one protein found in milk, fermenting it, then adding nutrients, and slapping “milk” on the label doesn’t make it milk. Nor, for that matter, is lab-grown meat biologically equivalent to pasture-raised meat.

And herein lies the problem. The entire framework for dealing with genetically engineered foods in the US is fundamentally broken. That’s because the federal government decided decades ago that the final product is all that matters, not the process used to create that product. This was codified in the 1986 Coordinated Framework for the Regulation of Biotechnology, which was updated in 1992 and again in 2017. Astoundingly, it wasn’t updated to install more robust safety measures to protect Americans from new and previously unthinkable forms of food. It was updated in large part to remove or mitigate “unnecessary costs and burdens” that “limit the ability of technology developers” to “navigate the regulatory process” which also “hamper economic growth, innovation, and competitiveness.” That is, the Framework was updated to make it easier for the biotech industry to ger their frankenfoods onto our dinner plates!

We’re worried that what’s coming are further “updates” to this framework that allow GE foods and those developed using synbio technologies to be considered “bioequivalent” to their natural counterparts—in essence, drinking the lab-grown food industry’s Kool-Aid. If regulators determine that synbio milk is equivalent to real milk, will consumers be allowed to make their own choices, or will we be sold out as we were with the sham GMO labeling law that allowed companies to hide the GM contents of their food in scannable codes?

Some countries are already moving in that direction: Costa Rica just adopted new regulations which treat a wide-range of gene edited products as equivalent to conventionally-bred products. This is something we have to keep a keen eye on.

The advent of lab-grown meat, plant-based meat, and products like Bored Cow show how inadequate our current laws are in dealing with these foods. Of course it matters how these foods are made! CRISPR, the gene-editing technology, is known to produce unintended outcomes. What evidence is there that eating food grown in laboratories from genetically modified yeast—food that is significantly different than the food we have evolved to eat over human history—is safe, much less healthy?

Put simply, the fake meat and milk synbio manufacturers are exploiting old rules never intended for synbio products so they can escape doing any safety testing before their products hit the market. They’re using all-too-familiar revolving doors with the FDA to get their way, and they want to deceive us into thinking they’re saving the planet from those nasty, carbon dioxide-producing animals while offering us foods that are as safe and healthy as those produced on real farms with the help of real animals—without any of it.

We’re watching these developments closely, and we’ll alert you as soon as we see an opportunity to take political action on this critical issue. In the meantime, please share this article widely, as we need a lot more awareness of how synbio makers are using the principle of ‘bioequivalence’ to get their questionable foods into our mouths.