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Food technology company Perfect Day claims its synthetic whey protein “ProFerm” contains “animal-free dairy proteins” that are “identical to those found in cow’s milk” and have “a smaller environmental footprint than conventional whey protein isolate.”
However, those claims are false and misleading, according to a lawsuit brought by the Organic Consumers Association and GMO/Toxin Free USA in the Superior Court of the District of Columbia Civil Division.
The nonprofits sued Perfect Day on behalf of themselves and the general D.C. public, alleging that Perfect Day’s “false, unfair, and deceptive marketing” of ProFerm violates the District of Columbia Consumer Protection Procedures Act (CPPA).
The CPPA is the district’s general consumer protection law, according to the Office of the Attorney General for the District of Columbia.
Alexis Baden-Mayer, political director for the Organic Consumers Association, said:
“Perfect Day markets the ‘milk’ as ‘identical’ to cow’s milk. That’s what we’re going after them for. That kind of false advertising is illegal, and it’s something we can take direct legal action against.”
GMO/Toxin Free USA’s Founder and Executive Director Diana Reeves called ProFerm a “nutritionally-devoid substance composed primarily of fungal proteins never before consumed by humans.”
Perfect Day uses genetically modified “microflora” to produce the synthetic milk protein. Its website states:
“Our animal-free milk from flora is the first of its kind, using whey protein made by microflora, not cows, to make dairy that’s identical to traditional milk. Yes, we said identical.”
Reeves said she finds it “deeply concerning” that this “potentially harmful food-like product could be labeled cow’s whey or be advertised as ‘identical to traditional milk.’”
The plaintiffs are demanding a jury trial. The suit seeks declaratory relief and an injunction to halt the deceptive marketing of ProFerm in the district.
Lawsuit highlights shortcomings of FDA’s ‘GRAS’ process
According to the complaint, ProFerm is a “synbio” dairy product.
“Synbio” — short for “synthetic biology” — technology uses genetic engineering to modify microorganisms like yeast, algae or bacteria to produce novel products, according to the Non-GMO Project.
The Non-GMO Project said, “The biotechnology industry is marketing this method as ‘precision fermentation’ because it exploits a natural process … but it’s actually a form of genetic engineering.”
Meanwhile, Perfect Day claims that ProFerm does not contain GMOs or genetically modified organisms. The company avoids describing its production process as involving “GMOs.” The company’s website explains “how we teach microflora to create sustainable protein.”
However, the complaint explains how Perfect Day’s process involves GMOs:
“Perfect Day takes the natural gene for cow whey protein, beta-lactoglobulin (‘ß-lactoglobulin’), genetically modifies it, inserts the genetically modified gene into the genome of a fungus cell, and uses an industrial fermentation process to propagate large amounts of the fungal cells containing the modified whey gene.”
The company adds chemicals to the resulting substance and then dehydrates and packages it.
Although the U.S. Food and Drug Administration (FDA) has not thoroughly studied ProFerm, it has allowed Perfect Day to market the product to consumers for the last five years.
Under federal law, food additives are subject to premarket review and approval by the FDA — unless the substance is considered, by the food manufacturer, to be “generally recognized as safe” (GRAS).
Under current FDA rules, companies like Perfect Day can self-affirm that new food additives are GRAS.
After Perfect Day told the FDA that the substance used in ProFerm was GRAS, the FDA on March 25, 2020, sent Perfect Day a “no-questions” letter that classified ProFerm as GRAS.
“Allowing this aberration into our food supply without safety testing and classifying it as GRAS (generally recognized as safe) highlights the urgent need to reevaluate our regulatory framework for food,” Reeves said.
On March 10, Health and Human Services Secretary Robert F. Kennedy Jr. directed the FDA to take steps to eliminate the GRAS loophole that allows companies to self-affirm that their ingredients are safe.
If the FDA changes its GRAS rules, the changes won’t affect the lawsuit because the case is about the company’s misrepresentation to consumers, not to the FDA, according to P. Renée Wicklund, co-founder of Richman Law & Policy, which represents the plaintiffs.
“But there is a connection,” Wicklund said, adding:
“This lawsuit highlights the woeful shortcomings of the current GRAS process. Manufacturers are more or less self-certifying, telling the FDA that they’ve looked at their own products and believe them to be safe.
“And the FDA is sitting on the sidelines while those products move into the marketplace. In this case, the creator of Perfect Day has even touted its GRAS status to consumers as if it represented true safety testing.”
Products containing ProFerm sold in ‘thousands of stores’
Perfect Day partners with other companies or licenses ProFerm to companies that use the synthetic whey protein in their own brands, the complaint states.
“We’re in thousands of stores across the world,” Perfect Day states on its website.
According to the website, the company’s partners include Bored Cow, Nestlé, Mars, Myprotein, Coolhaus, Renewal Mill, Brave Robot, Juiceland, Nick’s and Strive Nutrition.
Products containing ProFerm include ice cream, protein powder, cream cheese, non-dairy milk, baked goods, snacks and more, according to the complaint.
On X, Perfect Day calls ProFerm a “highly functional whey protein that makes your dairy products more sustainable & just as delicious.”
ProFerm™ Premium Protein. Dairy done better.
ProFerm™ is a highly functional whey protein that makes your dairy products more sustainable & just as delicious. It’s dairy done better for products that are better – for you, your customers & the planet.https://t.co/wT5JX3X0h2 pic.twitter.com/0szq3izU0N
— Perfect Day | Animal-free Dairy (@PerfectDayFoods) June 14, 2023
However, the plaintiffs allege that Perfect Day hasn’t proven its product is safe for humans or the environment.
According to the complaint:
“Perfect Day markets ProFerm as safe, environmentally friendly, identical to cow-derived whey protein, capable of creating milk identical to cow’s milk — including its nutritional profile — and as free from genetically modified organisms (‘GMOs’).
“The reality is markedly different. ProFerm is synthetic, composed primarily of fungal proteins not found in cow’s milk, and includes fungal waste byproducts from the fermentation process.
“ProFerm is used to produce a beverage with amino acid sequences that differ significantly from those in cow’s milk and contains only a fraction of cow’s milk’s nutritional value. Many of the fungal proteins and compounds have not been adequately studied for human consumption, and ProFerm’s production process itself may pose environmental risks.”
The complaint cites testing results by the Health Research Institute (HRI).
HRI, a nonprofit independent lab based in Fairfield, Iowa, examined multiple samples of Bored Cow’s “original” flavor milk, which uses Perfect Day’s ProFerm, using mass spectrometry to test the claim that the synthetic protein it contained was the same as real milk protein.
A press release about the lawsuit cited several of HRI’s findings that show Perfect Day’s claim that ProFerm is “identical to traditional milk” is false and misleading, including:
- ProFerm is only 13.4% cow’s whey protein.
- 86.6% of ProFerm proteins are fungal proteins.
- ProFerm contained 93 fungal compounds not found in cow’s whey.
- The fungal proteins and compounds are unknown to science, have never been part of the human diet, and are by-products of the GMOs used in the fermentation process.
- “Milk” produced with ProFerm contains a fraction of the nutritional value of cow’s milk, missing 69 nutrients and containing no omega 3, fatty acids, or vitamins B2, B5, and E.
Commenting on his lab’s findings, HRI’s chief scientist and CEO, John Fagan, Ph.D., told The Defender in an earlier interview, “There were 69 important nutrients present in natural milk, most of which were completely absent in synbio milk. A few were present in small or trace amounts.”
Fagan is a molecular biologist and former cancer researcher at the National Institutes of Health. He is a global pioneer in GMO testing.
Bored Cow’s milk contained only a trace of riboflavin, known as vitamin B2, while natural milk has very high levels, Fagan said. Pantothenic acid, known as vitamin B5, was “absolutely absent in the synbio milk.”
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Similarly, vitamin E was “essentially absent yet present in substantial levels in natural milk,” he said.
Additionally, forms of carnitine that are “really important for energy metabolism” were either missing or only present in trace amounts in the synbio product, he said.
The synthetic milk had “only a tiny trace of the important omega-3 fatty acid alpha-linolenic acid.
Alpha-linolenic acid is “the most abundant omega-3 fatty acid in plants.” Natural milk from grass-fed cows typically has “significant levels” of it, Fagan explained.
Fagan said, “a number of other lipids or fats — diglycerides and mono- and triglycerides — were undetectable in the synbio milk.”
Meanwhile, Fagan said he found it concerning that the Bored Cow samples contained a pesticide — a fungicide called Benthiavalicarb-isopropyl.
“I think the reason this fungicide is present is because they added it to the fermentation process to inhibit the growth of fungi that could contaminate the production system,” he said. “So the things that we see here are not really good for us, let me put it that way.”
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