A new wave of genetically engineered “precision fermentation” foods is quietly entering the US market—without GMO labels and without your informed consent. We’re working on a plan to challenge this violation of consumer rights and trust—stay tuned.

THE TOPLINE

• Companies are using genetically engineered microbes to produce egg and dairy proteins, yet current labeling laws and rules don’t require these products to be identified as bioengineered.
• Many precision-fermented ingredients enter the market through the GRAS pathway, allowing companies to self-affirm safety while regulators focus on the final product—not the genetic engineering used to create it.
• Genetic alterations in production microbes can lead to unintended byproducts and novel compounds, raising unanswered questions about allergenicity, contamination, and chronic health effects.

There is a new generation of genetically engineered foods entering the US marketplace—and you won’t see the words “genetically modified”, “GMO”, “bioengineered” or any other term anywhere on the label.

It’s called precision fermentation and there’s a huge marketing machine behind it hailing it as “the Future of Food.” We call it what it is: GMO 2.0.

And thanks to regulatory loopholes, you may never know you’re eating it.

Many think the problem was solved when the US Department of Agriculture (USDA) published a new rule in 2019, that came into effect on January 1, 2022, namely the National Bioengineered Food Disclosure Standard (NBFDS).  The rule requires many food manufacturers (including those making dietary supplements) to disclose when a product is a “bioengineered food” or contains a bioengineered food ingredient.

The Agricultural Marketing Service (AMS) of USDA keeps a list of foods or food ingredients it considers are derived through bioengineering. Currently there’s just 13 plant and a single salmon source on the list. All contain detectable levels of modified genetic material, most often determined using PCR.

Does it surprise you that biotech food producers have found a loophole?

Egg Proteins… Without Chickens

Consider The EVERY Company, a Silicon Valley startup founded in 2014 (originally Clara Foods). It has raised over $200 million to produce “egg proteins… without chickens.”

How?

The company uses genetically engineered yeast—specifically Komagataella phaffii—to express proteins found in eggs through precision fermentation. The yeast are genetically modified to produce egg white proteins in industrial vats. The protein is secreted into fermentation broth, filtered, and purified.

The company has received “no questions” letters from the FDA in response to its self-affirmed GRAS (Generally Recognized as Safe) determinations.

Here’s the catch: because the genetically engineered yeast is supposedly removed during processing, the final protein is not classified as “bioengineered” under US labeling laws.

So on a label, you may simply see “Egg white protein” or “Animal-free egg protein”

What you will not see is “bioengineered,” “genetically engineered,” or “precision fermentation.”

In short, there is no meaningful transparency about how this ingredient is made at point of sale.

There are a host of these products out there. We’ve been reporting about dairy proteins made through precision fermentation that are making their way into milk, ice cream, protein powders, nutrition bars, and sports drinks. Perfect Day, the company behind the synbio milk product Bored Cow, sells its precision fermented whey protein to be used in Brave Robot ice cream. The ingredients simply list “animal-free milk.”  Precision fermentation is entering the meat and seafood sectors as well. European food companies Revo Foods and Paleo, for example, have partnered to develop plant-based salmon “alternative” enriched with precision-fermented myoglobin for “enhanced taste and functionality.”

Precision Fermentation Is Not Traditional Fermentation

Humans have cultured microbes for centuries. We use naturally occurring bacteria to make yogurt. We use yeast to make bread. But precision fermentation is code for the use of gene-edited “synbio” microbes where the genes have been modified to produce a naturally occurring ingredient, whether these are proteins in milk or different animal foods.

If microbes are genetically altered—if their DNA is rewritten so they produce novel proteins that would never naturally occur in that organism—there is a very strong possibility other genes will express proteins that are entirely new to nature. These off-target effects of gene-editing techniques like CRISPR are well known, but not widely communicated to the general public: such is the desire to maintain consumer confidence in the technology and not lose public trust as was the case with GMO foods.

But let’s not lose sight of just how closely the two technologies are related. GMO v1.0 involved genetic modification of whole organisms, while modern bioengineering typically involves the editing of specific sequences in an organism that in turn produces a product that is chemically equivalent to one produced through conventional agriculture. However, if the production organism has been genetically modified, we are actually dealing with a GMO process. Shouldn’t this be something that is communicated transparently to the end consumer even if regulators pretend the final purified protein is “substantially equivalent” to a food component found in nature?

We’ve seen this movie before. It’s the GMO debate from 25 years ago, repackaged and concealed under friendlier language intended to keep consumers in the dark, and avoid producers having to go through the costly process of proving their products are safe. Secretary Kennedy has a remit on “radical transparency”; well in this area of synbio foods, we desperately need more transparency.  

“Substantial Equivalence” — The Old Trick Returns

Regulators focus primarily on the final product, not the method used to create it.

If a synbio milk protein looks chemically similar to a cow’s milk protein, it is treated as comparable under the law. The process that created it—industrial vats of genetically engineered microbes—is not itself the trigger for a separate regulatory category in the US.

This kind of milk conveniently escapes the National Bioengineered Food Disclosure Standard because the whey or casein within the synbio milk is the same as that from a cow. Let’s simply forget about any novel, off-target proteins that might have been generated in the process that contribute to the inflammatory profile of the American people that, in turn, underpins the country’s chronic disease epidemic. 

In Europe, novel foods face centralized premarket review through the European Food Safety Authority. In the U.S., many precision-fermented ingredients enter the market through the GRAS pathway. Companies can self-affirm safety without mandatory premarket approval. Some voluntarily notify FDA; others do not.

The result? A regulatory black hole.

Unknown Compounds, Unknown Risks

Take the example of Bored Cow, an animal-free dairy milk made using synthetic biology proteins originally developed by Perfect Day.

Independent testing reported the presence of dozens of unidentified compounds—92 unknown substances in one analysis. Even small genetic alterations can shift metabolic pathways in microbes, leading to unexpected byproducts.

Life depends on gene expression—and gene expression is regulated by epigenetics. Food is one of the most powerful environmental signals affecting gene expression. Introducing novel, engineered proteins into the diet is an open-air science experiment, and we’re the guinea pigs.

Low-level inflammation triggered by unfamiliar proteins or contaminants would not announce itself dramatically. It would hide behind the noise of modern life: chemical exposures, ultra-processed foods, chronic stress.

The Push to Normalize

Public acceptance is being engineered as carefully as the microbes.

These products are framed as sustainable, climate-friendly, inevitable. They are increasingly introduced through processed foods and institutional supply chains—where consumers have the least visibility and the fewest choices.

The language is deliberate:

• “Animal-free”
• “Sustainable”
• “Precision”
• “Identical to nature”

What’s missing are some simple words that tell us the product is the result of synthetic biology or synbio, one that has been bioengineered, gene edited, or plain old-fashioned genetically engineered.

Because under current US labeling rules under the NBFDS, if the engineered microbe is filtered out, the product does not have to be labeled as bioengineered.

The genetic manipulation disappears from the label…along with your informed consent.

The Illusion of Precision

“Precision” implies control.

But genetic engineering is not the same as flipping a light switch. There are risks. DNA insertion can cause unintended mutations. Microbes can produce off-target metabolites. Proteins expressed in yeast can undergo different post-translational modifications than those produced in animals, potentially altering allergenicity or immunogenicity.

The system assumes purification removes all risk. But industrial processes are never perfect. Contamination, instability, and unintended byproducts are inherent risks in any biological manufacturing system.

No Transparency, No Choice

At ANH, we believe in transparency and informed consent. Consumers have the right to choose real food over engineered substitutes—and that begins with honest labeling.

The new GMO wave is here. It’s up to us to demand the right to know what we’re eating and not to be lied to by the food and biotech industries.

We’ll let you know the minute we launch our initiative aimed at blocking the synbio loophole.

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The FDA’s new, more open tone on compounded bioidentical hormones is a promising shift—but without sustained public pressure, meaningful change is far from guaranteed. Action Alert!

THE TOPLINE

• FDA Commissioner Marty Makary signaled a potential break from the agency’s long-standing, biased hostility toward compounded bioidentical hormone therapy, offering a rare opportunity to push for evidence-based policy.
• Despite this encouraging tone, the FDA could still move to ban key compounded hormones like estriol based on a flawed, industry-influenced NASEM report that misrepresents the science and patient experience.
• Protecting access to cBHRT will require continued advocacy to ensure the FDA rejects the NASEM recommendations and preserves individualized, patient-centered hormone care.

In a surprising turn, FDA Commissioner Marty Makary made a comment recently that may signal a long-overdue shift in the agency’s position on compounded bioidentical hormone therapy (cBHT). During a press conference about removing black-box warnings from hormone products, Makary struck an encouraging tone when asked about compounded hormone therapy, suggesting that under his leadership, the FDA may take a more evidence-based, patient-centered view—unlike the government’s previous position that cBHRT is a “public health concern.”

If Makary’s remarks reflect a shift not just at the head of the agency, but also inside the agency, it could mark a significant victory for patients and practitioners. But we must remain vigilant and continue to make our voices heard. Particularly given that cBHT will be seen by Big Pharma manufacturers of synthetic HRT as direct competition.

How We Got Here

Estriol and other bioidentical hormones have been nominated to the FDA’s Demonstrably Difficult to Compound List (under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act); items that appear on the list when it is final will no longer be able to be made at compounding pharmacies. ANH-USA and other stakeholders pushed back forcefully against the nomination of estriol and other compounded hormones, so the FDA convened a NASEM committee to study cBHRT and aid in the agency’s final determination.

It is our view that the FDA wanted to ban hormones but knew they couldn’t do it quietly due to the large consumer response, so they commissioned NASEM to study the matter and give them cover to ban these hormones.

Unsurprisingly, the resulting report was hostile toward these therapies, claiming that their “widespread use poses a public health concern” due to “a lack of high-quality evidence.”

This conclusion ignores scientific literature showing that bioidentical hormones—when prescribed and compounded appropriately—can offer lower risks of breast cancer and cardiovascular disease and better symptom relief than synthetic or animal-derived hormones. It also ignores decades of clinical experience of tens of thousands of American women.

NASEM, it must be recognized, is not the objective, neutral body it purports to be. For example, conspicuously missing from the committee was anyone with an expertise on how compounded bioidentical hormones are used to treat patients. Further, a review of NASEM’s financials shows that they accept millions in donations from Big Pharma—that is, the very players that stand to gain from the elimination of cBHRT, which competes with pharmaceutical menopause products. 

It’s also clear that the FDA was heavily involved in the development NASEM’s final report, all but guaranteeing that it reached the “proper” conclusions. The most glaring example of this is the FDA’s insistence that Jane Axelrad, former associate director for policy at the FDA’s Center for Drug Evaluation and Research and the agency’s lead on compounding issues, help develop the NASEM committee’s final report. In her work overseeing the compounding industry, Ms. Axelrad on numerous occasions stated publicly her opposition to compounded medicines.

The point is, this was not an unbiased analysis of the facts. From the beginning, it was a carefully managed process to arrive at the desired conclusion: a ban on cBHRT.

What’s at Stake

To be clear, the FDA has not yet moved forward with a ban, which would require a formal rulemaking. We emphasize yet.

But when the FDA finalizes this ban, countless patients will lose access to the personalized hormone therapies that have improved their quality of life—sometimes after years of trial and error with commercial products that didn’t work or caused side effects.

By eliminating competition from compounded products, the FDA effectively hands the market over to a few large pharmaceutical manufacturers. Women lose, patients lose, and innovation loses.

A Chance to Change Course

Commissioner Makary’s recent comments give us a rare opening. They suggest that he recognizes the need to take a fresh look at compounded hormones based on real-world evidence and patient outcomes—not bureaucratic bias or industry pressure.

For years, ANH-USA has submitted data, practitioner testimony, and patient experiences to the FDA showing that compounded bioidentical hormones are safe, effective, and essential for individualized care. Makary’s remarks could mean that work is finally being heard.

But make no mistake: until we see concrete policy changes—such as the FDA rejecting NASEM’s conclusions and ensuring estriol remains available—this fight isn’t over.

Tell the FDA and Congress: stop the attack on compounded bioidentical hormones, listen to patients—not industry—and preserve access to individualized, evidence-based care.

Action Alert!

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This week, we’re proud to announce that multi-disciplinary scientist Dr. Verkerk has been appointed Executive Director of ANH-USA. Dr. Verkerk, who founded ANH International in 2002 in the United Kingdom, and has acted as its executive and scientific director ever since, brings decades of experience and passion as a pioneer of the natural health movement, ultimately aimed at changing the current healthcare paradigm to embrace the principles of regenerative health.

He succeeds Gretchen DuBeau, Esq, who, after overseeing remarkable growth and expanded reach at ANH-USA for 15 years, has decided to transition to the Board of Directors, where the organization can continue to benefit from her unique and wide-ranging experience.

ANH-USA would not be the organization that it is without Gretchen’s tireless leadership. The ANH teams on both sides of the Atlantic are all so grateful for her impact on the important work of protecting natural health for all Americans. ANH-USA is strongly positioned for continued success because of what she has built and accomplished.

In accepting the new position, while retaining his existing position heading up ANH International, Dr. Verkerk said, “I’m thrilled to take the reins at this critical time when governments and big corporations are attempting to negatively influence public perceptions of natural health while, with no adequate justification, tightening the noose on its regulation.”

“Perversely,” added Dr. Verkerk, “this is happening at the very time when all the evidence says natural health should be put front and center of healthcare. This is based on its enviable track record of effectiveness and safety, coupled with its public popularity for self-care which is crucial if we’re to see the chronic disease burden reduced.”

Apart from the well-known attacks on dietary supplements and compounded hormones, the gamut of threats to natural health continues to grow. These include the risks associated with pharmaceutical over-dependence, mandatory vaccination programs, unpredictable risks associated with mRNA vaccine and drug platforms, the erosion of long-standing principles of medical ethics, the suppression of free speech on science, the lack of safety studies on technologies associated with the Internet of Things (IoT), and the growing toxicity burden from new-to-nature chemicals, from glyphosate to PFAS.

The ANH-USA Board’s decision to appoint Dr. Verkerk as its new leader took into account Dr. Verkerk’s extensive experience dealing with some of the most draconian threats originating within the European Union. These, if not extinguished, are increasingly likely to land on US shores given the ever more authoritarian, globalized and coordinated function of national and international agencies and institutions.  Such concerns have also motivated the decision to closely integrate the operation and function of ANH-USA and its international counterpart.

In reflecting on her time as ANH-USA’s Executive Director, Gretchen said, “Looking back over the last fifteen years, I’m so proud of all that ANH-USA and the natural health community were able to achieve. There have been many victories: last year alone we stopped Durbin’s supplement attack, saved compounded glutathione, and stopped anti-supplement bills on the state level, to name just a few.”

Ms. DuBeau also stressed the tectonic shifts that have occurred during her tenure. “The landscape has completely changed,” she said. “I have seen a significant shift in the level of consciousness and awareness around natural health and health freedom. Most people didn’t even know what genetically modified organisms were when I started at ANH-USA back in 2008. This movement is building momentum and growing, and our wins are multiplying.”

“It brings me great joy to have been a part of the grassroots movement fighting for our freedom to live freely and naturally, locked arm in arm with our fellow freedom fighters over the past 15 years,” she continued, “and I’m honored now to pass the baton to Rob Verkerk for the next, exciting era of the organization’s growth and development.”

Under Dr. Verkerk’s leadership and in response to the scale of the challenges ahead, ANH-USA will be diversifying its strategic approach in 2023 and 2024, expanding the scope of its lobbying work in Congress, and is planning to initiate or support targeted legal actions.

ANH-USA is excited to enter this new chapter with Dr. Verkerk at the helm. The challenges before us are many, but we greatly look forward to working alongside you, our grassroots activists.

History tells us freedom isn’t something we should take for granted. Typically, it must be won. With that in mind, we so look forward to working alongside you to help win back a world where we can choose to stay healthy, naturally, free from suppression, coercion, and the diktats of conflicted regulatory authorities.  

If you have friends, family or others in your network who share our interests in natural health, we ask that you share this article with them and ask them to sign up to our free newsletter with the hope they will join our grassroots army that was able to impact 248 laws in 2022 alone.

Look out in the coming weeks for additional information on the RESTRICT Act, the latest threat to free speech and open expression. 

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Lately, there’s been a buzz over hydrogen in the media. Hydrogen-powered vehicles appear to be the next big thing after electric vehicles (EVs) inevitably run their course. Unlike EVs, they won’t require charging, nor will they depend on the energy-intensive and environmentally destructive mining of rare earths like lithium and cobalt. Upon combustion with oxygen in the air, they simply discharge clean water vapor—a miraculous energy source!

The only problems to surmount: Making hydrogen is very energy-intensive, and that energy has to be produced somewhere—windmills, solar panels, and geothermal won’t soon supplant fossil fuels as a source of electrification. And then there are memories of the Hindenburg, a hydrogen-filled airship that famously blew up. You don’t want that happening after a minor fender-bender during your daily commute on the 405!

So now there’s talk about hydrogen water. My initial impression was: “Scam Alert! This is gimmicky, another way to market expensive water—I’m already paying enough for the health aura of pricey mineral waters from branded spas.”

But I’ve come to realize there actually may be something to the concept of imbibing hydrogen, and the latest article on that subject—from no less a source than the prestigious American Journal of Clinical Nutrition—hit me with the impact of a Lakehurst, New Jersey zeppelin explosion.

Read the full article.

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