A federal ban on nearly all hemp-derived products — including the CBD and full-spectrum oils millions of Americans rely on — takes effect November 12, 2026. Two pro-hemp bills now in Congress offer the last realistic path to stop it. Action Alert!

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THE TOPLINE

• A near-total hemp ban will take effect November 12, 2026 unless overruled by either of two pro-hemp bills. The proposed ban stems from a provision in a 2025 appropriations law that redefines hemp and caps THC at 0.4mg per container — effectively outlawing most full-spectrum CBD oils, hemp supplements, and whole-plant extracts that millions use for wellness.
• The science behind the ban is deeply flawed: regulators are skipping proper risk-assessment methodology by treating any detectable THC as dangerous.
• Two Senate bills offer a path forward: the Hemp Planting Predictability Act would delay implementation by three years, while the broader Cannabinoid Safety and Regulation Act would replace the ban with a proportionate framework — mandatory testing, labeling, age restrictions, and a ban on synthetic cannabinoids — while explicitly protecting hemp-derived supplements.

What Happened

On November 12, 2025, Congress quietly enacted Public Law 119-37 through a spending bill. Buried inside was a provision that rewrites the federal definition of hemp. Under the 2018 Farm Bill, hemp was any Cannabis sativa product containing less than 0.3% delta-9 THC on a dry weight basis. That definition allowed a legitimate hemp industry to grow, allowing consumers access to a wide variety of natural hemp products.

The new law changes “delta-9 THC” to “total THC“ and adds a cap of 0.4 milligrams of THC per container on finished products. It also excludes any cannabinoid that wasn’t naturally produced inside the plant, sweeping in synthetics like much of the delta-8 market.

The official goal was to close the so-called “delta-8 loophole.” The actual effect is a near-total ban on the hemp industry. The full-spectrum CBD oils that contain trace, non-psychoactive amounts of THC — the very products most consumers buy for wellness — will likely not survive this threshold. Industrial hemp seed oil, hemp protein, hemp leaf teas, and the countless supplements built on whole-plant extracts are all in the crosshairs.

And perhaps that’s the point. Remember, the FDA has approved a CBD-based drug (Epidiolex), and the agency, in concert with its bureaucratic equivalents in the European Union, have long maintained that CBD cannot be sold as a dietary supplement. This is the back-channel we’ve written about for years — the mechanism by which natural compounds get converted into expensive pharmaceuticals while their affordable supplement versions are banned. The drug industry will be thrilled at the prospect of a de facto ban that eliminates many therapeutic natural products from the market.

The Broken Science Behind the Ban

It is critical to understand that, in enacting this de facto ban, the federal government is not following its own risk-assessment framework.

FDA’s risk-analysis process is supposed to follow a three-part structure derived from WHO guidance: risk assessment (what’s the actual hazard at what dose?), risk management (what policy responds proportionately?), and risk communication. The whole point of separating these is so policymakers don’t ban things that pose no real-world risk.

What the FDA and Congress are doing instead is collapsing the entire system, while conflating risk assessment with risk management. They take the existence of any potential hazard and skip straight to prohibition. Risk management is supposed to mean banning the harmful products or doses — not banning every detectable molecule. That’s why the allergen gluten is labeled for those who are sensitive or intolerant to it, and why wheat, barley, rye and other gluten-containing grains are not banned outright. The approach that allows potentially harmful ingredients to be banned or restricted, with closely related ones permitted, with or without specific qualifications depending on potential risks to specific sub-populations, is referred to as tiered or laddered risk management.

The European Food Safety Authority (EFSA), one of the world’s leading food-safety agencies, evaluates THC the way toxicologists typically evaluate risk: by looking at how much THC people actually consume, not how much happens to be present in a bottle, package, or container.

EFSA looked at the science and identified the lowest dose at which THC produced noticeable effects and then applied a series of safety buffers to account for uncertainty and differences between individuals. The result was an extremely conservative safety threshold designed to protect sensitive populations: 1 μg THC per kilogram of body weight, or about 0.07mg THC for someone weighing 154 lbs.

Note that critics have pointed out many flaws in EFSA’s assessment. EFSA based its calculations on studies involving particularly vulnerable patients and then layered additional safety factors on top of that. That’s what EFSA always done because it operates by the ‘precautionary principle’ which is built into its remit. The reality is that with such precautionary approaches intended to handle uncertainty, regulators may build multiple cushions into their calculations that were already highly protective, subsequently preventing a large number from being able to access beneficial amounts.

Even EFSA’s highly conservative THC assessment is based on actual exposure—how much THC a person consumes relative to body weight. Congress did something much more primitive scientifically: it imposed a flat 0.4 mg THC-per-container limit regardless of how the product is used. For example, a 30-day bottle of full-spectrum CBD oil containing 0.5 mg THC total would expose a consumer to just 0.017 mg THC per day—well below even EFSA’s conservative threshold for most adults—yet the product would be banned in the US. This makes no sense—unless you’re in Big Pharma and you want to eliminate any kind of competition for products that might be used in place of drugs.

Let’s put some more perspective on just how bad Congress has got this: If FDA regulators were forced to apply the same logic they’re using on THC to alcohol, they would have to restrict the sale of yogurt and other naturally fermented foods because fermentation produces trace amounts of alcohol. They would have to regulate flaxseed and apples, which contain cyanide compounds. They might even have to ban coffee because caffeine at high doses is known to be harmful.

Meanwhile THC — a substance with documented neuroprotective properties, a therapeutic index estimated greater than 50,000, no recorded fatal overdose in humans, and chronic toxicity observable only at massive doses — gets the harshest treatment of all.

What About Hormesis?

There’s an even deeper problem the federal approach refuses to acknowledge: the dose-response curve for many bioactive plant compounds is non-linear. It’s more often than not hockey stick-shaped. This is the principle of hormesis — the well-established observation that low doses of substances can produce effects opposite to their high-dose effects. Selenium is essential in trace amounts and toxic in larger ones, yet no one has ever been poisoned by brazil nuts that can contain over 100 micrograms of selenium per nut. The same hormetic relationship also applies to key botanicals like curcumin in turmeric and resveratrol in grape skins. The science is clear: it’s not just a question of understanding the dose/response relationship, context is also important. This means the matrix within which a compound is delivered can make a big difference to how the nutrient functions in the body. These kind of nuances appear to have completely escaped the authors of the hemp provisions in the appropriations bill.

Hemp contains close to 500 known compounds — more than 60 cannabinoids, more than 140 terpenes, plus fatty acids and other phytochemicals. The genuine therapeutic value of hemp comes from what researchers call the entourage effect: these compounds work together, and the whole is more powerful than any isolated piece. A 2015 study found that purified CBD modestly reduced inflammation and anxiety in mice, but a full-spectrum extract — the same CBD plus the natural supporting cast — worked substantially better.

A policy that pretends every molecule of THC is dangerous — that there is no safe trace dose— is not grounded in science. It’s politics, pure and simple.

What’s Next — And What You Can Do

The good news: this fight isn’t over. Multiple lifelines have been introduced in Congress, and grassroots pressure is exactly what they need to advance. If you value CBD and other products derived from hemp – please act now!

The Hemp Planting Predictability Act (S. 3686) — introduced January 15, 2026, by Senators Amy Klobuchar (D-MN), Rand Paul (R-KY), and Jeff Merkley (D-OR) — would extend the implementation window from 365 days to three years, giving Congress time to develop a workable regulatory framework rather than letting an entire industry collapse on schedule.

The Cannabinoid Safety and Regulation Act (CSRA) (S.3474) — introduced by Senators Ron Wyden (D-OR) and Jeff Merkley (D-OR) — is the broader fix. It would reverse the hemp ban outright and replace it with a real regulatory framework: mandatory testing for potency, pesticides, heavy metals, and byproducts; transparent labeling; a ban on synthetic cannabinoids like illicit delta-8; age restrictions at 21; and prohibitions on packaging designed to appeal to children. Crucially, it states explicitly that a dietary supplement may contain hemp-derived cannabinoids and cannot be deemed adulterated simply because it contains CBD or other cannabinoids — directly overriding the FDA’s drug-exclusion back-channel.

In other words, the CSRA does what proportionate risk management is supposed to do. It targets actual problems — untested products, synthetics, youth access — without criminalizing responsible adult use of safe, beneficial plant compounds.

Action Alert!

The post STOP the Proposed Hemp Ban That is Built on Broken Science first appeared on Alliance for Natural Health USA - Protecting Natural Health.

A bill in Congress would finally allow Americans to use HSA funds for dietary supplements—expanding access to preventive health tools and advancing health freedom. Let’s get behind it: Action Alert!

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THE TOPLINE

• New legislation—the Dietary Supplement Access Act—would allow Americans to use up to $500 annually in HSA and FSA funds for dietary supplements, removing current barriers that require a physician prescription.
• ANH-USA supports the bill as a major step toward preventive healthcare and health freedom, giving consumers greater flexibility to use tax-advantaged healthcare dollars on wellness tools they already rely on.

Americans deserve the freedom to use their own health savings to support the wellness strategies that work best for them. That’s why ANH-USA strongly supports newly reintroduced legislation that would allow Health Savings Account (HSA) funds to be used for dietary supplements.

The Dietary Supplement Access Act, sponsored by Senators Kevin Cramer (R-ND) and John Curtis (R-UT), would modernize outdated HSA rules and recognize a simple reality: millions of Americans already rely on supplements as part of their daily health routines.

Under current law, consumers generally cannot use tax-advantaged HSA or Flexible Spending Account (FSA) dollars to purchase supplements unless they obtain a prescription from a physician. This unnecessary barrier limits access, adds bureaucracy, and discourages preventive health approaches that may help people stay healthier in the first place.

The bill would expand the definition of “medical care” to include dietary supplements and allow consumers to spend up to $500 annually from these accounts on qualifying products. Similar legislation has been introduced several times over the past decade, reflecting growing bipartisan recognition that preventive health tools should be easier—not harder—to access.

Why This Matters

HSAs already help millions of Americans manage healthcare costs. These accounts allow individuals to set aside pre-tax money for qualified medical expenses, creating significant financial advantages for families trying to stay healthy amid rising healthcare costs.

HSAs provide a powerful triple tax benefit: contributions are tax-deductible, investment growth is tax-free, and withdrawals for qualified medical expenses are tax-free.

They also help consumers prepare for future medical costs, which can become increasingly burdensome with age.

A Step Toward True Preventive Healthcare

Americans spend billions of dollars out of pocket each year on supplements intended to support immune function, bone health, heart health, healthy aging, and general wellness. Allowing HSA funds to cover these products would give families more flexibility in how they manage their health while acknowledging the important role supplements play in preventive care.

The bill would not mandate supplement use or create new government programs. It would simply allow consumers greater freedom in deciding how to use their own healthcare dollars.

Congress Should Act

At a time when healthcare costs continue to climb, policymakers should be looking for ways to encourage affordable preventive approaches—not erect barriers to them.

The Dietary Supplement Access Act is a commonsense reform that empowers consumers, supports health freedom, and aligns federal policy with how millions of Americans already approach wellness.

Congress should move quickly to pass this legislation and expand access to the preventive tools Americans rely on every day.

Action Alert!

The post Support Expanded Access to Supplements first appeared on Alliance for Natural Health USA - Protecting Natural Health.

A new bill in the House could finally put an end to the FDA’s regulatory sleight of hand that threatens to eliminate compounded natural desiccated thyroid (NDT) for the 1.5 million Americans who depend on it. Action Alert!

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THE TOPLINE

• The PEAT Act of 2026, introduced by Rep. Michael Rulli (R-OH) and Rep. Diana Harshbarger (R-TN), would block the FDA from classifying a product as a biologic based solely on the presence of a clinically inactive protein — the exact justification the agency has used to reclassify natural desiccated thyroid (NDT) and threaten its availability.
• The FDA’s reclassification of NDT as a biologic hinges on the presence of thyroglobulin, a protein that does not provide any therapeutic benefit — the actual active hormones in NDT are levothyroxine (T4), liothyronine (T3) and reverse triiodothyronine (rT3), small molecules that have nothing to do with biologic regulation.
• For the millions of patients who rely on compounded NDT because synthetic alternatives have failed them, this bill is a crucial piece of health freedom legislation.

For years, ANH-USA has been sounding the alarm about the FDA’s campaign to eliminate patient access to natural desiccated thyroid (NDT). Now, Congress is finally pushing back.

Representative Michael Rulli (R-OH), joined by Representative Diana Harshbarger (R-TN), has introduced the Protecting Equal Access to Thyroid (PEAT) Act of 2026. The bill is straightforward: it would amend the Public Health Service Act to prohibit the FDA from treating a product as a biological product based solely on the presence of a protein that is a clinically inactive component.

If enacted, the bill would retain consumer access to NDT and compounded NDT—a lifeline for countless patients whose lives rely on these medicines.

What the FDA Has Been Doing

As we’ve reported in depth, the FDA issued letters in August 2025 to manufacturers, importers, and distributors declaring that NDT products — including both commercial products like Armour Thyroid and compounded formulations — are unapproved biologics. The agency’s justification? The presence of thyroglobulin, a protein found in porcine thyroid tissue used to make NDT.

Here’s the kicker: thyroglobulin is an inactive ingredient. It provides no therapeutic benefit. The clinical value of NDT comes entirely from the interplay between the natural forms—derived from thyroid glands of pigs or cattle—of three well-understood hormones, T4 (levothyroxine [thyroxine]), T3 (liothyronine [triiodothyronine]) and rT3 (reverse triiodothyronine), the very same versions of the hormones produced by the human thyroid. The FDA’s own guidance has long recognized that a product containing a protein only as an inactive ingredient is not considered a “protein” for biologic classification purposes.

In doing this, the FDA is, in our view, creating a regulatory pretext to remove a medicine that competes with Big Pharma’s synthetic thyroid drugs — drugs that simply don’t work for a significant share of the over 30 million Americans with hypothyroid conditions.

Why This Matters for Patients

Synthetic T4-only drugs like levothyroxine and Synthroid are the standard of care for hypothyroidism in conventional medicine. But the human thyroid produces five hormones — T1, T2, T3, T4, and calcitonin — and for many patients, T4 alone is not enough. A significant portion of the population cannot efficiently convert T4 to T3, and without adequate T3, symptoms like debilitating fatigue, depression, weight gain, and brain fog persist even when labs look “normal.”

Compounded NDT can fill these gaps. Compounding pharmacies can tailor doses, delivery mechanisms, and hormone ratios to match what individual patients need. This is the whole point of compounding — it exists precisely because one-size-fits-all commercial products don’t work for everyone.

If the FDA’s biologic reclassification stands, that option disappears. Biologics cannot be compounded by traditional compounding pharmacies. Patients who have finally found something that works for them would be forced back to drugs that don’t, with no path to the individualized care their condition requires.

What You Can Do

Getting the PEAT Act out of committee and to the floor requires sustained pressure from constituents who make clear to their representatives that this issue matters.

If you or someone you love depends on compounded NDT, your voice carries weight here. Contact your representative and ask them to cosponsor the PEAT Act. Tell them what compounded NDT has meant for your health. Tell them that the FDA’s biologic reclassification is a regulatory maneuver that would harm real patients without any corresponding benefit to public safety.

Action Alert!

The post Support New Congressional Bill to Protect Your Access to Natural Thyroid Medicine first appeared on Alliance for Natural Health USA - Protecting Natural Health.

A new scare campaign against peptides follows a familiar pattern: use a few cases of contamination to justify sweeping restrictions on natural therapies that compete with pharmaceutical drugs.

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THE TOPLINE

• A recent peptide study found contamination and purity problems in some “gray market” products—but contamination is already illegal, and the FDA already has authority to target bad actors.
• This mirrors the FDA’s approach to homeopathy and supplements, where isolated violations are used to portray entire categories as unsafe.
• The real battle is over access: as peptides gain attention for regenerative medicine, metabolic health, and healthy aging, regulators are moving toward tighter controls that favor patented pharmaceutical products over naturally derived therapies.

A new preprint study on “research-grade” peptides is already being used to reinforce a familiar narrative: natural or naturally-derived therapies are too risky for consumers and therefore require tighter FDA control. Sound familiar? We’ve seen the same playbook used against homeopathy, supplements, and compounded medicines for years.

The real danger is not peptides themselves. In fact—quite the opposite—peptides are among the most important signaling molecules (including hormones) in the body and deficiencies or imbalances in them are major reason for metabolic, hormonal, neurological and immunological dysregulation that leads to an array of different diseases and premature aging. It’s the growing effort to use isolated examples of contamination and bad manufacturing practices to justify restricting entire categories of therapeutic products that compete with pharmaceutical drugs. We think it’s no coincidence that hit-pieces against peptides are popping up just as RFK Jr. has recently signaled that he will take action to ensure consumer access to several important peptides.

The preprint analyzed more than 6,000 peptide samples from the so-called “gray market.” The authors found that many products did not meet purity benchmarks and that some contained endotoxin contamination.

Those findings should concern everyone. No one wants contaminated injectable products on the market. But contamination and adulteration are already illegal. The FDA does not need sweeping new authority to police unsafe manufacturing. Existing laws already prohibit contaminated, adulterated, or misbranded products. We’ve argued previously that FDA policy has had a hand in creating this gray market: when regulators restrict access to substances that patients and clinicians believe are beneficial, those substances don’t disappear—they’re pushed into the shadows where unscrupulous actors thrive.

The problem is enforcement against bad actors—not the existence of peptides themselves.

The Same Strategy Used Against Homeopathy

This is precisely the argument ANH-USA has made in its legal fight against the FDA’s crackdown on homeopathic medicines.

In court filings challenging the FDA’s anti-homeopathy campaign, we argued that the agency relied on isolated and unrepresentative instances of manufacturing violations to paint an entire category of products as unsafe.

As we explained, that’s like shutting down every restaurant in America because a few of them failed hygiene inspections.

You see how the same principle gets re-used in the FDA’s playbook—whether it involves peptides, homeopathics, or dietary supplements?

A contaminated peptide product is not evidence that all peptides are unsafe any more than a contaminated supplement proves all supplements are dangerous or a poorly manufactured homeopathic medicine invalidates homeopathy altogether.

Properly manufactured products made under Good Manufacturing Practices (GMPs) can be produced safely. The FDA already has authority to enforce GMP violations, seize contaminated products, and prosecute fraudulent manufacturers.

Instead, the agency repeatedly uses safety scares to justify broader restrictions on entire categories of natural health products.

Peptides Represent a Threat to the Drug Monopoly

Peptides are attracting enormous interest because they sit at the frontier of regenerative medicine, metabolic health, injury recovery, immune modulation, and healthy aging. Many are naturally occurring signaling molecules composed of amino acids—the same building blocks that make up proteins in the human body.

Research into compounds like BPC-157, thymosin alpha-1, kisspeptin-10, and epitalon has generated excitement because of their potential therapeutic applications. That promise also creates a commercial problem for the pharmaceutical industry.

Natural or bioidentical compounds are difficult to monopolize. As ANH-USA has long argued, the FDA approval system strongly favors patent-protected pharmaceutical products because only monopoly pricing can justify the enormous costs of FDA drug approval.

When naturally-occurring substances begin competing with patented drugs, regulators suddenly discover “safety concerns.”

We saw it with supplements. We saw it with homeopathy. We are now seeing it with peptides.

In 2023, ANH-USA warned that the FDA was moving to prohibit the compounding of multiple peptides by citing concerns over impurities and insufficient safety data. The agency placed numerous peptides into “Category 2,” meaning compounders could no longer continue producing them while FDA review was underway.

The justification? Potential contamination risks and theoretical safety concerns.

A Pattern of Regulatory Overreach

ANH-USA has documented this pattern repeatedly across natural health.

With supplements, the FDA has attempted to impose drug-style premarket requirements that threaten innovation and consumer access.

With homeopathy, the FDA abruptly abandoned decades of regulatory recognition of the category’s safety profile by pointing to isolated enforcement cases.

With peptides, the agency is again emphasizing contamination and impurity concerns while moving toward tighter restrictions that would conveniently leave pharmaceutical manufacturers holding the keys to access.

Meanwhile, properly manufactured compounded peptides and natural peptide therapies risk disappearing from the market entirely.

If the agency truly wants to protect public health, it should focus on enforcing existing manufacturing standards against bad actors while preserving access to properly manufactured peptide therapies. Otherwise, peptides may become the latest casualty in a long-running campaign against natural and naturally-derived health products—a campaign that consistently benefits pharmaceutical monopolies while restricting consumer choice.

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The post Watch Out for FDA’s Playbook: From Supplements to Homeopathy—Now Peptides first appeared on Alliance for Natural Health USA - Protecting Natural Health.

What if we had a common language and approach to look at what’s needed to maintain or build health? Might this help turn around the largely preventable chronic and degenerative disease epidemic that threatens to break our health systems? ANH founder, Rob Verkerk, Ph.D., lays out his thoughts on a ‘unified theory of health’.

Listen to the audio version of this article:

THE TOPLINE

• Natural health is not “alternative” medicine—it is the foundational framework that supports resilience, energy production, immune balance, and long-term wellbeing in an increasingly toxic and stressful world.
• From ultra-processed food and chronic stress to environmental toxins and sedentary lifestyles, modern living creates evolutionary mismatches that mainstream medicine is poorly equipped to address.
• ANH’s proposed “unified theory of health” identifies four core biological factors that determine whether the body moves toward repair and vitality—or inflammation, degeneration, and chronic disease.

By Rob Verkerk, PhD., executive & scientific director, ANH

The wellness world is full of new tools: GLP-1 drugs, synthetic peptides, repurposed pharmaceuticals, methylene blue, high-dose synthetic vitamins, cold plunges, heat therapy, biohacking routines, and more. Some may have value in the right context. But none of them can do the deeper work if the body’s foundations are neglected.

That’s where natural health comes in.

Natural health isn’t simply about using “natural” products instead of drugs. It’s about understanding the human being as a living system—one shaped by biology, environment, lifestyle, psychology, culture, and personal agency. It asks a different question from conventional medicine. Not only: “What disease does this person have?” But also: “What conditions are allowing dysfunction to emerge in the first place?”

In my full article on ANH International, I explore whether we can move toward a unified theory of health. The idea is not to reduce human beings to a simplistic formula. Quite the opposite. It’s to offer a practical lens that helps both practitioners and individuals understand where to focus attention especially to maintain and build health in an increasingly complex health landscape. It’s about focusing much more on the body and mind’s needs for health, rather than it’s needs once it has become diseased—an approach that often leads to treatments only beginning late in the disease cycle.

We’ve identified at least 18 major influences on health, from diet, sleep, stress, physical activity, toxins, microbiome exposure, light, electromagnetic fields, social connection, economics, culture, healthcare access, information environments, and personal autonomy. In the scientific literature, these are often called “determinants” of health, but that term can be misleading. They do not determine outcomes by themselves. They influence the body’s physiology, psychology and behaviour and, in turn, affect the internal terrain.

That terrain is where health or disease ultimately manifests.

The ‘unified theory of health’ model focuses on four foundational factors:

• Energy — especially mitochondrial function, ATP production, redox balance, and metabolic flexibility, but includes bioelectric and bioelectromagnetic energy. Without enough energy in the system, maintenance and repair of the ‘operating system’ is simply not possible.
• Structure — including cell membranes, tissues, organs, the musculoskeletal system, barriers, and the overall physical integrity of the body. Structures of the body separate elements of nature and organize them in ways that create life. Integrity of these structures is a necessity of healthy life.
• Environmental information — the signals the body receives from food, light, microbes, toxins, relationships, stress, nature, and biological rhythms have a dramatic influence on the terrain of the body. This comprises information that may have positive or negative effects, leading to anabolic (building) or catabolic (breakdown) processes.
• Gene expression patterns — the way genes are switched on or off, and how they are expressed (epigenetically) in response to the internal and external environment ultimately determines the overall pattern of gene expression of an individual that in determines health outcomes.

Together, these four factors shape what I call the human terrain. When the terrain is resilient, coherent, connected, and adaptive, disease has a much harder time taking hold. When the terrain is depleted, inflamed, dysregulated, structurally compromised, or poorly informed by its environment, disease becomes far more likely.

We hope this model may be useful for practitioners from any modality, acting as a common language. A functional medicine doctor, chiropractor, nutrition professional, naturopath, acupuncturist, health coach, or integrative physician may use different tools, but all are ultimately trying to influence the same elements of the terrain. The model, we hope, offers a shared map.

It may also help patients and citizens. It reminds us that health is not readily created in a doctor’s office alone. It is built every day through the food we eat, the light we receive, the way we move, the sleep we protect, the relationships we cultivate, the toxins we avoid, the meaning we find, and the freedom we retain to make informed health choices.

Modern medicine is often brilliant in emergencies. But it is poorly designed to rebuild the foundations of health, resolve evolutionary mismatches, or address chronic disease at its roots. That’s why natural health matters now more than ever.

It gives us a way to move beyond symptom suppression and toward resilience, prevention, and human flourishing.

Read the full ANH International article here: Towards a unified theory of health—and why natural health matters more than ever

The post Could a Unified Theory of Health Solve Our Health Care Crisis? first appeared on Alliance for Natural Health USA - Protecting Natural Health.

Some readers were confused by our Arizona statement released last month and assumed it applied only to people living in Arizona. To make the broader message clear, we’ve added a roundel to the graphic: “Forged in Arizona for ALL Americans.” While the statement originated in Arizona, the principles behind it—health freedom, informed choice, and accountability—are national issues that affect every American. Momentum is building, and now is the time to keep it going by gathering more signatures, sharing the statement widely, and helping demonstrate the growing public demand for action.

SIGN THE ARIZONA STATEMENT TODAY.

The post Forged in Arizona. Fighting for All Americans: Sign the Arizona Statement first appeared on Alliance for Natural Health USA - Protecting Natural Health.

Dr. Marty Makary is stepping down as FDA Commissioner after just over a year leading the agency, amid reports of mounting political pressure, internal conflict, and ongoing controversy over the FDA’s direction under the Trump administration and HHS Secretary Robert F. Kennedy Jr.

According to multiple reports, Makary’s resignation was likely not entirely voluntary. Major outlets, including Reuters and POLITICO, describe weeks of escalating clashes with White House and HHS officials over issues ranging from abortion-pill regulation to flavored vaping products. President Donald Trump reportedly pushed the agency to authorize flavored e-cigarette products more quickly, while Makary resisted over concerns about youth vaping.

Trump publicly acknowledged the resignation, saying Makary “was having some difficulty,” fueling speculation that the commissioner resigned in anticipation of being removed.

Kyle Diamantas will now serve as Acting FDA Commissioner. Diamantas previously served as the FDA’s Deputy Commissioner for Food and is considered a close ally of Secretary Kennedy and the “Make America Healthy Again” (MAHA) agenda.

Diamantas, a former corporate attorney, has already signaled support for major shifts in FDA food policy, including increased scrutiny of ultra-processed foods. His appointment suggests the administration intends to continue reshaping the FDA around Kennedy’s priorities — particularly in food regulation, chronic disease policy, and regulatory reform.

Time will tell whether the FDA’s leadership transition accelerates the kinds of reforms many in the natural health movement have long hoped to see under the broader “Make America Healthy Again” agenda. Whether those expectations translate into meaningful institutional change—or simply more political turbulence at an already unsettled agency—remains to be seen.

The post Makary Out at the FDA first appeared on Alliance for Natural Health USA - Protecting Natural Health.

A current FDA review of the definition of “dietary substance” could dramatically restrict supplements, limit consumer choice, and reshape the future of natural health in the U.S.

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THE TOPLINE

• The FDA has made its own case and is interpreting “dietary substance” narrowly—limiting supplements to what’s already in the typical American diet—despite Congress intentionally defining supplements broadly in the Dietary Supplement Health and Education Act of 1994.
• This approach could exclude a wide range of traditional, global, and innovative health products while reinforcing a regulatory system that favors pharmaceuticals and restricts what supplement companies can say about health benefits.
• While being dressed up like a safety measure, this shift is really about control that would reduce access and diversity of supplement products, stifle innovation, and align U.S. policy with more restrictive international standards.

When most people think about regulation, they picture inspections, raids, enforcement actions, or product bans. But one of the most powerful tools regulators have operates quietly in the background: definitions.

Right now, the FDA is deciding how to interpret the phrase “a dietary substance for use by man to supplement the diet by increasing the total dietary intake” that makes up a part of the definition of a dietary supplement. We gave a brief overview of this issue last week, but given it’s so important we felt it necessary to go into more detail this week because the outcome of this debate could reshape the entire supplement landscape. We need to make sure that good sense and science, not the anti-supplement agenda of FDA’s paymasters, win the day.

The Power of a Definition

Under the Federal Food, Drug, and Cosmetic Act (FDCA), dietary supplements are defined as products containing one or more “dietary ingredients” (such as vitamins, minerals, herbs or other botanicals, or amino acids). Congress intentionally wrote this definition broadly in the Dietary Supplement Health and Education Act (DSHEA) of 1994 to preserve consumer access to a wide range of health-supporting products.

One key part of that definition—in “clause (E)”—adds that a “supplement” is also:

“a dietary substance for use by man to supplement the diet by increasing the total dietary intake.”

This is clearly expansive. It reflects a common-sense idea: supplements exist to add to the diet, not merely replicate what is already commonly consumed. But the FDA has taken a very different view.

Freezing the “Diet” in Time

In the agency’s guidance, the FDA has stated that a “dietary substance” must be limited to foods and food components that humans already eat as part of their “usual diet”. In other words, if something isn’t already part of the typical American diet, it may not qualify.

There are significant problems with this interpretation. As ANH founder and Executive Director Rob Verkerk, PhD, stated in ANH’s comments to FDA on this issue, “The American diet is highly variable, increasingly globalized, and in many respects nutritionally poor. Making the modern ‘usual diet’ the limiting benchmark would perversely treat dietary inadequacy and market convention as regulatory boundaries.”

Human diets are diverse and evolving. A legitimate understanding of “dietary substance” must include:

• Foods and practices from other cultures and traditional diets
• Fermented foods, medicinal foods, and food-as-medicine traditions
• Botanicals, fungi, algae, and microbial ingredients
• Nutrients and bioactive compounds present in foods but used in concentrated forms
• Substances that are chemically equivalent to dietary components, even if produced using modern methods

The relevant question isn’t whether a substance appears in the average American grocery store. It’s whether it has a relationship to the human diet—through tradition, composition, or function. With FDA’s planned narrowing of the scope of the definition, thousands of plant, fungi-, and algal-derived ingredients from tropical regions, from the East, from Central and South America, and from the African continent, would be excluded.  

In this move, FDA would drift away from the expansive view of dietary supplements that was the will of Congress in 1994, and towards a view that is central to European regulators: that supplements are there only to maintain levels of micronutrients and have no role to play in warding off, let along remedying, any kind of chronic or acute disease. The subtext that is never stated is that FDA views supplements as competition for drugs and therefore its market must be kept in check.

A Broader Strategy to Restrict Consumer Choice

This debate over “dietary substance” isn’t happening in isolation. It’s part of a broader push to establish control over our health.

The FDA has a vested interest in restricting medicines that aren’t drugs because drug company user fees fund a substantial portion of the agency’s budget. It isn’t a coincidence that natural medicines over which the agency exercises less authority—supplements, homeopathy, and compounded medicines, for example—are frequent targets of FDA attack.

The result? Fewer products, less innovation, and reduced consumer choice.

The Legal Trap: Why Supplements Can’t Be “Medicine”

Zoom out, and an even bigger issue comes into focus.

Under U.S. law, a product becomes a “drug” if it is intended to diagnose, treat, mitigate, or prevent disease. That means a supplement company cannot legally tell you what the science says about how its product affects health—if that effect relates to disease.

This creates a paradox. You can buy supplements like curcumin, omega-3s, or vitamin D, but companies can’t tell you how they may help with inflammation, heart health, or immune function if those claims even hint at crossing into disease territory.

Why? Because making those statements would trigger drug classification—and with it, a regulatory process that can cost upwards of $1 billion and take a decade.

For natural substances that cannot be patented, that pathway is a dead end.

So companies stay silent. Consumers stay uninformed. And healthcare remains dominated by pharmaceutical interventions—not because they are always superior, but because they are the only legally recognized option for treating disease. (This is why we’re preparing a petition to the FDA to change that).

The Global Angle: Regulatory Harmonization

There’s also an international dimension to consider.

The United States has long been an outlier in allowing relatively broad access to dietary supplements. In contrast, the European Union imposes stricter limits on ingredient types and dosages.

Efforts like the FDA’s current interpretation of “dietary substance,” combined with its pre-approval framework for “new” supplements and Sen. Durbin’s bill for mandatory product listing, can be understood as steps toward harmonization—aligning U.S. rules with more restrictive standards from other countries.

For large multinational corporations, this makes business easier: one set of rules across multiple markets. For consumers, it means fewer choices and less access.

A Better Path Forward

ANH-USA is not arguing for a regulatory free-for-all. Safety and transparency matter. The FDA already has the authority to remove unsafe products from the market—and it should use that authority where appropriate.

But redefining “dietary substance” in a way that excludes legitimate, diet-related ingredients is less about safety and more about control.

A better approach would:

• Respect the broad definition Congress enacted in DSHEA
• Recognize the diversity and evolution of human diets
• Allow for innovation in how dietary ingredients are developed and delivered
• Focus regulatory efforts on safety—not arbitrary categorical restrictions

What’s at Stake

At a time when chronic disease is at historic highs, restricting access to safe, health-supporting tools is the wrong direction.

Definitions may seem technical. But in this case, they determine what products you can access, what information you can receive, and ultimately, what options you have to support your health.

If the FDA succeeds in narrowing the meaning of “dietary substance,” it could change the future of natural health in America. And that’s something we can’t afford to ignore.

Please share this widely among your network and help support our work to defend access to supplements with a donation.

The post FDA’s War of Words on Supplements first appeared on Alliance for Natural Health USA - Protecting Natural Health.

While the FRESH Act promises GRAS reform, a closer look reveals a shift toward burdensome FDA gatekeeping that could restrict access to safe, natural ingredients. Action Alert!

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THE TOPLINE

• The bill eliminates the long-standing “self-GRAS” pathway, effectively transforming GRAS into a pre-market approval system rather than a flexible safety standard.
• It introduces a two-tier review process that still expands federal control, including FDA-influenced third-party panels and increased reporting requirements.
• It imposes significant administrative burdens without adopting a risk-based approach, potentially stifling innovation and limiting access to low-risk, natural ingredients.

We’re inching closer to policies that will restrict access to natural ingredients you rely on.

At first glance, the FRESH Act looks like a measured attempt to modernize the “Generally Recognized as Safe” (GRAS) pathway. It is less disastrous than some of the other proposals we’ve seen introduced in Congress. Yet a closer look shows that this bill, too, fundamentally reshapes GRAS into something much closer to a pre-market approval regime that will negatively impact our access to safe, natural ingredients.

The Elimination of “Self-GRAS”

The most consequential change in the FRESH Act is that, moving forward, a substance can no longer be considered GRAS unless the FDA has been notified.

In other words, the longstanding “self-GRAS” pathway—where qualified experts can determine an ingredient is safe without mandatory FDA submission—is effectively eliminated.

Proponents argue that self-GRAS is a loophole that allows unsafe substances into the food supply. But that characterization doesn’t hold up under scrutiny. As we’ve documented before, many of the ingredients frequently cited in media reports as problematic were actually reviewed by the FDA—not slipped through via self-GRAS.

The real issue with self-GRAS isn’t that companies can reach GRAS conclusions independently. It’s that these determinations are generally not transparent.

Transparency, Not Pre-Market Gatekeeping

ANH-USA has consistently argued that GRAS reform should focus on transparency—not expanding FDA gatekeeping authority.

Our proposed solution, as documented in our April 2025 white paper, is straightforward: a comprehensive, publicly accessible transparency register of all GRAS determinations. This would allow independent scientists, researchers, and watchdogs to evaluate the evidence behind safety conclusions.

Increasing the FDA’s pre-market authority over food ingredients risks replacing one perceived problem with a far more restrictive system that slows innovation without meaningfully improving safety.

A Two-Tier System—With Strings Attached

The FRESH Act outlines two pathways for new GRAS ingredients:

• Full Notification: Companies must submit detailed information, including identity, manufacturing process, specifications, and a scientific rationale. The FDA has 90 days to review and can request more data or reject the submission.
• Third-Party Review Pathway: Ingredients reviewed by an “established scientific panel” can bypass full notification—but only if the panel is accredited by the Secretary and submits basic information to the FDA.

On paper, this second pathway appears to preserve some flexibility. In reality, it adds a new layer of federal control: scientific panels must be formally accredited, and their conclusions still have to be reported to the FDA. When the agency is effectively shaping who gets to serve on these panels, it’s reasonable to expect a narrow range of viewpoints—ones that tend to lean towards ever more EU-style, precautionary approaches. The result risks becoming more “government science” that is inherently skeptical of natural products, especially those that could compete with drug-based interventions.

Existing Ingredients: Not a Tsunami—But Still a Tidal Wave

To its credit, the FRESH Act does not require all existing GRAS ingredients to undergo full FDA review. Instead, companies must meet one of two conditions:

1. Submit a basic notification (identity and intended use), or
2. Ensure the substance is already listed in the FDA’s Substances Added to Foods database.

Basic notifications are automatically accepted and take effect after 30 days unless the FDA intervenes.

This avoids the worst-case scenario—a regulatory “tsunami” overwhelming both industry and the agency. But it still represents a massive administrative burden: a tidal wave of filings that smaller companies may struggle to manage.

The Missing Piece: Risk-Based Reform

One of the biggest shortcomings of the FRESH Act is its one-size-fits-all approach.

Not all ingredients pose the same level of risk. A synthetic chemical with no history of human consumption should not be treated the same as a vitamin co-factor, botanical ingredient or mushroom used safely for generations.

At ANH-USA, we are advocating for a tiered, risk-based system, where:

• Low-risk, natural ingredients with a long history of safe use face minimal regulatory burden
• Higher-risk, novel, or synthetic substances receive more rigorous evaluation

This approach protects public health and preserves access to beneficial products. The FRESH Act, by contrast, casts too wide a net.

Reform Without Overreach

There are problems with the current GRAS system. Bad actors can exploit gaps, and greater accountability is needed.

But eliminating self-GRAS and replacing it with a quasi pre-market approval system is not the answer.

GRAS has long served as an essential pathway for thousands of safe, health-promoting ingredients to reach consumers. Weakening that pathway risks reducing access, stifling innovation, and consolidating control over the food supply.

We should not throw the baby out with the bathwater.

A Better Path Forward

If lawmakers are serious about improving GRAS, they should focus on:

• Full transparency: A universal registry of all GRAS determinations
• Risk-based oversight: Tailored requirements based on an ingredient’s safety profile
• Preserving flexibility: Maintaining pathways for safe, natural ingredients to enter the market efficiently

The FRESH Act takes a step toward reform—but in doing so, it risks creating a system that is more restrictive, more bureaucratic, and ultimately less effective.

We can do better.

Action Alert!

The post The FRESH Act: Reforming GRAS—or Replacing It? first appeared on Alliance for Natural Health USA - Protecting Natural Health.

The FDA is signaling a narrower definition of “dietary supplement” that could sideline innovative natural products and limit consumer choice—unless it’s challenged.

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THE TOPLINE

• The FDA is considering a narrow interpretation of “dietary substance” that could exclude many natural, traditional, and innovative ingredients from qualifying as dietary supplements.
• This shift could push a wide range of products into regulatory limbo or the costly drug approval pipeline, reducing access and favoring pharmaceutical pathways.
• ANH is urging the FDA to follow the law as written, prioritize safety over restriction, and preserve consumer access to a broad range of health-supporting products.

What if the FDA could quietly redefine supplements in a way that puts many of your go-to health products out of reach?

At a time when Americans are facing a chronic disease crisis of historic proportions, you’d think federal regulators would be doing everything possible to expand access to safe, health-promoting tools. Instead, the FDA is moving in the opposite direction—quietly advancing an interpretation of the law that could restrict access to a wide range of dietary supplements.

That’s why ANH-USA has stepped in.

In a recent regulatory submission, ANH urged the FDA to stick to the law as written and reject efforts to narrow what qualifies as a “dietary supplement.” At stake is your ability to access innovative, natural products that can support your health.

What’s the Fight About?

The issue centers on how the FDA defines a “dietary substance”—a key part of the legal definition of a dietary supplement. Congress intentionally wrote this definition broadly in the Dietary Supplement Health and Education Act (DSHEA) of 1994 to ensure consumers would have access to a wide variety of safe products.

Section 201(ff)(1) defines a “dietary supplement” as a product, other than tobacco, intended to supplement the diet and bearing or containing one or more dietary ingredients, including vitamins, minerals, herbs or other botanicals, amino acids, “a dietary substance for use by man to supplement the diet by increasing the total dietary intake,” or a concentrate, metabolite, constituent, extract, or combination of such ingredients.

The FDA is signaling it may interpret the “dietary substance” portion of the definition (bolded above) narrowly—essentially limiting it to substances already commonly consumed in the typical American diet.

Why This Matters

If the FDA adopts this narrow view, it could shut the door on a huge range of beneficial ingredients, including:

• Compounds used in traditional diets from around the world
• Concentrated forms of naturally occurring nutrients
• Innovative ingredients produced through modern, safe technologies
• Emerging natural compounds that support health but aren’t part of the standard American diet

In other words, many of the most promising tools for improving health could be pushed out of the supplement category altogether and into a regulatory limbo—or worse, into the drug approval pipeline, where costs and barriers are so high that only pharmaceutical companies can compete.

The Bigger Picture

Why is the FDA doing this – especially now, while HHS Secretary Kennedy and FDA Commissioner Makary are ostensibly in charge? Dietary supplements are overwhelmingly safe. Serious adverse events are extremely rare—especially compared to pharmaceuticals. Yet the FDA stance appears unchanged under Kennedy and Makary’s leadership, the agency consistently adopting an aggressive posture towards supplements with the goal of not just limiting access, but creating the impression that supplements are not a legitimate way to maintain health. That’s what drugs are for!

A Better Approach

ANH is not arguing for a free-for-all. Safety and transparency matter. Bad products should be removed from the market.

But the law already gives the FDA the tools it needs to do that.

What ANH is advocating for is simple:

• Follow the statute: Congress deliberately created a broad definition that isn’t limited to constituents of the standard American diet.
• Focus on safety, not restriction: Evaluate whether products are safe, rather than excluding them outright.
• Allow innovation: New technologies and ingredients should be judged on their merits, not dismissed because they’re new.
• Protect consumer choice: People should have access to a wide range of safe options to support their health.
• Preserve our Constitutional rights: First Amendment protections should enable consumers to have full access to relevant health information about natural health products to allow them to make informed choices.

Why Now?

We are living through a surge in chronic illness—conditions like obesity, diabetes, and heart disease that are often preventable or manageable with better nutrition and lifestyle choices.

Dietary supplements can play a critical role in that effort. They’re not a cure-all, but they are an important part of a broader strategy to stay healthy and reduce reliance on drugs.

Restricting access to these tools at this moment is misguided and counterproductive.

The Bottom Line

This debate may sound technical, but its impact is very real.

A narrow definition of “dietary substance” means fewer choices, less innovation, and more barriers between you and the tools you use to stay healthy.

ANH is pushing back to ensure that doesn’t happen. In a country struggling with chronic disease, the last thing we need is less access to safe, effective, natural health solutions.

Please share this article widely in your network.

The post FDA Tries to Redefine Supplements—And Limit Your Access to Them first appeared on Alliance for Natural Health USA - Protecting Natural Health.