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.

A federal court dismissed ANH’s homeopathy lawsuit on procedural grounds—so we’re taking the fight directly back to the FDA.

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THE TOPLINE

• The court did not rule on the merits, dismissing the case instead for lack of standing.
• This leaves unresolved the core question of the FDA’s tightening restrictions on homeopathic medicines.
• ANH and Meditrend will file a new citizen petition within 30 days to press the case directly with FDA leadership.

On April 24, 2026, a federal court in Washington, D.C. dismissed ANH-USA and Meditrend’s lawsuit challenging the FDA’s crackdown on homeopathic medicines.

Importantly, the court did not rule on the merits—it never decided whether the FDA’s actions were lawful. Instead, the case was dismissed on a technical issue called “standing,” meaning the court found there wasn’t enough evidence directly linking the FDA’s specific actions to the harms claimed by the plaintiffs.

Speaking to these latest developments, ANH General Counsel Jonathan Emord said, “After holding standing present earlier in the case, the Judge did a volte face and ruled no standing present, doing so immediately before a decision on the merits of whether FDA acted in violation of the Administrative Procedure Act (APA). FDA did indeed violate the APA arbitrary and capricious decision-making standard when it presumed homeopathic drugs unsafe without requisite evidence. Because an appeal would add years to an already delayed decision on the merits, we are going back to FDA to demand the needed reforms, providing the reasons for, and the way to achieve, a reversal of the guidance FDA issued that revoked CPG 400.400 (the safe harbor for entry of homeopathic drugs into the market). We seek to reinstate CPG 400.400 as a first major step to save homeopathy in America.” 

What This Means

This is not a ruling against homeopathy. It simply means the case couldn’t move forward in its current form. The bigger issue—how the FDA regulates homeopathic products—remains unresolved.

What ANH Is Doing Next

Rather than pursue a lengthy appeal that could take years and still avoid the core issues, ANH and Meditrend have decided on a more direct path: filing a new citizen petition with the FDA within the next 30 days.

This approach puts the issue directly in front of FDA leadership and offers a faster opportunity to challenge the agency’s current stance.

Bottom Line

This is a procedural setback, not the end of the road. ANH remains actively engaged in protecting access to homeopathic medicines and is moving quickly to press the case through new channels.

More updates soon.

The post ANH Campaign to Protect Homeopathy: Update first appeared on Alliance for Natural Health USA - Protecting Natural Health.

A seemingly simple supplement registry could quietly reshape the entire natural health market—and limit what consumers can access. Action Alert!

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THE TOPLINE

• The proposed Dietary Supplement Listing Act is framed as a transparency measure, but it would effectively create a premarket approval system.
• The compliance burden would likely hit small and innovative supplement companies hardest, leading to market consolidation and fewer niche or practitioner-grade products for consumers.
• A centralized FDA registry could become a tool to target and remove certain supplements, while doing little to stop illegal or adulterated products that already evade existing laws.

Imagine walking into your local health store—or opening your usual online shop—and finding that a supplement you’ve relied on for years is suddenly gone. No warning, no clear explanation. It’s just gone.

For millions of Americans who use vitamins, minerals, and other supplements as part of their daily health routines, this could be the reality if Congress enacts the latest version of Dietary Supplement Listing Act, the bill long championed by Senator Dick Durbin (D-IL), but this time introduced by Representative Maxine Dexter, MD (D-OR).

On its face, the Dietary Supplement Listing Act sounds like a simple transparency measure. Who could oppose a basic product registry? But the reality is, as we’ve argued for years, this bill is the first step towards eliminating supplements you care about.

The Dietary Supplement Health and Education Act—the law governing how supplements are regulated in the US—was designed to treat supplements as a category of food, not drugs, with regulators stepping in when problems arise. This bill flips that logic, creating a de facto premarket approval system akin to how drugs are treated.

The burden won’t fall evenly. Large multinational firms will absorb the compliance costs; smaller companies—the ones driving innovation and offering specialized products—may not. The likely result is market consolidation and reduced consumer choice, particularly for practitioner-grade and niche formulations that don’t fit a mass-market model.

Supporters argue this will improve safety. But FDA already has robust authority to act against adulterated or misbranded supplements. The most serious risks in this space typically stem from illegal products that ignore existing law—not from a lack of paperwork. A sweeping new registry does little to address those bad actors, while imposing new hurdles on responsible companies trying to comply.

More concerning is what comes next. Once a centralized database is in place, the FDA can use the registry as a hit-list to go after supplements it doesn’t like. Maybe high-dose supplements are the first target. Maybe the FDA uses the list to go after supplements that haven’t complied with its over-expansive “new dietary ingredient” guidance (a policy that has yet to be finalized).

At stake here is whether consumers retain broad access to supplements and the freedom to make informed choices about their health. This bill may be framed as modest reform, but its real impact would be anything but modest.

Action Alert!

The post Durbin Bill Reappears: New Threat to Supplement Access first appeared on Alliance for Natural Health USA - Protecting Natural Health.

The current leadership of FDA may be softening its stance on peptides—but past patterns suggest the outcome is far from certain. Action Alert!

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THE TOPLINE

• Recent FDA activity—including a planned Pharmacy Compounding Advisory Committee (PCAC) review of peptides like BPC-157 and epitalon—along with changes to the Bulk Drug Substances List, signals a potential shift toward allowing broader access to compounded peptides.
• Despite encouraging signals, PCAC has historically taken a restrictive stance on natural compounds, often recommending limits or bans, raising concerns that the upcoming review may follow the same pattern.
• This process has favored FDA staff perspectives and could ultimately restrict access, reinforcing a pattern where natural therapies are sidelined while similar compounds later emerge as patented pharmaceuticals.

Access to some of the most promising emerging therapies in modern medicine is in peril. Behind the scenes, federal regulators are making decisions right now that could determine whether patients and practitioners can access natural peptide bioregulators—or whether those treatments are effectively pushed out of reach and into pharmaceutical monopolies or unregulated gray markets.

Following several signals from HHS Secretary RFK Jr. that the current administration will protect consumer access to compounded peptides, the FDA has taken two recent actions. A newly announced meeting of the Pharmacy Compounding Advisory Committee (PCAC) on July 23 and 24 has, as part of its agenda, a review of BPC-157 and epitalon. During the forthcoming meeting, the committee will make a recommendation to the FDA as to whether to allow these and other peptides to be compounded.

The FDA has also quietly taken another step: certain peptides are being removed from “Category 2” of the Bulk Drug Substances List which contains substances flagged for safety concerns. Removing peptides from this list is a positive signal that past biases against peptides are being corrected.

Taken together, these developments suggest movement. But whether they will produce meaningful progress remains to be seen.

A Window of Opportunity—Or More of the Same?

We know that RFK Jr. has made public statements in favor of retaining consumer access to peptides. The PCAC, however, has neither been friendly to natural substances in general, nor to peptides in particular.

Historically, the committee has taken a restrictive view of many natural substances, often aligning closely with FDA staff recommendations. PCAC has voted to ban the compounding of curcumin, aloe vera, and a host of other safe, natural compounds. It’s been much the same with peptides so far: PCAC has rejected several peptides for inclusion on the Bulks List, including thymosin alpha-1, despite decades of research supporting its immunological benefits.

ANH attended these PCAC meetings, and time and again we’ve been left with the impression that it is a rigged process. FDA staff are given hours to present the case for why natural substances should be banned from compounding. By contrast, those offering the alternative view are given 15 minutes to present their case for why each peptide should be permitted in compounding.

To be clear, PCAC’s vote is a recommendation. The FDA must go through the formal rulemaking process to ban these substances from compounding. But with RFK Jr.’s public statements in support of peptides, we hope this round of meetings will be different and the process will go beyond the kangaroo court of previous meetings.

A Familiar Pattern

You can reference our previous coverage for how we’ve ended up here. But it’s a familiar story. Natural substances with therapeutic promise are restricted due to theoretical safety risks and/or limited data, even when real-world harm is minimal or undocumented. At the same time, those same compounds often re-emerge later as patented pharmaceutical products.

This dynamic raises a fundamental question: is the FDA really concerned about safety, or about protecting pharmaceutical company profits?

Vigilance Required

There’s no question that recent developments are encouraging. A reopened docket, active FDA review, and signals from political leadership all point to the possibility of change.

Yet the PCAC process has historically narrowed access, not expanded it. If there is to be a genuine shift toward responsible, transparent access to peptides, it won’t happen automatically. It will require continued scrutiny, public engagement, and a willingness to challenge decisions that limit patient choice without clear evidence of harm.

Action Alert!

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A looming FDA rule could overhaul how everyday ingredients are regarded by the agency —putting thousands of supplements and natural products at risk of disappearing behind regulatory red tape. Action Alert!

THE TOPLINE

• A new FDA rule on the GRAS (Generally Recognized as Safe) system is under review, and could significantly change how ingredients are allowed to enter the marketplace—potentially affecting access to thousands of supplements and food ingredients.
• The proposal would likely require mandatory FDA notification for all GRAS determinations, ending “self-GRAS,” which could increase transparency but also overwhelm the agency and create major backlogs.
• Eliminating self-GRAS—the approach Secretary Kennedy has HHS Secretary has consistently reiterated—could restrict access to safe, natural ingredients and stifle innovation. Reform should focus on transparency and risk-based oversight—not a burdensome pre-approval system.

An update to the FDA’s Generally Recognized as Safe (GRAS) framework is around the corner. The Office of Management and Budget (OMB) has reportedly scheduled a meeting for April 20, 2026, to review a proposed rule that could significantly reshape how GRAS determinations are handled in the United States.

It may sound very “in the weeds” to be talking about GRAS. But what’s at stake is your access to thousands of safe, health-promoting ingredients; if we get the wrong kind of GRAS reform, they could disappear in the churn of a bureaucratic approval system. (For background on what GRAS is and how we got here, and how we think reform could be done in ways that work for everyone other than those selling harmful ingredients, you can check out our white paper.)

At this stage, full details of the rule have not been released, but we must stay vigilant and engaged to make sure the rule promotes transparency and supports consumer access to safe, natural ingredients, rather than installing additional bureaucratic red tape that eliminates supplement access.

What the Proposed Rule May Do

The proposed rule would require mandatory submission of GRAS notices to the FDA, effectively ending the practice of “self-affirmed GRAS” determinations that are not disclosed to the agency. (As we’ve explained in previous coverage, self-affirmed GRAS, or “self-GRAS”, is when a company independently concludes an ingredient is GRAS without FDA notification.)

Certain substances will be exempt from this requirement—namely, those already listed as GRAS by regulation or those that have already received an FDA “no questions” letter. The FDA would also maintain and update a public-facing inventory of GRAS notices, providing greater visibility into which substances are being used and on what basis they have been deemed safe.

The rule is also expected to clarify how the FDA determines that a substance is not GRAS, an area that has long lacked clear procedural guidance.

Problems With the Rule

At first glance, some of this sounds like the kind of transparency reform for which ANH has long advocated. But abolishing the self-GRAS pathway would be a huge mistake, as we outlined in our white paper last year.

Depending on how it’s done, abolishing the self-GRAS pathway creates more problems than it solves. Consider the fact that there are currently an estimated 10,000+ ingredients on the market today that are self-GRAS, many of them perfectly safe and natural supplement ingredients. If all of these are going to be forced through a mandatory FDA approval system, the agency would be overwhelmed, creating years, if not decades, of regulatory backlog.

Worse, this kind of blanket approach would likely sweep safe, beneficial ingredients off the market alongside risky ones, reducing consumer access to health-promoting products and potentially harming public health. It would also stifle innovation, particularly for smaller companies that rely on the flexibility of self-GRAS to bring new ingredients to market.

The issue is not the GRAS pathway itself, but the lack of transparency. The public and independent scientists should be able to review the data underlying self-GRAS determinations. But rather than creating a pre-approval regime, reform should focus on shining light on GRAS determinations and prioritizing enforcement against ingredients that pose a demonstrated risk.

>>>Read ANH’s GRAS Reform White Paper

Creating another de facto pre-approval system undermines the original purpose of the GRAS pathway: to streamline the introduction of safe ingredients, including many natural ingredients, into food.

Reform Done Right

There is broad agreement that the GRAS system needs reform. The current lack of transparency allows for potential abuse, and the public deserves greater visibility.

But eliminating self-GRAS entirely would “throw the baby out with the bathwater,” removing a pathway that has enabled the development of many safe and beneficial products.

ANH has outlined a better path forward in its white paper, Reforming GRAS: Food Safety Without Sacrifice, which proposes a tiered, risk-based approach to ingredient review. This model would focus regulatory resources where they are most needed while preserving access and innovation.

Waiting for the Details

The upcoming OMB meeting signals that change is imminent. But until the proposed rule is formally released, key questions remain unanswered.

Will the FDA strike the right balance between transparency and access? Or will it move closer to the burdensome, pre-approval frameworks being pushed in Congress?

For now, the only responsible position is cautious optimism—tempered by vigilance.

We will continue to monitor developments closely and provide updates as more information becomes available.

Action Alert!

The post GRAS Reform on the Horizon: What We Know—and What We Don’t first appeared on Alliance for Natural Health USA - Protecting Natural Health.

Big Food has been trying to weather increasing evidence that UPFs cause harm. We think we’re beyond the tipping point – UPFs are slowly killing those who depend on them for sustenance – it’s a Big Tobacco moment for Big Food.

By Rob Verkerk PhD, founder, executive & scientific director

If you’re reading this, chances are you already try to avoid ultra-processed foods (UPFs), recognizing UPFs contain ingredients you wouldn’t want in your own kitchen.

But many of your friends, family, and wider networks may not be in the same place—and crucially, may still believe that the science is “uncertain.” That’s because Big Food has spent many years trying to defend its position to use these ingredients and has ploughed vast sums into research and marketing, a chunk of which has been used to justify its position.

But that position is increasingly hard to defend—as we aim to show in this article, using some of the most prominent systematic reviews and meta-analyses published in mainstream, high-impact scientific journals.

Where we are today—something I hope to justify below—is that we’ve arrived at a Big Tobacco moment for Big Food—the same playbook, different story and era. 

When you can no longer hide from the science

A pivotal shift came in 2025 when the highly influential peer-reviewed journal, The Lancet, published an article by Monteiro et al. along with 12 linked articles. In their opener for the series, Professor Carlos A Monteiro, MD and colleagues from the University of Sao Paulo, Brazil, set out three biologically plausible mechanisms by which UPFs may drive harm:

• Disruption of appetite regulation, leading to overconsumption
• Direct biological effects of additives, altered food structures, and production of harmful byproducts
• Systematic displacement of health-promoting, minimally processed, protective foods

What we’re beginning to see now is a converging causal framework for how UPFs represent a classic slow-kill mechanism that underpins most of the chronic disease we see in industrialized societies that steals years and quality from lives, and threatens to overrun health systems.

Engineered to override satiety

Among the most compelling experimental evidence comes from a tightly controlled inpatient trial led by NIH researcher Kevin Hall. Participants consuming an ultra-processed diet ate ~500 kcal/day more and gained weight compared with those on a minimally processed diet—despite meals being matched for calories, sugar, fat, and fiber (Hall et al 2019).

This isn’t about someone’s willpower. It’s about design—foods designed to be addictive that create dependence. Texture, energy density, and hyper-palatability appear to bypass normal satiety signaling—directly supporting Monteiro’s first hypothesis.

The epidemiology is now overwhelming

Among the strongest syntheses of evidence to date comes from a systematic review and meta-analysis of 43 observational studies (including nearly 900,000 subjects) examining UPFs and chronic disease outcomes published by Lane et al 2021 in the peer-reviewed journal, Obesity Reviews.

The findings were striking:

• Higher UPF intake was associated with increased risk of obesity, cardiovascular disease, type 2 diabetes, and all-cause mortality
• Associations persisted across populations and study designs

Even allowing for residual confounding, the scale and reproducibility of these findings make dismissal increasingly untenable.

In case anyone is still in any doubt, a very recent meta-analysis and systematic review by Liang et al (2025) published in Systematic Reviews including 18 studies involving over 1 million subjects (and over 173,000 deaths), showed unequivocally that those who consumed the most UPFs had a 15% increase in risk of death from all causes. 

Sorry, Big Food, you can no longer hide from the evidence that it’s UPFs that make-up over half the total energy consumed by populations in the US and UK (here and here), are killing consumers of its products slowly, but surely. More to the point, the risks are dose dependent—so any effort to eat less of it moves your risk profile in the right direction.   

From pre-cradle to old age

The problem is akin to a ticking time bomb. We have yet to see the full age spectrum of industrialized societies exposed to UPFs from pre-conception to death.

What we know for sure is that young people are eating more of the stuff than older folk, and that should be a big wake-up call for individuals, families, and health authorities. The data also show that it’s the middle income groups that consume the most, not the poorest, this likely reflecting the relatively high cost of many UPFs.  

The science is increasingly revealing that harms are not confined to any one life stage—they impact people across the lifespan:

• Children and adolescents: High UPF consumption is linked to increased adiposity, poorer metabolic health, and emerging links to mental health outcomes. Early exposure may also shape lifelong food preferences (Lane et al 2021)
• Older adults: Recent evidence links higher UPF intake with frailty, cognitive decline, and increased mortality risk, suggesting acceleration of biological ageing (Shahatah et al 2025)
  
  But, that’s not all. UPFs have also been tied to reducing fertility, elevated risks during pregnancy and development of fetuses and infants.

Emerging research suggests UPFs may impair hormonal regulation, metabolic signaling, and fertility outcomes, including in males (Paula et al, 2022; Evans et al 2025; Preston et al 2025). While still developing, this aligns with known effects of metabolic dysfunction and inflammation on reproductive biology.

During pregnancy, the risks extend further. Maternal UPF intake has been linked to excess gestational weight gain and altered fetal development trajectories, raising concerns about long-term metabolic programming in offspring (Paula et al, 2022; Morales-Suarez-Varela & Rocha-Velasco 2025). 

As shown in a comprehensive review by Rondinella et al 2025, common UPF components—particularly emulsifiers, artificial sweeteners, and other additives in UPFs—can:

• Disrupt microbiome diversity
• Damage the intestinal barrier
• Promote systemic inflammation

This provides a biologically coherent explanation linking UPFs to chronic disease pathways—from metabolic disorders to neurodegeneration.

This is not just about individual health or the choices, informed or otherwise, of the individual—what parents and young people are eating will likely also influence the health of the next generation.

Coming back to the story of Big Tobacco, we learned that the industry “got away with it” up until it was no longer feasible for its leaders to deny causation. Now, with Big Food and its addictive UPFs, we see a similar progression: the increasing evidence of consistency of effects across the entire life course is really beginning to bolster the case for causality.

UPF manufacture generates killer chemicals

Critics are right: not all processing is harmful. Fermentation, freezing, and cooking can enhance nutrition and safety.

But ultra-processing is different. It involves fractionation and recombination of food components, technological additives designed to mimic real food, and structural changes that alter digestion and absorption.

As Prof. Monteiro and colleagues propose in their second hypothesis, UPF manufacture may often also involve application of extreme heat or other technological processes that induce reactions that in turn yield new by-products. This generates chemicals that were not in the original foodthat are associated with increased inflammation, neurotoxicity, and cancer risk.  

Even when adjusting for overall diet quality, studies continue to find independent associations between UPF intake and adverse health outcomes.

This suggests that UPFs are not merely markers of unhealthy diets—they are likely contributors to harm in their own right.

Time for honesty and accountability—not ‘healthwashing’

The food industry has long argued that “there are no bad foods, only bad diets.” That argument is becoming increasingly hard to sustain. Big Food’s response? “Healthwashing.”

Despite the growing body of negative scientific findings, food manufacturers, like their tobacco counterparts of yesteryear, are becoming increasingly adept at marketing ultra-processed products as part of a healthy lifestyle. Labels such as “high protein”, “low fat”, “gut friendly” or “plant-based” can create a powerful halo effect, even when the product remains highly processed.

Social media has amplified this phenomenon. Influencers, including celebrities and sports personalities, are frequently paid to promote food and drink products, blurring the line between genuine advice and advertising. The result is a digital landscape in which ultra-processed foods are not only normalized but actively positioned as desirable wellness choices.

At a systems level, there is a need to rebuild shorter, more transparent food chains that reconnect producers and consumers. Supporting regenerative agriculture, local food networks, and independent producers can play an important role in shifting the balance away from industrialized food systems. This is where we, as consumers, can play a powerful role in creating change in our food landscape by changing what we buy and where we buy from.

Policy change is equally critical. This includes developing more robust and meaningful ways to classify food, strengthening oversight of health claims—particularly in digital spaces—and investing in independent research that is free from commercial influence.

Time to reclaim real food

The debate around ultra-processed foods is both necessary and timely. But if it is to lead to meaningful change, it must move beyond simplistic narratives and address the deeper forces shaping our food system.

It’s time for people to engage, question and advocate for a more holistic approach—one that values real food, informed choice, and transparency at every level. Because ultimately, improving public health is not just about avoiding certain categories of food, but about rebuilding a system that truly nourishes both people and planet.

We cannot win this one without education. People have to know what they’re putting into their bodies and be cognizant of the ‘healthwashing’ that Big Food uses in its marketing, advertising and labelling.

Next we need to vote with our pockets – the message is a simple one: avoid UPFs most of the time. 

Those wanting to go minimal-UPF or UPF-free need to focus on eating whole foods and ingredients that can be recognized as foods. If you want some help, a great starting point is our book Reset Eating: Reset your health and resilience by turning what and how you eat into powerful medicine and our Food4Health Guide within. Find out more below.

>>> Discover Reset Eating from the ANH team, your science-based guide to healthy, UPF-free eating that supports balanced nutrition—whatever your dietary preferences.

>>> For more information on using unprocessed ingredients for healthy UPF-free eating check out our Food4Health guide. For kids under 6, see our Food4Kids guide.

The post Ultra-Processed Foods Are Killing Us Slowly: Why Big Food Can No Longer Ignore the Science first appeared on Alliance for Natural Health USA - Protecting Natural Health.

A new national declaration headed by ANH-USA calls for rethinking how we prevent and treat chronic illness that affects 3 in every 4 US adults. Add your name to support reform. Take Action – Co-Sign the Declaration Now!

Listen to the audio version of this article:

THE TOPLINE

• On February 10–11, 2026, we convened a summit comprised of healthcare, legal, scientific, and policy leaders in Scottsdale, Arizona, which culminated in the drafting of a declaration calling for structural reform of how America addresses chronic disease that is at risk of crippling society and breaking health systems.
• The Arizona Statement outlines legal, regulatory, and economic barriers that can limit access to preventive and non-pharmaceutical approaches—and proposes a path forward.
• This is a growing national effort that was among RJK Jr.’s key priorities when appointed HHS Secretary. He can’t do it alone. Add your name to help demonstrate public support for change.

The Arizona Statement has been released today!

>>> Read Press Release

The United States spends more on healthcare per capita than any country in the world—yet continues to struggle with high rates of chronic disease.

Conditions like diabetes, heart disease, and obesity now affect a majority of American adults. At the same time, many researchers and public health experts agree that a significant share of this burden is linked to diet, lifestyle, and other modifiable factors.

So why does prevention so often take a back seat?

The answer is complex. But many clinicians, researchers, and policy experts point to a common theme: the way our healthcare system is structured can make it harder to prioritize prevention and early intervention.

Natural and preventive approaches to health are at the margins of healthcare through the deliberate structure of legal definitions, regulatory enforcement, and professional gatekeeping that has been constructed—and defended—over decades.

That’s the challenge at the heart of the Arizona Statement on Reversing America’s Chronic Disease Epidemic, developed by ANH-USA with the help of a cross-disciplinary group of experts who met in February 2026 and have collaborated since. Now, we’re asking grassroots activists to help build momentum behind these ideas.

While an Executive Order established the Make America Health Again (MAHA) Commission in February 2025 and a 120-initiative strategy was launched in September 2025, to date the focus has been primarily on children’s health; the structural problems that impact informed choice and health freedom relevant to America’s 277 million adults has largely been avoided. Not only that, the chronic disease epidemic cannot be fixed by top-down government policy alone. It requires all layers of society to be involved and the removal of structural barriers that have accumulated over decades that work to protect Big Pharma and Big Food—with US citizens paying the price both in health and economic terms.

What the Arizona Statement Argues

The Statement does not reject modern medicine or the role of pharmaceuticals. Instead, it argues that the current system often underutilizes lower-cost, lower-risk approaches—including nutrition, lifestyle interventions, sanitation, and natural products—due to a combination of regulatory constraints and economic incentives.

Among the issues it raises:

• Individual liberty and informed choice. Every person has the right to receive truthful information about nutrition, lifestyle, and lawful health options—and to choose among them on the basis of fully informed consent. That right is currently being violated by a regulatory regime that decides what you’re allowed to know and what medicines you can access.
• Modern, science-based definitions. The legal definitions of “food” and “drug” that govern what can be said and sold in the American marketplace were not written with 21st-century nutritional science in mind. The Statement calls for modernizing these definitions so that foods, botanicals, and dietary ingredients with demonstrated therapeutic effects can be researched, discussed, and recommended without being classified as unapproved drugs.
• Prevention, root-cause care. America’s great gains in life expectancy over the 20th century were built on sanitation, nutrition, hygiene, and public health — not on pharmaceuticals. The Statement calls for restoring prevention and root-cause medicine to their rightful place at the center of health policy.
• Barriers to access and reimbursement. Many preventive or root-cause approaches are not covered by insurance programs, making them less accessible—even when they may reduce long-term health costs.

These ideas are not about replacing conventional medicine, but about broadening the toolkit available to patients and practitioners.

Why This Matters in Practice

For many Americans, this debate is not abstract. It can mean the difference between having insurance cover a medication that brings side effects, but not a safer nutrition-based intervention. It’s the difference between treating symptoms rather than the underlying or root causes. It’s about having the right to be informed about, and to choose, non-drug approaches to health.

The Arizona Statement argues that a more balanced system could improve outcomes, expand choice, and reduce long-term costs.

A Growing Coalition—And a Chance to Add Your Voice

The Statement has already been signed by a number of clinicians, researchers, attorneys, nonprofit leaders, and health advocates. The goal now is to demonstrate that these concerns extend beyond professional circles.

Your signature helps show policymakers, regulators, and the media that there is broader public support for rethinking how we approach chronic disease.

This list of signatories will support ongoing legal, regulatory, and legislative efforts aimed at expanding access to preventive and integrative approaches.

Add Your Name to the Arizona Statement…

• If you believe prevention should play a larger role in healthcare…
• If you support greater access to information and a wider range of options…
• If you think the system can do more to address the root causes of chronic disease…

Add your name to the Arizona Statement TODAY.

Once you’ve done this – please forward this email or share the URL arizonastatement.org. Help build the momentum for a more balanced, prevention-focused approach to health.

You can also find out more by tuning in to the Robert Scott Bell Show today at 3 pm ET (noon PT) and listen to our General Counsel Jonathan Emord and Executive & Scientific Director Rob Verkerk, the key authors of the Arizona Statement.

The post Sign the Arizona Statement: Join the Bottom-Up Movement to Reverse Chronic Disease first appeared on Alliance for Natural Health USA - Protecting Natural Health.