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.

Listen to the audio version of this article:

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.

Strong evidence of the impact of fluoridated drinking water on cognitive development was a major reason for HHS’s altered stance on fluoride. A widely cited new fluoridation study—relying on old data—claims there are no risks to brain development; but its flawed design and failure to address available evidence make its value limited.

Listen to the audio version of this article:

THE TOPLINE

• The study concludes fluoridated water doesn’t affect IQ, but relies on indirect, county-level estimates of exposure rather than measuring actual fluoride levels in individuals.
• Key methodological issues—including grouping different types of fluoride exposure, poorly timed variables, and use of a decades-old cohort—undermine its relevance and reliability.
• The findings conflict with more recent and comprehensive research using stronger data, raising concerns that the study may reflect policy advocacy more than rigorous science.

A newly published paper in Proceedings of the National Academy of Sciences is already being touted as definitive proof that water fluoridation poses no risk to brain development. The paper represents an effort to counter a ‘gold standard’ systematic review and meta-analysis published last year in one of the most influential journals, JAMA Pediatrics, which evaluated 74 cross-sectional and prospective cohort studies and found significant inverse associations between fluoride exposure and children’s IQ scores. This study, along with others showing how fluoride in drinking water disturbs the gut microbiota impacting children’s immunity, were key to the change in stance on fluoride of HHS under Secretary Kennedy’s leadership. 

In his Substack article, James Lyons-Weiler, PhD, reveals a catalogue of problems with the supposed debunking of the JAMA Pediatrics study that is being used for all it’s worth by the pro-fluoride, anti-Kennedy brigade. Beneath the headline-grabbing conclusion lies a study design that raises more questions than it answers and may ultimately obscure, rather than clarify, the real science on fluoride and cognition.

What the Study Claims

The study, drawing on data from the Wisconsin Longitudinal Study, concludes that exposure to community water fluoridation (CWF) is not associated with lower IQ in adolescence or reduced cognitive function later in life.

At first glance, that sounds reassuring. But the reliability of any scientific conclusion depends entirely on how the study was conducted. And that’s where the problems begin.

The authors present their work as a replication of earlier findings. But it’s not independent replication—the gold standard for building scientific consensus. Instead, it’s the same lead researcher, working with essentially the same dataset, confirming a prior result.

The Core Problem: Exposure Was Never Measured

Perhaps the most significant issue is this: the study never directly measures fluoride exposure in any individual.

There are no urine or blood fluoride levels, no measurements from participants’ drinking water, no clinical indicators like dental fluorosis. Instead, exposure is inferred from county-level records—essentially guessing who was exposed based on where they lived and when fluoridation began.

This kind of shortcut introduces what researchers call the ecological fallacy: assuming that group-level data accurately reflects individual experience.

A Critical Category Error

The study also treats all fluoride exposure as equivalent—but it isn’t.

Participants categorized as “exposed from birth” often lived in areas with naturally occurring fluoride in well water, not water treated with fluoridation chemicals used in modern systems.

These are chemically distinct substances with potentially different biological effects. Combining them into a single “exposure” category undermines the validity of the comparison from the start.

Timing Matters—and It’s Off

Another major flaw: the study measures “confounding variables” after years of supposed fluoride exposure have already occurred.

But if you’re trying to isolate cause and effect, your baseline measurements need to come before the exposure—not in the middle of it. Otherwise, you risk adjusting away the very effects you’re trying to detect.

A Study from a Different Era

There’s also a fundamental mismatch between the study population (high school graduates from 1957) and today’s reality.

Participants were born in the early 1940s—before widespread fluoridation standards, fluoride toothpaste, and modern dietary fluoride exposure.

Today’s children are exposed to fluoride from multiple sources simultaneously, creating a total exposure profile that simply didn’t exist in mid-20th century Wisconsin.

Using this cohort to answer today’s policy questions is like using 1950s air pollution data to evaluate modern emissions standards. It doesn’t work.

What About the Broader Evidence?

This study stands in contrast to more recent analyses, including:

• A 2024 review by the National Toxicology Program, which found moderate evidence linking fluoride exposure to lower IQ in children
• A 2025 meta-analysis in JAMA Pediatrics reporting similar concerns

These analyses rely more heavily on individual-level exposure data—the kind missing from the PNAS paper.

Policy Framing Raises Concerns

The study explicitly positions itself as a response to recent policy decisions to roll back fluoridation in some states.

That doesn’t automatically invalidate the research—but it does raise an important question: Was the study designed to investigate a question—or to defend a position?

The rapid publication timeline and methodological problems—each tending toward a null result—suggest the latter.

Why This Matters

Public health decisions affect millions of people—especially children. They should be grounded in the best possible science, not studies with built-in blind spots.

Let’s not forget: in a 2024 ruling, a federal court determined that fluoride levels in U.S. drinking water present an unreasonable risk to public health. The court found compelling evidence from human studies, including a review of over 70 epidemiological studies, which confirm that even lower levels of fluoride can have detrimental effects on children’s cognitive development.

One flawed study to the contrary doesn’t change this.

Science isn’t a fixed set of conclusions—it’s a process. The strength of the scientific method lies in its willingness to be challenged: to revisit assumptions, refine methods, and update conclusions when new data emerge. That means questioning isn’t a threat to science—it’s the engine that drives it forward.

On complex public health questions like fluoride exposure, where evidence is developing and stakes are high, that principle matters even more. Conflicting findings shouldn’t be dismissed or spun into certainty; they should prompt better research, more precise measurement, and a deeper look at what we may be missing.

If science is doing its job, the conversation doesn’t end with a single study—or even a consensus moment. It continues, evolves, and corrects itself over time. And public policy should remain open to that same process: grounded in evidence, but always ready to adapt as our understanding grows.

Please share this article widely in your networks.

The post Flawed Fluoridation Study Fails to Debunk Kennedy IQ Reduction Claim 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!

Listen to the audio version of this article:

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.

Listen to the audio version of this article:

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.

Listen to the audio version of this article:

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!

Listen to the audio version of this article:

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!

Listen to the audio version of this article:

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!

The post FDA Signals Positive Shift on Peptides—But the Fight Is Far From Over first appeared on Alliance for Natural Health USA - Protecting Natural Health.

The post Watch: Jonathan Emord on Why the Arizona Statement Is So Important first appeared on Alliance for Natural Health USA - Protecting Natural Health.

The post The Window for Change Is Open—Don’t Sit This One Out first appeared on Alliance for Natural Health USA - Protecting Natural Health.

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.