A pending FDA guidance on new dietary ingredients underscores why the agency’s GRAS overhaul could determine which natural products reach market—and which are eliminated. Action Alert!

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THE TOPLINE

• FDA guidance addressing the identity and safety evidence required for new dietary ingredients is undergoing White House review.
• GRAS determinations and new dietary ingredient notifications are closely connected, underscoring why GRAS reform has such a major impact on the supplement industry.
• FDA must increase transparency without creating regulatory burdens, suppressing innovation, and reducing consumer access.

The Food and Drug Administration (FDA) is scheduled to release another set of guidance documents that will control how innovative dietary ingredients reach the market.

A guidance titled New Dietary Ingredient Notifications and Related Issues; Identity and Safety Information About the NDI has been under review at the White House Office of Information and Regulatory Affairs since June 2, 2026.

The guidance is not yet public, so we don’t know the details. But its title suggests that FDA will address the evidence companies should provide to establish a new dietary ingredient’s identity and demonstrate safety. We’re concerned these standards could significantly affect consumer access to a large swath of supplements.

The NDI Bottleneck

Under federal law, a “new dietary ingredient,” or NDI, is generally an ingredient that was not marketed as a dietary supplement in the United States before October 15, 1994.

Unless an exception applies, a company must notify FDA at least 75 days before marketing a supplement containing an NDI and provide evidence that the product can reasonably be expected to be safe.

The danger we’ve been calling out all along with regard to the NDI guidance is that the FDA is trying to turn what is meant to be a pre-market notification system into a de facto pre-market approval system. When companies can’t meet what will likely be absurd safety requirements the FDA demands, consumers will lose out on products that can support health. We’ve outlined the many problems with the NDI guidance elsewhere.

Why GRAS Matters to Supplements

GRAS stands for “Generally Recognized as Safe.” Although primarily a food pathway, it can also provide a route for supplement ingredients.

The GRAS and NDI pathways are connected. An NDI generally does not require a notification if it has been used in the conventional food supply as a lawful food ingredient—including a GRAS substance—and will be used in the supplement without chemical alteration.

For example, imagine a beneficial plant extract is first used in a nutrition drink after being determined to be GRAS. If the same extract is later sold in a capsule without being chemically altered, the company generally would not need to file a separate NDI notification. This pathway helps turn promising food ingredients into convenient supplements.

We know that many companies make use of the GRAS pathway instead of the NDI pathway because in practice they get less pushback from the FDA. One analysis found the FDA deemed approximately 30 percent of NDI submissions as favorable, whereas the agency viewed 75 percent of GRAS notifications as favorable.

This is all to say that changes to the GRAS system could make that route more difficult and expensive—and that is exactly what is happening.

FDA has now proposed requiring companies to notify the agency whenever they conclude that a substance is GRAS. As we explained in our previous coverage and our white paper, ending undisclosed self-GRAS determinations would provide welcome transparency. But FDA estimates that a full GRAS notice takes approximately 180 hours to prepare. Its proposal also retains an outdated exception focused on natural ingredients consumed before 1958 and processed using methods conventional at that time. This could subject modern extracts, standardized botanicals, concentrates, and fermented ingredients to burdens designed for genuinely novel substances.

And that’s the major problem with the proposed rule: it treats safe, natural, healthy substances the same as novel ingredients. There is no nuance, just heaps of bureaucratic red tape that will take away your supplements.

If FDA simultaneously tightens NDI evidence requirements and makes the GRAS pathway more difficult, responsible innovators could be trapped between two costly regulatory routes. Consumers could face fewer products, higher prices, and a market dominated by companies able to absorb those costs.

The final GRAS rule should create a lower-burden pathway for ingredients with at least 30 years of credible safe use, recognize appropriate modern processing methods, and protect timely filers from FDA delays.

The public has until December 9, 2026, to comment on the proposed GRAS rule. We are in the process of preparing our substantive comments to the agency. If you haven’t already, leave your own message on the official GRAS docket telling the FDA to adopt risk-based GRAS reforms that protect transparency, natural-product innovation, and consumer choice.

Action Alert!

The post GRAS/NDI Double Trouble for Your Supplement Access first appeared on Alliance for Natural Health USA - Protecting Natural Health.

Prescriptions of GLP-1 drugs to children under 12 are rising at extraordinary speed. Are we turning a childhood health crisis into a lifetime pharmaceutical market?

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THE TOPLINE

• A national study found that 20,282 US children ages 8–11 with obesity but not diabetes received a GLP-1 prescription between 2019 and June 2026—a 310-fold increase.
• Wegovy’s safety and effectiveness for weight reduction have not been established in children under 12, and its adolescent evidence rests largely on one 68-week trial.
• New pancreatitis and vision warnings, together with surging FDA adverse-event reports, reinforce the need for stronger long-term surveillance.

The GLP-1 boom is moving into the elementary-school years.

A new Pediatrics study examined more than 3.5 million children ages 8–11 with obesity but not diabetes. Researchers found that 20,282 received prescriptions for drugs such as Saxenda, Wegovy, and Zepbound between 2019 and June 2026, representing 310-fold increase.

Use remained uncommon overall—about 0.6 percent—and nearly 94 percent of recipients had severe obesity. These children are not simply seeking a cosmetic shortcut. They face a genuine health crisis and deserve a pathway to good health.

But recognizing the problem does not require accepting the pharmaceutical industry’s preferred answer: placing ever-younger children on drugs that may need to be continued indefinitely while the conditions making them sick remain largely untouched.

Prescribing Is Racing Ahead of the Evidence

GLP-1 drugs can produce substantial weight loss and improve metabolic markers. For some high-risk patients, the benefits may be significant. The concern is the widening gap between adoption and long-term safety evidence.

Wegovy’s current US label states that safety and effectiveness for weight reduction have not been established below age 12. Its approval for those over the age of 12 rests largely on a 68-week trial of just 201 patients—hardly conclusive evidence against the possibility of exposure lasting decades.

Adverse effects were also common. In the trial, 62 percent of treated adolescents reported gastrointestinal reactions, compared with 42 percent receiving placebo. Nausea affected 42 percent and vomiting 36 percent. More than half experienced a maximum heart-rate increase of at least 20 beats per minute.

New Safety Warnings

And regulators continue to identify new risks. In January 2026, the UK medicines regulator strengthened class-wide pancreatitis warnings after receiving 1,296 reports, including 24 cases of necrotizing pancreatitis and 19 fatal reports.

Vision concerns have also arisen. The European Medicines Agency concluded that non-arteritic anterior ischemic optic neuropathy, or NAION—a condition that can cause sudden vision loss—is a very rare side effect of semaglutide. In July 2026, Australia added class-wide warnings for this potentially blinding condition.

Preliminary research presented at the 2026 American Academy of Orthopaedic Surgeons found that, at five years, GLP-1 users had higher recorded rates of osteoporosis and gout. This was an observational conference study, so more research is needed to confirm this concerning safety signal.

What we see in the news tells a different story of side effects. We hear about an ever-expanding list of the benefits of GLP-1 agonists. They improve heart health, protect your kidney, liver, and joints, give you better sleep, boost brain health—and maybe even slow aging.

Nearly 300,000 FDA Cases

But there is a story to be told about the harmful effects of these drugs.

At ANH-USA, we reviewed the FDA adverse-event database for semaglutide, tirzepatide, and liraglutide. The search returned 295,785 cases. Annual reports rose fifteen-fold between 2021 and 2025, from 5,451 to 82,419. Nearly 82 percent were received from 2023 onward, and gastrointestinal disorders appeared in roughly one-third.

These reports do not prove causation or reveal how frequently adverse events occur. The FDA warns that its system includes duplicate, incomplete, and unverified reports, while rising drug use also drives reporting. But the steep increase still demands stronger surveillance and better age-specific data—particularly when these drugs are moving toward younger patients.

A Lifetime-Treatment Model

GLP-1 drugs suppress appetite and slow gastric emptying while they are taken; they do not repair the food environment or build lasting metabolic resilience. A 2025 meta-analysis found significant weight regain beginning eight weeks after anti-obesity drugs were discontinued.

That creates a dependency problem: a prescription in childhood can become an implicit proposal for years or decades of treatment.

These drugs may have a role for selected high-risk patients, but they cannot substitute for prevention. America cannot inject its way out of a broken food system, sedentary living, and collapsing metabolic health. The 310-fold prescribing increase is a warning—not about the children, but about the direction of our healthcare system.

People taking a GLP-1 medicine should not stop or change treatment without consulting a qualified healthcare professional.

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The post The GLP-1 Generation: Are We Medicating Childhood Obesity Instead of Preventing It? first appeared on Alliance for Natural Health USA - Protecting Natural Health.

ANH founder Rob Verkerk explains why outdated food-drug definitions restrict consumer access to natural health options—and how a more proportionate system could better protect both choice and safety.

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The following is a transcript of an interview with Rob Verkerk, PhD, and ANH-USA’s Editorial Director, Michael Ames-Sikora.

Today I’m speaking with ANH founder and executive director Rob Verkerk about Beyond Binary Food-Drug Definitions: A Case for US and EU Modernization. Accepted for publication on July 20, 2026, and expected to appear in spring 2027, the paper was written by Rob as lead author and principal investigator, ANH legal researcher Chimnonso Onyekwelu, and our general counsel, Jonathan W. Emord—the “FDA Dragon Slayer,” who holds the record for the most legal victories against the agency. At its heart, the paper asks whether laws that force products into either a food or drug category still make sense when modern science shows that foods and natural compounds can have meaningful effects on health. In the conversation that follows, Rob and I discuss the paper’s key ideas, what they mean for consumers, and how we can build a better regulatory system.

Mike Ames-Sikora: Rob, you’re the founder and executive director of ANH. What made you want to tackle the way foods and drugs are defined?

Rob Verkerk: Mike, it’s really been over 25 years that I have seen that definitions are the mechanisms that Big Pharma and Big Food use to control what you can buy, what you can say. Particularly in the drug area, the drug definition controls the therapeutic space. It also really impacts what someone can buy, what you can be told about a product, and also whether or not it’s going to actually be found in a practitioner’s toolkit.

Ames-Sikora: Your paper argues that the law draws on increasingly artificial lines between foods and drugs. Why should anyone outside the legal profession care? And why should the average consumer care?

Verkerk: Well, our paper goes back over 100 years, looking at 18 different jurisdictions around the world, but focuses especially on the US and the European system. And when you take that kind of bird’s-eye view of what has been going on for over a century, you see that the initial justification for having regulation around foods and drugs was extremely laudable. It was very well-meaning. It really was about protecting consumers from dangerous goods, mis-sold goods, mislabeled goods, and whether they were drugs or of foods. What you see over the passage of time is this sleight of hand in which essentially the definitions have now become mechanisms to control specific categories of products for the benefit of those corporations. So we now have a rather ridiculous situation where essentially foods and drugs, fast foods, and ultra-processed foods are amongst the most dangerous foods that we consume, yet they’re perfectly legal. They fit those definitions. They can be unsafe. And we’ve got a situation where drugs that are licensed, that can carry claims like safe and effective, are amongst the leading causes of death in industrialized societies. Peter Gøtzsche’s work suggests that the that drugs may in fact be the 3rd leading cause of death in industrialized societies like the US or Europe.

Ames-Sikora: Yeah, and my understanding of that statistic too is that these are not abused drugs. These are properly prescribed medications that are used as intended.

Verkerk: 100%. Yeah, properly prescribed medications. The 3rd or 4th leading cause of death in industrialized countries.

Ames-Sikora: So you argue that these definitions can protect the pharmaceutical industry’s hold on the therapeutic market. How does that work?

Verkerk: Essentially, if you want to make any kind of disease treatment, disease prevention claim, you have to be channeled down the drug pathway. So it doesn’t matter how much science you’ve got to show that turmeric or rosemary or black cohosh, name any botanical or nutrient out there, it doesn’t matter how much science says this might reduce your risk of disease, you are disallowed from making that claim. Yet if you’ve gone through the drug pathway, you’ve essentially paid to play in order to get your license. You can shout your claim from the rooftop. And in fact, what’s even more interesting, you can shout claims that the science that got you the license never made at all, given that you can also make off-label claims. So generally speaking, drug companies will get a specific claim, that’s their pay-to-play license, but then medical doctors will often use the products off-label. Now, if you’re selling a nutrient, even if it has similar effects, even if the science is comparable, even if the science is stronger than the drug with little or no side effects, you cannot make the claim because you cannot discuss the product in any way in relation to the diagnosis, treatment, or prevention of disease.

Ames-Sikora: Yeah, we saw this with the cherry and walnut growers. I remember covering that for ANH over the years. So what does this mean for prevention and for people who already live with chronic disease?

Verkerk: Well, the biggest problem is that it means they can’t get the products that are most likely to be effective. The reality is that if we talk about prevention, primary prevention is actually trying to stop a disease happening in the first place. And we know the science around primary prevention is primarily around non-pharmaceutical interventions. So things like getting people to eat the right food at the right time in the right place in the right way, getting people to move in the right way or to respond to stress in a way that doesn’t harm them, or to spend less time sitting. These are all non-pharmaceutical interventions, and there’s very, very good science around them. Yet what’s happened is that the primary prevention space increasingly is dominated by pharmaceutical interests. So, you know, the use of vaccines to prevent disease, putting people on lifelong drug use, for the use of statins amongst those over 50, for example, which is a fantastic money spinner if you’re a statin manufacturer. The evidence is relatively weak in the sense that it doesn’t work for everyone, and for some people the side effects can be atrocious. Yet that’s viewed as a standard approach, either as primary or secondary prevention.

So if you look at the incredible science that shows how micronutrients and botanical substances and other substances taken from nature’s treasure trove can be used to bring our body into balance–let’s remember that it’s not usually the drug or even the botanical, the nutrient that itself is creating the shift. What it does is change the environment or the pathway in order to allow the body to self-heal. We sometimes forget how much work our body, our immune system, our neurological system, our endocrine system is doing to get things back into order. And that’s one of the ways in which non-pharmaceutical interventions can be really, really critical for prevention. for lifelong prevention that would have a massive impact on reducing chronic and degenerative disease. But these definitions prevent anyone from talking about it, so it doesn’t find its way into the mainstream approach or vocabulary.

Ames-Sikora: What has modern nutrition science revealed that these legal categories struggle to accommodate?

Verkerk: Well, nutrition science has moved on a great deal. That’s one of our primary arguments in the paper, that essentially there’s a whole catalogue of science that shows that nutrients can have a profound effect on disease. Governments recognize this. Mike, you’ll know in our FDA Modernization Act challenge that is running currently, where basically we presented the FDA and the Department of Health and Human Services with over 100 different nutrient disease claims that government agencies themselves are making. There’s a specific clause in the FDA Modernization Act that was written by none other than Jonathan Emord in the 1990s that basically said, look, you’ve reserved any kind of disease claim to the category of drugs. But because there are nutrients out there, how about a system that if you, as the authoritative agency, determines that the science says that there is a nutrient-disease relationship, then everyone can use that. That would avoid companies having to do lots of research on nutrients and disease, and then at the end of that, possibly after having spent hundreds of thousands of dollars, to be told, sorry guys, you’re a drug, you can’t sell the product.

So this is a fantastic pathway. Now there are— we found over 400 of these claims that the National Center for Complementary and Integrative Health, the Office of Dietary Supplements, the CDC, even the FDA are making. And we presented these to the HHS and said, look, we believe that these should be able to be used as authoritative statements under the clause in the FDA Modernization Act. And they’ve said, sorry, we have a little disclaimer that says these cannot be regarded as authoritative statements under the FDA Modernization Act. So it’s a crazy situation that says we are authorities that are making authoritative statements, but in this case, we’re not going to regard these as authoritative statements. So at the moment, they’re making none. And there’s still censorship of any nutrient disease claims. So we’ve got to push that particular roadblock over.

Ames-Sikora: You know, Rob, critics might hear this and assume that you’re calling for less regulation, which could expose them to unsafe supplements or even false hope. How would your proposed approach continue to protect consumers from unsafe products and exaggerated claims?

Verkerk: Well, basically, you’ve got to match the regulatory burden to the risk and the strength of the claim to the evidence. So there’s nothing that we’re doing in terms of modernizing definitions. That’s what we’re proposing—the definitions now are outdated and they don’t match the rapid development of nutritional science and health sciences. So essentially, what we would argue is that there is no additional risk at all. In fact, quite the reverse. It would reduce the risk because more people would be encouraged to take safer products that would essentially have a big impact on reducing their health risks, as well as ensuring that that there are adequate regulations already available that prevent companies from selling unsafe products. So yeah, unfortunately, that argument doesn’t hold a lot of water. And I think another part of our argument generally around some of the other initiatives that we have is that there’s always going to be a degree of uncertainty around any claim. And we strongly advocate this idea of communicating the amount of uncertainty clearly. And of course, Jonathan Emord was central in developing the qualified health claim regimen in the United States, and that’s what it’s all about.

So it’s about accurate communication of the science, and at the moment the definitions prevent that.

Ames-Sikora: What would a more sensible system look like? And if policymakers adopted one central recommendation from your paper, what should it be?

Verkerk: It should be: modernize the definitions. We need to see the food definition broadened. We’ve known since the time of Hippocrates that foods can have medicinal effects. There is copious amounts of evidence for that. And of course, the drug definition massively overlaps the food definition with the exception of very specific exemptions. So the Dietary Supplement Health and Education Act obviously gives an exemption for dietary supplements to make structure-function claims, but they cannot in any way relate to disease. Now, we need to have a system that allows claims about effects that will also be related to disease, but the system needs to be about proportionality. So you need proportionate assessment and not just an automatic push for products that are therapeutic in action to only be forced down the drug pathway.

Ames-Sikora: Well, great. Well, I look forward to seeing this paper finally see the light of day and for it to get a reaction from the public and the scientific community.

Verkerk: Yes. In essence, Mike, what the paper is about is laying down the intellectual academic foundation for why we need to change definitions. You’re going to be very involved, as I am, as all of us will be, in the advocacy program that actually works with Congress and with senators in order to change these definitions. And the interesting thing, we’ve done a lot of work in terms of what modifications may need to be made to bring them in line with the science. And it doesn’t involve a complete rewrite of the definitions. In fact, sometimes it involves only very small changes, but they can have profound effects, and they will work for millions of Americans. And that’s the solution.

ANH-USA will launch a major advocacy program once the paper is published—and we’ll be looking for your support to push through amendments to various food and drug related definitions. Stay tuned!

The post Who Decides What Counts as Medicine? Rob Verkerk Explains How to Fix the Food-Drug Divide first appeared on Alliance for Natural Health USA - Protecting Natural Health.

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THE TOPLINE

• FDA missed its February 10 deadline to clarify which cannabinoids count toward the new 0.4-milligram-per-container limit and what constitutes a “container,” leaving hemp businesses unable to prepare for the December 2026 restrictions.
• The new definition threatens many non-intoxicating, full-spectrum CBD products—not just synthetic intoxicants.
• Congress should enact the Hemp Planting Predictability Act to delay implementation and the Cannabinoid Safety and Regulation Act to establish risk-based safety standards while preserving access to responsibly made hemp products.

The Food and Drug Administration (FDA) was supposed to publish critical cannabinoid lists and clarify key packaging rules by February 10. More than six months later, consumers, farmers, and responsible hemp businesses are still waiting.

FDA Misses a Mandatory Deadline

Congress created this confusion when it included sweeping hemp restrictions in the fiscal year 2026 appropriations law signed in November 2025.

The law gave FDA 90 days to publish three lists: cannabinoids that can occur naturally in cannabis, naturally occurring tetrahydrocannabinol (THC)-class cannabinoids, and other cannabinoids known or marketed to produce effects similar to THC. FDA was also directed to clarify what counts as a product “container.”

None of that information had been published as of August 2026, according to an updated Congressional Research Service analysis.

The law’s 0.4-milligram-per-container limit depends heavily on which cannabinoids are counted and how “container” is interpreted. Yet businesses are being expected to prepare for compliance without those answers.

Full-Spectrum Hemp Is in the Crosshairs

Unless Congress intervenes, the new federal definition of hemp is scheduled to take effect November 12, 2026. Many non-intoxicating, full-spectrum CBD oils naturally contain trace quantities of THC, which means these products could disappear under the new policy. We explained this further in previous coverage. Put briefly, the risk assessment underpinning these restrictions is deeply flawed and unscientific. It would be like banning coffee because caffeine at high doses can be harmful.

ANH-USA supports targeted restrictions on dangerous synthetic intoxicants, adulterated products, deceptive marketing, and sales to minors. But Congress should not use those legitimate concerns to eliminate responsibly made, non-intoxicating hemp products that adults choose for their personal wellness.

A One-Month Bridge Is Not Enough

Congress has recently approved a funding measure that would delay most of the hemp restrictions until December 11 while allowing the ban on synthetic derivatives to proceed. The last step is for President Trump to sign the bill into law, which he is expected to do. This is positive but still a stopgap measure.

The bipartisan Hemp Planting Predictability Act, S. 3686 and H.R. 7024, offers a more meaningful pause. It would extend the implementation period from one year to three years, giving Congress time to build a workable regulatory framework instead of forcing an industry-wide crisis.

Regulation Without Erasing Access

The stronger long-term path is the Cannabinoid Safety and Regulation Act, S. 3474, introduced by Senators Ron Wyden and Jeff Merkley.

The bill would establish manufacturing, testing, labeling, registration, and age requirements for cannabinoid products. It would create a federal pathway for cannabinoid dietary supplements and permit truthful, substantiated structure-function statements. It also provides mechanisms for removing dangerous synthetic and semi-synthetic cannabinoids from the market.

That is the distinction Congress must preserve: regulate products according to their actual risks, rather than treating trace amounts in natural hemp extracts like high-dose intoxicants.

FDA’s missed deadline shows why consumers cannot rely on agency promises alone. Congress must protect access explicitly in law.

Tell your members of Congress to support the Cannabinoid Safety and Regulation Act and the Hemp Planting Predictability Act. Consumers deserve safe, tested, clearly labeled products without losing access to the full spectrum of hemp’s natural compounds.

Action Alert!

The post FDA Misses Deadline as Sweeping Federal Cannabinoid Ban Approaches first appeared on Alliance for Natural Health USA - Protecting Natural Health.

A new HHS report on questionable medical billing is part of a broader—yet at times inconsistent—effort to challenge pharmaceutical influence, improve nutrition, lower healthcare costs, and shift federal policy toward prevention.

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THE TOPLINE

• A new HHS report alleges that hospitals used questionable diagnostic codes to obtain insurance reimbursement for expensive medical interventions, exposing how financial incentives can distort patient care.
• Over the last two years, HHS has also advanced food-dye reform, infant-formula testing, nutrition education, drug-price negotiations, price transparency, and prior-authorization reform.
• These actions represent meaningful progress, but HHS must apply its skepticism consistently—including when FDA policies threaten individualized, natural, and non-patentable treatments.

A new report commissioned by the Department of Health and Human Services (DHHS) examines how financial incentives, institutional ideology, and questionable billing practices may have driven children toward expensive, long-term medical interventions.

One underlying issue—pediatric gender medicine—is highly charged politically. But the systemic problem identified by HHS is much broader: hospitals and pharmaceutical companies can profit when otherwise healthy people become lifelong medical patients.

Among its findings, the report identified nearly $11 million in claims from 2015 through 2025 for puberty blockers given to patients between 13 and 17 under a diagnosis of “precocious puberty.” Yet that diagnosis traditionally applies when puberty begins before age eight in girls or nine in boys; treatment is generally discontinued around ages ten or eleven.

HHS acknowledges that its claims analysis provides “directional signals” requiring verification against medical records. But it raises a serious possibility: providers may have used a physical endocrine diagnosis to obtain insurance coverage for drugs prescribed for a different condition.

If confirmed, this is a stark example of how reimbursement can corrupt medical decision-making. But it is not the only area where HHS has begun confronting the forces that keep Americans dependent on an expensive, intervention-heavy healthcare system.

Shifting the Focus to Food and Prevention

HHS and USDA released new Dietary Guidelines for Americans in January 2026 emphasizing whole foods, protein, healthy fats, fruits, vegetables, and home-prepared meals while discouraging heavily processed foods and artificial additives.

HHS and FDA have also announced an initiative to phase out six widely used petroleum-based synthetic dyes through industry cooperation by the end of 2027. Because much of that initiative remains voluntary, its ultimate impact will depend on whether manufacturers fulfill their commitments. Nevertheless, major companies are already reformulating products, and FDA has approved several non-petroleum alternatives. The agency is also pressing manufacturers to remove Red No. 3 before its 2027 food deadline, although the decision to revoke that dye’s authorization was made before Secretary Kennedy took office.

Another meaningful step is Operation Stork Speed, FDA’s first comprehensive review of infant-formula nutrient requirements since 1998. In April 2026, FDA released results from testing more than 300 formula samples for heavy metals, pesticides, PFAS, phthalates, and other contaminants. Most showed undetectable or very low levels, but FDA says it is conducting follow-up testing and developing contaminant action levels.

HHS has also secured voluntary commitments from over 70 medical schools in 31 states to provide at least 40 hours of nutrition education—or a competency-based equivalent—beginning in fall 2026. The department developed 71 suggested nutrition competencies and dedicated $5 million to an NIH nutrition-education challenge. These are voluntary rather than mandatory, but they address a glaring weakness in conventional medical training.

Challenging Healthcare Costs and Bureaucracy

The administration has reached drug-pricing agreements with 26 manufacturers, which it says represent 89 percent of the branded-drug market. The agreements provide most-favored-nation pricing in state Medicaid programs and discounted direct-purchase options for selected medicines. This does not mean every American now pays the world’s lowest price for every drug, but it represents a real challenge to pharmaceutical pricing power.

CMS has also strengthened hospital price-transparency requirements, including disclosure of cash prices, insurer-negotiated rates, and consumer-friendly pricing for at least 300 shoppable services. During his first term, President Trump established landmark rules requiring hospitals and insurers to disclose their negotiated prices and give patients cost-estimation tools. Since then, compliance and usability problems have persisted. The current administration has now imposed additional hospital requirements based on actual payment data and proposed further reforms to make insurer information easier to locate, standardize and compare.

Meanwhile, participating insurers have eliminated approximately 11 percent of prior-authorization requirements—about 6.5 million fewer authorizations—and new federal deadlines require faster decisions for Medicare Advantage, Medicaid, CHIP, and federal Marketplace plans. Prior authorization remains widespread, but this is tangible progress.

The Test Is Consistency

Taken together, these initiatives suggest a welcome shift: toward prevention, better nutrition, greater transparency, lower drug prices, and closer scrutiny of medical institutions that profit from chronic intervention.

But HHS cannot challenge the medical-industrial complex selectively. The same department includes an FDA that continues to threaten access to compounded medicines, natural desiccated thyroid, peptides, homeopathy, and other individualized or non-patentable treatments. So far, our legal initiatives aiming to open up free speech about natural products and to protect homeopathy have, unfortunately, been stymied by HHS or the FDA, demonstrating how deep the institutional bias towards Big Pharma runs.

The new direction is encouraging. The real test will be whether HHS consistently chooses patient health, informed choice, and medical freedom over institutional power—wherever that power is found.

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The post HHS Takes Aim at the Medical-Industrial Complex first appeared on Alliance for Natural Health USA - Protecting Natural Health.

This article is adapted from a longer personal account first published by ANH International.

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THE TOPLINE

• I developed a suspected serious hypersensitivity reaction within days of starting allopurinol ahead of foot surgery.
• My experience raises difficult questions about informed consent, individualized risk, baseline testing, dosing and monitoring.
• We do not need a war between conventional and natural medicine. We need connected healthcare that puts the person before the protocol.

For most of my adult life, I have lived almost entirely outside the pharmaceutical model—not because of ideology, but because of experience.

In my twenties, I was diagnosed with multiple chemical sensitivity following severe reactions to pesticides, solvents and pharmaceutical drugs. A particularly serious reaction to the antimalarial drug Lariam reinforced my caution. For more than 30 years after that, I avoided prescription medicines.

Then, earlier this year, that changed.

A Motorcycle Injury Comes Back to Haunt Me

In 1995, I badly damaged my right foot in a motorcycle accident in Malaysia. Decades later, increasingly painful inflammation was interfering with walking and cycling. Imaging showed a protective mass around the damaged bone, along with what appeared to be urate crystals.

An orthopedic surgeon agreed to remove the mass and remodel the bone, but first recommended six months of allopurinol—a standard uric-acid-lowering drug—even though I had never suffered from gout.

Busy with work and a house move, I deferred to the specialist and obtained the prescription. Six days after starting the drug, while driving, seemingly out of nowhere, extraordinary cramps spread across multiple muscle groups. The pain felt as though acid had been poured into my muscles. I stopped the drug, but the reaction did not stop.

Over the following days came worsening muscle pain, rashes, skin sensitivity, numbness and neuropathic symptoms affecting my arms, hands and one leg. At night, the pain became so intense I couldn’t sleep and the only relief I could get was by getting up and walking.

My research, subsequently supported by a medical center in France, pointed toward a serious hypersensitivity reaction. I discovered that full-blown allopurinol hypersensitivity syndrome is rare—estimated at around one in 1,000 users—but can carry a disturbingly high mortality rate of 20–25 percent.

With guidance from Nasha Winters, ND, a member of ANH-USA’s board, I pursued testing for possible effects on my kidneys, liver, muscles and nerves, while supporting recovery through rest, hydration, nutrition and targeted natural compounds. Thankfully, the symptoms are beginning to ease, with the neuropathic ones—especially numbness in the hands and left thigh—being the slowest to improve.

The Questions Every Patient Deserves to Have Answered

This experience left me asking:

• Why was my history of extreme sensitivity to drugs and chemicals not explored in detail by the orthopaedic surgeon?
• Why did I not feel properly informed about the possibility of a severe reaction?
• Why were these kinds of severe reactions nowhere to be seen on the patient information leaflet accompanying the prescription.
• Why was there so little interest in my wider biochemical, metabolic and nutritional terrain?
• Could baseline testing, lower starting doses, gradual titration or closer monitoring have reduced the risk?

These are not fringe questions. FDA-approved prescribing information warns that allopurinol can cause serious and sometimes fatal reactions. Yet allopurinol is the preferred first-line, standard-of-care medication for managing chronic gout in the United States, as recommended by the Arthritis Foundation. For gout patients, it calls for baseline assessment of uric acid, blood counts, liver chemistry and kidney function, and notes that lower initial doses with gradual titration can reduce serious adverse reactions.

Known Does Not Mean Normal

We have become far too accustomed to the phrase “side effect.” Television drug ads recite terrifying lists so routinely that they fade into background noise.

But a “side effect” can mean pain so severe you cannot sleep. It can mean being unable to walk comfortably or drive safely. It can mean wondering in the middle of the night whether something is going seriously wrong inside your body. A “side effect” may or may not include a hypersensitivity reaction—it depends who you ask.

A reaction does not become normal because it is listed in fine print. “Known” does not mean trivial—and it should never erase the obligation to consider susceptibility, alternatives and individual context.

Better Medicine Uses the Best of Both Worlds

Natural medicine cannot repair the structural damage in my foot. I still need a skilled surgeon. Modern imaging, laboratory medicine, emergency care and surgery are extraordinary achievements.

But imagine a system in which the surgeon was also deeply interested in the patient’s physiological, metabolic and nutritional terrain. Imagine conventional clinicians working routinely with professionals trained in nutritional, functional and natural medicine.

That would not be “alternative” medicine. It would simply be better medicine.

Patients must be partners, not passive recipients. Clinicians must see the individual before the protocol. And when suspected adverse reactions occur, they must enter the safety record. In the United States, patients and healthcare professionals can report them directly through FDA MedWatch. Clinicians are not required to file these reports, so patient reporting matters.

We do not need competing medical tribes. We need connected health systems that combine the safest and most appropriate tools available—from the operating room and diagnostic laboratory to the food we eat, the way we live and the natural world.

That is the future of healthcare I want to see—and the future ANH is working to create.

If you have suffered an adverse reaction to a drug or know someone who has, it is important to report the reaction. Find out how to do it via FDA’s MedWatch portal.

Please share this article widely so more patients recognize that informed consent and adverse event reporting are rights, not optional extras.

The post My Adverse Drug Reaction—and the Healthcare Lesson We Can’t Ignore first appeared on Alliance for Natural Health USA - Protecting Natural Health.

As animal health shifts toward pharma and biotech-driven interventions, basic determinants like nutrition, exercise and stress are being sidelined despite their immense impact on both health-span and lifespan.

Original article by Melissa Smith, Outreach & Communications Officer, ANH International

Abbreviated version below edited by Mike Ames-Sikora, Senior Editor, ANH-USA. Read the full version at ANH International

Listen to the audio version of this article:

THE TOPLINE

• Animals are increasingly developing the same chronic diseases as humans, driven by factors such as ultra-processed diets, inactivity, toxin exposure, stress and intensive farming conditions.
• Animal health is becoming more pharmaceuticalized, with growing use of drugs, novel vaccine technologies and biotech platforms, while questions remain around long-term safety, transparency and food-chain exposure.
• We need a prevention-first approach, prioritizing species-appropriate nutrition, movement, lower toxin exposure, ecological health and resilient farming systems over managing disease primarily through technological and pharmaceutical intervention.

Something has gone quietly wrong in the lives of our precious pets and livestock. Dogs are developing obesity, type 2 diabetes, cardiovascular disease and cancer at rates that would have seemed extraordinary a generation ago. Cats are being prescribed thyroid medication and insulin. Dairy cows are suffering metabolic disorders with increasing frequency. And now, a San Francisco biotech startup is on the cusp of becoming the first company in history to bring a longevity drug to market— not for humans, but dogs.

This is not simply about devoted pet owners and medical progress. It’s a discussion about how the same forces driving the chronic disease epidemic in humans are now operating across the entire animal world — and how the pharmaceutical industry has identified this as one of the most lucrative growth markets of the coming decade. It also digs into the introduction of novel vaccine technologies into the animal health space that could potentially enter the human food chain, a global governance framework positioning animals, under the World Health Organization’s (WHO) ‘One Health’ initiative, as disease reservoirs requiring pharmaceutical management, along with the explicit use of companion animals as a stepping stone to human drugs. These threads are not separate. They are woven from the same cloth.

Animals Are Mirroring Human Diseases

A peer-reviewed study published in late 2025 documented a sharp global rise in non-communicable (chronic) diseases in animals — not just pets, but livestock and even wildlife under human care. The conditions were striking in their familiarity: obesity, type 2 diabetes, cardiovascular disease, degenerative joint disease and cancer, all increasing across species.

The factors identified as driving this are precisely those driving the human chronic disease crisis: ultra-processed diets, reduced physical activity, environmental pollutant exposure, chronic stress and selective breeding that prioritizes commercial traits over physiological resilience.

The same wave of precision-fermented foods that are entering the human food supply are starting to enter animal foods as well.

All chronic disease states have root causes. They are not simply the inevitable fate of an ageing animal. In nature, animals live well until they pass. They do not spend the last third of their lives limping with chronic disease. But, as with humans, well animals are of no interest to the pharmaceutical industry.

The Technology vs Nature: saRNA Vaccines and the Food Chain Question

We’re also seeing the rapid introduction of self-amplifying RNA (saRNA) vaccines into companion animals and livestock, with little public debate about long-term implications or entry into the human food chain. Here’s the kicker. These technologies are already in use!

Unlike conventional vaccines, saRNA constructs contain replication machinery derived from alphaviruses, allowing the RNA to amplify itself inside cells and prolong antigen production from very small doses. This increased biological activity is central to the technology’s commercial appeal, but also raises questions about biodistribution, persistence, reproductive transfer and long-term exposure that remain insufficiently studied in food-producing animals.

Regulators argue that withdrawal periods prevent residues entering the food chain, but these frameworks were designed for conventional pharmaceuticals rather than self-amplifying genetic constructs. Publicly available long-term toxicology and biodistribution data remain limited, particularly regarding repeated exposure across industrial farming systems.

Another problem is that veterinary approval pathways are often faster and less precautionary than those used in human medicine, creating incentives to scale novel biotech platforms first through animals before wider human application. Once deployed across livestock systems, exposure expands from millions of animals to entire populations of consumers — without labelling, informed consent or long-term post-market evidence.

This reflects a broader pattern: increasingly complex biological technologies are being introduced at industrial scale before foundational questions about necessity, transparency and long-term safety have been properly answered, and before comparative effectiveness research has been conducted on less intrusive alternatives like nutrition, physical activity, and stress reduction.

The Framework: One Health and Pharmaceutical Governance

These developments are not occurring in isolation. They are unfolding within the rapidly expanding framework of “One Health” — the WHO-backed model that links human, animal and environmental health into a single global management system.

On the surface, the idea sounds reasonable: human and animal health are clearly interconnected. But One Health is not simply a scientific observation. It is also a governance model, increasingly tied to pandemic preparedness, biosecurity surveillance and coordinated pharmaceutical intervention across species.

Under the One Health framework, animals are increasingly viewed primarily through the lens of pandemic risk. This creates a powerful institutional justification for expanding vaccine platforms, genomic tracking and novel biotech interventions throughout both companion animals and livestock.

The concern is that One Health risks becoming less about improving the underlying health of ecosystems and more about building a permanent infrastructure for pharmaceutical management at population scale.

Industrial farming, environmental toxicity, biodiversity loss and habitat destruction drive chronic disease and zoonotic risk, yet receive far less attention than surveillance and pharmaceutical responses. From an ANH perspective, One Health increasingly manages the consequences through centralized monitoring and rapid vaccine deployment rather than addressing root causes through resilient food systems, metabolic health, ecological restoration and prevention.

Prioritizing Animal Health

We already know a great deal about what keeps animals healthy: species-appropriate natural, evolutionary-rational nutrition, minimal ultra-processing, physical activity, reduced toxin exposure, lower chronic stress and greater genetic resilience. For livestock, in addition to that list, farming conditions themselves — crowding, confinement and feed quality — are primary determinants of health outcomes.

The same principles apply to humans. But prevention is far less commercially attractive than lifelong treatment.

The ‘System’ at Work

The underlying cycle is consistent: industrial systems generate chronic disease, pharmaceuticals manage it, and regulation accelerates adoption.

Pet medicalization points to a broader shift—towards treating ageing, immunity and metabolism as conditions requiring continuous technological control rather than outcomes of lifestyle and environment. What is tested in animals today anticipates how human health will be defined tomorrow. The counter-position is preventive health rooted in evolutionary rational nutrition, movement, stress management and environmental integrity.

Please circulate this article among your networks.

The post Is Your Pet Being Exploited to Aid Pharma Profits? first appeared on Alliance for Natural Health USA - Protecting Natural Health.

The FDA under the leadership of Acting Commissioner Kyle Diamantas is poised to eliminate access to compounded natural desiccated thyroid. For patients who depend on individualized thyroid treatment, the consequences could be devastating. Action Alert!

Listen to the audio version of this article:

THE TOPLINE

• FDA is maintaining its position that natural desiccated thyroid (NDT/DTE) is a “biologic”, not a conventional drug, which means compounded NDT would not be permitted. 
• The policy could affect a large patient population: FDA estimates about 1.5 million patients received animal-derived thyroid prescriptions in 2024; some patients depend on NDT because synthetic thyroid medicines or standard commercial formulations do not meet their individual needs.
• We must urge Congress to pass the Protecting Equal Access to Thyroid Act of 2026 (PEAT Act, H.R. 8630), which would prevent a medicine from being classified as a biologic solely because it contains a clinically inactive protein, preserving a legal pathway for compounded NDT.

The Food and Drug Administration has issued a new statement on “unapproved” animal-derived thyroid medications, often called desiccated thyroid extract (DTE) or natural desiccated thyroid (NDT).

In an August 5 letter to industry, FDA said it is still working on guidance explaining how it plans to enforce its policies for these medicines and how manufacturers might seek approval for them.

Crucially, the FDA has reiterated that animal-derived thyroid medicines are biological products (“biologics”) and therefore cannot legally be compounded. Unless Congress acts, patients could lose access to compounded NDT as well as other commercially available products.

Why Is NDT Under Threat?

Millions of Americans rely on thyroid hormone replacement, and FDA estimates that about 1.5 million patients received prescriptions for animal-derived thyroid medicines in 2024.

For some patients, standard synthetic thyroid drugs work well. But they do not work for a significant share of the over 30 million Americans with hypothyroid conditions. We’ve explained why in prior articles.

Some patients feel best on NDT products such as Armour Thyroid. Others rely on compounded NDT because they need a dose, formulation, or combination that commercially manufactured products do not provide. The FDA’s actions threaten access to both kinds of products.

As ANH has previously explained, FDA is treating NDT as a biologic because it is derived from animal thyroid tissue and contains proteins, including thyroglobulin. Biologics are governed by a different regulatory law than conventional drugs. But the FDA’s interpretation is in our view simply incorrect. As ANH has pointed out, thyroglobulin is not what gives NDT its therapeutic effect. The active thyroid hormones are primarily T4 and T3 and these are incredibly well and easily characterized. FDA affirms that biologics have to be treated differently to conventional, synthesized drugs because “most biologics are complex mixtures that are not easily identified or characterized”. This reasoning just doesn’t apply to NDT.

Traditional pharmacy compounding is permitted for drugs under the Federal Food, Drug, and Cosmetic Act. But FDA’s position is that NDT falls under the Public Health Service Act instead. In FDA’s view, that means compounded NDT is illegal.

So even if a pharmaceutical company eventually wins FDA approval for a commercial NDT product, that would not necessarily protect patients who need customized compounded versions. Those patients could simply lose their medicine.

This Is About Real Patients, Not Regulatory Categories

For someone who has finally found a thyroid treatment that works, being forced to switch is not a minor inconvenience.

Thyroid treatment can be highly individual. Even small changes in dose or formulation can mean a return of fatigue, brain fog, weight changes, mood problems, temperature sensitivity, and other symptoms that can make everyday life difficult.

Patients who have spent months or years working with their doctors to become stable should not suddenly be told that their treatment is unavailable because FDA has placed it in a different regulatory box.

These issues are all-too-real for many patients, including ANH’s own Meleni Aldridge. Check out the clip below from our upcoming podcast series, The Mike Drop.

The goal should be safe, high-quality NDT with room for doctors and patients to choose individualized treatment when needed. Instead, FDA bureaucrats are replacing the clinical decision-making of doctors and patients.

Congress Can Stop This

The Protecting Equal Access to Thyroid Act of 2026 (PEAT Act, H.R. 8630) directly addresses the legal argument FDA is using against compounded NDT.

The bill would make clear that a medicine cannot be classified as a biological product solely because it contains a clinically inactive protein.

If Congress passes the PEAT Act, it could help preserve a pathway for compounded NDT and protect patients from being forced off treatments that work for them.

Take Action Now

Patients should not have to choose between accepting a treatment that does not work for them and going without the medicine they depend on.

FDA has made its position clear. Now Congress must act to protect access to natural thyroid medicine before patients lose it.

Action Alert!

The post FDA Doubles Down on Threat to Natural Thyroid Access first appeared on Alliance for Natural Health USA - Protecting Natural Health.

Vaccine choice only works when government recommendations, evidence, and potential conflicts are communicated clearly and consistently with sufficient transparency. Recent and past comments by HHS Secretary Kennedy don’t meet these standards and likely exacerbate public confusion and polarization.

Listen to the audio version of this article:

THE TOPLINE

• In a heated CNN interview, HHS Secretary Robert F. Kennedy Jr. endorsed measles vaccination.
• HHS should explain why it is pursuing separate measles, mumps, and rubella vaccines, what uncertainties remain around timing and sequencing, and whether policy changes reflect new evidence or different risk-benefit judgments.
• We need consistent, conflict-free vaccine policy focused on choice and disclosure, including transparency about manufacturers, federal funding or procurement, financial interests, and the evidence used to evaluate new vaccine options.

During a contentious CNN interview, HHS Secretary Robert F. Kennedy Jr. gave a clear endorsement of measles vaccination:

“Parents should get their children vaccinated for measles. A measles vaccine is effective. It stops measles in about 97 percent of the cases. People should get vaccinated.”

ANH-USA has no objection to Kennedy explaining why he believes a vaccine is effective or recommending it to families. The issue is that this message sits alongside broader administration policies that raise questions about how vaccines are combined, timed, sequenced, and recommended.

President Trump’s recent executive order directs HHS to expand options for administering core childhood vaccines, beginning with measles, mumps, and rubella, as separate vaccines rather than only as combination products. It also calls for further examination of vaccine timing and sequencing. In June 2025, Kennedy removed all 17 members of the Advisory Committee on Immunization Practices, adding committee members who were proponents of choice. He oversaw a narrowing of COVID-19 and newborn hepatitis B vaccination recommendations and later attempted to overhaul the childhood vaccination schedule.

ANH supports many of these reforms. Our position is simple: parents and patients should be able to make informed medical choices without coercion or unnecessary government interference.

But for informed choice to be meaningful, the administration must communicate its position clearly and consistently. If Kennedy pulls policy in one direction in some instances and in the opposite direction in others, that whiplash risks confusing the public and undermining the administration’s ability to translate its agenda into political success.

There is no inherent contradiction between saying that measles vaccination can prevent disease and saying that parents deserve greater flexibility over how vaccines are administered.

The effectiveness of a vaccine can be usefully expressed as relative (rather than absolute) effectiveness for a given subsector of the population. Prevention or treatment against any disease is very rarely, if ever, completely effective. Even when there are adequate data to demonstrate relative or absolute effectiveness, separate questions remain about combination products, simultaneous administration, timing, and whether every child should follow exactly the same schedule.

Choice Requires Information

The administration should explain more clearly why it is pursuing these changes. If HHS believes separate measles, mumps, and rubella vaccines would provide families with useful alternatives, it should say why, supporting its statements with plausible scientific data.

If officials believe vaccine timing or sequencing deserves further study, they should explain what questions remain open.

If recommendations are changing, the public should understand whether those changes reflect new evidence, different risk-benefit judgments, or a reassessment of previous policy.

Where the science remains uncertain, officials should say so. Choice without information is not meaningful choice.

Kennedy’s own history makes this especially important. He has previously been highly critical of vaccine policy and raised concerns about MMR. His more recent statements have been far more supportive of measles vaccination.

Does Kennedy now believe the existing MMR vaccine is generally safe and effective? Does he support separate vaccines primarily because families deserve more options or will reduce the relative risk of adverse reactions? Or does he believe combination products raise unresolved concerns?

Transparency Must Go With Choice

If and when separate vaccines are developed or introduced, HHS should also be transparent about the manufacturers involved, any federal grants or procurement commitments, relevant financial or advisory interests, and the evidence used to assess new products.

That transparency is especially important because Merck, one of the two companies currently supplying MMR vaccines in the United States, has appeared in President Trump’s own financial disclosures. While there is no evidence that the administration’s policy was designed to benefit Merck—or that Merck will ultimately manufacture separate measles, mumps, or rubella vaccines—the potential for financial interests to overlap with future federal decisions makes full disclosure essential. Any grants, contracts, purchase guarantees, investments, or other ties involving manufacturers and administration officials should be made public.

Health freedom means giving people access to the evidence, meaningful alternatives, and the ability to make their own medical decisions.

The executive order is a positive step toward greater flexibility and choice. Kennedy should now make that philosophy clear and consistent if he wants to accomplish his policy goals while reducing public confusion and polarization.

Please share this article widely in your networks.

The post RFK Jr. and MMR: Vaccine Choice Demands Consistency and Transparency first appeared on Alliance for Natural Health USA - Protecting Natural Health.

FDA’s proposed GRAS reform could deliver long-overdue transparency to what’s in America’s food supply—but unless the agency modernizes its approach to natural ingredients, consumers may pay the price in reduced innovation, choice, and access. Action Alert!

Listen to the audio version of this article:

THE TOPLINE

• FDA’s proposal would end undisclosed “self-GRAS” determinations by requiring companies to notify the agency and making GRAS notices and supporting information publicly available.
• Its exemption for traditional ingredients is tied to pre-1958 use and processing methods, potentially treating modern extracts, concentrates, fermented ingredients, and standardized botanicals much like genuinely novel chemicals.
• A better final rule would protect the streamlined pathway for existing ingredients, prevent companies from being penalized for FDA processing delays, and create lower-burden pathways for ingredients with a credible history of safe use.

With GRAS reform being a headline priority for Secretary Kennedy shortly after he came into office, FDA has finally moved to reform a key pathway for how certain food ingredients come to the market known as the GRAS (Generally Recognized as Safe) system. That is overdue. But the agency’s proposed cure—delivered as a proposed rule on August 10—could punish the natural product sector. Simply put, these changes could make it harder to access a variety of functional foods, health foods, and ready-to-drink products that millions of consumers rely on.

Reacting to the rule, ANH’s founder and Executive Director, Rob Verkerk, PhD, said:

There are some positive elements in FDA’s proposal, particularly the attempt to bring legacy GRAS ingredients into a more transparent system without immediately forcing every long-established substance through a full new safety dossier. But FDA has missed the opportunity to create a genuinely risk-based, tiered system that distinguishes between novel substances and ingredients with decades of safe human use—and that leaves considerable legal and regulatory uncertainty while potentially asking an already resource-strapped agency to scientifically evaluate far more GRAS notices than it can realistically handle.

FDA Ends Undisclosed Self-GRAS

The Food and Drug Administration (FDA) has unveiled a proposed rule that would require companies to notify the agency when they conclude that a substance is GRAS for a particular use in human or animal food. Under the current system, a company may reach an independent GRAS conclusion and place the substance into the food supply without notifying FDA. This practice is sometimes referred to as “self-GRAS.” (For more background, you can consult our previous coverage and our white paper.)

The lack of transparency in the self-GRAS system has been its real weakness. It has allowed some companies—likely a small minority—to cut corners in the way they have self-affirmed the safety of ingredients in the knowledge there is no agency or independent scrutiny, leaving consumers, independent scientists, and even FDA without a complete picture of substances entering the food supply. In our 2025 white paper, we called for disclosure and accountability while warning that reform must preserve access to safe, beneficial natural ingredients. It makes little sense to subject a familiar nutrient with a long history of safe human consumption to the same default regulatory burden as a genuinely novel, new-to-nature chemical with no comparable history of exposure.

A Welcome Off-Ramp for Ingredients Already in Use

There is some good news. FDA did not propose forcing every currently marketed self-GRAS ingredient through a mandatory GRAS application program. Instead, self-GRAS ingredients already on the market before a final rule takes effect could use a time-limited streamlined submission.

Speaking to this, ANH General Counsel Jonathan Emord said:

While the rule does not mirror the recommendations we made to FDA in our white paper, it does take into account many of the factors we recommended. In particular, rather than mandate that all self-GRAS determinations be rendered void subject to the filing of new GRAS applications with FDA, the agency has instituted a GRAS notice requirement. Under this requirement, any party that wishes to introduce a food additive must send a GRAS notice to FDA. FDA will then either approve the notice or reject it. If the latter, then the party has to file a GRAS application and obtain formal approval from FDA. This notification system is far less draconian and will present far fewer market disruptions than the mandatory GRAS application system many feared would be adopted.”

That is a partial win. It avoids the regulatory tsunami that could have followed if every existing independent GRAS conclusion had immediately required full review. It also gives FDA the information needed to build a more complete public inventory.

…With an Important Caveat

The proposed rule creates unnecessary legal uncertainty for companies that make these streamlined GRAS submissions. While FDA gives industry one year to make the filings, it sets no corresponding deadline for the agency to process or post them on its public list—yet the exemption from the full GRAS-notice requirement seems to depend on the submission being included on that list. FDA itself acknowledges that availability of the public list is necessary for industry to know whether the exemption applies.

This problem is compounded where multiple companies market the same ingredient. FDA contemplates that once a streamlined submission is posted, any person may rely on that listing for the same substance and conditions of use, potentially avoiding duplicative filings. But until FDA actually posts the submission, other companies have no clear basis for relying on it. Faced with the same one-year deadline, multiple suppliers may therefore submit substantially identical notifications simply to protect themselves, generating needless paperwork for industry and precisely the administrative burden FDA says the streamlined pathway is intended to reduce.

A company could submit all required information fully and on time yet remain in regulatory limbo for months, or longer, simply because FDA has not acted. The clearest interim solution will be for companies to cooperate on submissions, dividing labor on individual submissions between them, through trade associations and ANH’s own Corporate Leadership Circle.

The final rule should make the exemption effective upon FDA’s receipt of a complete, timely submission, require the agency to post complete submissions within a short, defined period, and provide a searchable mechanism allowing companies to identify and rely on pending submissions covering the same substance and conditions of use.

The Natural Ingredient Exemption Is Frozen in 1958

The proposal’s treatment of traditional ingredients leaves much to be desired. FDA would preserve a narrow exception for a food ingredient of natural biological origin that was widely consumed in the United States for nutrient purposes before January 1, 1958, without known detrimental effects or safety hazards, and only when processed using methods conventional before that date.

That standard does not reflect how natural ingredients are responsibly made today. Modern extraction, isolation, concentration, fermentation, and standardization can improve consistency and quality without necessarily changing an ingredient’s chemical identity or materially increasing exposure. Yet a long-used botanical supplied as a standardized extract, isolate, or fermented preparation will likely fall outside FDA’s narrow exception.

Take something like sulforaphane, a plant compound found at low levels in cruciferous vegetables like broccoli, cabbage, and kale. If a company were to isolate or concentrate sulforaphane from broccoli sprouts for use in food, the long history of eating broccoli and its young sprouts would not necessarily satisfy FDA’s exemption: consumers were not widely consuming isolated sulforaphane before 1958, and the modern extraction or concentration process itself may not have been conventional at that time. The result is that an ingredient derived from a familiar, long-consumed food could be pushed into the same mandatory notification framework as a genuinely novel substance simply because modern technology allows it to be delivered in a more standardized or concentrated form. This is exactly how the EU’s novel food program works and it has caused many challenges for modern botanicals caught in the crosshairs of over-zealous EU regulators.

ANH proposed a more rational safe harbor: ingredients with at least 30 years of credible safe food use would enter a low-burden first tier, while modern preparations of traditional ingredients could qualify when they do not change chemical identity or materially alter the relevant exposure profile. FDA largely declined that risk-based approach.

The FDA could also supply a non-exhaustive list of “grandfathered” ingredients under this clause so companies don’t need to guess which ingredients satisfy these criteria.

Not Premarket Approval, but Still a Commercial Gatekeeper

For new ingredients that do not qualify for an exemption, companies would have to assemble and submit a full GRAS notice. FDA proposes up to 45 days to decide whether to file it, followed by a 180-day evaluation period and as many as two 90-day extensions. That could mean 360 days of FDA evaluation after filing.

Strictly speaking, a company would not have to wait for FDA’s final response before marketing. Once FDA files the notice, the notification requirement is treated as satisfied. An eventual “insufficient basis” letter would not erase compliance with the filing requirement, but FDA says it could inform post-market action.

That distinction matters, but it does not eliminate the commercial risk. Investors, distributors, retailers, insurers, and larger brand customers may hesitate to support an ingredient while FDA review remains unresolved.

But the burden is not speculative: FDA estimates 180 hours to prepare a full notice and concludes that the proposal would have a significant economic impact on a substantial number of small entities.

In practice, a system can remain technically non-premarket while still becoming a de facto commercial gatekeeper. Large companies can spread compliance costs across bigger portfolios. A small botanical, nutraceutical, functional food, or ingredient company has far less room for delay, legal uncertainty, or a costly second submission.

What This Could Mean for Consumers and Practitioners

This all may sound very technical, but the practical effect on consumers will be real assuming the new rules go into law unchanged.

If smaller suppliers decide that a new botanical extract, phytonutrient, fermentation-derived ingredient, or other natural compound is too expensive or uncertain to bring through the GRAS process, consumers may see fewer functional foods and beverages containing those ingredients, less competition, and potentially higher prices. Practitioners who rely on food-based approaches to help patients improve nutrition and metabolic health could likewise have fewer innovative products to recommend.

There is also a subtler effect: innovation may migrate toward companies with the deepest pockets rather than toward the ingredients with the greatest potential benefit. ANH has warned that onerous evidence requirements can favor large corporations and create barriers for smaller natural-health innovators. That means the practical question is not simply whether an ingredient is legally permitted. It is whether anyone can afford to develop it, persuade retailers to carry it, and keep it on the market while regulatory uncertainty is unresolved.

Transparency Is the Clear Win

The proposal would make filed GRAS notices, FDA response letters, and non-exempt supporting information available through a public inventory. That advances a core ANH recommendation. New-found sunlight will be able to expose weak safety rationales, help responsible companies distinguish themselves, and give consumers and independent experts a clearer view of what is entering the food supply.

But transparency should be paired with proportionality. A long-used nutrient or botanical should not face the same default burden as a genuinely novel substance with no meaningful history of human exposure.

Next Steps

ANH will press FDA to keep the streamlined pathway for existing uses, modernize the outdated common-use exception, and adopt tiered evidence requirements that focus agency resources on substances presenting genuine safety concerns. Reform should also preserve the public inventory and meaningful disclosure.

We must urge FDA to protect transparency without turning a food-safety reform into a barrier that entrenches large companies, sidelines responsible natural-product innovators, and shrinks consumer choice.

Real reform should target risk, reward a credible history of safe use, and keep safe natural ingredients accessible.

Action Alert! Post a comment to the FDA’s docket below to call for rational reforms to the GRAS system.

The post FDA Gets GRAS Transparency Right, but Risks Natural Innovation first appeared on Alliance for Natural Health USA - Protecting Natural Health.