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

Listen to the audio version of this article:

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.

A sweeping new Executive Order could significantly reshape childhood vaccine policy by prioritizing individualized recommendations, parental choice, flexible scheduling, and new scrutiny of vaccine safety.

Listen to the audio version of this article:

THE TOPLINE

• The executive order would reshape the childhood vaccine schedule by narrowing universal recommendations, shifting some vaccines to risk-based or shared decision-making categories, and directing HHS to study vaccine timing, sequencing, and spacing.
• It would expand parental and clinician choice by encouraging more individualized vaccination decisions, making separate measles, mumps, and rubella vaccines available alongside MMR, and prompting review of school vaccine mandates and exemptions.
• It calls for additional vaccine-safety research, including comparative studies of aluminum adjuvants, development of possible alternatives, stronger safety monitoring, and ongoing evaluation of the benefits and risks of childhood vaccines.

President Trump’s August 10 executive order, “Delivering Gold Standard Childhood Vaccine Recommendations for Americans,” marks a significant change in federal vaccine policy.

The order directs the federal government to align core childhood vaccine recommendations more closely with those of peer developed countries while preserving access to vaccines and giving parents and doctors greater discretion over individual decisions.

The new framework divides recommendations into three categories: vaccines recommended for all children, vaccines recommended primarily for certain higher-risk groups, and vaccines to be considered through shared clinical decision-making.

Universal recommendations would include vaccines for measles, mumps, rubella, diphtheria, tetanus, pertussis, polio, Haemophilus influenzae type B, pneumococcal disease, HPV, and varicella. Other vaccines, including hepatitis A and B, meningococcal vaccines, influenza, COVID-19, rotavirus, and dengue, would fall into risk-based or shared decision-making categories depending on the circumstances.

ANH has long argued that there is a difference between asking whether an individual vaccine can prevent a particular disease and asking whether the entire childhood schedule—its timing, sequencing, combinations, and cumulative exposures—has been adequately studied. We’re not alone in asking these questions: a 2013 report from the National Academies of Sciences, Engineering, and Medicine noted that key elements of the vaccine schedule have “not been systematically examined in research studies.”

The executive order now directs the Department of Health and Human Services (HHS) to assess the “ideal timing and sequencing” of core childhood vaccines and revise the federal schedule where appropriate.

More Choice on Timing and Combination Vaccines

The order also calls for the combined measles-mumps-rubella (MMR) vaccine to eventually be available as three separate single-disease vaccines. Combination vaccines would remain available.

It further states that, to the maximum extent feasible, childhood immunizations should be given at separate medical visits.

Whether separating vaccines or spacing them differently produces better outcomes will require careful research. But giving parents and clinicians more options could allow vaccine decisions to be better tailored to an individual child rather than forcing families into an all-or-nothing approach.

That is an important component of meaningful informed consent that has largely been absent from the discourse for many years.

Aluminum Adjuvants Get a Closer Look

Another significant provision directs HHS to develop alternatives to aluminum adjuvants and conduct comparative safety and efficacy studies.

Aluminum salts have been used for decades in vaccines to strengthen the immune response. ANH has previously reported on questions surrounding cumulative aluminum exposure from childhood vaccines.

A 2022 CDC-funded observational study involving more than 325,000 children found an association between greater vaccine-associated aluminum exposure before age two and persistent asthma later in childhood.

A common refrain from those who tell us not to worry about these aluminum exposures is that aluminum is an abundant metal found in many foods, but this does not account for different absorption rates from aluminum ingestion versus direct injection.

There are many issues with the use of aluminum in vaccines that we’ve raised for years. The FDA has set a limit on the amount of aluminum that can be in vaccines, but this number was based on the amount of aluminum required to enhance the effectiveness of the vaccine. The agency has not empirically determined the safest amount of intramuscularly injected aluminum, relying instead on mere belief that current levels are safe.

The EPA determined a minimum risk level for orally ingested aluminum based on rat studies, which is often what is used to justify aluminum adjuvants in vaccines. The problem is that ingesting aluminum orally, where only about 0.25% is absorbed and then filtered by the kidneys, is very different than injecting it directly into muscle, where it may be absorbed at nearly 100% efficiency over time and can accumulate in organs, including the brain.

This gap in evidence verifying the safety of aluminum adjuvants in vaccines, combined with evidence demonstrating the potential of real harm, is unacceptable and should understandably concern any parent who entrusts health authorities with the safety of their children. If aluminum remains the safest and most effective adjuvant for certain vaccines, rigorous comparative studies should demonstrate that. If safer or more effective alternatives exist, families deserve to know that as well.

A Shift Toward Parental Choice

The Executive Order also encourages states to review school vaccine requirements and directs federal agencies to examine protections involving parental authority, religious liberty, disability accommodations, and medical or religious exemptions where applicable under federal law.

This could represent a broader philosophical shift in vaccine policy away from relying primarily on mandates and toward building public confidence through transparency, education, and informed consent.

ANH’s advocacy has centered for decades on preserving patient choice, so this is a welcome change. Too often, state legislatures have moved to limit or eliminate exemptions to vaccines and thus restricting patient autonomy. We should all have a say over what medical procedures our children are exposed to, yet this foundational principle is too often abandoned when it comes to vaccines.

The real test, however, comes next.

Within 90 days, the HHS Task Force on Safer Childhood Vaccines must develop plans addressing vaccine timing and sequencing, aluminum alternatives, continuous risk-benefit evaluation, improved safety monitoring, and greater transparency.

Families should not have to choose between unquestioning acceptance of every vaccine recommendation and rejecting vaccination altogether. There is room for a more evidence-based discussion about which vaccines are appropriate, for whom, at what age, in what sequence, and supported by what evidence.

This executive order may finally move that conversation forward.

Please share this article widely with your networks.

The post Childhood Vaccine Schedule Gets a Major Reset first appeared on Alliance for Natural Health USA - Protecting Natural Health.

A one-month bridge may keep full-spectrum hemp products legal long enough for Congress to act. Action Alert!

THE TOPLINE

• A Senate proposal would delay the federal hemp-product restrictions from November 12 to December 11, 2026, but the 29-day extension is not yet law and could be removed during negotiations.
• The bipartisan Lawful Hemp Protection Act could preserve full-spectrum CBD and create a federal pathway for hemp-derived supplements, but it gives the FDA overly broad power to impose limits that could effectively eliminate healthful, non-intoxicating cannabinoid products.
• Congress should pass targeted rules against natural and synthetic intoxicating cannabinoids, adulteration, and deceptive marketing—while protecting lawful CBD products, non-intoxicating “minor” cannabinoids, and truthful supplement claims.

A federal hemp ban is still barreling toward consumers, farmers, and small businesses later this year. Congress is now offering a brief delay on that ban while more permanent fixes are considered. We need to make sure this goes in the right direction so consumers have access to health-promoting hemp and cannabinoid products.

A 29-day Bridge, Not a Victory

Sweeping bans on hemp products are set to take place on November 12, 2026. A new Senate funding proposal would delay most of these only until December 11.

That month matters, but it is not yet law. The House-passed continuing resolution contains no comparable protection, so the Senate language would have to survive bicameral negotiations and receive the president’s signature.

Senator Ted Budd (R-NC) plans to seek removal of the extension. We must urge the Senate to reject that effort and preserve the delay on the ban.

What Happens if Congress Does Nothing

As we’ve explained previously, Congress quietly enacted a near-total hemp product ban late in 2025. The new law, among other things, capped the amount of THC (the main psychoactive and intoxicating component of hemp) in hemp products to 0.4mg per container. The practical effect? The full-spectrum CBD oils that contain trace, non-psychoactive amounts of THC — the very products most consumers buy for wellness — will likely not survive this threshold. Industrial hemp seed oil, hemp protein, hemp leaf teas, and the countless supplements built on whole-plant extracts are all in the crosshairs.

A New Pathway for CBD Supplements?

The Lawful Hemp Protection Act from Representatives Andy Barr (R-KY) and Angie Craig (D-MN) offers a path forward for lawful hemp products. It would remove the looming hemp ban, raise the plant threshold from 0.3 to 1 percent total THC by dry weight, exclude synthetic or altered cannabinoids, and regulate unfinished hemp-cannabinoid ingredients.

Crucially, the bill would recognize hemp-derived cannabinoid dietary supplements and exclude them from the drug definition. That would create the federal pathway for CBD supplements and full-spectrum oils that has been missing for years. FDA currently says CBD generally cannot be marketed as a dietary supplement because it was first investigated and approved as a drug ingredient.

The FDA Blank Check

Here is the problem. The bill orders FDA to set a maximum for total cannabinoid content per serving and package and a separate maximum for every cannabinoid present. That includes CBD and naturally occurring minor cannabinoids such as cannabigerol (CBG), cannabinol (CBN), and cannabichromene (CBC). To get some perspective, there are some 120 different phytocannabinoids that have been characterized and only 5 (~4%), including THC, have been shown to have potential intoxicating effects on humans (see here and here).  

Rulemaking must consider science, use data, adverse events, product form, intended use, and expert input. Yet the bill gives no meaningful floor for protecting non-intoxicating cannabinoids from an arbitrarily low ceiling. If FDA misses its 12-month deadline, interim limits apply only to total THC: 5 milligrams per oral serving and 50 milligrams per inhalable or topical serving.

This invites bureaucratic overreach, something FDA is famous for. FDA could preserve a legal category on paper while regulating products out of existence in practice. The FDA track record in protecting access to natural products is shockingly bad – why would it be any different here?

The bill would also deem a product misbranded if its label makes any claim about an effect on the body’s structure or function. That is far more restrictive than the usual supplement framework. It would call these products dietary supplements while denying the truthful, substantiated speech that helps consumers understand them. This is why we are hard at work trying to open the door to such truthful claims with both our live FDAMA suit and our soon-to-filed structure-function petition.

Why Full-Spectrum Hemp Matters

Protecting access to natural, full-spectrum hemp products has to be a top priority for natural health and freedom of choice. The human body has an endocannabinoid system (ECS), a signaling network that helps regulate pain, mood, appetite, metabolism, immunity, and brain activity. Researchers have proposed that disrupted endocannabinoid signaling may be involved in conditions as diverse as migraines, fibromyalgia, and irritable bowel syndrome.

Full-spectrum hemp preserves CBD alongside minor cannabinoids, terpenes, and trace THC. These compounds may work together through the proposed “entourage effect.”

The 0.4-milligram-per-container limit could eliminate non-intoxicating full-spectrum products simply because they contain trace THC, pushing consumers toward CBD isolates that miss out on the benefits of the full-spectrum, cannabinoid entourage effect. Congress should target synthetic intoxicants, adulterated products, and deceptive marketing without destroying access to responsibly made whole-plant hemp products.

Congress Must Use the Time Wisely

The immediate priority is clear: preserve the December 11 extension and stop the 0.4-milligram ban from taking effect while Congress works.

There is legislation already before Congress that creates a better regulatory framework in the form of the Cannabinoid Safety and Regulation Act. That bill does not give FDA the power to regulate non-intoxicating cannabinoids, just THC. It also preserves structure/function claims for CBD supplements.

The Lawful Hemp Protection Act should be amended before passage. Congress should focus FDA’s limit-setting authority on intoxicating cannabinoids, require evidence-based protections for non-intoxicating CBD and minor cannabinoids, preserve lawful structure/function claims, distinguish adult-use intoxicants from non-intoxicating supplements, and provide a workable transition period.

Consumers should not have to choose between an indiscriminate ban and a regulatory blank check. America needs rules that punish adulteration, deceptive marketing, and sales to minors while preserving access to responsibly made natural products.

Action Alert!

The post Congress’s New CBD Pathway: The Promise and the Peril first appeared on Alliance for Natural Health USA - Protecting Natural Health.

Loneliness and social isolation don’t just break hearts. Find out why social disconnection is a modern day disease epidemic and what we can do about it.

This article has been adapted from an article by Chimnonso Onyekwelu and Meleni Aldridge for our sister organization, ANH International. Read the full article here.

Listen to the audio version of this article:

THE TOPLINE

• Loneliness and social isolation are whole-body health risks, triggering stress, inflammation, impaired immunity, cardiovascular problems, sleep disruption, cognitive decline, and changes to the gut microbiome.
• Modern isolation is driven by factors including shallow digital interaction, car-centered communities, declining civic and neighborhood ties, dispersed families, remote work, long hours, and financial pressures.
• Rebuilding social health requires intentional habits such as regular check-ins, face-to-face activities, tech-free time, community participation, and the “5-3-1” approach: connect with five people weekly, nurture three close relationships, and aim for one hour of quality interaction each day.

Can human connection be so fundamental that losing it changes our biology?

Yes. Absolutely. 

Loneliness doesn’t just make people sad. Our brains interpret loneliness and social isolation as a survival threat.

And that level of threat can trigger a host of negative outcomes, including stress, inflammation, impaired immunity, cardiovascular risk, cognitive decline, disrupted sleep, and changes to the gut microbiome.

In other words, loneliness is not simply an emotion—it is a whole-body biological state. Left unaddressed and unresolved, the body is set on a downward spiral into ill health.

An Unrecognized Risk

When we think about the biggest threats to health, smoking, poor diet, lack of exercise and environmental pollution usually come to mind. Yet loneliness exerts a pathological power all of its own. Finally, a growing body of conventional evidence is underpinning this very important, but far less recognized, risk factor, although the research often centers on the impacts of ‘social isolation.’

According to the World Health Organization (WHO), around one in six people worldwide experiences loneliness, with social isolation linked to more than 871,000 deaths every year. Some researchers have even suggested that the health impact of chronic isolation may be comparable to smoking 15 cigarettes a day.

The Power of Connection

At the heart of the issue lies something often overlooked in conversations about wellbeing: social health. Just as physical health relates to the body and mental health to the mind, social health reflects our ability to build meaningful relationships, maintain supportive connections and experience a genuine sense of belonging.

As inherently social beings, humans thrive through connection. Strong social ties have repeatedly been linked to better health outcomes and greater longevity. In one Australian study, adults over the age of 70 with the strongest social networks were 22% less likely to die over a ten-year period than those with weaker social connections.

Why Are We Becoming More Isolated?

The rise in social isolation cannot be reduced to technology alone, but digital culture has clearly reshaped how connection happens. We can now communicate constantly, yet with less depth, meaning, or emotional connection. Seventy-three percent identify technology as a contributor to loneliness, alongside concerns about excessive digital use, especially among younger groups.

The physical and social design of modern life has also changed dramatically. Many cities now prioritize cars over people, while neighborhood cohesion, communal spaces, church communities and civic participation continue to decline. Families are more fractured and geographically dispersed; fewer people live in intergenerational households, and everyday opportunities for natural social interaction have steadily reduced.

Economic and cultural pressures have further deepened this fragmentation. Longer working hours, remote work, financial strain and rising housing costs leave many people overworked, exhausted and disconnected from support systems. Over time, isolation can become cyclical, with stress, grief and mental health struggles reinforcing withdrawal from connection.

The Biological and Psychological Consequences of Isolation

One of the clearest impacts of chronic disconnection is on mental health. Loneliness has been associated with depression, anxiety, emotional dysregulation and increased stress reactivity, with lonely individuals twice as likely to experience depression. Studies (here and here) also link prolonged isolation to suicidal thoughts and reduced psychological resilience. Young people appear particularly vulnerable.

The effects are not only psychological but neurological. Research increasingly shows that prolonged social disconnection alters brain function. Social isolation has been linked to cognitive decline, impaired memory and a significantly increased risk of dementia.

We have survived evolution through the power of coherence and connection—socially as much as physiologically and biologically. Hence, the body interprets chronic disconnection as a sustained threat. Isolation activates the stress response, increasing cortisol levels and driving chronic inflammation if the ‘threat’ remains unresolved. Over time, this contributes to immune dysregulation, cardiovascular strain, and metabolic dysfunction.

Strong social ties are a protective antidote. A Swedish study involving more than 17,000 people found that stronger social connections reduced the risk of death from all causes by almost 25% over six years.

Rebuilding Human Connection in an Age of Fragmentation

This trajectory is not inevitable. Rebuilding connection requires deliberate action at personal, community and policy level, with social health treated as essential rather than optional.

Below are practical ways to restore meaningful human connection in an increasingly fragmented world:

• Stay in regular contact with people who matter: Schedule daily or weekly check-ins through calls, messages or in-person time to maintain consistent connection.
• Prioritize face-to-face interaction: Shift parts of your routine into social spaces like cafés, parks or shared work environments to create natural interactions where you can exchange energies with others.
• Build connection through shared activities: Join clubs, classes, physical activity or community initiatives where in-person interaction happens around common interests.
• Create tech-free time each day: Step away from screens to improve presence, attention and the depth of real-world relationships.
• Ground in nature on a daily basis: Move naturally in nature’s playground
• Ask about Social Prescribing: Started in the UK, social prescribing aims to connect people to activities, groups and other support to help improve health and wellbeing through connection with others.
• Adopt small, consistent social habits: Use simple structures like regular meetups or the 5-3-1 approach to make connection routine rather than occasional:
  • 5: Spend time with five different people a week.
  • 3: Nurture three close relationships.
  • 1: Aim for one hour of quality social interaction a day.
• Protect your mental and physical health: Exercise, sleep well, eat properly and engage in calming activities to reduce stress linked to isolation.
• Follow a daily routine with purpose: For some, structure can create stability and increase opportunities for social interaction.
• Practice openness and active listening: Show genuine interest in others and share honestly to build trust and deeper relationships.
• Engage with your local community: Volunteer, attend events or simply introduce yourself to neighbors to build local social ties.
• Use support systems when needed: Access community groups, social prescribing, or services that help reconnect people who are at risk of feeling isolated and lonely.

Play your part in the re-connection movement and help those in your network re-connect socially: please share this article widely.

The post The Loneliness Epidemic first appeared on Alliance for Natural Health USA - Protecting Natural Health.

A key FDA advisory panel just handed patients and integrative practitioners a rare win. But the agency still has the power to ignore it. Action Alert!

Listen to the audio version of this article:

THE TOPLINE

• An FDA advisory committee voted to recommend adding six peptides—BPC-157, MOTS-c, KPV, TB-500, Epitalon, and Semax—to the 503A Bulks List, potentially preserving prescription-based access through traditional compounding pharmacies.
• The vote defied FDA staff recommendations to reject every peptide reviewed and marked a significant shift from earlier committee decisions, but it is not final: the FDA can disregard the panel and must still act through formal rulemaking.
• The larger fight concerns the FDA’s use of drug-approval standards for compounded medicines, which could eliminate access to non-patentable therapies and drive patients toward unsafe gray-market products; ANH-USA plans to press the agency and may pursue legal action.

At a July 23-24 meeting, the Food and Drug Administration’s Pharmacy Compounding Advisory Committee (PCAC) voted to recommend that six peptides be added to the federal “503A Bulks List,” which would allow traditional compounding pharmacies to make them for patients with a valid prescription. The peptides are BPC-157, MOTS-c, KPV, TB-500, Epitalon, and Semax. The only peptide rejected by the committee was Emideltide.

PCAC voted in favor of these peptides despite FDA staff recommending that every peptide under review be rejected. This reversal was presumably the result of the recently remade PCAC committee that included clinicians who actually use these medicines in their practice. It is a positive sign for patient access, but we must continue to press the FDA to ensure a favorable outcome.

What Are Peptides, and Why Do We Need Them?

Peptides are short chains of amino acids. Some are already used in medicine. Others are used by integrative and functional medicine practitioners as part of personalized care plans. They show great promise for helping the body’s ability to heal from injuries as well as supporting a slew of other biological processes, including potentially extending lifespan.

It is crucial that these medicines get added to the 503A Bulk Drug List, or else patients will either lose access to these medicines entirely or be forced to seek them out on the grey market, where adulteration and impurities are rampant.

In order to be compounded, a substance must either 1) be a component of an approved drug, 2) have a United States Pharmacopeia monograph, or 3) be added to the 503A Bulk List. The signaling peptides we’ve been writing about do not satisfy criteria 1 or 2, so if they are not added to the Bulk Drug List, they cannot be made at compounding pharmacies. At earlier PCAC meetings, the committee followed FDA’s recommendation and voted to reject thymosin alpha-1 (Ta1), AOD-9604, CJC-1295, kisspeptin-10, ipamorelin, ibutamoren, and—wait for it—the amino acid L-theanine, as found in green and black tea.

Reversing this trend and voting in favor of key peptides like BPC-157 and epitalon is a breath of fresh air. We must remember, though, that PCAC is an advisory body and only makes recommendations; the FDA will follow up with a formal rulemaking and is not obliged to follow the committee’s votes. We could only find one instance where the FDA did not follow PCAC’s recommendation: when the committee voted to allow the compounding of tranilast but the FDA rejected it in its proposed rule. We shall see if the agency continues with this pattern or chooses to reject patient access to peptide bioregulators.

The Bigger Threat: Drug-Approval Standards for Compounded Medicine

FDA’s central objection appears to be the lack of the kind of large clinical trial evidence normally required for new drug approval to prove safety and efficacy.

But compounded medicines are legally distinct from FDA-approved drugs and are exempt from the new drug approval process when they meet the conditions laid out in federal law.

If FDA demands pharmaceutical-style evidence for every compounded substance, it can effectively wipe out access to many non-patentable or low-profit natural and integrative therapies. Why? Because no company is likely to spend hundreds of millions of dollars running drug-style trials for a substance it cannot exclusively own.

That creates a rigged system where compounded and personalized medicines face an impossible standard.

Access Does Not Mean Hype

ANH-USA supports patient access, practitioner judgment, and lawful compounding. That does not mean every peptide claim made online is proven. It does not mean consumers should buy peptides from questionable internet sellers or rely on influencer medicine.

In fact, one of the strongest arguments for lawful compounding access is safety. When FDA blocks legitimate access, demand does not disappear. Patients may turn to gray-market products of uncertain quality, strength, purity, or sterility.

A prescription-based compounding pathway can provide more oversight than the current “buyer beware” marketplace.

Consumers deserve honest information, real safeguards, and access to practitioners who can help them weigh risks and benefits. They do not deserve a system that drives health options underground.

Keep Up the Pressure

FDA still must decide whether to add these peptides to the 503A Bulks List through formal rulemaking.

ANH-USA is developing a petition urging FDA to use a legitimate scientific framework for evaluating peptides used in compounding. That means looking at the totality of available evidence, not pretending that compounded medicines should be judged exactly like mass-market patented drugs.

We will be watching closely to see whether FDA respects the advisory committee’s vote. If the agency once again places its hostility toward compounding ahead of patient access and practitioner judgment, ANH-USA will work to challenge that decision, including through legal action if necessary.

This vote was a meaningful step forward. But the fight for peptide access, personalized medicine, and health freedom is far from over.

Action Alert!

The post A Win for Peptide Access, But the Fight Is Far From Over first appeared on Alliance for Natural Health USA - Protecting Natural Health.

The FDA has delayed a major food safety rule that could reshape which ingredients make it into foods, supplements, medical foods, and natural health products. The delay gives consumers more time to demand reform that improves safety without restricting access to beneficial ingredients. Action Alert!

Listen to the audio version of this article:

THE TOPLINE

• The FDA has delayed its proposed GRAS rule until December 2026, giving consumers, advocates, and the natural products industry more time to push for reforms that improve food safety oversight without restricting access to beneficial ingredients.
• ANH-USA agrees the current system needs greater transparency, independence, and accountability, but turning GRAS notification into de facto premarket approval could burden smaller companies, limit natural-product innovation, and raise prices.
• GRAS reform should be risk-based, focusing scrutiny on novel or potentially harmful additives while preserving streamlined pathways for traditional, low-risk ingredients with long histories of safe use.

The government’s latest regulatory agenda now lists December 2026 as the expected publication date for its proposed rule on substances “generally recognized as safe,” or GRAS. The rule would require companies to submit GRAS notices for certain uses of food substances, replacing part of today’s voluntary notification system.

FDA says the change would improve transparency and oversight. But if poorly designed, it could also create regulatory bottlenecks that make it harder for safe and innovative ingredients to reach consumers.

GRAS 101

GRAS is the legal pathway that allows food ingredients to be used when qualified experts agree they are safe under their intended conditions of use.

Companies may currently reach an independent GRAS conclusion—often called “self-GRAS”—and voluntarily notify FDA.

The system clearly needs reform, as we’ve explained in our white paper. Some companies have introduced ingredients without sufficient transparency or independent scrutiny. Consumers deserve to know what is being added to their food, and unsafe additives should not be protected by secrecy, conflicts of interest, or weak oversight.

But dismantling self-GRAS would be the wrong solution.

If notification becomes a de facto premarket approval requirement, smaller companies could face significant costs and delays. Traditional, low-risk natural ingredients with long histories of safe use could be subjected to the same burdens as novel synthetic additives with limited safety data.

The result could be fewer natural products, less innovation, and higher prices—while the most dangerous chemicals remain in the food supply.

Reform Must Be Risk-Based

ANH-USA supports meaningful GRAS reform. In our April 2025 white paper, we called for a public transparency register, stronger safeguards against conflicts of interest, and greater scrutiny of substances with credible evidence of harm. We also proposed a proportionate review system that distinguishes higher-risk additives from traditional and well-established ingredients.

The real problem is not every substance that uses the GRAS pathway. It is secrecy, weak accountability, and the failure to act against genuinely unsafe ingredients.

FDA should focus its resources where the risks are greatest, make GRAS determinations publicly accessible, and preserve streamlined pathways for low-risk ingredients consumers rely on.

The delay until December gives ANH, our allies, and health-conscious consumers more time to shape the rule before it is published.

Consumers should not have to choose between safety and freedom. ANH will continue fighting for both.

Action Alert!

The post FDA Delays GRAS Reform: Your Choices Are Still at Risk first appeared on Alliance for Natural Health USA - Protecting Natural Health.