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!

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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!

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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.

For years, Americans who questioned whether COVID-19 might have emerged from a laboratory were dismissed as conspiracy theorists. Now, newly released diaries from Dr. Anthony Fauci show that the possibility was being taken seriously at the highest levels of government from the pandemic’s earliest days.

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THE TOPLINE

• Fauci’s private diary records show that scientists raised the possibility of deliberate genetic insertion and an accidental laboratory release in January 2020.
• Within months, however, Fauci was publicly presenting a natural origin as the overwhelmingly likely explanation and dismissing the lab-leak possibility.
• At a July 29 Senate hearing, Fauci repeatedly invoked his right against self-incrimination, despite having received a sweeping pardon covering his federal actions during the pandemic.

When Dr. Anthony Fauci appeared before the Senate this week to answer questions about COVID’s origins, risky virus research, and the government’s pandemic response, he repeatedly invoked the Fifth Amendment rather than testify.

The more than 1,100 pages of diary entries released by Senate Homeland Security Committee Chairman Rand Paul reveal a striking gap between the government’s private deliberations and the certainty later presented to the public.

On January 31, 2020, Fauci recorded receiving an urgent call from Wellcome Trust Director Jeremy Farrar and evolutionary biologist Kristian Andersen. According to Fauci’s account, scientists believed mutations surrounding the virus’s furin-cleavage site might not have occurred naturally. They raised the possibility that genetic material had been deliberately inserted and that the virus had then been accidentally released.

According to the documents released by Sen. Paul, Fauci recommended convening a larger group of scientists and helped establish parallel scientific and national security inquiries. During a February 1 conference call, his diary says many participants believed deliberate insertion remained possible and that the issue could not simply be dismissed.

Yet the public narrative soon hardened. By April 2020, Fauci was saying the virus was “totally consistent” with a natural jump from animals to humans. The possibility that had prompted urgent private calls and a security review was increasingly portrayed publicly as an implausible conspiracy theory.

ANH warned about precisely this dynamic in 2021. We argued that it was entirely reasonable to say the virus’s origin remained unknown and that a laboratory accident should be investigated. Instead, those asking such questions were often maligned and pushed into the “tin foil hat” category.

This week, senators finally had the opportunity to question Dr. Fauci directly. But he repeatedly invoked the Fifth Amendment, declining to answer questions concerning gain-of-function research, intelligence-agency involvement, and whether the benefits of such research outweigh its potentially catastrophic risks. Fauci accused Paul of conducting a campaign designed to intimidate and prosecute him; Democrats defended his decision, while Republican senators argued that his pardon removed the possibility of federal self-incrimination.

On that issue, ANH-USA General Counsel Jonathan Emord argues:

“In the first instance, the pardon granted Fauci by someone in the Biden Administration is constitutionally defective. It does not identify any crime or potential criminal basis for prosecution and thus does not satisfy the requirements of the Presidential Pardon Clause of the Constitution. Second, assuming its validity, the pardon purports to eliminate criminal liability for everything Fauci had done as of its date. Consequently, congressional questions concerning his prior actions are ones which cannot be incriminating so long as he answers them truthfully. He may be held in contempt of Congress and may be referred to the Department of Justice for obstruction of justice charges.”

Invoking the Fifth Amendment is not proof of guilt. But after years in which officials demanded public trust while marginalizing legitimate questions, refusing to answer those questions deepens an already profound credibility crisis.

The issue is bigger than Fauci—or even COVID’s ultimate origin. It is whether public-health authorities may privately consider uncertainty while publicly enforcing certainty, and whether “misinformation” labels are used to protect the public or to protect institutions from scrutiny. As ANH International has warned, official narratives can become increasingly untenable as facts emerge, yet the machinery built to suppress dissent remains firmly in place.

Scientific integrity requires openness, humility, and accountability—not pardons, censorship, and silence.

Please share this article widely in your networks.

The post Fauci Takes the Fifth as Lab-Leak Questions Return first appeared on Alliance for Natural Health USA - Protecting Natural Health.

A major doctors’ group is calling for Congress to give the Food and Drug Administration (FDA) sweeping new power over dietary supplements. If they get their way, the vitamins, minerals, botanicals, probiotics, and specialty formulas millions of Americans rely on could be treated more like drugs than foods. Action Alert!

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THE TOPLINE

• The American College of Physicians is urging Congress to impose drug-style premarket approval, mandatory registration, and expanded FTC oversight on dietary supplements—a move that could reduce access to higher-dose, specialized, and innovative products.
• Supplements are already regulated under federal manufacturing, labeling, and safety laws. Rather than granting the FDA sweeping new powers, Congress should require the agency to use its existing authority more effectively against adulteration, contamination, hidden drug ingredients, and fraudulent claims.
• ACP’s safety case relies on adverse-event totals without adequate context, while mandatory product listing and pharmaceutical-level evidence standards could become tools to eliminate lawful products and censor truthful health information.

What ACP Is Demanding

The American College of Physicians (ACP) released a new position paper in Annals of Internal Medicine calling for Congress to “modernize” the Dietary Supplement Health and Education Act of 1994 (DSHEA). ACP wants supplements to undergo FDA registration and premarket approval, including products already on the market. It also calls for more Federal Trade Commission (FTC) policing of supplement marketing.

ACP says its recommendations are needed because more than half of American adults use supplements, while only about a quarter use products recommended by a healthcare professional. ACP also argues that some products may contain unlisted ingredients, unsafe dosages, illicit substances, or interact with medications.

No one at ANH-USA is defending adulterated products, hidden drug ingredients, false labels, or fraudulent disease claims. Bad actors should be removed from the market, period. And both FDA and FTC already have ample regulatory tools at their disposal to make this happen.

But ACP’s central proposal, a drug-style premarket approval system, would decimate consumer access to safe, natural products that millions of Americans rely on.

Premarket Approval Would Crush Consumer Choice

Drug pre-market approval costs can be recovered because drugs often receive strong patent protection and market exclusivity. Nutrients, herbs, and other natural substances generally cannot be patented in the same way. Requiring supplement makers to produce drug-style evidence before selling ordinary natural products would favor giant corporations with compliance departments and deep pockets. Smaller innovators would be pushed out. Higher-dose, practitioner-grade, niche, and personalized products would be most vulnerable.

The result would not be “better supplements.” It would be fewer supplements, more standardized formulas, less innovation, and fewer options for consumers trying to manage their health naturally. The USA would also lose its status as the global capital for research and development of dietary supplements.

Supplements Are Already Regulated

One of the most misleading talking points in supplement policy is that supplements are “unregulated.” They are not.

Dietary supplement manufacturers are subject to FDA current good manufacturing practice rules. These rules apply to companies that manufacture, package, label, or hold dietary supplements.

The real question is whether the FDA is using its existing authority effectively to address adulteration, contamination, illegal drug ingredients, and other bad actors. There have been periods when the agency appeared to tolerate the worst abuses in the supplement industry, seemingly in the hope that mounting problems would build support for repealing DSHEA and expanding the FDA’s power over supplements.

What we oppose is using a few bad apples to justify giving FDA sweeping new authority over the entire supplement market. This is the same playbook we see being used against homeopathy and peptides: use isolated examples of bad products or bad actors to justify an attack on an entire sector.

The “Safety” Argument Needs Context

ACP cites adverse event reports to argue that current regulation is inadequate. But raw adverse event counts do not tell us how dangerous supplements are as a category.

One 2023 narrative review cited in ACP’s paper reported 79,071 adverse events related to dietary supplements between 2004 and 2021 (about 4,651 per year on average). That number sounds alarming until we ask the basic scientific questions: How many people used supplements during that period? How many doses were consumed? How many reports were serious, and how many were mild (transient flushing or nausea)?

A safety rate requires a denominator. Let’s do some quick math. If half of American adults use supplements, that’s about 135 million people. With an average of 4,651 adverse events per year, that means that 0.0034 percent of supplement users experience an adverse event. By contrast, about 8.3% of people receiving primary care experienced an adverse drug reaction. In other words, primary care drug reactions are 2,441 times more common than supplement adverse events.

The FTC Is Already in Overdrive

ACP also wants more FTC resources to police supplement marketing, especially online and on social media. But the FTC is already aggressively expanding its reach to censor supplement benefits: something we’re pushing back on in the courts.

A National Database Could Become a Hit List

ACP’s proposed national supplement database also sounds benign. Transparency is good. But a mandatory product listing system can quickly become a tool for elimination.

ANH has warned for years that Senator Dick Durbin’s mandatory product listing proposal would give FDA a ready-made map of the supplement marketplace: ingredients, dosages, labels, and product identities. That could allow the agency to target high-dose supplements, supplements that compete with drugs, or products caught in FDA’s overbroad “new dietary ingredient” dragnet. ANH has also warned that mandatory listing could accelerate attacks on higher-dose supplements used by integrative doctors and informed consumers.

Consumers should not have to fear that a “database” is the first step toward disappearing the products they rely on.

An Assault on Your Health Freedom

The FDA and FTC already have tools to act against adulteration, misbranding, illegal disease claims, contamination, and deceptive marketing. Congress should demand better enforcement against real violations, not hand regulators a sweeping premarket approval system that would make supplements less accessible, less diverse, and more expensive.

ANH-USA will continue fighting attempts to turn supplements into drugs by another name. We will oppose premarket approval, mandatory product listing schemes that threaten access, and agency censorship of truthful health information.

Action Alert!

The post ACP’s Supplement Crackdown Would Put FDA Between You and Your Vitamins first appeared on Alliance for Natural Health USA - Protecting Natural Health.

For years, Americans who questioned vaccine safety, the childhood schedule, natural immunity, or informed consent were dismissed as anti-science. Now the federal government, under RFK Jr.’s leadership, is acknowledging that these issues belong on the table.

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THE TOPLINE

• The renewed National Vaccine Advisory Committee charter explicitly opens the door to examining natural immunity, vaccine adverse reactions, genetic and immune risk factors, personalized vaccination, non-immunization strategies, scientific integrity, and informed consent.
• These questions are especially important because major gaps remain in research on the childhood vaccine schedule as a whole, including the timing, number, order, and frequency of doses and which children may be more vulnerable to adverse reactions.
• The new charter offers an opportunity to rebuild public trust through transparent research, open scientific debate, individualized risk assessment, and respect for informed consent rather than dismissing legitimate questions.

The renewed National Vaccine Advisory Committee (NVAC) charter, filed July 7, 2026, includes language allowing subcommittees to examine topics ANH-USA and other health-freedom advocates have raised for years: preventing vaccine adverse reactions, identifying higher-risk individuals, genetic susceptibility, immune dysregulation, personalized vaccinology, natural immunity, non-immunization strategies, scientific integrity, and informed consent.

This is a major opening.

The Major Changes

Specifically, the new charter states that subcommittees may examine a variety of topics, including ways to strengthen natural immunity, identify people at greater risk of adverse vaccine reactions, advance personalized approaches to vaccination, protect those who cannot be vaccinated, assess the role of vaccines in preventing infectious and chronic diseases, and promote scientific integrity, product safety, and informed consent.

It is a strange state of affairs indeed where the ability or willingness to examine such topics is considered controversial, but that’s where we’ve been with this debate.

The Data Gaps Are Real

The National Academies of Sciences, Engineering, and Medicine admitted in 2013 that key elements of the childhood vaccine schedule, including the number, timing, order, frequency, and age of administration, “have not been systematically examined in research studies.” The same report found limited evidence on children who may be more susceptible to adverse reactions.

That should concern everyone. The public is told the schedule is settled science, yet one of the nation’s top scientific bodies has acknowledged major gaps in studying the schedule as a whole.

COVID Changed the Debate

The COVID-19 era provided a powerful reminder of just how important and urgent it is to find answers to these questions. Novel vaccines with no prior use at scale developed and authorized at unprecedented speed were promoted and deployed through sweeping public campaigns, employer and school mandates, and policies that often failed to account adequately for prior infection, natural immunity, age, health status, or individual risk.

At the same time, legitimate questions about adverse events, waning protection, transmission, repeated boosters, and the quality and transparency of government decision-making were too often dismissed rather than openly debated. Conflicting guidance and the marginalization of dissenting scientists further damaged public trust. If this was a major test of the principle of informed consent, the medical establishment failed miserably.

That experience demonstrated the danger of one-size-fits-all vaccine policy. The new NVAC charter offers an opportunity to learn from those failures by placing individualized risk, natural immunity, safety monitoring, scientific transparency, and genuine informed consent at the center of future vaccine policy.

The Henry Ford Controversy

The debate intensified after attorney Aaron Siri testified before a Senate subcommittee in September 2025 about an unpublished Henry Ford Health study comparing vaccinated and unvaccinated children. According to Siri, the study found higher rates of several chronic conditions among vaccinated children.

The study was not peer reviewed or published, and Henry Ford Health has disputed claims that it was “buried,” arguing that it had serious methodological flaws. But that is exactly why transparency matters. If the study is flawed, independent review can show that. If it raises valid safety signals, the public has a right to know.

Science Needs Open Questions

The new NVAC charter specifically allows discussion of natural immunity, adverse reaction prevention, personalized vaccinology, non-pharmaceutical strategies, scientific integrity, and informed consent. These should not be controversial topics.

ANH-USA is not arguing that vaccines are all good or all bad. We are arguing that science must be free to ask hard questions, especially when medical interventions are recommended for millions of healthy children and often required for school attendance.

Public health cannot rebuild trust by suppressing debate. It can only rebuild trust through transparency, rigorous research, and respect for informed consent.

Americans deserve vaccine policy that respects individual risk, informed consent, and health freedom. The renewed NVAC charter is a chance to move in that direction.

Please share this article widely within your networks.

The post New NVAC Charter Opens the Door to Vaccine Questions Washington Has Dodged first appeared on Alliance for Natural Health USA - Protecting Natural Health.

From Michelle Perro, MD. Visit her Substack for more.

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Prior to this part launch, part rant, and of course, weed whacking, I need to give credit to my podcast producer, Anne Temple. We were prepping for the next podcast and she mentioned that in her neck of the woods, the air was horrific from the Canadian fires. She asked what happens to glyphosate when it burns?

I thought I knew all things glyphosate, but I was stumped. I wasn’t sure, so I had to dig my way through the weeds and jump in the rabbit hole.

This article is dedicated to all the wonderful Canadians I’ve had the pleasure to get to know through the most unfortunate circumstances, including those brilliant minds behind the development of the National Citizens Inquiry.

Pictured left: Michelle Perro, MD.
Image source: https://gmoscience.org/dr-michelle-perro-resources/

Here goes…

It is July 2026. Over 900 active wildfires are burning in Canada across Ontario, Manitoba, and beyond while blazes in Minnesota’s Boundary Waters have crossed the border in both directions. Smoke has engulfed the Washington Monument and the Lincoln Memorial in an orange-gray haze. Detroit, Chicago, and Minneapolis have registered some of the worst air quality on the planet. Major League Baseball postponed games. The Soap Box Derby canceled events. The President is threatening tariffs. Millions of Americans from the Midwest to the Mid-Atlantic are checking air quality apps, sealing windows, and pulling N95 masks from drawers that hadn’t been opened since the pandemic.

The models generating those air quality readings track one variable: PM₂.₅ mass per cubic meter of air. They do not ask what is on the particulate. They do not model what happens when millions of hectares of glyphosate-sprayed forest burn, and the smoke crosses a continent.

No regulator in North America has ever asked that question. Not because it’s unanswerable. Because nobody has been required to.

The Scale of the Spraying

Canada does not track its own glyphosate use federally. No national database exists. What we know comes from patchy provincial data, often extracted through freedom of information requests.

Sapinski & Surette (2023) paper on New Brunswick confirms: In Canada, no jurisdiction — federal or provincial — monitors glyphosate presence in the environment or in human populations. The only testing done is by the Canadian Food Inspection Agency who monitors levels of glyphosate residues in food.

New Brunswick: Forestry accounts for 61% of all glyphosate use. Eighty-three percent is applied by helicopter. Roughly 0.5% of forested land is sprayed annually which may be small per year, but enormous when compounded across decades. New Brunswick sprays nearly ten times more forest than similarly sized Nova Scotia, ranking second only to Ontario in total area treated.

British Columbia: Over 430,000 hectares sprayed since the 1970s, increased to 738,000 when re-sprays are included.

Ontario: Rivals or exceeds New Brunswick. Precise figures are elusive.

Quebec: Banned aerial forestry spraying in 2001. The industry survived. The practice is not essential. It is a choice.

The dominant player in New Brunswick, J.D. Irving Limited, uses glyphosate to kill deciduous trees and accelerate conifer growth for pulp and timber. The economic logic is simple: spray the hardwoods, harvest the softwoods faster. The ecological logic has never been stress-tested against fire.

The Chemistry

Glyphosate (N-phosphonomethylglycine) decomposes above 198°C. At wildfire temperatures ranging from 600 to 1200°C, it breaks down almost instantly. But destruction is transformation.

Narimani and da Silva (2020) mapped the pathway: glyphosate eliminates phosphorous acid, producing imine intermediates that react with water vapor to form simple amines and carbonyl compounds. Mackie and Kennedy (2019) went further, identifying sarcosine and dimethylamine (DMA) as decomposition products (their paper, tellingly, was commissioned to evaluate the safety of incinerating glyphosate stockpiles). Controlled conditions. Engineered temperatures. Scrubbers.

A forest fire is none of those things.

Smoldering zones burn below 500°C which is hot enough to volatilize glyphosate, but not necessarily hot enough to fully destroy it. The USDA Forest Service’s own review concedes the following from their abstract;

Studies conducted on herbicides and insecticides indicate that hot fires (>500°C) thermally degrade most pesticides. Smoldering fires (<500°C) have the potential to volatilize significant amounts of some pesticides. Exposure analyses indicate that, even under conditions of smoldering fires, no significant human health risks occur from pesticides incorporated into or on forest fuels.

…then dismisses the risk based on prescribed burn data.

And deeper in the paper, they admit their risk analysis was based on burning herbicide-treated wood in a fireplace and that the safety margins they calculated assumed “unrealistically” complete volatilization. That’s their basis for dismissing the risk. A fireplace. Not 900 wildfires. Not megafires. Not decades of accumulated AMPA in the soil.

AMPA: Worse Than Glyphosate

Glyphosate degrades in soil into aminomethylphosphonic acid (AMPA). It is three to six times more toxic to aquatic organisms and far more persistent. Glyphosate’s soil half-life ranges from 1.5 to 53 days, lasting longer depending on soil conditions such as pH. AMPA’s: 26 to 45 days under warm conditions, up to 958 days in some studies. In one lysimeter experiment, glyphosate and AMPA together still constituted 59% of the original application 748 days after spraying.

AMPA is also more thermally stable. Boiling point: ~358°C versus glyphosate’s 230°C. Half-life at 1000 K: 4 milliseconds versus glyphosate’s 0.1. In a smoldering fire, AMPA may volatilize without fully decomposing, re-condensing onto smoke particulate as the plume cools.

The forest floor in sprayed zones carries years of accumulated AMPA. When it burns, all of it is up for grabs.

Smoke as a Chemical Courier

The idea that fire remobilizes soil-bound chemicals is documented, not speculative.

Genualdi et al. (2009) measured pesticides (dacthal, endosulfan, and γ-HCH) in smoke from Siberian fires reaching Oregon and Washington. Soil analysis showed 34 to 100% of pesticide mass was lost from burned plots.

Primbs et al. (2008) detected elevated pesticide concentrations at a remote Oregon observatory when air masses passed over fires in Alaska and Western Canada.

A 2026 study of aged wildfire PM₂.₅ collected in Maryland which was over 1,000 miles from the source detected phosphorus-containing organic molecules. The researchers weren’t looking for glyphosate or AMPA. But both are organophosphorus compounds. Phosphorus in transcontinental smoke is consistent with what you’d expect to find if they were riding the plume.

No study has specifically measured glyphosate or AMPA in wildfire smoke. The methods exist. The funding and the mandate do not.

Our Children: The Lungs That Pay

Children breathe more air per pound of body weight than adults which is roughly double. Their airways are narrower, and their detoxification systems immature as compared to adults. When wildfire smoke spikes PM₂.₅ by 3.82 μg m⁻³ across an entire country, the math is shockingly unforgiving: more particulate per breath, more breaths per minute, more years of accumulated damage ahead.

The 64,300 chronic deaths attributed to the 2023 fires capture mortality. They say nothing about asthma diagnoses, emergency visits, missed school days, or the cognitive effects of chronic neuroinflammation from inhaled particulate. And none of the models accounted for what was riding on that particulate such as glyphosate, AMPA, dimethylamine, or phosphorus fragments: compounds never tested for inhalation toxicity in combination. Imagine that scenario in a five-year-old.

The Institutional Gap

Regulators approved aerial glyphosate based on a static model: chemical binds to soil, degrades before reaching water, exposure limited to the application window. Fire does not appear in any environmental impact assessment. It never has.

New Brunswick’s Chief Medical Officer published a health assessment in 2016 concluding that existing measures were adequate. The report arrived during the IARC controversy when the WHO had classified glyphosate as “probably carcinogenic” the year prior and was met with skepticism. But the deeper failure is structural: the assessment couldn’t model combustion exposure because the data doesn’t exist.

No Canadian jurisdiction monitors glyphosate or AMPA in the environment or in human populations. No air monitoring. No water monitoring. No biomonitoring of exposed communities. No testing of wild-land firefighters who are indeed the canaries in this particular coal mine before, during, or after deployments on spray-zone fires.

The USDA’s own review dismisses pesticide-in-smoke risks on the logic that the smoke itself is already so toxic the pesticide adds nothing meaningful. This argument works only if you accept the baseline toxicity of wildfire smoke as acceptable. It is not. And the populations breathing it never consented to that faulty logic.

Quebec banned aerial forestry spraying in 2001. The industry survived. The rest of Canada chose otherwise. That choice carries consequences, and those consequences are now burning with a global impact.

Regulators approved aerial glyphosate on the assumption that the forest stays put. It doesn’t. The chemistry says glyphosate and AMPA decompose under heat into amines, phosphorous acid, and carbonyl compounds. The atmospheric science says fire-volatilized pesticides travel thousands of kilometers on smoke. The institutional record shows no regulator has ever connected these two bodies of knowledge and asked what it means for the people breathing the smoke.

The question isn’t whether glyphosate and AMPA decomposition products are in the smoke. The chemistry says they are. The question is why, after decades of spraying and years of mega-fires, no agency has ever measured them and what they’re afraid they’ll find if someone finally does.

What You Can Do

This is not a problem that requires new science. The analytical methods exist. The sampling protocols are standard. What’s missing is the political will to ask the question and that’s where you come in.

Contact your representatives. If you live in a state or province affected by wildfire smoke and in 2026, that’s most of North America, ask your elected officials a simple question: Has any agency measured glyphosate or AMPA in the smoke I’m breathing? If not, why not?

Demand answers from the agencies. These are the offices with the mandate, the data, or both:

• USDA Forest Service, Rocky Mountain Research Station — Flagstaff, AZ. Ask whether the 2000 fire-and-pesticides review has ever been updated, and whether its risk assessment applies to mega-fires burning through decades of accumulated spraying.
• EPA Office of Air and Radiation — Ask whether PM₂.₅ monitoring includes chemical speciation for pesticides or their thermal decomposition products. Ask why it doesn’t.
• Canadian Forest Service, Natural Resources Canada — Ask whether Canada maintains a national database of forestry pesticide applications, and whether it has ever overlaid spray data with fire data.
• BC Ministry of Forests — Ask whether the province has modeled glyphosate or AMPA fate during wildfire on its 738,000 hectares of sprayed forest.
• New Brunswick Department of Natural Resources and Energy Development — Ask whether the province has conducted any air monitoring or firefighter biomonitoring related to glyphosate — in the jurisdiction that sprays the highest proportion of its forests in the country.

Support independent monitoring. Organizations like the Breathe Project and various university-based atmospheric chemistry labs have the equipment and the expertise. They lack funding. If you have the means, direct your dollars toward groups doing air quality monitoring that goes beyond PM₂.₅ mass (the ones asking what’s in the particulate, not just how much of it there is).

Protect yourself and your family. While the institutions catch up and they will take years, invest in HEPA air filtration for your home. Wear an N95 or better when air quality indices spike. Keep windows sealed during smoke events. These measures reduce particulate exposure. They may also reduce exposure to whatever is riding on the particulate. We won’t know until someone measures it.

Don’t wait for permission to protect your lungs.

Action Alert!

The post Forest Fires and Glyphosate: An Examination of the Unspoken first appeared on Alliance for Natural Health USA - Protecting Natural Health.

The EPA is retreating from stronger safeguards against PFAS-contaminated sewage sludge, leaving farmers, families, and the food supply exposed to toxic “forever chemicals.” Action Alert!

Listen to the audio version of this article:

THE TOPLINE

• The EPA’s new draft guidance replaces an earlier risk assessment that warned PFOA and PFOS in sewage sludge could create serious health risks, even at very low concentrations, with largely voluntary recommendations.
• Nearly 60 percent of sewage sludge is spread on land, including agricultural fields, where persistent chemicals can contaminate soil, private wells, crops, livestock, fish, milk, meat, and eggs.
• Federal lawmakers should mandate comprehensive PFAS testing, prohibit contaminated sludge from being used on food-producing land, hold industrial polluters responsible, and phase out nonessential uses of PFAS.

The fertilizer spread on American farms may be carrying toxic “forever chemicals” into our soil, water, crops, livestock, and food. Instead of stopping that contamination, the EPA is retreating from stronger safeguards and leaving farmers and families to deal with the consequences.

On July 1, 2026, the EPA replaced a warning about serious PFAS risks in sewage sludge with weaker guidance. The agency dismissed its own earlier findings as too focused on worst-case scenarios and defended continued use of contaminated sludge as fertilizer.

But make no mistake: this is another example of the EPA rolling back protections against a dangerous class of chemicals.

The Earlier Assessment Raised Red Flags

The January 2025 EPA draft risk assessment found that PFOA and PFOS in sewage sludge could pose human health risks when sludge is land-applied, surface-disposed, or incinerated. EPA said some modeled scenarios exceeded acceptable risk thresholds by several orders of magnitude when sewage sludge contained just 1 part per billion of PFOA or PFOS.

EPA identified possible exposure through contaminated drinking water, fish, milk, beef, eggs, and certain fruits and vegetables from impacted properties. The agency also said PFOA and PFOS are persistent chemicals linked to adverse health effects, and noted that EPA classified both as likely carcinogenic to humans in 2024.

EPA now stresses that the earlier assessment focused on people living on or near impacted properties, not the general public. That is true. But it should not be used to minimize the stakes for the very people who are most exposed: farm families, rural residents, people with private wells, children playing in contaminated soil, and consumers eating food grown on affected land. Remember our pilot study on PFAS contamination in kale? Even organic samples tested positive for the presence of PFAS, and contaminated sewage sludge is one vector by which this contamination can occur. This problem affects all of us.

Let’s also not forget the propensity for PFAS chemicals to travel, even to the most remote places on Earth: they have been detected from Antarctica to the Mariana Trench.

Sewage Sludge Is a Pathway into the Food Supply

Sewage sludge is the semi-solid material left over after wastewater treatment. EPA uses the term “biosolids” for treated sewage sludge intended for land application as fertilizer or soil amendment. Under existing federal rules, biosolids may be applied to agricultural lands, forests, tree farms, golf courses, turf farms, and other land; they may also be sold in bags for lawns and home gardens. EPA’s own data says nearly 60 percent of sewage sludge is land-applied.

That should alarm anyone who cares about clean food and clean water. PFAS are called “forever chemicals” because they persist. They do not simply disappear after a crop cycle. Once introduced into soil and water, they can move through the environment and into the food chain.

EPA’s new recommendations tell the public to research sludge suppliers and avoid applying sludge where children may contact soil, or in garden beds for foods such as leafy greens and root vegetables, or where egg-laying hens forage.

Read that again: the federal agency charged with protecting public health is telling families to figure out whether the fertilizer they bought may contain toxic forever chemicals. The EPA is abdicating responsibility and outsourcing its job to the American people.

The Bigger PFAS Rollback

This sewage sludge move is not happening in isolation. On May 18, 2026, EPA announced proposed changes to the national PFAS drinking water rule. One proposal would keep enforceable limits for PFOA and PFOS but allow some systems until 2031 to comply. Another would rescind drinking water regulations for PFHxS, PFNA, GenX chemicals, and a hazard-index mixture standard.

In other words, at the same time PFAS contamination is being found in water, food, sludge, soil, and consumer products, EPA is busy rolling back public protections.

EPA should require robust PFAS testing in sewage sludge, stop contaminated sludge from being spread on food-producing land, force industrial polluters to keep PFAS out of wastewater systems, and move toward a broad phaseout of nonessential PFAS uses.

Americans should not have to become chemical detectives to keep forever chemicals out of their gardens, wells, eggs, milk, meat, and vegetables.

Action Alert!

The post EPA’s PFAS Sludge Retreat Puts Farmers and Families at Risk first appeared on Alliance for Natural Health USA - Protecting Natural Health.

Paraquat is so poisonous that a single sip can kill, yet it is still sprayed on American farmland and allowed near the food supply. Action Alert!

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THE TOPLINE

• The EPA acknowledges that one small sip of paraquat can be fatal and that there is no antidote, yet the chemical remains approved for agricultural use.
• Multiple studies and laboratory findings raise serious concerns about damage to the dopamine-producing brain cells involved in Parkinson’s.
• The bipartisan Paraquat Prevention Act would ban paraquat, prohibit the use of existing stocks, revoke allowable residues on food, and close the loophole for imported foods grown with the chemical.

Paraquat is so toxic that the Environmental Protection Agency says one small sip can be fatal. It cannot be used around home gardens, schools, parks, playgrounds, or golf courses. Yet it can still be sprayed in American agriculture, where farmers, farmworkers, rural families, and the food supply bear the risk.

That could finally change.

Representatives Anna Paulina Luna (R-FL) and Chellie Pingree (D-ME) have introduced the Paraquat Prevention Act, a bipartisan bill that would cancel all registered uses of paraquat, revoke food residue tolerances, ban the sale and use of existing stocks, and prevent EPA from re-registering the chemical in the future.

This is exactly the kind of common-sense health freedom legislation Congress should pass. Americans should not have to depend on a slow-moving captured agency to protect them from a pesticide already banned in more than 70 countries.

EPA Knows Paraquat Is Exceptionally Dangerous

EPA calls paraquat “highly toxic” and reports that accidental ingestion from illegal transfer into drink containers causes roughly one to two deaths per year. EPA requires paraquat to be used only by trained, certified applicators and says it should never be used around residential dwellings, home gardens, schools, recreational parks, golf courses, or playgrounds.

That raises the obvious question: if paraquat is too dangerous for a golf course, why is it acceptable where food is grown?

The Parkinson’s Evidence Keeps Building

Paraquat has been linked in multiple studies to increased Parkinson’s disease risk. A major Agricultural Health Study paper found Parkinson’s disease was strongly associated with paraquat and rotenone, pesticides used in laboratory models of Parkinson’s-related damage. A more recent study in California’s Central Valley found further evidence that agricultural paraquat exposure increases Parkinson’s risk.

The biology is deeply concerning. Parkinson’s develops as dopamine-producing neurons are damaged or lost. Laboratory research has shown that paraquat can harm dopaminergic neurons, the very cells central to Parkinson’s disease.

EPA has long resisted concluding that paraquat causes Parkinson’s in humans. But public health policy should not require absolute certainty when the stakes are irreversible neurological disease, fatal poisoning, and repeated exposure among farm communities.

The Bill Closes the Import Loophole

The Paraquat Prevention Act does more than cancel registrations. It also directs EPA to revoke any food tolerances that allow paraquat residues on food. That matters because a domestic ban without a residue ban can become a loophole: U.S. farmers lose the chemical, but imported food grown with paraquat can still enter the country.

A true ban must protect consumers, farmers, and honest competition. If paraquat is too dangerous for American fields, it should not be tolerated on imported food either.

EPA Keeps Protecting Chemicals, not the Public’s Health

Paraquat fits a familiar pattern. First, a chemical becomes entrenched in agriculture. Then health evidence accumulates. Then the agency asks for more data, more review, more time. Meanwhile, industry insists the science is unsettled, and the public keeps absorbing the risk.

This is the same failed model Americans have seen with glyphosate, PFAS, and other chemicals regulators allowed to remain on the market while independent scientists, exposed communities, and advocates raised alarms.

Congress should not wait for EPA to find the political courage to act. The agency already knows paraquat is highly toxic. The scientific record already supports urgent concern. More than 70 countries have already acted.

Now the federal government must choose: protect people, or protect a pesticide.

Action Alert! Tell Congress to support the Paraquat Prevention Act and ban paraquat nationwide.

The post One Sip Can Kill. Why Is Paraquat Still on Our Food Fields? first appeared on Alliance for Natural Health USA - Protecting Natural Health.

For years, the FDA’s approach to compounded peptides has looked less like careful regulation and more like a campaign to eliminate patient access to products that compete with Big Pharma. There may at last be reason for cautious optimism. Action Alert!

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THE TOPLINE

• The FDA’s newly remade Pharmacy Compounding Advisory Committee will meet July 23-24, 2026, to consider whether key peptides—including BPC-157, KPV, TB-500, MOTs-C, Epitalon, and others—should be allowed for use by traditional compounding pharmacies.
• Unlike past panels that rejected access to peptides such as thymosin alpha-1, the new PCAC includes physicians and pharmacists with real-world experience in personalized, regenerative, and integrative medicine—raising cautious hope for a more balanced approach.
• FDA restrictions are pushing patients toward risky “research use only” gray-market products, while properly regulated compounding offers a safer path through physician oversight, pharmacy accountability, and enforceable quality standards.

For too long, patients seeking personalized peptide therapies have been forced into a cruel choice: go without treatments their doctors believe may help, or turn to the unsafe gray market created by FDA restrictions. Now, a newly remade FDA advisory panel could offer a rare opening to restore common sense, protect patients, and keep safe, natural peptides available through lawful, physician-supervised compounding.

The FDA’s Pharmacy Compounding Advisory Committee, or PCAC, has been remade with members who appear to understand what patients, physicians, and compounding pharmacists already know: access to properly compounded medicines can be a lifeline, especially when conventional medicine offers limited options. This is almost certainly due to RFK Jr.’s influence, and we commend him for taking this action to protect consumer choice.

That matters because PCAC is preparing to review another slate of peptides for potential inclusion on the FDA’s 503A Bulk Drug Substances List. The committee will meet July 23-24, 2026, to consider BPC-157, KPV, TB-500, MOTs-C, emideltide, Semax, and Epitalon.

PCAC’s Importance

PCAC does not make the final law. It advises the FDA.

For many peptides, however, the committee’s recommendation is a critical step. Under Section 503A of the Federal Food, Drug, and Cosmetic Act, a traditional compounding pharmacy may compound from a bulk drug substance only if the substance has a United States Pharmacopeia or National Formulary monograph, is a component of an FDA-approved drug, or appears on the 503A Bulks List.

If PCAC recommends adding a substance, the FDA must still go through notice-and-comment rulemaking before formally adding it. In other words, even a favorable PCAC vote is not an immediate green light. But a negative vote can help the FDA justify continued restriction.

That is why the composition of this committee matters so much.

A Needed Departure from the Old PCAC

Past PCAC panels have been dominated by academic and institutional voices that often appeared to accept the FDA’s framing rather than challenge it. The result has been predictable: peptide after peptide, and natural substance after natural substance, have been rejected.

At its December 4, 2024 meeting, PCAC voted against adding CJC-1295, AOD-9604, and thymosin alpha-1 to the 503A Bulks List. Thymosin alpha-1, or Ta1, was rejected by a vote of 17 to 4.

The remade roster looks different. FDA’s current PCAC roster includes physicians and pharmacists with expertise in cellular medicine, regenerative therapies, internal medicine, family medicine, pharmacy, and personalized medicine. Members include Asare B. Christian, MD, founder and medical director of Aether Medicine; Melissa Loseke, DO, owner and physician at Re-New Institute; Joshua Starbuck, MD, owner and physician at Makena Health; Kris Wusterhausen, DO, founder and medical director of The Resurge Clinic; and pharmacists Timothy Fensky and Tennessee State Senator Robert Harshbarger III.

Critics have attacked these appointments because some members work in clinics or businesses connected to peptides, hormone therapy, or regenerative medicine. The Associated Press reported that the new panel includes doctors and pharmacists with ties to the peptide and wellness space and contrasted it with prior panels made up mostly of academics and researchers.

But that criticism misses the point. Patients do not need another committee that treats real-world clinical experience as a liability. They need a committee willing to ask whether FDA policy is pushing patients toward greater danger or denying them access to safe and effective products.

The Thymosin Alpha-1 Warning

Thymosin alpha-1 (Ta1) shows what goes wrong when FDA treats natural peptides as regulatory threats.

Ta1 is a peptide naturally occurring in the thymus and has long been studied for immune-modulating properties. A 2020 review describes thymosin alpha-1 as naturally occurring in the thymus and notes its longstanding recognition for modifying, enhancing, and restoring immune function. The literature also describes Ta1 and thymalfasin as having well-studied safety profiles and being generally well tolerated, with mostly minor side effects.

Yet PCAC still rejected it.

The FDA has cited concerns including immunogenicity, possible impurities, and inadequate safety information for certain compounded uses.

As we’ve argued previously, lack of data does not imply risk. If impurities are the concern, FDA should issue clear quality-control guidance for compounding pharmacies and bulk ingredient suppliers. If route of administration is the issue, FDA should address route-specific safeguards.

For natural peptides with meaningful safety histories, the answer should be better standards, not prohibition.

Restriction Fuels the Gray Market

The FDA’s peptide crackdown has had a predictable consequence: patients have not stopped seeking peptides. Many have simply been pushed out of the medical system.

Products labeled “for research use only” are widely available online. These products—often imported from shady overseas suppliers—may have uncertain purity, questionable sterility, inaccurate labeling, or no meaningful medical oversight.

Properly regulated compounding offers a better path: physician oversight, patient-specific prescriptions, pharmacy accountability, certificates of analysis, and enforceable standards.

The FDA’s own 503A framework recognizes that bulk drug substances used in compounding must meet specific conditions, including valid certificates of analysis and manufacturing by registered establishments.

If FDA’s goal is patient safety, it should prefer licensed pharmacies over anonymous online sellers.

Epitalon Is Next

Epitalon deserves especially close attention at the July 24 meeting.

Epitalon is a tetrapeptide, Ala-Glu-Asp-Gly, also known as AEDG. It was synthesized based on the amino acid composition of Epithalamin, a bovine pineal gland extract, before being identified in pineal gland polypeptide complex solution. Like Ta1, Epitalon sits closer to the natural-peptide end of the spectrum than many new-to-nature compounds.

There are gaps in the safety data. But lack of complete data is not the same as evidence of harm, especially when used under the care of a physician through licensed compounding pharmacies.

Access to Epitalon is critically important. It sits at the heart of the life’s work of the pioneer of bioregulatory peptides, the late Prof. Vladimir Khavinson — a field he developed over more than four decades and described as “the future of medicine.” Khavinson regarded the pineal peptide system as a central regulator of biological resilience and ageing, and in his clinical framework Epitalon is often used as a foundational bioregulator alongside organ-specific peptide preparations. Removing physician-supervised access to Epitalon would therefore cut off one of the most important examples of a natural-sequence peptide approach that is biologically targeted, individualized, and fundamentally different from conventional drug intervention.

Stay Vigilant

ANH is preparing to defend access to key peptides through a petition focused on substances that are, above all, safe and natural. The peptide category is broad. Some substances are naturally occurring. Some are natural analogues. Others are essentially new-to-nature compounds that may warrant more caution.

Our priority is to protect access where the safety case is strongest and where patients and integrative physicians have the most to lose from FDA overreach.

The remade PCAC is not a guarantee. FDA career staff may still push the same restrictive assumptions. The agency may still hide behind speculative risks rather than engage with quality-control solutions. And even a favorable PCAC recommendation does not mean the FDA will take the committee’s advice.

But this is an opening.

Patients deserve access to personalized medicine. Physicians deserve tools beyond one-size-fits-all drugs. Compounding pharmacies deserve a regulatory system that rewards quality rather than punishes innovation. And FDA should not be allowed to drive patients into the gray market while claiming to protect them.

Action Alert!

The post Will FDA Panel Shake-Up Restore Access to Compounded Peptides? first appeared on Alliance for Natural Health USA - Protecting Natural Health.

The federal government just did something rare in supplement regulation: it drew a line that targets a dangerous opioid adulterant without sweeping away a natural botanical used in its natural leaf form. Action Alert!

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THE TOPLINE

• DEA’s proposed action targets highly concentrated, synthetic, or chemically enhanced 7-OH products—not traditional kratom leaf products containing only trace, naturally occurring levels of 7-OH.
• ANH supports this more precise approach because it distinguishes between natural botanicals and drug-like products engineered to deliver stronger opioid-like effects.
• Regulators must also address high-dose mitragynine extracts so bad actors cannot simply replace one risky product with another while continuing to exploit the kratom market.

Bad actors have been hijacking kratom’s name to sell concentrated, opioid-like products that bear little resemblance to the traditional botanical. For once, federal regulators may be drawing the right line: crack down on the dangerous adulterants without destroying access to the natural plant.

On July 1, 2026, the Drug Enforcement Administration announced its intent to temporarily place 7-hydroxymitragynine, or 7-OH, above a specified threshold into Schedule I of the Controlled Substances Act. DEA also moved to temporarily schedule three related synthetic substances: mitragynine pseudoindoxyl, MGM-15, and MGM-16.

This is a move in the right direction.

ANH has long warned that regulators too often use the worst actors in a product category as an excuse to attack the entire category. That is not what appears to be happening here. DEA and HHS have made clear that the action is aimed at highly concentrated, synthetic, or chemically enhanced 7-OH products, not natural kratom leaf products containing only naturally occurring trace levels of 7-OH. We applaud HHS Secretary Robert F. Kennedy Jr. and former FDA Commissioner Dr. Marty Makary (who helped spearhead this initiative) and hope this nuanced approach can be applied more broadly across the natural products sector moving forward.

A Dangerous Product Masquerading as Kratom

Kratom comes from the leaves of the Mitragyna speciosa tree, a botanical traditionally used in Southeast Asia. Its primary alkaloid is mitragynine. In natural leaf material, 7-OH occurs only in very small, trace amounts, while it can also be formed in the body following oxidation of mitragynine in the liver. As noted in FDA’s 2025 scientific report, 7-OH is has much greater affinity to opioid receptors than mitragynine and therefore larger, repeated exposures tend to both induce opioid-like, sedative effects, not dissimilar to morphine, while also increasing the potential for addiction.  

None of these problems have been associated with traditional use of kratom leaf in Southeast Asia. It is the explosion of concentrated 7-OH, and more recently mitragynine pseudoindoxyl-based products, sold online and in gas stations, vape shops, convenience stores, and smoke shops in the form of tablets, gummies, shots, powders, capsules, and dissolvable strips that are at the root of all the problems with kratom in the USA.

FDA has warned that these products may contain enhanced or concentrated 7-OH levels and may be inaccurately labeled or marketed as “kratom.” DEA says these products often contain far more 7-OH than naturally occurring botanical kratom.

This is what smarter regulation should look like: protect consumers from deceptive, addictive, chemically manipulated products while preserving access to traditional botanicals.

For once, the federal government appears to be recognizing that a plant, an isolated alkaloid, and a semi-synthetic high-potency product are not the same thing.

The Line DEA Drew

DEA’s proposed threshold would cover botanical kratom material containing more than 0.050 percent 7-OH on a dry weight basis. It would also cover synthetic or further-processed alternative dosage forms, including extracts, concentrates, processed edibles, and pressed pills, when they contain more than 0.050 percent 7-OH or more than 1.00 milligram of 7-OH in the article.

FDA’s report states that concentrated 7-OH products are an emerging public health threat, citing opioid-like effects, dependence, withdrawal, and respiratory depression concerns. The report also notes that 7-OH has shown approximately 13-fold greater potency than morphine in one functional assay, a finding that helps explain why these products should never have been allowed to masquerade as ordinary supplements.

But There Is a Loophole

Here is the next problem: high-dose mitragynine.

Mitragynine is the dominant alkaloid in kratom, and research indicates that mitragynine is readily metabolized by CYP3A liver enzymes into 7-OH. If regulators remove high-7-OH products but ignore highly concentrated mitragynine extracts, bad actors may simply pivot.

That means FDA and HHS should not stop at 7-OH. They should, in our view, develop a science-based maximum mitragynine framework for finished products, especially concentrated extracts. This approach will prevent a marketplace shell game in which sellers replace one high-risk opioid-like product with another product designed to generate similar effects through a different pathway.

Kratom Is Used by Millions. Regulation Must Be Precise.

Kratom use in the United States has gained popularity. Survey research by Oliver Grundmann and colleagues reported a 9.1 percent active-use estimate among U.S. adults. Millions of Americans may be affected by how regulators handle kratom.

That is why blanket bans are the wrong answer.

Traditional kratom products, high-dose extracts, concentrated 7-OH, and synthetic derivatives require different regulatory treatment. A one-size-fits-all prohibition would punish responsible consumers and companies while doing little to address the real problem: adulterated, drug-like products sold under the cover of natural health.

Health Freedom Requires Guardrails Against Bad Actors

Health freedom does not mean allowing deceptive products to be sold to vulnerable consumers with no meaningful standards. Adults should retain access to natural health options, with truthful labeling, reasonable safeguards, and enforcement against fraud and adulteration.

FDA already has tools to act against illegal foods, drugs, and adulterated dietary supplements. DEA’s temporary scheduling action, if finalized, gives regulators another tool against concentrated synthetic 7-OH products. The challenge now is to use those tools effectively.

ANH will be watching whether HHS and DEA keep their promise not to sweep natural kratom into this action. We will also be watching whether FDA develops a rational standard for high-mitragynine products, because without one, this crackdown may simply shift the market rather than clean it up.

This is a welcome step. Now regulators must finish the job: ban the harmful, preserve the safe, and stop the cowboys from turning natural health products into unapproved opioid-like drugs.

Action Alert!

The post At Long Last: Regulators Target Dangerous Kratom Knockoffs, Not the Natural Leaf first appeared on Alliance for Natural Health USA - Protecting Natural Health.