They're Calling It Hemp, Cannabis Medicine. Pesticides, Mycotoxins, Fraudulent Lab Reports? And Medicare Is Now Reimbursing It

Audio By Carbonatix

Pesticides. Mycotoxins. Fraudulent Lab Reports. Forged Certificates of Analysis. This Is the State-Licensed Cannabis and Hemp Supply Chain the Courts and DEA Just Handed a Federal Registration Pathway - While the FDA Commissioner Looked Away and Judge McFadden Said Nobody Has Standing to Complain.

WASHINGTON, D.C. / ACCESS Newswire / June 1, 2026 / Let's start with what medicine actually is. Pesticides. Mycotoxins. Fraudulent Lab Reports. Now Covered by Medicare.

Medicine is a substance manufactured under validated, documented, reproducible conditions - conditions that guarantee, to the highest scientifically achievable degree of certainty, that what is in the bottle is what the label says, that nothing else is in the bottle that shouldn't be, and that the patient receiving it is not simultaneously being dosed with pesticide residues, carcinogenic mycotoxins, heavy metals, or microbial pathogens that the testing laboratory was paid to pretend weren't there.

That is what 21 CFR Part 211 - current Good Manufacturing Practice for finished pharmaceuticals exists to ensure. That is what EU GMP exists to ensure. That is what the FDA's ICH Q8 pharmaceutical development framework, Q9 quality risk management, and Q10 pharmaceutical quality system exist to ensure. These are not bureaucratic rituals. They are the accumulated scientific knowledge of a century of catastrophic pharmaceutical failures - thalidomide, sulfanilamide elixir, contaminated heparin - codified into law to prevent the next one.

Now ask yourself one question: does a single product in the state-licensed cannabis supply chain that just received an expedited DEA Schedule III registration pathway meet any of those standards?

The answer is documented. It is peer reviewed. It is confirmed by Europe's own food safety authority. And it is damning beyond any political spin the industry's lobbyists can construct.

WHAT EUROPE FOUND - AND WHAT IT MEANS

During the assessment of Charlottes Web hemp cannabidiol as a novel food, EFSA's NDA Panel identified significant data gaps. Concerns focused on potential adverse effects on the liver, gastrointestinal tract, endocrine, nervous and reproductive systems. Literature searches covering animal and human studies confirmed the persistence of these gaps, as many of the new studies suffer from methodological limitations, including non-standardized protocols, short durations and concomitant treatment with medicine. Marijuana Moment

Europe's food safety authority - which is not a lobbying organization, not a trade group, not a Mar-a-Lago donor producing videos about the endocannabinoid system - looked at the peer-reviewed science on CBD safety and found that the data gaps identified years ago have not been closed. The studies are methodologically compromised. The protocols are not standardized. The durations are too short. The interactions with other medicines are uncharacterized.

CBD isolate applications were assessed under the EU Novel Food regulation requiring rigorous safety demonstration. Uncertainties remain concerning the type of formulations that the applicant intends to market, and consequently on the possible presence of small particles including nanoparticles and their potential bioavailability implications. Harris Sliwoski

Europe is still assessing CBD's basic safety profile for food supplements. The United States just put it in Medicare.

THE CONTAMINATION RECORD THAT CANNOT BE DISMISSED

With this emerging interest in Cannabis, concerns have arisen about the possible contaminations of hemp with pesticides, heavy metals, microbial pathogens, and carcinogenic compounds during the cultivation, manufacturing, and packaging processes. This is of particular concern for those turning to Cannabis for medicinal purposes, especially those with compromised immune systems. High Times

Compromised immune systems. That is the precise clinical description of a significant proportion of Medicare's patient population - elderly Americans, cancer patients, transplant recipients, patients on immunosuppressive medications. The population CMS just decided should have convenient Medicare-covered access to products from a supply chain with a documented, systemic contamination problem.

Cannabidiol food supplements made of Cannabis sativa extracts have quickly become popular products due to their health promoting effects. However, potential contaminants, such as mycotoxins and pesticides, can be co-extracted during the manufacturing process and placed into the final product. Up to six different Fusarium mycotoxins were found in seven out of ten tested CBD-based products, the most prevalent being zearalenone and enniatin B1, both found at a maximum level of 11.6 ng/g. Substack

Seven out of ten. Not a fringe finding from an advocacy group. A peer-reviewed analytical chemistry study using ultra-high-performance liquid chromatography with mass spectrometry confirmation - the same class of instrumentation required under pharmaceutical GMP - finding Fusarium mycotoxins in 70% of tested CBD products. Zearalenone is an estrogenic mycotoxin with reproductive toxicity. Enniatin B1 is a cytotoxic compound with documented membrane disruption effects. Both are co-extracted with CBD during standard production - meaning they are invisible to a manufacturer who is not specifically testing for them using validated methods.

The state-licensed cannabis supply chain is not specifically testing for them using validated methods. There is no requirement that they do.

This review discusses the mycobiome of cannabis and hemp flowers with a focus on plant-infecting and toxigenic fungi that are most commonly found and are of potential concern - Aspergillus, Penicillium, Fusarium, and Mucor species. Fewer than 1% of cannabis studies have examined microbial contamination, and only 0.5% have addressed mycotoxins or spoilage organisms. This underscores a critical knowledge gap and highlights the urgent need for developing improved detection methods to safeguard consumer health. Cannabisriskmanager

Aspergillus. The fungal genus responsible for invasive aspergillosis - a life-threatening infection in immunocompromised patients with a mortality rate exceeding 50% in high-risk populations. It is found in cannabis flowers. It produces aflatoxins - among the most potent hepatocarcinogenic compounds known to science. And fewer than 1% of cannabis studies have examined whether it is present in the products being sold.

The DEA just opened an expedited registration pathway for the supply chain producing those products. The FDA Commissioner said he won't enforce pharmaceutical standards against them. Judge McFadden said nobody has standing to complain.

THE FRAUDULENT LAB REPORT EPIDEMIC NOBODY WANTS TO NAME

Between 2020 and 2024, multiple state-licensed testing laboratories lost their certifications for falsifying THC potency results, failing to detect pesticides at levels 600 times the legal limit, and manipulating safety data. Fraudulent or substandard Certificates of Analysis represent one of the highest-risk failure points in cannabinoid supply chains. Marijuana Moment

Six hundred times the legal limit. Not slightly elevated. Not within measurement uncertainty. Six hundred times. Meaning laboratories that are supposed to be the last line of defense between a contaminated product and a patient were instead the mechanism by which contaminated products received passing certificates and entered the legal supply chain.

California regulators withdrew the license of a cannabis testing laboratory after it was determined that the lab tampered with equipment and faked test results so it could provide passing test results to marijuana products that were possibly contaminated with mold and dangerous pesticides. GreenState

Tampered with equipment. Faked results. Contaminated with mold and dangerous pesticides. This happened in California - the state with the most mature and ostensibly most regulated cannabis market in the country. If this is the enforcement record of the most developed state regulatory framework, what is happening in states with younger, less-resourced regulatory programs?

In June 2024, a major Los Angeles Times investigation found residues of concerning chemicals in products from popular legal California brands. Part of the problem: the state's list of regulated pesticides has been frozen at 66 compounds since 2018, a number that researchers and consumer advocates describe as far too narrow to capture the full range of chemicals that growers actually use. A September 2024 follow-up documented the political and regulatory repercussions, with mounting pressure on the state cannabis agency and calls from county officials for a formal health emergency designation. CNBC

A formal health emergency designation. In the legal market. From county officials. About products sold in licensed dispensaries with certificates of analysis attached. And California issued 63 cannabis recalls and nearly 500 product embargoes in 2024 alone. Marijuana Moment

Five hundred embargoes. In one state. In one year. From a legal, licensed, regulated supply chain.

This is the supply chain the federal government just decided deserves expedited DEA registration and Medicare access.

THE MAKARY LETTER'S FATAL FOUR WORDS

The FDA does not intend to enforce sections 502(f)(1) or 505 of the Federal Food, Drug, and Cosmetic Act with respect to an orally administered, hemp-derived CBD product, provided that the product is not contaminated. Cannabis Business Times

"Provided that the product is not contaminated."

Four words. The entire patient protection framework for Medicare-covered hemp-derived cannabinoid products rests on four words with no enforcement mechanism, no validated testing requirement, no ICH Q8 design space, no 21 CFR Part 211 manufacturing controls, no ISO 17025-accredited analytical laboratory requirement, and no independent verification of any kind.

The FDA Commissioner says: don't be contaminated. The peer-reviewed literature says: 70% of tested CBD products contain mycotoxins. California says: 500 product embargoes in 2024. Europe says: the safety data gaps have not been closed.

And the FDA's enforcement posture is: we won't check.

WHAT 21 CFR PART 211 ACTUALLY REQUIRES - AND WHY IT EXISTS

This is not regulatory overhead. This is not pharmaceutical industry protectionism. This is the codified scientific response to what happens when manufacturing controls fail.

21 CFR Part 211 requires validated manufacturing processes - meaning you have scientifically demonstrated, with documented evidence, that your process consistently produces a product meeting its specifications. It requires finished product testing against pre-established, validated specifications. It requires stability testing demonstrating that the product remains within specifications throughout its labeled shelf life under defined storage conditions. It requires raw material testing confirming identity, purity, and quality before use. It requires equipment qualification, cleaning validation, environmental monitoring, microbial testing, and batch record documentation that creates a complete, auditable trail from raw material to finished product.

EU GMP requires the same, harmonized under the International Council for Harmonisation standards that MMJ has been following for eight years.

The increasing use of Cannabis sativa products for medicinal, dietary, and recreational purposes has raised concerns about mycotoxin contamination in cannabis and hemp. DNA damage indicates that mycotoxins may induce genome instability through indirect mechanisms, with evidence of potential aneuploidic effects. Combined exposure led to a reduction in CBD's potential beneficial properties, suggesting mycotoxin interference with the intended therapeutic activity of CBD itself. Fierce Healthcare

Not only are the mycotoxins toxic. They interfere with the CBD's own therapeutic mechanism. The contamination doesn't just add harm - it subtracts the intended benefit. A patient receiving a mycotoxin-contaminated CBD product is simultaneously being dosed with a toxin and receiving a reduced therapeutic effect from the compound they were told would help them.

This is what happens when you call something medicine without making it meet pharmaceutical standards.

THE REGULATORY DISCRIMINATION IN ONE PARAGRAPH

MMJ BioPharma Cultivation has spent eight years and more than $10 million satisfying every requirement of 21 CFR Part 211, EU GMP, ICH Q8, Q9, and Q10. Its facilities have been DEA-inspected. Its analytical laboratory holds a Schedule I DEA registration confirming it meets the agency's highest security, recordkeeping, and compliance standards. Its manufacturing processes are subject to FDA IND Chemistry, Manufacturing, and Controls review. Its products will be tested using validated analytical methods against pre-established specifications in ISO-compliant laboratories. Its stability program will confirm that every batch meets specifications from manufacture through expiration.

The state-licensed operators who just received an expedited DEA registration pathway under the April 23, 2026 order are subject to none of these requirements. Their testing laboratories have documented histories of falsified results. Their pesticide panels cover 66 compounds in California and fewer in most other states - a fraction of the compounds actually used in cultivation. Their mycotoxin testing is inconsistent, non-standardized, and often nonexistent. Their manufacturing processes have no validated design space, no proven acceptable ranges, no critical quality attribute documentation.

FDA-regulated products containing cannabidiol are subject to the same legal and regulatory requirements as other FDA-regulated products. Cannabis Business Times

The FDA Commissioner wrote that on April 1, 2026. Then suspended enforcement of those requirements for the exact product category being distributed to Medicare seniors.

MMJ must satisfy all of them. Its competitors must satisfy none.

Judge McFadden says MMJ has no standing to object because it has no product on the Medicare market.

MMJ has no product on the Medicare market because it is spending eight years satisfying the requirements its competitors are exempt from.

THE PATIENTS WHO HAVE NO IDEA

There is an elderly Medicare patient somewhere in America right now who has been told by their physician - under the BEI program - that a hemp-derived CBD product may help with their pain, their anxiety, their sleep. They trust that because their doctor recommended it. They trust that because Medicare is paying for it. They trust that because the federal government's fingerprints are on every piece of paper that put that product in their hands.

They do not know that the certificate of analysis attached to that product may have been issued by a laboratory that in the prior year falsified results for products contaminated with mold and pesticides. They do not know that 70% of tested CBD products contain Fusarium mycotoxins. They do not know that Europe's food safety authority has not approved CBD for general consumption because the safety data gaps have not been closed. They do not know that there is no validated manufacturing process, no stability program, no ICH Q8 design space, no 21 CFR Part 211 compliance standing behind the supplement facts panel on that label.

They were told it's medicine. The government called it medicine. The physician recommended it under a government program. The federal treasury is paying for it.

It is imperative to develop universal standards for cultivation and testing of products to protect those who consume Cannabis. This is of particular concern for those turning to Cannabis for medicinal purposes, especially those with compromised immune systems. High Times

Universal standards. The scientific community has been saying this for years. The peer-reviewed literature has documented the contamination. Europe has refused to approve the products without adequate safety data. The FDA's own guidance says quality cannot be tested into products - it must be built in by design.

The federal government's response was to create a Medicare distribution program, suspend enforcement of pharmaceutical standards, issue an expedited DEA registration pathway for the supply chains with the documented contamination record, and tell the one company that actually built quality in by design that it has no standing to complain.

THE VERDICT

"After eight years, millions invested, FDA INDs, Orphan Drug Designation, DEA inspections, and a completed federal investigation, MMJ demands the government explain why companies that followed federal law were left behind," said Duane Boise, CEO of MMJ International Holdings. ACCESS Newswire

The answer - the one the government does not want to give in open session on June 29 - is this:

The companies that followed federal law were left behind because following federal law was expensive, slow, and inconvenient for a political agenda that needed cannabis reform to happen on a donor's timeline rather than a scientist's.

Patients with Huntington's disease and Multiple Sclerosis waited. Their diseases progressed. The science that might have helped them was bureaucratically buried.

And now, in the same regulatory moment that the DEA opens an expedited pathway for the contaminated supply chains those patients were never supposed to need - the federal government is putting those same uncharacterized products into the hands of the most vulnerable Medicare population in the country, backed by four words of phantom safety assurance from a commissioner who has since resigned.

Cannabis isn't medicine because a lobbyist says it is. Cannabis isn't medicine because a Mar-a-Lago donor made a video about it. Cannabis isn't medicine because CMS covers it or the DEA registers its producers.

Cannabis is medicine when it is manufactured under validated controls, tested with validated methods, characterized for its critical quality attributes, documented through a complete and auditable batch record, and delivered to patients with the certainty - not the hope - that what is in the bottle is what the label says and nothing else is there that shouldn't be.

That standard has a name. It is called 21 CFR Part 211. It is called EU GMP. It is called pharmaceutical quality.

It is the only standard that should apply to anything being called medicine for America's Medicare patients.

Until it does - for everyone in the cannabinoid market, without exception, without exemption, and without enforcement discretion - the federal government is not delivering medicine to seniors.

It is delivering an uncontrolled experiment. And the patients are the subjects.

MMJ International Holdings, MMJ BioPharma Cultivation, and MMJ BioPharma Labs are represented by counsel in all pending federal proceedings. The DEA rescheduling hearing begins June 29, 2026. The June 22 participant selection decision is the first test of whether the federal government's rescheduling process will be conducted with the scientific integrity that cannabis-as-medicine demands.

CONTACT:

Madison Hisey

[email protected]

203-231-8583

SOURCE: MMJ International Holdings