WASHINGTON, D.C. / ACCESS Newswire / May 10, 2026 / Imagine your mother is 74 years old. She has cancer. She's on blood thinners, blood pressure medication, and chemotherapy. Her doctor sits down with her and says Medicare will now cover CBD hemp products - up to $500 a year - and suggests she try them for pain and anxiety.
She asks: has this been tested? Is it safe for someone on my medications? Did the government check?
The answer to all three questions, right now, is no.
That is not an opinion. That is the conclusion of the world's top food safety scientists - and it is directly contradicted by what the U.S. government is currently doing with your tax dollars and your Medicare system.
First, Let's Explain What Just Happened
In April 2026, the Centers for Medicare and Medicaid Services - the federal agency that runs Medicare - quietly launched a new program called the Substance Access Beneficiary Engagement Incentive, or BEI. The name sounds harmless enough. What it actually does is allow doctors participating in certain Medicare programs to recommend hemp, marijuana-derived CBD products to their elderly patients - including cancer patients - and provide up to $500 per year toward those products.
Dr. Mehmet Oz, the TV doctor turned CMS Administrator, announced it with fanfare at a White House ceremony. President Trump called it a way for seniors to get pain relief without addictive opioids. CBD companies celebrated. Contracts were signed. Products started flowing to healthcare providers serving millions of Medicare patients.
Here is what nobody mentioned at that ceremony.
What Europe Just Found Out
Think of the European Food Safety Authority - EFSA - as Europe's FDA. It is the continent's gold standard for deciding whether food and supplement products are safe for human consumption. It does not answer to politicians. It answers to science.
In March 2026 - the same month the Medicare CBD program was gearing up to launch - EFSA published its official scientific review of a CBD hemp extract made by Charlotte's Web. You may have heard of Charlotte's Web. It is the largest CBD company in America. It is one of the companies now positioned to supply products to Medicare seniors under this program.
EFSA's conclusion was five words long: "The safety of the NF cannot be established."
In plain English: we looked at this product, we reviewed all the science, and we cannot tell you it is safe.
Why couldn't they tell? Because when scientists actually examined what was inside the Charlotte's Web extract, they found that between 20 and 30 percent of the product's ingredients could not be identified at all. Nearly a third of what goes into your body when you take this product is unknown - even to the scientists, even to the company that makes it.
The safety tests the company submitted were not even performed on the actual product. They were done on a completely different version of the product made through a different manufacturing process. The scientists concluded those tests were essentially worthless for evaluating what Charlotte's Web was actually asking them to approve.
No human safety studies. No data on what it does to elderly patients. No information on whether it interacts dangerously with common medications. Allergic potential: unknown. Long-term safety: unconfirmable.
Europe said no. America said come on in.
There's THC In There - And That's a DEA Legal Problem
Here is something that will surprise most people. Hemp products are only legal under federal law if they contain less than 0.3% delta-9 THC - the chemical in marijuana that makes you feel high.
When EFSA actually measured the THC in Charlotte's Web's extract, they found it averaged around 1% THC by weight. That is more than three times the legal limit for hemp under federal law.
Now, companies will tell you this is fine because the extract gets diluted before it reaches the consumer as a finished product. The final gummy or tincture may contain much less. That is technically true.
But here is the part the industry does not advertise: under the DEA's own rules - rules published in the Federal Register in 2020 and still in effect today - any hemp extract that exceeds 0.3% THC at any point during the manufacturing process, even for a moment, even before it is diluted, is legally a Schedule I controlled substance. The same category as heroin. The same legal status as cocaine.
The DEA was explicit about this: there is no exception. There is no safe harbor. It does not matter whether the final product ends up below the limit. If it crossed that line during production, it was marijuana under federal law at that moment, and handling it without a DEA license is a federal crime.
The Charlotte's Web extract that Europe evaluated had THC levels averaging over 1% - more than three times the point where federal law says you are no longer holding hemp. You are holding marijuana.
Meanwhile, a Kentucky Company Won a Contract to Supply 68,000 Hospitals and Clinics
While Charlotte's Web was dealing with its European rejection, a Louisville company called Cornbread Hemp was celebrating. In March 2026, it announced a contract to supply its hemp CBD products to a purchasing network serving 68,000 healthcare provider locations across America - before the Medicare program had even officially launched.
Cornbread Hemp makes USDA Organic certified CBD products. Its co-founder had a ribbon-cutting with Senator Rand Paul. It has a Medical Advisory Board. Its products are tested for potency and contaminants. These are real credentials.
What Cornbread Hemp does not have is a single FDA clinical trial. It has never submitted an Investigational New Drug application. No Phase 1 study. No Phase 2 study. No study specifically examining what its products do to elderly patients on multiple medications - the exact population it is now serving through Medicare.
Cornbread Hemp's own co-founder called participating in the Medicare program "an extraordinary leap of faith." He said this because there is a legal deadline coming on November 12, 2026 - just seven months away - when federal law will change and reduce the allowable THC in hemp products from 3 milligrams per serving to 0.4 milligrams per container. When that happens, virtually every product currently eligible for this Medicare program becomes federally prohibited overnight.
The federal government launched a Medicare healthcare program knowing that most of its products will likely become illegal before the year is out - and did not tell seniors enrolled in the program.
So Why Is This Happening?
The honest answer requires understanding how the rules work - and how they were bypassed.
When a pharmaceutical company wants to give a drug to patients, it goes through a process that takes years and costs hundreds of millions of dollars. It starts with laboratory tests, then animal studies, then human trials with carefully monitored volunteers, then larger trials in the actual patient population, then FDA review of all the data. Only if science confirms safety and effectiveness does the drug reach patients.
This process exists because Americans died before it did. The FDA was created after a drug called thalidomide caused thousands of birth defects in Europe in the 1950s. The clinical trial system was strengthened after people were harmed by drugs that turned out to be dangerous. Every requirement exists because someone, somewhere, was hurt by the absence of it.
CBD hemp products have not gone through that process. Not one of them has completed FDA clinical trials as a consumer wellness product. Not one has been specifically tested in elderly Medicare patients on multiple medications.
The Medicare CBD program bypasses that entire system. It was created not by the FDA - the agency responsible for drug safety - but by the CMS Innovation Center, which has authority to test new payment and care delivery models. Critics, including the plaintiffs in a federal lawsuit challenging the program, argue that "testing a payment model" is very different from "introducing an untested product into the care of millions of vulnerable seniors" - and that CMS dramatically exceeded its authority by treating those two things as the same.
A federal court in Washington D.C. heard arguments on this question on May 1, 2026. As of this writing, Judge Trevor McFadden has taken the case under advisement, meaning a ruling is expected soon. He has not ruled quickly, which legal observers say signals he recognizes the weight of the question.
The Company That Did Everything Right Is Watching From The Outside
While CBD companies were signing Medicare contracts and celebrating at White House ceremonies, a small pharmaceutical company in Washington D.C. was watching with a particular kind of frustration.
MMJ International Holdings has spent nearly a decade doing exactly what federal law requires to bring cannabinoid medicine to patients. It has FDA Investigational New Drug applications for treatments targeting Huntington's disease and Multiple Sclerosis - two devastating neurological conditions with no cure. It has DEA registration. It has orphan drug designation, a status reserved for medicines targeting rare diseases with serious unmet medical need. It has built pharmaceutical-grade manufacturing facilities and conducted the kind of analytical chemistry work the FDA demands.
It has done, in other words, everything the government told it to do.
And it has watched as the government that told it to do all of that opened a side door for companies that did none of it - handing them access to the same patient population, through the Medicare system, without clinical trials, without FDA review, without a single study on elderly patients.
MMJ CEO Duane Boise put it plainly: "You cannot responsibly introduce products into a Medicare population when their chemistry is not fully defined and their safety cannot be established. This is not a policy debate - it's a scientific one. MMJ followed the FDA pathway because patients deserve certainty, not guesswork."
He added: "The EFSA scientific record proves what federal regulators refuse to acknowledge: the Charlotte's Web CO2 hemp extract contained delta-9 THC at concentrations averaging over 1% by weight - more than three times the federal threshold that defines the legal boundary between hemp and a Schedule I controlled substance under the DEA's own rules. There is no safe harbor. There is no exception. And yet the federal government is facilitating access to products made through that same process for 68 million Medicare seniors."
What This Means For Your Family
If you have a parent, grandparent, or loved one on Medicare, here is what you should know right now.
Their doctor may soon recommend - or may already have recommended - a CBD hemp product as part of their care. That recommendation will feel official. It will come with Medicare attached to it. It will sound like the government has vetted it.
It has not been vetted the way every other drug your loved one takes has been vetted. There has been no FDA clinical trial. There has been no safety study in elderly patients. There has been no review of interactions with the blood thinners, heart medications, seizure drugs, or cancer treatments your loved one may already be taking.
CBD and THC are known to interact with a family of liver enzymes called CYP450 - the same enzymes responsible for processing dozens of common medications. The interaction potential is real and documented in scientific literature. Whether it is dangerous at the doses in these products, in this population, has not been studied.
The product may contain THC - a psychoactive compound - at levels that were legally marijuana during production under federal law. You will not see that on the label.
The program it comes through may be shut down by a federal court any day now. Or the products may become federally prohibited in November when the law changes. If either happens, the clinical conversations your loved one's doctor started - the recommendations already made, the products already integrated into a care routine - will need to be unwound.
Your loved one is not being told any of this.
The Bottom Line
When a new cholesterol drug reaches your doctor's office, it has been through years of clinical trials. Thousands of patients were monitored. Side effects were catalogued. Drug interactions were studied. The FDA reviewed all of it before a single prescription was written.
That is not what happened here.
What happened here is that a federal agency created a payment incentive program, attached it to Medicare, invited CBD companies to sign up, launched it on April 1, and called it innovation - while Europe's scientists were simultaneously publishing a formal conclusion that the safety of one of those companies' products cannot be established.
The question at the center of this moment is a simple one that every American should be asking: Can federal healthcare systems introduce therapeutic products before they are proven safe and effective? Congress.gov
For every other drug your Medicare-enrolled family member takes, the answer has always been no.
A federal judge is deciding right now whether it should be different for CBD.
Your seniors deserve the same answer they have always been given. Science first. Proof of safety first. Then access.
Not the other way around.
The case Smart Approaches to Marijuana et al. v. Robert F. Kennedy Jr., Case No. 1:26-cv-01081, is pending before U.S. District Judge Trevor N. McFadden in the U.S. District Court for the District of Columbia. A ruling is expected imminently. MMJ International Holdings is a party to related federal litigation challenging the CMS program.
Madison Hisey
MHisey@mmjih.com
203-231-8583
SOURCE: MMJ International Holdings
View the original press release on ACCESS Newswire
