Medicare's Hemp Program Continues Despite Federal Restrictions Taking Effect in Less Than Six Months
Court Declines to Address Safety, Legality, or Congressional Intent, Allowing CMS Hemp Program to Continue While Seniors Remain the Test Population
Duane Boise, CEO of MMJ International Holdings:
"The Court never ruled that CMS acted lawfully. The Court never ruled these products are safe. The Court never ruled Congress intended Medicare to become a distribution channel for non-FDA-approved cannabinoid products. The Court simply concluded that no one had been harmed enough yet to challenge the program. Waiting for harm before allowing judicial review is a dangerous standard when America's seniors are the ones being exposed."
As Federal Restrictions Approach and Safety Questions Mount, Medicare Beneficiaries Remain the Test Case
WASHINGTON, D.C. / ACCESS Newswire / May 23, 2026 / MMJ International Holdings today sharply criticized the Centers for Medicare & Medicaid Services (CMS) for continuing its Substance Access Beneficiary Engagement Incentive (BEI) program, which allows participating Medicare providers to furnish hemp-derived cannabinoid products to seniors despite mounting regulatory, scientific, and legal concerns.
The controversy comes as Congress has already enacted sweeping restrictions on hemp-derived cannabinoid products, European regulators have refused to establish the safety of a Charlottes Web hemp extract product, and a federal court recently declined to stop the program-not because it found the program lawful, but because it ruled the plaintiffs had not yet demonstrated sufficient injury to challenge it.
Congress Already Acted
On November 12, 2025, Congress enacted Section 781 of the Continuing Appropriations and Extensions Act of 2026 (Public Law 119-37), fundamentally reshaping the federal hemp marketplace.
Beginning November 12, 2026, hemp-derived cannabinoid products may contain no more than 0.4 milligrams of total THC per container.
Not per serving.
Not per gummy.
Not per dose.
Per entire package.
The new law creates a compliance challenge for a substantial portion of today's hemp-derived cannabinoid market and signals Congress's growing concern regarding the rapid expansion of largely unregulated cannabinoid products.
Yet only months after Congress passed the legislation, CMS launched the BEI program, creating a federally supported pathway for Medicare beneficiaries to obtain hemp-derived cannabinoid products that have not undergone FDA drug approval.
Europe Raised the Alarm
In March 2026, the European Food Safety Authority (EFSA) issued a scientific opinion concluding that the safety of a major hemp extract product could not be established.
EFSA cited significant concerns, including incomplete toxicology data, unidentified components representing a substantial portion of the product, insufficient human clinical evidence, and unresolved safety questions.
The findings sent shockwaves through the international cannabinoid industry because they involved the same general category of hemp-derived cannabinoid products now being furnished through the CMS BEI program.
The Court Never Examined the Merits
On May 22, 2026, Judge Trevor McFadden of the United States District Court for the District of Columbia dismissed the lawsuit challenging the BEI program.
The court did not determine whether the program is lawful.
The court did not determine whether CMS exceeded its authority.
The court did not determine whether the products are safe.
The court did not determine whether taxpayers should be funding the distribution of non-FDA-approved cannabinoid products to Medicare beneficiaries.
Instead, the court concluded that the plaintiffs had not yet demonstrated sufficient injury to establish standing.
Lead plaintiff Smart Approaches to Marijuana immediately announced it is evaluating appellate options.
"We fundamentally disagree with the court's decision today. All parties demonstrated substantial injury that exceeds the threshold required by Article III. We are currently reviewing all our options, including an appeal. We will not rest until we ensure America's seniors are safe from these false medical claims and the harms of dangerous marijuana products."
- Kevin A. Sabet, President and CEO, Smart Approaches to Marijuana
Who Protects Seniors While Everyone Waits?
According to MMJ International Holdings, the most troubling aspect of the decision is that no court has yet examined the underlying safety, scientific, or regulatory questions before allowing the program to continue.
"The Court's ruling creates a dangerous regulatory vacuum," said Duane Boise.
"Congress has already acted. Europe has already raised serious safety concerns. Yet CMS continues facilitating access to hemp-derived cannabinoid products for Medicare beneficiaries, and the Court has effectively said no one can challenge the program until someone suffers a sufficiently concrete injury. That is not prevention. That is waiting for a problem and hoping it never arrives."
Boise continued:
"For eight years MMJ has followed every federal rule. We obtained FDA INDs, earned Orphan Drug Designation, built a DEA-registered laboratory, and invested millions proving safety before reaching a single patient. Meanwhile, CMS is allowing products that have never undergone FDA drug approval to reach seniors through a federal healthcare program. The question is simple: if Congress has already spoken and Europe has already raised red flags, who is accountable if something goes wrong between now and November 12, 2026?"
A Tale of Two Standards
MMJ International Holdings has invested more than $10 million pursuing FDA-regulated cannabinoid medicines for Huntington's disease and Multiple Sclerosis.
The company has:
FDA Investigational New Drug applications;
FDA Orphan Drug Designation;
A DEA Schedule I analytical laboratory registration;
A pending DEA bulk manufacturing registration application dating back to 2018;
Nearly a decade of investment in the federal pharmaceutical pathway.
Under the pathway MMJ follows, products must demonstrate safety, quality, consistency, and efficacy before reaching patients.
Under the BEI program, none of those FDA drug approval requirements apply.
The Countdown Has Begun
The practical reality is becoming increasingly difficult to ignore.
In less than six months:
Federal hemp restrictions enacted by Congress take effect.
Questions raised by European regulators remain unanswered.
The legal challenge continues toward a possible appeal.
Medicare beneficiaries continue receiving products through the BEI program.
The court may have dismissed the lawsuit.
But it did not answer the fundamental question at the center of the controversy:
Why is the federal government encouraging access to hemp-derived cannabinoid products through Medicare while Congress moves to restrict them, regulators abroad question their safety, and no FDA approval is required?
For MMJ International Holdings, that question remains unanswered-and increasingly urgent.
CONTACT:
Madison Hisey
MHisey@mmjih.com
203-231-8583
SOURCE: MMJ International Holdings
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/congress-banned-it.-europe-rejected-it.-cms-is-still-giving-cbd-to-se-1170218
