In SAM et al. v. Kennedy (1:26-cv-01081), the Court Weighs Whether CMS Overstepped Its Authority by allowing Hemp, Marijuana Cannabinoid Access Without FDA Approval.
Duane Boise, CEO of MMJ International Holdings stated "By holding the motion under advisement rather than ruling immediately, the court signaled that the issue is both complex and consequential."
WASHINGTON, D.C. / ACCESS Newswire / May 8, 2026 / The future of federal cannabinoid policy now sits with the court after Judge Trevor N. McFadden took under advisement an emergency motion to halt the Centers for Medicare & Medicaid Services' (CMS) cannabinoid access program.
The case,
Smart Approaches to Marijuana (SAM), et al. v. Robert F. Kennedy Jr., et al.
Case No. 1:26-cv-01081 (D.D.C.),
challenges whether CMS exceeded its authority by allowing provider mediated furnishing of certain cannabinoid products to Medicare beneficiaries without approval from the U.S. Food and Drug Administration.
A Decision With National Implications
At issue is not just one program-but a fundamental question:
Can federal healthcare systems introduce therapeutic products before they are proven safe and effective?
For decades, the answer has been no.
The established federal sequence has been:
clinical research - clinical trials - FDA approval - patient access
The CMS Beneficiary Engagement Incentive (BEI) model reverses that order.
The Court Signals the Stakes
By holding the motion under advisement rather than ruling immediately, the court signaled that the issue is both complex and consequential.
Legal analysts note that such decisions typically involve:
statutory authority limits
separation between CMS and FDA roles
the evidentiary threshold for patient safety
Why This Matters for Patients
The debate is not abstract.
It affects real people-particularly seniors relying on Medicare.
Key concerns raised in the litigation include:
lack of FDA approval for cannabinoid products being furnished
absence of standardized dosing and manufacturing controls
limited long-term safety data
potential exposure of vulnerable populations to unvalidated therapies
The Impact on Scientific Development
Clinical-stage developers pursuing cannabinoid therapies through FDA pathways warn that reimbursement-first models may undermine the incentive to conduct rigorous trials.
Companies investing in:
Investigational New Drug (IND) programs
stability and formulation testing
safety and toxicology studies
face a growing concern:
If access comes before evidence, the incentive to generate evidence weakens.
CMS Authority Under Scrutiny
The Centers for Medicare & Medicaid Services Innovation Center has broad authority to test payment and care delivery models.
However, the lawsuit argues that this authority does not extend to redefining what qualifies as a therapeutic product eligible for Medicare-connected use.
That role has historically belonged to the FDA.
What Happens Next
The court is expected to issue a written ruling in the coming days, determining whether the CMS program:
proceeds as implemented
is partially restricted
or is halted pending further litigation
In Closing
The outcome of this case will help define the future of cannabinoid medicine in the United States.
At its core, the issue is simple:
Should medicine follow science-
or should access come first, and evidence later?
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/judge-takes-cms-hemp-marijuana-cbd-program-under-advisement-as-eviden-1165298
