The CBD Hearing That Won't Go Away: SAM v. Kennedy Gets New Plaintiffs, New Date, and a Standing Problem

The federal lawsuit threatening to derail Medicare's new CBD pilot program just got more complicated — and more interesting.

SAM et al. v. Kennedy et al. (Case 1:26-cv-01081, D.D.C.), the case brought by Smart Approaches to Marijuana and a coalition of anti-cannabis groups seeking to block the Centers for Medicare & Medicaid Services' hemp-CBD coverage initiative, has been reshuffled. The preliminary injunction hearing originally set for April 20 — yes, 4/20, a scheduling choice that practically wrote its own headlines — has been moved to May 1. The plaintiff roster just got bigger. And the entire case has been procedurally reset around a freshly filed amended complaint.

What's the Case About?

In late March, CMS quietly rolled out a new program called the Substance Access Beneficiary Engagement Incentive, or BEI. The short version: doctors participating in certain CMS Innovation Center models (ACO REACH and the Enhancing Oncology Model) can now recommend hemp-derived CBD products to Medicare beneficiaries, with up to $500 per year in coverage. CMS Administrator Mehmet Oz orchestrated the initiative in conjunction with President Trump's December 2025 executive order directing expedited cannabis rescheduling and expanded access to full-spectrum CBD.

SAM and its allies filed suit on March 30 — two days before the program launched — arguing that CMS bulldozed through federal administrative law to get this done. Their core claims: CMS skipped the required notice-and-comment rulemaking under the Administrative Procedure Act, bypassed FDA drug approval standards, and contradicted CMS's own rule from last year that explicitly declared cannabis products ineligible for supplemental Medicare coverage.

The defendants in the case are Health Secretary Robert F. Kennedy Jr., CMS Administrator Mehmet Oz, HHS, and CMS.

The TRO That Wasn't

On March 31, U.S. District Judge Trevor McFadden — a Trump appointee — denied SAM's request for an emergency temporary restraining order that would have frozen the program before launch. McFadden called a TRO an "extraordinary and drastic remedy" and said SAM didn't meet the high bar required. The BEI went live the next day, April 1.

But McFadden didn't dismiss the case. He set a preliminary injunction hearing for April 20 and ordered expedited briefing — government opposition due April 9, plaintiffs' reply due April 13. The signal was clear: the pilot can run for now, but the court isn't done asking questions.

Amended Complaint, New Plaintiffs, Fresh Motion

Here's where it gets interesting. Rather than simply adding intervenors to the original complaint, SAM's legal team went back to the drawing board. At 4:32 p.m. on Monday, April 13, plaintiffs filed an amended complaint — which is now the operative complaint in the case — adding several new plaintiffs to shore up what was looking like a shaky standing argument.

The new additions include Americans Against Legalizing Marijuana, the Drug Free America Foundation, and multiple MMJ BioPharma entities (MMJ International Holdings and its subsidiaries, MMJ BioPharma Labs and MMJ BioPharma Cultivation). MMJ is a pharmaceutical cannabinoid company that has spent nearly a decade developing FDA-pathway therapies for Huntington's disease and multiple sclerosis — IND authorization, stability testing, dose-form validation, preclinical trials, the full regulatory gauntlet.

The original plaintiff coalition was a familiar cast of prohibition-aligned organizations: SAM, the Cannabis Impact Prevention Coalition, Save Our Society From Drugs, and individual plaintiff David Evans (a SAM donor and consultant who is also a Medicare recipient). Their standing argument leaned on organizational resource drain and Evans' altered "healthcare relationship" with CMS. During the March 31 TRO hearing, Judge McFadden raised questions about whether those plaintiffs actually had legal standing — a problem that clearly drove this amended filing.

The MMJ addition changes the dynamics significantly. Their argument isn't that CBD is dangerous. It's that CMS is creating a backdoor approval system that rewards companies who skipped the FDA process and punishes those who played by the rules. That's a standing argument rooted in concrete competitive injury — much harder for a court to dismiss than SAM's organizational resource drain theory.

Along with the amended complaint, plaintiffs filed a new emergency motion for a preliminary injunction and stay, supported by a memorandum and eight exhibits. Notably, the renewed motion dropped the TRO request that McFadden already denied under the original filing — a signal that the legal team is tightening its approach rather than relitigating what didn't work.

In response, Judge McFadden issued a minute order denying the original emergency motion, the government's motion to dismiss, and a related consent motion — all as moot. The slate is wiped. Everything resets around the amended complaint.

The docket also shows that on April 14, an additional attorney filed a pro hac vice motion to join the case, indicating the litigation team is continuing to expand.

Why the Hearing Moved

With the amended complaint resetting the case, Judge McFadden formally vacated the April 20 hearing and issued a new scheduling order. The government's response to the renewed injunction motion is now due April 20. Any reply from plaintiffs is due April 24. The parties must appear for an in-person hearing on May 1 at 2:00 p.m. before Judge McFadden.

The procedural reset actually works in SAM's favor — they get a cleaner shot at the injunction with stronger plaintiffs and a tighter motion, while the government now has to respond to a substantially different case than the one it was originally briefing against.

The Bigger Picture

This case sits at the intersection of several colliding federal policy tracks:

The hemp definition time bomb. The 2026 Agriculture Appropriations Act, signed by Trump in December, shifts the definition of legal hemp from 0.3% delta-9 THC by dry weight to 0.3% total THC concentration, effective November 2026. SAM argues the BEI's allowance of products containing up to 3 milligrams of total THC per serving conflicts with that incoming standard. As one commentator put it: you could start receiving a product in April that technically becomes illegal to manufacture by November.

The rescheduling overhang. The separate DEA administrative hearing on moving cannabis to Schedule III has been stalled since January 2025 after the presiding judge canceled the hearing and an interlocutory appeal froze proceedings. Trump's December EO directed the AG to expedite the process, but no firm restart date has been set. The ALJ who was overseeing the hearing has since retired, leaving DEA without a presiding judge for the rescheduling matter. If rescheduling ultimately happens, it changes the legal calculus for CBD coverage — but right now, marijuana remains Schedule I.

The FDA enforcement gap. The White House Office of Management and Budget has scheduled meetings on April 16 and 17 to discuss a new FDA enforcement policy for CBD products. How the FDA decides to regulate the CBD market will directly impact whether the BEI's approach — covering products that haven't gone through FDA approval — survives legal scrutiny. If the FDA moves toward a clearer regulatory framework before May 1, it could shift the ground under the case entirely.

What to Watch on May 1

The in-person hearing at 2:00 p.m. will come down to a few key questions:

First, does the expanded plaintiff group solve the standing problem? The amended complaint was clearly designed to answer Judge McFadden's March 31 concerns. MMJ's FDA-pathway competitor injury argument is significantly stronger than SAM's organizational resource drain theory. Whether the court agrees will determine if this case has legs.

Second, will the government refile its motion to dismiss? McFadden mooted the original dismissal motion along with everything else when the amended complaint landed. The government may take a fresh run at dismissal in its April 20 response, or it may focus purely on opposing the injunction. How they play that will signal how confident they are on standing and the merits.

Third, is the BEI actually a "rule" that required notice-and-comment, or is it something CMS can do under its innovation authority? CMS has argued the BEI isn't a traditional Medicare coverage expansion. SAM says it imposed binding obligations on participating healthcare providers without going through the Federal Register.

Fourth, the balance of harms. The BEI is already live. Providers are participating. Beneficiaries may already be receiving products. The longer it runs, the harder it becomes for a court to pull the plug without causing disruption of its own.

This case isn't just about CBD gummies for seniors. It's a test of how far CMS can push its innovation authority, how the courts will handle the growing collision between cannabis policy and federal administrative law, and whether the FDA pathway still means anything in a world where the government is covering products that never went through it.

May 1 just became one of the most important dates on the cannabis policy calendar.