Some random weekend thoughts regarding the SAM(Smart Approaches to Marijuana)+MMJ Holdings lawsuit against CMS/CMMI...
I think the dates of recent events are meaningful. SAM filed suit against CMS on March 30th, and then almost immediately after that, on April 1st, the FDA Commissioner "took the unusual step" of publishing his letter, seemingly as a response, to explicitly state that the FDA will allow the CMS/CMMI+CBD program to proceed anyway, based on clear conditions, lawsuit be damned...I think that chronology matters... https://www.fda.gov/media/191782/download
On April 1, 2026, FDA Commissioner Marty Makary took the unusual step of announcing in a letter that FDA will not enforce its own drug-approval and labeling requirements against a defined category of hemp-derived CBD products furnished in connection with a new CMS pilot program. The letter represents a departure from FDA's longstanding posture toward CBD, but it does not fully resolve the deeper regulatory uncertainty surrounding these products. While the letter's scope is limited, it comes amidst a broader federal government review of CBD enforcement policy.
I also think it should be obvious that the FDA's new pending CBD Compliance and Enforcement Policy must jive with the FDA Commissioner's recent letter. Which means the policy will state that Cannabinoids can be Dietary Supplements as long as the products meet the same standards listed in the Commissioner's letter.
SAM+MMJ's complaint about "no comment period" regarding the CMS/CMMI CBD Pilot is directed at CMS, but the Whitehouse has had an open public meeting period since 3/13/2026 regarding the new pending FDA CBD Compliance and Enforcement Policy. That's two weeks before SAM filed their suit. As a matter of fact, during that same two weeks, SAM even got to publicly schedule and attend their own Whitehouse meeting(on 4/20 of all days) regarding the upcoming FDA+CBD policy change. So they definitely did get to make their opinion heard(they always do). How many of us get a scheduled meeting to complain directly to the Whitehouse about anything?... SAM's Meeting on 4/20... https://www.reginfo.gov/public/do/viewEO12866Meeting?viewRule=true&rin=0910-ZC82&meetingId=1361974&acronym=0910-HHS/FDA
The details of the FDA's new CBD policy haven't even been made public yet, as the policy is still currently under Whitehouse review, but the review is estimated to take around 90 days from 3/13/2026... https://www.reginfo.gov/public/do/eoDetails?rrid=1312062 So, the details should be published sometime within the next month. SAM will get a chance to comment then as well. The SAM portion of the lawsuit seems very weak to me.
The MMJ Holdings portion of the lawsuit mostly leans on Cannabinoids being categorized solely as "Drugs". However, the FDA Commissioner's recent letter clearly stated, as the #1 requirement in the last paragraph, that CBD products supplied through the CMS/CMMI program must be manufactured, marketed, and labeled specifically as "Dietary Supplements", not "Drugs".
MMJ Holdings was pursuing an IND(Investigational New Drug), not an NDI(New Dietary Ingredient). Cannabinoids that are marketed and sold as Dietary Supplements are not in the same market as the purported Drug candidate from MMJ Holdings. If MMJ Holdings still wants to pursue their Botanical Drug approval, there is nothing stopping them from doing so. If MMJ Holding's condition specific Botanical Drug candidate(s) can't outperform Dietary Supplements that aren't designed to target specific conditions, then maybe MMJ's problem actually is that they don't even have a drug candidate at all.
Here's the kicker though...CWBHF is doing both...they're participating in the CMMI Cannabinoid Dietary Supplement Pilot while also pursuing a Botanical Drug approval with DeFloria. So...if the Judge does end up ruling in favor of SAM+MMJ simply because MMJ Holdings has a Cannabinoid based Botanical Drug candidate, wouldn't DeFloria then also be an aggrieved party, just like MMJ Holdings? CWBHF is a winner either way then lol. CWBHF+DeFloria can simultaneously be both the Premier Partner for the CMMI Cannabinoid Dietary Supplement Pilot Program and the Premier Aggrieved Botanical Cannabinoid Drug Approval applicant. Now that's Strategic Positioning!🤓
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