💸 The Tape

In a quiet but highly significant move, the FDA submitted a notice titled “Cannabidiol (CBD) Products Compliance and Enforcement Policy” for White House review on March 13. Now pending at the Office of Information and Regulatory Affairs (OIRA) under Executive Order 12866 and classified simply as a “notice” rather than a formal rule, the filing marks the first concrete step toward structured federal oversight of the sprawling CBD marketplace.

While the actual text remains under wraps, its appearance in the regulatory pipeline is telling. After nearly a decade of sporadic warning letters and studied silence, the agency is signaling it intends to move beyond “technically illegal but we’re mostly looking the other way” into a more predictable compliance and enforcement framework.

The timing could hardly be more deliberate. The public still awaits a final marijuana rescheduling order (accelerated by President Trump’s December 2025 executive order directing the DEA to complete the shift to Schedule III). Meanwhile, Medicare and CMS are preparing to launch the government’s first-ever limited CBD reimbursement pilot later this year. The FDA isn’t just tidying up loose ends — it’s positioning itself at the center of a rapidly maturing cannabis policy ecosystem.

The Long Road of Regulatory Whiplash

Rewind to the 2018 Farm Bill, which legalized hemp cultivation and derivatives containing less than 0.3% delta-9 THC. What followed was less a gentle bloom and more a green tsunami. CBD gummies, tinctures, creams, beverages, and pet treats flooded shelves from gas stations to Amazon, turning a niche curiosity into a $6–8 billion industry (with optimistic forecasts pushing higher if federal barriers ease).

The FDA’s official stance never wavered: CBD is an active ingredient in the approved drug Epidiolex, rendering it ineligible for dietary supplements or conventional foods under current law. Enforcement, however, remained light-touch. Warning letters targeted the worst offenders — companies peddling cancer “cures,” contaminated products laced with heavy metals or pesticides, or synthetics masquerading as natural CBD. Most of the market operated in a regulatory gray zone thicker than a hemp field at harvest time.

That laissez-faire approach produced predictable headaches: wildly inconsistent potency labeling, questionable safety profiles, and a patchwork of state rules attempting to fill the federal vacuum. Consumers rolled the dice every time they bought a bottle; responsible businesses operated under a cloud of uncertainty that chilled investment and innovation. It was the regulatory equivalent of a blinking yellow light: proceed at your own risk.

This new compliance and enforcement policy notice suggests the light is about to turn a decisive shade of regulatory amber — and possibly red for some players.

What This Notice Actually Signals — and Why It Matters

Because the document is a “notice” rather than a proposed rule, it will likely take the form of guidance outlining enforcement priorities, compliance expectations, and risk-based approaches rather than immediately binding requirements. Think of it as the FDA drafting the referee’s rulebook before blowing the whistle.

Expect the policy to tackle perennial pain points: standardized testing protocols for potency and contaminants; restrictions on unsubstantiated health claims; current Good Manufacturing Practices (cGMP) expectations; and clearer distinctions between acceptable structure/function language (“may support relaxation”) and illegal drug claims (“treats anxiety”). It may also carve out safe harbors for compliant manufacturers while signaling heightened scrutiny for high-risk categories like children’s products or ingestibles making aggressive wellness promises.

The filing’s significance lies less in its immediate legal force and more in what it represents: the end of regulatory radio silence. In an environment where Congress is tightening the hemp definition effective November 2026 (effectively banning most intoxicating hemp derivatives such as delta-8), and Medicare is about to write taxpayer-funded checks for CBD therapies, the FDA is ensuring its house is in order before the broader cannabis policy party begins.

Implications: Winners, Losers, and a Safer (Slightly Pricier) Future

Public health and legal implications extend further. Better standardization reduces unnecessary risks, particularly for vulnerable populations. It also smooths coordination once marijuana rescheduling finalizes: the line between hemp-derived CBD (still technically Schedule I exempt under the Farm Bill) and pharmaceutical-grade cannabis products will sharpen. Medicare’s pilot adds another layer — only products meeting FDA-aligned standards are likely to qualify for reimbursement, creating a de facto quality benchmark that private insurers may eventually follow.

Broader interstate commerce benefits too. A federal framework could reduce the current patchwork of state laws, easing shipping and sales while minimizing the risk of conflicting requirements. Politically, the move aligns with the current administration’s emphasis on targeted enforcement rather than blanket prohibition — protecting legitimate wellness uses while cracking down on the reckless fringes.

What Comes Next: FDA’s Likely Roadmap

The filing is merely the opening act. Here’s the probable sequence industry and observers should watch:

1. OIRA Review — The White House office will assess economic impact, small-business burden, and interagency coordination. Expect this to take weeks to a few months, depending on complexity.

2. Publication — Once cleared, the policy will likely appear in the Federal Register as guidance or an enforcement policy statement. This gives the market a preview of the FDA’s thinking without immediate legal mandates.

3. Stakeholder Engagement — Although not formally required for a notice, the agency may invite public input, host listening sessions, or engage directly with industry groups — especially given overlapping Medicare and rescheduling timelines.

4. Enforcement Ramp-Up — With clearer priorities established, anticipate more systematic actions: targeted warning letters, import alerts, product seizures, and possible injunctions focused on high-risk categories rather than the scattershot approach of the past.

5. Path to Formal Rules — This notice could serve as a bridge to deeper rulemaking. An Advance Notice of Proposed Rulemaking or full NPRM might follow if the FDA decides a dedicated regulatory pathway for CBD in supplements or foods is warranted — something it has hinted at for years.

6. Interagency Coordination — Close collaboration with the DEA (on scheduling distinctions), USDA (on hemp farming standards), and CMS (on Medicare reimbursement criteria) will be essential. The goal: a coherent federal approach rather than siloed efforts.

Smart companies are already auditing supply chains, strengthening quality systems, and reviewing marketing materials in anticipation.

The Bigger Picture: From Chaos to (Cautious) Order

This quiet filing reflects a broader maturation of U.S. cannabis policy. The Trump administration’s rescheduling push, congressional hemp reforms, Medicare’s new program, and now the FDA’s enforcement framework together suggest a pragmatic strategy: allow evidence-based access while imposing adult supervision on the marketplace’s wilder edges.

After treating CBD like that eccentric family member with questionable business ideas, the FDA is finally ready for a serious conversation about expectations and boundaries. Whether the resulting policy strikes the right balance — meaningful safety standards without stifling innovation — remains to be seen. Overly restrictive rules could limit consumer choice; too lenient an approach would undermine public health gains.

For now, the hemp haze is beginning to clear. Responsible businesses should view this as an invitation to elevate their game. Consumers can look forward to safer, more transparent products. And policymakers across agencies have a rare opportunity to get cannabis regulation right the first time around.

The Wild West chapter of CBD is closing. The next chapter — one with clearer rules, better products, and fewer regulatory surprises — is just beginning. Stay tuned; the referee is warming up.

📈 Dog Walkers

$AVCNF Enters Phase 1 In Anxiety Trial

In the race to turn cannabinoids into legitimate pharmaceuticals, Avicanna Inc. (TSX: AVCN) (OTCQX: AVCNF) (FSE: 0NN) just moved the needle — literally and figuratively.

The biopharmaceutical company announced today the launch of a new Phase I randomized, double-blind, placebo-controlled, dose-finding trial at the University of Calgary’s Cumming School of Medicine. Led by Dr. Leah Mayo and supported by Dr. Matthew Hill, the single-site crossover study will enroll 24 healthy adults to evaluate Avicanna’s proprietary AVCN319301b THC capsules at single oral doses of 6 mg, 9 mg, and 15 mg, plus placebo, with washout periods between sessions.

Primary endpoints focus on validated psychometric assessments of anxiety and subjective response. Secondary measures include mood, intoxication, cardiovascular parameters, circulating stress biomarkers, endocannabinoid markers, and detailed pharmacokinetic profiling. The goal: map the therapeutic window of oral THC with high-resolution data and better understand interindividual variability.

What sets this apart is the delivery system. The capsules use Avicanna’s patent-pending Solid Self-Emulsifying Drug Delivery System (SEDDs), designed to overcome the classic cannabinoid problem of poor water solubility and inconsistent absorption. Previous pharmacokinetic research has shown SEDDs can deliver faster onset and improved bioavailability compared to standard formulations.

Dr. Karolina Urban, Executive Vice President of Medical and Scientific Affairs, called the trial a strategic milestone: “This represents our second randomized controlled trial evaluating our proprietary capsule and marks another important step in advancing our pharmaceutical development pipeline through rigorous, investigator-led research.”

The same SEDDs platform is already being tested in a pilot Phase II osteoarthritis trial with the University Health Network, demonstrating versatility across formats from capsules to commercial liquid infusers and drops.

For a company focused on plant-derived cannabinoid medicines, this trial is more than data collection — it’s proof-of-concept for turning complex lipophilic compounds into reliable, non-inhalation therapies. With anxiety as the primary focus and a robust secondary biomarker suite, the results could help define precise dosing strategies that clinicians actually trust.

Avicanna’s move into this space underscores a broader industry shift: from recreational flower to precisely engineered pharmaceuticals. If the data deliver, these capsules could become a cornerstone for anxiety management without the variability that has long plagued oral cannabis products.

The trial is now underway, with results expected to inform future development. In the meantime, Avicanna continues building a pipeline that blends traditional plant medicine with modern drug-delivery science — one well-emulsified capsule at a time.

$CGC ( 0.0% ) Closes MTL Acquisition

In a move that feels less like a corporate handshake and more like a strategic high-five, Canopy Growth Corporation (TSX: WEED) (Nasdaq: CGC) has officially completed its acquisition of MTL Cannabis Corp. (CSE: MTLC) (OTCQX: MTLNF). The deal, structured as a plan of arrangement, makes MTL a wholly-owned subsidiary and cements Canopy’s position as Canada’s leading medical cannabis platform.

The combination brings together MTL’s premium cultivation expertise with Canopy’s scale, creating a more robust supply chain for both domestic medical patients and regulated international markets — especially Europe. MTL’s profitable, cash-generating operations are expected to accelerate Canopy’s path to positive adjusted EBITDA in fiscal 2027.

“We have long admired MTL and their approach to cannabis and business, and together we are Canada’s leading medical cannabis company,” said Luc Mongeau, Chief Executive Officer of Canopy Growth. “Today, we are better positioned to deliver higher-quality products, operate more efficiently, and scale strategically to meet growing demand in international markets.”

Key MTL leaders have joined the Canopy team, including Mike Perron as Chief Operating Officer, while co-founders Richard Clément and Michel Clément will serve as strategic advisors on cultivation and integration.

Strategically, the deal delivers immediate wins: #1 medical market share by revenue, enhanced premium flower supply, deeper Québec presence (Canada’s second-largest market), stronger adult-use positioning, and retained cultivation expertise. MTL shareholders received 0.32 Canopy shares plus $0.144 cash per MTL share, resulting in the issuance of approximately 41.2 million Canopy shares and a $18.5 million cash payment.

MTL shares are expected to delist from the CSE around March 16, 2026.

In an industry still navigating consolidation, Canopy just planted a very healthy crop for the future.

🗞️ The News

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Viriginia Is For Cannabis Lovers and TerrAscend Earnings Download | TTB Powered by Flowhub

What we will cover:

✅ Trade To Black Podcast with Anthony Varrell is back with another packed episode covering the biggest stories shaping the cannabis industry, multi-state operators, and hemp regulation.

We kicks things off with Michael Bronstein of ATACH to break down the latest on Virginia cannabis, the evolving regulatory backdrop, and the implications of the pending Texas THCA flower ban. As lawmakers and regulators continue to crack down on intoxicating hemp and THCA products, this conversation dives into what it could mean for operators, consumers, and the broader cannabis and hemp markets.

In our second segment both Ziad Ghanem and Jason Wild from TerrAscend (TSX: TSND) hop on to discuss the company’s latest earnings, operational performance, strategic priorities, and what investors should be watching next. From margin trends to market expansion and capital allocation, this segment offers a closer look at one of the industry’s most closely followed operators.