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Exposing Pharma Strategies to Dominate the US Cannabis Market 

- by Theresa Yarbrough, Georgia Cannabis Industry Alliance

Introduction

Federal rescheduling of cannabis from Schedule I to Schedule III under the Controlled Substances Act (CSA) stands poised to be the most significant regulatory catalyst in the U.S. cannabis industry in 50 years. While much attention has been paid to the surge and correction in “pure play” cannabis equities and to state-legal operators awaiting tax and banking relief, comparatively less light has been shed on the multi-billion-dollar pharmaceutical conglomerates—often referred to as “Big Pharma”—and their calculated maneuvers to control the next chapter of the cannabis market. 

This report investigates the extensive infrastructure, legal, scientific, and commercial groundwork Big Pharma has built in anticipation of federal rescheduling. It systematically dissects the components of Big Pharma’s cannabis playbook: patent accumulation, acquisition strategies, clinical trial and research capabilities, regulatory lobbying, DEA licensing, synthetic cannabinoid initiatives, partnerships at the state and university levels, investments in cultivation technology, data science projects,financial industry engagement, and political financing. Using numerous specific company examples and referencing the latest developments through mid-2025, the analysis aims to reveal the depth and breadth of Big Pharma’s preparations to dominate the U.S. cannabis market post rescheduling.

Table 1: Big Pharma Cannabis Strategy Matrix (2021 - 2025)

This table synthesizes several categories covered below, each expanded upon in detailed sections.

Patent Filings & Intellectual Property Strategies

Big Pharma’s foremost tactic in securing future cannabis revenues has been its aggressive stance on intellectual property (IP), particularly in patenting both natural-derived and synthetic cannabinoids, delivery mechanisms, manufacturing processes, and clinical applications.

Leadership in Patent Volume

A 2019 survey showed that leading pharmaceutical companies already ranked among the highest cannabis-related patent holders in both the U.S. and Canada, eclipsing even leading cannabis pure-plays. 

(Marinol/dronabinol) holds 59 U.S. cannabis patents; Pfizer  has at least 25, Sanofi 39, Merck 35, and BMS 34. These patents span speci􀀁c cannabinoid formulations, synthetic conversion processes, and methods for treating conditions such as epilepsy, pain, glaucoma, and various digestive disorders. GW Pharmaceuticals, later acquired by Jazz, built a fortress around puri􀀁ed, plant-derived CBD for epilepsy, locking in method-of-use patents and supply chain protections.

Recent Patent Activity & Scope

Patent filings have surged in the last 􀀁ve years, coinciding with rising expectations around U.S. federal cannabis reform. Bloomberg Law found that up to 70% of all U.S. cannabis-related patents (in the A61K “medical preparations” class) have been issued since 2016, with a sharp uptick from 2019 onward. Innovations focus not just on isolated cannabinoids but also on their extraction, puri􀀁cation, stability, delivery (oral, sublingual, vaporized, transdermal, etc.), and even combination therapies with other pharmaceutical actives . This enables companies to claim exclusivity on both the molecules themselves and their most commercially viable forms.

Patent Strategy as Market Gatekeeper

The core outcome of Big Pharma’s IP activity is both offensive and defensive: it stakes out proprietary territory for newly approved drugs, and raises barriers for state-legal and cannabis-only 􀀁rms that wish to develop, market, or export similar compounds post-rescheduling. Once the FDA pathway is open for cannabis-based medicines, patent-holders are poised to become the 􀀁rst, and potentially dominant, suppliers able to legally manufacture and distribute prescription cannabinoids at scale within the U.S., with additional rights to block or extract royalties from competitors as the market matures .

Analysis: While the effectiveness of cannabis patent enforcement has been limited by federal illegality (inhibiting federal court actions), the anticipated realignment under Schedule III will enable more effective prosecution and defense of cannabis-related IP, with Big Pharma wielding litigation and licensing as a market control lever.

Acquisitions & Strategic Investments

Pharmaceutical Pure-Play Partnerships

Major acquisitions have set the stage for Big Pharma’s deep involvement in cannabis therapeutics: 

• Jazz Pharmaceuticals’ $7.2B acquisition of GW Pharmaceuticals: Marked the largest buyout in cannabinoid pharmaceuticals, giving Jazz control over Epidiolex (plant-derived CBD for epilepsy) and a pipeline of additional cannabis-based medicines (nabiximols for spasticity, investigational drugs for autism, and more). This deal provided Jazz with an FDA-approved asset, expansive R&D base, and global marketing/distribution reach.

• Pfizers’s $6.7B purchase of Arena Pharmaceuticals: Brought the oral CB2 agonist olorinab (APD371), a promising candidate for gastrointestinal pain, into its late-stage pipeline alongside other cannabinoid research programs. Arena’s assets positioned Pzer at the forefront of synthetic cannabinoid therapeutics and deepened its clinical IP. 

• Novartis’ (Sandoz) global partnership with Tilray: Sandoz didn’t pursue outright acquisition but instead structured a sweeping co-branding, supply, and development alliance with Tilray, commercializing non-smokable cannabis products globally and integrating cannabis medicines into its generic/biotech platform.

Cross-Border Expansion

These cross-border partnerships and acquisitions signal that Big Pharma is not only waiting for the U.S. federal 􀀂oodgates to open but is already consolidating capabilities in medical cannabis markets abroad (Europe, Canada, Australia), acquiring both regulatory experience and market access.

Financial Industry Engagement

The scale of these investments dwarfs the capital available to most state-legal operators. Constellation Brands’ (alcohol giant) $4B buy-in to Canopy Growth is not strictly pharmaceutical, but it illustrates how massive capital investments create vertically integrated platforms ready for mainstream medical and adult-use cannabis reform.

Analysis: Acquisitions enable Big Pharma to leapfrog the line — bypassing a decade of startup uncertainty and regulatory delay — by instantly acquiring licensed products, established trial infrastructure, and proprietary supply chains. These can then be scaled and priced to outcompete less capitalized players constrained by costly compliance and fragmented distribution.

Clinical Trial Infrastructure Development

Unmatched Scale & Speed

Traditional cannabis companies, hamstrung by prohibition, have struggled to conduct gold-standard, multi-site, multi-armed, placebo-controlled trials in the U.S. In stark contrast, Big Pharma already commands the clinical trial networks, regulatory relationships, and clinical research organization (CRO) partnerships necessary to execute large pivotal studies—essential to satisfying FDA requirements for Schedule III drug approvals.

Recent Clinical Trial Network Examples

• GW/Jazz ran multiple phase III global trials across epilepsy syndromes, multiple sclerosis, and movement disorders. Their ability to enroll hundreds of patients at dozens of hospitals—while maintaining consistent supply and producing FDA-level safety data—was key to winning approval for Epidiolex under the most restrictive conditions.

• Pfizer’s Olorinab program utilized global gastroenterology networks for rapid subject recruitment, dosing studies, and biomarker validation. This approach, native to pharma, ensures that post-rescheduling, new clinical indications for cannabis-based drugs can be pursued with minimal operational delay.

• Sanofi’s and Merck’s parallel investments in cannabinoid analytic labs and data platforms at European and Canadian academic centers further indicate Pharma’s preparation for an eventual surge in U.S. clinical trial approvals.

Partnerships with Contract Research Organizations (CROs)

CROs like Cannaovation Clinical Research Partners  now specialize in cannabis-based clinical research. Their function is often to “plug in” to pharma clients, managing everything from pre-IND meetings to phase IV post-marketing studies, and are frequently run by executives with extensive experience in both DEA-licensed manufacturing and FDA trialing.

Comparative Advantage: When cannabis moves to Schedule III, Pharma’s existing clinical trial infrastructure allows for immediate IND submissions, speedy scale-up into new therapeutic categories, and parallel real-world evidence (RWE) initiatives to satisfy increasingly powerful health technology assessment (HTA) and payer requirements.

Regulatory Lobbying & Political Advocacy

Direct Engagement with Federal Policymaking

Big Pharma commands a formidable lobbying corps in Washington, spending tens of millions annually to influence regulatory and legislative outcomes:

• Pharmaceutical Research and Manufacturers of America (PhRMA) routinely spends $25M+ per year, actively engaging Congress, the DOJ, FDA, and DEA to ensure favorable developments on matters like drug scheduling, data exclusivity, insurance coverage, and patent duration.

• Individual firms (Pfizer, Johnson & Johnson, Merck, etc.) have steadily increased their contributions and meetings with legislators on the issue of cannabis rescheduling, especially in the wake of 2024–2025 federal movement on DEA classification.

Regulatory White Papers and Agency Testimony

Pharma-aligned trade groups routinely submit policy recommendations to DEA and FDA dockets, advocating for regulatory frameworks that favor clinical prescription models, high manufacturing standards (GMP/cGMP), and federal preemption over state law, all of which benefit the centralized, high-compliance model they excel at.

Ensuring a Schedule III Favorable to Pharma

While large cannabis multistate operators (MSOs) lobby for relaxed banking and tax via the SAFE Banking Act, Pharma’s lobbying focus is on ensuring that Schedule III classification still requires FDA approval for prescribing, strict manufacturing controls, and limited “whole-plant” cannabis exposure—closing off avenues for easy over-the-counter or “craft” cannabis to enter the mainstream pharmaceutical marketplace.

Political Contributions and Campaign Financing

Executives and PACs for Pfizer, Merck, Novartis, Johnson & Johnson, Abbvie, Amgen, and others have donated millions to both Democratic and Republican campaigns in this cycle, spreading influence as rescheduling, tax, and insurance policy come to the floor. Funding is distributed to key committee members in the House and Senate, and to state-level political organizations in emerging medical and recreational states as well.

Takeaway: Big Pharma’s access, resources, and bipartisan approach allow it to “write the regulatory rules” to favor prescription-based, high-barrier cannabis models, securing a gatekeeping role.

DEA Licensing & Bulk Manufacturing

Oligopoly in Legal Cannabis Production

The DEA has issued only 8 bulk manufacturing licenses for cannabis research in the U.S., including National Center for Natural Products Research (Univ. of Mississippi), Groff NA, Biopharmaceutical Research Company LLC, Hemplex LLC, Irvine Labs, Maridose LLC, Royal Emerald Pharmaceuticals, and Scottsdale Research Institute. These registrants serve as the federally legal supply chain for research-grade cannabis and are positioned to become the only federally compliant domestic sources of cannabis for FDA drug development should Schedule III be enacted.

Limited Access = Market Control

Unlike state-level operators, DEA-registered bulk manufacturers already produce under GMP, have the required recordkeeping/reporting capacity, and maintain rigorous security. Once the U.S. federally recognizes medical cannabis under Schedule III, these eight companies will effectively have the initial legal authority to supply both domestic and export markets for medical cannabis ingredients, consolidating market control with a handful of federally privileged actors.

Strategic Partnerships

Pharmaceutical companies are already initiating or exploring exclusive agreements with these DEA registrants for seed sourcing, molecule production, and supply for clinical or commercial products—a preemptive step towards vertical integration in the new regulatory paradigm17.

Analysis: Big Pharma is using federal research licensing not just for compliance, but as a mechanism to pre-select its future production partners, securing early, privileged access for scale-up and distribution.

Synthetic Cannabinoid Drug Development & FDA Approvals

FDA-Approved Cannabis-Derived and Synthetic Medicines

Big Pharma, facing the regulatory risks of whole-plant cannabis, has prioritized synthetic and purified cannabinoids for FDA approval:

• Marinol (dronabinol; AbbVie): Synthetic THC, approved for AIDS wasting and chemo-induced nausea.

• Syndros (dronabinol oral; Insys Therapeutics): Liquid format, schedule II, similar indications28.

• Cesamet (nabilone): Synthetic THC analog, approved for chemo nausea.

• Epidiolex (Jazz/GW): First plant-derived CBD for epilepsy, a blockbuster.

Synthetic Pathways Around “Whole Plant” Barriers

Schedule III still requires significant standardization and uniformity of content for FDA approval. Big Pharma’s extraction, purification, and chemical synthesis technologies allow them to rapidly develop consistent, pharmaceutical-grade products, surmounting the major “whole plant” challenge that constrains both regulatory and commercial viability for small operators.

Next-Generation Cannabinoids

Ongoing studies target the “minor” cannabinoids (CBG, CBN, THCV, CBC) for a variety of new indications (pain, inflammation, sleep disorders, neurodegeneration), with proprietary methods for extraction, synthesis, and formulation likely to form the next wave of patent applications and drug approvals10.

Implications: Post-rescheduling, Pharma will swiftly deploy synthetic and semi-synthetic cannabinoid drugs through the existing FDA regulatory machinery, defending these assets through IP, marketing data exclusivity, and aggressive payer negotiation.

Partnerships with State-Legal Operators and Academic Institutions

Selective Collaboration with State-Legal Firms

While direct ownership stakes in U.S. cannabis businesses have been restricted by federal law, Big Pharma has sought relationships that keep it close to emerging clinical, cultivation, and formulation expertise among MSOs and specialist labs (e.g., via data-sharing, research, and licensing deals).

Academic/Public-Private Collaborations

Pharma has accelerated research partnerships with major U.S. universities, unlocking expertise in dosing, pharmacology, and longitudinal outcomes research:

• Massive real-world evidence cohorts managed at University of Florida, University at Buffalo, and Johns Hopkins, evaluating outcomes, safety, and genomics of medical cannabis use3018.

• International partnerships with King’s College London, University of Toronto/JLABS (Johnson & Johnson’s innovation incubator), University of Connecticut, and others in Canada/Europe bolster Pharma’s legitimacy and regulatory intelligence.

New CROs and Clinical Networks

CROs like Cannovation CRP and others now offer turnkey clinical trial management for cannabinoid therapeutics, close relationships with Pharma funders, and have DEA Schedule I (soon III) research licenses in place for seamless transition to phase II/III trials post-rescheduling.

State Regulatory Influence

State-level lobbying and non-profit “advisory” participation by Pharma not only shapes the patchwork of state medical programs (ensuring strict prescription/track-and-trace) but also keeps a tight channel open for transition to federally sanctioned models.

Analysis: As soon as federal Schedule III is enacted, Big Pharma will be able to leverage long-standing academic/cannabis industry partnerships to launch multi-state, multi-center trials—and capture trial readouts and market access faster than virtually any incumbent state operator.

Investments in Cultivation and Manufacturing Technology

Advanced Cultivation

Pharma’s presence in upstream technology is rapidly growing:

• LED lighting partnerships: Companies like Pfizer have invested indirectly in advanced cannabis lighting tech, seeking patentable, energy-efficient, and precision-controlled cultivation to ensure uniformly pharmaceutical-grade inputs for clinical and commercial supply.

• Genomics/Seed IP: Partnerships with ag-biotechnology firms and university genetics labs enable Pharma to lock down access to unique high-yield, high-purity cultivars, again supporting patent and trade secret positions.

Vertical Integration with Manufacturing

Many DEA registered manufacturers and Pharma-friendly CROs provide in-house cGMP extraction, formulation, and packaging, guaranteeing quality practices and regulatory readiness for FDA inspection.

Analysis: Owning or controlling patented cultivation technology and suppliers positions Pharma to dictate quality and consistency standards—often prerequisites for FDA and insurance acceptance.

Data and Real-World Evidence (RWE) Initiatives

Big Data Integration

Pharma leverages both existing longitudinal patient registries and new, cannabis-specific RWE platforms:

• Global tracking of efficacy, safety, genomic, and patient-reported outcomes for cannabis-based medicines.

• Supervising or funding initiatives like Project Twenty and Florida’s state-level outcomes consortia, which generate the post-marketing data necessary for future FDA label expansions, payer/pricing negotiations, and patient/provider education campaigns.

Complementing RCTs

RWE bolsters Pharma’s position at regulatory and commercial bodies, enabling broader or expanded indications, and providing data on real-world effectiveness relative to existing therapies (opioids, antidepressants, etc.).

Integration with Insurance and Value-Based Care

Through RWE and digital health platforms, Pharma can support both the medical and economic cases for coverage of cannabinoid-based medicines, integrating them into major public and private formularies.

Strategic Outcome: Robust RWE solidifies Pharma’s position as the gold-standard provider of cannabis medicine—with indisputable data for prescribers, payers, and regulators.

Financial Industry Engagement and the SAFE Banking Act

Advocacy for Normalized Banking

Big Pharma’s call for clear, protected banking access for cannabis businesses comes largely as a means to facilitate their own future market entry—ensuring that insurance billing, pharmacy distribution, and global payments (all essential to prescription drug business) will be possible once FDA cannabis drugs reach the U.S. market.

Direct and Indirect Financing

While financial giants still hesitate to back “plant-touching” companies until reform is signed into law, they are increasingly willing to lend to biotechnology and pharmaceutical firms developing synthetic cannabinoids, layering yet more capacity for Pharma’s domination of the sector.

Forward-Looking Analysis

SAFE Banking is not only a boon to state operators but also removes friction for Pharma’s M&A, asset sales, and global distribution, unlocking the full potential for FDA-approved cannabis medicines across all 50 states and international export.

Partnerships with Contract Research Organizations and Academic/State Collaborations

Emerging CRO Models

• Many cannabis CROs are run by former Pharma executives and now offer integrated cannabis/FDA regulatory expertise, accelerating early-phase development of cannabinoid medicines.

• State-university-pharma consortia (e.g., at University at Buffalo, University of Florida, Johns Hopkins, and international centers) are springboards for launching formal FDA efficacy trials and RWE data capture—resources unattainable by most smaller cannabis companies.

University and State Research Synergy

As cannabis research transitions into mainstream medical schools and pharmacy programs, Pharma is embedding itself as both direct funder and collaborator—ensuring it controls not just the products, but also the medical discourse and provider guidelines.

Political Contributions and Campaign Financing

Bipartisan Investment in Influence

Pharmacy PACs, corporate lobbyists, and executive donors straddle both Republican and Democratic Party lines, targeting key committee members and state leaders at every legislative and electoral inflection point.

Shaping the 280E, Scheduling, and Insurance Debate

Funding aims not just to win favorable rescheduling but to steer the outcome towards models where “prescription for FDA-approved drugs” is the norm, rather than widespread, easy access to nonprescription or over-the-counter cannabis.

Political donations also reinforce Pharma’s influence over insurance reimbursement, tax policy (ending or preserving 280E for cannabis operators, depending on competitive interest), and the transition from federal-state conflict to a pharma-dominated regulatory environment.

Tax Policy and 280E Repeal Efforts

The 280E Battlefield

Section 280E, as interpreted by the IRS, has prevented all state-legal cannabis companies from deducting typical business expenses, hammering their profit margins and discouraging new investment. Rescheduling to Schedule III would erase this penalty for all compliant operators.

However, some lawmakers have introduced bills to preserve a version of 280E even if cannabis is rescheduled, reflecting Pharma’s preference for keeping tax advantages selective and for reducing the profitability of non-FDA-approved competitors.

Pharma’s Real Interest

Big Pharma, which already deducts substantial R&D and commercial expenses for all other DEA Schedule III drugs, stands to gain the most if 280E is removed. This gives it a lasting cost advantage over high-taxed state operators until and unless federal legalization is total and all companies are placed on a level playing field.

Conclusion: Big Pharma’s Playbook for Post-Rescheduling Cannabis Dominance

Big Pharma’s preparations for federal cannabis rescheduling represent a multi-pronged, long-term strategy leveraging its dominance in patents, acquisitions, clinical research, regulatory access, manufacturing infrastructure, technology partnerships, data science, and political advocacy. The outcome of these efforts is not only privileged access to the first FDA-approved cannabis markets but also regulatory, financial, and operational control mechanisms that will define the terms of competition for years to come.

When the U.S. officially moves cannabis to Schedule III, pharmaceutical companies are poised to:

• Rapidly launch new and repurposed cannabinoid drugs through established FDA channels, defended by robust patent portfolios.

• Scale up clinical trials, RWE initiatives, and payer negotiations to rapidly expand from legacy epilepsy and nausea markets into pain, sleep, psychiatry, neurology, and more.

• Use their vertical control of manufacturing (via DEA bulk licensing) to supply both domestic and export markets to the exclusion or subordination of state-licensed competitors.

• Continue to steer the broader regulatory, banking, tax, and insurance landscape—using their influence, infrastructure, and capital to slow, smooth, or accelerate reform as needed for maximum profit extraction.

Several major multistate operators (MSOs) have formed strategic relationships with Big Pharma—some directly, others through partnerships, licensing, or shared infrastructure. Here’s a breakdown of the most notable connections as of 2025:

Table 2: MSOs with Direct or Strategic Pharma Ties

How These Relationships Work

• Co-branding & Licensing: Tilray’s alliance with Novartis/Sandoz allows it to distribute pharmaceutical-grade cannabis products globally.

• Clinical Trial Infrastructure: MSOs like TerrAscend and Cresco Labs are partnering with academic institutions and contract research organizations (CROs) to prepare for FDA-style trials.

• Investor & ETF Exposure: Green Thumb and Curaleaf are heavily represented in pharma-aligned ETFs like MSOS, which attract institutional investors with pharmaceutical interests.

• Regulatory Alignment: Trulieve and others are lobbying for medical frameworks that mirror pharma standards, positioning themselves for Schedule III compliance.

For incumbent cannabis-only firms and state-legal operators, the coming phase is both an opportunity and an existential threat: partnership with, acquisition by, or supply-chain access to Pharma incumbents may enable survival, but the days of open, uncontrolled expansion are likely over.

Rescheduling is, in this light, not merely deregulatory—it is a hard reset of who holds power in the U.S. cannabis economy, and Big Pharma, by almost every metric, is ready to take the lead.

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          Does 280E Still Apply? Breaking Down Cannabis Taxation and Rescheduling