Stage – Smoke Master https://smoke.vmondeika.com The ultimate smoking source Sat, 29 Aug 2026 06:38:42 +0000 en-US hourly 1 https://wordpress.org/?v=7.1.1 https://smoke.vmondeika.com/wp-content/uploads/2026/01/cropped-SMG_logo_favicon-32x32.png Stage – Smoke Master https://smoke.vmondeika.com 32 32 Federal Rescheduling Sets The Stage For Marijuana Business Acquisitions As Pharma And Ag Firms Eye Industry (Op-Ed) https://smoke.vmondeika.com/federal-rescheduling-sets-the-stage-for-marijuana-business-acquisitions-as-pharma-and-ag-firms-eye-industry-op-ed/ Sat, 29 Aug 2026 06:38:42 +0000 https://smoke.vmondeika.com/federal-rescheduling-sets-the-stage-for-marijuana-business-acquisitions-as-pharma-and-ag-firms-eye-industry-op-ed/

“The practical question isn’t whether this is something to celebrate, it’s whether your business is positioned to be a consolidator, an attractive acquisition target or something different.”

By Christopher B. Lynch, Dickinson Wright PLLC

There are a lot of rumors and misinformation out there about what the April 23 federal marijuana rescheduling order means. Some will tell you a story about legalization finally arriving. Others will tell you that not much is changing. But if you look closely, there’s another interesting story emerging: one of careful planning, swift action and targeted consolidation.

Since Acting Attorney General Todd Blanche moved Food and Drug Administration (FDA)-approved and state-licensed medical marijuana products from Schedule I to Schedule III of the Controlled Substances Act, the businesses that I think are best positioned to take advantage of rescheduling aren’t popping champagne—they’re positioning themselves to take advantage of new first-mover opportunities.

That, more than any headline about “federal legalization,” is the real story of rescheduling’s first year: not a national market opening overnight, but a faster, harder sorting of who survives in the one we already have.

NewLake Capital Partners CEO Anthony Coniglio put it well: “Each year brings predictions of a major M&A wave in cannabis. And so far, each year has mostly delivered tuck-in deals rather than transformative consolidation.”

We’re seeing deals that are smaller, more frequent and often faster with less diligence. Two months after Blanche’s order, the Department of Justice opened an expedited administrative hearing to consider rescheduling marijuana in full, including adult-use. That hearing has now concluded, and a recommendation could come at any time.

But for license holders and investors making decisions today, the more immediate question isn’t when the Drug Enforcement Administration (DEA) and DOJ finish the bigger rulemaking. It’s whether their business is built to be an acquirer, an acquisition target or neither, in a race that’s already started.

What the order actually does

The April order reclassified medical marijuana that is FDA-approved or state-licensed, moving it out of Schedule I—reserved for drugs deemed to have no accepted medical use —and into Schedule III, the category for substances with accepted medical use and an abuse potential lower than Schedule I or II drugs. Blanche limited the order to medical products, citing U.S. international drug treaty obligations as the reason adult-use marijuana stayed on Schedule I.

Licensed operators got a 60-day window to opt into a priority DEA registration pathway.

Many took advantage of that pathway, and we’re seeing some of the results: in June, Trulieve restructured to separate its 206 DEA-registered medical dispensaries from its adult-use business and became the first U.S. cannabis company to list on the New York Stock Exchange proof that registration can be a path to markets and resources this industry has been shut out of for a decade.

Tax relief under Section 280E—which prevents deductions for operations that sell Schedule I and II drugs—is the clearest near-term benefit of registration, but there are arguments for federal trademark protection and other prospective benefits.

Where the broader rescheduling case stands today

The bigger question of full rescheduling was the subject of DOJ’s separate administrative hearing, which ran from June 29 through July 15. Final briefs were filed August 19, and Chief Administrative Law Judge Derek C. Julius is now finalizing the record ahead of a recommendation.

That recommendation won’t be law; it goes to DEA Administrator Terrance Cole, who, together with Blanche, will decide whether to issue a final rule. There’s no statutory deadline to rely on, so there could be an update next week or next year—and that’s assuming none of the legal challenges cause further delay.

What began as a single petition challenging the rescheduling move by Smart Approaches to Marijuana has become three consolidated lawsuits in the D.C. Circuit, plus a coalition of doctors, activists and the attorneys general of Indiana and Nebraska (Louisiana has since withdrawn).

And if you need proof that of the value of the opportunities that rescheduling can bring, just look to the claims by MMJ International Holdings, which argues it now faces competitors reaching Schedule III for free after it spent years (and significant capital) pursuing FDA approval the traditional way to get a market advantage.

The plaintiffs in the consolidated lawsuits have asked the court to stay the order while the case proceeds. The DOJ opposed that, and plaintiffs filed their reply on July 17. Two operators, MedPharm Iowa and Tri-Mountain Pure, have since moved to intervene in defense of the order.

A ruling granting a stay could freeze DEA registrations and potentially suspend benefits that operators are banking on.

Why “rescheduled” doesn’t necessarily mean “legalized”

If you operate under a state medical marijuana license, hold dual medical and adult-use authorizations or are evaluating an investment in this industry, treat this moment as the start of a compliance project, not the arrival of a legalized market—we still have many more questions than answers.

State law compounds this, since no two states built their systems alike. The right strategy in Maryland may be wrong in Michigan or Washington, and the ground could shift again fast if the D.C. Circuit grants a stay, or if the ALJ’s recommendation or the eventual final rule reshapes the framework.

Some states could tie state licensure to DEA registration—Oklahoma already has, telling license holders to get DEA registration or risk losing their state permits next year.

Layer on top of all that new DEA regulation of license holders, which could mean on-demand facility access and inspection authority, DEA security requirements, mandatory disclosure of employees’ Social Security numbers and potential exposure for co-located medical and adult-use businesses.

This industry could look very different twelve months from now.

Striving for pole position

Rescheduling alone isn’t going to turn leaden cannabis equities into gold overnight, and I don’t think institutional capital is going to dive into the market immediately—that still requires congressional legislation such as the SAFER Banking Act and operators with the earnings and balance sheets to earn institutional trust.

But in the meantime, rescheduling is drawing interest from pharmaceutical, agricultural and consumer products companies that stayed on the sidelines while marijuana sat on Schedule I and well-positioned operators are already using this window to plan restructurings, seek new partners, acquire distressed assets and target new markets.

This is a genuinely significant moment in the fifty-year history of federal cannabis policy, and one that I think will reward careful, jurisdiction-specific planning and analysis.

The practical question isn’t whether this is something to celebrate, it’s whether your business is positioned to be a consolidator, an attractive acquisition target or something different, and the race for pole position is already underway.

As the smoke clears on rescheduling, start preparing now to take advantage of the opportunity.

Christopher B. Lynch is a Member in Dickinson Wright PLLC’s Seattle office, where he practices in the firm’s Mergers and Acquisitions and Cannabis Law groups.

Photo by Kyle Jaeger.

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Thousands of CBD Products Enter Final Stage of UK Novel Foods Approval https://smoke.vmondeika.com/thousands-of-cbd-products-enter-final-stage-of-uk-novel-foods-approval/ Sun, 18 Jan 2026 14:19:27 +0000 https://smoke.vmondeika.com/thousands-of-cbd-products-enter-final-stage-of-uk-novel-foods-approval/

The UK’s long-running project to regulate CBD (cannabidiol) products has taken another major step forward, seeing thousands of products make it to the final phase of the novel foods approval process. 

Yesterday, the Food Standards Agency (FSA) announced that its 12-week public consultation to discuss the authorisation of three applications, which represent nearly 3000 CBD isolate products. 

After almost a decade, this marks the final step towards the UK becoming the first country to officially regulate the non-intoxicating cannabis extract, in what the European Industrial Hemp Association (EIHA) called ‘a crucial milestone confirming the safety profile of hemp-derived CBD’. 

It comes just six weeks after the new board of the FSA met with industry stakeholders to discuss its plan of action to move the process forward, a promise that, so far, it appears to be delivering on. 

First products reach the final stage of the novel foods approval process

Three applications have now passed the ‘risk management’ phase, meaning that the FSA is preparing to make recommendations to government ministers to officially authorise these products for sale, becoming the first regulatory body in the world to do so. 

These three dossiers, RP07, RP350, and RP427, were the first to pass through the risk assessment phase last year. The former two received their first positive safety assessments in April, and RP427 followed in August. 

Chanelle McCoy, the producer of Pureis, said in a press release: “This progress comes after a decade of time and significant investment in a comprehensive suite of Safety Clinical and toxicology studies to support its Novel Food application since its initial submission in January 2020.  

The company’s namesake, founder and CEO said she ‘commends the FSA’ and that this work has set a ‘new global standard’ for CBD regulation, which she hopes can be replicated across the world.  

Daniel Kruse, President of EIHA and CEO of EIHA projects GmbH, commented: “Years of coordinated investment and research have brought us here. Achieving the safety assessment and now advancing into the risk management phase shows that cooperation works. At the same time, the coming months will be crucial: the details matter, and we must make sure this framework can truly support both industry and consumers.” 

  • Chanelle McCoy / Pureis
  • RP07
  • 11 products
  • Cannaray
  • RP350
  • 43 products
  • EIHA Consortium
  • RP427
  • 2718 products

Public consultation phase: ‘The details matter’

On August 28, 2025, the FSA announced the launch of a 12-week public consultation, which will shape the key elements of the request to government ministers for approval. 

This is perhaps the most critical phase of the process to date, as it will inform the regulatory pathway for CBD products for years to come, and potentially influence models elsewhere in the world. 

With many of the stipulations for approval remaining highly controversial this will represent a last-ditch effort to iron out some of these issues with the regulator. 

Each of the three application holders has now received a draft risk management recommendation from the FSA. 

Over the course of the next three months, the consultation will seek to establish the terms of authorisation, such as permitted food categories, the 10 mg/day acceptable daily intake (ADI), and the required safety labelling

As Francesco Mirizzi, Managing Director of EIHA, noted: “It is… important to underline that the consultation period will be key: we will raise a number of points to ensure that the final authorisation, definition and conditions for CBD novel foods are fit for purpose, viable for businesses, and safe and transparent for consumers.”

The FSA’s consultation, launched on 28 August 2025 and open until 20 November 2025, invites feedback on the three applications, targeted at food businesses, trade associations, enforcement authorities, consumer groups and the wider public across England, Wales and Northern Ireland, with Food Standards Scotland (FSS) running a parallel process later in the summer.

The consultation seeks views on the proposed terms of authorisation, including permitted uses, labelling and safety conditions, alongside any evidence on the economic or consumer impacts of authorising CBD foods. 

Under the Windsor Framework, authorised CBD products placed on the GB market would also be eligible for sale in Northern Ireland through the Northern Ireland Retail Movement Scheme, although NI-based firms would not be permitted to manufacture their own CBD foods.

Responses can be submitted via the FSA’s online survey or email. Once closed, the FSA and FSS will publish a summary of responses within three months and use this input to inform final recommendations to ministers before any authorisations are granted.

According to the Cannabis Trades Association (CTA), which has played a key role in engaging with the regulator on behalf of industry stakeholders, alongside EIHA, a number of key issues are set to form the bulk of discussion over the coming months. 

  • Daily intake: The fixed 10 mg/day limit does not reflect body-weight differences; a mg/kg model could provide more accurate guidance.
  • Product scope: Restricting approvals to isolates and synthetic CBD risks excluding broad-spectrum hemp products favoured by consumers, potentially driving demand to the unregulated market.
  • Labelling: Full warning statements may be impractical for small packs; a tiered model with core on-pack messages and extended information via QR code or leaflet is suggested.
  • THC limits: The proposed 0.00001% w/w threshold is unrealistic given testing variability and inconsistent with the Home Office’s 1 mg/container exemption; harmonisation is needed.
  • Data protection: Five-year exclusivity could disadvantage SMEs relying on the Public List; an equivalence route would help balance innovation and fair access.
  • Enforcement: Divided responsibilities between local authorities (Novel Foods) and police (controlled substances) create complexity; stakeholders argue for a joint FSA–Home Office protocol.

Once the consultation comes to a close, and the terms of authorisation have been established, Ministers in England, Wales and Scotland will then decide whether to approve the applications. 

Since regulatory reforms came into force in April 2025, ministerial decisions now take effect immediately and are published on the official registers of authorised products, rather than being delayed by secondary legislation.

While there is a meaningful change in both the transparency and proaction from the FSA, many questions remain surrounding how companies currently on the public list move ahead or choose to reformulate, an option only announced last month. 

Looking further ahead, should a regulatory pathway be formally established, it remains unclear how new players can enter the market. 

This article was originally published by Business of Cannabis and is reprinted here with permission.

New analysis has found that NHS access to medical cannabis could boost the UK’s economy by £13.3 billion over the next decade by returning thousands back to work.

Widening NHS access to medical cannabis could add £4.5 billion to the economy over five years, and £13.3 billion over a decade, according to an economic analysis by the Centre for Economics and Business Research (Cebr).

The research, commissioned by Curaleaf Clinic, also suggests NHS access could help thousands of people with long-term health conditions return to work, while reducing hospital admissions for those eligible by 28% a year.

Since its legalisation in 2018, private prescriptions for cannabis-based medicines have already contributed around £283 million in Gross Value Added (GVA) by helping people get well and back to work.

Roughly 2.8 million people in the UK are currently locked out of employment due to long-term illness2. Polling3 conducted alongside the Cebr study, found 62% of those who have been out of work and prescribed medication believe they have exhausted all traditional treatment options.

Those behind the research say the findings reveal a missed opportunity to improve lives, relieve pressure on the NHS, and support the government’s five-year plan to get more people working.

“Our analysis shows that appropriately prescribed medical cannabis can help people with chronic conditions return to work,” commented Pushpin Singh, Managing Economist at the Centre for Economics and Business Research.

“Expanding NHS access would benefit patients while delivering significant productivity gains and cost savings to the UK economy.”

READ MORE: Economic analysis finds medical cannabis could save NHS £4 billion each year

Out of work and out of options

Many people who have experienced unemployment due to long-term illness are frustrated with traditional medications. In total, 55% who have been prescribed medication report they provide little relief and 48% say they negatively affect their quality of life.

Being excluded from the workforce also takes a heavy emotional toll. Over half report a loss of self-esteem (56%) and declining confidence (52%), while 46% feel helpless. Mental health is also affected, with 47% saying unemployment has harmed their wellbeing and 39% experiencing feelings of embarrassment.

Fatma Mehmet, a patient at Curaleaf Clinic, says medical cannabis has helped her regain her independence.

“Living with chronic pain took a huge toll on my physical and mental health. As someone independent and career-driven, not being able to get out of bed and go to work made me feel as if my identity was being stripped away,” she says.

“When I felt like I was at rock bottom and out of options, I discovered medical cannabis. I now have the ability to work, lead a team, and regain my independence. Expanding medical cannabis via the NHS would mean greater choice for more people, which can only be a good thing.”

A roadmap towards improving access 

However, there is interest in medical cannabis as an alternative therapy with nearly half (44%) who have not previously been prescribed it saying they would consider trying it if it were more widely available on the NHS.

Nearly two-thirds of UK adults (64%) believe people with chronic ill-health should have more treatment options to get back to work, while 71% of those directly affected say medical cannabis should be made more widely available if it can help.

But 40% of those who have struggled with employment due to a diagnosed long-term health condition are still unaware that medical cannabis is a legally available treatment in the UK, and 33% describe the current system as confusing, inaccessible or unclear.

“As a doctor, I see daily how chronic illness doesn’t just affect someone’s health – it removes them from the workforce, creates economic hardship, and leads to a cascade of social and psychological problems that can worsen the cycle of ill health,” says Dr Simon Erridge, Director of Research at Curaleaf Clinic.

“This analysis shows that medical cannabis isn’t just a health issue – it’s an economic one too. Our goal is to give people affected by poor health more choice and control in their treatment, helping them build independence and, where appropriate, re-enter the workplace. This report highlights a way forward.

“We urgently need a roadmap towards improving access to medical cannabis via the NHS for suitable patients,  with the required investment in essential research to deliver this.”


Cannabis Health Symposium 2025 – advancing clinical practice in CBMPs

As patient access grows and prescribing frameworks evolve, health professionals need up-to-date, evidence-based guidance. The Cannabis Health Symposium 2025 brings together clinicians, prescribers, pharmacists, and researchers to explore the latest clinical evidence, policy updates, and real-world applications of cannabis-based medicines.

What to expect:

  • Evidence-led sessions on prescribing, safety, and efficacy
  • Policy and regulatory updates for UK healthcare settings
  • Practical insights from frontline clinicians and researchers
  • Networking with peers, prescribers, and industry leaders

Join us in London for a day of clinical education and discussion on the future of cannabis in healthcare.

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