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In an industry defined by local operators struggling to stay afloat and confined within their borders, Michael Sassano, founder and CEO of Somai Pharmaceuticals, has created a blueprint for scaling cannabis worldwide with pharmaceutical discipline and regulatory agility. With headquarters in Lisbon and operations in 12 countries today, Somai is preparing to reach 18 by year’s end.

The company has already secured distribution in Germany, the UK, Italy, Australia, and New Zealand, with France recently authorizing Somai’s products for its growing patient program. By the end of this year, six more markets, including parts of Eastern Europe, will be added to the roster.

“Every new country is like starting a company from scratch,” Sassano said in an interview. “You have to understand not only the national regulations but also how local medical communities perceive cannabis, how prescriptions are written, and what distributors are required to do. There’s no one-size-fits-all approach.”

Operating across borders has taught Somai how to adapt to widely different healthcare environments. In Germany, cannabis is covered by insurance in some instances, requiring negotiations with health funds. In the UK, the market is dominated by private clinics and cash-paying patients. Australia and New Zealand have highly structured import programs, while France is still moving cautiously through pilot projects.

This incremental, country-by-country buildout has given Somai real-world experience operating across multiple regulatory systems, positioning the company as one of the most credible voices on international cannabis harmonization.

High Standards Are Key

At the core of Somai’s global strategy is its pharmaceutical manufacturing facility in Lisbon, certified under EU-GMP (Good Manufacturing Practice). This certification is a mandatory requirement for selling medical-grade cannabis products in the EU and most international markets.

“EU-GMP is the gold standard,” Sassano says. “Without it, you simply can’t access the bulk of the world’s regulated medical markets.”

This distinction highlights one of the biggest differences between the US and international cannabis industries. In the United States, the market is fractured by a state-by-state model, with companies forced to duplicate infrastructure in every new state because products can’t cross state lines. By contrast, Somai can centralize manufacturing in Portugal and distribute to multiple countries. Products produced in Lisbon are eligible for export across Europe, Australia, New Zealand, South Africa, Brazil, and other compliant markets.

Unlike US operators who may quickly launch products like gummies with minimal oversight, a EU-GMP market-authorized medicine requires approximately two and a half years of validation, stability testing, and regulatory review before reaching patients. The payoff is consistency, safety, and the ability to meet the expectations of regulators, physicians, and patients alike.

By owning EU-GMP manufacturing and pairing it with distribution partnerships across 12 (soon 18) countries, Somai is among a select handful of cannabis companies capable of bringing pharmaceutical-grade products to the global market.

Strategic Partnerships, Cultivation, and Research

Somai’s global growth relies on a carefully balanced supply chain strategy that combines in-house cultivation with an extensive network of international partners. In addition to cultivating indoor flower at its own facilities, it also works with about 15 cultivation partners worldwide.

In most European markets, pharmaceutical cannabis must move through distributors before reaching pharmacies. Somai works with leading distribution companies, ensuring products reach doctors and patients in compliance with local laws.

Research partnerships are also part of Somai’s business strategy. The company collaborated with a university in Lisbon to conduct clinical research evaluating its manufacturing process, ensuring consistency from one product to another and from batch to batch. This validation of consistency is crucial for Somai to claim medical status and prove it.

“There are really only five global operator brands today in the market, and then a lot of localized brands, clinic brands, and white-label brands,” Sassano notes. “Our focus is on building a pharmaceutical brand with true international reach.”

Pharmaceutical Rigor from the Start

“In pharmaceuticals, quality is binary,” Sassano explains. “Either you meet the exacting standards or you don’t. There is no middle ground.”

This applies from raw material sourcing to batch release protocols. Unlike the US, which often requires independent third-party lab testing, the EU herbal medicine framework permits EU-GMP-certified facilities, such as Somai, to conduct all necessary testing in-house. Somai operates its own EU-GMP lab, a rarity in cannabis but standard in pharma.

The lab operates under strict oversight from a Qualified Person (QP), who leads the independent Quality Assurance (QA) department. The QA/QP team conducts regular onsite reviews of all procedures and documentation, ensuring that production, laboratory testing, and batch releases adhere to rigorous protocols. “Nobody can influence the lab or its reports,” Sassano emphasizes. Each product undergoes multiple checks: raw material testing, formulation verification, and random dosage confirmation.

Even packaging and labeling are treated with pharmaceutical precision. Labels must comply with each country’s language and dosage requirements, and patient information leaflets are tailored to the regulatory environment. “It might seem like a small thing, but one mistake on a label can stop a shipment at customs and delay patient access by months,” Sassano notes.

Sassano supports the rigorous framework. “Doctors will only prescribe, and patients will only trust cannabis if it meets the same standards as any other medicine on the shelf.”

Navigating a Patchwork of Regulations

Some nations allow doctors to prescribe freely, while others limit access to a narrow list of conditions. Even within the same country, patients may face dramatically different experiences.

Sassano points to Italy as a case in point. While prescriptions are permitted, the way pharmacists prepare medicines can vary region by region. “A patient in Milan might get a different preparation than a patient in Rome, even with the same prescription,” he explains. “That creates inconsistency for patients and makes it extremely challenging for producers to standardize.”

The difference between magisterial preparations and finished dosage form medicines illustrates the unevenness of the system. In newer markets, such as the UK and Australia, patients now receive finished dosage products that are fully packaged, labeled, and ready to use, just like any other pharmaceutical. But in older systems, pharmacists were often required to compound medicines themselves, a legacy from the early years when manufacturers didn’t exist and flower was the only product available.

Germany still clings to this model. Pharmacy compounding laws require pharmacists to fill vape cartridges or re-bottle oils instead of allowing manufacturers to deliver standardized, child-proof, finished dosage forms directly. “In some cases, they’re literally just swapping a cap, calling it magisterial prep, and charging patients double,”

Sassano notes. “It’s an archaic system that needs to go.”

Despite these hurdles, Sassano sees eventual harmonization as inevitable. “Europe cannot sustain a market where 27 countries have 27 different systems,” he argues. “Over time, patient demand and cross-border trade will push regulators toward standardization. Finished dosage forms are the future.”

Global Market Access

Somai’s EU-GMP certification positions it for international distribution. Unlike the US state-by-state system, where borders are closed and infrastructure must be duplicated in each market, EU-GMP allows a single production hub to supply multiple countries. As a recognized pharmaceutical standard, it enables Somai’s products to move across borders into any country that accepts EU-GMP medicines.

This flexibility is critical because cannabis is treated differently around the world. Europe and many international markets have strong herbal medicine traditions, so cannabis extracts fall under the herbal pharmacopoeia as true medicines and are subject to rigorous pharmaceutical rules. In contrast, the US market is closed off under FDA oversight, which historically favors synthetic cannabinoids over botanical extracts.

Still, Somai is positioning itself for future entry. “We’re working with the U.S. Department of Veterans Affairs because there is no federally approved cannabis extract made domestically,” Sassano says. “If cannabis is ever integrated into federal programs, it will need to be a registered medicine, not a dispensary product.”

Beyond the U.S., Somai has already secured FDA-style registrations in countries like Thailand, is pursuing approvals in Japan, and has entered France’s government-controlled medical program, where cannabis is subsidized for patients.

“These are true medicines that can travel cross-border,” Sassano says. “Wherever cannabis is accepted as a medicine, we want to be there.”

Conclusion

Michael Sassano’s insights offer a roadmap not just for his company but for the entire industry. “Cannabis is a medicine first,” he emphasizes. “Our responsibility is to show regulators, doctors, and patients that it can be produced, prescribed, and trusted like any other pharmaceutical. Once that trust is established, global acceptance will follow.”

Quick Q&A Recap

Q: Who is Michael Sassano?
A: Michael Sassano is the founder and CEO of Somai Pharmaceuticals, a company scaling cannabis globally with pharmaceutical-grade standards.

Q: What is Somai Pharmaceuticals’ global footprint?
A: Somai currently operates in 12 countries and plans to expand into 18 by the end of the year.

Q: Why is EU-GMP certification important in cannabis?
A: EU-GMP (Good Manufacturing Practice) is the gold standard for pharmaceutical products and a requirement to sell medical cannabis in most international markets.

Q: How does Somai’s model differ from U.S. cannabis companies?
A: Unlike U.S. operators confined by state borders, Somai can centralize manufacturing in Portugal and distribute across multiple countries under EU-GMP rules.

Q: What are the main challenges of international cannabis expansion?
A: Each country has unique regulations, healthcare systems, and distribution requirements, forcing companies to adapt market by market.

Q: How does Somai ensure pharmaceutical quality?
A: The company operates its own EU-GMP-certified lab with strict Quality Assurance oversight, ensuring consistency, safety, and regulatory compliance.

Q: What role do partnerships play in Somai’s strategy?
A: Somai balances in-house cultivation with about 15 global cultivation partners and works with leading distributors to reach doctors and patients.

Q: What is the future of cannabis regulation in Europe?
A: Sassano believes eventual harmonization is inevitable, with standardized finished dosage forms replacing outdated pharmacy compounding practices.

Q: Is Somai targeting the U.S. market?
A: Yes. Somai is collaborating with the U.S. Department of Veterans Affairs and preparing for potential federal approval of cannabis-based medicines.

October 12, 2025

How Cannabis Moves Around the World: Inside the Global Supply Chain

By Pam Chmiel

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Global cannabis trade is well underway as legalized countries move forward to establish a supply chain infrastructure in a newly formed and rapidly evolving industry. At the forefront of transportation logistics is Cannabilog, an Israeli company led by pharmaceutical industry veteran Yoram Eshel. In an interview, he shared his playbook for building a compliant, efficient, and scalable supply chain for global cannabis import and export trade.

The Complex Web of Global Cannabis Trade Regulations

According to Eshel, not surprisingly, the global cannabis trade hinges on regulatory compliance and requires expertise to manage the movement of products across continents. Unlike pharmaceuticals, where harmonized frameworks such as those of the European Union apply across borders, cannabis regulations differ drastically from country to country.

Some nations permit imports, while others ban them entirely. Even within importing countries, the rules vary by product category. “Some will allow flower, others only oil or genetics,” Eshel explains. “It’s never a simple straight line.”

Every aspect of the supply chain requires specific licensing under narcotics laws, from cultivation and storage to import and export. Adding to the challenge is the constant evolution of these laws. For example, Thailand initially embraced its booming local market and export-friendly policies, but the new government abruptly switched course and limited cannabis use to medical purposes only. In addition, Thai producers seeking to export face roadblocks because European authorities do not recognize their local GACP certifications, which are based on “Good Cultivation and Harvesting Practices for Medicinal Plants.”

Eshel emphasizes that failing to keep pace with changing laws can be costly.

“If you export cannabis products to another country and they can’t clear customs, the shipment is destroyed. There’s no way back.”

Medical Cannabis Must Meet Pharmaceutical Standards

The second major pillar of the international cannabis trade is adherence to pharmaceutical-grade standards. “Governments treat medical cannabis as a medicine,” says Eshel. “It’s exactly like Tylenol or any other drug.”

Even though cannabis has not gone through the traditional drug registration process, regulators treat it as a pharmaceutical product, which means it must comply with strict Good Distribution Practice (GDP) requirements. That includes temperature control, data logging, and rigorous quality management throughout the supply chain. Every shipment is audited and must be approved by a Qualified Person (QP) on the receiving end before entering the market. If any quality parameters are unmet, the product is rejected.

Logistics providers like Cannabilog must operate under EU GDP certification and maintain pharmaceutical-grade systems and documentation. “We are audited constantly,” Eshel says.

The difference between the medical and recreational markets often catches producers off guard, especially those in countries like Canada, which has a more recreational mindset, similar to that of the US. “When you move into the medical space,” Eshel notes, “you suddenly need temperature-controlled vehicles, validated packaging, and specialized labeling. It requires training and experience.”

Globally, countries such as Germany, Australia, and Israel classify cannabis exclusively as a medical product. “It’s not even close to recreational,” Eshel stresses. “And in most countries, recreational use is still illegal and requires special licensing.”

Managing Cold Chain Logistics

After navigating complex regulations and meeting pharmaceutical-grade standards, the final piece of the international cannabis trade puzzle, says Eshel, is execution.

“You can have your licenses, your permits, your quality system, but if you don’t execute correctly, everything can fail.”

Execution means maintaining control over every step, including packaging, labeling, documentation, temperature regulation, and secure transportation. Shipments must move through carefully selected routes using temperature-controlled vehicles, warehouses, and flights, with continuous monitoring to ensure product integrity is preserved. In some countries, even armed escorts are required for security.

Eshel explains that cannabis logistics is not one-size-fits-all. Each product type, including genetics, flower, and concentrates, has unique handling and storage protocols. For instance, cannabis clones present one of the most challenging forms of transport. “Most clones are unrooted,” he says. “From the moment you cut them from the mother plant, you have three to four days to keep them alive. That requires special packaging, rapid shipping, and customs clearance to get them back into water in time.”

Temperature management is another major operational challenge. Most global regulators require cannabis products to be stored and transported between 59 °F and 77 °F, known in the pharmaceutical world as Controlled Room Temperature (CRT). In the United States, many recommend that temperatures should not exceed 70 °F for optimal cannabis preservation. Eshel clarifies that maintaining actual CRT conditions demands active temperature monitoring and specialized packaging, not just insulated boxes.

For every shipment, Cannabilog conducts a route risk assessment to evaluate potential environmental extremes along the supply chain. Eshel cites the example of shipments from Canada to Australia, where opposite seasons create complex thermal risks.

“Winter in Canada is summer in Australia, making temperature management a challenge from continent to continent; you have to plan for that,” he says.

To minimize exposure, Cannabilog uses pharma-grade airline partners that store and handle products under strict temperature conditions and prioritize loading and unloading to reduce time on the tarmac. Each shipment includes data loggers that record temperature throughout transit.

“If there’s an excursion outside the allowed range,” Eshel notes, “the products are rejected.”

European regulators, he adds, tend to enforce these standards more rigorously than their U.S. counterparts. While the United States has many GMP-certified cannabis facilities, most are not EU-GMP certified, which limits their ability to export to Europe when the time comes, even though the differences are not that big.

Eshel contrasts this with Canada, where much of the market remains recreational. While medical exporters adhere to strict temperature control and quality management, domestic recreational products are often transported under looser conditions.

“You can’t count on the weather,” he says. “Temperature management is part of the medical cannabis infrastructure.”

The Last Mile in Cannabis Preservation

Most of Cannabilog’s shipments are from a cultivation or production facility to a licensed wholesaler or distribution center, rather than directly to pharmacies.

“We verify that every facility we deliver to is properly licensed and has temperature-controlled storage,” Eshel says.

Cannabilog provides insurance coverage for every shipment, including losses related to temperature excursions or other transport issues. However, ultimate product responsibility remains with the manufacturer, much like in the pharmaceutical industry.

“If something goes wrong, it’s the manufacturer’s duty to investigate, and if needed, issue a recall,” Eshel explains.

Each transfer of custody, whether at the port, airport, or distribution warehouse, marks a shift in responsibility defined by the buyer-seller agreement. Still, Eshel stresses that all parties must adhere to Good Distribution Practices (GDP) and maintain detailed documentation, including lab tests and Certificates of Analysis (COAs), to ensure transparency and traceability.

Without mandatory cold-chain standards, products are often transported in “hot trucks,” leading to product degradation. Eshel agrees: “The last mile is often the weakest link in the supply chain infrastructure as the industry strives to build a cold chain custody from seed to sale.”

Even last-mile deliveries must be temperature-controlled. The difference, Eshel says, comes down to mentality. “In Europe, it’s purely medical. There’s no confusion between recreational and medical use, so cannabis is treated just like any other medicine.”

September 26, 2025

From The Lab

An Inside Look at Germany’s Cannabis Supply Chain With The Grünhorn Group

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On April 1, 2024, Germany launched Pillar 1 of its adult-use legalization framework, building on its established medical cannabis program that has been in place since 2017. Since then, the number of medical patients has surged, as prescriptions remain the only fully legal access point for cannabis aside from home cultivation or membership in non-commercial private clubs, both still limited by incomplete regulations. Unlike the United States, where dispensaries are the backbone of cannabis sales, Germany maintains a more tightly regulated model: patients must secure a doctor’s prescription and fulfill it through a pharmacy.

The next stage, Pillar 2, is expected to introduce licensed retail outlets for adult-use sales, eliminating the requirement for prescriptions. However, with the Christian Democratic Party now in office and maintaining a strong stance against cannabis legalization, these plans face significant uncertainty. While advocates remain hopeful for progress, the CDU’s opposition could delay, restrict, or even reverse parts of the rollout, leaving the future of Germany’s adult-use market in question.

In the meantime, Germany is laying the groundwork for a national infrastructure rooted in its medical system, a stark contrast to the fragmented, state-by-state patchwork in the U.S. This centralized approach not only offers greater oversight and consistency but also positions Germany as a potential model for other European nations exploring reform.

At the center of this rapidly evolving landscape is the Grünhorn Group, one of the country’s most influential players. With an estimated 20 percent market share serving between 5–7 million patients in a nation of 84 million, Grünhorn has established a vertically integrated supply chain that spans importing biomass from global producers, EU-GMP-certified manufacturing, and robust distribution networks. Beyond production, the company operates Germany’s largest online pharmacy platform, giving patients access to products from multiple manufacturers. According to Matthias Fischer, Managing Director of Canymed, Grünhorn’s distribution partner, the group generated €33 million in revenue in 2024, provided medicine to approximately 60,000 patients, and engaged with nearly 6,000 prescribing physicians.

Prioritizing Data Collection for Medical Research For Grünhorn, data is at the core of both its medical mission and its business strategy. The company systematically collects patient feedback on the effects of its products—whether for sleep, anxiety, focus, or other conditions—to inform evidence-based product development. This feedback loop allows Grünhorn to collaborate closely with cultivation partners in designing strains that balance cannabinoids and terpenes to address specific therapeutic needs.

Beyond patient-level insights, Grünhorn is also investing heavily in analytical research. The company operates a gas chromatograph to precisely measure and map the cannabinoid and terpene composition of imported biomass, creating a detailed strain database. To date, Grünhorn has cataloged between 400 and 500 strains of interest, providing one of the most comprehensive genetic and chemical libraries in Germany’s cannabis sector.

“I think the future lies in predicting and knowing which cannabinoids will effectively address specific health indications,” says Fischer, underscoring the company’s long-term vision of turning raw data into targeted, science-driven therapies.

Germany is an Import Market

While Germany has licensed domestic cultivation, led by producers such as Tilray, Demecan, and Aurora, the country remains heavily dependent on imports. According to Fischer, the quality of German-grown cannabis has not yet reached the standards set by established cultivation markets in Canada, Portugal, Denmark, and Colombia. To maintain product consistency and meet patient expectations, Grünhorn partners with a Canadian grower, underscoring the ongoing importance of international supply in Germany’s cannabis ecosystem.

Economic factors also weigh heavily on domestic production. High energy costs make large-scale cultivation within Germany particularly challenging, pushing wholesale prices above those of imported flower. As a result, most of the market is supplied by international partners who can cultivate at scale more efficiently and deliver the product at a lower cost.

This reliance on global supply chains is not unique to Grünhorn.

Cantourage, one of Germany’s largest medical cannabis manufacturers, has built its strategy around imports, maintaining partnerships with 40 cultivators across 17 countries. Together, these dynamics reinforce Germany’s role as one of the world’s largest import-driven cannabis markets, even as it develops its own infrastructure.

Bottlenecks in the Pharmacy System

Germany’s pharmacy network, spanning both retail and online channels, remains the cornerstone of cannabis dispensing in the country. As patient demand surges, many traditional pharmacies have launched digital platforms to streamline order management. Grünhorn has leaned into this shift, expanding its online pharmacy delivery while forging partnerships with local pharmacists who see cannabis as a valuable revenue driver.

Yet the system is under strain. Because only licensed pharmacists can legally fulfill prescriptions, they often face capacity challenges. Compounding, bottling, labeling, and testing must still be performed manually, creating bottlenecks in day-to-day operations. To keep pace, some pharmacists pre-produce standardized products based on everyday patient needs, despite the model being designed for on-demand compounding. Recognizing these inefficiencies, Grünhorn is investing in custom machinery and software solutions to help pharmacists scale production without compromising compliance, while maintaining oversight of quality and safety.

Another hurdle is product consistency. With prescriptions filled at thousands of independent pharmacies, often by third-party providers, slight variations in formulation are inevitable. “It’s like having 6,000 different factories manufacturing your product,” Fischer explains. To address this, Grünhorn is working on standardized fulfillment models to align independent pharmacies with the quality benchmarks already set by its own online platform.

To further streamline the process, Grünhorn has integrated telemedicine into its supply chain. Patients can now connect directly with physicians, obtain prescriptions, and submit them seamlessly for fulfillment. This innovation helps address a recurring frustration: doctors inadvertently prescribing products that are out of stock, despite having access to inventory databases, ultimately reducing delays and ensuring patients remain on consistent treatment plans.

Partnerships and Opportunities Grünhorn’s pharmacy data reveals that 20-30 percent of products generate 80 percent of revenue, indicating a potential for future product consolidation, according to Fischer. For investors, this presents an opportunity to fund medical brands with proven track records that are poised for growth and expansion.

In addition to producing its wholesale product line, Grünhorn is well-positioned and equipped to assist other brands looking to enter the German marketplace and welcomes co-branded product partnerships. They forged a partnership with Somai Pharmaceuticals, based in Portugal, resulting in a two-year, €10 million manufacturing and distribution deal.

Fischer also believes AI will play a significant role in managing the industry in the future, suggesting an opportunity for those looking to enter the German market through technological innovation.

“The biggest challenge we must overcome in the next couple of years is to generate data and medical studies,” Fischer emphasizes. “We have many products with nice ideas, interested patients, and qualifying physicians, but we need more studies and proven evidence to present to new doctors and insurance companies, who are still challenging cannabinoid therapy and requesting data studies.”

For more insights into the German market, listen to an interview with Matthias Fischer on the Innovating Cannabis podcast.

September 12, 2023

The CBD Regulatory Environment in Europe: Part 4

By Shelley Stark

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This is the final piece of a four-part series discussing European cannabis regulations. Click here for Part One, here for Part Two and here for Part Three. Part Four wraps up the series below.

Where is the future of CBD heading?

A review of these various jurisdictions, the EU, the UK, and the USA, makes it clear that testing of CBD to ensure public safety is paramount to staying in business, and indeed to the survival of the industry. In the UK it is imperative to be active in the Novel Food licensing regime to remain on the market. In the EU, it is imperative for a legitimate market at all.

In the USA, it may very well become an imperative, if not because of the FDA or even Congress, but rather because as the U.S. market matures, lawsuits over product liability are almost inevitable, pointing to the lack of toxicology reporting or to the way a product was manufactured or marketed. Until the FDA plays a more robust role in establishing standards for the safety of CBD in food products, the best means for companies to protect themselves is with a Novel Food inspired testing regime to confirm product safety.

What this means for the CBD industry

Companies want a clear path forward for investments in the CBD sector. Litigation is predictable, especially in a litigious society like the U.S., as companies prepare themselves with toxicology reporting that satisfies the FDA. There will be clear winners and losers in the CBD market place, most likely based on a toxicology report.

The EFSA, FSA, FDA, the various state level hemp associations dotted across America and more intriguingly, businesses who see testing requirements as a legal means of ousting the less-well-financed competition, are all advocating for testing. This makes sense: There is no future in betting on the unknown. Anything short of a clear safety standard is just guessing with people’s health and thus the company’s future.

So, what are we left with?

Clearly, there is a need for a toxicology report prepared on behalf of the CBD sector. And one about CBD as a food supplement, not as a medicine. It is worth noting that Miller also remarked on how Epidiolex contained high doses of CBD. It needs to be made clear that the medical study of Epidiolex is not consistent with a study of non-medical levels of CBD when used as a supplement.

At present, the biggest challenge facing CBD product manufactures, whether in the USA, EU or UK, is the lack of controlled studies and thus the inability to illustrate the necessary toxicology reporting in their portfolio. Even in the US, the FDA has said it can’t conclude that CBD meets the standard of “generally recognized as safe” (GRAS) for use in human or animal food. Thus, the future of CBD lies in a company’s ability to illustrate by means of a study and accompanying toxicology reports that their brand is firmly in line with the required safety and data standards.

Just some fo the many CBD products in the U.S. market out there

Here is where the EU and the UK may have an advantage, through involvement in the Novel Food application and licensing procedures. The needed legal security for the marketing of CBD products can only be achieved by their approval as Novel Foods. Projected costs for an individual company registering CBD isolate and full spectrum distillate under the Novel Food guidelines requires an investment of €3.5 million. As this is prohibitively high for most companies, at the June 2019 General Assembly, the EIHA proposed the creation of a consortium, with the aim of submitting a joint Novel Food application and sharing these costs among the members.

How the “EIHA projects GmbH” Partnership Works

The founding members of the EIHA projects GmbH have a preferential partnership rate. As a partner, I am able to sub-license products or brands in the EU and this license will be valid in the UK when the application is validated and on the Union list, and is equally valid in the USA.

The Atlantic Ocean is getting smaller and it appears that the FDA might very well decide that the US needs the same European safety standards applied to products at home. Sub-licensing is clearly an inexpensive pathway for an American brand to claim toxicology and safety testing PLUS get access to the EU market. It is imperative for businesses going forward to take a serious look at their future business goals and align themselves with an advancing regulatory environment confirming their commitment to approved quality products.

August 28, 2023

The CBD Regulatory Environment in Europe: Part 2

By Shelley Stark

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This is Part Two of a four-part series discussing European cannabis regulations. Click here for Part One. Part Two analyzes the differences between the UK, the EU and the US. Part Three, coming next week, dives into dosage, approvals and more. Stay tuned for more.

EU Regulatory Environment

We Europeans look with envy at the American market and wonder, why can’t we be more like that? The differences between the American market, the UK and the EU economic zone couldn’t be more different, but changes seem to be on the horizon. While both the UK and the EU apply the Novel Food law, implementation varies significantly.

In the EU, applications are submitted to the EU Commission, and approval can take up to nine months – just for approval of the application – not the testing that will follow. And while the application carries no fee, collecting the required data just to make the application can be expensive, and can run into six figures or higher. Once the application is approved, there may still be data gaps and uncertainties, with toxicology testing that can take years to complete, and ultimately must be approved and validated by EFSA (European Food Safety Authority). The required toxicology testing is where things get really expensive, with both the EIHA (European Industrial Hemp Association) and EFSA estimating costs around €3.5 million.

The EFSA’s Panel on Nutrition, Novel Foods and Food Allergens (NDA) has received 19 applications thus far for CBD as a novel food, with more in the pipeline. According to their website, NDA chair Prof. Dominique Turck reported that they “have identified several hazards related to CBD intake” and that many data gaps need filling before evaluations can go ahead. However, she concluded, “It is important to stress that we have not concluded that CBD is unsafe as food.”

As always, with food and drug reviews, it is up to the applicant to prove that a product is safe for human consumption. And for the EU Commission, EFSA is conclusive. And while initial testing is with animals, it also includes human testing, which helps explain the high cost.

At present, the EFSA has been unconvinced by the applications submitted so far, and seeks more data regarding the effect of CBD on the liver, gastrointestinal tract, endocrine system, nervous system and on people’s psychological well-being, as well as the impact on human reproduction.

Thus, in 2019, the EIHA formed a German corporation, the “EIHA projects GmbH”, formed for the purpose of pooling partners money to pay for the application and toxicity testing. The Novel Food applications (NFAs) for CBD isolate and synthetic CBD were submitted on November 4, 2022 and full spectrum will follow in April/May of 2023. It should be noted that the application for synthetic CBD has been completely dropped as no testing was ever preformed.

The applications must be reinforced by a series of tox studies under the auspices of the EFSA and for the UK, the FSA. The EFSA will start the risk assessment as soon as the suitability check is performed. The suitability check is a process performed by EFSA to make sure that they have enough data to perform the risk assessment. According to their webpage, the risk assessment can take nine months.

In the case of the application put forth by the EIHA projects GmbH, the CBD isolate dossier will be submitted to the EFSA in September and enter the risk assessment phase. In this phase, the EFSA will go over the data and can ask for more data, should they feel it necessary. They are allowed 9 months to complete this task and submit their recommendations to the EU commission for a 27-member vote, whereby the EIHA projects GmbH application will be valid and legally binding. The EIHA projects GmbH is expecting a validation during the course of 2024. This is a huge game changer!

The application for Full Spectrum distillate should be readied by the end of 2023, whereby the EFSA should be finished with the risk assessment near the end 2024. As Full Spectrum takes into account minor cannabinoid as well as limited THC, it is more complex. It should be noted, that testing full spectrum distillate with a 0.2% THC limit, tests the limit for how much THC can be ingested by humans without side effects. This study is unprecedented and might well have an enormous impact on the issue of THC and its possible future legalization. It is also costing a further one million euros to bring to fruition.

The UK Regulatory Approach

The UK Novel Food approach differs greatly from the EU’s, which has both strengths and weaknesses. What makes the UK CBD market so robust is that the FSA allows products to be sold as long as they were on the market prior to February 13, 2020 and are linked to applications submitted before March 31, 2021. As a result, the FSA was flooded with applications – many later denied on technical grounds, in great part because they didn’t meet these terms. Currently, some 11,000 products worth a projected 1 billion GBP in revenue remain on the FSA list, having passed pre-validation while the FSA awaits the final toxicology report. Only 400 CBD products have been culled from the list, but to date, not a single application has yet been approved. Pre-validation status is incumbent upon a toxicology report, and it remains to be seen how many companies are able to produce such a report.

Important to note is that due to Brexit, a UK validation when it does come, will not be valid in the EU, but products with an EU application accepted on the Union list will be valid in the UK.

Still with a projected 1 billion GBP at stake, it is easy to why UK CBD manufacturers work to appease the FSA despite the regulatory hurdles. By keeping the door open, the UK has managed to keep investors interested in the CBD market and the public safe from unmonitored products.

This is certainly not the case in the EU, where despite a smattering of products still ducking the authorities, the EU market remains thin by comparison. Their approach has stymied growth compared to the UK where robust Novel Food regulation is in place, but approached differently.

At present, a market comparison of the EU to the UK or North America seems bleak, at least for now, but following approval, future EU-wide distribution could be highly profitable. As we inch closer to a Novel Food listing, the European market may yet prove to be one of the largest markets for the safest CBD products in the world.

The American Market

Still, it is the American market that makes our mouth water; where oils, tinctures, candies, cakes, and drinks with every cannabinoid from CBD to Delta 9, Delta 8, and HHC are available and producers are on their way to becoming millionaires. With a market currently estimated at $6 billion, forecasts reach upwards of $16 billion by 2026.

And the health-related concerns, the testing requirements? Are these limited to the UK and the EU? Let’s take a closer look! A mood of caution is emerging in the American cannabis market, that includes producers and lawmakers alike, who are pushing for stricter laws and enforcement.

In America, the FDA (Food and Drug Administration) has alerted the public to CBD’s potential harmful side effects on their website and hope to force congress to deal with the issue.

Many of their concerns validate those of the FSA and the EFSA. For example: on their website the FDA makes a reference to only one CBD product that has been approved: a medicine called Epidiolex. The FDA cites the review of the Epidiolex’s application in 2018 when they identified certain safety risks, including potential for liver damage. The EFSA requires testing on the same issue.

August 21, 2023

The CBD Regulatory Environment in Europe: Part 1

By Shelley Stark

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This is Part One of a four-part series discussing European cannabis regulations. Part One serves as an introduction. Part Two, coming next week, will analyze the differences between the UK, the EU and the US. Stay tuned for more.

As I walk through any European cannabis expo – events like Cultiva Hanfexpo, Cannafest Prague or Spannabis – it is easy to be struck by the differences to those in the U.S. First, there are no THC products, nor are there any CBD food products such as drinks or confectionaries. This is because of the EU Novel Food regulations: “which applies to any food stuffs not commonly used for human consumption before 15 May, 1997.”

As a result, American CBD manufacturers – with virtually no regulation of cannabinoid infused products – have an enormous advantage. In the EU, any “novel food” must be tested and proven to be safe for human consumption.

Still, hemp was not always considered “novel.” In 1997, hemp plant products were considered outside the scope of the regulations EC 258/97.” And more specifically, “that hemp flowers … are considered to be food ingredients” (e. g. used for the production of beer-like beverages). Hence, not ‘novel.’

So, right until the end of 2018, nature more or less aligned with the legal establishment, and many products made it safely to market because extracts of cannabidiol (CBD) were considered ‘novel’ only if the levels of CBD were “higher than the CBD levels in the source of the plant itself: Cannabis sativa L.”

However, in January 2019, the catalogue entries for “Cannabis sativa L.” were updated, such that even a naturally occurring level of cannabinoids are now excluded. For the industry, this was a frustrating turn of events, affecting any and all food products to which CBD might be added – confectioneries such as gummies, brownies or cakes, but also includes oils and tinctures containing CBD extracts and other cannabinoids.

Technically, all products on the EU market containing natural CBD or an isolate or distillate are illegal. So, the industry has been playing a cat and mouse game, where consumer labels display vague information or simply state ‘not for human consumption’. The result is a well-developed gray market, that hinges on benign authorities in your jurisdiction.

Sometimes, a producer is able to convince authorities that their product is allowed under Article 4 submission, whereby the producer claims that any CBD content in the food is naturally occurring and a traditional food.

Article 4 is a provision of the Novel Food Regulation (EU) 2015/2283 that allows an operator to check with the national authority on the status of a particular food before bringing the product to market. In the framework of this EU regulation, the operator checks whether the food is traditional or novel. If the food is considered traditional, then the food can be placed on the market immediately. But, if it is novel, it requires a Novel Food authorization.

Good news emerged on June 2, 2023, where in the EU, it has been agreed that once again, hemp leaves are considered a traditional food and are no longer considered Novel. Hemp leaves and tea can be marketed in the EU without further hurdles, but this does not include extracts.

In the case of extracts, CBD isolate and distillate are Novel, not traditional, and a firm must provide toxicology reporting. Both EU and UK law provides that any product containing a CBD extract placed on the market falls under the Novel Food regulations. Ultimately, tests must verify with a high degree of certainty whether CBD is safe to ingest in any amount. And how much is safe before changes occur to internal organs such as the liver or reproductive systems. The FSA will verify results in the UK, while the EFSA is responsible for the EU.

In the EU, the EFSA will send their final recommendation to the EU commission for approval, where after a 27-member vote, the item will be added to the Novel Food Catalogue. Approval at the individual state level, is next to impossible to acquire, for example, Austrian law states: “Oils/extracts containing cannabinoids placed on the market as such or in foods are considered novel foods and must be authorized in the EU.” No such approval is currently available. Placing it on the market is therefore not permitted.

No ambiguity there!

Some EU countries, such as Greece for example, appear more lenient and others not, but it is retail that is first in line for fines if an investigative authority walks in the door. The situation is certainly nerve-wracking, and having suffered through several of these AGES investigations, I closed my store as a result. Others have had similar experiences. One large retail chain owner reported that he fears the check by the authorities, as each one leads to a fine of some sort, or the demand to remove products. Without notice, he says, the health authorities could decide on even harsher punishments such as larger fines or even removing his business license. Then what, he wonders?

July 25, 2023

Unpacking the New German Cannabis Reform Bill

By Michael Sassano

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Following the German cannabis reform movement is like watching a snowboard jump competition. We launch into the big jump with lofty promises, only to face the difficulty of gaining meaningful, immediate momentum at the bottom of the halfpipe. Nevertheless, we persevere through smaller political moves that set us up for more advanced regulatory jumps, all the while believing that broader cannabis legalization requires sacrifice and the skills to navigate the course properly.

The Cannabis Act is a significant step forward. Although we rarely get exactly what we want, it holds promise for the EU-GMP cannabis producers that have invested heavily in creating a global, pharmaceutical-grade market.

Reforms to Medical Cannabis in Germany

The Cannabis Act proposes reforms to how doctors prescribe cannabis, removing the narcotic designation that stigmatized prescriptions and created liabilities for doctors. If passed, doctors and telemedicine groups will be able to prescribe cannabis for almost any condition without fear of lengthy paperwork or the stigma of controlled substance liabilities.

This framework is reminiscent of early medical programs in the USA and Canada. In these countries, obtaining a prescription for cannabis became steadily easier as patient-driven demand took over. As we can see, the cannabis industries in these nations have flourished.

Home Cannabis Cultivation for German Citizens: A Small Step Forward

Allowing citizens to grow three cannabis plants at home is not monumental. However, it is a strong symbolic statement about how accessible the cannabis plant should be to the broader population and is the first step toward a decriminalization bill.

This Act signals growing national acceptance from politicians and a shift toward treating the plant as a right for all Germans. Though small, this change needs applause from both institutional cannabis producers and the cannabis advocates that have fought so hard to bring it to fruition.

Cannabis Social Clubs in Germany

Social clubs are a completely unproven economic model, reminiscent of “coffee shop” models paired with small legal grows to service the club. These social clubs are a legal version of those around Barcelona and mirror proposals in Malta and Switzerland.

Though novel, the social club model is a positive shift toward a smaller-scale adoption of cannabis. It addresses a niche market for flower connoisseurs and appeals to cannabis entrepreneurs who want to explore their green thumb. The effect on the illicit market is yet to be seen, just like home grows, but progress here sets us up for the next move.

Looking Toward German Dispensaries

Cannabis institutional investors and producers are all looking towards the next step: American- and Canadian-style dispensaries that allow any adult to walk into a store and purchase a high-quality, regulated product. These establishments will likely compete directly with the illicit market and produce the capital necessary to push cannabis toward national legalization. Although not in the current text of the bill, all eyes are on the future as we celebrate our progress thus far.

The Cannabis Act Holds Promise for the Future

There is something for everyone in the latest Cannabis Act, whether you are a home enthusiast, advocate, members-only green thumb enthusiast or large-scale institutional player. This bill leaves little doubt that we are moving through the legalization course. There is much more work to come, but we are moving forward together and have hope for the future of regulated cannabis in Germany.

January 4, 2023

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Investment Strategies for Entering the European Cannabis Market

By Niklas Kouparanis

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For U.S. venture capitalists (VCs), the burgeoning European cannabis market provides opportunities to break into the industry on the heels of adult-use legalization. Germany has set its sights on implementing a recreational market by 2024, and the country, along with several other European Union (EU) countries–Malta and Luxembourg–came together in September 2022 to draft a joint statement on why the EU needs a new approach to cannabis use for adult-use production, sale and consumption.

In October 2022, Germany took further steps to solidify its plans for legalization further when its Health Minister Karl Lauterbach presented a cornerstone paper on planned legislation to regulate the controlled distribution and consumption of cannabis among adults. Such actions have signaled to both the EU and the world at large that cannabis legalization in Germany is imminent, and the country is championing the new age of cannabis policy.

With the new German cannabis market soon to be on the horizon, both foreign and domestic VCs are considering how to best leverage investment opportunities into existing cannabis companies within the current medical-only market that will transcend into adult use. For U.S. investors, it’s important to do their due diligence to find the company that will transcend into the next progression of cannabis policy. In addition, European cannabis companies must do their own meticulous research when it comes to aligning with investors to meet both their financial and business goals.

How U.S. VCs Can Evaluate Investment-Worthy European Cannabis Companies

As with any investment, VCs benefit from researching the company and market they are planning to invest in. Regarding the company of interest, it’s important to examine which part of the cannabis market the company is serving: growers, retailers, ancillary products, service providers and biotechnology companies all exist as potential investment options within the space. An investor should look into a company’s annual revenue, evaluating whether it has increased, remained steady or decreased over time. Revenue growth is often provided on a company’s income statement.

In addition to making sure they have a thorough understanding of the business model and its value proposition, investors should also familiarize themselves with the company’s management team to make sure that they are knowledgeable and experienced in both running a company and the cannabis industry. For those interested in entering the German market, VCs should consider the businesses that are currently key players in the country’s medical cannabis industry and that plan to expand their services into the adult-use sector once legalization comes into play.

For example, Tilray, founded in 2014, was one of Canada’s first licensed medical producers. When Canada legalized adult-use cannabis several years later, in 2018, Tilray was one of the companies that successfully transitioned to expand its market share in Canada’s medical to the adult-use cannabis industry.

Another consideration for VCs is the reputation of the business and its leaders. Investors should seek out those who have become authorities within the industry and the movers and shakers who are providing key insights into the market. These business leaders should be front and center, discussing everything from current operations and compliance to cannabis policy and legislation to new endeavors and growing their businesses. With recreational cannabis legalization being a completely new endeavor for the EU, it is important for leaders within today’s European medical space to be visionaries for the next phase of cannabis legalization and be guides for creating regulations for this new market to be safe, sustainable and scalable.

In addition to executive teams, VCs should check if the business is meeting the current marketplace’s expectations and is ready to adapt and evolve as needed. This means that the company has access to a steady supply of high-quality cannabis at an affordable price and access to consumers (medical patients) and potential consumers. With adult-use legalization soon to be a reality in Germany, investors must consider which players in the medical-only market will be able to not only survive the transition but grow to become leaders in Germany’s new recreational market and within the EU as a whole.

What Do European Companies Look For in Terms of U.S. VCs

Just as VCs must find the right fit for them in terms of investments, cannabis companies must also align with investors that help them meet their financial and business goals. For cannabis companies, many seek to align themselves with VCs experienced in consumer, technology, and healthcare investments. While there are benefits to working with a VC with a cannabis background, companies should not deter investors who do not meet those specific criteria, as the cannabis market is still a fairly new and ever-transforming industry. In light of this, it’s important that investors approach opportunities with an open mind for both the industry’s current state and its potential.

european union states — The European Union

As with most investments, both VCs and companies should be prepared to agree to a term sheet, a document that outlines the relationship between the investor and the business. An ideal investor would need to be supportive, well-connected, and add value by providing relevant business knowledge. While some investors seek a more hands-on role, in most cases, the VC’s support will not be equal to the business’s micromanagement or control of its day-to-day operations. Generally, those responsibilities would remain with the company’s executive team.

As an investor, it’s important to be supportive of the business; be a cheerleader for the company when things go well, and lift up the business when challenges occur. In addition, offering a network of referrals and strategies to excel is key to being a good asset to the business. Also, having a diverse portfolio of companies with synergistic opportunities can be very beneficial to growing cannabis businesses.

A question many investors ask before entering the space is how much in assets they should have on hand to be considered an eligible investment size. Typically, this depends on the business and its financial needs. Small profitable cannabis businesses that want additional financing may be able to secure a bank loan, if possible, in their home countries or seek a seed investment-focused VC for some capital. Leaders in Germany’s current medical-only market are seeking investors, both from the U.S. and abroad, to partake in Series A/B funding, seeking financial partners that can help them reach a goal of $20-80M USD.

European cannabis companies are within a high-growth market, so U.S. VCs looking to enter through investment do not have to go through a private equity firm. An investor can approach companies through networking or direct outreach. It is also important to note that investors do not have to convert their assets from USD to EUR, as it is done automatically when making investments. For the first time in 20 years, the USD and EUR are about equal, so now is a great time for U.S. investors to consider making the leap into European cannabis.

July 6, 2022

CBD Safety in Edibles: What Regulators are Thinking

By Steven Gendel, Ph.D.

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Despite the popularity of cannabidiol (CBD) infused edibles among consumers there are storm clouds on the horizon for this market. The potential threat stems from continuing uncertainty about the regulatory status of CBD in the United States (US) and the European Union (EU). Recent statements by government agencies in both areas are reminders that regulators could make decisions or take actions that would suddenly end the viability of this market. Any company that sells, or is planning to sell, CBD infused edibles such as bakery items, candy and beverages needs to understand what the regulators are thinking now and what might happen in the future.

in the US, the 2018 Farm Bill created a category of products called hemp that are derived from the Cannabis sativaplant and contain less than 0.3% tetrahydrocannabinol (THC). This law also explicitly confirmed the authority of the US Food and Drug Administration (FDA) to regulate the safety of hemp-derived infused edibles. This means CBD needs to navigate the New Dietary Ingredient pathway for dietary supplements, and either the food additive petition process or the Generally Recognized as Safe (GRAS) pathway for foods before it can be used as an ingredient in a food. All three of these processes require that someone (an individual, a company or a group) acting as a petitioner or notifier must submit safety data to the agency or arrange for a safety evaluation by independent experts.

Just some of the many hemp-derived CBD products on the market today

In the EU, CBD is regulated as a Novel Food in a process that is triggered by a submission to the European Commission. The submission must include safety data that is evaluated by the European Food Safety Authority (EFSA). In England and Scotland, CBD products are also novel foods and are evaluated using a process like that in the EU. As in the US, it is the responsibility of an applicant to provide the safety data.

The standard used by the FDA to judge the safety of new food substances in all three pathways is that there should be a “reasonable certainty in the minds of competent scientists that the substance is not harmful under the conditions of its intended use.” The standard used by EFSA for novel foods is, “the food does not, on the basis of the scientific evidence available, pose a safety risk to human health.”

It is important to realize that both in the US and the EU the safety standard for evaluating new food substances only considers the safety of that substance. The laws or regulations that define agency authority do not allow for consideration of any potential benefits. Approval (or rejection) must be based solely on the safety of the substance. Further, safety is evaluated in the context of the intended use of the substance, the planned level of use and the resulting consumer exposure to that substance.

What do we know about FDA’s and EFSA’s current thinking about CBD safety?

Unfortunately, both the FDA and EFSA have made it abundantly clear that they believe the available scientific data does not meet the required safety standards. FDA has issued multiple warning letters to companies that sell CBD products and has rejected two NDI notifications for CBD. Although these actions were primarily based on non-safety issues (illegal health claims and the drug exclusion provision in the FD&C Act, respectively), in each case the FDA also raised safety concerns. This was done by saying that the agency is not aware of any data that would support a GRAS determination or that the products raise “concerns about the adequacy of the safety evidence.” This doubt echoes statements from the agency in public meetings and advisories. These doubts were expressed as recently as June 2022 during a meeting of the FDA Science Advisory Board.

Similarly, EFSA has stated that they feel that there are critical gaps in the existing CBD safety data. In April 2022, they published a statement with a detailed analysis of the relevant scientific literature and explicitly identified critical data gaps. EFSA said that these data gaps prevented them from evaluating CBD as a novel food.

What do the regulators see as data gaps?

Although the details of each of the data gaps are technically complex, for both the FDA and EFSA they fall into few broad categories.

The first is that the agencies feel that they need better information on how CBD behaves in the human body. This is described as understanding the absorption, distribution, metabolism and excretion (ADMA) of CBD. The agencies also would like to see data on whether repeated use of CBD might cause damage to specific organs that does not occur from single exposures.

The second need is for more data related to the negative effects that have been observed in some previous work. This includes effects on the liver and reproductive system. In particular, the agencies would like to know whether it is possible to identify a level of exposure that is low enough to not cause any negative effects. This is termed the No Observed Adverse Effect Level (NOAEL). In an ingredient safety assessment, the NOAEL is used to establish a safe intake level, called the Acceptable Daily Intake (ADI). Comparing the ADI to the expected exposure for the intended use allows the regulators to assess overall safety for a substance. If the expected exposure is below the ADI, the substance is considered safe. Both agencies feel that the existing data do not allow them to identify a NOAEL for CBD.

The third data need relates to the composition of the CBD products used in safety studies. Food safety determinations are based on the total composition of an ingredient that is produced using a fully defined process. Even if the potential ingredient is 95% or 99% pure, a safety evaluation needs to know what is in that other 5% or 1%, and that this is the same from batch to batch. For example, the presence or absence of residual processing chemicals (such as extraction solvents) and the nature and concentration of substances such as other cannabinoids and terpenes will differ between manufacturers and processes. These differences could affect the overall safety profile for each CBD product. Therefore, it is considered important that studies supporting a safety determination for a new substance be carried out with the actual article of commerce.

Unfortunately, many different CBD preparations have been used in past studies, and in most cases these preparations were poorly characterized. This makes it difficult or impossible to combine the safety data obtained using one product with data obtained with a different product. For example, data obtained using CBD isolates from two different sources cannot be combined unless it can be shown that they were made using the same process and have the same overall composition.

What does this mean for the future?

Neither the FDA nor EFSA is likely to take any positive action on CBD until they receive safety data that fill the gaps that they have identified.

Given these data problems, it is likely that there will be little or no movement on regulatory approvals for CBD in edibles (or dietary supplements in the US) for at least several years. In the US, these products will remain in legal limbo, with state regulations playing the leading role in determining what is allowed on the market. Products with health claims will continue to be particularly vulnerable to FDA action. The situation in the EU will be at least as confusing because, in the absence of action from EFSA, the regulatory and market status of CBD edibles will be determined by each member country independently.

In view of this uncertainty and business confusion, that are three ways that companies making CBD and CBD edibles can respond. First, in the short term, they can develop and implement manufacturing processes that ensure that their products are consistent from batch to batch and that they have the intended dose of CBD per serving or per product unit. This includes working with the analytical community and organizations such as AOAC and ASTM to ensure that there are validated testing methods available for the CBD and for the final edible products.

In the medium term, business risk management plans for companies that make CBD and CBD infused edibles should consider the possibility that new scientific data will push food safety authorities to actively conclude the CBD does not meet the current regulatory safety standards. In that case, the regulators might start to act against all CBD-containing products.

The structure of cannabidiol (CBD), one of 400 active compounds found in cannabis.

Businesses should also be aware that the agencies could make a positive safety determination but that they would use the available data to establish a low maximum allowed dose per serving or set very low limits on the presence of specific contaminants such as other cannabinoids.

In the longer term, the CBD industry as a whole might consider advocating for legislative changes. The best statutory fix is likely to be one that that regulates all cannabis-derived products in a system or agency that is separate from the food safety system. This approach is being used in Canada under the Cannabis Act. It is also similar to the way that alcoholic beverages are regulated in the US. This approach, if appropriately designed, could avoid the need for safety determinations but might also limit market access. While this approach could bring clarity and certainty to the market, it is important to remember that it will take time and effort to create a functionally system under this scenario.

There are many market reports that forecast on-going high rates of growth for the CBD market. However, the regulatory and scientific developments that are likely to occur of the next couple of years will determine whether those projections can become reality.

Companies making these products need to monitor changes and prepare to respond to either positive or negative events.

These companies should also remember that edible products are mostly made from food ingredients using standard food product processes. It is critical that these products be made under a system that prevents food-borne hazards.

May 10, 2022

Aurora Launches New Product Line in UK

By Cannabis Industry Journal Staff

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Aurora Cannabis announced today that they will be launching a new product line for patients in the United Kingdom. The Berlin-based company says they are debuting new cannabis extracts for the United Kingdom that meet EU GMP standards and are developed using, “a new extraction process has been developed to ensure the terpene profile of its products consistently remains at a high level,” according to the press release.

The new product line comes from Aurora Nordic, their facility located in Odense, Denmark. While the press release does not disclose exactly what kind of extraction technology and post-processing methods are involved, they claim their processes result in consistent concentrations of cannabinoids and rich terpene profiles.

Back in 2019, the UK loosened their rules around medical cannabis and allowed a handful of cannabis-derived drugs to be prescribed. Shortly after the British government began loosening restrictions around hemp-derived CBD and medical cannabis, Aurora made its first foray into the UK market. Still, only a small number of patients actually get medical cannabis prescriptions and accessibility is still a hot button issue in the country.

Trisha Cassidy, managing director for Aurora Cannabis in the UK & Ireland, says they are still trying to get into the market further, working on accessibility, advocacy and reimbursement issues through the NHS. “We are dedicated to helping improve access to medical education for healthcare professionals and are happy to share our medicinal cannabis knowledge and expertise,” says Cassidy. “The effectiveness and tolerability of medical cannabis has already been shown in several clinical studies and even more data from 20,000 UK patients will become available once the first patient registry for medical cannabis in Europe is completed. The UK market is still young and much work needs to be done to dismantle the obstacles that continue to prevent patients from receiving the treatment they need. Aurora is committed to these patients and will continue its dedicated work in the UK.”