Tag Archives: international

International Trade and Cannabis Decontamination Considerations

By Jeff Adams
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With shifting perceptions, economic incentives, and the evolution of international regulatory frameworks, more countries around the world are starting to embrace legal cannabis for its medical and recreational uses.

One of the hotspots of legalization remains the European Union, where countries like Malta and Luxembourg have legalized cannabis for adult use, and Switzerland and the Netherlands have pilot programs in place. These pilot programs are temporary, limited initiatives that are implemented by a country’s government to test and gather data on the effects of legalizing and regulating the sale of cannabis. Rather than diving headfirst into full-blown adult-use legalization, many nations will take this approach to study the impact different regulatory models can have in a smaller, controlled environment.

As of May 2024, twenty-one of 27 EU states have legalized cannabis for medical use, with one of the most prominent being Germany. After passing the Cannabis Act (CanG) in April 2024, Germany’s medical cannabis industry expanded rapidly as the legislative action improved patient access and removed some administrative burdens for prescribing physicians.

Reliance on Foreign Partners for Optimal Market Growth and Efficiency
As legal cannabis use spreads globally, nations will need to continue to build and rely on partnerships with one another to provide ongoing support for safety and quality assurance and foster symbiotic market growth. For example, Canada legalized cannabis for adult use in 2018. In the years that followed, the country faced challenges due to oversupply. In 2020, Health Canada reported an excess of 600,000 kilograms of unpackaged dry cannabis flower and an additional 46,413 kilograms of packaged flower. To help counteract the buildup of excess product, Canada has now emerged as the largest exporter of medical-grade cannabis to EU states with thriving medical cannabis markets like Germany.

Quality & Safety Controls for Medical Cannabis

To be able to import cannabis for medical purposes into the EU, it must meet stringent rules and regulations for safety and quality control. Contaminated cannabis has the potential to cause harm, especially to medical patients who are immunocompromised or have respiratory conditions. Several types of contaminants can be found in cannabis, including microbial, particulate, and chemical. Microbial contaminants, including bacteria, viruses, yeast, and mold, can be introduced to the product from the environment, raw materials, equipment, or personnel.

Good Agricultural and Collection Practice (GACP)
A first step in quality assurance for medical cannabis is the Good Agricultural and Collection Practice (GACP). GACP provides broad technical guidance on collecting high-quality medicinal plant materials for herbal goods classified as medicines, including medical cannabis. The goals of GACP are to ensure the quality of medicinal plants by providing a broad guide on quality, safety, and efficacy, establishing standard operating procedures, and encouraging and supporting the sustainable cultivation and collection of high-quality plants for medicinal purposes.

European Union-Good Manufacturing Practice (EU GMP) Certification

Developed by regulatory agencies such as Health Canada, the U.S. Food and Drug Administration (FDA), and the World Health Organization (WHO), the European Union-Good Manufacturing Practice (EU GMP) certification is one of the most stringent sets of standards in the international pharmaceutical industry. Regardless of where the cannabis originates from, the product must be GMP-compliant to be sold in the EU.

Under GMP standards, products must be:

  • Of consistent high quality;
  • Appropriate for intended use;
  • Meet the requirements of the marketing association or the clinical trial authorization.

Cannabis must pass regular quality control testing to ensure the product meets the standards for potency, purity, and consistency. The flower must be tested for the presence of microbial contaminants. The goal of a manufacturer following GMP standards is a contamination rate as close to zero as possible. If contaminants are found, the product must be decontaminated and retested, or it risks being rejected and destroyed.

Additional Considerations for Decontamination Tech

Since quality control testing is a significant step in meeting EU GMP compliance, decontamination technology may also play a crucial role in the process. Tech using X-ray, gamma-ray irradiation, ozone gas, or radiofrequency, among others, may be used to decontaminate cannabis of specific microbes.

For example:

  • X-ray decontamination – Highly effective on mold, bacteria, and spores.
  • Gamma-ray irradiation – Highly effective against all microbes, including spores, but can be harmful to the plant because of intense doses.
  • Ozone gas – Effective for mold, mildew, and bacteria. Decontaminates at the surface level only.
  • Radiofrequency – Kills mold, yeast, and bacteria. Has the potential to heat the plant and affect its integrity.

While the technology itself does not need to be EU GMP certified, the decontamination technology and process must be compatible with the EU GMP processes of the cultivator and manufacturer, or risk negating their certification.

My company, XRpure, specializes in producing decontamination systems – our models include the XR16 and the XR12 – that allow X-rays to penetrate through cannabis flower and neutralize microbes while preserving its cannabinoid profile.

We recently announced our company’s expansion into Canada to service cultivators and producers exporting medical cannabis to the EU. We are currently implementing several advancements to our technology to align with EU GMP processes, as well as achieving new milestones to demonstrate compliance with foreign directives.

We are currently implementing several changes to the technology’s user interface, including the addition of user profiles in the software: a user profile, an administrator profile (used to set up new users), and an engineer profile (used to set up new recipes). Additionally, we are currently seeking to obtain the CE mark for electrical safety on our decontamination systems. A CE mark signifies that the manufacturer has declared the product complies with all applicable EU directives for safety, health, and environmental protection.

Depending on the system and the process of the cannabis cultivator or manufacturer, other changes to the technology may be required to comply with their EU GMP processes.

As the global cannabis industry continues to expand, countries will continue to rely on foreign partnerships to foster collaboration, innovation, growth, and support for their burgeoning markets. The EU remains an area for cannabis industry expansion, especially in medical markets such as Germany. To support a large base of medical cannabis patients, Germany relies heavily on import partners like Canada for its supply.

 

For countries seeking to balance growth with safety and compliance, meeting EU GMP and GACP standards is crucial. Technologies like decontamination systems demonstrate how innovation and regulatory oversight can work in tandem to ensure product safety, consistency, and intended use. By continuing to progress alongside evolving international frameworks, the global cannabis industry can achieve sustainable, long-term growth and deliver high-quality products to patients and consumers.

 

 

 

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.”

 

The United Nations Poised To Recognize Cannabis Culture

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Beyond its wellness benefits, cannabis carries a rich and diverse cultural legacy that spans the globe. In a  technical paper submitted to Mondiacult 2025, the Cannabis Embassy calls for global recognition of cannabis cultures as an integral part of humanity’s cultural diversity, and as essential to building inclusive, rights-based, and peace-oriented cultural policies in the 21st century.

Mondiacult 2025, UNESCO’s World Conference on Cultural Policies and Sustainable Development, will be held in Barcelona, Spain, from September 29 to October 1, 2025. The gathering brings together ministers, policymakers, cultural professionals, and civil society leaders from all 194 UNESCO Member States to shape the global cultural agenda for the years ahead.

The Roots of Cultural Erasure

The paper begins by tracing how cannabis’s regulation transformed into prohibition. In 1925, the International Opium Convention first put cannabis derivatives under international control. But it was the 1961 Single Convention on Narcotic Drugs that went further, specifically mandating in its Article 49 that traditional or non-medical uses of cannabis should be “abolished” as soon as possible.

This legal architecture effectively criminalized centuries of cultural practices almost overnight, without regard for the histories, traditions, or worldviews of communities that had used cannabis as part of their heritage.

The authors highlight a stark paradox: although Article 49 attempts to eradicate non-medical uses, cannabis use and culture never disappeared. Instead, they persisted and adapted underground, often at great social and legal risk to the people involved.

Culture of Resilience

Criminalization has driven cannabis traditions underground, disrupting the transfer of knowledge across generations and forcing communities to safeguard their heritage in secrecy. The war on drugs has made it risky to openly celebrate or develop cultural practices tied to the plant.

Yet despite decades of stigma and repression, cannabis cultures have shown remarkable resilience. Communities have preserved knowledge orally, sustained clandestine cultivation networks, and reinvented social practices to keep traditions alive.

Still, criminalization has silenced open expression, marginalized traditional growers and knowledge holders, and left indigenous and legacy communities sidelined in legalization efforts that rarely create fair or inclusive opportunities.

Human Rights, Cultural Rights & the Need for Reconciliation

The technical paper frames this struggle in the language of cultural and human rights. International human rights instruments (e.g., UDHR, ICESCR, ICCPR, and treaties protecting indigenous and minority cultures) affirm that all peoples have the right to participate in cultural life, to transmit traditions, and to enjoy “the moral and material interests” tied to their cultural expressions.

Yet, the authors argue, cannabis communities have been systematically denied these rights through prohibition, stigma, and exclusion. Tools of cultural safeguarding (such as UNESCO’s 2003 Convention on the Safeguarding of Intangible Cultural Heritage) have rarely been applied to cannabis-related practices. The paper calls for a recalibration of international norms so that cannabis communities can access recognition, protection, and support.

Policy Recommendations & Pathways Forward

As the world convenes for Mondiacult 2025, this moment presents a window for structural change. The paper sets out key recommendations:

  1. Acknowledge a cultural crisis: explicitly recognize how prohibition has impaired the cultural rights and heritage of cannabis-associated communities.
  2. Reexamine conflicting treaties: address the tensions between Article 49 of the Single Convention and human rights frameworks (UDHR, ICESCR, ICERD).
  3. Support community-led safeguarding efforts by investing in participatory processes to document, revitalize, and protect cannabis-related cultural expressions.
  4. Create enabling environments at national and regional levels, and remove legal and social barriers that prevent communities from freely maintaining or developing their traditions.
  5. Promote equitable benefit–sharing and protections: guard against exploitation or biopiracy of cannabis genetic resources and traditional knowledge.

By recognizing cannabis cultures as part of the global mosaic of cultural expression, and by re-centering rights, dignity, and community control, the authors argue, we can shift from a “war on drugs” mindset toward a culture for peace paradigm.

Read the full report from the Cannabis Embassy here:

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.

 

Quality From Canada

Inside Red Light Holland’s Plan to Bring Psilocybin Products to the Global Market

By Pam Chmiel
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Red Light Holland (CSE: TRIP) has established its foundation in the Netherlands, where psilocybin truffles, the underground sclerotia of psilocybin mushrooms, are legally permitted for cultivation and sale. The above-ground mushroom is prohibited, but the truffle is treated differently under Dutch law, despite delivering the same psychoactive effects.

“It’s really the same thing, with the same effects,” says CEO Todd Shapiro, “but because it forms underground, it can be sold in compliance with Dutch law.”

From its cultivation facility, RLH distributes truffles through a wholesale partnership to over 150 wellness shops under its brands iMicrodose and Maka. “We like to think of them as wellness shops rather than smart shops, like they are referred to in Holland,” Shapiro explains, underscoring the company’s emphasis on education, QR-code-based information, and community engagement. While regulations prevent RLH from turning truffles into edibles such as gummies or chocolates, its vacuum-sealed, raw truffles have become a steady revenue stream. “They’re a bit walnut-y,” Shapiro notes, “but they sell well and people rarely complain.”

 

Canada: Positioning for a Regulated Future                                                           In Canada, RLH is preparing for the potential regulatory shift that could pave the way for the legalization of psilocybin products. The company has already developed psilocybin gummy formulations, but for now, it only sells them as functional mushroom products that don’t contain psilocybin. This approach not only helps build brand recognition, but it also keeps the company R&D-ready, allowing it to move quickly if Health Canada establishes a legal framework for psilocybin.

 

United States: Research Partnerships for Validation                                        South of the border, RLH has partnered with Irvine Labs, a DEA-registered laboratory in California. The lab is testing RLH’s truffles, imported from the Netherlands, to confirm potency, safety, and pharmacological value. The partnership is central to RLH’s long-term vision of formulating psilocybin capsules tailored to various needs, including microdosing, therapeutic use, and wellness.

Shapiro frames the multi-pronged approach as deliberate groundwork for the future. “The Netherlands gives us a legal, revenue-generating business today. Canada positions us for tomorrow. And in the U.S., we’re laying the foundation with science so that when the regulatory environment changes, we’ll be ready.”

 

Research & Consumer Insights                                                                                In addition to building commercial distribution, Red Light Holland is investing in research that could help shape future regulations. Through its iMicrodose app, the company collects voluntary, anonymized data from consumers in the Netherlands on how they are using psilocybin truffles, whether for trauma, pain management, recreation, or general wellness. Shapiro points to a substantial interest in using psilocybin to tame menopause symptoms from their data.

 

“We ask our consumers if they’d like to participate in the app and give us data on how they’re using it,” explains Shapiro.

 

The data was analyzed in collaboration with Drug Science UK under the leadership of renowned neuroscientist Professor David Nutt, one of the most respected voices in psychedelic research and policy. The published study confirmed that RLH’s data provided meaningful evidence of consumer benefit. “A lot of it is anecdotal research, which is key research,” says Shapiro. “It’s almost like its own Phase 1.”

The findings also carried a regulatory impact. RLH presented its consumer data to lawmakers in Oregon as they developed the state’s psilocybin program, contributing to the inclusion of microdosing language in the final bill. “This was a huge win for the company,” Shapiro says. “It adds credibility, validation, and shows how we can responsibly influence policy through science-backed data.”

For RLH, consumer research serves a dual purpose: it provides a self-regulatory framework for the safe distribution of products today, and it informs the company’s plans for future formulations as regulations evolve.

 

Standardization & Medical Pathways                                                                   Red Light Holland is also working behind the scenes to prepare psilocybin for the medical market. The company has partnered with labs in both Canada and the U.S. to analyze and standardize its products, laying the groundwork for future pharmaceutical-style formulations.

In Canada, RLH has collaborated with Seacrest Laboratories in Montreal, securing multiple permits for the import of psilocybin from Health Canada. These projects have produced certificates of analysis (COAs) to understand psilocybin content better and explore standardized dosing formats. “We’re learning about the standardization of our product,” says Shapiro, “whether that eventually becomes ground into powder form or an extract. The end goal is to move toward a consistent, pill-like product for microdosing.”

In the U.S., RLH works with Irvine Labs in California, a rare FDA-approved, DEA-compliant facility, to advance similar objectives. The partnership underscores RLH’s long-term ambition: validating its Dutch truffles as a source for medical-grade psilocybin products that could one day be distributed under compassionate care or special access programs.

“It’s a slow path,” Shapiro admits. “No one would normally start a business that they could only sell in about one percent of the world. But if you want to be an outlier versus an outlaw, you take the careful approach by generating sustainable revenue in Holland while advancing science and regulations in North America.”

 

Slow and Steady                                                                                                    While regulatory doors are starting to crack open in places like Germany, Australia, New Zealand, and the Czech Republic, RLH isn’t rushing in. Shapiro is careful to point out that the company has no interest in repeating the mistakes of many cannabis operators who built massive facilities before the market was ready, only to burn through cash and collapse in oversaturated conditions. Instead, RLH is pacing itself, positioning products, standardizing formulations, and preparing for the moment commercialization becomes viable.

“It’s frustrating for some investors who want instant results,” Shapiro admits, “but the reality is we can only sell in one percent of the world right now. We’d run out of money if we tried to scale too fast. Every move has to be deliberate.”

For RLH, the mission remains steady: take psilocybin from the underground to the mainstream. Until regulations evolve, the company is committed to cautious progress, ensuring it will be ready to deliver once legalization expands.

 

Market Readiness                                                                                                       To help normalize psilocybin, RLH has leveraged functional mushrooms with its Happy Caps grow kits and mushroom gummies to establish brand awareness. Happy Caps started as homegrow kits for lion’s mane, shiitake, and oyster mushrooms, products that ended up on the shelves of Costco and other major Canadian retailers. The idea is simple: just as Canada allowed adults to grow cannabis at home after legalization, psilocybin might one day follow a similar path. If that happens, RLH will already be positioned with both the distribution channels and consumer familiarity to shift from lion’s mane to psilocybin.

More recently, RLH launched mushroom gummies in Canada made with a lion’s mane and shiitake blend. These gummies carry a Health Canada–approved NPN number, which allows the company to make validated health claims, such as immune-boosting and antioxidant properties that most competitors cannot legally advertise. Shapiro says this not only sets RLH apart in the crowded functional mushroom category, but also provides a ready-made blueprint for psilocybin gummies once regulations allow. “It’s a much easier way to consume than chewing on a raw truffle,” he explains. In other words, today’s Happy Caps gummies are tomorrow’s psilocybin edibles.

In parallel, RLH is deepening its scientific foundation through a partnership with Irvine Labs. The company has already imported truffle samples for testing, focusing on potency, shelf-life stability, and consistency—critical steps in moving psilocybin from a naturally variable product to a standardized medicine. “If you’re microdosing for medical reasons, you want to be sure each dose delivers the same effect,” Shapiro explains.

That requires rigorous testing under pharmaceutical standards, much like cannabis research has revealed the complexities of the entourage effect.

Shelf stability has emerged as one of the biggest challenges. Like fresh produce, truffles degrade quickly if not kept under controlled conditions. For RLH, understanding how to preserve potency over time is key to developing future formulations, whether in pill or extraction form. “Consistency is always the goal when it comes to drug discovery,” Shapiro notes.

 

Strategic Growth Through M&A                                                                    Beyond consumer products and R&D, RLH is also exploring mergers and acquisitions as a path to scale. Shapiro says the focus is on acquiring brands with strong recognition and the potential to be cash flow positive, rather than companies burning capital. “A great Instagram account and loyal customers can be half the battle,” he notes. The idea is to consolidate products, share resources, and expand distribution while maintaining financial discipline.

Still, opportunities are scarce. After reviewing more than 40 companies over the past two years, Shapiro says nearly all were losing money. The demands of major retailers compound the challenge—fulfilling large orders requires significant upfront inventory and the ability to survive long payment cycles, which can stretch 90 days or more.

While RLH has heard of pioneering efforts, such as Oregon’s first psilocybin edibles, local ownership laws, and public company reporting requirements make direct entry into that market difficult. For now, the company continues to evaluate partnerships and acquisitions that align with its strategy, while supporting others that advance the industry. As Shapiro puts it, “Rising tides lift all boats.”

 

Looking Ahead                                                                                                        Red Light Holland is narrowing its focus on CPG products, leveraging its experience in the Netherlands while preparing for a global market. While the company continues some cultivation, its strategy centers on creating standardized, science-backed psilocybin products that can reach more people and address the growing mental health crisis. “We’re a psilocybin company at the end of the day,” says Shapiro, “focused on products that can help people, responsibly and sustainably, while navigating complex regulations and building a foundation for future growth.” By combining research, consumer insights, careful regulatory planning, and selective M&A, RLH is positioning itself to take psilocybin from niche wellness shops to mainstream markets worldwide.

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.

The CBD Regulatory Environment in Europe: Part 3

By Shelley Stark
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This is Part Three of a four-part series discussing European cannabis regulations. Click here for Part One and here for Part Two. Part Three dives into dosage, approvals and more. Stay tuned for the final Part Four, coming next week.

But does CBD harm the liver?

Here, it is important that we compare apples to apples. Supplements are intended in addition to one’s usual diet. Medicines, on the other hand, are meant to alter a condition to solve a problem. Epidiolex is a medicine, not a supplement. According to Epidiolex the recommend dosage of Epidiolex, a highly purified form of CBD, is between 5mg and 25mg per kilo body weight per day. That means that an average 70 kilo adult would need to take between 350mg and 1750mg per day!

At this moment, even the FSA states that a recommended dosage should not exceed 70mg per day and most recommendations are much lower. This is because supplements are not medicines.

Epidiolex-GWThe point is that Epidiolex is an FDA-recognized medicine and should not be compared to a supplement. Supplements may range from vitamins, minerals, herbal products and botanicals, and are offered without a prescription to people who wish to maintain or improve their health. Purchasers of supplements, as the word suggests, are supplementing their diet or lifestyle, they are not seeking a doctor prescribed medicine.

The supplement or additive industry has no desire to confuse the objective of a supplement with one of a medicine. The objective of testing CBD is to confirm its usage as a supplement, so a firm line can be drawn between what is a medicine, formed to make conditional changes to the body, and what is a supplement to a normal diet.

Despite the FDA’s website warning that CBD is not a legal additive to food or drinks, at this point, the Agency seems to limit actions to claims, and not the safety of the product itself.

This position may be about to change.

The FDA has made inquiries with the European authority, EFSA, concerning testing and safety requirements. It is quite possible the FDA prefers the ‘EU approach’ over the current ‘wild west approach’ driving the American CBD industry.

In response to interview questions directed to FDA spokesperson, Courtney Rhodes says:

“CBD cannot lawfully be sold as a dietary supplement or as an ingredient in food under the FD&C Act. (Bold italics by the FDA) Food ingredients must be shown to be safe to be lawfully added to food. That means, there must be a reasonable certainty that an ingredient’s intended use won’t cause harm”.

FDAlogoIf this is the case, one may well wonder why the FDA is not enforcing the FD&C Act. The answer might lay in great part to the specifics of the 2018 Farm Bill (formally, the Agriculture Improvement Act), where the only statutory metric for cannabis as a controlled substance is the reference to the 0.3% delta 9 THC level. Many see this poorly written bill as an open door for cannabinoids to hit the markets legally, much to the chagrin of many state lawmakers.

FDA spokeswoman Rhodes says that the 2018 Farm Bill effectively “removed hemp from [DEA] regulation.” By defining hemp as Cannabis sativa L. with a delta-9 concentration of 0.3% or less, “hemp derivatives, [like] CBD, …meet that definition of hemp and [are] not prohibited under the Controlled Substances Act.”

Thus, any enforcement on the part of the FDA is legally hamstrung due to the way the 2018 Farm Bill was written.

But is change in the air?

Research has yet to settle on “how much CBD can be consumed, and for how long, before causing harm,” says FDA Principal Deputy Commissioner Janet Woodcock. The existing regulatory framework for food and supplements are inappropriate for CBD, she says, and the FDA does not, in fact, intend to pursue rulemaking that would allow for the inclusion of CBD in dietary supplements.

So, what does the FDA intend to pursue?

While the FDA has generally focused on unsubstantiated health claims for food and beverage products, it is also on record stating that available data did not show CBD products as meeting the safety standard for a human or animal food supplement. “A new regulatory pathway for CBD is needed,” the Agency says, “that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks.”

What would such “a new regulatory pathway” look like? Most likely, that new testing requirements for CBD could come into effect. This could eventually mean testing requirements much like those in the EU.

Have the studies of Epidiolex, with findings based on extremely high dosage levels tainted the CBD discussion?

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

“The FDA is relying on pharmaceutical studies that show risks at larger doses,” says Jonathan Miller, general counsel for the U.S. Hemp Roundtable, adding that there is a decade of clear and established evidence of the safety of CBD products sold at retail. This is hard to deny: The industry has been selling CBD products for the last 10 years without any significant health issues arising. Thus, says Miller, creating a new regulatory pathway would not be necessary as the dietary supplement and food pathways are already provided for under the FD&C Act.

Authorities and industry leaders alike want regulations that promote business while at the same time protecting consumers. “The FDA’s inaction for the past year has facilitated an unregulated marketplace — which is bad for consumers and bad for business. It’s time for FDA to announce a legal pathway to market for these CBD-containing supplements and to commence meaningful enforcement against products that flout category-wide requirements for dietary supplements,” says Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), quoted on the crnusa.org website.

It is clear that the FDA does not want CBD in food and beverages and likewise claims there is no clear regulatory pathway, citing scientific data on CBD based on the Epidiolx study, which has little room for claiming CBD could be safely used as a supplement because the study is based on medicine, not a supplement.

Parallel to this, the US Hemp Roundtable and other industry stakeholders are urging the U.S. House Committee on Oversight and Accountability to move forward with an investigation into the lack of regulatory action on CBD products by the U.S. Food and Drug Administration (FDA). Does this mean that hemp lobbyist Jonathan Miller for Hemp Roundtable wants toxicology testing? “Yes,” he definitively answered.

Serious business requires the security that only toxicology reporting can give. Most of the large industry stakeholders have been engaged in toxicology testing for years, as time, not just funds, is a crucial factor. The EIHA projects GmbH began testing in 2020 and is not yet finished.

If congress and the FDA were to require toxicology reporting tomorrow, would your company be ready?

Soapbox

Congress Wants YOU To Make Safe Products.

By David Vaillencourt
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Recently, Congress requested detailed information regarding the regulation of CBD and other cannabinoids. This comes on the heels of frustration around federal inaction with regards to cannabinoid-containing products produced from Cannabis sativa L. plant extracts that can be classified as “hemp” products amidst the clear need for safety standards that goes above and beyond state minimum compliance requirements.

A Historical Deja Vu?

The author will be joined by his colleagues leading the Seed to Sale Safety Workshop on October 16 at the Cannabis Quality Conference. Click here to learn more. Product safety standards predate the birth of our nation (and many others). From the days of the first pharmacopeias which rival the oldest documented use of the cannabis plant, to modern regulations, the quest for safety has been a constant theme. But as the saying goes “Old habits die hard,” but so do safety issues. From peanuts to thalidomide and tobacco, we’ve seen this movie before – and it is time for a new ending.

A Universal Desire for Safety

Whether you are an investor, executive, technician or anywhere in between – nobody in the cannabis industry (and all its end uses, including industrial hemp) wants to knowingly produce unsafe products. The risks of ignoring safety are real and tangible. Whether it is 20+ years in jail for being an executive of a company that knowingly sold adulterated products and was linked to seven deaths or 10,000+ deformed children, many of whom died at birth because of a drug approved for morning sickness – there is no shortage of case studies we can learn from. Even cannabis has been known to cause injury and death in consumers – not because of the d9-THC, but the impurities. As the industry continues to innovate and develop new product form factors – whether it is new delivery methods of d9-THC in soluble beverage forms, or the rise of manufactured cannabinoids in unregulated marketplaces – it’s critical to understand the risks of your entire production process and to mitigate them. No cannabis company is immune from making costly and dangerous mistakes. It’s not just about compliance – it’s about public health and safety.

Safety Can Be a Sticky Subject

Safety is indeed a complex subject, especially when it comes to cannabis products. For instance, acceptable limits for microbial contaminants for the inflorescence of a Cannabis sativa L. plant are quite literally all over the map. What about the route of administration? Take an inhaled product (like a vape pen) vs. an ingested product (e.g. an edible). Many outdoorsy people like myself may enjoy the smell of cooking s’mores over a campfire, but the particles and VOCs can irritate our lungs, especially when exposed over long periods of time. We aren’t inhaling those s’mores – so the production of the marshmallow, chocolate and graham crackers come with different risks we need to evaluate. It’s not just about the product – it’s how it’s consumed.

Safety Standards – the Fabric of Our Society

Standards are unsung heroes of our daily lives. Whether it’s to keep planes from falling out of the sky, cribs and dressers from crushing young children, preventing train derailments or ensuring the safety of our food and medical products – standards keep us protected – just like grandma’s quilt. The absence of standards can be expensive, and anyone familiar with the accusations of d9-THC lab-shopping and inflated label claims knows that the cannabis industry is the poster child for this.

Congress has long recognized the importance of standards in protecting everyday consumers, as demonstrated by numerous legislative acts. A few notable and relevant ones to cannabis are below:

  • 1848 Drug Importation Act: First major act that combated the importation of substandard – adulterated drugs imported from overseas into the nation which was having a major impact on soldiers of the Mexican-American War.  This Act included legal requirements for drugs to meet the US Pharmacopeia’s standards for strength, quality, and purity.
  • 1906 Food and Drugs Act: After an increase in adulterated and misbranded foods and drugs – made famous by Upton Sinclair’s The Jungle, the relentless work of Dr. Harvey Wiley, a Chief Chemist with the then US Department of Agriculture and his “poison squad” – led to significant oversight of adulterated food and drugs including legal adherence to the US Pharmacopeia and paved the way for the current FDA.
  • 1938 Food Drug, Cosmetic Act: Shortcomings in the 1906 Food and Drugs Act were catalyzed by over 100 deaths after a wonder drug that was analogous to antifreeze led to an outcry that led to the passage of the FDC&A. From factory inspections, to strict marketing and label requirements, to legally enforceable food standards and tolerances for certain poisonous substances – the FDA was given substantial more oversight to protect the growing United States. It also expressly recognized USP quality standards for medicines with USP standards also binding for any dietary supplement manufacturer that labels their products as being compliant with USP specifications.
  • 1994 Dietary Supplement Health Education Act (DSHEA) defined and regulated dietary supplements which carved out significant exemptions for the dietary and herbal supplement industry from most FDA drug regulations. This act has been met with significant controversy as it greatly limited the FDA’s capacity to ban or restrict supplements until evidence of a major safety or adverse event is tied to the product of concern.
  • 1995 National Technology Transfer Advancement Act (NTTAA) – A lesser known act that is focused on standards and technology that requires participation of federal agencies in voluntary consensus standards bodies. Extending beyond foods and medicines – this act covers a broad array of infrastructure and technology regulations that ensure the fabric of our society operates (largely) without issue.

Over 1,000 ASTM standards are incorporated by reference in the US Code of Federal Regulations across nearly 30 federal agencies (searchable here), a demonstration of the value and impact public voluntary standards have in our society.

At the FDA, ASTM standards are used every day to keep us safe. Whether it is to measure the absorbency of tampons (21 CFR 801.430), enforce safety specifications of synthetic and natural wax coatings that are used to coat much of our produce, gummies and more (21 CFR 178.3770), quantifying the impurities in our bottled water (21 CFR 165.110) and many more.They have long been recognized as the de facto minimum standards that balance the need to protect consumers without imposing undue burdens on innovation by industry.

The process of developing an ASTM standard, which was developed and used to keep our trains from derailing 125 years ago, is now the home of 510+ cannabis industry specific standards. Whether it’s acceptable water activity levels in cannabis flower, a truly universal symbol to alert consumers of intoxicating cannabinoids, medical cannabis flower specifications developed in close guidance of the US Pharmacopeia, or how to apply the principles of HACCP to cannabis products, a lot of the hard work has already been done for the industry. It’s simply a matter of knowing where to look and how to use them!

The path to safe and sustainable cannabis products is clear, and the tools are available. It’s time that we learn from the past, apply the standards of the present and mitigate the risks of the future. Now more than ever before, it’s easy to make safe cannabis products and a credible marketplace not just a goal, but a reality.

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.

UKflagStill 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.

FDAlogoAnd 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.

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.’

european union statesSo, 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?