Tag Archives: safety

Target Just Opened the Door — Is Your Brand Compliance-Ready for Mass Retailers?

By Pam Chmiel
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Will Target’s move to sell THC drinks be the catalyst the industry needs to push for higher standards?

Target’s decision to start selling hemp-derived THC beverages marks a major milestone for the cannabis industry and a reality check for brands hoping to follow. Selling into mass retail is not just about scaling production or packaging appeal. It requires proving that your product meets the same safety and manufacturing standards as food, pharma, and cosmetics.

As Darwin Millard, Technical Director at CSQ Certification, explains, “Retailers like Walmart and Target protect their liability by only buying from GMP-certified producers. That certification is their shield.” Without an accredited Good Manufacturing Practices (GMP) certification, cannabis brands may not make it past the first round of vendor qualification.

The cannabis industry has traditionally operated in a silo, selling B2B to other licensed operators that rarely demand third-party certifications. Mass retailers operate differently. They rely on accredited certification programs to verify every layer of the supply chain, from ingredient sourcing to packaging. This mitigates risk and ensures traceability if something goes wrong.

Many hemp brands rely on co-manufacturers already bottling for alcohol and alternative beverage industries, but those manufacturers are often not GMP-certified for cannabis products. Existing food safety schemes, such as SQF or BRC, do not yet recognize cannabinoids as approved ingredients. Target may have overlooked this gap when approving its current selection of hemp beverages, but this is likely to be addressed going forward.

Target’s move could push the entire cannabis supply chain to adopt GMPs to protect consumers and ensure consistent quality. As Millard warns, “It could be the thing that gives our industry its biggest black eye if something goes wrong, or the moment that raises the bar for safety and quality once and for all.”

 

What It Takes To Get GMP Certified

GMP certification is a rigorous, multi-step process that demonstrates a company’s commitment to verified quality and safety standards. While companies may perform internal audits or have business partners review their processes, the most widely recognized and trusted method is third-party certification.

Third-party certification involves an independent organization auditing every aspect of your operation to ensure compliance with established GMP requirements. This provides a clear, objective verification that processes, documentation, and product handling meet global standards.

Not all third-party certifications carry the same weight. Accredited certifications are independently verified by an external authority and recognized internationally as meeting stringent standards for quality and safety. Unaccredited certifications, in contrast, may offer internal assurance but generally do not hold the same credibility with regulators, retailers, or international partners.

For brands targeting mass retail or global trade, third-party certification serves as proof that safety, traceability, and quality standards are adhered to.

 

What Compliance Looks Like

Not only does the cannabis industry need to embrace standards for scaling to mass retail, but it also needs to embrace standards for global trade. That includes accredited GMP certification rather than a certificate from an unverified auditor.

Cultivation falls under Current Good Agricultural Practices (GACP), ensuring that every stage of plant growth and harvest meets rigorous safety and quality benchmarks.

Effective cultivation standards cover both indoor and outdoor grow environments and include strict protocols for:

  • Water quality and irrigation management
  • Equipment sanitation and maintenance
  • Crop protection and propagation materials (including clones, seeds, and tissue culture)
  • Temperature and atmospheric control during drying and curing

Once plants are harvested, the process transitions from GACP to GMP standards, marking the shift from cultivation to manufacturing. “Harvest is the hard line,” says Millard. “Once you start to process the plant in a controlled environment by trimming, curing, or packaging, you’re operating under GMP.”

The CSQ Cultivation program also covers flower handling, grinding, and pre-roll production, but stops short of infused or extracted products. When it comes to post-harvest remediation techniques like irradiation, CSQ doesn’t explicitly prohibit them but requires detailed, documented procedures.

“We treat drying and curing like refrigerated or frozen food storage,” Millard explains. “There are specific temperature and environmental conditions that must be maintained to preserve product safety and quality.”

In the extraction process, standards define best practices for processing and handling cannabinoid materials. Standards cover everything from raw extracts, such as live resin or rosin, to refined materials, including distillate or purified cannabinoids. They also include formulation, risk assessment, and allergen implications for products intended for inhalation, ingestion, or topical use.

 

The Last Mile: Warehousing and Distribution

Once cannabis products leave the manufacturing facility, maintaining safety and quality becomes the responsibility of distributors and warehouse operators. Mass retailers will expect vendors to follow the same high standards throughout storage and transit as they do during production.

Controlled storage environments are a requirement for ensuring product preservation. Temperature, humidity, and atmospheric conditions must be monitored and documented to preserve volatile compounds in concentrates, infused products, and THC beverages, similar to perishable food or beverage items.

Proper warehousing protocols also protect against contamination, degradation, and liability. Companies that can prove systems for handling, tracking, and storing products across the supply chain will have a competitive advantage with mass retailers.

 

Retail Responsibility: Preserving Quality and Mitigating Liability

Once cannabis products reach the retail shelf, the responsibility for maintaining safety and quality shifts to the retailer. Like perishable foods, cannabis products can degrade if not stored under proper temperature, humidity, or lighting conditions. For high-end concentrates or infused products, even minor lapses in any of these factors can significantly impact potency, consistency, and the overall consumer experience.

If products degrade, retailers could face legal liability or incur costly recalls. In some cases, manufacturers may prove that products left the facility compliant with Certificate of Analysis (COA) standards, but without proper storage at the retail level, those standards cannot be maintained.

Standardized operating procedures (SOPs) for storage, handling, and temperature monitoring remove liability from the retailer and make sure consumers receive the quality product they are promised. Batch records, documented storage conditions, and adherence to best practices allow them to demonstrate that they took all reasonable steps to maintain product integrity.

High-end extractors and other manufacturers often worry that retail infrastructure is not yet equipped to handle sensitive products. Improper storage can result in financial losses and reputational damage. Embracing certifications and best practices will become increasingly essential as the industry matures and customers demand higher quality.

Consumers expect cannabis products to be safe, consistent, and accurately labeled. Maintaining quality throughout the supply chain ensures that products match what is promised. Otherwise, what reaches the shelf may be nothing more than THC content with degraded flavor, aroma, or texture, far from the intended experience.

 

Raising the Bar For Cannabis Quality

Target’s entry into hemp-infused beverages marks a turning point for the cannabis industry. Success in mass retail requires rigorous quality standards, including GMP and GACP practices, temperature-controlled storage, and documented SOPs, to protect consumers and retailers while preserving product quality. These practices position brands for mass retail and prepare the industry for international trade, where standards are even more stringent.

Dive deeper into standards with Darwin Millard on the Innovating Cannabis Podcast.

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.”

 

Wellness Watch

Why America Needs a National Medical Cannabis Program, Now

By Pam Chmiel
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The cannabis industry’s fragmented foundation is creating a host of problems tied to the lack of federal legalization. Many experts believe that without a national medical cannabis framework, the future of cannabis as a medicine in America could leave patients unprotected, research underfunded, and the industry consumed by unchecked commercial interests.

Few voices have been more vocal about this than Dr. Jordan Tishler, a Harvard-trained physician who spent 15 years working in a VA hospital before dedicating his career to cannabinoid medicine. Today, as the founder of InhaleMD and the president of the non-profit Association of Cannabinoid Specialists, Tishler is a leading advocate for creating a structured, federally recognized medical cannabis system.

 

“Over 180 million Americans over the age of 50 will develop one or more illnesses that can be treated with cannabis,” Tishler explains. “We cannot leave their care to marketing claims, dispensary staff, or patchwork state laws. Patients deserve proper medical treatment.”

 

Why Federal Legalization Falls Short

The current push for legalization often centers on ending prohibition, addressing social justice issues, and creating economic opportunities. While those goals matter, Tishler argues that legalization without a medical framework could actually undermine the perception of cannabis as medicine.

 

“Without a national medical system, we will see an industry driven by sales rather than science,” he warns. “Companies will have no incentive to invest in costly clinical research if they can simply go to market and make unverified claims. That would be the death knell of cannabis as a legitimate medicine.”

 

The problem is already visible in the hemp market, where unsubstantiated health claims and mislabeled products have flooded store shelves. Without federal oversight, Tishler says, cannabis risks becoming more snake oil than science-backed treatment.

Patients Caught in the Middle

Right now, medical cannabis patients face enormous disparities depending on where they live. In states like California, only a small fraction of cannabis is sold through medical channels, leaving patients to rely on retail budtenders for guidance.

 Florida remains the only state that requires a prescription-style “Order” that dispensaries must follow, but most states treat cannabis more like a consumer good than a medication. That lack of structure leaves vulnerable patients, many of them elderly or living with chronic illness, without consistent, professional guidance.

What a National System Could Look Like

According to Tishler and the Association of Cannabinoid Specialists, a true medical cannabis system would need to accomplish several key goals:

  1. Federal legalization of medical cannabis so patients can access treatment under the care of qualified clinicians.
  2. A standardized prescribing system that ensures patients receive consistent dosages, product types, and usage instructions.
  3. Insurance coverage so treatment is accessible to all patients, not just those who can afford to pay out of pocket.
  4. Ban on unsubstantiated claims to protect patients from predatory marketing.
  5. Interstate operability so patients can travel with their medicine without fear of losing access or facing discrimination.
  6. Ongoing scientific research is driven by a regulatory framework that incentivizes companies to conduct clinical trials.

These policies would not only protect patients but also advance cannabis science, strengthen the healthcare system, and put the U.S. on par with other countries, like Germany and Israel, that have integrated medical cannabis into national health programs.

The Social Justice Connection

For Tishler, the conversation about medical cannabis is inseparable from social justice. Healthcare outcomes in the U.S. are already poor compared to other developed nations, and they are significantly worse for communities of color. Without a national program, cannabis care will continue to follow the same inequitable patterns.

“Medical cannabis treatment must be part of the social justice discussion,” Tishler says.”Ending the war on drugs is not enough. Patients need safe, effective medicine and knowledgeable guidance to achieve the best outcomes.”

 

A Call to Action

The cannabis industry has an opportunity to rally around this cause, but time is running out. As recreational legalization spreads state by state, the risk grows that medical care will be sidelined, leaving patients to fend for themselves in a marketplace driven by revenue, not medicine.

“Congress is willfully overlooking the importance of proper medical cannabis treatment,” Tishler says. “We need a national system now, before the window closes.”

The Association of Cannabinoid Specialists has published a white paper outlining the essential elements of reform to ensure that patient care remains at the center of cannabis policy. Their message is clear: cannabis medicine is not simply a consumer product; it is a healthcare issue.

If the U.S. hopes to move beyond prohibition while protecting patients and fostering scientific innovation, a national medical cannabis system may be the industry’s most important cause yet.

 

 

 

 

 

 

 

 

 

https://www.cannaspecialists.org/a_federal_framework_of_regulation_for_medical_cannabis_use

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.

Wellness Watch

Why You Should Consider Medical-Grade Dry-Herb Vapes

By Pam Chmiel
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dry herb vaping    Switching from smoking to dry-herb vaping offers a safer way to consume while also preserving the delicate terpene and cannabinoid profiles that contribute to the entourage effect. Unlike combustion, which produces tar, carbon monoxide, and other toxic byproducts, vaporization heats cannabis at controlled temperatures to release active compounds with far fewer harmful emissions. While vaping is not risk-free, acute impairment, potential lung irritation, and the unknowns of long-term use remain, there is growing consensus that dry-herb vaporization represents a safer and more consistent method of consumption when paired with high-quality flower and rigorously tested devices.

Why Hardware Matters                                                                                                  Whether vaporizing concentrates or flower, the quality of the hardware is critical. Cheaply manufactured devices can pose significant health risks, ranging from heavy metal contamination to inconsistent heating elements that fail to maintain optimal temperatures. Recognizing the importance of safety, ASTM International (American Society for Testing and Materials) launched the D37 Vape Device Safety & Testing Initiative in 2024. The initiative is developing global standards around material safety, emissions testing, power regulation, and device disassembly, creating benchmarks to reduce consumer risk and ensure more reliable performance across devices that manufacturers should adhere to.

Compound Preservation and Temperature Control are Key                                            One of the biggest advantages of dry-herb vaping is compound preservation. Analytical studies have demonstrated that medical-grade vaporizers achieve exceptionally high decarboxylation efficiency for cannabinoids with vapor recovery rates ranging from 51–83% depending on the device and study conditions. This means that patients and consumers are not just avoiding harmful byproducts; they’re also gaining access to the therapeutic compounds they expect.

Temperature plays a central role in this. Research and industry guidelines suggest that the optimal vaporization range is between 180–230°C, just below the combustion threshold of 235°C. Within this window, active cannabinoids and terpenes are efficiently released without producing smoke. Different terpenes vaporize at different temperatures: myrcene around 166°C, limonene around 176°C, and linalool closer to 198°C, so patients and consumers can tailor both flavor and therapeutic effects by adjusting heat settings.

Devices with precision temperature controls, capable of maintaining a stable hot-air stream with minimal fluctuation, enable reproducible results, better flavor, and a reliable vapor cloud. For patients, this translates into a more predictable therapeutic experience; for recreational consumers, it enhances taste and enjoyment.

Reduction of Harmful Toxins                                                                                              The contrast between smoking and vaporization is stark. Analytical data show that the vapor produced by a medical-grade dry-herb device can be composed of up to 95% cannabinoids with minimal toxic byproducts. In comparison, combustion produces more than 100 additional chemicals, many of them carcinogenic or otherwise harmful to respiratory health.

For operators and healthcare providers, this distinction highlights the potential of vaporization as a harm-reduction tool. The reduction in carbon monoxide, tar, and irritants makes dry-herb vaping a cleaner alternative that aligns with both patient safety and public health objectives.

Reproducibility and Dosage Control                                                                       Consistency is essential in medical and clinical contexts. Temperature-controlled vaporizers can deliver stable, reproducible doses of cannabinoids, which is a critical advantage for patients who require predictable symptom relief. Clinical researchers also prefer vaporizers over smoking in trials because they ensure consistent cannabinoid delivery, making study outcomes more reliable.

In addition to dosage stability, these devices reduce airway irritation by cooling the vapor before inhalation. This combination of precision and patient comfort has positioned dry-herb vaporizers as valuable tools in both research and treatment settings, offering a reliable way to study cannabis pharmacology while ensuring consistent exposure levels.

Limitations and Safety Concerns                                                                                  Despite the advantages, it’s important to recognize limitations and potential risks.

  • Microbial Bioburden: Research indicates that vaporizing cannabis flower at standard temperatures (around 190°C) does not significantly reduce microbial contamination present on the plant material. For immunocompromised patients, this underscores the importance of sourcing flower that have undergone rigorous quality testing and meet pharmaceutical-grade standards.
  • Elemental Impurities: Cannabis naturally absorbs trace amounts of heavy metals from soil, but recent FDA-funded research found that using a dry-herb vaporizer does not significantly transfer those impurities into inhaled vapor. Even concerning elements such as lead, arsenic, cadmium, and mercury were detected at levels far below safety thresholds, reinforcing that vaporization is a much cleaner option than smoking.
  • Pesticide Residues: Many pesticides are heat-stable, meaning they can survive vaporization temperatures. This makes proper cultivation and third-party testing essential to ensuring that inhaled vapor is free from harmful residues.

In short, while device technology greatly mitigates risks associated with inhalation, the quality and purity of the raw cannabis remain equally critical to consumer safety.

Device Reputation and Regulatory Acceptance                                                        Medical-grade dry-herb vaporizers are required to meet GMP (Good Manufacturing Practice) certification. These devices have been widely adopted in clinical trials and medical cannabis programs across the globe, offering regulators and researchers a trusted platform for studying cannabis vaporization.

Among them, the Storz & Bickel Volcano has become one of the most widely recognized models, frequently used in laboratory settings to deliver reproducible cannabinoid vapor while minimizing harmful byproducts. First launched in 2000, the Volcano remains a gold standard and was among the first devices approved for distribution in regulated medical markets, such as Germany and Israel. More recreational and portable-friendly devices, such as the Mighty, Venty, and most recently the Veazy, have since followed, further expanding medical-grade options for consumers, patients, and researchers.

Key Criteria for Medical-Grade Dry-Herb Vaportizers                                                  Not all vaporizers are created equal. Medical-grade devices are manufactured to stricter standards than consumer-grade products, with regulations that ensure safety, consistency, and compliance with relevant laws and regulations.

  • Certified Quality Systems: Medical-grade vaporizers are manufactured to ISO 13485 certification, a quality management system specifically designed for medical devices. This ensures every stage, from design and materials to production and final testing, meets rigorous standards.
  • Regulatory Compliance: In Europe, these devices must comply with the EU’s Medical Device Directive and related safety standards, placing them under the same category of oversight as other medical devices.
  • Precision Heating: Controlled heating technology keeps temperatures in the ideal vaporization range. This allows cannabinoids and terpenes to be released effectively without crossing into combustion, ensuring consistent dosing and minimizing the formation of harmful byproducts.
  • Material Safety: Only medical-grade, inert materials, such as stainless steel, ceramics, or specialized plastics, are used in components that come into contact with cannabis or vapor. This reduces the risk of contamination from metals or chemical leachates.
  • Controlled Production Environments: Devices are typically assembled in cleanrooms or under Good Manufacturing Practice (GMP) protocols to prevent contamination and ensure product purity.
  • Battery and Electrical Safety: Portable models must meet strict safety standards for lithium-ion batteries, with safeguards against overheating, short circuits, and malfunctions.

These manufacturing criteria set medical-grade vaporizers, like the Storz and Bickel brand, apart in both clinical and commercial contexts. For patients, they provide peace of mind. For regulators, they demonstrate compliance. For operators, this highlights the level of quality assurance that may become the benchmark as cannabis markets continue to professionalize.

The Takeaway For Industry Stakeholders                                                                            As consumers become more educated about the value of preserving cannabinoids and terpenes, vaporizers are well-positioned to become the preferred method of inhalation when smoking remains the chosen form of consumption.

As regulatory standards evolve and clinical research expands, medical-grade dry-herb vaporizers will continue to demonstrate their value, not just as consumer products, but as essential tools for harm reduction, patient care, and scientific study. For brands, aligning with this higher standard of creating medical-grade products is not only beneficial for patients and consumers but also crucial for setting safe industry standards.

Cannabis in Texas: A Look Ahead to Legalization and Beyond

By Abraham Finberg, Rachel Wright, Simon Menkes
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A Uniquely Texas Approach to Cannabis

The last few decades have seen the United States move forward state-by-state with the legalization of cannabis. Every state is charting its own unique path, and nowhere is this truer than with the state of Texas.

The Lone Star State has made its way from being staunchly anti-cannabis to expressing its own blend of temperance and careful action, combined with a medical cannabis program that’s expanding.

Any predictions regarding the future of cannabis in Texas must take into consideration both the state’s past and its values. In the end, it’s clear that Texas will embrace cannabis in its own individual way and at its own pace, but with a timeframe that appears to be arriving sooner rather than later.

The Debate Continues

108 years after Texas first banned cannabis and the debate continues. Even though Texas has a medical cannabis program, cannabis is still illegal in the state, with possession of less than two ounces a misdemeanor. Possession of more than four ounces is a felony punishable by a $10,000 fine and from 2-99 years in jail.

Texas’s 2015 Compassionate Use Act created the state’s medicinal cannabis program, which now makes treatment available only in the form of low-THC oil of a maximum strength of 1%, and only to a small list of serious conditions: epilepsy, terminal cancer, autism, multiple sclerosis, amyotrophic lateral sclerosis (ALS), seizure disorders, incurable neurological disorders such as Alzheimer’s, Parkinson’s, Huntington’s Disease and PTSD.

Support for a Stronger Medicinal Cannabis Program Comes from Prominent Politicians

Texas Department of Agriculture Commissioner Sid Miller, a leader in Texas politics and one of the architects of Texas’s burgeoning hemp industry, has encouraged Texas legislators to create a more complete medical cannabis program.

Texas Department of Agriculture Commissioner Sid Miller

“I am for medical use,” Miller said in an August 2023 interview. “We have so much good science now. And we know what diseases it can treat, yet our legislature picks winners [and] losers. If you’ve got this disease, you can get treated, but if you’ve got this disease and cannabis will help you, you can’t get treated. We need to let the doctor-patient relationship make those medical decisions and not some bureaucrat or some politician … I’m not a supporter of recreational marijuana, but if someone has a condition that this chemical will help, they should be able to use it.”

Texas Representative Joe Moody from El Paso has worked for many years to promote adult-use cannabis. He recently co-authored two pro-cannabis bills, HB 1805, which would have expanded covered medical conditions and defined a per-doze THC limit instead of a percentage limit on cannabis products, and HB 218, which would have decriminalized cannabis.

Although both bills passed the House of Representatives, they were stopped in the Senate. The next session of the state legislature, which happens every two years, won’t begin until January 2025, so that is the earliest any change in cannabis statutes could take place.

The Future of Medicinal Cannabis

There are currently only three dispensaries in Texas. They appear to be servicing the state’s 268,000 square miles through a series of weekly drop-offs to satellite “partner locations,” which are open an average of only two days per week. This is not exactly a corner-CVS type of arrangement, and the need for new dispensaries for the state’s 61,000 registered patients is high.

The Texas Department of Public Safety took applications for new medical dispensary licenses between January and April 2023. Tony Gallo, managing partner of Sapphire Risk Advisory Group, which helped twelve licensees prepare their applications during this round, anticipates around ten new dispensaries being approved.

All licensees must be vertically integrated – product must go from seed-to-sale under one license – and each applicant paid $7,356 to apply. If approved, the applicants will owe another $488,520.00 for a two-year period.

Many knowledgeable Texans, including Agriculture Commissioner Sid Miller, predict a fully-functioning medicinal cannabis market is just a few years away. “If you can get it to the floor, probably 70% or 80% of the legislative body will vote in favor of it because we have such good science on it. [Originally] we thought, ‘Well, that’ll lead to recreational use or more drug use,’ but it’s not. It’s a plant derivative. Medical marijuana is not nearly as addictive as some of the prescription drugs we use now.”

The Push is On for Adult-Use

Representative Joe Moody believes that adult-use is not too far away in Texas’s future either, and that the way to speed its arrival is through education. He recently sponsored HB 3652, the Texas Regulation & Taxation of Cannabis Act, in order to start a dialogue on what a retail cannabis market will look like in Texas.

Texas Representative Joe Moody

On April 26, 2023, Moody and his bill received a public hearing in the House Committee for Licensing and Administrative Procedures in which many points about setting up a retail market in Texas were discussed. A 10% cannabis tax was proposed by Moody, to be split evenly between the state and local government. Licenses would be required for those growing, selling, transporting or testing cannabis, although individuals would be allowed to grow or possess it in small amounts for personal use. Legal sale and consumption would be limited to adults 21 years of age and older, like alcohol. And of course, cannabis possession would be decriminalized.

How Strong is the Market Potential for Cannabis?

One indication of how strong even a fully-open medical cannabis market might be in Texas came during Moody’s hearing from the testimony of Estella Castro. Castro owns two medical dispensaries in Oklahoma just across the state line from Texas and suspects most her buyers are from Texas. “They have a Texas plate and they come in and buy $500 to $600 worth of product,” she said. Her two shops generated $158,000 in taxes to Oklahoma, most of which she believes should have gone to Texas.

New Mexico recently legalized adult-use cannabis, and the small towns along the Texas-New Mexico border are seeing a lot of traffic from Texas. In the first week of adult-use sales, the New Mexico did adult-use sales totaling $6 million. Of those sales, $1.5 million came from dispensaries in 5 small border towns.

Florida and California Suggest the Scope of a Mature Cannabis Market in Texas

The potential for a fully developed medical cannabis market can be gleaned by studying the next smaller state, Florida, which has an open, mature, medical cannabis market. Florida, with 20 million people, is about two-thirds the size of Texas, which has 30 million inhabitants. Right now, Florida boasts 700,000 cannabis patients whereas Texas only has 61,000. Simple math suggests a fully open, mature, medical cannabis market in Texas could see over a million patients gain relief.

California is the nation’s most populous state with 39 million inhabitants, and its cannabis revenue gives some perspective as to the size of a Texas adult-use market. 2024 estimates of California’s cannabis revenue suggest the Golden State will see $7.2 billion legal cannabis sales while the illegal market will generate another $6.4 billion for a total of $13.6 billion. With a reduction for Texas’s smaller size, these numbers suggest a fully-mature Texas adult-use cannabis market could generate close to $10 billion in annual revenue.

Large adult-use states like California and New York are notorious for having an illicit market that threatens to derail their legal, tax-paying cannabis license holders. Texas’s strong business-friendly focus should help deter such an illicit marketplace from gaining too significant a foothold.

The Back-Door Cannabis Industry

Meanwhile, an extensive “back door” cannabis industry is in full swing in Texas. CBD shops now sell delta-9 (fully psychoactive) THC/CBD gummies and tinctures made from the hemp plant, which is the low THC-version of the cannabis plant. These THC/CBD products adhere to the 0.3% definition of hemp as required by the federal 2018 Farm Bill and are legal and available for over-the-counter or online purchase in Texas’s CBD stores.

Gummies, tinctures and other products made form them hemp plant

Current estimates are that there are over 5,000 hemp, CBD and cannabinoid retailers, manufacturers and distributors in Texas that employ more than 50,000 workers and generate more than $8 billion in annual revenue. With these numbers, the 1,100+ licensed Texas hemp growers are sitting well where they are and are poised to take advantage of a legal adult-use market if and when Texas decides it is ready to go down that path.

Next Steps for Texas’s Cannabis Market

People familiar with Texas’s cannabis market believe that adult-use is a ways down the road for the Lone Star State, and that the near-term focus needs to be on decriminalization and achieving an unincumbered medical cannabis system. Tony Gallo of Sapphire Risk Advisory Group advises the Texas cannabis community to concentrate on “increasing what conditions are allowed for medicinal use” and “increasing what areas of the state it’s allowed to be sold.”

There is a groundswell of public support for decriminalizing cannabis as well as for allowing adult-use. A December 2022 poll showed 55% of Texans support legalizing at least small amounts of cannabis for recreational purposes, and another 28% said it should be legal for medicinal purposes.

A February 2023 poll by the University of Houston found that 82% of Texans support the Legislature passing a bill that would allow people to use marijuana for a wide range of medical purposes with a prescription. The belief that cannabis is a “gateway drug” that would make people more likely to use other illegal drugs is losing traction as well – 70% said it would make people less likely to do so or would have no impact.

Final Thoughts

The demand for cannabis in the Lone Star State is strong. With the likelihood of a fully-functioning medical cannabis market coming soon, and the possibility of decriminalization not too far behind, it’s clear that the future of cannabis is bright in Texas.

While the legalities around adult-use will take longer to work out, and the place of hallucinogenic hemp in the mix needs to be examined and clarified, one fact is certain. The path forward that Texas cannabis takes will certainly be a unique one, as unique and as individual as the Texan people themselves.

Cannabis Lab Testing Problems Continue Nationwide

By Cannabis Industry Journal Staff
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In Maine, a laboratory released a study they conducted, finding a 17% failure rate of dangerous pesticides in cannabis samples tested. The state requires testing for adult use cannabis, but not for medical cannabis. Just under 4% of adult use samples failed a pesticide screening, while over 20% of all medical samples they tested failed the same screening. Nova Analytic Labs conducted the study and found piperonyl butoxide, bifenthrin, spinosad, imidacloprid and pyrethrins in both adult use and medical cannabis samples.

labsphotoAlso in the Northeast, a NY Cannabis Insider investigation found labs breaking rules for reporting pesticides and other contaminants as well as companies misreporting numbers and selling cannabis that has failed tests. New York only allows outdoor cultivation to encourage environmental sustainability, but some say that rule is what is behind high microbial test failure rates. To ease the burden, New York simply removed mandatory microbial testing.

Now, Oregon is doing the same: removing microbial testing burdens because too many businesses are failing them. Back in March of this year, Oregon started to require tests for aspergillus contamination, but a legal challenge halted that rule in late August and state regulators complied, doing away with the testing requirement for now. Stakeholders in many cannabis markets, including New York and Oregon, still debate just how much of a public health risk microbial contamination in cannabis truly is.

Meanwhile in California, regulators have sent warning letters to labs threatening stiff penalties if inaccurate test results are found. While these warning letters highlight THC potency inflation and laboratory shopping, a rising concern in markets across the country, they also mention falsifying scientific data, which has been known to occur in pesticide testing results as well.

The common theme across these markets is lab testing policy at the state level and an inability of an entire industry to come to any agreement. In lieu of any federal guidelines on a national level, disjointed state policies and preventable lab testing problems like these continue.

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.