Tag Archives: Testing

By Pam Chmiel

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.

November 4, 2025

The Shift Toward Stability Testing for Cannabis Products

By Liz Cornish

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Cannabis products are increasingly held to the same standards as food and pharmaceuticals, and that means verifying how their potency and composition change over time. Cannabis stability testing provides the data needed to establish reliable shelf life, confirm product consistency, and guide formulation optimization for improved stability and performance.

Cannabinoids and terpenes are complex, naturally derived compounds that react to light, heat, oxygen, and humidity. Even slight variations in these factors can alter potency or flavor. By conducting cannabis shelf life studies, manufacturers can determine how long a product maintains its intended properties under defined storage conditions.

Why Cannabis Stability Testing Is Necessary

Unlike synthetic pharmaceuticals, cannabis-based formulations are highly sensitive to environmental conditions. During processing, exposure to air or high temperatures can cause degradation of cannabinoids and oxidation of terpenes. Packaging materials also play a role—improper barriers can accelerate loss of aroma and potency.

To quantify these effects, samples are stored under controlled conditions such as:

Long-term studies: 25°C ± 2°C / 60% RH ± 5% RH

Accelerated studies: 40°C ± 2°C / 75% RH ± 5% RH

Products are tested at specific intervals for changes in potency, moisture, and appearance. The results support expiration dating, regulatory compliance, and product reliability across batches. Over time, stability datasets also reveal how formulation or packaging changes affect performance, helping manufacturers continually refine production methods.

Temperature and Storage: The Role of Cold Chain

Temperature control directly affects cannabinoid and terpene integrity. Fluctuating conditions during storage or transport can cause emulsion separation, texture changes, or reduced potency.

For high-value products, a cold supply chain helps maintain consistent quality. Refrigerated or temperature-monitored storage slows degradation, stabilizes emulsions, and preserves the sensory characteristics that distinguish premium formulations.

Although cold chain infrastructure can be costly, it is becoming a defining factor in cannabis quality assurance as brands compete on consistency and shelf stability. Stability study data can guide cold chain validation—determining the temperature range at which a product remains within specification. Those findings also support labeling statements such as “store below 25°C” or “refrigerate after opening,” allowing producers to base handling instructions on verified evidence rather than assumptions.

Terpene Testing and Product Stability

Terpenes are among the most volatile compounds in cannabis and degrade faster than cannabinoids. Their loss can indicate declining freshness long before measurable changes in potency occur.

Despite their importance, terpene data are often missing from Certificates of Analysis (COAs). The omission isn’t usually due to a lack of interest, but rather to the complexity and cost of additional testing.

Adding Terpene Profiling to Cannabis Potency Testing

Integrating terpene profiling into cannabis potency testing programs offers deeper insight into product quality, aroma stability, and freshness.
However, accurate analysis requires:

Advanced analytical instrumentation such as GC-MS or GC-FID

Specialized calibration standards for quantifying individual terpenes

Consistent testing intervals to track degradation patterns

Interpreting Terpene Stability Data

Testing terpene levels at regular intervals—monthly for accelerated studies and quarterly for long-term studies—reveals how quickly compounds evaporate or oxidize. Changes in terpene ratios (for example, limonene relative to myrcene) can identify which compounds drive shifts in aroma or flavor and signal the onset of degradation. These findings inform packaging design, storage recommendations, and shelf-life targets across product lines.

Toward Standardized Terpene Stability Metrics

As analytical capabilities advance, terpene stability metrics are expected to become part of routine quality control. Standardized testing will promote transparency, consistency, and product differentiation as consumers become more discerning about formulation and freshness.

Formulation Optimization and Shelf Life Extension

Stability data often reveal opportunities for formulation optimization—adjusting the balance of active ingredients, excipients, or stabilizers to enhance product longevity.

Factors influencing cannabis product stability include:

Excipient selection: Emulsifiers, antioxidants, and carrier oils can affect degradation rates.

Packaging materials: Glass, plastic, and multilayer films offer varying levels of protection from oxygen and light.

Moisture control: Desiccants and humidity-resistant containers can prevent microbial growth.

Refining formulations based on empirical data extends shelf life, minimizes waste, and supports consistent consumer experiences across product lines. Effective formulation optimization bridges product development and regulatory compliance by ensuring each new formulation undergoes verification before scaling for the market.

Designing a Reliable Cannabis Stability Program

Effective cannabis stability testing starts with asking the right questions:

Which environmental factors most affect each formulation?

How should sampling intervals be defined?

What level of potency loss is acceptable for regulatory or label claims?

A comprehensive program typically includes:

Accelerated testing for early insight into degradation trends

Long-term studies that confirm real-world performance

Validated analytical methods, such as HPLC for cannabinoids and GC-MS for terpenes

Robust documentation of storage conditions, results, and analytical methods

Data trending across studies allows manufacturers to identify recurring patterns in potency loss or terpene volatility. Predictive models based on historical data can estimate shelf life for new formulations with similar matrices, reducing time-to-market. These programs should follow the guidelines in ICH Q1A(R2) and align with GMP and ISO/IEC 17025:2017 standards to ensure data integrity and reproducibility.

Connecting Stability Testing to Product Safety

As cannabinoids and terpenes degrade, they can form secondary compounds that alter efficacy or safety. Moisture fluctuations may also allow microbial growth, which presents additional health risks.

For infused products, ingredients such as fats, sugars, or botanical extracts are subject to oxidation or spoilage. Monitoring these variables through stability testing enables producers to identify early signs of degradation and take preventive measures, thereby protecting consumers and supporting regulatory compliance.

Long-term datasets also support post-market surveillance by providing reference points when investigating product complaints or performance discrepancies. This continuity between laboratory data and field results builds trust with regulators, retailers, and consumers alike.

The Future of Cannabis Stability Testing

The cannabis industry continues to evolve toward pharmaceutical-grade quality systems. Future advances in analytical equipment, automation, and data management will make cannabis stability testing faster and more precise.

The integration of stability studies, terpene profiling, and environmental monitoring will provide a comprehensive understanding of product performance over time. Manufacturers that invest in scientific validation and continuous improvement will be best positioned to meet both regulatory demands and consumer expectations.

October 20, 2025

The Industry Is Failing At Last Mile Cannabis Preservation

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Multiple scientific studies and lab results have provided compelling evidence that terpenes and volatile metabolites in cannabis rapidly degrade when exposed to light, oxygen, heat, and time, and therefore, reduce the entourage effect that depends on a specific balance of cannabinoids and terpenes. Because of this, what the product label promises is not what the consumer is getting.

The clock starts ticking at harvest, where terpenes start degrading at a rapid rate if not handled and stored correctly. Evaporation, oxidation, or structural change can alter both the composition and balance of compounds.

Fragile Aromas, Fading Effects: The Science of Terpene Loss

Terpenes, the aromatic compounds responsible for cannabis’s distinctive scent and effects, are highly sensitive to environmental stress. Studies show that these same conditions also degrade cannabinoids like THC, which converts to the less potent CBN over time. A 2021 study in the Journal of Cannabis Research found that flower stored at higher temperatures lost both THC and terpene content, while a 2024 Scientific Reports study revealed that UV light can degrade THC and CBD within days.

Each terpene reacts differently to stress. The lighter ones, like pinene and myrcene, start to fade at even modestly warm temperatures. Mid-weight terpenes such as limonene (that bright citrus note) and linalool (the floral lavender scent) hold on a bit longer but still break down when air or light gets in. Even the heavier, more stable compounds—like caryophyllene and humulene—eventually oxidize when storage conditions are poor. As those delicate aromas disappear, so does much of what makes each strain unique, subtly changing the flavor, scent, and effects of the flower.

Beverages Under Attack

Cannabis-infused beverages are particularly susceptible to potency loss if not properly stored. One primary cause is oxidation, where THC degrades into cannabinol (CBN), a compound with significantly less psychoactive effect. This transformation can occur rapidly in beverages due to the increased surface area of emulsified droplets and the presence of oxygen in the liquid. For instance, a study by Vertosa demonstrated that exposure to light and oxygen can lead to a potency loss of up to 8 percent over 12 weeks in specific formulations.

Additionally, physical interactions between the beverage’s emulsion and packaging materials can exacerbate potency loss. Hydrophobic emulsion droplets may adhere to hydrophobic surfaces, such as the interior linings of aluminum cans, leading to a reduction in cannabinoid content over time. To mitigate these issues, it’s best to use antioxidant-rich formulations, select appropriate packaging materials, and maintain proper storage conditions to maintain the efficacy of cannabis-infused beverages.

This is why information on a certificate of analysis can differ dramatically from what a consumer ultimately experiences in the end product.

When product degradation occurs, your label no longer accurately represents the contents of the product, and now the consumer is not receiving what they were promised. The danger also here is in dosing; if THC turns into CBN and loses potency because of degradation, but the label says 10mg of THC, the customer will not have an accurate baseline for dosing.

Improper storage without temperature control can lead to microbes growing in your product, so moisture content and water activity will play a big role in sabotaging shelf stability.

Degradation in Concentrates and Formulated Products

Concentrates, vape oils, and infused products are also vulnerable, if not more so, to degradation. No matter the format, cannabinoids and terpenes are delicate molecules that break down under unfriendly environmental conditions. In fact, research shows that these environmental factors can change the very chemistry of the extract, reducing potency and altering the product’s intended effects.

According to SC Labs, which regularly tests and studies terpene stability, even “sealed” vape cartridges and concentrate jars can experience terpene evaporation and oxidation when exposed to warm or brightly lit environments. Over time, this not only dulls the aroma and flavor but can also create new by-products as terpenes and cannabinoids oxidize. Monoterpenes, the lighter, more volatile compounds that give cannabis its bright, complex aroma, are especially quick to disappear, while heavier sesquiterpenes linger longer but still degrade without proper storage.

A review by Broughton and colleagues (2023) on cannabinoid stability found that THC and CBD are highly unstable under poor conditions, and their breakdown accelerates in liquid or semi-liquid formats like vape oils and emulsions. Another study published in Chemical Research in Toxicology found that high temperatures used in dabbing or vaping can produce degradation by-products, including isoprene and benzene derivatives, especially when terpene concentrations are high. Even during extraction, terpene loss can occur; the transition from flower to concentrate often strips away the lighter aromatics, leaving a narrower and chemically altered profile.

All of this means that the degradation “clock” starts much earlier than most realize, beginning at harvest, accelerating through packaging and transport, and continuing on the dispensary shelf. Proper temperature control, opaque airtight containers, and low-oxygen environments are needed to maintain chemical integrity and preserve the original profile that the product label promises.

Packaging and Storage Impact: Terpene and THC Stability
Terpene and cannabinoid degradation in cannabis products is heavily influenced by packaging and storage conditions. The material and closure system of the packaging are critical for preservation. Semi-permeable plastics or non-airtight closures can allow water vapor and oxygen to penetrate, accelerating product degradation. Packaging specifications, such as water vapor and oxygen transmission rates, directly affect shelf life; cheaper options with higher transmission rates can drastically reduce product quality. Improper handling—leaving packages open, exposing them to heat, or subjecting them to light—can further degrade THC and terpenes, making all cannabis formats, from flower to edibles to concentrates, vulnerable to potency loss.

Retailers play an extremely important role in the preservation process. How cannabis is stored, moved, and displayed in the store can either protect or accelerate product degradation. One of the biggest offenders is the widely used deli-style showcase for selling cannabis flower, where buds are exposed to light and frequent handling, dramatically increasing the risk of terpene and THC loss. Even the most carefully cultivated and processed products can lose stability if retailers fail to maintain proper temperature, light protection, and airtight handling during storage, stocking, and transfer.

The bottom line: Protecting and preserving cannabis means keeping the supply chain cool, airtight, and out of the light, from processing all the way to the retail shelf, where it might impact the stability of your product and a consumer’s experience.

September 25, 2023

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.

Also 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.

September 12, 2023

The CBD Regulatory Environment in Europe: Part 4

By Shelley Stark

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

Where is the future of CBD heading?

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

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

What this means for the CBD industry

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

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

So, what are we left with?

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

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

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

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

How the “EIHA projects GmbH” Partnership Works

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

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

September 6, 2023

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.

The 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”.

If 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?

September 5, 2023

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.

August 29, 2023

Data-Driven Decision Making: Mastering Methodologies for Cannabis Market Research

By Lara Fordis

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In any industry that is labeled as the “Wild West,” the ability to discern your target market, collect accurate data and strategically drive success has become paramount. With factors such as invisible shoppers, anyone who is a customer of a brand or dispensary and does not personally purchase what they consume, it’s critical to understand how and where the data an organization is using to make decisions is sourced. Effective market research is the cornerstone upon which cannabis brands can build their trajectory to growth, armed with a diverse array of methodologies designed to provide insightful data-driven insights. Through leveraging the power of dependable data, organizations can navigate the intricacies of the cannabis industry across a wide variety of markets, develop solutions that address actual pain points and position themselves as leaders in their niche.

Not to mention, in an industry where competition is fierce and resources have become increasingly scarce, market research emerges as the North Star guiding businesses along their decision-making path. The era of relying on intuition and gut feelings alone is behind us. As this industry matures, making decisions based on inadequate syndicated data has proven detrimental. This is where robust market research steps in, instilling confidence in decision-makers by offering comprehensive and intelligent data for well-informed and defensible choices. Market research naturally falls into two overarching categories: qualitative and quantitative methodologies. Within these categories, various research approaches can be employed to collect actionable insights across the industry.

Your research can hone in on consumers’ preferences, perceptions, motivations and pain points.

Qualitative research delves deep into the intricacies of human behavior, motivations and preferences. Techniques like in-depth interviews and focus groups—whether conducted virtually or in person—unearth nuanced insights that transcend mere numerical data. This type of research is particularly invaluable for discerning the human side of B2B interactions within the cannabis industry.

On the other hand, quantitative research focuses on the collection and analysis of numerical data. Through surveys, questionnaires and statistical analysis, companies can glean valuable insights into demographics, preferences and market trends. This data can be powerfully visualized through charts, tables and infographics, providing a clear picture of the market landscape.

A wide spectrum of methodologies can be put in place to garner actionable insights across various aspects:

Precision Product Testing: This methodology empowers businesses to amass authentic feedback regarding product quality, user experience and overall satisfaction. By employing a hybrid approach of qualitative and quantitative methods, companies can refine and develop their offerings, ensuring alignment with the expectations of customers. This approach ensures not only a product’s efficacy, but also its appeal in the context of the consumer’s interaction with the product.

In-Home Usage Tests (IHUTs): IHUTs involve providing cannabis products to customers for testing within their operational or natural environments. Often conducted as “diary studies” over a designated time frame, IHUTs provide invaluable insights into aspects like usability, practicality and long-term effects. For instance, conducting an IHUT study on cannabis-infused products designed to aid sleep can assess factors like taste, texture and efficacy, thereby tailoring products to meet specific needs.

Hands-On Collaboration Sessions: Site-based, central location or mobile product testing enables real-time observation of product trials, enabling an immediate evaluation of sensory attributes and practical effects. These collaborative sessions can involve consumers directly engaging with the products, such as the scenario where consumers grind, roll and smoke their joints. This hands-on approach fosters deeper understanding and involvement, leading to more actionable insights for product enhancement.

Strategic Online Surveys: While online surveys are a well-established approach for capturing quantitative data from a broad consumer base, by designing targeted questionnaires tailored for specific market segments, companies can assess preferences, satisfaction levels, brand perceptions, and even purchasing intentions. These insights are invaluable in engineering products and services to specific consumer needs.

Focus groups can provide unique insights from many different perspectives.

Nuanced Focus Groups (FGs): Focus groups bring together a small group of individuals for facilitated discussions. These discussions can be conducted in a central location or even virtually, allowing geographically diverse participants to contribute insights. This approach is perfect for delving into perceptions, motivations and pain points. For instance, a focus group centered on testing prototypes for cannabis-related accessories can provide valuable input for refining products catering to specific needs.

Tailored In-Depth Interviews (IDIs): In-depth interviews, conducted either in person or virtually, provide an opportunity for one-on-one engagements. These interviews are particularly useful for exploring sensitive or controversial topics. For example, assessing the suitability of a prototype product for budtenders through in-depth interviews ensures candid feedback without the influence of group dynamics.

When embarking on cannabis market research, it’s imperative to navigate the intricate landscape of state regulations, especially when dealing with THC-based products. The cannabis industry operates within a patchwork of regulations, which vary from state to state, impacting the feasibility and logistics of product testing. Adhering to and understanding these regulations ensures compliant product testing, upholds participant safety and generates indispensable insights for product development.

At the end of the day, market research is actively emerging as the linchpin for the short- and long-term prosperity of our industry. Leveraging a blend of qualitative and quantitative approaches, such as surveys, focus groups and product testing, equips businesses with a profound understanding of preferences, motivations, and feedback. By embracing data-driven decision-making, cannabis companies position themselves at the vanguard of data-driven achievement, fortified with confidence and assurance.

August 17, 2023

Cannabis Vape Clarity: How to Help Consumers Shop Smart

By Vitaly Mekk

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Between 2020 and 2021, cannabis vape cartridges saw 25% year-over-year growth and all-in-one vapes grew a whopping 64% as a category during the same time period. Two years later, the vape space shows no signs of slowing down. There are more strain and extraction style options than ever, not to mention advances in consumption device technology.

That huge growth and diversification means consumers have a lot of choices and decisions to make. Cutting through that noise takes a little know-how, however. For a shopper who’s hesitant or overwhelmed when comparing multiple vape options, brands and budtenders can start with some informative, friendly education on how terpenes deserve their consideration.

Why are terpene profiles so important? Imagine going into a wine store and only getting a recommendation for red or white at different price points. You might end up with something delicious that fits your budget, but you’re missing out on deeper nuances that could enrich the experience. Consumers don’t know what they don’t know. But brands can do better.

Terpenes and the Entourage Effect for Vape Products

Instead of the indica-sativa-hybrid trichotomy, focus on the kind of experience you want to have. Understanding terpenes can go a long way to helping consumers find the strains that produce their favorite flavors, scents and sensations. Also key is understanding how terpenes work together in different strains—a phenomenon known as the entourage effect.

Figure 1: The chemical structure of cannabidiol. — The chemical structure of cannabidiol (CBD)

The entourage effect is often simplified to a collaboration between major and minor cannabinoids like CBD, CBG, CBN and THCV. But a true entourage effect isn’t just the combination of different cannabinoids. It’s the combination of terpenes, cannabinoids, flavonoids and other chemicals such as esters.

Why does this matter? The best cannabis represents the best of each of these elements, not simply terpenes and cannabinoids. As a result, the best cannabis vapes are the ones that can preserve all of these elements and produce an entourage effect.

This is where it’s worth pointing out the pros and cons of low-end cannabis vape products. Cheaper strain profiles typically feature fewer ingredients, including the terpenes, flavonoids and esters that contribute to a distinctive entourage effect. It’s not a matter of upselling: Sure, the price point might be attractive, but one-size-fits-all weed isn’t the experience most consumers are ultimately looking for.

How Extraction Methods Impact Cannabinoids, Terpenes and Other Chemical Compounds

The loss of crucial members of a cannabis cultivar’s entourage is one reason extraction methods make such a big difference. It can be hard for many consumers to cut through the jargon of resin vs. rosin, CO2 vs. butane, ice vs. heat and so forth. But one simple way to break it down is this: botanical, aka distillate, terpene profiles typically have 30-60 ingredients. Meanwhile, cannabis-derived terpene profiles will have over 100.

On the high end of that spectrum is rosin. Rosin products typically will have the largest number and range of flavor components. That’s one reason this category is so popular with cannabis connoisseurs who are particularly dialed into the flavors and effects of the products they consume, vape carts included.

Why Hardware Matters

There are two primary types of vape consumption hardware—510 thread batteries combined with various brands of vape carts, or all-in-one vape devices that come pre-loaded with proprietary concentrates. 510 thread systems were carried over from the nicotine vape space, and quickly became the industry standard because they allow consumers to try vape carts from many different brands with the same rechargeable battery. There is a caveat: Temperature variance can affect the consumer’s experience for the worse, particularly with sensitive terpene boiling points.

All-in-one devices have been gaining popularity because they’re so easy to use. They come pre-loaded with concentrates and don’t require any charging cables or changing device settings. All-in-ones are typically pre-set to a tight temperature range well-suited to their unique concentrate formula—all a consumer has to do is put the device to their lips and pull.

A quality piece of vape hardware won’t produce a burnt flavor or irritate the nose. The flavor will come through cleanly and the draw should be smooth and consistent. Indeed, the latter is another sign of quality vape hardware consumers should know to look for—the resistance of that pull can vary widely between brands. The concentrate should draw easily from the chamber. If it feels like sucking a hefty milkshake through a straw, both the hardware and the concentrates inside are probably not the highest quality.

Whichever terpene profile, strain, extraction technique or device category is on a customer’s mind, it’s critical for brands and budtenders to help guide consumers to their individual best-fit cannabis vape experience.

August 16, 2023

Soapbox

How Automation Drives Performance Advantage in Vaping

By Jacob Haugen

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The vaping technology market is a constantly evolving landscape, driven by the changing needs and preferences of consumers. Staying relevant in this competitive market requires companies to deliver exceptional vape experiences. Airo Brands has risen to the challenge since its inception, offering a diverse product portfolio that includes multiple vaporizers, pod blends and flavor combinations, all crafted with the latest technology, natural ingredients and intuitive features. Airo Brand’s commitment to delivering state-of-the-art products has resulted in impressive year-over-year growth and expansion into new markets.

Maintaining Consistency Across a Diverse Product Portfolio is Challenging

With three types of vaporizers and an array of cartridge oil formulations, Airo Brands needed a machine that could accommodate various products, streamline operations and produce consistent, high-quality devices to grow the business. But given Airo’s complex product offering, there were potential challenges with oil viscosity, temperature and dispense control, making it essential to find a reliable machine that could switch between products easily and streamline operations without compromising quality.

Finding an Easy-to-use Machine that Evolves with Time is Critical

Airo Brands recognized the significance of investing in a machine that could handle product variations, was simple to use and could accommodate their growing footprint. Airo Brands turned to Thompson Duke Industrial, an original equipment manufacturer that creates automated solutions for filling and capping vaporizer cartridges. Early on, our teams worked together to test and revise a custom septum-fill adapter to fit their needs. Airo was impressed with our availability to troubleshoot issues and come up with solutions in real-time. As the industry evolved, Airo Brands updated to a new cartridge design and switched to automated machines, a transition that our machinery and team handled with ease.

With Thompson Duke Industrial’s IZR machine, Airo Brands’ partners can fill a variety of different products, up to 30 variations. The machine’s straightforward design allows its operators to turn over and switch between various products in only a few minutes. The IZR’s simplicity and efficiency with setup, clean-up and maintenance make a huge difference in output. Airo now has the ability to train partners on how to fill their products with one machine versus several, which has also been a huge advantage.

Strong Partnerships Go a Long Way

As a result of our partnership, Airo Brands was able to implement automatic solutions that evolve with the industry to accommodate its diverse product portfolio and growing footprint. Erik Stewart, COO of Airo Brands said, “Thompson Duke Industrial’s machinery handles viscosity, temperature, and processing challenges with ease – and this is exactly what we need to create consistency and quality across our growing business.”

How to Choose the Right Equipment to Set Up Your Business for Success

When choosing cannabis equipment, it is important to work with a partner who is capable of developing innovative solutions that align with evolving industry needs. In the world of machinery, simplicity is key. Streamlined setup, uncomplicated maintenance processes and quick product turnover enhance operational agility. For companies managing multiple partners, the ability to train teams on a single machine is also an advantage.

As your business expands into new markets, consider your equipment’s adaptability, scalability, and capacity to deliver high-quality consistent products. Airo Brands is an example of how automation can drive unprecedented growth. Due in part to the introduction of efficiencies and speed through automation, they were able to expand their footprint across 17 states and increase their SKUs, rising from 38 to 180.