Tag Archives: Federal

CU Boulder, Charlotte’s Web Begin Sleep & Anxiety Studies

By Cannabis Industry Journal Staff
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Charlotte’s Web Holdings announced a new collaboration with the University of Colorado-Boulder and their Research and Education Addressing Cannabis and Health (REACH) Center. The University’s REACH Center will conduct a preclinical study on how hemp oil can influence sleep quality and anxiety.

Charlotte’s Web and University of Colorado-Boulder Collaborative Study to Assess CBD and CBN’s Potential to Support Improved Sleep (CNW Group/Charlotte’s Web Holdings, Inc.)

The study will use Charlotte’s Web hemp products, including their full spectrum hemp formulations containing CBN, CBD and less than 0.3% THC. Monika Fleshner, PhD, Professor of Integrative Physiology and member of the Center for Neuroscience at the University of Colorado, will be the project lead and will conduct the study in her Stress Physiology Laboratory. “There is a great need for properly controlled experimental studies that are designed to test the potential neural and physiological impacts of hemp derived phytocannabinoids,” says Dr. Fleshner. “With support from CU REACH and Charlotte’s Web, our research will explore both the efficacy and mechanisms of how these substances can affect complex brain-mediated behavior, such as disturbed sleep.”

Tim Orr, senior vice president of Charlotte’s Web and president of its CW Labs division, is currently working on more than twelve scientific research studies with the company. “Charlotte’s Web is committed to advancing science on the benefits and safety of CBD and other hemp phytocannabinoids through rigorous scientific investigations such as this sleep and anxiety study,” says Orr. “We’re honored to team up with CU’s REACH Center to explore the potential impacts of full-spectrum hemp extract with CBD and CBN on anxiety and sleep quality.”

Long term, Charlotte’s Web expects this study will help build the foundation for future clinical studies to “better understand how specific ratios of cannabinoids and different delivery formats are effective at supporting improved sleep quality and instilling healthier sleep architecture in humans,” reads the press release.

Amazon Now Backs Federal Legalization

By Cannabis Industry Journal Staff
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Amazon’s Senior Vice President of worldwide operations, Dave Clark, wrote a blog post yesterday that is making headlines in the cannabis community. Clark’s blog announced a couple of major changes coming to the company’s operations.

Clark first touted changes to their “Time off Task” policy, a way to measure employee’s time spent logged in to company software. The changes basically boil down to averaging over a longer period of time to better gauge how employees spend their time.

Dave Clark, Senior Vice President of Worldwide Operations & Worldwide Consumer CEO

The second company policy change is why the blog post made headlines in the cannabis community. Clark says in the blog that Amazon will adjust its drug testing policy and no longer test for cannabis use in their drug screening program. “We will no longer include marijuana in our comprehensive drug screening program for any positions not regulated by the Department of Transportation, and will instead treat it the same as alcohol use,” says Clark.

The new drug testing policy change is big news for such a large and influential employer to make the shift in the United States, where surely other companies will follow. But even more influential is their backing of federal legalization. “And because we know that this issue is bigger than Amazon, our public policy team will be actively supporting The Marijuana Opportunity Reinvestment and Expungement Act of 2021 (MORE Act)—federal legislation that would legalize marijuana at the federal level, expunge criminal records, and invest in impacted communities,” says Clark. “We hope that other employers will join us, and that policymakers will act swiftly to pass this law.”

Given Amazon’s extremely large influence in American business and policy, the company backing federal legalization is sure to lead other large companies down a similar path. The show of support for the MORE Act represents the growing normalization of cannabis use and brings us another step closer to federal legalization.

The Importance of Smart Cannabis Packaging

By John Shearman
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Regardless of their size, all consumer package brands spend a significant amount of money and resources on packaging to attract consumers’ attention. We are all very visually oriented and gravitate to items that pique our interests. Cannabis brands are no exception when it comes to branding their products. Packaging plays a big part in carrying their brand forward and standing out on the dispensary shelves. When I was in Las Vegas at a CBD tradeshow in early 2020, I visited a dispensary, and it was beautiful. I remember commenting to a colleague that was with me how spectacular the product packaging was in the glass cases. One had unique artwork on each different product they offered, and it was indeed art. Yes, I did purchase this one that pulled me in.

The cannabis industry in the United States presents a challenge to brands because there is no overall federal guidance for packaging. Each state is controlling the cannabis legislation and, with it, the packaging guidelines. So multi-state operators (MSOs) have to manage each state as a separate entity and abide by the packaging regulations, which is not very efficient and adds a cost burden. As the industry matures and becomes federally legal across the country, packaging regulations will be easier to implement.

Louis Vuitton bags are one of the many goods that are commonly counterfeited
Image: UK Home Office, Flickr

Let’s take a look at counterfeit products across all product categories. There is a significant global problem with counterfeits, as articulated by the below statistics.

The total global trade in fakes is estimated at around $4.5 trillion. 

Fake luxury merchandise accounts for 60% to 70% of that amount, ahead of pharmaceuticals, entertainment products and representing perhaps a quarter of the estimated $1.2 trillion total trade in luxury goods.

Digital plays a big role in this and perhaps 40% of the sales in luxury fakes take place online.

Customs and Border Patrol confiscated $1.3 billion worth of counterfeit goods in the U.S. for Fiscal Year 2020. (The value of 2020’s seizures are actually down compared to the $1.5 billion worth of counterfeit goods seized by CBP in 2019).

Unfortunately, the figures above are concerning, and the cannabis industry will face the same counterfeit issues that will add to these stats in the future. What can be done to help fight the problem and alleviate the pain for cannabis brands? Smart technology.

The trend towards “smart technology” varies by sector, but the underlying concept involves building levels of technology systems designed to impede or limit the highly sophisticated counterfeiter from replicating or replacing products. These levels typically include a forensic level control on the product, digital systems to track the material and customer facing systems to articulate the underlying value to the consumer.

Building these levels of smart technology into cannabis-products and packaging allows consumers to authenticate real versus fake, and in the case often in cannabis, legal versus illegal. Molecular technology is one forensic level of control option that can be used as a unique identifier for product authentication. Each brand would get its unique identifier to apply to the raw materials that make up its product, such as oil or an isolate. Then a sample can be tested at the origin point and subsequent nodes in the supply chain using a remote testing device. All the digital data is captured in a secure cloud database for traceability and transparency to the end consumer, to show them the authenticity of the product they are consuming. The same molecular technology can be applied to the ink or varnish for packaging and labels. A great application to help combat counterfeits and product diversion across the globe.

Counterfeiters can create near duplicate versions of the original

Another engaging platform is called StrainSecure by TruTrace Technologies. Their SAAS platform allows cannabis manufacturers to track all their product batches and SKUs tied to a blockchain. It also facilitates the interaction between the manufacturer and third-party testing facilities to conduct product testing and reporting. The data is captured within the platform, and with easy access dashboard views, it provides the insights to authenticate products at any time.

A company out of Australia called Laava is producing a product called Smart Fingerprints. It’s the next evolution of QR codes. The Smart Fingerprints can be applied to each package, providing a unique identifier that consumers can read with a mobile phone application. The consumer is provided with information concerning the product’s authenticity and any additional information the brand wants to share with the user. Smart Fingerprints are a great example of customer engagement at the point of activity that is secure.

The above three solutions show the availability of advanced technologies the cannabis industry can implement on its packaging and products to ensure authentic and safe products are sold to consumers. It provides consumers with vital information and insights about products so they can make informed buying decisions. There is no one silver bullet solution that provides all the answers. As with every high value product, counterfeiters will work to create near duplicate versions of the original until it becomes unsustainable to do so. It will take a technology ecosystem to seamlessly connect and provide actuate and timely information between supply chain partners and ultimately the end consumer. As the US works to separate the legal from illegal production for both the adult use and medical supply of cannabis, the looming challenge will be on protecting and communicating authenticity, packaging will be the first step in this.

Growing the Seed of Sale: Integrating Security with Business Opportunity

By Ryan Schonfeld
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Anyone in the cannabis industry is well aware that theft of crops can economically devastate a grower. Security is critical, and thankfully, growers and dispensaries have many tools available to protect their investment. There is simply no excuse for not having a solid security posture to keep your business in compliance, from public-private partnerships to advanced security tools – in fact, it’s required in most jurisdictions.

In 2020, nationwide cannabis sales increased 67%, and support for legal marijuana reached an all-time high of 68%. New Frontier Data found that U.S. legal cannabis market is projected to double to $41.5 billion by 2025.

The industry’s advancement impacts numerous areas such as job and tax revenue creation and providing a wide variety of valuable opportunities. For cannabis facilities to keep up with the market expansion and experience success, they must face two significant challenges: achieving adequate security and efficient business operations. Though both can be seen as separate concerns, growers and producers must merge processes and solutions to tackle the issue as a whole.

Dispensaries are prime targets for burglary. Defending your storefront requires a comprehensive security plan

Along with rapid growth, dispensaries face traditional security risks, such as workplace violence and retail theft, while cybersecurity risks have also become more prevalent. These potential issues make it clear that the stakes are high, and as the potential impact on a business rises, the need for real-time, predictive response increases. Insider threats are another issue plaguing the industry when you look at the rate of theft, diversion and burglary that is attributable to employees.

The cannabis market is complex: it’s expanding rapidly, has to meet essential regulatory requirements and faces high-security risks. Therefore, security needs to be looked at holistically since it can be challenging to determine where a potential threat may originate.

With security top of mind, it is critical to move away from responsive behaviors and seek ways to manage security in a manner that gets ahead of threats, prevent them before they happen and respond to them in real-time. But does a grower or retailer have the time and expertise to manage all this while keeping an eye on how security affects the business?

Remote Security Operations

The ability to comply with government regulations and protect a valuable cannabis crop at all stages of its journey from seed to sale makes security systems a mission-critical asset for cannabis growers. Security operations centers create a safer and more productive environment and provide state-of-the-art tools to protect employees, retail locations and grow facilities. But some businesses in the cannabis market may not have the resources or space to have their centralized security operations, leading them to piece-meal security together or do the best with what they can afford at the time. Running these facilities can also be prohibitively expensive.

Security operations centers create a safer and more productive environment and provide state-of-the-art tools to protect employees, retail locations and grow facilities.

But new options take the process of security off the table. The business can focus on the growth of its core functions. Remote security operations services allow companies to take advantage of advanced security services typically only possible in larger enterprise environments. These services are offered on a subscription basis, delivered through the cloud, and are entirely customizable to detect risks unique to your business operations while saving each company significant expense.

Centralized security operations centers leverage intelligent tools, standard operating procedures and proven analytic methods to provide cannabis facilities with the information and guidance necessary to mitigate issues like retail or grow theft before they can have a significant impact.

The integrated, holistic response center staffed by experienced operators and security experts delivers a comprehensive security and regulatory compliance method. This approach is designed to provide complete data about what is happening across a cannabis business, from seed to sale, and how individual events can impact the company as a whole. As a result, stakeholders get the security intelligence they need, without the high overhead, personnel investments and complex daily management.

For those businesses in the cannabis market looking to supplement their security operations with other workforce but may not have the budget or infrastructure to do so, remote security operations services are something you should consider. With the experts handling all the heavy lifting, leaders can focus on growth. And, right now, in the cannabis industry, the sky is the limit in terms of opportunity.

The New Delta 8 THC Market: A Q&A with the Founders of DeltaVera

By Cannabis Industry Journal Staff
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Delta 8 THC (delta-8-tetrahydrocannabinol) sprung onto the scene late last year in a big way. While similar to the much more widely-known delta-9-tetrahydrocannabinol that produces a lot of the psychoactive effects associated with ingesting cannabis, delta 8 THC can be derived from hemp with less than 0.3% delta 9 THC. Given the legality of hemp-derived products following the 2018 Farm Bill, delta 8 THC can be produced in some states where delta 9 THC still remains illegal.

While delta 8 is considerably different in its psychoactive effects from its cousin, it does overlap in some ways. It can still produce some more manageable, less “heady” versions of delta 9’s effects like euphoria and relief found in the many medical applications of cannabis. DeltaVera, a company that launched less than six months ago, aims to share that more manageable THC experience with the masses.

The sharp rise of the delta 8 market means that DeltaVera is poised for growth. With distribution contracts inked, exciting partnerships in the works and a large surge in consumer demand, the founders of DeltaVera are at the ready to capitalize on this lesser-known molecule and bring it to the forefront of the nascent hemp industry. Starting out as a small family business, Sam and Craig Andrus launched DeltaVera with their third founder, PK Isacs.

We sat down with Sam Andrus and PK Isacs, two of the founders of DeltaVera, an award-winning brand, to ask them about their plans for expanding, how they became entrepreneurs and why they think delta 8 is the next big thing in cannabis.

Cannabis Industry Journal: Tell me about your company. How did you get started in the cannabis space?

Sam Andrus, cofounder of DeltaVera

Sam Andrus: I had an early start in the Delta 8 THC industry on the sales side. We knew we wanted to get into the market, but observed a number of aspects in the space that needed to be addressed: the most important being quality control, transparency and brand trust. With this as a backdrop we launched DeltaVera. Highly curated, approachable, transparent and value-oriented with a strong focus on reliability and trust. The DeltaVera family is made up of three operating managers and the sales team. We are three founders with complementary skill sets: Craig, who has domain expertise in finance, governance and startups, PK who has experience in business and marketing and my sales experience round out the management team.

We have yet to solicit outside capital and have funded ourselves internally as we create our brand and refine our product offering. That said, we are seeing numerous opportunities in strategic partnerships and expansion, which will require additional capital. And we are excited to start this expansion process.

CIJ: What makes the Delta 8 space so remarkable? Why are your SKUs primarily formulated with Delta 8?

Sam Andrus & PK Isacs: Delta 8 THC is an alternative/complement to delta 9 THC, CBD and other cannabinoids. Its status as non-federally scheduled and its less potent psychoactive effects make it appealing in its own right. Delta 8 THC can help with healthier sleep patterns and with pain management in a way that CBD can’t, without a strong “head high” that many of our customers like to avoid. Additionally, it’s shorter lived and doesn’t give you any negative residual effects, which makes it beneficial for people on tighter schedules. These factors make it easier for us to approach markets that are inaccessible to both delta 9 THC and CBD, such as older demographics. In a world where delta 9 is legal, there will still be a place for delta 8.

PK Isacs, cofounder of DeltaVera

While we are very proud of our suite of smokable products, we are currently focusing our efforts on edibles: our Delta Discs are our mainstay, though we are expanding our product line to include nano-emulsion products such as liquid shots and nano gummies. They strongly appeal to our target demographics; additionally, the edible market is growing very quickly in states that allow the sale of hemp-derived consumables.

CIJ: Continuing on the delta 8 front – right now it is considered a cannabinoid legal for interstate commerce, much like CBD, correct? Do you think that will change? 

Sam & PK: That is currently the case. Delta 8 THC is newer, and as such, it has even more ambiguity in regards to its legal future. But what’s most exciting (and our most challenging task right now), is informing consumers about the benefits of delta 8. We are one of a few companies solely focused on the consumption of delta 8, because of its similar benefits to delta 9 and CBD – our products are the perfect happy medium: a high with less psychoactive effects and all the health benefits of both, making it a desirable alternative to all consumers.

In addition, we are looking at some combinations of delta 8/CBDA, delta 8/CBN, delta 8/THCV and are very excited to begin test marketing these combinations. These proprietary blends of minor/major cannabinoids can cater to a niche target demographic as they can be curated to have very specific and unique effects when combined in the right quantities with the right delivery system. They will also be able to serve a larger customer base as these cannabinoids can all be derived from hemp.

CIJ: How do you think the FDA would regulate your product? Do you welcome federal oversight?

DeltaVera gummy products

Sam & PK: Regardless of whether or not we are regulated we are committed to a high level of transparency and trust. As noted in unregulated markets, like the supplement market, you don’t always know what you are getting in terms of purity and potency. We are changing that paradigm by adding unique QR codes to our sustainable containers which reference COAs [certificates of analyses] specific to the contents of the case. A lot of the space is naturally trying to avoid that kind of regulatory interference, but we are currently doing our best to self-regulate and make sure that our consumers are fully informed about what they’re receiving.

We will be the first to say that there aren’t as many laws governing delta 8 THC as there could be, and that’s why we’ve spent so much time and money on self-regulation. All of our products have very clear nutritional information in addition to test results down to one hundredth of one percent. As for what category these products should fall under: we have a wide range of products, and each one has its place under a different umbrella of regulation. We hope that the federal government will take advantage of the vast array of studies that have been conducted on delta 8 THC since it was first extracted in 1942 to step up to this product that is, in our experience, helping so many people.

CIJ: Tell me about how your business has grown so far.

Sam & PK: When we sell to a retailer, we try to provide them with as much material as possible on what delta 8 THC is and what differentiates DeltaVera’s products. Still, we’ve had some difficulty in places with limited delta 8 THC exposure. That being said, when someone tries our product, there is a high likelihood that they become a repeat customer (and they tell their friends). Given our newness to the market (Our brand launched in January 2021) initial indications are – we have a good rate of repeat orders, and we’ve heard the same from our brick-and-mortar partners.

The DeltaVera Delta Discs

Our distribution network has grown tremendously; we’ve taken a three-pronged approach to distribution: partnerships with like-minded companies in compatible spaces, an e-commerce market on our website, and a commission-based sales structure to reach brick-and-mortar establishments. To date, most of our distribution takes place in the latter two spaces, due to the added time and commitment involved in forming partnerships. As a company we are taking a more creative approach on how we present our product and alternative ways to consume it. We have some exciting collaborations in the works; follow us on social media to stay up to date with everything on the horizon. We are very enthusiastic about our partnerships however, with our first collaboration with WaxNax, a Denver-based company revolutionizing the cannabis dabbing experience, hitting the shelves this week.

CIJ: What is your marketing plan?

Sam & PK: We are working on building a social media presence. Natalie, who is leading the charge on social media, recommended we take an organic approach to build our base. We want to avoid falling into the “paid ad”, “spam” vibe as long as we can. We are currently focused on building a community through delta 8. Our mission is making DeltaVera a brand for all lifestyles, athletes, creatives, travelers or business professionals. We’re confident in our product, and have faith that it can speak for itself.

CIJ: How do you ensure quality in your products?

Sam & PK: Our products are of guaranteed quality with our licensed growers and manufacturers. We provide COAs, informing the retailer & consumer about each product, displaying full panel tests on cannabinoids and heavy metals. These preliminary and secondary lab tests ensure our product is below 0.3% delta 9 THC in all our products. Through third-party labs, we run full panel tests which pick up a variety of cannabinoids; for most of our products we focus on the level/purity of delta 8. Our products are screened for both contaminants and heavy metals.

All this information is housed conveniently on our website that can be reached through our QR codes.

CIJ: What are your plans to grow the business in the future? 

Sam & PK: We feel very confident in our three methods of distribution: partnerships, e-commerce and a commission-based sales structure. We’ve made tremendous ground on partnerships, and are very excited about numerous partnerships we have in the pipeline. We’ve reached out to some incredible groups in the CBD space, the THC space and a few groups that you wouldn’t normally associate with cannabinoids, but with whom we’ve workshopped some really creative ideas that we’re really looking forward to bringing to market.

Readers can use promo code “CIJ” to get 15% off their first order here

Support Grows for Federal Cannabis Legislation with the SAFE and CLAIM Acts

By Jay Virdi
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Things are about to change for cannabis and cannabis-related businesses, as landmark legislation to reform federal cannabis banking and insurance laws is just around the corner with the SAFE and CLAIM Acts now making their way through Congress.

The Secure and Fair Enforcement (SAFE) Banking Act, which already passed in the House, would allow financial institutions to do business with cannabis companies without facing federal penalties. There are high expectations the proposal will make its way through the Senate and onto President Biden’s desk.

The Clarifying Law Around Insurance of Marijuana (CLAIM) Act was introduced in Congress in March and is in the first stage of the legislative process. If it passed, it would allow insurance companies to service cannabis businesses without the threat of federal penalties.

For years, fear of sanctions kept banks and credit unions from working with the cannabis industry, forcing cannabis businesses to operate on a cash basis which made them targets of crime and created complications for financial regulators. This is a significant first step for cannabis businesses toward conducting more legitimate and safe operations.

The SAFE Banking Act: Providing a Legitimate Avenue to Banking and Loans

With 37 states and D.C. having taken action to legalize cannabis in some way, it is clear the federal cannabis regulatory model has shifted and the path forward for the SAFE Banking Act shows promise.

The bill creates a safe harbor for banks and credit unions to the extent they would not be liable or subject to federal forfeiture action for providing financial services to a cannabis-related business.More competition means greater capacity and lower premiums for all. 

The bill would prohibit a federal banking regulator from:

  • Recommending, incentivizing or encouraging a depository institution not to offer financial services to an account holder affiliated with a cannabis-related business or prohibit or otherwise discouraging a depository institution from offering services to such a business
  • Terminating or limiting the deposit insurance or share insurance of a depository institution solely because the institution provides services to a cannabis-related business
  • Taking any adverse or corrective supervisory action on a loan made to a person solely because the person either owns such a business or owns real estate or equipment leased to such a business. 

The CLAIM Act: Backing Cannabis Businesses with the Right Insurance Coverage

Should the CLAIM Act pass, it will protect insurance companies that provide coverage to a state-sanctioned and regulated cannabis business. It would also prohibit the federal government from terminating an insurance policy issued to a cannabis business and protect employees of an insurer from liability due to backing a cannabis-related business.

The CLAIM Act will be a boost for the insurance market and drive more underwriters to write cannabis policies. More competition means greater capacity and lower premiums for all. The act would also have a notable impact on currently hard-to-source policies like Cyber coverage, Directors & Officers (D&O) insurance, Errors & Omissions (E&O) and other management liability policies that have been extremely limited to cannabis businesses.

Cannabis Sales Still Growing Strong Globally 

The cannabis market is not slowing down in the United States or globally. Recent forecasts have U.S. sales reaching $28 billion in 2022.

As was the case in Canada where cannabis was made federally legal in 2018, there’s going to be a steep learning curve industry-wide for financial services and insurance vendors who don’t yet understand the risks and liabilities of cannabis operations, even if the SAFE and CLAIM Acts pass this year. And yet this is one giant step in the right direction toward the safe and equitable sales of cannabis country-wide.

ISO/IEC 17025 Accreditation Falls Short for Cannabis Testing Laboratories

By Kathleen May
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What is the role of the Quality Control (QC) Laboratory?

The Quality Control (QC) laboratory serves as one of the most critical functions in consumer product manufacturing. The QC laboratory has the final say on product release based on adherence to established product specifications. Specifications establish a set of criteria to which a product should conform to be considered acceptable for its intended use. Specifications are proposed, justified and approved as part of an overall strategy to ensure the quality, safety, and consistency of consumer products. Subsequently, the quality of consumer products is determined by design, development, Good Manufacturing Practice (GMP) controls, product and process validations, and the specifications applied throughout product development and manufacturing. These specifications are specifically the validated test methods and procedures and the established acceptance criteria for product release and throughout shelf life/stability studies.

The Code of Federal Regulations, 21 CFR Part 211, Good Manufacturing Practice for Finished Pharmaceuticals, provides the minimum requirements for the manufacture of safe products that are consumed by humans or animals. More specifically, 21 CFR Part 211: Subpart I-Laboratory Controls, outlines the requirements and expectations for the quality control laboratory and drug product testing. Additionally, 21 CFR Part 117, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food: Subpart B-Processes and Controls states that appropriate QC operations must be implemented to ensure food products are safe for consumption and food packing materials and components are safe and fit for purpose. Both food and drug products must be tested against established specifications to verify quality and safety, and laboratory operations must have the appropriate processes and procedures to support and defend testing results.

ISO/IEC 17025, General Requirements for the Competence of Testing and Calibration Laboratories is used to develop and implement laboratory management systems. Originally known as ISO/IEC Guide 25, first released in 1978, ISO/IEC 17025 was created with the belief that “third party certification systems [for laboratories] should, to the extent possible, be based on internationally agreed standards and procedures”7. National accreditation bodies are responsible for accrediting laboratories to ISO/IEC 17025. Accreditation bodies are responsible for assessing the quality system and technical aspects of a laboratory’s Quality Management System (QMS) to determine compliance to the requirements of ISO/IEC 17025. ISO/IEC 17025 accreditation is pursued by many laboratories as a way to set them apart from competitors. In some cannabis markets accreditation to the standard is mandatory.

The approach to ISO/IEC 17025 accreditation is typically summarizing the standard requirements through the use of a checklist. Documentation is requested and reviewed to determine if what is provided satisfies the item listed on the checklist, which correlate directly to the requirements of the standard. ISO/IEC 17025 covers the requirements for both testing and calibration laboratories. Due to the wide range of testing laboratories, the standard cannot and should not be overly specific on how a laboratory would meet defined requirements. The objective of any laboratory seeking accreditation is to demonstrate they have an established QMS. Equally as critical, for product testing laboratories in particular, is the objective to establish GxP, “good practices”, to ensure test methods and laboratory operations verify product safety and quality. ISO/IEC 17025 provides the baseline, but compliance to Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) and even Good Safety Practices (GSP) are essential for cannabis testing laboratories to be successful and demonstrate testing data is reliable and accurate.

Where ISO/IEC 17025 accreditation falls short

Adherence to ISO/IEC 17025, and subsequently receiving accreditation, is an excellent way to ensure laboratories have put forth the effort to establish a QMS. However, for product testing laboratories specifically there are a number of “gaps” within the standard and the accreditation process. Below are my “Top Five” that I believe have the greatest impact on a cannabis testing laboratory’s ability to maintain compliance and consistency, verify data integrity and robust testing methods, and ensure the safety of laboratory personnel.

Standard Operating Procedures (SOPs)

The understanding of what qualifies as a Standard Operating Procedure (SOP) is often misunderstood by cannabis operators. An SOP is a stand-alone set of step-by-step instructions which allow workers to consistently carry out routine operations, and documented training on SOPs confirms an employee’s comprehension of their job tasks. Although not required per the current version of the standard, many laboratories develop a Quality Manual (QM). A QM defines an organization’s Quality Policy, Quality Objectives, QMS, and the procedures which support the QMS. It is not an uncommon practice for cannabis laboratories to use the QM as the repository for their “procedures”. The intent of a QM is to be a high-level operations policy document. The QM is NOT a step-by-step procedure, or at least it shouldn’t be.

Test Method Transfer (TMT)

Some cannabis laboratories develop their own test methods, but a common practice in many cannabis laboratories is to purchase equipment from vendors that provide “validated” test methods. Laboratories purchase equipment, install equipment with pre-loaded methods and jump in to testing products. There is no formal verification (what is known as a Test Method Transfer (TMT)) by the laboratory to demonstrate the method validated by the vendor on the vendor’s equipment, with the vendor’s technicians, using the vendor’s standards and reagents, performs the same and generates “valid” results when the method is run on their own equipment, with their own technician(s), and using their own standards and reagents. When discrepancies or variances in results are identified (most likely the result of an inadequate TMT), changes to test methods may be made with no justification or data to support the change, and the subsequent method becomes the “validated” method used for final release testing. The standard requires the laboratory to utilize “validated” methods. Most laboratories can easily provide documentation to meet that requirement. However, there is no verification that the process of either validating in house methods or transferring methods from a vendor were developed using any standard guidance on test method validation to confirm the methods are accurate, precise, robust and repeatable. Subsequently, there is no requirement to define, document, and justify changes to test methods. These requirements are mentioned in ISO/IEC 17025, Step 7.2.2, Validation of Methods, but they are written as “Notes” and not as actual necessities for accreditation acceptance.

Change Control

The standard speaks to identifying “changes” in documents and authorizing changes made to software but the standard, and subsequently the accreditation criteria, is loose on the requirement of a Change Control process and procedure as part of the QMS. The laboratory is not offered any clear instruction of how to manage change control, including specific requirements for making changes to procedures and/or test methods, documented justification of those changes, and the identification of individuals authorized to approve those changes.

Out of Specification (OOS) results

The documentation and management of Out of Specification (OOS) testing results is perhaps one of the most critical liabilities witnessed for cannabis testing laboratories. The standard requires a procedure for “Nonconforming Work”. There is no mention of requiring a root cause investigation, no requirement to document actions, and most importantly there is no requirement to document a retesting plan, including justification for retesting. “Testing into compliance”, as this practice is commonly referred to, was ruled unacceptable by the FDA in the highly publicized 1993 court case United States vs. Barr Laboratories.

Laboratory Safety

FDAlogoSafe laboratory practices are not addressed at all in ISO/IEC 17025. A “Culture of Safety” (as defined by the Occupational Safety and Health Administration (OSHA)) is lacking in most cannabis laboratories. Policies and procedures should be established to define required Personal Protective Equipment (PPE), the safe handling of hazardous materials and spills, and a posted evacuation plan in the event of an emergency. Gas chromatography (GC) is a common test method utilized in an analytical testing laboratory. GC instrumentation requires the use of compressed gas which is commonly supplied in gas cylinders. Proper handling, operation and storage of gas cylinders must be defined. A Preventative Maintenance (PM) schedule should be established for eye wash stations, safety showers and fire extinguishers. Finally, Safety Data Sheets (SDSs) should be printed and maintained as reference for laboratory personnel.

ISO/IEC 17025 accreditation provides an added level of trust, respect and confidence in the eyes of regulators and consumers. However, the current process of accreditation misses the mark on the establishment of GxP, “good practices” into laboratory operations. Based on my experience, there has been some leniency given to cannabis testing laboratories seeking accreditation as they are “new” to standards implementation. In my opinion, this is doing cannabis testing laboratories a disservice and setting them up for failure on future accreditations and potential regulatory inspections. It is essential to provide cannabis testing laboratory owners and operators the proper guidance from the beginning and hold them up to the same rigor and scrutiny as other consumer product testing laboratories. Setting the precedence up front drives uniformity, compliance and standardization into an industry that desperately needs it.


References:

  1. 21 Code of Federal Regulations (CFR) Part 211- Good Manufacturing Practice for Finished Pharmaceuticals.
  2. 21 Code of Federal Regulations (CFR) Part 117;Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food: Subpart B-Processes and Controls.
  3. ICH Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients; Laboratory Controls.
  4. World Health Organization (WHO).
  5. International Building Code (IBC).
  6. International Fire Code (IFC).
  7. National Fire Protection Association (NFPA).
  8. Occupational Safety and Health Administration; Laboratories.
  9. ASTM D8244-21; Standard Guide for Analytical Operations Supporting the Cannabis/Hemp Industry.
  10. org; ISO/IEC 17025.

Defining Hemp: Classifications, Policies & Markets, Part 1

By Darwin Millard
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What is “hemp”?

The word “hemp” has many meanings. Historically the term has been used as the common name for the Cannabis sativa L. plant. Just like other plants, the cannabis plant has two names, a common name, hemp, and a scientific name, Cannabis sativa L. After the ratification of the UN Single Conventions on Narcotic Drugs and Psychotropic Substances, in 1961 and 1972 respectively, the term started to be used to distinguish between resin producing varieties of the cannabis plant and non-resin producing varieties of the cannabis plant. Nowadays the term is generally used to refer to cannabis plants with a delta-9-tetrahydrocannabinol (d9-THC), a controlled substance, content equal to or less than the maximum allowable limit defined by each marketplace.

Tetrahydrocannabinol (THC), just one of hundreds of cannabinoids found in cannabis.

In the United States and Canada, the limit is defined as 0.3% on a dry weight bases, and until November 2020, in the European Union, the limit was defined as 0.2%. After years of effort the “hemp” industry in Europe was successfully able to get the limit raised to 0.3% to be in line with the United States and Canada – creating the largest global trade region for hemp products. But there exist several marketplaces around the world where, either through the consequences of geographic location or more progressive regulations, the d9-THC content in the plant can be substantially higher than 0.3% and still considered “hemp” by the local authority.

To address these variances, ASTM International’s Technical Committee D37 on Cannabis has been working on a harmonized definition of hemp, or industrial hemp, depending on the authority having jurisdiction, through the efforts of its Subcommittee D37.07 on Industrial Hemp. The following is a proposed working definition:

hemp, n—a Cannabis sativa L. plant, or any part of that plant, in which the concentration of total delta-9 THC in the fruiting tops is equal to or less than the regulated maximum level as established by an authority having jurisdiction.

Discussion: The term “Industrial Hemp” is synonymous with “Hemp”.

Note: Total delta-9 THC is calculated as Δ⁹-tetrahydrocannabinol (delta-9 THC) + (0.877 x Δ⁹-tetrahydrocannabinolic acid).

This definition goes a long way to harmonize the various definitions of hemp from around the world, but it also defines “hemp” as a thing rather than as a classification for a type of cannabis plant or cannabis product. This is a concept rooted in the regulatory consequences of the UN Single Conventions, and one I strongly disagree with.

The definition also leaves the total d9-THC limit open-ended rather than establishing a specified limit. An issue I will address further in this series.

Can “hemp products” only come from “hemp plants”?

If you are an invested stakeholder in the traditional “hemp” marketplace, you would say, yes.

But are there such things as “hemp plants” or are there only cannabis plants that can be classified as “hemp”? (The definition for hemp clearly states that it is a cannabis plant…)

A field of hemp plants, (Cannabis sativa L.)

There is no distinction between the cannabinoids, seeds, and fibers derived from a cannabis plant that can be classified as “hemp” and those derived from a cannabis plant that cannot. The only difference is the word: “cannabis,” and the slew of negative connotations that come along with it. (Negative connotations that continue to be propagated subconsciously, or consciously, whenever someone says the “hemp plant” has 50,000+ uses, and counting, and will save the world because it’s so green and awesome, but not the “cannabis plant”, no that’s evil and bad, stay away! #NewReeferMadness)

The declaration that “hemp products” only come from “hemp plants” has some major implications. “Hemp seeds” can only come from “hemp plants”. “Hemp seed oils” can only come from “hemp seeds”. “Hemp fibers” can only come from “hemp plants”. Etc.

What does that really mean? What are the real-world impacts of this line of thinking?

Flat out it means that if you are growing a cannabis plant with a d9-THC content above the limit for that plant or its parts to be classified as “hemp”, then the entire crop is subjected to the same rules as d9-THC itself and considered a controlled substance. This means that literal tons of usable material with no resin content whatsoever are destroyed annually rather than being utilized in a commercial application simply because a part or parts of the plant they came from did not meet the d9-THC limit.

Some of the many products on the market today derived from hemp

It is well known that d9-THC content is concentrated in the glandular trichomes (resin glands) which are themselves concentrated to the fruiting tops of the plant. Once the leaves, seeds, stalks, stems, roots, etc. have been separated from the fruiting tops and/or the resin glands, then as long as these materials meet the authority having jurisdiction’s specifications for “hemp” there should be no reason why these materials could not be marketed and sold as “hemp”.

There are several reasons why a classification approach to “hemp plants” and “hemp products” makes more long-term sense than a bifurcation of the “cannabis” and “hemp” marketplaces, namely from a sustainability aspect, but also to aid in eliminating the frankly unwarranted stigma associated with the cannabis plant. #NewReeferMadness

That said, say you are a producer making shives from the stalks of cannabis plants that can be classified as “hemp” and then all of a sudden, the market opens up and tons of material from cannabis plants that cannot be classified as “hemp,” that was being sent to the landfill, become available for making shives. Would you be happy about this development? Or would you fight tooth and nail to prevent it from happening?

In this segment, we looked at the history of the term “hemp” and some of the consequences from drawing a line in the sand between “cannabis” and “hemp”. I dive deeper into this topic and provide some commonsense definitions for several traditional hemp products in Part 2 of Defining Hemp: Classifications, Policies & Markets.

How to Build a Brand that Lasts After Federal Decriminalization

By Frank Knuettel II
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Despite President Biden’s reticence in tackling cannabis reform, Senate Democrats led by Chuck Schumer of New York have insisted that they intend to move forward with descheduling and decriminalizing cannabis with or without the President. This begs the question, what could brands across the legal cannabis industry look like as the federal regulatory environment evolves? As part of this, will interstate restrictions come down and allow for efficient regional and even national brands or will the structure continue to require a state-by-state strategy and rollout?

Currently, state borders set boundaries that dictate supply, distribution and sale, setting strict regulations on cannabis industry operations. As of today, many companies throughout the U.S. cannabis industry are structured as multi-state operators (MSOs), in which the companies own products or dispensary brands that are available in multiple legal state markets but operate in virtual silos from one another. This poses an interesting challenge that may need to evolve with federal legislative changes that could determine redrawing of these supply chains both on a regional and national level.

Brands like Korova, a popular edibles and flower brand based in California, with operations in Oregon and licensees in Oklahoma and Arizona, must keep its operations entirely separate, even if it operates under the same name in different states. Moreover, cannabis flower and extract sourced from California cannot legally be shipped to Oregon or other states. Thus, the MSO often creates vertical operations in each state in which it operates. It creates an entirely distinct process from cultivation to extraction to retail facilities. This difference in operation, even slight, can affect brand quality and consistency across markets if not managed carefully. 

When federal cannabis legislation changes, these types of decisions will most likely be left to the states. I view it as similar to how the alcohol industry operates. In this case, states want to work to protect tax revenue and jobs. Whatever new federal legislation materializes, it is likely that states will retain considerable control over their borders and will have little to no immediate change in terms of vertical operations or the supply chain. The industry is still very nascent, and today’s companies have already developed competitive moats.

On the other hand, if federal barriers are abruptly lifted, we head into a massive free for all. In this scenario, massive consolidation and disruption will occur across the industry, and companies with larger footprints, either in large, important states or across states, will likely be merged together or acquired outright, by either larger MSOs or consumer packaged goods companies that enter the cannabis industry. Along the way, smaller, private companies would go out of business. This would have a massive impact on the industry, with considerable local or state-level disruption to tax revenues and employment. No politician wants to be responsible for something like this, especially during this time of economic turmoil.

If the federal government goes all in on legalization and offers interstate commerce and travel across state lines, companies will no longer have to operate within their own states, nor will MSOs need to create separate vertical operations in different states with hopes that brands maintain consistency. If this occurs, it will ease major strains that presently exist for corporations throughout the industry. Large operators will certainly have an advantage if movement is freed for brands. However, challenges will most likely persist for smaller operators looking to make a splash in the market and the likelihood of this happening for the reasons stated above is low.

Interstate cannabis commerce will be the game changer. While it remains unlikely, in my view, that there will be interstate commerce allowed in any legislation we see out of this Congress, it will happen eventually, just as interstate alcohol laws have also evolved overtime. Having ownership of good assets and brands in important markets and building a strong revenue base is key to both short and long-term success as the industry continues it consolidation, a measure which will only be accelerated with more federal legislation. For Terra Tech, which is acquiring Korova and other brands, it is a fundamental part of our strategy.

So how does a company identify the strongest brands and best operations to work with in our incredibly fragmented industry with no national brands? While there are companies trying to move in that direction, none of them have national brand stature at this point, providing an opening. The brands most likely to succeed are the ones that are more likely to resonate with consumers across various markets. These brands tend to have higher quality and potency at a good perceived value, and which have history in the community of delivering consistent products.

When it comes to choosing markets to get involved in, some choose to do it regionally and others seek out available markets regardless of geography or marketing segments. Unlike many leaders of multi-state operations, I don’t prefer to buy smaller operations in a bunch of states. In my experience, organizing our operations by region increases our efficiency and profitability.  I’m very firmly in support of creating one larger brand than smaller regional brands. It’s easier to develop with marketing and advertising.

european union states

European Cannabis is Starting to Look Like the US Market 10 Years Ago

By Michael Sassano
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european union states

As the cannabis industry — now estimated to be worth more than USD 200 billion — continues to erupt around the world, Europe is about to take off.

This draws a parallel with the watershed legislative events of November 2012, when Colorado Amendment 64 and Washington Initiative 502 were implemented. These two bills kicked off a wave of medical and adult use acceptance in the United States. Europe’s medical referendums which started in 2017-2018 and the recent December 2020 United Nations acceptance of medical attributes of cannabis will do the same in that continental marketplace. Europe is following science and studying popular opinion about cannabis, just like the United States nearly a decade ago.

In many ways, the American “medical” market has been a political ploy, while the European market is truly medical in every way. Distribution through pharmacies and mainstream channels is the wave of the future. This method of distribution will both increase access and taxable bases quicker than the U.S. “medical” dispensary model. People who truly need cannabis should not be hindered by any rules or regulations to get the medicine, and the U.N. has paved the way for access while the U.S. still awaits rescheduling.

Markets in Europe require EU-GMP manufacturing for a variety of different products

The road to medical cannabis in Europe is more stringent than that of the U.S. and Canada. This is because most European markets have strict medical standards and medicines must be produced in European Union Good Manufacturing Practices (EU GMP) certified pharmaceutical manufacturing facilities. This is the same standard that all medical Active Pharmaceutical Ingredient (API) producers are held to.

Both Canadian companies, who have just launched extraction with Canada’s “Cannabis 2.0”, and American manufacturers alike are unfamiliar with pharmaceutical API production. Some argue that food-grade GMP standards are the most similar to already-existing systems in the U.S. and Canada. However, the meaning of “medical” is clear in Europe — it means medical. Improving access for patients to products will be the central challenge for Europe over the next few years as patient growth increases.

Europe is also embracing its potential adult use markets. First came Denmark, then Luxembourg, and now the Netherlands are all beginning to engage with the question of adult use cannabis legalization. We expect Portugal will soon join this list. After all, in a post-coronavirus world, every country will be looking for a means to grapple with a devastated economy and to boost employment to widen its taxable base.

The United States was supposedly founded by Puritans escaping gregarious Europeans. Now it’s likely America will legalize cannabis within the year and Europeans will be left asking, “Why them and not us?” And it will become harder to explain why such potential for growth in employment and increased tax revenue isn’t being taken advantage of as Europe begins to emerge from lockdown. It would be shrewd to expect a wave of European adult use kick-offs in 2022.

budtenderpic
It’s anyone’s guess what retail will look like for the cannabis market in Europe as it evolves

It is clear that 2021 is setting a blistering economic pace: from mergers and acquisitions to monster capital raises, to increased debt raises to the hot special purpose acquisition companies (SPACs) London Stock Exchange (LSE) up listings and initial public offering (IPO) fever. This year will be a cannabis-fueled explosion that Europe will not be able to ignore. With Canada, the U.S. and Mexico all likely to legalize cannabis in the near future, how long will it be before South and Central America follows suit? And then, how long for this wave to reach Europe?

The real answer is, it’s already here. Early adopters of cannabis overbuilt as the Canadians were given more money than they deserved, while the U.S. market was largely fueled by private equity and proved that it could be the biggest and best-run model. Europe will follow its own path by acknowledging the failures and successes of these markets, blending them to form its own unique European model.

The American dispensary will eventually pop up in Europe in a form similar to the current social clubs of Barcelona and coffee shops of Amsterdam. Possibly specialized pharmacies will carry more cannabis products, but it’s too early to call — countries are only just beginning to figure out how cannabis rules might be shaped to fit their needs and values.

2021 could be a decisive year for the European cannabis market

There are greater issues people are dealing with in the age of COVID-19, but that will change. Economic recovery, the need to provide medicine more quickly and affordably, social reform, green projects and many more pressing issues will become thematic of a post-COVID world; a set of themes for which a cannabis-shaped solution checks many of the necessary boxes.

There is a certain misrepresentation of cannabis as a panacea, able to cure every medical ailment and remedy every social problem if only it were legalized more broadly. While cannabis certainly is not a cure-all, it can fix many issues facing governments today. People were grateful for cannabis during these troubled times with cannabis stockpiling and usage through the roof in the early stages of the pandemic. As a result, 2021 has the potential to shatter old establishment perceptions as more consumers speak out.

Now, it is only a question of how the individual and collective European nations choose to regulate expansion across the continent. And the power to create a truly world-beating cannabis model is in their hands; without the international market differences and troubles that plague the North American sector, there will be virtually no limits to cannabis expansion throughout Europe if those in charge believe it to be so.