HHS Recommends Rescheduling Cannabis, Surprising an Entire Industry

By Joshua Weiss, Osiris Morel

In the most unexpected development to hit the cannabis industry in years, the U.S. Department of Health and Human Services’ (HHS) Secretary Xavier Becerra shared his agency’s recommendation that, based on data and scientific analysis, cannabis, a Schedule I drug under the Controlled Substances Act, should be reclassified as a Schedule III drug. The announcement was made on Wednesday, August 30.

The Background

HHS’ conclusion was sent by letter to the Drug Enforcement Administration (DEA), the agency with authority to reclassify how various substances are treated under federal drug laws. The HHS recommendation means that the nation’s top health agency no longer considers cannabis a drug that lacks medical value and carries the high potential for abuse.

The announcement comes just under a year after President Biden and his administration made a statement on cannabis reform. In that statement, which he made on Oct. 6, the president requested that the Secretary of HHS and the Attorney General (AG) initiate an administrative process to review how cannabis is scheduled under federal law, in addition to pledging to pardon all prior federal offenses of simple cannabis possession, directing the AG to develop an administrative process for the pardons and urging all governors to follow suit for state and local offenses. In a statement, Secretary Becerra said the agency acted “expeditiously” and completed the rescheduling process in less than 11 months, “reflecting the department’s collaboration and leadership to ensure that a comprehensive scientific evaluation be completed.” Indeed, the agency’s announcement reflects the administration’s desire to quickly resolve the country’s failed approach to cannabis reform, as prior rescheduling efforts have taken years. Few thought the federal government would move quickly on cannabis, let alone under a year.

The White House has chosen not to comment on the HHS recommendation as the “administrative process is an independent process led by HHS and DOJ and guided by the evidence.” During a press conference, White House Press Secretary Karine Jean-Pierre reiterated the administration’s position, saying that the administration is taking a more hands-off approach and allowing the federal agencies to determine cannabis’s classification without political influence.

What Does This Mean for the Cannabis Industry?

Although a historic announcement, many industry members hoped for a report that would completely remove cannabis from the CSA. Rescheduling cannabis as a Schedule III drug could provide a route for the FDA to assume a more hands-on regulatory role, and it could open up opportunities for interstate commerce in cannabis. A Schedule III designation does not amount to federal legalization, which means the industry will continue to lack a comprehensive regulatory framework addressing the conflicts between federal and state cannabis laws. Rescheduling cannabis also does not address long-overdue concerns about decriminalization and the effect the war on drugs has had on incarceration rates and racial disparities among the imprisoned.

With the HHS recommendation out in the open and the ball firmly in the DEA’s court, concerns have shifted to the DEA’s timeline for considering rescheduling. No hard deadline exists for the agency to complete its review, and industry stakeholders already know that the rescheduling process can be grueling and lengthy. The last time the DEA rescheduled a drug, hydrocodone combination products (HCPs) in 2004, the process took nearly a decade. In fact, each time the DEA has previously considered rescheduling cannabis, in 2001 and 2006, the process took over two years and resulted in no changes.

While many stakeholders speculate that a decision will be made ahead of the November 2024 presidential election, others remain skeptical given the strict anti-drug posture hardwired into how the DEA operates. In fact, the HHS recommendation coupled with the DEA’s approach to drug policy has led some to speculate that the DEA may compromise by moving cannabis into Schedule II, a category reserved for medicines with high potential for abuse and dependence, including most common opioids.

Either way, the agency’s recommendation is a momentous moment for an industry that has been reeling from falling sales and rising costs. Rescheduling cannabis could open the floodgates to more and better research into cannabis. The Schedule I designation has severely limited scientists’ access to cannabis for research purposes. A Schedule III designation would also have a significant financial impact on cannabis companies that have been deprived of tax deductions and banking services on which most companies depend.

The DEA has confirmed that it received the HHS letter and recommendation and will initiate its five-factor review, which differs from HHS’s eight-factor criteria. It remains to be seen what the DEA will do or when it will be done, but thousands of cannabis companies across the country will be watching closely.

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 11, 2023

Alternatives to Bankruptcy for Cannabis Companies: Part 3

By Brent Salmons, Yuefan Wang

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Part 1 of this series discussed the lack of bankruptcy protections for cannabis companies, since bankruptcy in the U.S. is an exclusively federal procedure and cannabis remains illegal under federal law and proposed a number of alternative options for businesses struggling in the current environment. Part 2 of this series focused on state law receiverships for several states.

In this the third and final part of this series, we continue to review state law receiverships for several additional states and discuss the final non-bankruptcy option for cannabis companies, an assignment for the benefit of creditors.

Below is an overview of the laws and rules governing receiverships in several additional states which have legalized cannabis.

Massachusetts

In Massachusetts, receiverships are governed by statute, with numerous statutes for receivership in various industries and entity types but, in general, the appointment of a receiver is granted by a court after the filing of a complaint by third party, most frequently a secured creditor.

In keeping with its industry specific approach, the state cannabis regulator has enacted rules detailing the steps for a cannabis receivership. Most notable among these rules is a requirement to provide notice to the state regulator at least five days before filing a petition to appoint a receiver and, similar to the approach of Nevada, establishing minimum requirements for a person to serve as a receiver for a cannabis company (which generally require a person to pass a background check and have a crime-free past). In addition, because of the fairly restrictive local licensing in Massachusetts, coordination with the locality in which a cannabis company has operations is also required.

Michigan

Michigan has a broad receivership statute, in addition to both entity and industry specific statutes. The general receivership statute allows for the appointment of receivers as part of a court’s equitable powers so long as the appointment is permitted by law. In 2020, Michigan law was amended to specifically permit receivers to be appointed over cannabis companies. The state cannabis regulator’s rules require notice to such agency within 10 days following the appointment of a receiver, and Michigan law further provides that receivers may only operate a cannabis facility upon approval by the state regulator.

Anyone may seek the appointment of a receiver in Michigan, even if they have a connection to the property or business to be placed in the receivership. However, an action may not be brought solely to appoint a receiver but must instead be sought after an action for another claim has already been made. If a court determines it has cause to appoint a receiver, such receiver must have “sufficient competence, qualifications, and experience to administer the receivership estate”. Receivers in Michigan appointed under the general commercial receivership statute (including receivers over cannabis companies) are subject to the court’s equitable discretion but have broad powers, including the power to operate, restructure, liquidate, and sell the business.

Missouri

Like Michigan, Missouri has a general receivership statute as well as statutes for specific receivership situations, notably with respect to corporations. However, Missouri has not enacted any particular rules with respect to cannabis companies and as a result receiverships in Missouri have been conducted under the general receivership statute.

Receivers in Missouri are appointed by a court order following the application of a person with an interest in the assets over which the receivership is sought and an appointment may be made prior to any judgement having been rendered. In addition, the appointment of a receiver may be sought as an independent claim and not as an ancillary claim to another primary claim. Receivers may be granted powers as a general receiver (similar to “equity receivers” in other states) with powers over all of the assets of a debtor, or over specific property of a debtor.

Missouri’s cannabis regulations contain very few rules that specifically relate to a receivership, other than a requirement to provide notice to the state cannabis regulator within 5 days of a receivership filing. While some parties have cited a lack of cannabis specific rules as creating a lack of clarity regarding receivership in these states, Missouri courts and the state regulator appear to be applying the general receivership rules to the industry with at least one receivership in the state in the final stages of completion.

Assignments for the Benefit of Creditors

To conclude this series, we want to revisit another option we discussed in Part 1 for dealing with a financially troubled firm: an assignment for the benefit of creditors (ABC). While voluntary negotiations with creditors is typically taken where the value of the underlying business clearly exceeds the liabilities of the business, and receivership is an avenue for creditors to seek a court to force a restructuring or liquidation of a business, even over the objections of the business itself, an ABC process can be appealing where the creditor and debtor maintain relatively amicable relations, but the value of the business is such that it is clear the equity holders have little to no value remaining in the business. A creditor may view the ABC process, which is generally a lower cost option as compared with a court-supervised receivership, as the superior proposition in these circumstances.

An ABC is a state common law or statutory remedy available to debtors that is roughly analogous to a Chapter 7 bankruptcy or liquidating Chapter 11 bankruptcy. Unlike a receivership, where a creditor applies to a court for the appointment of a receiver and such an appointment can be granted even over the objection of the debtor, an ABC is a step taken by the debtor itself to liquidate its assets in an orderly fashion with the proceeds paid to its creditors. While courts can be involved to resolve specific matters, and ABC process is principally undertaken without court involvement or direct supervision.

Unlike a receivership, an ABC is a step taken by the debtor itself to liquidate its assets in an orderly fashion with the proceeds paid to its creditorsTo initiate an ABC process, the debtor selects the assignee to take ownership of its assets and such assignee holds such assets in the functional equivalent of a trust for the benefit of the creditors of the debtor. As such, the assignee, while selected by the debtor, owes duties (typically fiduciary duties under state law) to the body of creditors.

Once the assignment has occurred, the assignee will engage in a relatively significant diligence effort in order to gain a clear understanding of the assets and liabilities of the debtor, to complete the assignment and to provide notice to third parties and creditors of the fact that the assignment has occurred. The assignee then generally oversees the operation of the business (if it is continuing) while moving to create a sale process for its assets, whether through some sort of public auction or a privately negotiated sale (which, as in bankruptcy proceedings, may include stalking horse bids).

One notable difference between the bankruptcy and receivership process and an ABC is that, in general, assets sold in an ABC are not sold free and clear of all underlying liens, meaning that senior secured creditors must consent to any sale, or their liens will travel with the assets.

While ABCs offer many advantages over receiverships, including a typically lower cost, flexibility in the selection of the assignee, and a generally easier and faster path to liquidation of assets, there are limitations, including the risk that a third party may seek to appoint a receiver after an ABC has been commenced or that the compensation package granted the assignee is disproportionately high, each of which could ultimately result in higher costs for all involved. Furthermore, sales of assets in an ABC are not automatically sold free and clear of all liens.

In the end, regardless of where a cannabis company may be operating, the lack of access to federal bankruptcy courts does not deprive the company or its creditors of viable avenues to restructure or liquidate a business. However, because these options are less familiar to those who typically operate in the bankruptcy-centric restructuring arena in other industries, companies and creditors in the cannabis space are well advised to consult with counsel familiar with the cannabis industry and the restructuring alternatives that remain available to them.

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 1, 2023

Alternatives to Bankruptcy for Cannabis Companies: Part 2

By Brent Salmons, Yuefan Wang

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Background

A cannabis operation facing financial difficulties may try to avail itself, on the one hand, of the contractual remedies described in Part 1 of this series, but these remedies may be flimsy given their narrow scope and reliance on voluntary negotiation between parties whose relationship is already likely tense; on the other hand, the statutory remedies described in Part 1 of this series may be too rigid and absolute, necessitating the disposition of a business as a collection of assets, instead of its continued operation as a going concern. An alternative is receivership, a flexible but powerful quasi-judicial approach paralleling federal bankruptcy able to be administered by state courts. Compared to federal bankruptcy, state receivership is both over and under-inclusive: while receivership can be used in many more situations than insolvency, such as a financially healthy business that is nonetheless subject to regulatory action, receivership provides less comprehensive protection for an insolvent business.

Receiverships have their roots in English and Welsh courts of equity, which were seen as offering fairer remedies than their contemporary common law courts, bound as they were by ponderous precedent. In contrast, courts of equity had more discretion to apply remedies which could be more tailored and “equitable” to an individual petitioner, even if such remedies were not codified. While this separation of equitable and common law courts does not generally exist in the modern U.S. legal system (except for a few hold-out states, most notably, Delaware), the legacy remains in the type of civil remedy available: while most remedies are awarded as monetary redress for a past wrong suffered by a plaintiff (e.g. liquidated damages for the discloser of confidential information or the “benefit of the bargain” for the seller of a company), equitable remedies often require prospective action (or forbearance of an action) by the defendant (e.g. an injunction on disclosure by a recipient of confidential information or specific performance by a purchaser of a company). To draw the analogy out, bankruptcy is a “legal” process to address insolvency since it is governed by a comprehensive regime of federal statutes and rules in the Bankruptcy Code (which is, ironically, applied by specialized federal courts), while receivership is the “equitable” side of the same coin: a judicially-created remedy to manage or liquidate a business, among other actions, where it would not be equitable (or, most importantly for cannabis businesses, not possible) for a bankruptcy action.

Some states with legalized cannabis have cannabis-specific receivership statutes, usually providing that the receiver either be temporarily or fully licensed similar to any other operator of a cannabis business.As an equitable remedy used by various states and federal entities, generalizations about the receivership process are difficult to make. However, broadly speaking, a typical receivership process begins with a complaint filed against the entity for which receivership is sought in state court. This filing can be made by a variety of parties outside of the standard debtor-creditor relationship (reflecting the equitable nature of receiverships), including by regulators and disputing owners of a business. After this filing, a motion to appoint the receiver (which is usually but not always a third party) is filed with the court; consent of the opposing party is generally not required in appointing a receiver but can often make the process easier. The complainant must then establish standing and the occurrence of certain events, including insolvency, but also mismanagement of a corporation or a foreclosure. The requirements of such events are fact-specific and may often be governed by statute or the contractual relationship between parties. The order appointing the receiver usually sets out the specific powers the receiver has in any given case to oversee the disposition or operation of the assets subject to the receivership (called the “receivership estate”) for the benefit of its’s creditors.

Receivership laws generally fall into two categories: some states provide for a broad general statute, sometimes accompanied by statutes specific to industries which are heavily regulated, entity types, or process, while in other states the power is an extension of the court’s powers, set forth in the state’s rules of civil procedure. States also differ as to whether a receivership is considered an independent remedy, a standalone legal action which can be pursued in and of itself (e.g. a petition by a creditor to appoint a receiver to resolve settle an unpaid debt), or an ancillary remedy, a legal action that supports a primary claim (e.g. a request to appoint a receiver in connection with a dispute over the ownership of a business). Some states provide for general receiverships, which allows receivers to take control of an entire business, while other states also allow limited receiverships, which allows the receiver take control of a portion of a business, while the owner operates the remainder. Some states with legalized cannabis have cannabis-specific receivership statutes, usually providing that the receiver either be temporarily or fully licensed similar to any other operator of a cannabis business.¹

Below is an overview of the laws and rules governing receiverships in certain states which have legalized cannabis.

Arizona
In Arizona, receivership is governed by statute, with a general statute and specific statutes for certain industries and type of receivership. Arizona law recognizes that principles of equity apply to all matters relating to receivers, providing the court overseeing the receivership with additional power to decide the remedies available to the receiver. In addition, Arizona has enacted a specific statutory framework for the appointment of receivers for commercial real property and personal property related to or used in operating the real property. Arizona also uses a separate receivership statute to provide for corporate dissolution receiverships, in which a court in a judicial corporate dissolution proceeding may appoint one or more receivers to wind-up, liquidate, or manage the business and affairs of the corporation.

There are no specific statutes governing receiverships of cannabis businesses, so the general receivership statute applies to cannabis businesses, subject to Arizona’s rules governing the operation of a cannabis business. For example, Arizona cannabis regulations that require anyone volunteering or working at a medical or recreational cannabis dispensary to be registered with the cannabis regulator similarly apply to a receiver appointed over a licensed cannabis business.

California

California does not have significant entity-specific or industry-specific statutes for receiverships; rather a California court’s power to appoint a receiver is granted under the state’s rules of civil procedure. Receiverships in California are solely an ancillary remedy; a receivership is commenced once a complaint is filed and any party to the action may seek to appoint a receiver. Circumstances that allow for the appointment of a receiver are fact-specific and at the discretion of a judge, although contractual provisions for the appointment of a receiver are given weight under the rules. Sales of assets in the receivership estate must be submitted to, and approved by, the appointing court.

While the rules of civil procedure provide for the general powers of a receiver, the specific powers a receiver possesses in any given case is granted by the judicial order appointing the receiver; this appointment order is therefore, along with the court itself, the primary authority for the parties in any given receivership. California explicitly disqualifies certain persons, such as parties to the lawsuit, an attorney of a party, a person interested in an action, or any person related to any judge of the court within the third degree, as receivers.

While California’s receivership rules do not explicitly contemplate cannabis businesses, receiverships for cannabis companies have taken place, but in our experience are less common in California than assignments for the benefit of creditors (which we will address in a later article). Like other licensed businesses in California, cannabis companies must provide notice to the state regulatory agency which granted the license. It is up to the agency’s discretion whether the business may be operated under the existing license or whether the receiver must secure a new or temporary license.

Colorado

Like California, no generally applicable receivership statute exists in Colorado; instead, receiverships are governed by the state’s rules of civil procedure. Under these rules, a receiver can be appointed under a court’s general equitable powers. Appointment of a receiver is an independent remedy in Colorado, but is contingent on a lawsuit having commenced and the court having deemed the receivership as necessary and proper. In addition to the court’s general equitable powers to appoint a receiver, and unlike California, Colorado has receivership statutes that are entity and industry specific. The entity-specific statutes permit the appointment of a receiver for the judicial dissolution of for-profit corporations, non-profit corporations, limited liability companies, and cooperatives, and the industry-specific statutes permit the appointment of a receiver for the windup of failed insurance companies and the closure of long-term care facilities.

Similar to California, the court order appointing a receiver governs the entire receivership process and any disposition of the assets of the receivership estate must be submitted to and approved by the court.

As befitting the first state to legalize adult-use cannabis, Colorado’s cannabis regulations specifically address receiverships: the rules create a notice and application requirement for all court appointees, including receiverships, and require receivers to register with the regulator as a “temporary appointee” of the court.

Illinois

Illinois does not have a comprehensive receivership statute; instead, the state has industry-specific statutes, including for regulated industries such as nursing home facilities and telecommunication carriers. Illinois also provides for “equity receiverships”, which are used as an ancillary remedy in business disputes in order to stabilize a business that is adversely affected by fraud, neglect, waste, dissipation, or other misconduct during the pendency of the underlying proceeding. If the underlying matter is within the general or statutory jurisdiction of the court, then such court has jurisdiction over the receivership.

There are no specific statutes governing receiverships of cannabis businesses, but the governing statute does contemplate operation of a cannabis business by a receiver, so regulations promulgated thereunder should apply to receivers as well, including with respect to licensing.

Maryland

Adult-use cannabis sales only began in Maryland July 1, 2023. Maryland has a general receivership statute.

Receivers in Maryland are generally appointed by the person seeking appointment, including the court, and must meet certain qualifications, such as not having any material financial interest in the outcome of the receivership, and not having any debtor-creditor relationship with or equity interest in any party to the receivership. While the general receivership statute provides for broad powers of the receiver, including general management of receivership property, hiring professionals, and issuing subpoenas, the court may modify or expand the powers of the receiver via the appointment order.

While there is no cannabis-specific receivership statute, Maryland’s medical cannabis rules contemplate and authorize the transfer of licenses to a receivership; similar rules have been proposed for adult-use cannabis licenses as well.

Nevada

Nevada has a broad receivership statute, in addition to both entity and industry specific statutes. Case law is not well-developed and mostly predates the current statutory scheme, but there is support for a receiver being appointed outside of a statutory context, specifically when the situation is governed by contractual agreement.

The general receivership statute provides that a receiver may be appointed in a variety of situations, such as fraudulent property purchases, foreclosure of mortgages, or the dissolution or insolvency of a corporation.

Nevada has a statutory regime for receiverships for cannabis companies. Unlike the general statute, there are significant requirements for who can be a receiver for a cannabis business. A receiver must first secure a cannabis establishment agent registration card for a cannabis receiver issued by Nevada’s cannabis regulator. In addition, the receiver must submit an application to the regulator accompanied by, among other requirements, a statement saying the receiver has not previously had an agent registration card revoked. The receiver must also provide proof that she has (1) experience or knowledge of the cannabis industry, (2) experience as a receiver appointed by a court, (3) knowledge and skills necessary to make reasonable financial decisions, and (4) adequate financial capacity to fulfill the duties of a receiver. If the regulator is satisfied with the receiver’s application, it will issue the receiver an agent registration card which must be renewed two years after issuance. It is worth noting that Nevada’s statute governing the non-transferability of certain agent registration cards for cannabis allows the regulator to adopt regulations that give priority in the processing of transfers of licenses for transferors subject to receivership. To date, however, no such regulations allowing priority for receivership processing have been adopted.

Washington

Washington has a general receivership statute, but not any entity or industry-specific receivership statutes. Washington’s receivership structure with overhauled in 2004 with the passage of a new law, so it is not completely settled whether receivership is now an independent or ancillary remedy; however, the language of the statute language suggests that it is an independent remedy.

To be appointed a receiver in Washington, the individual must meet certain requirements, including not being a party to, or be closely controlled by a party to, the underlying action and not having materially adverse interest to the person against whom receivership is sought. The general statute specifically outlines the powers of the receiver. Certain actions by the receiver require court approval before being finalized, including the assumption or rejection of executory contracts, and sales of property outside the ordinary course of business.

Washington law specifically provides for receiverships for cannabis companies. To be a receiver, the person must satisfy the requirements of Washington’s receivership law, and either be preapproved by the cannabis regulator or else be approved post-application. In order to qualify for the regulator’s preapproved receiver list, or be approved post-application, the putative receiver must (1) submit an application, (2) have been a Washington resident for at least six months prior to submission, (3) submit to and pass a criminal background check, (4) provide financial disclosures as requested by the regulator, and (5) disclose any interests in the cannabis licensees. Once a person is appointed as receiver for a cannabis licensee, she shall not have a financial interest in, or simultaneously serve as receiver for, another licensed cannabis retailer. The receiver may not also serve as a receiver for, or be a party of interest in, more than five cannabis retail licensees or more than three cannabis producer and/or processor licensees at the same time. Finally, any person who files a receivership action involving a cannabis licensee must provide notice to the regulator.

Part 3 of this series on Alternatives to Bankruptcy for Cannabis Companies continue our review of receivership in various states and other bankruptcy alternatives, including assignments for the benefit of creditors.

Reference

As cannabis legalization continues to spread, more robust industry-specific receivership rules may be promising given the heavily regulated and specialized nature of the business, similar to how a number of states have industry-specific rules for other heavily regulated industries.

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 28, 2023

The CBD Regulatory Environment in Europe: Part 2

By Shelley Stark

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

EU Regulatory Environment

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

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

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

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

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

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

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

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

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

The UK Regulatory Approach

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

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

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

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

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

The American Market

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

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

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

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

August 24, 2023

Training, Education & Compliance: A Q&A with Chase Eastman, CEO of Rootwurks

By Cannabis Industry Journal Staff

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Founder and CEO Chase Eastman officially launched Rootwurks in January 2022. But the journey began years earlier, and passed through industries including food safety training and digital media and television. Rootwurks at its core is a training platform. The cannabis industry deals with an incredibly complex system of regulatory environments that vary widely from state to state.

Rootwurks is participating in the upcoming Seed to Sale Safety Workshop at the CQC on October 16. Click here to learn more.Making sense of different and evolving rules across this patchwork of regulations is a very daunting practice that every cannabis company must undertake. Enter Rootwurks, which helps companies meet compliance demands while maintaining their quality standards across state lines and jurisdictions.

We sat down with Chase to chat about his background, what he thinks of regulatory compliance in the industry, and how the future of training might mold the cannabis marketplace.

Cannabis Industry Journal: Can you tell us about your background? How did you get involved in the cannabis industry?

Chase Eastman: Both of my parents were career entrepreneurs. At some level, I was always destined to give this a shot. As a teenager, I started working at Alchemy Studios, my father’s company, before it became the training company it is today – back then we were a small marketing studio that sold creative services & learning development to Fortune 500 companies.

About a decade later, I started working for a home shopping network and was instantly hooked on the fun, fast-paced environment of the marketplace. I eventually became head of the digital media department of the company, right about the time Groupon started making waves in 2012-2013.

At the home shopping network, content was key for sales. At the same time, learning platforms like Linda.com (LinkedIn Learning) & YouTube were exploding in popularity and my dad and I started having a lot of conversations about the role these new technologies would have on the adult learning landscape. I decided to go back to work with my father at Alchemy Systems, focusing on end-user learning content.

Our specialty was the food manufacturing space, and we were constantly experimenting with different strategies for blended learning, mixed media formats, and adult learning. This focus on using technology to connect people to expertise is at the very core of what Rootwurks provides.

This was my 20-year journey to education and training, but my path to cannabis began at home, with my family as my mom battled cancer. Years earlier our neighbors and dear family friends encouraged my mom to try cannabis to treat the side effects of chemotherapy.

With cannabis, my mom could cope better with the pain and nausea, helping her eat and build up her strength. I witnessed all of this first-hand and cannabis quickly found a special place in my heart as a life-changing medicine.

My mother, father and I started to look for ways to use our expertise in training and compliance systems to help the cannabis industry ensure the safety and effectiveness of cannabis products. We quickly realized that the best way to help the industry is by making it easier for companies to deal with compliance demands and the frustrating lack of universal standards and consistency in cannabis.

Food regulations are by no means simple. But cannabis is far more complex, especially for smaller companies that just want to grow weed and help people find the products that will work best for them.

CIJ: Alright so what is Rootwurks? Tell us about your company.

The Rootwurks Learning Experience Platform

Chase: Rootwurks is first and foremost a training platform where education and compliance meet.

We believe that compliance adherence happens when people are doing what they should be doing when and where they need to do it. We also know that employees must have access to the information they need in real time, in a simple and easy-to-understand manner.

The Rootwurks Learning Experience Platform is also a communication tool and learning aid devoted to our goal of connecting people with expertise. For specific use cases like sales training for budtenders, the authoring tool and templates make it very easy to disseminate communication or training on a wide scale.

I like to talk about the Ebbinghaus Forgetting Curve – a theory that essentially says adults are forgetful AF and lose a lot of information very quickly if it isn’t reinforced. The Rootwurks platform contains built-in operational reinforcement tools that flow into auditing, verification & validation modules. All this information feeds into a corrective action engine helping companies develop and deploy preventive actions.

A checklist module in the Rootwurks training platform

The ecosystem is based on the premise of training and reinforcement. Checklist modules can be adjusted to create training that reinforces the quick, easily-digested micro learning models. Embedded videos in the modules can include checklists for employees to follow, or they can simply watch videos to reinforce learning at the end of a training module, for example.

Employees can use the dashboard to instantly see all of their learning activity for the day. Companies can simultaneously use the platform for onboarding new hires while also providing ongoing education and training for longtime employees.

Flexibility is at the core of the system. Cannabis regulations include a massive amount of unnecessary complexity and all of it varies from state to state. A large operator going into a multi-state phase will have different SOPs for each state, and must still maintain quality standards across every company location. This is why we built all of our programs as templates that customers can adjust to meet compliance guidelines in each and every state they operate.

But this isn’t an “off-the-rack” platform. Companies can customize the system with their branding and training materials as they see fit. This solves the “blank screen paralysis” that companies face with training programs.

Our goal is to remove these hurdles and help companies schedule, assign, and validate training.

CIJ: In the food industry, the culture of safety and quality is such a standard practice. In your eyes, how does the cannabis industry compare and in what areas do you see a need for improvement? In other words, what are the biggest problems facing cannabis from a safety and quality perspective?

Chase: In the food industry, there is an expectation that safety and quality is ingrained in daily operations. The food industry also knows full well the importance of having a proactive accountability culture in the workplace backed up by internal auditing. The FDA has partnered with the food industry to promote these principles for more than a decade – so we shouldn’t expect this to happen overnight in the cannabis industry.

Audit insights can help train employees to maintain regulatory compliance

But the food industry had a decades-long headstart on the cannabis industry, during which they’ve pushed back on non-practical regulations and built partnerships with state regulatory bodies.

In a lot of ways, time is the biggest thing that the cannabis industry needs. It needs time for industry to work in partnership with regulators to honor the intent of the rules, while still maintaining practicality. Succeeding as a cannabis business is tough even without factoring in these regulations, which throw all types of inefficiencies into the manufacturing and sales process.

It’s no wonder we’re dealing with so much confusion, with so many states having such different sets of regulations. We’re seeing all types of companies really struggle, because the current state of affairs is not as sustainable as they thought.

We need to find ways to honor the fun, subversive, and life-enhancing aspects of cannabis culture while also building partnerships between the industry and regulators. It’s going to take time, but I’m confident we can get there.

CIJ: How do you envision the future of education and compliance within the cannabis industry and where do you see this market going in the next ten years?

Chase: The easy answer to that is the sky’s the limit. We timed the launch of Rootwurks right with a global recession at a time when the cannabis industry is facing unprecedented headwinds. We still need SAFE Banking to cross the finish line and full access to the financial system. There’s too much momentum behind cannabis and I think we’ve reached a tipping point.

Moving forward, I think the brands that succeed will be the ones that implement training and education programs and treat them as vital to their daily operations.

The next 24-36 months won’t be easy. But we are learning so much as we go and we are not done figuring out all the different ways the plant can be utilized. The industry is only going in one direction and I’m thrilled that at Rootwurks, we can help more and more companies achieve their dreams in cannabis.

August 22, 2023

As Mastercard Exits Cannabis, There’s a Cash Opportunity

By Shawn Kruger

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Late last month, Mastercard decided to halt their debit card transactions with cannabis dispensaries, notifying financial institutions and payment processors to stop processing purchases. This isn’t the first digital payment solution to swiftly exit the industry – late last year, vendors turned off services to their cashless ATMs. These abrupt decisions have made major headlines, shocking cannabis dispensary owners, operators and consumers as they scramble to shift focus back to the remaining legal payment tools.

For the cannabis industry veterans like myself, these exits aren’t a surprise at all. Why? Cannabis is federally illegal and federal regulations restrict banks and other financial services companies from working with cannabis businesses – even if it is legal at a state level. Due to this massive legal hurdle, cannabis dispensaries often lack access to typical banking services and have limited payment options for consumers, making it challenging to manage and facilitate payments.

Some believe that this decision by Mastercard, the second largest payments provider in the world, and by other payment vendors, coupled with the political pressure to legalize cannabis could help push legalization or the Secure and Fair Enforcement (SAFE) Banking Act to help mitigate the lack of access to banking services in the longer term. Even though cannabis represents an economic opportunity – MJBizDaily estimates that combined medical and adult use cannabis sales could reach $33.6 billion by the end of 2023, and $53.5 billion by 2027 – hurdles to legalization mean that, for now, cash will be the most prevalent payments option.

Let’s Talk About Cash

Cash remains the longstanding and most prevalent payment option in cannabis. However, it presents difficulties for businesses. Physical cash is difficult to manage for dispensaries for several reasons, primarily due to the costs to count, track and manage cash volumes and the labor required to count the cash. In fact, in most dispensaries, associates count cash an average of six times a day. Each time cash is manually counted, dispensaries risk miscounts, shrinkage, security and safety concerns due to robberies.

This manual labor required to oversee a business’s balance sheet and keep dispensaries operating is inefficient and unsustainable, and many have attempted to incorporate debit payments or cashless ATM transactions to help mitigate the costs associated with cash. However, while cash presents logistical and operational challenges for dispensary owners, it remains one of the more dependable payment options consumers and dispensaries have for cannabis transactions. Dispensaries can integrate simple strategies to improve their cash handling and operate more efficiently.

Best practices with cash management for dispensaries

The biggest and most impactful strategy is incorporating cash automation tools to help secure, count and manage their payments. The largest and oldest dispensary in Washington D.C. incorporated sophisticated automation tools into their cash handling practices, which have alleviated massive headaches and burdens from store associates, managers and its accounting team, who previously relied on manual cash processes to count, sort and manage their cash.

This cash-handling technology has improved count accuracy, saved time for staff, improved visibility and enabled real-time reporting. These tools have transformed the day-to-day duties of staff. The dispensary’s accounting team and associates no longer get overwhelmed when anticipating increased cash flow on 4/20 or other holidays because they have tools that eliminate the extreme costs of handling cash. Additionally, they now confidently support audits as they have complete reports of each transaction by user, date and time. Before automation, audits were next to impossible to execute confidently.

The greatest benefit of cash automation tools is the near elimination of shrinkage, a term referring to the cash lost due to employee theft or miscounts. With cash automation, cash is as affordable as digital payment options, with the added confidence that cash won’t disappear as a payment option for consumers.

Have a Cash Strategy

While Mastercard’s decision to leave the cannabis industry leaves dispensaries in the lurch, the cannabis payments ecosystem continues to evolve and transition quickly. Dispensaries must be agile and incorporate strategies for the payment options, both inbound from consumers and outbound to their vendors, that they can rely on.

As the cannabis industry continues to evolve, embracing cash automation will be crucial for sustainable growth and success. Cash automation is a transformative solution for cannabis reducing the cost of managing cash while addressing the unique challenges associated with high cash volume operations. Embracing cash automation allows dispensaries to thrive in an evolving industry while maintaining control over their cash ecosystem, no matter who enters or exits the payments space.

August 21, 2023

The CBD Regulatory Environment in Europe: Part 1

By Shelley Stark

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

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

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

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

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

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

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

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

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

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

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

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

No ambiguity there!

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