Tag Archives: companies

By Dr. Markus Roggen, Amanda Assen

What do Aurora Cannabis, Tilray and Pfizer all have in common? They all produce and sell products used for medicinal purposes, they are top competitors in their field and they all have statements on their websites claiming that science is one of the most important things to their business. But unlike Pfizer, Aurora and Tilray do not have any positions in the executive suite for scientists or medical personnel. This led us to wonder, why does the structure of their corporate ladder (as well as so many other cannabis companies) not align with what they claim to be their values?

According to Aurora Cannabis, “Science is at the core of what we do”.¹ Look up the definition of “core” and you will get “foundational, essential, central, and enduring.”² Sounds important. Meanwhile, Tilray’s main page states: “For the therapeutic value and risks of cannabinoid-based medicines to be fully understood, Tilray believes it is critical to evolve current scientific understanding of the field.”³

You would assume that somebody in the executive suite would have a position and an educational background relating to the central and enduring part of a business, right? We looked at 10 of the biggest Canadian cannabis companies, their founders’ educational backgrounds and whether there were executive positions for science, R&D or medicine (Table 1). We also looked at the same data for the top 10 biggest pharmaceutical companies (Table 2). As expected, every pharmaceutical company had upper-level (C and/or P level) positions for scientists and/or medical personnel. However, only 2 of the 10 cannabis companies had this.

To figure out why this is, (as scientists) we did some research. It turns out, the consensus is scientists are bad at commercialization. Scientists are rarely successful as CEOs because they are (usually) not good at attracting customers and get confused by things like revenue models.⁴ As Akshat Rathi bluntly put it, “just because you are the smartest person in the building does not make you capable to run a company.” In fact, many CEOs of life science companies got to the top by pursuing business, finance, marketing or sales. In the 90s, some life science companies took a chance on scientists and hired them as CEOs, but when they hit financial turmoil, they quickly undid this.⁵

So maybe scientists aren’t always cut out to be the CEO of a company. But that still doesn’t explain why so few large cannabis companies have a chief scientific/medical officer, or even a president of R&D.

Maybe we are looking in the wrong place. Maybe their value of science can be demonstrated by their spending on research. Typically, a larger agricultural company will spend 9% or more on R&D, and a smaller company will spend 2-4%.⁶ Meanwhile, the major pharmaceutical companies we looked at spent between 12 and 25% of their revenue on R&D during their most recent fiscal year. Since a cannabis company falls somewhere in between we approximate they would spend around 9-12%.

However, Canopy Growth was the only company that fell into our prediction range, spending 10.5% of their revenue on R&D in 2021.⁷ Tied for a distant second place were Charlotte’s Web and Aurora Cannabis (a subsidiary of Tilray), spending 4.6%. At the very bottom were Tilray which only spent 0.16% on R&D and TerrAscend which spent 0.21% during their most recent fiscal year.^8,9 With most of the cannabis companies, we saw a gradual decrease in R&D funding over time, which intensified with the Covid-19 pandemic.

So why the heck are these companies going on about how they value science? To give them the benefit of the doubt, maybe they do think they value science, but they don’t know how to value it.

It’s hard for a company to take actions that show they value science if there are no voices for scientists at the executive level. After all, how can you make decisions based on science if nobody in the room understands it? Sure, we saw the argument that people who make it to the top can “learn enough science to ascend to the executive suite without much trouble”.⁵ But what is “enough science”? The mitochondria is the powerhouse of the cell?

This leads to our argument for putting scientists in the executive suites of cannabis companies and giving them a more powerful voice. Whereas scientists are not good at marketing, those in managerial roles tend to overly rely on intuition – even when the evidence is against them.¹⁰ For those relying on intuition, R&D is an easy target during times of crisis (like a global pandemic). Cutting costs in R&D yields a short-term immediate increase in profit and the negative impacts are often not felt until years later.¹¹ However, cutting R&D investment is the opposite of what you should do during a time of crisis. Evidence suggests companies that maintain or even increase spending in marketing and R&D and focus on operational efficiency (such as process optimization) are the ones that will come out as the top competitors in the long run.^12,13 Having a chief scientific officer or an executive for R&D with a scientific background can help sustain companies by promoting R&D during hard times and indicating what projects will be the most promising to help the company optimize their processes.

Having a scientist in the executive suite can also help keep everyone in check. “Senior execs live in a feedback loop of positive reinforcement making them unlikely to question their decisions,” according to Stefan Thomke and Gary Loveman.¹⁰ They claim the best way for those in managerial roles to avoid over relying on instinct and break out of that positive feedback loop is by “thinking like a scientist”. This involves not letting bias get in the way of truth, studying anomalies, being skeptical, developing strong hypotheses, producing hard evidence and probing cause and effect. To add to this, we think a major part of thinking like a scientist is by having at least one high up in the team. In our own company, giving equal value to scientific voices has resulted in all parties learning and thriving by making fact-based decisions.

Finally, scientists deliver! To be a scientist (with a PhD), one must master the field, find a gap in the knowledge, then fill that gap – all for little pay and no guarantee of a job at the end. This makes them dedicated workers whose main goal is to contribute something unique to their field, or in this case, their company.¹⁴ Having someone up top who is dedicated, passionate, innovative and trained to look for gaps in knowledge can be an invaluable voice in the executive suite. They are likely to point out potential money-saving solutions (i.e.: optimizing extraction conditions) that others up top may not have thought of on their own.

If you feel strongly that science is at the core of what you do, and you already know that R&D is crucial for the long-term survival of your company, you are already on the right track. In addition to this, consider giving a voice to scientists at the executive level in your company. The cannabis industry is still in its infancy. This means there is potential for R&D in more than just new product development. Basic stuff like extraction, modifying plants to be heartier against harsh conditions and pathogens, curing and safety testing processes have all barely been studied and optimized to reduce costs. These things won’t be solved by a Juris Doctor, an MBA or even an engineer, they will be solved by scientists, and it will take a scientist up top to ensure the whole company recognizes the importance of these projects.

Table 1: Top cannabis companies stats on founders and their educational backgrounds, presence of scientific executive positions and spending on research and development

Company	Founders	Founder’s Educational Backgrounds	Science executive position?	% Revenue spent on R&D
Aphria Inc. (now owned by Tilray)	Cole Cacciavillani and John Cervini	Cole: B. Eng John: Born into a family greenhouse business	Chief science officer Garry Leong: B.Sc. Chem, M.B.A. Quality Management ¹⁵	NA
Canopy Growth Corp	Bruce Linton and Chuck Rifici	Bruce: Ba Public Policy, Minor: Economics. ¹⁶ Chuck: B. Eng, MBA	no	10.5% ¹⁷
Aurora Cannabis Inc. (subsidiary of Tilray)	Terry Booth, Steve Dobler, Dale Lesack and Chris Mayerson	Terry: Master Electrician¹⁸ Steve: B. Eng Chris: Concrete business Dale: Electrician and homebuilder	no	4.6% ¹⁹
Village Farms International Inc.	Michael A. DeGiglio	BSc Aeronautic Science	no	No data available on R&D expenses
Tilray Inc	Brendan Kennedy, Christian Groh, Michael Blue	Brendan: Ba. Architecture, Msc: Eng, MBA²⁰ Christian: Ba. unknown, MBA²¹ Michael: Ba. Finance, MBA²²	no	0.16% ²³
Ayr Wellness Inc	Jonathan Sandelman	Juris Doctor, Law Degree²⁴	no	No data on R&D spending available
TerrAscend Corp	Michael Nashat	Pharm. D . Post doc in Neuroscience²⁵	no	0.21% ²⁶
HexoCorp	Sebastien St-Louis	Ba. Economics, MBA ²⁷	no	3.09% ²⁸
Fire & Flower Holdings Corp	Trevor Fencott	Ba (unknown), and Law degree²⁹	no	No data on R&D spending
Zenabis Global Inc (now owned by hexo corp)	Rick Brar, Mark Catroppa, Monty Sikka	Rick: Ba. (unknown) Mark: Ba. Finance ³⁰ Monty: Ba Accounting and Finance³¹	Chief science Officer: Natasha Ryz PhD experimental medicine.³²	NA

Table 2: Top pharmaceutical companies founders and their educational background, presence of executive positions for scientists and spending on R&D

Company	Current Executives	Educational Background	Science executive positions?	% Revenue spent on R&D
Amgen	Robert A. Bradway	BSc. Biology, MBA³³	Chief Medical officer: Darryl Sleep, M.D. ³³ Senior VP in R&D: Jean-Charles Soria PhD molecular Biol, MD	18.5% ³⁴
Sanofi	Paul Hudson	Ba. Economics, honorary doctorate in business³⁵	Executive VP, R&D: John Reed, MD, PhD in Immunology³⁵	14.51% ³⁶
Bristol-Myers Squibb	Giovanni Caforio	MD.³⁷	Chief Medical Officer: Samit Hirawat, MD. Rupert Vessey: Executive VP: R&D PhD molecular immunology ³⁷	24.58% ³⁸
Takeda	Christophe Weber	PhD. pharmacy and pharmacokinetics, Msc. pharmaceutical marketing, accounting, and finance³⁹	Director President, R&D: Andrew Plump, MD. Ph.D. in cardiovascular genetics ³⁹	14.25% ⁴⁰
AbbVie	Richard A. Gonzalez	No college degree. Practical experience in biochemistry research.	Vice chairman and president, R&D: Michael E. Severino, MD, Bsc biochem⁴¹	12.60% ⁴²
Novartis	Vasant Narasimhan	Bsc. Biology, MD, Msc Public policy	President, Biomedical research, James Bradner M.D. President innovative medicine, Victor Bulto: Msc. Chemical engineering, health economics, and pharmaeconomics, MBA. Chief medical officer, John Tsai BEng. MD⁴³	18.04% ⁴⁴
Merck	Robert M. Davis	Ba Finance, MBA, Juris Doctor⁴⁵	Executive VP and president of Merck Research Laboratories; Dean Li MD, PhD cardiology⁴⁵	25.14% ⁴⁶
Johnson & Johnson	Joaquin Duato Vanessa Broadhurst Peter Fasolo	Joaquin: MBA, Master of international management Vanessa: Ba, Master of Business Administration Peter: PhD in organizational behavior, Msc. Industrial Psychology, Ba Psychology⁴⁷	Executive VP, Chief Medical Safety Officer; William Hait MD. PhD Oncology Executive VP, Pharmaceuticals R&D; Mathai Mammen MD. PhD Chemistry	15.69% ⁴⁸
Pfizer	Dr. Albert Bourla Sally Susman Payal Sahni Becher Rady Johnson	Albert: Doctor of Veterinary Medicine (biotechnology) Sally: Ba Government Payal: Ba psychology, Msc Psychology Rady: Accountant⁴⁹	Chief Development Officer: William Pao: MD. PhD oncology Chief Scientific Officer, Worldwide R&D: Mikael Dolsten; MD. PhD Tumor Immunology⁴⁹	17.01% ⁵⁰
Roche	Dr. Severin Schwan, William N. (Bill) Anderson, Dr. Thomas Schinecker, Dr. Alan Hippe	Severin: Ba economics, PhD law William: Msc in management and chemical engineering Thomas: Bsc genetics, Msc molecular biology, Phd molecular biology Alan: Ba, Phd in administration⁵¹	CEO Roche Diagnostics; Dr. Thomas Schinecker; PhD in Molecular Biology⁵¹	23.563% ⁵²

References:

Aurora Webpage. Auroramj https://www.auroramj.com/#science.
Definition of Core. Merriam-Webster Dictionary https://www.merriam-webster.com/dictionary/core?utm_campaign=sd&utm_medium=serp&utm_source=jsonld.
Tilray Brands WebPage. https://www.tilray.com/.
Rathi, A. Why scientists make bad entrepreneurs—and how to change that. Quartz (2015).
Mintz, C. Science vs. Business: Who Makes A Better CEO? Life Science Leader (2009).
Fuglie, K., King, J. & David Schimmelpfennig. Private Industry Investing Heavily, and Globally, in Research To Improve Agricultural Productivity. US Department of Agriculture, Economic Research Service (2012).
Canopy Growth R&D expenses. https://ycharts.com/companies/WEED.TO/r_and_d_expense.
Tilray R&D expenses. Ycharts https://ycharts.com/companies/TLRY.TO/r_and_d_expense.
TerrAscend R&D expenses. Ycharts.
Thomke, S. & Loveman, G. Act Like a Scientist. Harvard Business Review (2022).
Knott, A. M. The Trillion-Dollar R&D Fix. Harvard Business Review (2012).
Gulati, R., Nohria, N. & Wohllgezogen, F. Roaring Out of Recession. Harvard Business Review (2020).
Soferman, R. Why You Shouldn’t Cut R&D Investments In Times Of Crisis And Recession. Forbes (2020).
Madisch, I. Why I Hire Scientists, and Why You Should, Too. Scientific American (2018).
Havn Life Sciences Inc. Announces Appointment of Gary Leong as Chief Science Officer. https://apnews.com/press-release/accesswire/science-business-life-sciences-inc-aphria-inc-319a516963144b308d146d97dee0dc69 (2020).
Bruce Linton. Elite Biographies https://elitebiographies.com/biography/bruce-linton/.
Canopy Growth Page . Ycharts https://ycharts.com/companies/CGC.
Lee, A. 20 Things You Didn’t Know About Terry Booth. Money Inc (2020).
Aurora Cannabis page. Ycharts https://ycharts.com/companies/ACB.
Brendan Kennedy Profile. linkedin https://www.linkedin.com/in/kennedybrendan/.
Christian Groh Profile. Bloomberg https://www.bloomberg.com/profile/person/17139193.
Micheal Blue Profile. Bloomberg https://www.bloomberg.com/profile/person/18227502.
Tilray Page. Ycharts https://ycharts.com/companies/TLRY.
A Jonathan Sandelman Profile. zoominfo https://www.zoominfo.com/p/Jonathan-Sandelman/2245250.
Dr. Michael Nashat Appointed President & CEO of TerrAscend. https://markets.businessinsider.com/news/stocks/dr-michael-nashat-appointed-president-ceo-of-terrascend-1012862002 (2018).
TerrAscend Page. Ycharts https://ycharts.com/companies/TRSSF.
Sebastien St-Louis Profile. Linkedin https://www.linkedin.com/in/sstlouis/?originalSubdomain=ca.
HEXO Corp Page. Ycharts https://ycharts.com/companies/HEXO.
Trevor Fencott Profile. bezinga.com https://www.benzinga.com/events/cannabis-conference/speakers/trevor-fencott/.
Mark Catroppa Profile. linkedin https://www.linkedin.com/in/markcatroppa/.
Monty Sikka Profile. linkedin https://www.linkedin.com/in/monty-sikka-3024a1a6/.
Natasha Ryz Profile. crunchbase https://www.crunchbase.com/person/natasha-ryz.
Senior Management Amgen Page. Amgen https://www.amgen.com/about/leadership.
Amgen Stocks Page. YCharts https://ycharts.com/companies/AMGN.
Sanofi Executive Team Page. https://www.sanofi.com/en/about-us/governance/executive-committee.
Sanofi Stocks Page. Ycharts https://ycharts.com/companies/SNY.
Bristol Myers Squibb Leadership Team. https://www.bms.com/about-us/leadership/leadership-team.html.
Bristol Myers Squibb Stocks Page. YCharts.
Takeda Executive Leadership Page. Takeda https://www.takeda.com/who-we-are/company-information/executive-leadership/.
Takeda Pharmaceutical Co Stocks Page. YCharts.
Abbvie Our Leaders Page. Abbvie https://www.abbvie.com/our-company/leadership.html.
Abbvie Inc Stocks Page. YCharts https://ycharts.com/companies/ABBV.
novartis executive committee page. novartis https://www.novartis.com/about/executive-committee.
Novartis AG Stocks Page. YCharts https://ycharts.com/companies/NVS.
Merck Executive team Page. Merck https://www.merck.com/company-overview/leadership/executive-team/.
Merck Stocks Page. YCharts https://ycharts.com/companies/MRK.
Johnson and Johnson Our Leadership Team Page. Johnson and Johnson https://www.jnj.com/leadership/our-leadership-team.
Johnson and Johnson Stocks Page. YCharts https://ycharts.com/companies/JNJ/market_cap.
Pfizer Executive Leadership Page. Pfizer https://www.pfizer.com/about/people/executives.
Pfizer Inc Stocks Page. YCharts https://ycharts.com/companies/PFE.
Roche Executive Committee Webpage. Roche https://www.roche.com/about/governance/executive-committee.
Roche Holding AG Stock Page. YCharts https://ycharts.com/companies/RHHBY.

April 21, 2022

New Jersey Launches Adult Use Sales

By Cannabis Industry Journal Staff

No Comments

On Thursday, April 21, a handful of dispensaries in New Jersey begin selling cannabis to adults over the age of 21. The state has so far issued licenses for adult use sales to seven alternative treatment centers (ATCs), otherwise known as medical cannabis businesses already established in the state. In total, thirteen dispensaries in the state can sell cannabis to adults over 21.

The reason why adult use sales could not start on April 20 is because of “unmanageable logistical challenges for patients and other buyers, surrounding communities, and for municipalities,” Toni-Anne Blake, communications director for the New Jersey (CRC) told The Philadelphia Inquirer. “Regulators and industry representatives agreed it was not feasible.”

The seven ATCs awarded adult use licenses are Ascend, Curaleaf, GTI, Acreage, Verano, Columbia Care and TerrAscend. The state’s roll out created a lot of controversy over allowing already established, larger medical cannabis businesses and multi state operators to begin adult use sales before smaller businesses and social equity applicants get licensed.

According to The New York Times, the CRC gave condition approval to 102 companies for cultivation and manufacturing, but they need local approval and real estate before commencing operations. Another 320 organizations have applied for licenses for the New Jersey adult use cannabis market, but could wait up to a year or more before they begin operating.

Regulators in New Jersey say the seven companies commencing sales will need to follow social equity rules, including providing technical knowledge to social equity applicants. “We remain committed to social equity,” says CRC Chair Dianna Houenou. “We promised to build this market on the pillars of social equity and safety. Ultimately, we hope to see businesses and a workforce that reflect the diversity of the state, and local communities that are positively impacted by this new and growing industry.”

Jeff Brown, executive director of the CRC, says they anticipate long lines and crowds. “We expect 13 locations for the entire state will make for extremely busy stores,” said Jeff Brown, executive director of the New Jersey Cannabis Regulatory Commission. “The dispensaries have assured us that they are ready to meet the demand without disrupting patient access, and with minimal impact on the surrounding communities, but patience will be key to a good opening day.”

Adults in New Jersey can purchase up to one ounce of flower, up to five grams of concentrates or up to ten 100mg packages of edibles. Click here for a list of the locations opening their doors for business.

July 29, 2021

Soapbox

Can Cannabis Avoid Alcohol’s 3-Tier Distribution System?

By Rick Kiley

No Comments

As an experiential marketer that works with a lot of vice-oriented brands, I’ve always been fascinated by the story of the rise of spirits in the US – a history marked by ingenuity in the face of heavy restrictions, clashing social norms, crime and political ideals. Since then, those same qualities have emerged in the story of cannabis and how, against all odds, it has recently begun to push its way into the mainstream. But on the path to legalization, cannabis can also learn a lot from the spirits industry about what not to do.

For example, when laws governing the spirits industry were written in the post-Prohibition 1930s, the federal government wanted to create an equitable landscape. So, they created a 3-tier system – manufacturers or importers must sell to wholesalers, wholesalers must then sell to retailers and retailers sell to us. They figured that keeping manufacturing interests separate from wholesale and retail interests would keep any large company from owning an entire supply chain, muscling out smaller competitors.

In theory, it’s not a bad idea. Imagine the consequences of massive companies like Diageo or AB InBev using their money to pay bars and liquor stores to only stock their brands and not competitors. Add on the Tied House Laws, which basically says an entity in one of the three categories cannot have an ownership stake in any of the others, and you get a seemingly even-handed marketplace.

Tied House Laws theoretically limit one entity from monopolizing a supply chain

In truth, it makes it almost impossible to be disruptive or for new brands to break through. Other industries have innovated by cutting out the middleman and selling direct-to-consumer – something that simply cannot happen in alcohol (minus the wineries and distilleries that can sell direct out of their tasting rooms). Also, now distributors are so consolidated that there are only one or two big distribution companies in each state. So, as a company trying to bring a new product to market, you have to get into one of these highly selective and competitive distributors if you are going to be successful – a challenging ask for a small, independent brand.

Protection racket

Now, imagine that same challenge coming to the cannabis space. With legalization around the corner, the adult use (as opposed to medical use) cannabis industry could easily look like alcohol in the rules that will be set up.

Right now, adult use manufacturers can sell their products to dispensaries directly. Some use a distributor, but there is no nationwide mandate to – which is probably for the best. If a distributor isn’t a requirement, it forces brands to offer something new to differentiate themselves. It will spark innovation, rather than add an extra profit margin that will get rolled into the final price – a price that is already higher than it should be due to the murky federal legal status. Adding complexity and cost will only make it harder to compete with the illicit market. For the industry to grow, costs for illicit cannabis can’t be lower than its legal counterpart.

Of course, we are in the nascent stages of legalization here and we’ve come a long way culturally and technologically since the 30s. But remember, the rules governing alcohol were written nearly 100 years ago along with the passage of the 21st amendment repealing prohibition. Startlingly, those laws haven’t changed that much since they were written, so any mistakes made now in dealing with the cannabis industry could last for a long time.

A new way forward

What the cannabis industry needs is a new model for the adult use/recreational space, keeping some of what exists in the alcohol industry but without ever mandating use of a distributor – the middle tier. This would mean keeping Tied House Laws in place and applying them to cannabis so that a manufacturer could never hold an interest in a retailer, while still allowing them to sell directly to dispensaries and to consumers. Currently, some states allow for vertical integration, which would change under Tied House Laws.

This should be pretty simple, since most states are already separating licenses by type of activity (manufacturer, retailer, etc.) and it would promote competition while bringing the widest array of products possible to each consumer. Also, it would prevent any behemoths from squeezing out the up and comers.

extraction equipment — Constant innovation is a hallmark of the cannabis market and a key factor in continuous growth.

Of course, some retail license allowances could be considered on a case-by-case basis. For example, I would carve out an exception that growers/manufacturers could sell direct to consumers through a single “tasting room” at their brand home. This is similar to the operations of microbreweries, distilleries and wineries. It would encourage education for consumers, and provide great opportunities for brands to show why their products are better or unique.

Given the technology and logistics solutions available to businesses in a 21st century economy, mandated distributors create a sometimes-unnecessary barrier to an already efficient supply chain. If mandated, prices will inflate to cover added margin, thus making it harder to bring consumers over from the legacy market to the legal one. I’m not against the idea of a distributor – they can add tremendous value, but the mandate would seriously curtail industry growth.

Direct-to-retail and direct-to-consumer sales are necessary for the economic health and growth of the industry. Without this, using alcohol as a cautionary tale, at some point the middle tier cannabis brands will inevitably begin to wield an outsized amount of power. We are living at a time where innovation is going to be the key to explosive growth in the cannabis industry, so it’s important to do everything possible to let the market find its way without falling into a century-old trap.

March 22, 2021

Cannabis Revival and Year of the SPAC’s: What’s To Be Expected the Rest of 2021?

By Michael Sassano

No Comments

The unusual nature of 2020 gave rise to a reciprocally roller-coaster-like cannabis market. Cannabis was cemented officially as an essential industry with the rise of COVID-19, and November elections resulted in even more United States markets welcoming medical and adult-use sales.

The stagnant cannabis stock market of 2019 became a thing of the past by the end of 2020. Throughout the course of last year, bag holders anxiously watched cannabis options creep back up. Now, nearly two years since market decline in 2019, the cannabis stock market is exploding with blank checks and buyout fever. Much of this expectant purchasing is due to Canadian companies considering U.S. market entrance. Combined with the recent surge in the use of special purpose acquisition companies (SPACs) to invest, this has led to an increase in asset prices.

A SPAC is defined as “a company with no commercial operations that is formed strictly to raise capital through an initial public offering (IPO) for the purpose of acquiring an existing company.” Though they have existed for decades, SPACs have become popular on Wall Street the last few years because they are a way for a company to go public without the associated headaches of preparing for a traditional IPO.

In a SPAC, investors interested in a specific industry pool their money together without knowledge of the company they’re starting. The SPAC then goes public as a shell company and begins acquiring other companies in the associated industry. Selling to a SPAC is usually an attractive option for owners of smaller companies built from private equity funds.

The U.S.-Canadian market questions that this rising practice asks are: Can Canadian companies enter a bigger market and be more successful? Is it advisable for U.S. companies to sell their assets to Canadian corporations whose records may be marred by a history of losses and a lack of proper corporate governance? Regardless — if both SPAC’s and Canadian bailout money is here, what comes next?

What is Driving this Bull Market?

Underpinning these movements are record cannabis sales internationally, making last year’s $15 billion dollars’ worth of sales in the U.S. look small in comparison. New markets have opened up in various states and countries throughout 2020, and that trend is only expected to continue. New demographics are opening up, especially among older age groups. This makes sense, as most cannabis sales — even in a recreational setting — are people treating something that ails them like insomnia or aches and pains.

Cannabis is set to take off, and we are entering only the second phase of its market expansion. The world is becoming competitive. Well-run companies that are profitable in key markets are prime targets for bigger, growing companies. At the same time, the world of SPACs will continue to drive valuations. Irrespective of buying assets, growing infrastructure is and will continue to be greatly needed.

The Elusive Profitability Factor

When Canada blew up, one of the biggest changes was companies began focusing the year on cost cutting and — most importantly — profitability. Profitability became the buzzword. But bigger companies are on the search for already-profitable enterprises, not just those that have the potential to be. However, profitability is currently still unobtainable in Canada. Reasonable forecasters should expect this year will show a few companies getting bailed out while many others will be forced to either merge for survival or declare bankruptcy.

An ideal company’s finances should highlight not only revenue growth, but also profitability. Attention should be focused on how well businesses are run, and not on how much money they have the potential to raise or spend. Over the years, there have been many prospective companies that spent hundreds of millions only to barely operate, and are now shells in litigation. Throwing money at any deal should have been a lesson learned in the past, but SPACs are tempting because they are trendily associated with new, interesting management styles and charismatic businesspeople.

Companies should be able to present perfect and clear financials along with maintenance logs for all equipment. In today’s day and age, books must be stellar and clean. As money pours into SPACs, asset valuations for all qualities of companies will rise. The focus instead becomes about asset plays, which will cause assets to continue rising as money is poured into SPACs.

Once upon a time, if number counters presented a negative review or had to dig too much, executives would turn a cold shoulder on investment. But in the age of SPACs, these standards of evaluation will be greatly undervalued. Aging equipment and reportability of every piece of equipment may or may not be properly serviced and recorded in a fast-moving market. Costs of repair or replacing equipment that isn’t properly maintained may be a problem of the past. Because when money comes fast, none care for the gritty details.

Issues for SPACs

Shortage of talent and training has become a big concern already in the era of SPACs. How many quality assets are out there? Big operators in the U.S. are content and don’t see Canada as an enticing market to enter. So, asset buys are likely to primarily be in the U.S. Large companies like Aphria may buy out some of the major American players, but most Canadian companies will use new funding rounds to pay down debts. Accordingly, they will then be forced to piece together smaller operators as a strategy.

A cannabis company’s personnel and office culture are very important when looking to integrate into a larger corporate culture. Remember, it’s not just the brick and mortar that is being invested into, it is also the people that run a facility. Maintaining employee retention when a deal occurs is always critical. Your personnel should be highly trained and professional if you want to exit. Easy to plug-in corporate structures make all the difference in immediately gaining from the sale or having to retool the shed and bring in all new people.

The rise of the SPAC-era and Canadian entry into the U.S. market will cause asset increases, but it is only the second chapter in the market expansion of cannabis. Proper buys will nail profitability, impeccable books, proper maintenance records and will have created an efficient corporate structure with talented personnel. The rest will be overpriced land buys that will require massive infrastructure spending. The basics of a well-run organization don’t change. The cannabis market is going to ROAR, but don’t worry if the SPACs pass you by- they are buying at the start of cannabis only.

February 3, 2021

Canadian Lab Offers Vapor/Smoke Analysis

By Cannabis Industry Journal Staff

No Comments

According to a press release sent out last week, Complex Biotech Discovery Ventures (CBDV) has expanded their testing capabilities considerably with the new addition of a vapor/smoke analyzer. CBDV is a licensed cannabis and psilocybin research laboratory embedded in the University of British Columbia, led by CEO Dr. Markus Roggen.

Dr. Markus Roggen, Founder of Complex Biotech Discovery Ventures (CBDV)

The ability to analyze vapor and smoke is a relatively novel concept for the cannabis space, but has been utilized by the tobacco industry for years now. In the early days of adult-use cannabis legalization in the United States, stringent testing regulations for contaminants like pesticides were adopted out of a fear for what would happen when consumers ingest toxic levels of contaminants.

One of the common refrains iterated throughout the industry over the past ten years was that there just wasn’t enough research on how different contaminants affect patients and consumers when burned and inhaled. We still don’t know too much about what happens when someone smokes a dangerous pesticide, such as myclobutanil. Beyond just contaminants, the new technology allows for companies to measure precise levels of cannabinoids in vapor and smoke, getting a more accurate reading on what cannabinoids are actually making it to the end user.

This new development coming from our neighbor to the north could lead to a breakthrough in the cannabis lab testing and research space. CBDV claims they can now analyze cannabis material with a much more in-depth analysis than basic compliance testing labs. The new technology for analysis of smoke, vapor, plant material and formulations allows companies to thoroughly understand their materials in each stage of the product formulation process, all the way to product consumption.

Beyond just smoke and vapor analysis CBDV also offers NMR spectroscopy, metabolomics, nanoparticle characterization, computational modeling and other testing services that go far beyond the traditional compliance testing gamut.

“Our new services offer comprehensive insights into plant material, extracts, end-products and even the smoke/vapor by using state-of-the-art analytical instruments,” says Dr. Roggen. “By understanding the chemical fingerprint of the material, cannabis producers can eliminate impurities, adjust potencies, and optimize extraction processes before wasting money and resources on producing inconsistent end products. As a chemist I am really excited about adding NMR and high-res mass spectroscopy to the cannabis testing offerings.”

January 4, 2021

The Cannabis Industry and Tax Implications of Entity Structure: Issues to Consider

By Calvin Shannon

2 Comments

This piece is intended to provide some considerations that current and potential license holders should think about as they work with advisors to make entity selection decisions or consider potential tax elections. Please note that this article is a high-level overview and is not intended to declare the best type of entity structure for a license holding entity. Although there are numerous tax variables that should be contemplated, tax issues are not the only concerns relevant to determining entity type. In addition, some states may tax entities differently than how the entity is taxed for federal purposes.

First, let’s look at the legal entity types that may be set up to hold a license, operate a business and what that may mean for how an entity is taxed. Often, entities are set up as either limited liability companies or corporations.

If a limited liability company is organized and the entity is owned by only one owner, a single member LLC, the default tax treatment would be that the entity is disregarded for tax purposes. In other words, it would not file a separate federal income tax return, except in some states including CA, TX, TN and RI. All the tax consequences of the activities within the legal entity are reported on the tax return of the owner of the entity.

If a limited liability company is set up and the entity is owned by more than one owner, a multiple member LLC, the default tax treatment would be that the entity is taxed as a partnership. An entity taxed as a partnership reflects the tax consequences of the activities within the legal entity on a partnership return. The partnership generally does not pay tax on the activity, but rather the taxable income and loss are passed through to the owners of the LLC. The owners of the LLC reflect the taxable income or loss on their tax return and are responsible for paying any resulting tax. In the rare instance of an entity being audited, there is a possibility that the entity may have to pay tax on the partners behalf, depending on the ownership structure. Either a single member LLC or a multiple member LLC may elect to treat the LLC as a C-corporation or an S-corporation for tax purposes.

The Taxation of C-Corporations & S-Corporations

The default treatment for an entity set-up as a corporation is the entity will be taxed as a C-corporation. An entity taxed as a C-corporation, including an LLC electing to be taxed as a C-corporation, pays the tax on any taxable income generated by activities within the entity. Additionally, any distributions of earnings from the C-corporation to the owners of the entity are generally considered dividends which are required to be reported as taxable income by the owners when received. In other words, the earnings of an entity taxed as a C-corporation are potentially taxed twice. Once, as they are earned within the entity, and then again upon distribution to the owners of the entity.

An entity set-up as a corporation, a single member LLC or a multiple member LLC may elect to be treated as an S-corporation. Like an entity taxed as a partnership, an S-corporation does not pay tax at the entity level, but rather passes the taxable income and loss through to the owner or owners. Additionally, like a partnership, distributions from an S-corporation are not taxable as dividends to the owner when received.

Since we covered how different entities are taxed based on how they are set-up, and what elections they may or may not make, we will explore some of the issues that should be considered when making an entity selection. We will also address potentially electing to treat an entity one way or another for tax purposes.

S-Corporations

Advantages: The advantages of an S-corporation are limited to the avoidance of double taxation associated with C-corporations, as well as some potential benefits of lower Social Security and Medicare taxes.

Disadvantages: The primary disadvantage of an S-corporation for a license holding company is any non-deductible expenses resulting from 280E are passed through to the owner(s), which then reduces the ownership’s tax basis in its investment in the entity. A reduction in tax basis is determinantal to owners of an entity because the basis is used to reduce taxable income when/if the owner liquidates ownership in the entity.

Other disadvantages of S-corporations include but are not limited to restrictions on ownership of the entity, a requirement for reasonable compensation paid to owners and a lack of flexibility in the allocations of earnings among owners.

Partnerships

Advantages: The advantages of a partnership include but are not limited to the avoidance of double taxation associated with C-corporations, flexibility in the allocation of earnings and losses among owners, and flexibility in the type of owners of the entity.

Disadvantages: Like S-corporations, the primary disadvantage of a partnership is any non-deductible expenses resulting from 280E are passed through to the owner(s).

Other disadvantages of partnerships include potential self-employment taxes on earnings allocated to active owners, potential complexity in the allocations of taxable income and losses among partners in entities with many owners or different classes of ownership.

C-Corporations

Advantages: In contrast to S-corporations and partnerships, the tax basis resulting from the ownership’s investment in the entity is not subject to reductions from non-deductible expenses being passed through to owners. This protection of tax basis is particularly important to owners of license holding entities.

An additional advantage of C-corporation tax treatment may be a lower tax rate applied to taxable income.

Disadvantages: The most significant disadvantage of C-corporation tax treatment is the potential double taxation of earnings that might be applicable if the entity does have earnings that are distributed.

In addition to the items address above, the advantages and disadvantages of the entity type and related tax elections, additional considerations include:

How much of the 280E nondeductible expenses will the taxpayer be subject to?
How much earnings will the entity be distributing to the owners?
How complex is the entity’s ownership?
The lack of certainty regarding whether or not the qualified business income deduction (QBID) enjoyed by pass-through entity owners is allowable as a deduction by owners receiving pass-through income from an entity subject to 280E.
Are there plans for selling the entity and if so, what is the time horizon for doing so?

At Bridge West, we advise taxpayers to consult with cannabis advisors who have experience in the industry, can help navigate the complexities of tax compliance and Code Section 280E and are experienced with entity structures.

June 19, 2020

Cannabis Contracting: The Potential Invalidity Defense Created By Federal Prohibition

By Brett Schuman, Barzin Pakandam, Jennifer Fisher, Nicholas Costanza

No Comments

The overwhelming majority of Americans now live in a state where cannabis is legal at the state level for at least some purposes.¹ However, cannabis (excluding hemp) remains criminal under federal law for all purposes. This conflict between state and federal law presents challenges for participants in the state legal cannabis industry, including enforcing their contractual agreements. This is because a number of federal court rulings have called into question whether contracts involving cannabis are enforceable in federal court.

In this article, we explore how federal courts and state legislatures have addressed the enforceability of contracts relating to cannabis and provide some practical tips for cannabis companies to protect their contractual rights.

The “Illegality Defense” in Federal Courts

“No principle of law is better settled than that a party to an illegal contract cannot come into a court of law and ask to have his illegal objects carried out . . . .” Mann v. Gullickson, 2016 WL 6473215 at *6 (N.D. Cal. Nov. 2, 2016) (quoting Wong v. Tenneco, Inc., 39 Cal. 3d 126, 135 (1985)).

Bart St. III v. ACC EnterprisesApplying this principle, a number of federal courts have refused to enforce contracts relating to state-legal cannabis. For instance, in Bart St. III v. ACC Enterprises, LLC, No. 217CV00083GMNVCF, 2020 WL 1638329 (D. Nev. Apr. 1, 2020), the parties entered into a loan agreement wherein the plaintiff-lender, Bart Street III, loaned the defendant cannabis cultivators in Nevada approximately $4.7 million to fund operating costs, pay down debts and purchase land for a cannabis cultivation facility in Nevada. Id. at *1-2. The loan agreement specified that it was governed by Nevada law. The cannabis cultivators defaulted on the loan, and Bart Street III sued for breach of contract and unjust enrichment. The cannabis cultivators argued that they could not be liable for breach of a contract that is illegal under the Controlled Substances Act of 1970, as amended (the CSA). Id. A federal judge in Nevada ruled that certain provisions of the loan agreement (i.e., a right of first refusal provision and another provision concerning disbursement of operating costs) were illegal under federal law and could not be enforced. The judge was unable to decide on summary judgment whether the illegal provisions could be severed from the other parts of the agreement, so on that basis the cannabis cultivators’ summary judgment motion was denied as to the breach of contract claim. However, the judge granted the cannabis cultivators’ motion as to the unjust enrichment claim based on the following reasoning: “Plaintiff cannot prevail for unjust enrichment because the parties’ contract involves moral turpitude. If the Contract is unenforceable, it is because Plaintiff invested in Defendants’ marijuana cultivation business primarily to obtain a pathway to an equity investment therein . . . . Providing funds in exchange for equity violates the CSA because it would allow the investor to profit from the cultivation, possession, and sale of marijuana . . . . Conspiracy to cultivate marijuana is a crime of moral turpitude.”

Polk v. GontmakherThe illegality defense was also raised in Polk v. Gontmakher, No. 2:18-CV-01434-RAJ, 2020 WL 2572536 (W.D. Wash. May 21, 2020), which involved two business partners—Polk and Gontmakher— who owned a licensed cannabis processing facility and retail store through an entity called NWCS. When Polk decided to leave the business, Gontmakher refused to acknowledge Polk’s ownership interest because Polk had a prior criminal record, which violated ownership requirements for cannabis businesses under Washington cannabis regulations. Polk sued Gontmakher for breach of a verbal partnership agreement and sought to recover past and future profits of the cannabis business. Gontmakher moved to dismiss, and the district judge granted the motion: “Mr. Polk’s claim that his requested relief would not require a violation of the CSA defies logic. He is demanding the future profits of a business that produces and processes marijuana in violation of federal law. How does Mr. Polk anticipate NWCS will generate these future profits? The Court cannot fathom how ordering [Gontmakher] to turn over the future profits of a marijuana business would not require them to violate the CSA. And as this Court has previously explained to Mr. Polk, it cannot award him an equitable interest in NWCS because to do so would directly contravene federal law.” Polk, WL 2572536 at *2.

J. Lilly, LLC v. Clearspan Fabric Structures Int’l, Inc.Certain federal district court judges have addressed the illegality defense directly, even when it has not been asserted by the parties. In J. Lilly, LLC v. Clearspan Fabric Structures Int’l, Inc., No. 3:18-CV-01104-HZ, 2020 WL 1855190 (D. Or. Apr. 13, 2020), a licensed cannabis cultivator in Oregon contracted with Clearspan, a lessor of commercial greenhouse equipment located in Connecticut, to lease greenhouse equipment for the facility and also have the facility constructed. After construction began, the cultivator notified Clearspan (and the sub-contractor) of numerous defects in the facility that were impeding cultivation efforts, and after Clearspan allegedly fixed only one defect, the cultivator sued for breach of the agreements and claimed lost profits due to the inability to cultivate cannabis, in the amount of $5.4 million. While Clearspan moved to dismiss the claims on the basis that the cultivator waived any contractual right to consequential damages, the District Court raised the issue of the illegality of the contracts under federal law sua sponte at oral argument. After supplemental briefing on the issue, the Court held that “awarding Plaintiff damages for lost profits [for the sale of cannabis] would require the Court to compel Defendants to violate the [CSA…and] provides an independent basis to dismiss Plaintiff’s lost profits claim in addition to” the issue of waiver, and other merits issues. Id. at *11-12.

And in Ricatto v. M3 Innovations Unlimited, Inc., No. 18 CIV. 8404 (KPF), 2019 WL 6681558 (S.D.N.Y. Dec. 6, 2019), Ricato (an investor) and M3 (the intended cannabis operator and licensee) entered into an agreement to purchase a plot of land in California for M3 to develop as a cannabis processing facility. The investor sued to enforce the investment instrument, and M3 moved to dismiss. The court granted M3’s motion to dismiss on other grounds but noted that “it is not readily apparent to the Court that it could [even] enforce such a contract [as] ‘[m]arijuana remains illegal under federal law, even in those states in which medical marijuana has been legalized,’” such as California. Id. at *5, n.4.

Ricatto v. M3 Innovations Unlimited, Inc.However, under some circumstances a federal court may enforce a cannabis contract. In Mann v. Gullickson, Mann loaned Gullickson money to be used in a cannabis-related business. The agreement was governed by California law. When Gullickson defaulted on the promissory note, Mann sued for breach of contract. Gullickson asserted that the contract was illegal under federal law and moved for summary judgment. In an order denying Gullickson’s motion, the court said that “even where contracts concern illegal objects, where it is possible for a court to enforce a contract in a way that does not require illegal conduct, the court is not barred from according such relief.” 2016 WL 6473215, at *7.

Federal courts are wary of parties seeking the enforcement of cannabis contracts. If there is any possibility that the issuance of a court order enforcing the contract would result in a party violating the CSA, federal courts are likely to deny relief.

State Laws Protecting the Enforceability of Cannabis Contracts

At the state level, legislatures in some states that have legalized cannabis for adult use have enacted laws to protect the enforceability of cannabis contracts. These statutes specifically exempt commercial cannabis activities from general laws voiding contracts that are in furtherance of illegal activities. Examples of these state laws include:

Massachusetts: In December 2016, Massachusetts enacted a statute providing that “[c]ontracts pertaining to marijuana enforceable” and providing that contracts entered into by cannabis licensees or their agents, or by landlords of cannabis licensees, “shall not be unenforceable or void exclusively because the actions or conduct permitted pursuant to the license is prohibited by federal law.” (Mass. Gen. Laws ch. 94G, § 10)

California: In January 2019, California enacted a statute providing that “commercial activity relating to medicinal cannabis or adult-use cannabis conducted in compliance with California law and any applicable local standards, requirements, and regulations” shall be deemed the lawful object of a contract and not contrary to law or against public policy, notwithstanding any law that requires all contracts have a “lawful object” under state or federal law. (Cal. Civil Code § 1550.5)

Nevada: In 2016, a ballot initiative was passed in Nevada, which was then codified under state law, declaring “[i]t is the public policy of the People of the State of Nevada that contracts related to the operation of marijuana establishments under this chapter should be enforceable,” and that such contracts “shall not be deemed unenforceable on the basis that the actions or conduct permitted pursuant to the license are prohibited by federal law.” (N.R.S. § 678B.610).

Similar statutes have been enacted in other states, including in Oregon (January 2018), Michigan (December 2018), Illinois (June 2019) and Colorado (January 2020). See Or. Rev. Stat. § 475B.535 (In Oregon, “[a] contract is not unenforceable on the basis that” commercial cannabis activity legal in Oregon is illegal under federal law); Colo. Rev. Stat. § 13-22-601 (similar to Oregon); Mich. Comp. Laws § 333.27960 (Public policy in Michigan is that “…contracts related to the operation of marihuana establishments [are] enforceable.”); 410 Ill. Comp. Stat. § 705/55-75 (similar to Michigan).

However, many states that have legalized cannabis do not have statutes exempting contracts relating to cannabis activities from the illegality defense.

Contracting Tips for Cannabis Companies

Notwithstanding the uncertainty and inherent risks caused by the conflict between federal and state law, there are certain steps parties entering into commercial cannabis agreements can take to protect their contractual rights, including:

Always include a forum selection clause specifying resolution of disputes in state court and waiving any right to remove the dispute to federal court.
If entering into an agreement in a state that has enacted a statutory provision exempting cannabis contracts from the illegality defense, consider selecting that state’s law (as opposed to New York or Delaware law, which are often the jurisdictions of choice for transactional lawyers who don’t know better) in a choice of law provision.
If neither the parties nor the performance of the agreement have any nexus to a state that has enacted a statutory provision protecting the enforceability of cannabis contracts, consider incorporating the contracting entity in one of those states. In the same way that Delaware is the jurisdiction of choice for incorporating most companies, a state like California may on balance be the better choice for cannabis industry participants due to the legal recognition of commercial cannabis activity.
Consider using an arbitration clause in commercial cannabis agreements. These clauses require parties to arbitrate disputes that may arise in connection with the agreement. As a general rule, arbitration is both more efficient and less expensive than litigation, and arbitrators are less likely than federal judges to refuse to enforce an agreement because it relates to federally illegal cannabis activity.

Conclusion

Notwithstanding expanding legalization at the state level, and general federal tolerance of the state-legal cannabis industry, federal courts remain a dangerous place for cannabis companies. If possible, cannabis companies should specify state court (or arbitration) for resolution of disputes in their contracts, and they should choose a state law that expressly excludes cannabis contracts from the illegality doctrine.

References

Cannabis is legal for medical purposes in 33 states plus the District of Columbia; cannabis is legal for adults over 21 in 11 states plus the District of Columbia. Approximately 76.5% of the population of the United States lives in a state with some form of legal cannabis. See https://www.census.gov/data/tables/time-series/demo/popest/2010s-state-total.html#par_textimage_1574439295. This figure excludes Texas, which has a limited medical cannabis program as of this writing. However, if Texas is included, then over 85% of the population lives in a state with some form of legal cannabis.

May 19, 2020

The Brand Marketing Byte

Business Development Impact: Chalice Farms

By Cannabis Industry Journal Staff

No Comments

The Brand Marketing Byte showcases highlights from Pioneer Intelligence’s Cannabis Brand Marketing Snapshots, featuring data-led case studies covering marketing and business development activities of U.S. licensed cannabis companies.

Here is a data-led, shallow dive on Chalice Farms:

Chalice Farms – Business Development Impact

Based in Oregon, this company is a retail and edibles brand in the Golden Leaf Holdings portfolio. Chalice Farms has a number of locations in the Portland area, capitalizing on an effective regional strategy.

However, 2019 was a tough year for Oregon cannabis companies. Increased competition and heavy market saturation led to plummeting prices, forcing Chalice Farms to implement layoffs last Spring. 2020 appears to show Chalice Farms doing much better than the previous year.

In addition to tightening operations, the company engaged in several new business development initiatives recently. They’ve expanded distribution of their signature fruit chews into California and Nevada. They also implemented a sales initiative called “an extended 420 celebration,” covering the month of April. All six of the company’s branded retail locations have pivoted to curbside pickup and home delivery during the coronavirus pandemic.

All of those initiatives led to a boom in earned media for Chalice Farms. They were mentioned on CNN and in Forbes, among other national news outlets. The company also improved their web activities considerably, adding keywords, backlinks and a notable increase in web traffic.

Chalice Farms ended the month of April on a high note, moving to the 11^th hottest web property, according to data from Pioneer Intelligence. This continued into May; Chalice Farms claimed the #26 position on the Pioneer Index, the highest it has been to date.

May 5, 2020

Some CBD Companies Are Getting Millions in Federal Aid

By Aaron G. Biros

No Comments

As we’ve covered previously, the coronavirus pandemic has impacted the cannabis industry in the United States in a number of ways. Many states with legal medical and recreational cannabis markets have deemed those cannabis businesses essential, allowing them to remain open during statewide stay-at-home orders. Congress passed the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) to help small businesses through the economic downturn, directing trillions of dollars to the Small Business Administration (SBA) to administer emergency loans, paycheck protection programs and other financial assistance to small businesses affected by the coronavirus pandemic.

CV Sciences received $2.9 million in federal aid from the SBA

However, pretty much all state-legal medical and recreational cannabis businesses are ineligible to receive money from the SBA because cannabis is designated as a Schedule 1 controlled substance. While Rep. Earl Blumenauer (D-OR) and Rep. Ed Perlmutter (D-CO) introduced legislation recently that would allow cannabis businesses to become eligible for federal assistance, it is unclear if that bill will become law. Furthermore, even if it does pass, cannabis businesses will likely receive little or no help at all, as a vast majority of the funds administered by the SBA have already been spoken for.

Enter the hemp and CBD products market. Thanks to the 2018 Farm Bill, which removed cannabis containing less than 0.3% THC from the list of controlled substances, hemp and CBD companies are not exempt from the SBA’s relief efforts.

According to VICE News, The Trump Administration has handed out millions of dollars to companies that sell CBD products. When VICE News looked into some SEC filings, they found more than $4 million in federal loans that have been granted to CBD products companies.

They found three CBD companies that scored big with federal assistance:

CBDMd: $1.5 million in federal aid
CV Sciences: $2.9 million in federal aid
Lifted Made: $150,000 in federal aid

Despite state-legal medical and recreational cannabis businesses being left to fend for themselves, these large online CBD products retailers have received more than $4 million in federal aid money.

December 2, 2019

FDA Issues Warnings to 15 CBD Companies, Updates Safety Concerns

By Aaron G. Biros

1 Comment

On November 25^th, the U.S. Food and Drug Administration (FDA) sent out warning letters to 15 different companies for “illegally selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act).” They also published a “Consumer Update” where they express concern regarding the general safety of CBD products. The press release also states that at this time the FDA cannot say that the CBD is generally recognized as safe (GRAS). To see the list of companies that received warning letters, check out the press release here.

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

While the FDA is still trying to figure out how to regulate hemp and hemp-derived CBD products, they published these releases to let the public know they are working on it, according to FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D.:

“As we work quickly to further clarify our regulatory approach for products containing cannabis and cannabis-derived compounds like CBD, we’ll continue to monitor the marketplace and take action as needed against companies that violate the law in ways that raise a variety of public health concerns. In line with our mission to protect the public, foster innovation, and promote consumer confidence, this overarching approach regarding CBD is the same as the FDA would take for any other substance that we regulate. We remain concerned that some people wrongly think that the myriad of CBD products on the market, many of which are illegal, have been evaluated by the FDA and determined to be safe, or that trying CBD ‘can’t hurt.’ Aside from one prescription drug approved to treat two pediatric epilepsy disorders, these products have not been approved by the FDA and we want to be clear that a number of questions remain regarding CBD’s safety – including reports of products containing contaminants, such as pesticides and heavy metals – and there are real risks that need to be considered. We recognize the significant public interest in CBD and we must work together with stakeholders and industry to fill in the knowledge gaps about the science, safety and quality of many of these products.”

The Warning Letters

The warning letters sent to those 15 companies all mention a few types of violations to the FD&C Act. Those include marketing unapproved human and animal drugs, selling CBD products as dietary supplements and adding CBD as an ingredient to human and animal foods. All 15 companies are using websites, online retailers and social media in interstate commerce to market CBD products unlawfully, according to the press release.

This is not the first time the FDA has sent out warning letters to CBD companies. Previously, most of the warning letters were sent out regarding companies making unsubstantiated drug and health claims. This new round of 15 warning letters reaches beyond just unsubstantiated claims and identifies a few new areas of regulatory oversight that CBD companies should be wary of.

Of the 15 warning letters sent out, some were sent to companies that are marketing CBD products to children and infants, some were sent to companies using CBD as an ingredient in food products, some were marketed as dietary supplements and one company marketed their products for use in food-producing animals, such as chickens and cows. With this press release, the FDA is saying loud and clear that the above list of marketing strategies are currently unlawful, that is, until they finish their work in devising a regulatory framework for hemp-derived CBD products.

Updated Safety Concerns

Regarding the FDA saying they cannot deem CBD as generally recognized as safe (GRAS), they published a fact sheet titled “What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD.” The key words there should be noted in the parentheses: And What We’re Working to Find Out. The FDA’s research is by no means over with and, if anything, has only just begun. Refer to the fact sheet to see why the FDA couldn’t say that CBD is GRAS.

In the FDA’s research, they have found a few potential health problems associated with taking CBD. During the marketing application for Epidiolex as a new drug, the only approved CBD drug on the market, the FDA identified a couple of safety risks. The first one is liver injury, which they identified in blood tests, but mentioned that it could be managed easily with medical supervision. Without medical supervision, potential liver injury due to CBD consumption could go undetected, according to the FDA.

The second health concern is drug interaction. During the new drug approval process for Epidiolex, they found that other medicines could impact the dose of CBD and vice versa. The other major health concern they have is male reproductive toxicity. The FDA says that studies in lab animals showed male reproductive toxicity, including things like decrease in testicular size, inhibition of sperm growth and development and decreased circulating testosterone. They do mention, however, that “it is not yet clear what these findings mean for human patients and the impact it could have on men (or the male children of pregnant women) who take CBD.” The fact sheet also some side effects that CBD use could produce including sleepiness, gastrointestinal distress and changes in mood.

What Now?

The FDA says they are actively researching and working on learning more about the safety of CBD products. They listed a couple risks that they are looking into right now: Those include, cumulative exposure (What if you use CBD products daily for a week or a month?), special populations (effects of CBD on the elderly, pregnant or nursing women, children, etc.) and CBD in animals (safety of CBD use in pets or food-producing animals and the resulting safety of human food products like milk or eggs).

While the CBD products market could still be classified as a bit of a gray market currently, the FDA says they are working on researching it more to develop an appropriate regulatory framework. What that might look like is anyone’s guess. One thing that remains clear, however, is that the FDA will not tolerate CBD companies marketing products in ways described above. Those include making unsubstantiated health claims, marketing to children, using CBD as an ingredient in foods and marketing it as a dietary supplement.