On the afternoon of October 6, President Biden issued a statement that many would call an October Surprise. Biden announced a three-part plan addressing cannabis reform, taking the first steps since he has taken office to address his campaign promise of tackling cannabis prohibition.
In his speech, Biden laid out the three steps he will take: First, he is pardoning all prior federal offenses for simple cannabis possession. Second, he is calling on all governors to do the same for state-level offenses. Thirdly, he announced that he is initiating a federal review of the current Schedule 1 status of cannabis.
Too many lives have been upended because of our failed approach to marijuana. Hear from @POTUS on the three steps he is taking to right these wrongs. pic.twitter.com/IqOxHxjgue
As I often said during my campaign for President, no one should be in jail just for using or possessing marijuana. Sending people to prison for possessing marijuana has upended too many lives and incarcerated people for conduct that many states no longer prohibit. Criminal records for marijuana possession have also imposed needless barriers to employment, housing, and educational opportunities. And while white and Black and brown people use marijuana at similar rates, Black and brown people have been arrested, prosecuted, and convicted at disproportionate rates.
Today, I am announcing three steps that I am taking to end this failed approach.
First, I am announcing a pardon of all prior Federal offenses of simple possession of marijuana. I have directed the Attorney General to develop an administrative process for the issuance of certificates of pardon to eligible individuals. There are thousands of people who have prior Federal convictions for marijuana possession, who may be denied employment, housing, or educational opportunities as a result. My action will help relieve the collateral consequences arising from these convictions.
Second, I am urging all Governors to do the same with regard to state offenses. Just as no one should be in a Federal prison solely due to the possession of marijuana, no one should be in a local jail or state prison for that reason, either.
Third, I am asking the Secretary of Health and Human Services and the Attorney General to initiate the administrative process to review expeditiously how marijuana is scheduled under federal law. Federal law currently classifies marijuana in Schedule I of the Controlled Substances Act, the classification meant for the most dangerous substances. This is the same schedule as for heroin and LSD, and even higher than the classification of fentanyl and methamphetamine – the drugs that are driving our overdose epidemic.
Finally, even as federal and state regulation of marijuana changes, important limitations on trafficking, marketing, and under-age sales should stay in place.
Too many lives have been upended because of our failed approach to marijuana. It’s time that we right these wrongs. – President Joe Biden
Entrance into the cannabis industry is not equally accessible; it’s no secret it tends to be easier for those who are male and white. As a business leader, why should you take on the problem of equal market entrance opportunities? This just may become your company’s competitive advantage.
As a female entrepreneur with a first name associated with being male (and white, maybe a rancher in Wyoming), I have been accidentally invited to and witnessed the consequential shock of more than one exclusive, male-centric event, where any ladies were intended to be accessories and not present for business-talk with the boys. After enjoying their discomfort (and getting over my own), I see these moments as opportunities to advocate for inviting diversity into their discussion, seeking to make small changes to open doors for exponential progress. After all, it wasn’t so bad to have invited the woman, albeit accidentally; it was actually better because it happened.
In a dynamic and challenging industry, increasing diversity access is how to become future-ready. As will be discussed, companies see measurable financial performance and adaptability improvements with relatively small changes in leadership makeup. Here are three overarching tactics for you to increase cannabis market accessibility and champion diversity.
Facilitate Access to Capital for Cannabusinesses with Diverse Perspectives
The past two years of pandemic hardship have posed unique challenges for women, especially Black, Latina, and Indigenous women, who have had to put careers on pause to pick up additional heavy burdens of caregiving. Women’s unemployment is four times higher than men’s, and according to Forbes, the situation is worse for women of color.
Overall deal activity for female-founded companies is discouraging and downright dismal for Black female founders, who receive less than 1% of all venture capital investment. This is particularly vexing when considering that women-led or co-founded start-ups generated 78 cents of revenue compared to 31 cents for male-only-led startups over five years. EBIT margins were nine percentage points higher than companies with below-average diversity on their management teams. Relatively small changes exponentially improve operating earnings over operating sales.
Relatively small changes exponentially improve operating earnings over operating sales.
It’s always been difficult for women to access capital. Women have historically been cordoned into home-keeping and caregiving roles and are often still expected to balance those capacities alongside a full-time career. Accordingly, female entrepreneurs receive fewer invitations to extra-work events and business relationship-building opportunities, such as pursuing financing, mergers, or joint ventures.
Companies with diverse leadership teams have reported nearly twenty percent higher revenue from innovation. Investors would do well to recognize these are the businesses better able to respond and adapt to changes in customer demand quickly.
Increase Diversity Awareness and Facilitate Equal Opportunity
While financial investments are imperative, consider the following non-pecuniary methods of support as part of a full-picture, equitable accessibility solution.
Invite Activity, Provide Mentorship
Businesspeople can play a critical role in accelerating inclusion by actively seeking out people they do not already know. Employers can do this through the non-financial investment of time and resources to grow the pipeline of underrepresented people with skills to serve on investment teams. When under-invested groups bolster one another, the likelihood that investment pans out increases.
Mentoring must be a part of this process, as it provides essential guidance and support for individuals looking to enter or advance within these fields. By creating opportunities for mentorship and collaboration, you can play an active role in breaking down barriers and building a more inclusive economy for everyone.
Open the Door to Accessing Opportunities
Businesses can increase diversity awareness and facilitate equal entry into the cannabis industry by opening the door to events that help connect underrepresented candidates to professional development and capital.
Hosting free webinars is a great way to facilitate learning, conversation, and the exchange of empowering ideas. Webinars allow attendees to ask personalized questions and present your business with a stage from which you can speak about the importance of equity and inclusion.
Consider attending, sponsoring, or running a job fair with a focus on diversity hiring. Diversity hiring practices help businesses identify qualified candidates from different backgrounds, leading to a less homogenous workforce.
Make Continued Education Central
As the President of Oaksterdam University, I see firsthand the importance and empowering quality of ongoing education. I also recognize that not everyone can afford or receives equal access to continued education and accordingly offer this advice to help bolster equitable educational opportunities.
Make partnerships with educational institutions to offer your workforce chances to learn, and ensure they have paid working time to do so. If you can reduce the burden of learning for candidates with extra-work responsibilities, they have a greater chance of absorbing and putting that information into practice. If you have an employee with an incredible entrepreneurial idea, boost them up by offering to pay for a capital-raising class or a fundamental business course they may not be able to afford otherwise.
No one solution will “fix” equal access to education. Every step from open-source databases and free webinars to full college degrees is an incremental movement toward increased cannabis industry participation for traditionally disadvantaged populations.
Realize Social Equity Programs Are Not a Catch-All
Rather than focusing on any one aspect of diversity, the goal should be to invest in and build diverse teams across many dimensions.
Even the best-intentioned social equity program cannot accommodate every disadvantage a potential candidate will encounter. Take women as an example: There are many accommodations to consider for female-identifying participants, as they are at a more significant disadvantage in the licensing/permitting and job preparedness process. Some call for women participants qualifying for cannabis equity program services to receive additional funds and services (e.g., funding for childcare) to ensure equal access to opportunity.
The cannabis industry cannot atone for all the damages of the drug war, nor can a nascent industry that is not federally legal pay to uplift all of society. With that said, cannabis industry investors, executives, and workers might be the tipping point back toward baking justice, equity, and access to the laws we operate under. Better yet, we can raise expectations of one another as we do business and ask, “What do you do to increase fair play, diversify your leadership team, and address the imbalance?”
A Person is Not Diverse, But the Cannabis Industry Can Be
Addressing social equity and the concept of diversity can feel amorphous and confusing. Above all, it’s imperative to remember that a single person is not diverse; rather, a group of people is. A team can be diverse, and within your team is a great place to begin shaping the industry you wish to see. Rather than focusing on any one aspect of diversity, the goal should be to invest in and build diverse teams across many dimensions. Value comes from a range of differences, such as the national origin of executives, the variety of industry backgrounds, education levels, ages, and finding gender balance. The goal is that these different people feel they belong.
Equal market accessibility is not a problem you can solve passively — it must constantly be spoken of, worked toward, and embodied within each business decision and entrepreneurial move. An industry full of entrepreneurs making such decisions will undoubtedly result in a more equitable market than the one we’ve built so far. You will find yourself in a room of folks just like this. Lean into the awkward and invite the unfamiliar in – you will find you and your company are better for it.
Businesses often require outside capital to finance operating activities and to enable scaling and growth. Financing in the cannabis industry is notoriously challenging with regulatory obstacles at the local, state and federal levels. Recent market dynamics pose additional challenges for both financiers and cannabis operators.
We sat down with Travis Goad, Managing Partner of Pelorus Equity Group to learn more about Pelorus and to get his perspective on recent market trends.
Aaron Green: In a nutshell, what is your investment/lending philosophy?
Travis Goad: Our investment and lending philosophy is focused on being honest, upfront and doing what we say we’re going to do for both our borrowers and our investors. At Pelorus, we lend against cannabis-use real estate assets.
Every lender in this space is a hybrid between real estate and corporate lending. However, if you think about it as a political spectrum, with one side being pure real estate lending and the other pure corporate lending, Pelorus is as close as you can be to pure real estate lending in this sector while also being properly collateralized. What sets us apart from our recently launched lending peers is that we lend against the real estate asset value only, even though we’re collateralized by the real estate and license.
We lend between 60% to 75% of the value of the real estate, which means sponsors need to raise equity for the 25% to 40% remainder of the project cost. This allows us to be covenant-lite for our borrowers while giving them the flexibility to grow their business as they see fit.
Travis Goad, Managing Partner at Pelorus Equity Group
The other lending options in the space are much different. While our lending peers may call themselves mortgage REITs, they really are based on a business development company (BDC) lending model. While they may lend borrowers as much as 150% to 180% of the real estate value, they will require significant financial covenants, require control of major decisions and most often want a board seat. We’ve seen this model severely hamstring growth of companies.
The third option available to sponsors is a sale-leaseback. In this structure, lenders will buy your real estate for 100% of the value, but require you to enter into a 15-to-20-year lease that increases 3% each year. There is a temporary benefit to this model from a federal tax perspective, but that will go away when 280E is addressed, either by descheduling cannabis or amending the tax code.
While this structure means you don’t have to raise equity, it gives up the most valuable asset cannabis companies have in the early stages of the industry. Once you sell this asset, it hampers optionality for sponsors – and in a fast-growing industry like cannabis – optionality is the most critical thing a company has. Pelorus’ structure allows maximum optionality, as well as the ability to lower your cost of capital as the industry matures.
From an investor standpoint, they should know that the BDC and sale-leaseback models are a lot riskier than our model. While we’ve seen those models work well in mature industries, we think the cannabis industry is too early-stage and too volatile to go that far out on the risk spectrum. We have the longest history in the space of deploying capital successfully and seeing it returned. Prior to making any loans, we spend a lot of time underwriting the company we’re working with, the real estate and the projections. We look for strong sponsors, great projects and attractive markets.
Before we entered the cannabis lending space, our team at Pelorus had more than 5,000 transactions under our belt, worth $5B, and we leveraged our decades of underwriting experience when starting the Pelorus Fund. As the first dedicated lender in the cannabis space, we have more data and experience than anyone in terms of transactional volume – we’ve looked at more than 2,000 deals and have made 71 deals, worth $468M. We know the intricacies of every market, the particular ordinances, what the costs should be, and utilize the data to help our borrowers succeed. Through our deals and sustained success, we’ve made a name for ourselves as the most trusted and efficient lender in the cannabis space.
Green: What types of companies are you primarily financing?
Goad: We finance construction and stabilized loans for a range of clients including MSOs, SSOs and ancillary companies. We don’t lend on outdoor cultivation, but are open to working with any cannabis-related business that has commercial real estate, strong financials and experience in the cannabis space. Today, our sweet spot is closing loans in the $10M to $30M per transaction range, but we can fund loans $100M+ and as low as $5M. Since 2016, we’ve financed 4.2M feet of cannabis-use properties for a total of $468M in loans – roughly 15% to 20% of the entire US market.
Green: What qualities do you look for in a cannabis industry operator or operating group?
Goad: We are meticulous in our underwriting process and underwrite the company, the real estate and the market. We’re one of the few lenders today that has capital to deploy, which has given us the opportunity to continue to take market share while also increasing the quality of our borrowers. Whether you’re an MSO, smaller state operator or ancillary business, we recognize quality across the sector. Brand affinity and shelf space are critical in this market, and we like working with companies that have a competitive edge in getting their branded product to customers. We try to target companies that offer a unique product, or have a unique position within the state they are located.
To qualify for our lending program, borrowers need to own their real estate. If the sponsors own the real estate or intend to own the real estate, we offer two main lending products: we provide construction loans that range between 60% to 75% of the project that are typically 18-month terms; and more recently implemented, we also lend on fully stabilized assets that are cash flowing and operational up to 75% of the value and up to a 5-year term.
By the time a borrower comes to us, they should already have a license (or be acquiring a license at closing), have their required equity raised to completely fund the project and have all local approvals to begin construction.
Green: Capital market dynamics have led to significant public cannabis company revaluations in 2022. How has this affected your business?
Goad: As far as how market dynamics have impacted our fund, we’ve been pretty insulated because we are a privately held company. From our inception, we’ve worked hard to create an innovative model, and have had many firsts. We were: the first dedicated lender in the cannabis sector; the first lender to become a private mortgage REIT; the first to be issued an FDIC warehouse line of credit; the first to get an investment grade rating; the first to issue an unsecured bond with institutional investors; the first to update our fund to a billion dollars. Amid all these firsts, we made a conscious decision not to go public. This has been one of the best decisions we’ve made and has shielded us from much of the market volatility we are seeing.
As for the broader market, we’ve seen our sponsors that are publicly traded impacted pretty significantly by the recent market dynamics. We’ve also seen flow-on effects for non-publicly traded firms. Our loan book is performing excellently, but we’re in a very challenging market for marijuana-related businesses to raise equity, making debt even more attractive. For most of our competitors, who chose to go public, they’ve been unable to raise much capital to deploy, whereas our market share is increasing and we continue to grow in this tough environment. We remain bullish on the sector in the medium/long term and are finding excellent opportunities to lend in this challenging environment.
Green: Debt on cannabis companies balance sheets have increased significantly in recent years. What is your perspective on that?
Goad: Increased access to debt capital markets is a sign of a maturing market. The U.S. cannabis sector has a great tailwind with growth of new markets, but it’s facing some significant headwinds tied to tax inefficiencies and inadequate state-level enforcement. All of these issues can be solved with political action, but so far that hasn’t happened and it’s causing pain in the industry. These industry dynamics are set against a broader macro backdrop of risk-asset repricing and increased volatility, which leads to outsized volatility in cannabis due to limited liquidity. That increased volatility has made it very challenging to raise equity in this market.
For companies that have strong assets on their balance sheet, they’re still able to access capital via the debt markets. This is creating clear winners and losers, as companies that choose to sell their real estate have significantly fewer capital raising options than those that choose to keep real estate assets on their balance sheets. Overall, this increased debt trend has been great for our business – our pipeline has increased rapidly and we’re able to lend to strong operators with solid assets at attractive rates for investors. Our fund continues to have inflows, and since we’re one of the few lenders with capital to deploy, we’re still open for business and deploying capital in this challenging environment.
Green: How does the lack of institutional investor participation in the cannabis industry affect your business?
Goad: The current regulatory environment impacts the type of investor that comes into this space. Rather than being dominated by institutions, this sector has largely been funded by retail investors and family offices. This has created challenges in aggregating large amounts of capital, both on the operator and the debt-fund side of the business. It can lead to delays in loan closings, as it takes borrowers a longer amount of time to raise the required equity to close their transaction. As we’re seeing with our publicly traded peer group, it can also lead to lenders having trouble raising capital to deploy. As for Pelorus, we’ve been very fortunate that our length of time in the industry and track record of successfully making loans and having them repaid has set us apart in fundraising. Our decision to stay private has been a critical factor in our fundraising success as well. Overall, the lack of institutional investor participation is a double-edged sword: the lack of liquidity has caused challenges broadly, but since we’ve had significant capital to deploy, it’s created great opportunities for us to make loans with attractive risk/returns in this challenging market.
Green: What would you like to see in either state or federal legalization?
Goad: Given the stalemate in the Senate and the sharp bipartisan divide, I don’t think federal legalization will happen during this administration. That said, there are incremental actions that the government should take to strengthen the cannabis sector. First of all, the Cole Memo needs to be reinstated to add additional protections for cannabis and cannabis-related businesses. As 280E has clearly been detrimental to the overall health of the cannabis industry, we also believe the tax code should be amended, or better yet, we should address the conflict between state and federal policy. We also need to get SAFE Banking approved in order to open up the cannabis sector to credit cards and potentially open up banking to the sector in a more material way. Unfortunately, there’s a choke point in the Senate to get SAFE Banking approved, since there needs to be 60 votes to be filibuster proof. And while there is some talk of SAFE Banking passing during the lame duck session, we are not holding our breath.
Green: What trends are you following closely as we head towards the end of 2022?
Goad: The biggest trends we’re following are on the legislative front (both federally and at state level), which heavily impact revenue and net cash flow growth for the industry. We’re following emerging state markets, such as Alabama and Mississippi, as well as current medical markets poised to transition to adult use in the near term, such as Missouri. The more addressable the population, the faster the industry can grow.
We’d also like to see current legal states address the often-heavy tax burdens that have led to additional challenges for legal businesses and kept illicit markets thriving. No state got everything right at the beginning, but we’re starting to see states address some of the inequities and harmful policies now. California has made some progress in this area, however there are many issues that still need to be addressed.
Federally, 280E is the other major headwind that needs to be addressed as extremely high tax rates are one of the biggest problems for the industry. We’d really like to see that addressed, as cannabis is the only new industry, I’m aware of in the U.S. that has had such disadvantages out of the gate.
The success of reputable cannabis and CBD brands has inspired an influx of inexperienced and disreputable competitors in the market. These so-called “bad actors” in CBD advertise products that are not manufactured under current Good Manufacturing Practices (cGMP), which help to ensure that all products are consistently produced and controlled according to specified quality standards. cGMP helps guard against risks of adulteration, cross-contamination and mislabeling to guarantee product quality, safety and efficacy.
Joseph Dowling, Author & CEO of CV Sciences
CBD products without cGMP regulations are often inaccurately labeled and deceiving to consumers. In fact, in a test of over 100 CBD products available online and at retail locations, Johns Hopkins Medicine found significant evidence of inaccurate, misleading labeling of CBD content. The prevalence of such brands not only reduces consumer confidence in CBD but also limits the growth of the sector as a whole. Fortunately, CBD consumers and retailers can easily discriminate between a well-tested, reputable brand and inferior bad actors with a few straightforward, minimum requirements to look out for when selecting a product.
Why are “bad actors” a problem for consumers and the industry?
Bad actors in CBD sell products that are not produced under cGMP conditions and are typically not tested by third-party laboratories to ensure identity, purity, quality, strength and composition. This means they are not verified for contaminants, impurities, label claims and product specifications. This frequently results in misleading advertising with inaccurate levels of cannabinoids or traces of compounds not found on the label, like THC. To combat this, the FDA issues warning letters to actors that market products allegedly containing CBD—many of which are found not to contain the claimed levels of CBD and are not approved for the treatment of any medical condition. Still, bad actors manage to slip through the cracks and deceive consumers.
The structure of cannabidiol (CBD), one of 400 active compounds found in cannabis.
Bad actors that put anything in a bottle and make unsubstantiated medical claims hurt the reputable operators that strive to create safe and high-quality products. It is easy for consumers to be drawn to CBD products with big medical claims and lower prices, only to be disappointed when the product does not produce the advertised results. Inaccurately labeled products may contain unexpected levels of cannabinoids, including ingredients that consumers may not intend to ingest, like Delta-9 or Delta-8 THC. Along with unexpected levels of THC, many CBD products available now are not as pure as advertised, with one in four products going untested for contaminants like microbial content, pesticides, or heavy metals.
Further, inaccurate labeling of products and their compounds also prevents consumers from establishing a baseline impact of CBD on their bodies, leaving them vulnerable to inconsistent future experiences. Such a poor experience can turn consumers off to the category as a whole, drawing their trust away from not only the bad actors but also the reliable, reputable brands on the market. The saturation of the market with these disreputable brands delegitimizes a category that has only just begun to break down the stigmas, creating stagnation rather than growth as consumers remain wary of low-quality products.
How can consumers identify bad actors in CBD?
There are several simple ways to identify a bad actor among CBD products and make certain that both consumers and retailers purchase quality, reliable and safe brands in legitimate sales channels. To start, consumers should avoid all CBD products that are marketed with unsubstantiated medical claims. This is a significant area of abuse, as brands that relate any form of CBD product to a disease state, like cancer, should not be trusted. The science to support such medical claims has not been completed, yet, product marketing is years ahead of the evidence to support such claims. Unsupported medical claims could also mislead consumers that may need more serious medical intervention.
Just some of the many CBD products on the market today.
Additionally, consumers must review the packaging, which should include nutrition information in the form of a supplement fact label. The label should include the serving size, number of servings per container, a list of all dietary ingredients in the product and the amount per serving of each ingredient. All labels should include a net quantity of contents, lot number or batch ID, the name and address of the manufacturer, and an expiration or manufacturing date. These signs of a reputable brand are easy to look for and can save consumers from the trouble of selecting the wrong CBD product.
What to look for when selecting a CBD product
With this in mind, products from reputable, tested brands can be identified by a few key factors. Reputable CBD companies are already compliant with the FDA regulations on nutritional supplements, including a nutritional or supplement fact panel on the packaging—just like vitamins. The information in this panel should include all the active cannabinoids in the product, both per serving and package. Clear potency labeling allows consumers to confidently select products that suit their needs and understand the baseline impact of CBD concentration on their bodies, thus helping them to tailor their experience with thoughtful product selection.
Reputable brands also include a convenient QR code on the packaging, linking the product to a certificate of analysis that details the testing results to demonstrate compliance with product standards and label claims. In terms of specific ingredients, consumers should be skeptical of high concentration levels of “flavor of the month” minor cannabinoids, which are often associated with unsubstantiated medical claims. Current scientific research has set its focus on major cannabinoids like CBD and Delta-9 THC, leaving additional research necessary for understanding minor cannabinoids. Minor cannabinoids are typically included in full spectrum products at concentrations found naturally in the cannabis plant, which is a safer approach to consuming CBD until more research is completed.
Consumers should not let the existence of unreliable, untrustworthy brands curtail their confidence in the CBD sector—there are many high-quality, safe and trusted brands on the market. With a knowledgeable and discerning eye, consumers and retailers can easily select top-quality CBD products that millions of consumers have found to improve many aspects of their health and well-being. Looking ahead, clear federal regulations for CBD products that require mandatory product registration, compliance with product labeling, packaging and cGMP will be crucial in weeding out bad actors and will allow compliant companies to gain consumer trust and responsibly grow the CBD category.
Business often require outside capital to finance operating activities and to enable scaling and growth. Financing in the cannabis industry is notoriously challenging with regulatory obstacles at the local, state and federal levels. Recent market dynamics pose additional challenges for both financiers and cannabis operators.
We sat down with Len Tannenbaum, CEO & Partner of Advanced Flower Capital Gamma (AFC Gamma, NASDAQ: AFCG) to learn more about AFC Gamma and to get his perspective on recent market trends.
Aaron Green: In a nutshell, what is your investment/lending philosophy?
Len Tannenbaum: AFC Gamma is one of the largest providers of institutional loans to cannabis companies nationwide in all aspects of production: cultivation, processing, and distribution. Cannabis companies, no matter the size, traditionally lack the lending opportunities that other enterprises have available, and that’s where AFC Gamma comes in. As an institutional lender, we provide financial solutions to the cannabis industry.
AFC Gamma is a commercial mortgage REIT that provides loans to companies secured by three pillars: cash flows, licenses, and real estate. We provide term loans, draw facilities, and construction loans. Each loan is unique and tailored specifically to meet the needs of our borrowers. This unique partnership approach with our clients allows us to find solutions to help them expand and grow alongside them.
Since starting AFC Gamma, we have completed almost $500 million of transactions. We provide capital to an industry that others do not and, in turn, allow these operators to build cultivation facilities, production facilities, and dispensaries.
Green: What types of companies are you primarily financing?
Len Tannenbaum, CEO & Partner of Advanced Flower Capital Gamma
Tannenbaum: AFC Gamma seeks to work with operators, ideally in limited license states. We make loans to companies secured by three pillars: cash flows, licenses, and real estate. We tend to lend to operators in regulatory-friendly states, such as: Ohio, Pennsylvania, New York, New Jersey, Maryland, Massachusetts, Arizona, New Mexico, Missouri, Illinois, Michigan, and Nevada. Traditionally, we shy away from states like California, Washington and Oregon given our approach to lending. We have 16 borrowers in 17 states, and what we look for are companies that we can grow with over the long term.
Green: What qualities do you look for in a cannabis industry operator or operating group?
Tannenbaum: We tend to work with three different buckets of operators. You have the large publicly traded multi-state operators (MSOs) we have lent to, such as Verano. Then you have the tier right below the top tier MSOs, where you have some public enterprises like Acreage, who is one of our borrowers, and then some private companies such as Nature’s Medicine and Justice Grown. The third tier are smaller operators. They’re single or two-state operators, and we’re typically coming in to help them build out licenses that they want or help them expand within that state. That’s why state-by-state dynamics are so important to us and why we typically only lend to limited license states.
We look at portfolio diversity on a step-by-step basis rather than a borrower-by-borrower basis. We tend to focus on deals in limited license states and also deals that have real estate as collateral. We have found that REIT loans give our clients the most flexibility, and we are able to finance more companies this way.
Green: Capital market dynamics have led to significant public cannabis company revaluations in 2022. How has this affected your business?
Tannenbaum: Although capital market dynamics have made an impact on a significant number of public cannabis companies’ revaluations this year, our overall business hasn’t been affected too much and that’s because the other lending options available right now are not ideal choices for most borrowers. One of the ways a lender can achieve credit enhancements or securities is by raising capital in the public markets. When the markets are more challenging, those companies have a harder time accessing capital when they may need it most. In turn, this could cause slow growth overall, more cash conservation and it removes one of the benefits to lenders. We’d like everyone to have more robust equity from that standpoint, but the flip side is, if equity gets too high in price, those borrowers won’t come to us lenders and they’ll raise capital in the equity markets since the equity is cheap. We’re definitely conducting a lot of business because the equity market is not available to cannabis companies. If that were to change, while our loans would be theoretically safer, they would choose equity instead of debt.
Green: Debt on cannabis companies balance sheets have increased significantly in recent years. What is your perspective on that?
Tannenbaum: When equity markets were free and the valuations were high, cannabis companies raised money in the equity markets rather than take on debt. Now that the equity markets have been somewhat closed and valuations are much lower, we see their debt has increased over the past two years.
Green: How does the lack of institutional investor participation in the cannabis industry affect your business?
Tannenbaum: Right now, we are one of the biggest lenders in cannabis. Looking to the future, though, if the SAFE Banking Act passes, we could see an influx of institutional capital that would increase competition amongst cannabis-specific and mainstream lenders. From the outset, most of the competition will come from hedge funds, not big banks. This competition will drive down interest rates and attract borrowers like MSOs.
Green: What would you like to see in either state or federal legalization?
Tannenbaum: The Senate passing the SAFE Banking Act. Should this happen, lenders, including AFC Gamma, will be able to borrow cheaper, which will, in turn, allow lenders to lend cheaper. It will be a net positive for all operators. It could also be positive for lenders assuming they have the infrastructure and capabilities to scale and decrease the cost of capital once the money starts flowing and more deals are being made.
Green: What trends are you following closely as we head towards the end of 2022?
Tannenbaum: The most important trend we’re following is state by state trends. We’re excited to see new states getting their act together like New York. We’re excited about Georgia. We’re also looking forward to Missouri going rec. On the flip side, we’re also watching Virginia issue more than 400 licenses, diluting down the limited license states into basically an unlimited license state, which personally doesn’t make sense.
The other trend we’re watching across the country is cannabis prices. There is definitely a gray and legacy market that goes across border that should be enforced. That flow of cannabis product is depressing prices, especially in the unlimited license states. I believe there is a chance that trend starts reversing as many grows are now inefficient. The low end of inefficient grows are going to start closing, which may increase prices going into next year.
PARSIPPANY, NJ, October 17, 2022 – The Cannabis Quality Conference & Expo (CQC) just announced the newest addition to the event’s agenda. Commissioner Maria Del Cid-Kosso of the New Jersey Cannabis Regulatory Commission will deliver a keynote presentation at 1:00 PM EST on Monday, October 17.
Commissioner Maria Del Cid-Kosso of the New Jersey Cannabis Regulatory Commission
Commissioner Del Cid is an inaugural commissioner of the NJ Cannabis Regulatory Commission, the government body overseeing regulating the state’s new cannabis industry. Prior to being appointed by Governor Phil Murphy in February of 2021, she was the Director of Policy and Legislative Services at the New Jersey Department of Health. She was awarded the Union County Women of Excellence Award in Government, the Hazel Frank Gluck Award from the Eagleton Institute of Politics, Urban League of Union County Young Professionals Award in Government, and has been recognized as Insider NJ’s 2021 Top 6 Millennial; Insider’s 100 Cannabis Leaders; Insider’s 50 under 30; and Insider’s Top 100 Millennials (2018, 2019, and 2020).
Following Commissioner Del Cid’s keynote presentation, a panel discussion on The Future of East Coast Cannabis: Social Equity, Justice & Legalization will take place in the afternoon. Following that will be a panel on The Standardization State of the Union: Science-Based Resources for Driving Cannabis Safety with an overview of the New Jersey cannabis marketplace to end the first day.
The second day will kick off with a Keynote titled Centering Equity in Cannabis Policy, Quality & Business with Toi Hutchinson, President & CEO at Marijuana Policy Project. Other agenda highlights include:
The State of the State: An Update on New Jersey Legalization by Steven M. Schain, Esquire, Attorney at Smart-Counsel, LLC
Tri-State Cannabis: Pro Tips for Winning Applications by Sumer Thomas, Director of Regulatory Affairs and Russ Hudson, Project Manager at Canna Advisors
Navigating Cannabis Testing Regulations for Multi-State Operations by Michael Kahn, President & Founder of MCR Labs
Keynote by Edmund DeVeaux, President of the New Jersey Cannabusiness Association
A Guide to Infusion Technology | Design Experiences that Inspire and Innovate with Cannabis Ingredients by Austin Stevenson, Chief Innovation Officer at Vertosa
Valuable Analysis Ahead of Asset Acquisition by Matthew Anderson, CEO of Vanguard Scientific
Registration options are available for in-person, virtual and hybrid attendance.
Event Hours
Monday, October 17: 12 pm – 6:30 pm (ET)
Tuesday, October 18: 8 am – 5:45 pm (ET)
Wednesday, October 19: 8 am – 12 pm (ET)
Cannabis industry professionals also interested in the food industry can attend the Food Safety Consortium, which begins on Wednesday, October 19 – Friday, October 21.
About Cannabis Industry Journal
Cannabis Industry Journal is a digital media community for cannabis industry professionals. We inform, educate and connect cannabis growers, extractors, processors, infused products manufacturers, dispensaries, laboratories, suppliers, vendors and regulators with original, in-depth features and reports, curated industry news and user-contributed content, and live and virtual events that offer knowledge, perspectives, strategies and resources to facilitate an informed, legalized and safe cannabis marketplace.
About the Cannabis Quality Conference & Expo
The Cannabis Quality Conference & Expo is an educational and networking event for the cannabis industry that has cannabis safety, quality and regulatory compliance as the foundation of the educational content of the program. With a unique focus on science, technology, safety and compliance, the “CQC” enables attendees to engage in conversations that are critical for advancing careers and organizations alike. Delegates visit with exhibitors to learn about cutting-edge solutions, explore three high-level educational tracks for learning valuable industry trends, and network with industry executives to find solutions to improve quality, efficiency and cost effectiveness in the evolving cannabis industry.
PARSIPPANY, NJ, October 17-19, 2022 – The Cannabis Quality Conference & Expo (CQC) heads to New Jersey October 17-19 this year. The agenda features three tracks of educational talks, panel discussions, keynotes and breakout sessions.
At this year’s event, the conference will debut two new features of the program: Lunch & Learn sessions and Happy Hour Roundtables. Matthew Anderson, CEO of Vanguard Scientific, will sit down with two experts in cannabis law for interviews during the lunch hour:
Investigations & Enforcement: A Former Federal Prosecutor’s Perspective
Matthew Anderson will interview Barak Cohen, Chair of the Cannabis Industry Group at Perkins Coie, to discuss federal investigations, Justice Department prosecutions and white-collar offenses. This Lunch & Learn will take place 12:00 to 12:25 PM on Tuesday, October 18.
Compliance is Key: Best Practices for Your New Jersey Cannabis Business
Matthew Anderson will interview Casey Leaver, Director of Regulatory Compliance at Vicente Sederberg, to discuss compliance culture, quality controls, New Jersey regulations and more. This Lunch & Learn will take place 12:35 to 1:00 PM on Tuesday, October 18.
Following the conference agenda on Monday, October 17 and Tuesday October 18, attendees are invited to join the cocktail reception for Happy Hour Roundtables. From 4:45 to 5:45 PM, subject matter experts will be available to chat, answer questions & offer guidance on the following topics:
Regulatory Compliance: Jason Thomas, Precision Quality & Compliance
Banking, Finance & Real Estate: Steve Schain, Esq., Smart-Counsel LLC
Standards in Cannabis: David Vaillencourt, The GMP Collective
Social Equity & Justice: Ernest Toney, BIPOCANN
The conference will begin with a panel discussion on The Future of East Coast Cannabis: Social Equity, Justice & Legalization. Following that will be a panel on The Standardization State of the Union: Science-Based Resources for Driving Cannabis Safety with an overview of the New Jersey cannabis marketplace to end the first day.
The second day will kick off with a Keynote titled Centering Equity in Cannabis Policy, Quality & Business with Toi Hutchinson, President & CEO at Marijuana Policy Project. Other agenda highlights include:
The State of the State: An Update on New Jersey Legalization by Steven M. Schain, Esquire, Attorney at Smart-Counsel, LLC
Tri-State Cannabis: Pro Tips for Winning Applications by Sumer Thomas, Director of Regulatory Affairs and Russ Hudson, Project Manager at Canna Advisors
Navigating Cannabis Testing Regulations for Multi-State Operations by Michael Kahn, President & Founder of MCR Labs
Keynote by Edmund DeVeaux, President of the New Jersey Cannabusiness Association
A Guide to Infusion Technology | Design Experiences that Inspire and Innovate with Cannabis Ingredients by Austin Stevenson, Chief Innovation Officer at Vertosa
Valuable Analysis Ahead of Asset Acquisition by Matthew Anderson, CEO of Vanguard Scientific
Registration options are available for in-person, virtual and hybrid attendance.
Event Hours
Monday, October 17: 12 pm – 6:30 pm (ET)
Tuesday, October 18: 8 am – 5:45 pm (ET)
Wednesday, October 19: 8 am – 12 pm (ET)
Cannabis industry professionals also interested in the food industry can attend the Food Safety Consortium, which begins on Wednesday, October 19 – Friday, October 21.
About Cannabis Industry Journal
Cannabis Industry Journal is a digital media community for cannabis industry professionals. We inform, educate and connect cannabis growers, extractors, processors, infused products manufacturers, dispensaries, laboratories, suppliers, vendors and regulators with original, in-depth features and reports, curated industry news and user-contributed content, and live and virtual events that offer knowledge, perspectives, strategies and resources to facilitate an informed, legalized and safe cannabis marketplace.
About the Cannabis Quality Conference & Expo
The Cannabis Quality Conference & Expo is an educational and networking event for the cannabis industry that has cannabis safety, quality and regulatory compliance as the foundation of the educational content of the program. With a unique focus on science, technology, safety and compliance, the “CQC” enables attendees to engage in conversations that are critical for advancing careers and organizations alike. Delegates visit with exhibitors to learn about cutting-edge solutions, explore three high-level educational tracks for learning valuable industry trends, and network with industry executives to find solutions to improve quality, efficiency and cost effectiveness in the evolving cannabis industry.
Even for the soaring cannabis industry, recruitment and retention of a qualified workforce remains a significant challenge in 2022. Although a tight labor market was not a new situation for many industries, the COVID-19 pandemic made it much worse and widespread, and the pain has yet to subside. In 2021, 47 million workers voluntarily left their jobs and nearly half of small businesses are experiencing worker shortages.
About 43% of workers who quit their jobs cited inadequate benefits as a factor in their decision. Among workers who cited benefits as a top concern, more than three-quarters said retirement plans are a “must-have” benefit. Most small businesses in the U.S. (74%) of 50 employees or fewer, however, do not check that box on a potential hire’s requirements list.
Offering a 401(k) plan, therefore, can help any company attract and retain workers. Even companies in emerging fields like cannabis can add 401(k) retirement savings plans to the roster of benefits for its employees.
In addition, there are tax benefits for the company should it offer a 401(k) plan and also match employee contributions. Employer contributions are deductible on the employer’s federal income tax return, so long as those contributions stay below the limitations described in section 404 of the Internal Revenue Service’s Internal Revenue Code.
Given the complexity of the cannabis industry and its hazy legal status in the U.S., however, it can be more challenging for cannabis companies to find benefits providers willing to create a program. Finding the right partners to navigate the process will help cannabis companies provide this significant employee benefit package.
Cannabis organizations have run into similar roadblocks finding banks and payroll providers willing to partner with them, and some large financial firms that offer retirement plans often decline to work with cannabis companies as well. But a growing number of boutique firms offer 401(k) programs and other benefits for this industry — it just requires the right partners to find the right plan.
Four tips for creating a 401(k) for cannabis workers
These four tips can help cannabis companies offer a 401(k):
Plan Structure and Objectives: Outline the goals of the 401(k) plan and how it will be set up, including how employees will be rewarded for participation. Consider developing a formal investment policy statement that includes monitoring the plan.
Matching Contributions and Auto-enrollment: Offering to match employee contributions tends to increase participation in retirement plans and increase employee satisfaction. There are a wide variety of paths the company could follow, but a good example would have the company matching 50% of salary up to 6%. Regarding automatic enrollment of employees into the plan, such a policy has shown to increase both participation and engagement.
401(k) 101: The company may need to educate its employees on the basics of a 401(k) plan if one was not offered previously. Employees may be unfamiliar with how these plans work and how to optimize their investment choices. Cannabis companies need to offer clear information on the benefits of the program, including information on managing their portfolio. This approach will make workers feel more comfortable with their investments and encourage engagement.
Partner with 401(k) Experts: Emerging industries like cannabis can be complex. Cannabis companies that want to implement a 401(k) should partner with consultants who understand the intricacies of the sector and know what retirement benefits companies cater to the industry.
Benjamin Franklin famously advised fire-threatened Philadelphians in 1736 that “an ounce of prevention is worth a pound of cure.”
With industry growth and maturation comes increased opportunities and challenges. As the cannabis business matures and spreads into new geographic regions, the industry can take advantage of larger markets; however, it also faces increased risk and litigation across a myriad of its operations. This article identifies some of those growing pains along with suggesting how to avoid the more obvious and typical types of issues before they become a problem.
Contracts/Commercial Agreements
One source of emerging trends in cannabis litigation notes that about 1/3 of litigation in 2022 could be classified broadly as commercial disputes. As the various state laws allow for expansion of legal cannabis operations into more states, operators will enter into more commercial agreements to grow and scale operations across the United States.
I am surprised by how many companies do not adequately document their commercial agreements. A host of issues too numerous to discuss in depth here should be addressed in a commercial agreement depending on the type of transaction. In short, make sure agreements are in writing, signed and include an effective date. They should be complete and unambiguous, allocating responsibilities and risk as intended.
Fundraising
When fundraising, whether as debt or equity, a company must comply with complicated and technical U.S. and applicable state securities laws. These laws and regulations require either the registration of the securities offering, which is very expensive, or an applicable exemption from a registration. Failure to comply could lead to lawsuits filed by investors trying to recoup all their money, even if they have no damages, along with possible fraud claims or fines and penalties imposed by applicable federal or state agencies.
Landlord-Tenant disputes
When renting commercial real property, create agreements that address the major issues in writing in case of disputes with property owners. Understanding the lease terms and requirements, as well as tenant rights and duties under state and local law, are essential. Pay attention to lawful uses, minimum term and renewal options, operating expenses and tax requirements, tenant default issues, base rent and other rental charges, common area maintenance charges, maintenance and repair, tenant improvement requirements and allowances, sublet and assignment, and requirements for the refund of the security deposit.
Employment
A common area of misunderstanding that leads to disputes is the law governing employee relations. Companies often misclassify employees, creating valid claims for past due benefits, fines and other damages for failure to classify correctly. In California, for example, correctly classifying a worker as an independent contractor is difficult. Some common mistakes to avoid include:
Designating non-exempt workers as exempt and misclassifying employees as independent contractors.
Failure to pay required minimum wages or overtime.
Not providing required meal and rest breaks.
Failure to keep accurate time records for non-exempt workers.
Inaccurate and noncompliant payroll records (aka “wage statements”) with all the required information.
Improperly administering leaves of absence, especially for employees with medical conditions or disabilities.
Not carefully documenting performance issues by using performance reviews, or “writing up” poor performance, etc.
Failure to have a written employee handbook covering important policies such as vacation and required conduct, as well as misapplying those policies, can lead to disputes. Pay attention to state and local employment laws that apply at the different stages of development and growth.
Intellectual Property
Protecting the company’s intellectual property is important to maintain the goodwill and value of a business. Carefully evaluate the requirements for any patent, trademark, copyright, and/or trade secret protection and come up with a plan to implement and monitor the applicable intellectual property assets. Do not disclose possible patentable intellectual property and inventions before filing a provisional patent application, or the ability to obtain patent protection will be destroyed. Before using a tradename or trademark in commerce, investigate if anyone else is using a similar name for similar goods and services. Failure to do so could lead to claims for infringement and a judgement requiring the company to stop using its preferred name or logo after investing time and money in creating the brand. Consider registering at the state and federal level the name and logo to secure your rights in the brand. What and where a cannabis company can register its brand name and logo for protection are currently limited, so be advised registration can be tricky.
Trade secret protection attaches to valuable information not readily ascertainable by lawful means, such as a formula, pattern, method, device, compilation, program, technique, or process that is secret. Protection afforded to trade secrets does not expire if the information is kept secret. For instance, the Coca-Cola formula has been kept secret for over 100 years, thus maintaining its value. Companies must also implement and maintain appropriate measures to protect the inadvertent disclosure of the information in order to maintain an asset’s status as a trade secret. Before disclosing any confidential information, make sure to have a proper written confidentiality agreement in place with the recipient, or you may lose the protection afforded by trade secret law.
Hiring the right workers to develop valuable intellectual property is important to the success of any business. Make sure to have employees and contractors assign their interests and ownership rights to the work they create, and develop a written invention-assignment agreement in favor of the company to avoid ownership disputes. Interests in copyrightable works created by service providers must be assigned in a written agreement. Failure to do so could diminish the company’s value.
Taxes & Licensing
Sometimes a business unavoidably gets behind in paying its taxes. Failure to pay taxes on time leads to penalties and fines and possible expensive audits by the tax authorities. In addition, personal liability can attach to directors and officers for failure to pay employment taxes. Cannabis companies may have several licensing requirements as well that are important to track to stay in good standing.
Insurance
Adequate insurance is a must-have for every business. Conduct a periodic checkup of the company’s insurance coverage. Consider directors’ and officers’ insurance, general commercial liability and property, products liability, workers’ compensation, employment practices liability coverage, cybersecurity, and business interruption insurance. Those types of coverage are important protections for the risks related to any business that sells a product or service, has employees, deals with the public, or could lose income from unanticipated events like fire, natural disasters and civil interruptions. Discuss your particular insurance needs with a qualified insurance broker, as one size does not fit all.
Consult with Qualified Legal Counsel
Consult with legal counsel to analyze and prepare for the risks noted in this article and other common legal issues to protect the company’s assets, avoid disputes and build and maintain company value. Otherwise, you may find that, as old Ben Franklin noted, you’ll spend many pounds to try to cure problems that could have been avoided with just an “ounce of prevention.”
The global vitamin supplement market is projected to grow at 6.2% compound annual growth rate (CAGR) to $71.37 billion by 2028 with the most rapid growth now occurring in the gummy vitamin segment. Gummy supplements are expected to have the fastest CAGR at 12.6% to exceed $33 billion by 2028. Initially developed for youths, gummies are now preferred by all age segments as an alternative to tablets, capsules and pills.
As one might expect, cannabidiol (CBD) gummies are also projected to grow rapidly at a 30.7% CAGR to $13.9 billion by 2028. In terms of actual number of CBD gummies produced last year, a rough estimate would be at least 1.7 billion. For perspective that equates to 53 gummies produced every second, 24 hours a day, 365 days per year. One might reasonably ask, “So where do all these gummies come from?” and “Who makes them and under what conditions and quality assurance standards?”
There is no short answer to these questions nor confidence that all cannabinoid gummies are manufactured with adherence to a minimum set of safety and quality standards. Gummy recipes and ingredients are readily available online and there is no shortage of hobbyists who make small batches for family, friends and to sell at retail pop-ups and farmers’ markets. There are a number of well-known brands that started out in home kitchens and garages. In terms of production scale, on the other end of the spectrum are companies like Bloomios, Inc. (OTCQB: BLMS), that operates a 51,000-square-foot Current Good Manufacturing Practices (cGMP) compliant facility in Florida.
The Hobbyists
A variety of CBD products on the market today
For the hobbyist producer, they often begin to scale out of their home kitchen and take over part of their garage or basement and while the entrepreneurial spirit is admirable, most consumers wouldn’t be comfortable with their pharmaceuticals, supplements or even grocery items being manufactured under these conditions which often lack:
Rigorous sanitary practices
Measures to mitigate contaminants entering the production areas
Quarantine, chain-of-custody audit and testing of active ingredients used in production
Standardized and rigorous quality assurance testing of finished product
Certificate of Analysis (COA) for active ingredients in finished product for certainty of dosage levels
Labeling and packaging standards to ensure product information and volumes are correct
Batch record data collection, retention and audit procedures.
However, the hobbyists constitute only a very small fraction of gummy production today, and they typically take great pride in their work and show a high degree of care in production practices. Thus, when demand begins to outpace the artisanal home production capacity, many growing brands turn to contract manufacturers to assist with scaling the production side while the brand focuses on the sales, marketing and distribution side of the business. This is an ideal solution as high quality product can be produced at volume in cGMP facilities which enhances the consumer experience, confidence in the product and further grows brand value. This is a best-case scenario of small emerging brands that care deeply about their reputations and their customers’ experience scaling production and growing responsibly.
The Opportunists
The real underbelly of commercial gummy production is characterized by the pure profit seeking producers that set up semi-permanent production lines in flex-industrial spaces not suitable for food handling, with limited buildout for isolation of each production stage. This process includes: materials storage, weight/measures prep, ingredient mixing, molding, dehydration, coating, sorting and filling, labeling and finish packaging. Lacking cGMP compliant facilities and practices, they neglect or fail entirely to maintain batch records, COAs or chain-of-custody practices and have limited ability to address defective product once in the stream of commerce. Let’s refer to these manufacturers as the “Opportunists.”
Opportunists see the current cannabinoid gummy market for what it is. It is an emerging market really taking form only since the 2018 Farm Bill legalized hemp derived cannabinoids. As such it is very much in its “gold rush” phase with many of the participants having just entered the sector. Many participants have adopted ad hoc practices with no standardization and no explicit federal oversight because the FDA has yet to acknowledge any cannabinoids under its generally regarded as safe (GRAS) standard.
In addition, the FDA has excluded CBD products from the dietary supplement definition of the Food, Drug and Cosmetics (FD&C) Act. Under the FD&C Act, if a substance is an active ingredient in a drug product that has been approved or has been authorized for investigation as a new drug, then products containing said substance are excluded from the definition of dietary supplement. So far cannabinoid gummy demand has continually outstripped supply supporting attractive margins and with little oversight. The Opportunist mindset has focused on maximizing profits while they can before regulation increases costs, compresses margins and reduces profits.
The Opportunists have more cover to seek profit maximization as opposed to incurring the cost of setting up cGMP facilities and adhering to rigorous standards due to the fact that the brands consumers recognize are often manufactured by one or more third-party contract manufacturers. Some brands also want to maximize near-term profits and manufacturers with a lower cost structure can more effectively compete on price as opposed to quality.
As demand surges, some brands will supplement their third-party cGMP produced product with additional product sourced from Opportunists and “recycle” the valid COAs from their cGMP product without the cGMP manufacturer or consumers even knowing. With lax regulatory oversight, these brands are inclined to look the other way on their contract manufacturer’s production practices so long as the large volume orders are delivered on time and at lower cost.
For gummies produced by Opportunists, if there are product defect issues, the consumers likely won’t be able to rely on the batch record data and purported COAs linked to/from QR codes on the container, many of these COAs have been recycled from legitimate batches or simply doctored up and reproduced rather than generated on a per batch basis. There is limited to no audit trail and recalls are unlikely to be effective, if even initiated. A refund is the most likely solution a consumer has which leaves perhaps a much larger run of defective product in the market still unaddressed. Moreover, brands that suffer reputational harm due to quality issues can simply launch a substitute brand with a similar look through its same distribution channels and maintain much of its market share.
Best Practices
If today’s CBD gold rush sounds much like the Wild West, you would be correct. However, as more consumers become aware of cannabinoids’ health and wellness benefits in addition to the recreational uses, this larger and more diverse consumer base is raising the bar and demanding more transparency and certainty on manufacturing practices than ever before.
A roughly estimated 1.7 billion CBD gummies were produced last year
How are the leading cannabinoid nutraceutical manufacturers proactively addressing consumers’ desire for high quality, rigorously tested products manufactured in accordance with standards already imposed on mainstream nutritional supplement and prepared food manufacturers? Although the answer may be simple, the implementation and ongoing compliance is not.
The answer is voluntary adoption and compliance with the same regulations applicable to non-cannabinoid dietary supplement manufacturers. Given that the FDA has not recognized cannabinoids as dietary supplements quite yet, certain aspects of dietary supplement regulation can’t be adhered to such as notifying the FDA of structure/function claims as new products are brought to market or notice of new dietary ingredients. On the other hand, many of the regulations can and should be adhered to by cannabinoid nutraceutical manufacturers to ensure its safe, transparent orderly growth.
Chief among the FDA requirements that Bloomios and other leading manufacturers adhere to are:
Register with the FDA as a food handling and production facility.
Adopt Current Good Manufacturing Practices for dietary supplements which establishes uniform standards needed to ensure quality throughout the manufacturing process and verification of the identity, purity, strength and composition of their products.
Undertake at least annually an independent third-party cGMP audit of their facility and procedures.
Comply with Code of Federal Regulations (21 CFR 101.36) supplement label requirements to ensure that the ingredients list is accurate, and the content matches the amount declared on the label among other disclosures.
The most significant challenge in adopting all of the above best practices is cGMP facility qualification and ongoing compliance. The cGMP standards require specific facility build-out features, equipment, and of course standard operating procedures. There are significant additional costs to bring a cGMP facility on-line, additional time and required experienced personnel that can implement the operating procedures and recertification every time a production line’s configuration is changed or augmented with additional equipment.
Bloomios annual cGMP audit was conducted in August and over 130 specific requirements were evaluated and graded. While Bloomios passed the audit and evaluation, what is of far greater significance is that cGMP practices become part of a company’s culture so that these high standards are maintained year-round and not rushed into practice just for the audit.
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