In a press release sent out last week, KCA Laboratories announced they have been awarded hemp testing contracts for Massachusetts and North Dakota. They received the notices through the North Dakota Department of Agriculture and through the Massachusetts Department of Agricultural Resources’ Hemp Program that they were awarded the contract.
KCA Laboratories is an independent, third-party testing laboratory based in Nicholasville, Kentucky that specializes in hemp testing.
According to Ryan Bellone, Commercial Director for KCA Labs, they started the company to focus strictly on hemp testing. “The team here at KCA Labs is grateful for the opportunity to analyze North Dakota’s and Massachusetts’ hemp samples for Total THC content,” says Bellone. “We started KCA Labs to elevate the quality of testing in the hemp industry. It has been our goal from inception to service regulators, farmers, processors, and retailers with trusted results. KCA is excited to work with North Dakota and Massachusetts as well as the farmers and processors they serve.”
Bellone says they have started seeing a backlog of samples in a number of states for hemp regulatory compliance testing. “For years, a lack of laboratory testing was a bottleneck for the industry and now that the market has more options, testing turnaround time should not be a barrier.”
Reports estimate that up to 8 million people in the UK use CBD for its variety of wellness benefits. The market is currently worth £300 million, a figure which is expected to more than triple in the next five years.
Sales of CBD already outstrip those of Vitamin C at £301 million vs £119 million and given that almost 90 percent of users in the UK purchase CBD online, new investments into omnichannel and e-commerce capabilities are likely to lead to even more growth.
Yet, for all this excitement, the truth is the UK’s CBD industry is facing a bit of a roadblock.
The structure of cannabidiol (CBD), one of 400 active compounds found in cannabis.
Until this year, CBD has been in a period of regulatory uncertainty and the industry faced understandable criticism when high profile cannabis probes found that over half of the most popular CBD oils did not contain the amount of CBD promised on the label. On February 13, 2020, the Food Standards Agency (FSA) unveiled new plans to better regulate the industry and announced a deadline of March 31, 2021 for the submission of a valid application for novel food licence for businesses selling food and food supplements containing CBD in the UK. Contained in the announcement was a warning to all CBD companies that failure to comply may result in products being taken off the shelves.
Consumers are also advised by the FSA to “think carefully” about taking CBD, and not to consume more than 70mg a day, making the UK the first country in the world to set recommended limits for CBD consumption, despite no scientific basis for the 70mg recommended limit.
Whilst it is undeniable that the CBD market requires some form of regulation and standards need to be raised for CBD products, to ensure consumers are receiving safe, legal and quality products, this will be a complex and costly process. CBD companies, particularly smaller CBD brands, will need to ensure they have the necessary infrastructure, expertise and resources to meet this deadline.
The deadline is fast approaching, and no extension has been granted despite of the difficulties caused by COVID-19. This will put all businesses under pressure, as the process for applying for Novel Food status requires supplying a large amount of data from rigorous testing. For larger players, this will likely be nothing more than a costly inconvenience, but for smaller, nascent businesses, these costs may put their longevity at risk. There are hundreds of CBD start-ups which have done great work to future-proof their businesses and create safe, high-quality products. Now, instead of preserving costs to try and stay afloat during the pandemic, these businesses must put a significant amount of precious resource and funds into finalising their applications in time.
Improving end user confidence in CBD products and understanding the process from seed to shelf is crucially important in this developing industry, however, I firmly believe these regulations are suffocating the market. I fear that on April 1, 2021, many smaller firms who haven’t managed to achieve Novel Food status yet have a superior product, will suddenly find themselves unable to legally trade.
On the other hand, there is the argument that the FSA ruling may increase the importation of CBD products from firms based outside of Europe. So far, the large cannabis firms in North America, which have the budget and expertise to meet FSA standards, have held back on importing CBD products to the UK. This may well have to do with the slightly dubious legal status CBD has so far had in the UK, so it will be interesting to see whether this changes in April next year and which players will enter the market. The CBD market will continue to grow and diversify but it will be essential that this leads to increasing consumer choice rather than confusion.
In my opinion, the only way the UK will be able to fully harness the potential of CBD is to create an independent, self-sufficient industry that not only helps consumers but contributes to the wider economy through jobs, skills and investment. The pandemic has done well to put a spotlight on the huge access issues cannabis patients face in the UK, bolstering the case to ‘onshore’ the industry.
Whilst this would require a streamlining and simplification of the licensing laws around growing cannabis, the development of a UK-based industry would have endless benefits. Not only would medical cannabis patients see improved access to their medication, CBD firms would no longer have to ship oil in from the dominating wholesale nations such as Poland, Czechia and Italy, this in turn having huge economic benefits. The development of a UK industry should involve the creation of a new regulatory system specifically designed for cannabis products and preferably for a new regulatory body, similar to the Office of Medicinal Cannabis in the Netherlands, to oversee all cannabis regulation, licensing, importation and approvals. This would mean a move away from the current solution of forcing CBD products into the Novel Food category and subjecting them to inappropriate regulations which will soon begin to smother the market with unnecessary red tape.
People are increasingly turning to more natural health and wellness solutions, so as Britons become better informed about CBD products and as the market matures, demand will certainly increase. Yet with both Brexit and standardisation of cannabinoid regulations occurring in parallel, the future and scale of the CBD market is still to be determined. A huge UK market could potentially help push it in a positive direction, facilitating processes for CBD producers.
The cannabis industry is resilient and until this point, has managed to grow at an exponential rate despite regulatory uncertainty. As acceptance and demand continues to increase, so the case for an independent UK industry will strengthen and regulatory roadblocks finally overcome.
Here is the good news: There are beginning to be regional- and country-specific guidelines on at least one widely grown cannabis crop internationally. This includes a range of regs on the medical side (GMPs) but they are also expanding for the “other” cannabis crop too. Namely, hemp.
Now, here is the bad news: The regulation that is developing in different regions is frustratingly not uniform, and can still differ greatly in critical areas. Most notably, for some reason, while the U.S. Farm Bill of 2018 created a new national standard for the amount of THC that could be contained in American hemp crops (0.3%), the same conversation in Europe during the same period of time led to a decision to set the level of allowable THC in hemp plants and products at a slightly lower one: 0.2%. As a further confusing muddle, Switzerland has set its THC limits at 0.1% (Switzerland is not in the European Union), and other countries across the region have also attempted to limit the THC in industrial hemp production to no more than this level, no matter what regulators rule at the EU level.
Just some of the many CBD products on the market today.
Beyond a lack of scientific reasoning obvious in the same, by definition, this creates a natural trade barrier between hemispheres. If U.S. farmers are looking for export opportunities to Europe (for example) not to mention other states, they have to worry about both local as well as destination standards – which on the surface at least, are currently incompatible.
It is also creating some frustrating issues for anyone who is in the market for hemp as either a buyer or seller.
Other Issues In The Mix Markets are driven by many factors – including regulations but also cost and of course consumer demand for a product within a certain price range. Certainly, the CBD industry if not the recreational THC one right behind it (even in Europe now) desperately wants to attract those who are known euphemistically as “daily consumers.”
This means that both the price point and consumer opportunities must hit a mainstream distribution norm. While the recreational market will continue to be distorted by delayed, but inevitable discussions about reform across Europe, the medical market is beginning to set some groundwork that is also bleeding into the entire discussion. Namely, that extracts will play a large role here.
What does this wrinkle mean in a world where the agricultural cultivation standards are different?
Biomass And Extracts Are Gaining In Importance For those in the strictly “flower” game, the market at least in the U.S., will remain a place where pretty flower crops will gain premium prices as long as they meet local spec.
However, this is a limited proposition, even now – especially in the CBD business. The edibles market, for one, has created a huge potential for vast quantities of industrially produced, outdoor grown hemp, bound for extraction and downstream, a vast variety of end products across a wide spectrum of niches – from wellness to purely cosmetic. So is the burgeoning medical market in Europe.
This means two things. The first is that consumer-facing products with any amount of cannabinoid (take your pick) can be produced to order, no matter the cannabinoid concentrations of the original plant. The second, by definition, means that biomass bound for extraction, particularly export, will gain an increasingly larger share of the wholesale market.
Does it really matter, in other words, to a European extractor, that the source product is of higher THC concentrate than is allowed for B2C sale in Europe? No. Indeed, all it means is that they have to buy lower amounts of biomass. The rest is merely a mechanical problem.
Playing The Regulatory Game For an increasingly competitive hemp market in the United States, in other words, foreign exports are absolutely an intriguing option for revenue right now, and will continue to be as long as price competitiveness and overall quality issues remain high. Furthermore, there will be almost no pressure to regulate the market globally to the same standards, particularly if CBD itself is descheduled in December by the WHO.
In other words, the regulatory disconnect between the U.S. and Europe right now, and certainly for certain kinds of unfinished bulk product, could therefore open a new niche in the market that is unlikely to be “fixed” anytime soon.
There is no doubt all industries are feeling the effects of the coronavirus pandemic; however, cannabis businesses face a unique set of challenges.
Business operations, consumer behavior and financials will be analysed more than ever as businesses seek to position themselves during the pandemic and beyond when lockdowns will eventually be alleviated. As Benjamin Franklin said, “Out of adversity comes opportunity.” COVID-19 is an opportunity for cannabis firms to restructure their business model from a direct, consumer, wholesale and partnership level; eradicate inefficiencies and reassess launch or expansion plans.
Like many other sectors, the cannabis market should still expect to lose revenue due to factors like store closures, disrupted supply chains and restricted transport.
The outlook may seem bleak, but it’s not all doom and gloom when looking at the CBD and medical cannabis markets in more detail.
CBD consumption
With social distancing measures still in place, cannabis firms which offer an online sales platform are seeing a surge in business. During COVID-19, there has been a greater focus on staying healthy and boosting immune systems which is driving consumers to a variety of health-focused products including CBD.
The structure of cannabidiol (CBD), one of 400 active compounds found in cannabis.
Fortunately, many of the physical retailers who stock CBD products in the UK have been permitted to stay open, despite a nation-wide lockdown, so some consumers are bulk buying their usual products while others are turning to e-commerce and delivery services. This demonstrates how quickly some firms have adapted to keep their businesses afloat.
However, border restrictions have tightened and as many supply and logistics workers remain in quarantine, the CBD market could see challenges in maintaining supply lines as the pandemic continues.
This comes in addition to CBD firms working to process a Novel Food Application and fulfill the necessary requirements by March 31, 2021. Despite lobbying from the Cannabis Trades Association (CTA) and despite the impact the global pandemic is having on the sector, the deadline has not been extended.
CBD businesses need to capitalise on the opportunities arising during this downturn; be creative and pin-point ways to keep CBD consumers engaged. By building on their brand and refreshing where necessary, they can attract consumers and develop a loyal customer base. Sustaining a strong online presence and enhancing social media and marketing strategies can lead to an increase of online sales. The brands which can leverage awareness and embody trustworthiness will be the winners.
CBD cannot cure COVID-19
As the epidemic continues into May, there has been no shortage of scammers attempting to try and short-change a fearful, confused population. Unfortunately, the cannabis industry has seen some shameful claims by CBD and hemp companies, notably in the US, who claimed their products could cure or fight off the symptoms of COVID-19.
CBD has been positioned as having several positive health effects by manufacturers and retailers – most notably in reducing pain and inflammation, decreasing anxiety and helping sleep – which may be on the rise within this unsettling environment.
The International Association for Cannabinoid Medicine (IACM), issued a statementon the coronavirus pandemic saying, “there is no evidence that individual cannabinoids or cannabis preparations protect against infection … or could be used to treat COVID-19.” Trials have been launched in Israel to explore whether CBD’s anti-inflammatory properties can be an effective COVID-19 treatment. Until this has been clinically proven, cannabis firms must not make unsupported claims.
Medical Cannabis
During COVID-19, health systems are under unprecedented pressure, which is impacting patient access to all medical treatments, including cannabis.
The medical cannabis industry has swiftly adapted to these challenges by rolling out video consultations and other online consultation services to enhance patient access.
While the Home Office activity for licencing will be limited during this time, companies must work with regulators to keep supply lines open, so that those in need receive their medicine without relying on black-market activity. On April 29, the government published emergency legislation to allow patients to continue accessing controlled drugs for the duration of the epidemic, from pharmacies, without a prescription. This only applies to patients with ongoing NHS treatment, so there is still a long way to go, as private cannabis clinics must fill the gap in the meantime.
The global pandemic has impacted us all, and many patients are concerned about how they will access vital services. Many patients receiving medical cannabis have underlying health conditions which make them more susceptible to contracting COVID-19 and those with chronic neurologic conditions like epilepsy are in danger of suffering potential side effects.
Several of the qualities needed to survive the coronavirus pandemic – awareness, self-containment and support – are basic skill sets to carers. Beyond the pandemic, policy shifts, investment and education are needed to lift the barriers to medical cannabis access, and this will require all businesses operating in the cannabis industry to drive change.
2020 is a defining year for cannabis
The cannabis industry is resilient against socio-economic, political and policy drivers- this we’ve seen time and time again. Now we must create an even stronger UK industry, where products are safely and readily available to those who need them. As the cannabis market matures and the competition things out, only quality cannabis products and services will be in play. Those that can innovate their approach to production, distribution and consumption during the pandemic can be the catalyst for long-lasting changes for the cannabis industry to operate for the better.
The village of Langholm, known locally as the “Muckle Toon,” with its most famous descendent being Neil Armstrong (the first man on the moon) is about to get another first. Namely, it will be the location of the first Scottish cannabis farm.
Father and son entrepreneurs William and Neil Ewart (who also own an agricultural farm, raise Angus cattle and have a racehorse stable) have obtained permission to produce enough cannabis to create 200 liters of oils a year. The production facility is also expected to employ about 50 people – from scientists to growers and IT staff.
However, this is just the beginning. Despite being given planning permission, the Ewarts will now have to apply for a license to actually produce medical cannabis.
Reform in the UK marches on
At present, British patients are in one of the toughest situations anywhere cannabis reform has ostensibly started to happen.
Domestic production, in other words, is a vitally needed part of British reform.The UK has moved forward on cannabis reform in fits and starts – one step forward and several back, for the last several years. Late last year, a full year after the drug was approved for prescription, in an abrupt change, cannabis was denied to everyone but Epilepsy and MS patients and those suffering from nausea due to chemo treatments. NICE, the agency in the UK who sets domestic prescription policies, shamefully excluded chronic pain patients from the new guidelines. This is despite the fact that there are chronic pain patients in the UK who had received prescriptions for cannabis after the law changed in 2018. Not to mention the fact that this subset of patients represents the largest percentage of people prescribed the drug in every other jurisdiction, from Colorado to Canada.
Those who have “qualifying conditions” must now find a doctor to prescribe – still no easy task. If GW Pharmaceuticals’ products (Epidiolex and Sativex) do not work, patients must then import the drug, at great expense from overseas. Even though this importing process has gotten significantly easier in the last months, supplies are still highly expensive imports from elsewhere (mostly Holland and Canada). This runs, at minimum, about $1,000 a month.
Domestic production, in other words, is a vitally needed part of British reform. It is also seen, increasingly, as a high value crop that can be exported elsewhere. Time will tell however, if the expensive British labor market can compete with product grown in Europe (in places like Spain, Portugal and Greece).
So far, the UK has lagged behind Germany, which itself went through a torturous and expensive process to not only approve its first cultivation bid, but is also now in the process of lowering prices. The first German grown cannabis is likely to hit pharmacy shelves by the third or fourth quarter of 2020. Don’t expect any cannabis exports to the UK, at least for now however, as there is not enough domestically cultivated German product to even serve existing German patients.
An Aberdeen clinic plans to be the first Scottish private facility to prescribe As of mid-February, the privately run Sapphire Medical Clinics announced plans to become the first Scottish private medical clinic to prescribe cannabis. The facility will require a referral from a regular GP. This has so far, not been popular with the National Health Service (NHS). Some administrators have expressed concern that the process will result in doctors using their time to funnel patients into private healthcare to receive treatments not available or recognized by the NHS.
That said, as Sapphire has pointed out, the approximately 1.4 million patients in the UK have few other options beyond the black market.
Cannabis reform, in other words, is clearly inching forward in the British Isles. One cultivation facility and prescribing clinic at a time.
As legalization of cannabis products from hemp to medical cannabis takes root across the U.S., there’s a growing need to understand and build good security practices. While many think of security as safeguarding assets like facilities and product, effective security does much more. It protects a business’ workers, providing them secure workplaces and incomes. Ideally, it reaches from supply chain to customers by ensuring consistently safe products.
To truly understand the value of this for a brand or for the industry as a whole, consider the opposite: the destructive effect – on a brand and on the industry at large – of unsafe or tampered product reaching customers, or of crimes occurring, just as the industry seeks to demonstrate its validity and benefits. Security is vital not only to individual farmers, processors or customers but to all who value what the industry brings to those who rely on CBD or medical cannabis products for their wellbeing.
Know the Threats.
Part of the learning process involves understanding the value of the product.Security is all about anticipating and reducing risks. These can include physical threats from natural sources – think flood, fire, tornado or crop fail – or from human threats. Human threats can arise from organized criminals, hackers, amateur thieves, vandals – or insiders.
As regulated industries, hemp and cannabis businesses also face risk of losses, which can be significant, from penalties ranging from fines to being shut down for non-compliance. While rules vary from state to state and continue to change, a disciplined approach to security is foundational to reducing risk at many levels. Rigorous operational processes must incorporate security that addresses risks at multiple points of access, transport and sale of products.
Learn the Rules.
In a rapidly evolving industry, one of the most important things producers can do is to learn. Security requirements vary by region and providers need to be aware of what is available. Get to know your state, local and federal resources for your operating area. California law, for example, specifies use of high-resolution video surveillance in dispensaries, while others do not.
Joshua Wall, Chief Operating Officer at Harvest Connect LLC
Part of the learning process involves understanding the value of the product. With medicinal cannabis, it’s helpful to grasp both its commodity value and the street value that could make it attractive to thieves. In “Why Marijuana Plant Value is So Important for Adjusters,” Canadian Underwriter Magazine gave examples that indicate the size of losses that may occur in growing and processing operations:
“In the medical marijuana space, ClaimsPro has already seen losses primarily between $150,000 and $750,000. These losses, mostly on Vancouver Island, were for fire and water damage, as well as boiler machinery issues, physical damage to buildings and specialized greenhouse equipment, as well as extra expense and business interruption.”
The same article notes a claim over $20 million at another single flower greenhouse. Security needs to reflect what’s present on our premises.
Educating the community can reduce risk as well. Producers of industrial hemp may need to inform would-be thieves that what they are looking at is not street-valued product. To protect the crops, which are generally grown outdoors and do not require a full security detail, a best practice is simply posting signs on the property that say explicitly “No THC.”
Begin with a Risk Assessment.
Security begins with a professional evaluation of site vulnerabilities, examining key weaknesses that could be exploited by attackers. These include:
Monitoring access to the site is a foundational principle of security.
Design limited access points into the facility as well as prepare for possible facility breaches with perimeter access control, technological redundancies and ballistic glass for defensive architecture measures.
Look at route vulnerabilities as well.
Hedge site risk by not limiting your operation to a single site where one incident could wipe out an entire year’s crop.
The nature of threats is always changing. A 2018 Newsweek article described the struggles of legal cannabis farmers against illegal and potentially cartel-backed and violent operations in California. While a 2020 Business Insider report described indications that legalization was prompting some cartels to leave cannabis alone and move on to fentanyl and meth. “While Mexican drug cartels made their money predominantly from marijuana in past decades, the market has somewhat dissipated with the state-level legalization of cannabis in dozens of states across the US.”
Define Levels of Risk and Access.
The best security matches spending to risk in a commonsense way. Are you more at risk from the occasional smash and grab incident or is there reason to anticipate an organized assault? As in many industries, the greatest risk often comes from employee fraud or theft. Hiring carefully, paying fairly and training staff well are important to long term security.
Iron Protection Group in a training session Image credit: Tampa Bay Times
How will the product be moved around within the facility and beyond it – and what staff are responsible for each part of the journey? Who can enter the cultivation areas and what protocols must they follow? On site staff should be trained on what to look for if they observe a security breach. Consider biometrics such as retinal scans, fingerprint scans or similar.
In cases where valuable product or cash is present, guards can play an important role. Harvest Connect uses only high-level former military or police officers in these roles, an approach recognized by many. Hunter Garth of Iron Protection Group notes they have “the ability to de-escalate a potentially harmful situation and the fortitude to see a mission through to completion, no matter what external circumstances may arise.”
Inventory and Transaction Controls
Inside threats from sloppy processes can be just as insidious as attacks. Poor tracking of inventory by Oregon’s legal cannabis producers made headlines in 2018 as The Oregonian reported, “U.S. Attorney Billy Williams told a large gathering that included Gov. Kate Brown, law enforcement officials and representatives of the cannabis industry that Oregon has an ‘identifiable and formidable overproduction and diversion problem.’’ Discipline, applied by state pressure but carried out by producers themselves, has begun to reduce the diversion of untracked product into the black market a year later.
Cannabis businesses need a professional approach to monitoring all product and money that moves through its systems. These operational processes can include time, date and attendance stamps on all inventory. Similarly, accounting systems and software must follow the highest professional standards. Lastly, when breaches occur, it is essential that fraud and theft are caught, eliminated and prosecuted as appropriate.
Nurturing an Emerging Industry
Security resources are an integral part of maintaining the integrity of a business’ supply chain. As the product moves from the fields to processing centers to consumers, purity assurance becomes an operational objective. Ultimately, protecting the product through secure and professional practices is the optimal way to serve customers, build a brand, and sustain the industry.
Former NFL player Kyle Turley made headlines this week for some eye-catching remarks. The retired offensive lineman entered the cannabis industry in 2017, when he launched Neuro Armour (now called Neuro XPF), a brand of CBD products.
Turley and his Neuro XPF brand made claims in recent weeks, both on their website and in various social media posts on Facebook and Twitter, saying that their CBD products can cure COVID-19. Two quotes below, one from their website and one from a Facebook post, show how the company touted CBD as an effective medicine for treating COVID-19.
“Crush Corona . . . While scientists around the world are working 24/7 to develop a COVID-19 vaccine, it will take many more months of testing before it’s approved and available. However, there’s something you can do right now to strengthen your immune system. Take CBD . . . CBD can help keep your immune system at the stop of its game. . . . We want everyone to take CBD and take advantage of its potential to help prepare your body to fight a coronavirus infection. So, we’re making all of our products more affordable.”
“Crush Corona! Your best defense against the COVID-19 blitz starts with a strong immune system. It’s what protects your body from the everyday attacks of bacteria, viruses, parasites and a host of other nasties. Learn more here: https://neuroxpf.com/crush-corona/”
The U.S. Food & Drug Administration (FDA) got wind of these marketing tactics and sent Turley and his brand a warning letter. “FDA is taking urgent measures to protect consumers from certain products that, without approval or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people,” reads the warning letter. “As described below, you sell products that are intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. We request that you take immediate action to cease the sale of such unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.”
Before entering the cannabis space, Turley was diagnosed with chronic traumatic encephalopathy (CTE) and then early onset Alzheimer’s as a result of sustaining head injuries while playing in the NFL. Turley has a reputation for being an outspoken cannabis activist, crediting cannabis with improving his quality of life and eliminating the need for prescription opiates.
In a tongue-and-cheek response to the FDA, Turley posted the following on twitter: “OK OK, YOURE ALL RIGHT, ILL ADMIT IT! CHEAP CBD BRAND PRODUCTS WILL NOT PREVENT OR CURE COVID19!” Turley, making light of the situation, inserted the term “cheap” in there, almost challenging the FDA and disregarding their warning letter.
OK OK, YOURE ALL RIGHT, ILL ADMIT IT! CHEAP CBD BRAND PRODUCTS WILL NOT PREVENT OR CURE COVID19! @MarijuanaMoment
However, the FDA is not joking when they send these warning letters. According to the letter, Turley and his company have 48 hours to remediate the situation or face a federal court injunction.
The Center for Food Safety is a non-profit public interest and environmental advocacy organization. They work to protect public health and the environment by helping curb the use of harmful food production and promoting organic production and other sustainable agriculture practices. Earlier this month, the Center for Food Safety launched a new campaign in the hemp and CBD space: their Hemp CBD Scorecard evaluates some of the widely-known hemp and CBD companies on their production and processing methods, testing protocols and transparency to consumers.
Medterra is a CBD products company founded in 2017. They are one of a handful of companies to receive an ‘A’ letter grade on the Center for Food Safety’s Hemp CBD Scorecard. Jay Hartenbach, CEO of Medterra, says 3rd party testing, validation and strict quality standards are the key to earning recognition from organizations like the Center for Food Safety. We sat down with Jay to hear more about how his company is leading the industry in the space of self-regulation, transparency and sustainability.
Jay Hartenbach, CEO of Medterra
Cannabis Industry Journal: Tell us a bit about the history of Medterra – how did it become the brand it is today?
Jay Hartenbach: I’ve always had a passion for entrepreneurship and science. At Duke, I focused on Engineering Management and earned my B.S. in Biomedical Engineering from Miami University in 2012.
In 2016, I received a call from my former college mate J.P. Larsen who pitched me the idea to start a CBD company. After recognizing the potential of CBD to help a variety of issues, we set up shop in my living room and started building out Medterra in 2017.
With this growing need for trusted products without THC at affordable pricing, our startup of two expanded to nearly 100 employees in less than three years. We currently operate out of our headquarters in Irvine, California as one of today’s leading global CBD brands.
From the beginning, we recognized the power of CBD to help all walks of life. With so many companies prioritizing profits over their consumers, we saw an opportunity to stand out with world class customer service, affordable pricing, and efficacious amounts of CBD.
These priorities have remained unchanged for us as a company and it makes decision making easy for us. If you focus on prioritizing your customers, there is not any ability to cut corners or be content with the status quo of the industry. Consumers know they can trust the Medterra brand and we are continually pushing ourselves to make more effective products.
CIJ: Tell us about your quality standards – what do you do to ensure safety, quality and transparency with consumers?
Jay: We are consistently recognized in the industry for adhering to only the strictest standards for quality. From cultivation to finished product, we test our products multiple times to ensure quality standards are met and there are no unwanted compounds. Medterra CBD has always committed itself to manufacturing CBD products consumers can feel confident in.
In addition, Medterra is proud to be one the first 13 CBD companies to be given the U.S. Hemp Authority’s Certification Seal. This is currently the most stringent 3rd party certification in Hemp. With audits on cultivation, manufacturing and final products, the US Hemp Authority Seal signifies that we as a company meet the highest standards in the industry.
Furthermore, our partnership with Baylor College of Medicine was the first of its kind. Focused on testing both current products as well as validating new products, our partnership with Baylor allows us to provide the most efficacious products to our consumers.
CIJ: Tell us about your farming, processing and testing practices.
Jay: Medterra provides customers with true seed-to-sale purchases. Our industrial hemp is grown and extracted in accordance with the strict guidelines of the Kentucky Department of Agriculture. Each and every product that leaves the facility must be third-party tested to ensure consistency, quality and safety.
CIJ: How do you think the Hemp CBD Scorecard helps move the industry forward?
Jay: Given the unclear federal regulatory landscape, this is an important step in the right direction for CBD companies, because it allows consumers to be confident in the products they use. The more 3rd party testing and verification of CBD companies the better. With these presented to the public, CBD companies are less likely to cut corners and are forced to act in their consumer’s best interest. The Hemp CBD Scorecard helps move the industry forward because it forces accountability.
CIJ: How do you think the hemp/CBD industry will evolve with respect to product safety and transparency without government regulation?
Jay: We at Medterra will continue to go the extra mile and take steps to ensure consumers are getting only quality ingredients. Through these efforts, we hope to remove the stigma associated with cannabis cultivation and educate consumers on the efficacy and sustainability of hemp-derived CBD.
On March 5, 2020, the U.S. Food and Drug Administration (FDA) issued a press release to the public about their work on devising a regulatory framework for cannabidiol (CBD) products. The FDA also submitted a report to Congress on their rulemaking progress.
The main theme of the report is the same story we’ve been hearing from the FDA for a while now: They are still working on figuring out how to regulate CBD products and wants to do more research before they tackle the rulemaking.
The most intriguing new development from this report is the FDA’s newfound interest in regulating CBD products like dietary supplements:
“FDA is actively considering potential pathways for certain CBD products to be marketed as dietary supplements. Under current law, CBD products cannot lawfully be marketed as dietary supplements, but FDA has the authority to create an exemption through notice-and-comment rulemaking that would allow products containing CBD to be sold legally as dietary supplements.”
If you’ve been living under a rock for the past couple years, here’s a recap: In June of 2018, the FDA approved GW Pharma’s drug, Epidiolex, for the treatment of rare forms of epilepsy. This allowed a drug containing CBD to go to market, but only through the agency’s drug approval process. When the 2018 Farm Bill (Agricultural Improvement Act of 2018) was signed into law in December later that year, the federal government removed cannabis (hemp) with less than 0.3% THC from the Controlled Substances Act, essentially legalizing it on a federal level. Congress tasked the FDA with figuring out how to regulate the market. Without any FDA guidance in the early days, the subsequent market growth created mass confusion for the industry and consumers alike, with no one really knowing if selling CBD products is legal or not. In May of 2019, the agency held a comment period and public hearing on CBD, which included a lot of discussion around the benefits, the risks and further research on CBD. Throughout 2019, the FDA sent a large number of warning letters to companies marketing CBD products with unsubstantiated health claims. Towards the end of 2019, Congress passed a bill mandating that the FDA update them on their progress to regulate the market within 60 days. That deadline came and went, and then the FDA issued the public update and submitted the report mentioned above to Congress last week.
The FDA says they intend to take a number of steps towards providing some market clarity, while still protecting the public from unknown risks. Firstly, they want to educate the public more about potential risks associated with CBD. “We remain focused on educating the public about the number of questions that remain regarding CBD’s safety,” reads the update. “There may be risks that need to be considered before using CBD products outside of the monitored setting of a prescription from your health care provider.” Those concerns mentioned above include potential liver injury, drug interactions, reproductive toxicity and more benign side effects like drowsiness.
The agency also wants to try and close knowledge gaps in the areas of safety and potential benefits. In this section of the update, the agency asks industry stakeholders for help. “We’re seeking reliable and high-quality data.” The agency is requesting data on sedative effects, impacts of long-term use, pharmacokinetics, safety of various drug delivery mechanisms, safety for animals, different processes for full or broad spectrum or isolate derivation, among other areas of interest. They plan to re-open the public docket from the public hearing back in May 2019, extending the comment period indefinitely as a tool for stakeholders to share information with the FDA.
As far as enforcement actions go, the agency wants to take a risk-based approach to it. While there is still no official enforcement policy, the FDA is working on it. Their biggest concern is with companies marketing CBD products using drug and health claims, which could “deter consumers from seeking proven, safe medical therapies for serious illnesses – potentially endangering their health or life.” The agency is also worried about potential contamination risk and consumer exposure to things like residual solvents and heavy metals. Their last concern in this area involves truth in labeling, like making false label claims, not listing every ingredient or incorrectly stating the amount of cannabinoids in the product.
“Our ongoing efforts related to CBD, including the steps we’re announcing today, are in line with our mission to protect the public, foster innovation and promote consumer confidence. We recognize the significant public interest in CBD and we must work together with stakeholders and industry to develop high-quality data to close the substantial knowledge gaps about the science, safety and quality of many of these products. We are committed to working efficiently to further clarify our regulatory approach to these products – as always, using science as our guide and upholding our rigorous public health standards.”
Overall, the public update and the report don’t disclose anything groundbreaking. They do, however, provide some much-needed guidance for the CBD market on how stakeholders can help the FDA’s efforts. The fact that they are investigating dietary supplements as a path toward a regulatory framework is the by far the biggest take away from all this.
According to a press release published earlier this month, the U.S. Department of Agriculture (USDA) announced two new programs available for hemp growers to mitigate their risk.
The first is called Multi-Peril Crop Insurance (MPCI), which is a pilot hemp insurance program designed to cover against “loss of yield because of insurable causes of loss for hemp grown for fiber, grain or Cannabidiol (CBD) oil.” The second plan is Noninsured Crop Disaster Assistance Program, which protects against losses from lower-than-normal yields, destroyed crops or “prevented planting” where permanent crop insurance is not available.
Both of the programs are now accepting applications and the deadline to apply is March 16, 2020. “We are pleased to offer these coverages to hemp producers. Hemp offers new economic opportunities for our farmers, and they are anxious for a way to protect their product in the event of a natural disaster,” says Bill Northey, Farm Production and Conservation Undersecretary.
The MCPI program is available for hemp producers in 21 states, according to the press release. Th program is available in certain counties in Alabama, California, Colorado, Illinois, Indiana, Kansas, Kentucky, Maine, Michigan, Minnesota, Montana, New Mexico, New York, North Carolina, North Dakota, Oklahoma, Oregon, Pennsylvania, Tennessee, Virginia and Wisconsin.
There are a handful of requirements to be eligible for that program, such as having one year of growing under their belt and have contracts in place for the sale of their crops. Hemp growers producing CBD must have at least 5 acres and hemp growers producing fiber must have at least 20 acres cultivated.
In 2021, the press release states, “hemp will be insurable under the Nursery crop insurance program and the Nursery Value Select pilot crop insurance program.” With those programs, hemp crops can be insured if grown in containers and in accordance with federal law.
To apply for any of these programs, hemp growers must have a license and must be totally compliant with state, tribal or federal regulations, or be operating under a state or university research plot from the 2014 Farm Bill. Growers need to report their hemp acreage to the Farm Service Agency, a division of the USDA.
The press release also mentions that if the crops have above 0.3% THC, the crop becomes uninsurable and ineligible for any of the programs.
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laboratory based in Nicholasville, Kentucky that specializes in hemp testing.
