On Wednesday, November 6th, the number of licenses suspended dropped to a total of 385, including 63 retailers, 61 delivery services, 47 microbusinesses, 185 distributors and 29 transportation licenses. That’s almost 5% of all the cannabis business licenses in California.
According to Alex Traverso, spokesman for the BCC, licensees were given plenty of opportunities to fix their errors. Businesses were given notice that they needed to enroll in Metrc within five days following their provisional licensing. The BCC gave those businesses a reminder roughly three months ago and sent an additional warning in late October regarding the deadline.
It’s a relatively easy fix for those trying to get back in compliance. The rationale behind suspending the licenses is that those businesses need to undergo a mandatory traceability system training so they know how to use Metrc and get credentialed. Enroll in the Metrc system, get credentialed and your license should be restored.
“It’s relatively simple to get your license out of suspension,” Traverso told KPBS News. “These are growing pains. I think we knew it was going to be a process and it was going to take some time, and that it was going to be an adjustment period for a lot of people who have been doing things one way for some time now.”
Traverso added that about 80 businesses enrolled in the Metrc system as soon as they received the notice that their license is suspended. Those licenses should be restored to active shortly, Traverso said.
The German city of Bremen (perhaps you know it from the Brothers Grimm and the animal musicians) is determined to force the federal German government to play another tune when it comes to basic access within the city.
For those without the special geographic knowledge that comes with being a “local” this is also a deliberately strategic political move. Bremen, like Berlin, is a strange German hybrid, a city-state.
Change here, of course, like Berlin, would have wide impact on other German states.
It is not a new campaign of course. None of these city campaigns for home-grow really are. They are the result of efforts, at this point with elected officials involved, of literally decades of patient activists, who are still necessary. But this time, they have politicians involved. When the national ones don’t listen, the local ones are being dragged in.
That said, don’t expect any breakthroughs or miracles from Bremen or Berlin either right now for that matter. This experiment, in Bremen just like the country’s capital, is still at least several years off, no matter its regular recycling in news stories for the last several years.
The German city of Bremen Image: Chaim Dönnewald, Flickr
Politically right now it is hard to understand the CDU’s continued reluctance to embrace the weed. The CDU is Germany’s strongest and largest “middle of the road” party. Particularly because they along with everyone else of alternative political persuasions are highly alarmed by the right wing AfD’s popularity and spread. It is not inconceivable that even Germany’s largest if not highly beleaguered party might use a little cannabis to stop that. And they are being pushed, hard now, by the fringes.
The Outpricing Of The Patient Movement
Talk to any cannabis-connected company right now and chances are you will hear the phrase “patient first.”
That means nothing in an environment where most patient groups are kept out of the room when legislation opening markets is being written (certainly in Europe). And of course, it is precisely the individuals that these groups represent who cannot afford the legal medication hitting the markets early.
Here, because of the focus on high-quality, GMP-certified product, the chances of a patient collective actually being able to afford a cultivation license (for example) are so far non-existent.
As a result, there is an active foment on the ground right now in almost every country in Europe. This is meeting other kinds of frustration right now and that can be a powerful weapon for change. However, without funded lobbyists in most European capitals and Brussels, there is more power and money behind the established industry right now to keep the (almost) status quo.
As strange as they seem to the cannabis industry right now, GMP certification is a standard pharmaceutical designation.
The boogeymen in the room right now, in other words, for every strong patient group, with its own grey market distribution channels, are the well-funded companies who are in fact getting the laws to change.
Patients, in these environs, as well as their concerns, are left out entirely.
The Strength of The European Gray Market
For this very reason, the gray market problem is going to be large in Europe for quite some time to come. Patients are effectively priced out of the legitimate market if they cannot get insurer approvals and for most that is still the biggest problem in the room.
Are there large gray market grows all over Europe? Yes. As one German activist told Cannabis Industry Journal recently, echoing the comments and practices of thousands of others, “Yes, they made me jump through the hoops, and I have packaging from all the big guys. That’s how I carry my home grow these days.”
Forget “patient cards” that some enterprising distributors are trying to get patients to carry.
The cops don’t challenge legit packaging. And every producer, distributor and patient knows that. Buy once, no matter how exorbitant, and that is all she wrote.
For that reason, “patient numbers” if not “sales” actually mean very little.
It does not matter, in other words, if a cannabis company announces its market entry in any country right now. What matters is that they can prove consistent supply and sales and real patient numbers – which if GDPR (European privacy legislation) is strictly followed, producers and distributors should never really know at a level that such sales are trackable per patient.
And that is where this all gets difficult down in the weeds.
Are there large gray market grows all over Europe? Yes. Are they all under the purview of the criminal black market? No. There are very organized patient non-profit networks locally in just about every city and town in Europe. If not other places.
And, where those fail, certainly in Germany, there is always the area around every local train station. If you are hard up enough and desperate enough, skunk and hash albeit of an indeterminate source, will cost you about $12 per gram.
There is no cannabis company in the room anywhere in Europe that can provide legit product via any pharmacy, for that price at point of sale. Yet. And therein, as always, lies the rub.
The topic of sustainability has grown in importance and priority for both consumers and regulators. From reducing emissions to lowering energy and water consumption, cannabis growing facilities face unique challenges when it comes to designing sustainable operations. Moreover, as the cannabis market grows and usage becomes more accepted, regulatory bodies will continue to increase the number of directives to help ensure the safety and quality of cannabis products.
Non-porous flooring options are impervious in nature, helping to isolate contaminants on the surface, thus enabling proper cleanup and disposal.
Ubiquitous throughout cannabis grow rooms and greenhouses, flooring can be easily overlooked, yet offers an economical way to create more sustainable facilities. Many of today’s grow rooms are located in old retrofitted warehouses or former industrial buildings that were designed without sustainability or environmental concerns in mind.
Combined with energy efficient lighting and more thoughtful water usage, flooring can help create a more efficient facility that not only improves business operations, but also contributes to a better bottom line.
Whether in an old warehouse space or a new structure designed from the ground up, cannabis businesses face unique operational challenges when it comes to sustainable best practices.
Energy Consumption: Like any indoor farm, lighting plays an important role in cannabis growing facilities. Traditional grow lights can utilize a large amount of electricity, putting a strain on the company budget as well as regional energy resources. Switching to highly-efficient LED lighting can help facilities reduce their consumption, while still maximizing crop yield.
Water Consumption: Among the thirstiest of flora, cannabis plants require consistent and plentiful watering for healthy and fruitful crop production.
Carbon Dioxide (CO2) Enrichment: In many cases, carbon dioxide is introduced into facilities to help enhance the growth of crops. However, this practice may pose safety and health risks for workers, the surrounding community and the planet at large. CO2 is a greenhouse gas known to contribute to climate change.
In order to head off upcoming regulatory restrictions, as well as to alleviate the mounting safety and health concerns, it behooves cannabis grow room managers and owners to explore alternatives for improving sustainability in their facilities.
Flooring Requirements for More Sustainable Cannabis Facilities
Spanning thousands or even hundreds of thousands of square feet throughout a facility, flooring can be a unique way to introduce and support sustainable practices in any grow room or greenhouse.
When seeking to improve operational efficiency and implementing the use of sustainable practices in cannabis facilities, look for flooring systems with the following characteristics:
Impervious Surfaces— Fertilizers, fungicides, and other chemicals can infiltrate porous unprotected concrete to leach through the slab matrix and into the soil and groundwater below. Non-porous flooring options, such as industrial-grade, fluid-applied epoxies and urethanes, are impervious in nature, helping to isolate contaminants on the surface, thus enabling proper cleanup and disposal.
Light-Reflective Finishes— Light-colored white or pastel floor surfaces in glossy finishes can help reduce the amount of energy needed to properly illuminate grow rooms. By mirroring overhead lighting back upward, bright, light-reflective flooring can help minimize facilities’ reliance on expensive ceiling fixtures and electricity usage.
USDA, FDA, EPA, OSHA and ADA Compliancy— With cannabis industry regulations currently in flux, grow facilities that select food- and pharmaceutical-compliant flooring will be ahead of the game. Governing bodies in some states have already begun expanding the facility requirements of these sectors to the cannabis market.
Durable and Easy Care— Having to replace flooring every couple of years imposes high costs on businesses as well as the environment. Installation of many traditional types of flooring produces cut-off waste and requires landfill disposal of the old floor material. In contrast, by installing industrial-grade flooring systems that are highly durable and easy-to-maintain, facilities can count on long-term performance and value, while helping to minimize disposal costs and concerns.
Light-colored white or pastel floor surfaces in glossy finishes can help reduce the amount of energy needed to properly illuminate grow rooms.
Optimal flooring can help cultivation facilities reduce waste, improve the efficacy of existing lighting and lengthen floor replacement cycles for a better bottom line and a healthier environment. Additionally, having the right grow room floor can assist facilities in meeting regulatory requirements, help ensure production of quality products and improve the safety for consumers and staff.
Flooring Benefits for Employees and Consumers
Safety is paramount in any workplace. When it comes to the manufacture of foodstuffs and other consumed products, government oversight can be especially stringent. With the right compliant flooring in place, cultivation facilities can focus on the rest of their business, knowing that what’s underfoot is contributing to the safety of employees and their customers.
Here’s how:
Chemical Resistance— Floors can be exposed to a high concentration of chemicals, acids and alkalis in the form of fertilizers, soil enhancers and other substances. In processing locations, the proper disinfecting and sanitizing of equipment can require harsh solvents, detergents and chemical solutions, which can drip or spill onto the floor, damaging traditional flooring materials. It pays to select cannabis facility flooring with high chemical resistance to help ensure floors can perform as designed over the long term.
Thermal Shock Resistance— Optimal cannabis facility flooring should be capable of withstanding repeated temperature cycling. Slab-on-grade structures in colder climates may be especially vulnerable to floor damage caused by drastic temperature differences between a freezing cold concrete slab and the tropical grow room above. This extreme contrast can cause certain floor materials to crack, delaminate and curl away from the concrete substrate. The resulting crevices and uneven surfaces present trip and fall hazards to employees and leave the slab unprotected from further degradation. As an alternative, thermal shock-resistant floors, such as urethane mortar systems, furnish long-lived functionality even when regularly exposed to extreme temperature swings.
Humidity and Moisture Resistance— Traditional floor surfaces tend to break down in ongoing damp, humid environments. Cannabis facility flooring must be capable of withstanding this stress and more.
Pathogen Resistance— Undesirable microbes, fungi and bacteria can thrive in the moist, warm environments found in grow rooms. Floors with extensive grout lines and gaps provide additional dark, damp locations for pathogen growth. Fluid-applied flooring results in a virtually seamless surface that’s directly bonded to the concrete. Integral floor-to-wall cove bases can further improve wash down and sanitation.
Proper Slope and Drainage— Where food and/or pharmaceutical facility regulations have already been extended to cannabis operations, flooring is required to slope properly toward a floor drain. This prevents puddling, which can be a slip hazard as well as a microbe breeding ground. Unlike more typical materials, resinous flooring offers an economical solution for correcting floor slope wherever needed.
The Problems Presented by Traditional Flooring Options
Previously, cannabis growers often relied on traditional greenhouse-type flooring, including tamped down dirt floors, gravel or bare concrete. However, current and upcoming regulations are curtailing the use of these simple flooring options.
Growers often compare and contrast the benefits and value of traditional greenhouse flooring with more modern solutions, such as fluid-applied epoxy and urethane floors.
Dirt and gravel flooring offers little opportunity to properly sanitize, thus potentially inviting microorganism and pathogen invasion, contamination and costly damage. Growers who have turned to bare concrete floors face other concerns, including:
Unprotected concrete is inherently porous and therefore able to quickly absorb spilled liquids and moisture from the air. In addition, organic and synthetic fertilizers, fungicides, and chemicals can leach through the concrete floors, contaminating the groundwater, injuring the surrounding environment and wildlife.
Older slabs often lack an under-slab vapor barrier. Even in new construction, a single nail hole can render an under-slab barrier ineffective. In these situations, moisture from underneath the floor slab can move upward osmotically through the alkaline slab, leading to blistering and damage to standard commercial floor coverings.
Bare concrete floors can stain easily. These dark stains tend to absorb light instead of reflecting it, contributing to a potential increase in energy usage and cost.
The mold proliferation encouraged by the warmth and humidity of grow rooms can easily penetrate into the depths of unprotected slab surfaces, eventually damaging its structural integrity and shortening the usable life of the concrete.
While traditional greenhouse flooring options can initially seem less expensive, they frequently present long-term risks to the health of cannabis grow businesses. In addition, the performance of dirt, gravel and bare concrete floors runs counter to the industry’s commitment to reducing the carbon footprint of growing facilities.
Choosing Sustainable Grow Room Flooring
It’s no secret that the cannabis industry is undergoing enormous change and faces numerous environmental challenges. Luckily, optimal flooring options are now available to help growers economically increase their eco-friendly practices on many fronts. By focusing on quality resinous flooring, cannabis growers can get closer to meeting their sustainability goals, while simultaneously contributing to improved operation efficiency, enhanced yields and an increased bottom line.
No matter what type of packaging you select for your cannabis product, it needs to be dependable. Packaging is not only the first impression of your company to consumers; it must securely contain and protect the product inside. No one wants to purchase products inside packaging that looks dirty or isn’t sealed properly – it is imperative that packaging looks clean and safe to consumers. How does your cannabis packaging stack up? Is it sealed properly? Is it clean and defect-free? Does it conform to the ever-changing regulations?
Using plastic bottles and closures is a great way to secure your cannabis product and showcase your brand. Plastic cannabis packaging offers many different options: bottles can be produced using sustainable materials and come in many different shapes and capacities. Typical closures are child-resistant, lined or unlined, and with a text or pictorial top.
Because packaging performs so many functions for your cannabis business, it is important to realize that not all plastic bottles and closures are the same. High density polyethylene (HDPE), low density polyethylene (LDPE), polypropylene (PP) and polyethylene terephthalate (PET) bottles and closures are widely used for cannabis packaging. Keep in mind that bottle selection is only half of the equation. Equally important is selecting a closure that works with the bottle and has the right features you need.
So, how do you select the right plastic closure for your cannabis bottles? Your packaging manufacturer should be able to guide you towards the solution that’s right for you. However, there are several key factors that will help you identify a superior packaging solution.
Closure Seal
Unevenly manufactured bottle tops can result in poor closure seals and an increased risk of product contamination. Choosing the incorrect lining material can lead to poor protection of your product or may not provide the proper tamper evidence required by regulatory agencies.
A bad seal can also jeopardize the freshness of your cannabis product. It can cause the flower to become excessively dry, resulting in overfilling to make up for weight loss. Situations like these can lead to higher product costs for your company.
Child-Resistant
What’s more important than keeping cannabis out of the hands of children? Child-resistant (CR) packaging not only increases safety; it instills consumer trust in your products and your brand. A closure that doesn’t fit the bottle can prevent the bottle and closure from working properly together, leading to possible accidents if the product is around children. CR closures are available in many different styles and functions – from traditional push-and-turn systems to snap caps and more.
Individual states are cracking down on child-resistant packaging certification for cannabis products. Although FDA approval is not currently required, it will be in the future. Be a leader in the cannabis industry and make preparations now to be compliant with future regulations.
Senior-Friendly
Closures can be child-resistant and at the same time be senior-friendly. Select closures that enable use by individuals who may have problems opening traditional capping systems. Innovative companies are designing closure systems that can be both safe for children as well as easy-to-open for those who have difficulty using their hands.
Compatible Bottles
Be sure that the closure you select works correctly with your chosen bottle. Can your packaging partner manufacture and supply closures that guarantee complete functionality with the bottle to protect your product? Closures produced by the same manufacturer as the bottles will ease your mind that the closure and bottle function correctly together. A one-stop-shop approach will also save you time and money.
Country of Origin
Is the packaging you use manufactured in the United States? Plastic bottles and closures manufactured overseas may have impurities in the resin or colorant that could leach or bleed into your cannabis products. They may not have documentation of origin or comply with FDA regulations. Your cannabis packaging partner should be able to provide this documentation so you can rest assured that your bottles and closures are manufactured under strict guidelines for the safety of your consumers and that your product won’t be affected. In today’s emerging cannabis market, there are stringent regulations on all types of cannabis packaging. If you use packaging that does not conform to regulations, you are putting your company at risk for product recalls, decreased sales due to low consumer confidence and other undesirable risks.
Selecting poor closures and bottles for your cannabis packaging can have long-term consequences. Not only will your brand be diminished, but your profitability will be reduced as well. Understanding how to identify the characteristics of quality plastic packaging that can help you avoid declining consumer confidence and lost sales. Work with a plastic packaging manufacturer that understands how important perfect quality is to your business.
You have read the press releases. You may have heard about such ideas at a recent cannabis conference in and around the EU of late. Or you may have encountered new distributors coming into the game with a German presence and a decidedly interesting ex-im plan that sounds a bit, well, off the map.
No matter how geographically creative some of these plans are, the problem is that many of these ideas literally do not make economic sense. Either for the companies themselves (if not their investors), and certainly not for patients. Not to mention, truth be told, the looming price sensitivity issues in the European market that North Americans, for starters, seem to still just be waking up to.
Some Recent Examples….
Yes, exports from Denmark have been much in the news lately (including into both Germany and Poland). Truth be told, however, this makes about as much sense, economically, as importing ice to eskimos. Why? Denmark, for all its looser regulations and less-uptight approach to the cannabis discussion generally, is one of the most expensive labour markets in Europe. Fully automated production plants are one thing, but you can build those in other places too. Especially warmer climates, with lots of sunshine. German production, as it comes online, will also make this idea increasingly ludicrous.
Who on earth got on this bandwagon? It seems that the enthusiasm in the room began when Denmark began to import to Germany (where the disparities in wages in production are not so noticeable). However, lately, several Canadian companies with a Danish footprint have been eying Poland of late.
And on that particular topic – there are many who are doing the math and trying to figure out, as the alternatives get going, if even Canada makes much sense, or will in a few years.
Low Wage Markets With Sunshine Are Hotspots For European Cannabis Production
Like it or not, the European market is extraordinarily price sensitive – namely because it is not “just” consumers called patients picking up the tab but health insurance companies demanding proof of medical efficacy.
That starts, a bit unfortunately, with understanding wage economics across Europe. The warmer the climate, in other words and the further east on the map, wages drop precipitously. That is “good” for an industry looking to produce ever cheaper (but more compliant) product.
It is also good, at least politically, for countries whose elected leaders are being forced to admit that cannabis works, but are less than copacetic about encouraging local production. See Germany for starters, but places like Austria, Poland and most recently France (which has just embarked on a first of its kind medical cannabis trial).
Here, no matter the temporary buzz about Denmark, are the places that cannabis production makes sense:
Portugal: The country is a newcomer in the cannabis discussion this fall, although in truth, the seeds of this reality were sown several seasons ago when Tilray began to build its production plant in the country in 2017. They are far from the only company who has seen the light, and these days, farmers are getting hip to the possibilities. Especially if they are already exporting crops throughout Europe.
Spain: The industry that can afford GMP certification is getting going, but everyone else is stuck in a limbo between pharmaceutical producers and the strange gray market (see the patient clubs in Barcelona). That said, political groups are beginning to discuss cultivation as an economic development tool, if not sustainable food and medication strategies.
Greece: The weather is warm, and the investment climate welcoming. Of all the countries in the EU, Greece has embraced the economic possibilities that cannabis could bring. How that will play out in the next years to come is an intriguing story.
Italy: The southern part of the country in particular is ripe for cannabis investment and it’s full of sunshine. However, as many have noted, organized crime in this part of the world is a bit fierce and starts with the letter M.
Malta: The island is a comer, but does importing cannabis from here really make economic sense? There are trade routes and economic treaties tying the island both to the apparently Brexiting British and Europe. Why not, right? Just remember that along with labour, transportation costs are in the room here too.
And Just Outside The EU…
The country now (sort of) known as North Macedonia and struggling to get into the EU if France would just get out of the way is also going to be a heavyweight in this discussion for years to come. Wages, of course, will increase as part of EU membership, but in general, this country just north of Greece is going to play a highly strategic role in exports throughout Europe.
One of the surest ways to understand that you are entering not just another country, but what is called an “emerging market” is when you travel from Germany to Poland by train.
There is only one “intercity” option from Berlin Hauptbahnhoff – a far cry from the modern, internet-connected, fast ICE trains that go West. This line is run by the Poles. By the time you reach Warsaw five hours later, however, it is clear at least some parts of this country are booming. The skyscraper construction in the center of town rivals London and Berlin.
Like every emerging market, there are vast disparities in wealth and income, if not opportunity here. And into this discussion, now is coming the entire cannabis discussion. Visiting, as an American, in particular, one is reminded of a city that could be East Berlin 15 years ago.
As a cannabis journalist, it feels, from this perspective, like every American state in the 1990’s. Reform is on the tip of everyone’s tongue. But not quite realized yet, except for a few elites. Beyond such realities which are common in the world of cannabis, how very, well, Iron Curtain.
The difference of course, these days, is that the conversation next door in Germany, as well as other places, is finally forcing the Polish government to face reality. But it is clear, from interviews with activists and patients in particular, as well as the nascent newcomers from abroad testing the cannabis waters, that this fight is not going to be easy on the ground.
Then again, when and where has it ever been?
The Patients….
As always, real reform and market opening is driven by the sheer numbers of sick people who brave arrest to gain access to the plant. Some do it for themselves. Many do it for their children (of all ages). An elderly, boomer couple who talked to Cannabis Industry Journal about their ordeal also see it as a form of justified struggle. And Poles are no strangers to that, far from the cannabis kind.
That ethic is much in the room among the nascent industry that is also struggling to find respect. The Polish side of the discussion is looking at hemp. And growing THC illicitly, just like elsewhere.
But the budding movement here is highly organized, including on the business end, with hundreds of thousands of members. How this translates into a legal industry (besides media and hemp products) is of course, still up for grabs.
That is very much in the minds of those who brave the struggle daily. The patient collective in Warsaw is also highly organized – providing free and non-profit product to those most in need. It is an impressive operation. And further one that is increasingly distrustful of foreigners seeking “market share.” If not the already floating “suits.” Just knowing how to speak Polish, as the activists are, at least realizing, is not a guarantee that they will not be dealing with cannasharks only interested in their contacts and mailing lists. Patients over profits is a phrase you hear a lot here. This has nothing to do with not wanting to support a legit, safe industry. But when you are poor, you find ways to improvise. Including getting your medication.
The Foreign Companies…
Aurora and Canopy Growth are already in the room and there are other Canadians lining up to follow. However, these two are the only ones so far who have been able to get their products registered locally and even then, availability is still in the offing.
These are also highly expensive products. And do not begin to compete with producers now eying the Polish market from North Macedonia and the rest of Eastern Europe.
The foreign companies, in other words, are already broadly falling into two camps. North American curiosity seekers (at this point), and companies, mostly from the East and South, who are looking to Poland to be the “next Germany.” Especially because their product is so price and geographically convenient.
A Battle For Poland’s Emerging Market
It is clear that at least the Canadian companies are already lining up against more home grown and patient interests. Just as what happened in Germany and the rest of Europe so far. And not even on purpose, but more on matters of price.
Like other pre-commoditized markets, the Polish industry is still trying to be (relatively) equal and fair, as much as there is a huge amount of positioning already just below the surface. Everyone is tired of struggling. Dreams of cannabis riches are enticing just about everywhere.
Of course, add to that, patients are dying here, and that always sets the tone – especially when only the richest and lucky few can afford to access the drug through legitimate channels. Face pain, unpleasantness or death or buy in the black market? For the Polish industry on the forefront of the debate, in other words, the stakes are high, the government is moving glacially, and those on the ground are organizing to meet the winds of change.
Foment for another kind of Green Perostroika? Perhaps.
There will, almost certainly as a result of these forces, be a call for a Polish bid – and further one that allows for local producers to enter the medical market.
But the bottom line is that this strange, and exciting and certainly new market is going to be as volatile, and wild west as any in Europe for the immediate future. Expect interesting things, if not more of the same.
Secretary Perdue made the announcement in a YouTube video titled “USDA’s Hemp Policy.” Later in the week, an interim final rule formalizing the program will be published in the Federal Register, according to the USDA’s website. “The rule includes provisions for the U.S. Department of Agriculture (USDA) to approve hemp production plans developed by states and Indian tribes including: requirements for maintaining information on the land where hemp is produced; testing the levels of delta-9 tetrahydrocannabinol; disposing of plants not meeting necessary requirements; and licensing requirements,” reads the press release. “It also establishes a federal plan for hemp producers in states or territories of Indian tribes that do not have their own approved hemp production plan.” The interim final rule will go into effect as soon as it is published in the Federal Register, which should be by the end of this week.
You can find a preview of the rule here. The agency has also developed guidelines for sampling and testing procedures, which you can find here. Those documents are meant to provide more information for hemp testing laboratories.
You can watch the YouTube video and read the announcement he made below:
Hello everyone, as I travel across this great country of ours, I hear a lot about a strong interest in a new economic opportunity for America’s farmers: the production of hemp. Which is why today I am pleased to announce the USDA has published the rule establishing the US domestic hemp production program. We said we’d get it done in time for producers to make planning decisions for 2020 and we followed through. We have had teams operating with all hands-on-deck to develop a regulatory framework that meets Congressional intent while seeking to provide a fair, consistent and science-based process for states, tribes, and individual producers who want to participate in this program. As mandated by Congress, our program requires all hemp growers to be licensed and includes testing protocols to ensure that hemp grown under this program is hemp and nothing else. The USDA has also worked to provide licensed growers access to loans and risk management products available for other crops. As the interim final rule, the rule becomes effective immediately upon publication in the federal register. But we still want to hear from you. Help us make sure the regulations meet your needs. That’s why the publication of the interim final rule also includes a public comment period continuing a full and transparent rulemaking process that started with a hemp listening session all the way back in March 2019. At USDA, we are always excited when there are new economic opportunities for our farmers and we hope the ability to grow hemp will pave the way for new products and markets. And I encourage all producers to take the time to fully educate themselves on the processes, requirements and risk that come with any market or product before entering this new frontier. The Agricultural Marketing Service will be providing additional information, resources and educational opportunities on the new program. And I encourage you to visit the USDA hemp website for more information. As always, we thank you for your patience and input during this process.
Both labs are located in Streetsboro, Ohio, becoming A2LA’s first accredited labs in the state. North Coast Testing does cannabis testing for Ohio’s medical cannabis industry, whereas North Coast Analytical does testing for the hemp industry.
Carolyn Friedrich, Ph.D., scientific director at North Coast Testing, says they are excited to help ensure the safety of patients for Ohio’s medical cannabis program. “We are extremely proud of the work of our entire team in rapidly developing and implementing a comprehensive quality management program that can give all participants in the Ohio Medical Marijuana Control Program confidence in the quality and safety of products tested in our laboratory,” says Friedrich.
Nick Szabo, laboratory director at North Coast Analytical, says A2LA went “above and beyond at every step, we greatly appreciate their efforts. Our accreditation by A2LA is a testament to our ability to meet the most rigorous quality management standards in analytical testing of hemp products, and a vote of confidence in our team’s ability to perform at the highest levels.”
According to a press release published back in September, Steep Hill announced their expansion to the state of Oklahoma. Steep Hill, a cannabis science company that started with cannabis testing labs in California, has been on an impressive expansion trajectory over the past few years.
Kandice Faulkenberry, co-owner and CEO of Steep Hill Oklahoma, says they hope to raise the bar for cannabis lab testing in Oklahoma. “With Oklahoma being one of the fastest-growing medical markets in the nation, we are excited and honored to be a part of our state’s growth,” says Faulkenberry. “We hope to be a valuable resource in our community and Oklahoma’s cannabis industry. Through our partnership with Steep Hill, the world’s leading cannabis science company, we aim to raise the bar in laboratory services, education, and product safety for the medical cannabis industry in the Sooner State.”
Dr. Chris Orendorff, the other co-owner of Steep Hill Oklahoma, is a family physician based in Sallisaw, Oklahoma. “As a physician, I understand that safety and regulations are critical to patient outcomes and I look forward to providing the same assurance for my patients and fellow Oklahoma residents in the cannabis industry,” says Dr. Orendorff. “I am excited to partner with Steep Hill to provide the highest quality testing in the State of Oklahoma.”
Project Yosemite, a cannabis product innovation and brand development company, announced earlier this month the appointment of Jennifer Raeder-Devens as their new Chief Scientific Officer. Raeder-Devens is a veteran of the MedTech industry, working for companies like Becton Dickinson, Cardinal Health, Medtronic and 3M.
Prior to joining Yosemite, she was the Vice President of Research & Development at Becton, Dickinson, where she oversaw product development and technology strategies to launch infection prevention products including the ChloraPrep first-in-the-US sterile solution patient preoperative topical antiseptic. She was previously the Vice President of R&D, Strategy and Innovation at Cardinal Health. She’s also held roles at Medtronic, 3M Drug Delivery Systems and 3M Skin Health Division and she has a number of patents in drug delivery and medical devices.
Jennifer Raeder-Devens, Chief Scientific Officer at Project Yosemite
In November of 2018, Project Yosemite launched their first product, OLO, which is an infused, controlled-release sublingual strip. Part of Raeder-Devens’ new role at the company is the continued development and expansion of the OLO sublingual strip technology platform. Andrew Mack, CEO and founder of Project Yosemite, says he’s thrilled to have Raeder-Devens on the team. “Jennifer is an extremely accomplished scientist and engineer with extensive experience driving innovation and R&D in the pharmaceutical and medical device industries,” says Mack.
We caught up with Jennifer over the phone to talk about her background in the MedTech space, why she decided to jump ship to join the cannabis industry and what she’s excited to work on now.
Cannabis Industry Journal: Can you tell us about your background, including your work with 3M and Medtronic?
Jennifer Raeder-Devens: I’m coming directly from Becton Dickinson, a global med tech company, where I supervised the development of drug-device combination products for topical antiseptics. I spent about 10 years there, mostly in topical drug and combination product development. Prior to that, I was at 3M and Medtronic working in drug-device combination products. At 3M, I was supervising a team of technology developers for the 3M Drug Delivery Systems business. I had experience working with designing and manufacturing transdermal, nasal, buccal and inhalation drug delivery mechanisms for pharmaceutical partners.
I worked on implantable drug delivery systems at Medtronic, which included working on the biocompatibility of things like pacemakers and drug infusion pumps and optimizing them to reduce infection and enhance healing after the implantation procedure.
CIJ: What made you consider joining the cannabis industry?
Jennifer: With my work in topicals, transdermal and inhalation drug delivery, I had an easy understanding of the different routes of administration we see today in the cannabis industry. And so, from the technology standpoint, I thought this was a place I could contribute to immediately. And then what got me really excited about it was thinking about cannabis, and just like any other drug, with oral drug delivery, you’ve got first class metabolism and side effects from the 11-Hydroxy-THC that are undesirable and you’d rather not have delivered through the gut.
OLO sublingual strips have a 10-minute onset time
I got excited when I saw the development of things like sublingual strips that were focusing on alternatives to smoking that would preserve that relatively fast onset and mitigate some of the side effects of edibles.
The other thing I really like about the cannabis industry: Previously I have been very focused on known drugs that are already approved and repurposing them into a new delivery system. What really interests me about the cannabis industry is the active cannabinoids and terpenes are somewhat known and somewhat unknown, so there is this really interesting challenge there of trying to separate the wheat from the chaff in terms of producing therapeutic effects.
It is a really interesting space where the indications of certain molecules are evolving along with the delivery technology. So, it is a really exciting and eye-opening way to take the next step in my career and have this wide-open space in front of me, both in terms of the different cannabinoids, their effects and the delivery systems we can use.
CIJ: How might you be prepared, given your background, for some of the challenges in the cannabis space?
Jennifer: I think the challenges in cannabis delivery are not different from the challenges in pharmaceutical drug delivery. It’s just that we have this additional complexity of the entourage effect. We can be engineering not just the main ingredient of THC, but also all the other cannabinoids and terpenes. So, for example, with my background in infection prevention, we build a product that we know reduces the risk of infection, but we are really challenged to actually prove it reduces the risk of infection. We have a similar situation in the cannabis industry, where we can get the THC, or CBG or CBN where we want it to go, but then we are really challenged to figure out how we can find, what we call in the pharmaceutical industry, a surrogate end point for efficacy, so that we can test that product and really believe that when we put the product on the market, even though we haven’t tested thousands of users or conducted large randomized clinical trials, that the effect will be shown. We are networking and partnering with a good scientific community to build the right product and do some testing at a small scale that really demonstrates the product achieves the effect that we are really looking for.
CIJ: Can you tell us a little about your new role with Project Yosemite?
Jennifer: My job description falls into three buckets: The first part is that we are forming a scientific advisory board and we are working with some of the leading cannabinoid researchers around the country and around the world. These are the people identifying whether or not certain cannabinoids could reduce cancer cell metabolism or whether cannabinoids contribute to weight loss or diabetes control and other things of that nature. We are trying to reach as far upstream as we can to grasp the emerging understanding of the performance of cannabinoids and terpenes in the endocannabinoid system. So, part of my job is to chair that scientific advisory board, get the thought leaders together in the room and have them bring their knowledge and explore with our own knowledge what cannabis can really do.
The OLO sublingual strips
I have worked in topical, transdermal, buccal, nasal, inhalation drug delivery. In the second bucket of my job, we are trying to understand a given indication or experience that our users want to have, what would be the right route for them. We are challenging our sublingual delivery mechanism to see how fast of an onset we can really get. Right now, we are at 10 minutes for drug delivery in sublingual and we are still trying to get an even faster onset time for the sublingual strip.
For other indications, like chronic pain, we may want to think about a sustained release, so sort of aligning the different indications with which different cannabinoids and terpenes will work for it and see which delivery platform will work for what we are trying to accomplish in each indication. So, we do not plan to remain solely a sublingual strip company, but will build out additional delivery platforms as we develop new indications.
Right now, we are working upstream with the growers and the processors to get cannabis oil and extracts. Some of the growers are working on different genetics in their cultivars to grow plants that have different ratios of different cannabinoids that we know from the emerging research will have an impact on people’s experience. Now we are working with growers to really get ahead of the curve on how to formulate products with various cannabinoids.
We have an R&D team in house that I supervise. We are always working with our production team to make small improvements such as the faster onset and the dissolution rate and things like flavors, which covers a downstream focus as well.
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According to Alex Traverso, spokesman for the BCC, licensees were given plenty of opportunities to fix their errors. Businesses were given notice that they needed to enroll in Metrc within five days following their provisional licensing. The BCC gave those businesses a reminder roughly three months ago and sent an additional warning in late October regarding the deadline.
