After a delay due to their proficiency testing program roll out, the Colorado Marijuana Enforcement Division (MED) will now require all medical infused products and concentrates be tested for potency and homogeneity, starting November 1st, 2017.
After November 1st, all production batches of concentrates from medical product manufacturers will need to have a potency test before being sold, transferred or processed. The same goes for medical infused products, such as edibles and topicals. The homogeneity test refers to making sure THC or other active ingredients are distributed evenly throughout the product.
According to Alex Valvassori, author of a regulatory compliance-focused blog post on Complia’s website, these new testing requirements could lead to a surge in pricing, passed on to patients. He also recommends dispensaries take a close look at labels coming in from suppliers. They need to make sure potency data is listed clearly on the label to stay compliant.
Production batches created before November 1st are not required to meet the new testing regulations, but any and all batches after that date will be required to perform those tests.
As cannabis conference backdrops go, Cologne (or Köln as it looks to the locals) has some major plusses. Cologne is a German city that has all sorts of both historical and cutting edge things to explore. Plus of course there is the timing. This part of the world just pre-Oktoberfest is a refreshing splash of multi-hued natural colors populated by people who wear lederhosen and dirndls in public (and with great enthusiasm).
Beyond its postcard settings, Cologne is a German center of medical research, as well as public policy making. The intricacies of pre and post war, not to mention post reunification politics, have made this whole region (which includes both Düsseldorf and Bonn) a major powerhouse in both deciding how things get done and then making sure they do. Including on all things scientific and medically focussed.
Overview of the Conference
Where German geographical proximity intersects with the global cannabis research and medical community is the work of the people who have made the International Association for Cannabis Medicines (IACM) one of the leading international scientific and medical cannabis conferences in the world. One look at the speakers list confirms that the top people in the cannabis research world came, spoke and even discussed unpublished research. Yes, that is the mark of a real academic conference. But in a world where medical efficacy is still being challenged, it is worth saying.
Even if you were not old enough to know about cannabis or well read, and had just showed up for the day, the subject matter and presentations were clear, easy to understand and stunning both individually and altogether.
Topics and abstracts ranged from trial data to changing legislation. Peppered between those were visions of where cannabis as medicine is clearly going as well as a far greater understanding of the role of the endocannabinoid system.
As a medical doctor, researcher, public policy expert or medical cannabis distributor, in other words, it is already a must-attend event. It is also packed with investors, not only from Europe but far from its shores.
If there was a message beyond the fact that the cannabis industry is now jumping the shark and going global, it was that the industry has now arrived in Europe and there is no turning back. On any front.
Most Interesting Highlights
It is very hard to pick which was the most ground-breaking research. It all is at this point and it is all fascinating. One of the most heartening abstracts was submitted from Montana. It was just a single patient study. However it showed visual evidence of a stage 1A malignant melanoma completely resolving after 60 days of treatment both topically and orally. Research out of Tel Aviv (of course) was presented showing that low doses of THC might even reverse age-associated cognitive impairments.
All of the genetic research into the plant not to mention new knowledge about terpenes was, literally, spell-binding to those who follow the science. Some of the presentations about ingestion technology in particular, were a clear indication of how much this world will be impacted by tech, where it is not already.
It was stunning just to sit and listen to ground-breaking science that is being produced by globally-known scholars at internationally renowned universities, but still ignored in every place where medical cannabis is not only still illegal, but out of reach of patients.
The current dire situation facing German medical users, of course, was frequently mentioned throughout the conference, and even from the presenting stage, as a human rights crisis.
The Ambassador Program
The conference was, by definition, not only an exchange of information and research, but also a gathering of the scientific cannabinoid community with a global reach. It was also clearly a gathering of academics and scientists on a mission. The dire need to educate both doctors and patients as the details and kinks get worked out on the ground is well recognized here. The IACM at least is also trying to do something about it.
On Friday night, the first full day of the conference, IACM organizers invited conference participants to a side meeting they at first wanted to limit to 30. The idea was to discuss the launch of an ongoing “Ambassador” program as well as a pilot project to help doctors and researchers communicate with each other. More than 60 people showed up and stayed, even if it meant standing against the wall for several hours.
The mood was helpful and light. Dr. Franjo Grotenherman, the best known and leading cannabis advocacy doctor in Germany, kicked off the gathering by serving food to guests before opening the floor to attendees to introduce themselves.
The idea clearly here, is to spread the word, no matter how, as quickly as possible.
An Intimate, Science-Based Networking Event
The event has a different vibe from purely “industry” events. While the industry was clearly in attendance, in other words, it was clearly there in a supportive role. The star of the show was the unbelievable wealth of scientific knowledge that spilled from the stage.
That is not to say that there was not a lot of business conducted here. On all levels. The networking is terrific. And this being the cannabis industry, most people are friendly, open and willing to give a polite stranger a few minutes of their time.
This is an absolutely intriguing event to consider, particularly for Americans who do not have much insight into the European medical or scientific worlds when it comes to cannabis. That includes cannabis clinics in legalizing states to prescribing doctors looking for medical evidence of using CBD in treating their patients. Canadians, Israelis and Swiss were here in force, beyond the locals with representatives from most countries in Europe. If looking to network with an international crowd of doctors, scientists and companies on the cutting edge of cannabis globally, this is absolutely one of the best places on the planet to be.
A number of cannabis businesses have pursued federal intellectual property protection for their cannabis-related innovations, such as U.S. patents that protect novel cannabis plant varieties, growing methods, extraction methods, etc. Enforcement of such federal IP rights requires that the IP owner file suit in federal court asserting those rights against another cannabis company. However, given that cannabis is still illegal under federal law, the industry is uncertain about whether a federal court will actually enforce cannabis-related IP rights. This question might be answered soon.
The potential impact of this case goes way beyond the two parties involvedOrochem Technologies, Inc. filed a lawsuit in federal court in the Northern District of Illinois on September 27, 2017, seeking to assert and enforce trade secret rights against Whole Hemp Company, LLC. According to the complaint, Orochem is a biotechnology company that uses proprietary separation methods to extract and purify cannabidiol (CBD) from industrial hemp in a way that produces a solvent-free and THC-free CBD product in commercially viable quantities.
The complaint goes on to say that Whole Hemp Company, which does business as Folium Biosciences, is a producer of CBD from industrial hemp and that Folium engaged Orochem to produce a THC-free CBD product for it. According to the allegations in the complaint, Folium used that engagement to gain access to and discover the details of Orochem’s trade secret method of extracting CBD so that it could take the process and use it at their facility.
The complaint provides a detailed story of the events that allegedly transpired, which eventually led to an Orochem employee with knowledge of the Orochem process leaving and secretly starting to work for Folium, where he allegedly helped Folium establish a CBD production line that uses Orochem’s trade secret process. When Orochem learned of these alleged transgressions, it filed the lawsuit, claiming that Folium (and the specific employee) had misappropriated its trade secret processes for extracting and purifying CBD.
While the particular facts of this case are both interesting and instructive for companies operating in the cannabis industry, the potential impact of this case goes way beyond the two parties involved.
If it moves forward, this case will likely provide a first glimpse into the willingness of federal courts to enforce IP rights that relate to cannabis. Orochem is asserting a violation of federal IP rights established under the federal Defend Trade Secrets Act (DTSA) and is asserting those rights in federal district court. As a result, the federal district court judge will first need to decide whether a federal court can enforce federal IP rights when the underlying intellectual property relates to cannabis.
If the court ultimately enforces these federal trade secret rights, it could be a strong indication that other federal IP rights, such as patent rights, would also be enforceable in federal court. Since the outcome of this case will likely have a far reaching and long lasting impact on how the cannabis industry approaches and deals with intellectual property, it’s a case worth watching.
According to a PennLive article, Pennsylvania’s Department of Health approved the first two cannabis laboratories for their medical cannabis program. ACT Laboratories of Pennsylvania LLC and Keystone State Testing LLC are the companies that were approved to perform analytical testing for safety and quality in cannabis products.
Both laboratories expect to be operational before the end of 2017, according to the PennLive article. Those labs are required to test for CBD and THC content, pesticides, moisture content, residual solvents and microbiological contaminants.
The temporary lab testing regulations are somewhat comprehensive, detailing lab reporting, licensing, sampling protocols and ownership stipulations, among other rules. ACT and Keystone, the labs that were approved by the Department of Health, have their approval for two years and can renew their license after.
While the state still expects the program to be fully implemented by 2018, Health Secretary and Physician General Dr. Rachel Levine said last week they are hoping to launch the program sometime next year, according to a press release. December 2017 will mark a full year since the state opened applications for licensing businesses.
January 2018 has long been the goal for the full implementation of the program. “We have made significant progress in getting this program off the ground since Governor Wolf signed the Medical Marijuana Act into law last year,” says Dr. Levine. “These proposed regulations for patients and caregivers to participate are one of the final pieces we need to have in place to launch the program sometime next year.”
In July, we sat down with the folks at Digipath, Inc. when they received their testing license in Nevada for the adult use market. In that conversation, they mentioned they were looking to expand into California.
According to a press release published September 25th, DigiPath, Inc. has entered a joint venture to establish their first cannabis-testing lab in California. They will be working with Don Ashley, an experienced real estate developer and cannabis entrepreneur, to launch Humboldt Botanical, LLC, conducting business under the name “Digipath Botanical Testing”.
Ashley says they expect to be fully operational by Q1 of 2018. “We expect to break ground on this project in the next few weeks and hope to be operational in early Q1 2018 just after the state-wide adult-use market is expected to launch, as we have already obtained approval from the local planning authorities for the entire complex,” says Ashley.
Todd Denkin, president of Digipath, is optimistic for California’s market and the coming regulations. “The state of California is estimated to be the single largest cannabis market in the U.S. Adult-use cannabis legislation was approved by California residents last November, and we expect these new regulations to be implemented in 2018,” says Denkin. “The good news for the industry is that the requirements for cannabis testing will be significant, and we are excited to partner with Don and his team to pursue this opportunity in Humboldt County.”
Ashley is contributing roughly $2 million to build and equip the lab with instrumentation, while Digipath Labs will manage and supervise operations at the lab. According to the press release, Digipath will provide a non-exclusive license to use its intellectual property for the operation of the lab. Digipath Labs will retain rights over all the scientific data generated in the lab.
According to Cindy Orser, PhD., chief science officer at Digipath, that data will be put to good use. “Digipath Labs has developed an algorithm for use in strain authentication based largely on terpene profiling from our testing lab in Nevada and we are eager to further test our hypothesis with an expanded dataset from cannabis grown in Northern California,” says Orser.
While testing labs are primarily seen as safeguards for public health and safety, using data to correctly identify strains is a relatively new concept. “Digipath Labs is all about public health and safety through testing for adulterants,” says Orser. “Another component to quality is having confidence in product authenticity at the dispensary level. Not only is the consumer buying quality assured products but truth in advertising when it comes to strain nomenclature.”
Denkin says they were proactive in working toward getting the license early on. “Our partners have been dealing with the local regulators while we have been providing the proper SOP’s for the local government in order to receive the proper licensure in the area,” says Denkin. Taking their experience from Nevada to California, Orser says they have been asked to present to the California Toxicology Association on their experience with cannabis testing in the highly regulated marketplace of Nevada.
The laboratory in Humboldt is going to be part of a “cannabis industrial park,” alongside an R&D facility, oils/concentrate manufacturing center, health and wellness center, distribution and processing facility, tissue culture nursery, hemp clothing outlet, and coffee bistro, according to the press release.
Looking forward to growing their business, Denkin says they hope to launch a lab in Southern California. “We do expect to have a larger footprint in California because of the size of the market and are looking for locations in Southern California as well,” says Denkin. When asked about any new plans to expand elsewhere, Denkin says they’ll let us know. “We are continuing with our business plan and actively seeking the right mergers and acquisitions. Stay tuned.”
Last month, G3 Labs LLC, a Las Vegas-based cannabis-testing lab, had their license suspended for an unknown regulatory compliance issue. According to Stephanie Klapstein, spokeswoman for the Nevada Department of Taxation, the reason why their license was suspended is confidential. “We can’t disclose the details of the suspension, including anything about penalties,” says Klapstein.
When asked about the license suspension, Klapstein told us it was a compliance issue, but could not go into detail. “I can confirm that we did suspend G3’s license for compliance issues,” says Klapstein. “We are working with them to bring them back into compliance. In the meantime, they cannot operate.” Klapstein told the Las Vegas Review-Journal that the Nevada Department of Agriculture tested cannabis samples from the lab to determine if there was a need for a recall. She also confirmed with us that the compliance issue does not necessitate any product recalls.
According to the Las Vegas Review-Journal, this is the first time a cannabis business license is suspended in the state since the beginning of adult-use sales back in July of this year. Nevada’s cannabis regulations require independent lab testing of products before they reach shelves. That required testing includes checking for potency, microbials, pesticides, residual solvents, moisture content, growth regulators, Mycotoxins and foreign matter.
When we reached out to G3 Labs, they did not immediately respond to a request for comment.
Dr. Chao-Hsiung Tung, lab director at G3 Labs, told the Las Vegas Review-Journal that they couldn’t comment, based on advice from their legal counsel. “G3 Labs is actively sorting out the issues with the Department,” Dr. Tung told the Review-Journal in an email.
According to a press release issued on Friday, September 22nd, the Colorado Department of Public Health and Environment (CDPHE), along with the Colorado Department of Revenue (DOR) and the Colorado Department of Agriculture (CDA), issued a public health and safety advisory for cannabis products tainted with pesticide residue.
The advisory was issued after the detection of pesticide residues on retail cannabis plant material and products with cannabis grown by RK Enterprises LTD, doing business as Rocky Mountain Remedies. The CDA confirmed that they detected the pesticide, Avermectin, an insecticide with a relatively high acute toxicity.
When pesticides like this are not on the list approved for use in cannabis cultivation, it is considered an off-label use. According to the press release, some of the products affected include flower, trim, concentrates and infused-products.
Consumers are advised to look at the label of their products and check to see if it matches the license number 403R-00180 and harvest batch numbers r206goldenkush9.11.17 and m206larryog9.11.17. Consumers are told to either dispose of the product properly or bring it back to the retail store where they purchased it.
Back in April of 2016, the Colorado Legislature passed HB 1436 in an effort to make infused products less appealing to children. On October 1st, 2017, the new law goes into effect, which will prohibit the sale of edibles in the shape of a human, animal or fruit.
Colorado has a history of regulating the market like this, with laws designed to limit the dosing, consistency and appeal of edibles to children. In 2015, regulators placed a 100-milligram cap on THC in infused products, separated into 10-milligram servings. In 2016, regulators began requiring the THC stamp on edibles, a symbol with a clear representation of what the product contains.
Some in the industry are welcoming of these new laws, while others think it might be overregulation. Regardless, manufacturers that have previously produced things like fruit candies or gummy bears now need to update their processes to use non-descript shapes for their products in order to stay compliant.
Bob Eschino, founder and president of Incredibles, an infused product manufacturer in Colorado, says these rules are not very effective at preventing kids from obtaining edibles, but it could help. “I believe consumer protection comes from CRP [child-resistant packaging], proper labeling, education and safe storage,” says Eschino. “CDPHE said themselves that stamping or shaping the products is the least effective way to prevent accidental ingestion. It’s a step that will add to consumer protection in a small way, but every little bit helps for now.” There are a number of more effective measures that regulators in Colorado take to prevent edibles from getting in the hands of children, such as child-resistant packaging, prohibiting advertising of cartoon characters, requiring opaque packaging and warning messages on labels.
According to Peggy Moore, partner of Love’s Oven, an infused product manufacturer, and board president of the Cannabis Business Alliance, the major change companies need to make to stay compliant is ordering new molds. “Depending on the quantity ordered, molds can cost $10,000 or more to fabricate and produce.,” says Moore. “If a company was not using molds previously there is also training that may be required to orient production staff on technique for making molded confections.” She says there are still plenty of options for manufacturers to use like botanical shapes (a cannabis leaf, for example), circles, squares, rectangles and other shapes.
Her company, Love’s Oven, makes caramels, baked goods, crackers and other non-descript shapes already. “At this point I am not aware of any manufacturers who are not already compliant with this rule in advance,” says Moore. “The most common solution is to move to a square, circle or other shape utilizing molds. “ Moore believes it is a producer’s duty to make products that are not enticing to children. “Regardless of the industry (alcohol, cannabis, pharma) I think we should exercise great caution to not produce products that are targeting children,” says Moore. “While I would love to see manufacturers self-regulate in this regard, clearly some guardrail regulations are needed at this point.”
In addition to the rule on using non-descript shapes, HB 1436 prohibits the use of additives in retail cannabis products that are designed to make it addictive, more appealing to children or misleading consumers. The rule does, however, exclude common baking and cooking ingredients. There is also a stipulation that permits local fire departments to perform annual fire inspections at cannabis cultivation facilities.
Emerald Scientific recently announced their proficiency-testing program, The Emerald Test, has been approved by Colorado as a third party provider for proficiency testing in licensed cannabis laboratories. The Emerald Test, held twice annually, is an inter-laboratory comparison and proficiency test (ILC-PT), allowing data to be collected pertaining to the performance of laboratories on a national scale. Proficiency testing is designed to measure how accurately laboratories perform and is a critical tool for quality assurance.
Colorado requires labs to participate in a proficiency-testing program in order to be certified to conduct required testing on cannabis and cannabis products for safety and quality. According to the press release, Colorado’s Marijuana Enforcement Division, under the Department of Revenue, conducted an evaluation process to determine which applicants could meet the performance standards for regulatory compliance concerning proficiency testing. The contract was awarded to Emerald Scientific following this evaluation process.
According to Ken Groggel, director of the Proficiency Testing Program at Emerald Scientific, a number of states have recognized the need for independent proficiency testing as a required piece of regulatory compliance. “The Emerald Test Inter-Laboratory Comparison/PT is state approved in Washington & Colorado for cannabis testing laboratory licensure,” says Groggel. “States with cannabis or hemp production, as well as labs in other countries are now actively participating in the Emerald Test as a tool for quality improvement, efficiency upgrades and product safety.” He says the Colorado Marijuana Enforcement Division has contracted with Emerald Scientific to provide third party PT programs for microbial contaminants, residual solvents and pesticides.
Beginning in 2014, The Emerald Test has been offered twice a year and, in 2017, over 50 labs participated from 14 states and 2 countries. “Laboratories that have enrolled more than once have seen significant improvement in their results, an indicator of improved performance for industry customers,” says Groggel.
Proficiency testing is important for ensuring quality, safety and product content accuracy. “This should be the priority whether you are a grower, manufacturer, testing laboratory, regulatory entity, medical patient or adult use consumer,” says Groggel. It also helps labs meet regulatory requirements and achieve ISO 17025 accreditation. “Independent proficiency testing helps determine if the lab is able to deliver the services marketed to its customers,” says Groggel. “Regulatory agencies can use this information when licensing, monitoring & enforcing good science for public safety.”
As new states legalize cannabis and develop consumer protection regulations, proficiency testing programs can help labs demonstrate their commitment to responsible and accurate testing. “When PT results show the cannabis testing lab is capable it is up to the government to ensure accountability for performance on behalf of all its citizens,” says Groggel. Labs can enroll starting on September 25th in the Fall 2017 Emerald Test ILC/PT.
As of early September, Canopy and Spektrum also announced their next strategic European move. They have just entered into a supply license agreement with Alcaliber, S.A., a leading Spanish pharmaceutical company. Alcaliber specializes in research, as well as the development, breeding and preparation of plant-based and other raw materials into narcotic medicine. More significantly, it is already a leading company in the global pharmaceutical and narcotic space.
According to Bruce Linton, chairman and chief executive officer of Canopy Growth, the partnership opens a lot of doors. “This agreement gives us additional resources to aggressively enter the European market where federally permitted by law, while we continue to work to establish our own complimentary production footprint for cannabis cultivation, value-add oil extraction and Softgel production in the European Union,” says Linton.
Alcaliber is one of the largest producers of morphine in the world (27% of global production) and supplies 18% of its codeine. Cannabis is also considered a narcotic drug in Europe. This kind of track record is exactly what governments are looking for as they figure out how to integrate cannabinoids as medical products into existing pharmaceutical production and distribution. They are equally excited about the possibilities this partnership brings, according to Jose Antonio de la Puente, chief executive officer of Alcaliber. “There is a clear demand for pharmaceutical cannabis produced in accordance with pharmaceutical standards and the expertise we have developed manufacturing narcotic derivatives for over 40 years,” says de la Puente.
The agreement is also the first of its kind between a Canadian cannabis company and a separate, established, international pharmaceutical company. The fact that Alcaliber is located in Spain (albeit Madrid and not Barcelona) makes this new alliance even more interesting, and for several reasons. Not just in Europe or even Canada for that matter.
In the EU? GW Pharmaceuticals, the only other existing pharmaceutical manufacturer and grower of cannabis in Europe, and based in the UK, just got major European if not global competition.
And then of course, there is what is going on Down Under. Australian and Tasmanian companies moving into the game now (with pharma connections, background in opioids and a global footprint) as the medical market in Australia begins to take shape, are about to go head to head with the Canadian-Spanish-German alliance now forming on the other side of the world.
Cross-Continental Plays Are Now Forming
Just as in the U.S., Europe is turning out to be literally a state-by-state chess game of legalization, regulation and supply. Unlike the U.S., however, European countries are bound by both European law and in some cases, sub-regional agreements – like what exists in the so-called Schengen States.
However, even here, the new world is graduating into federal and regional law. And how that will play out in Europe, where the focus is still largely on medical use, is going to be interesting.
What does this mean for Canada’s largest LP? A strong, multi-country presence in the medical cannabis space that, strategically, is par to none other. There are other Canadian LPs who are planning production facilities in other EU countries of course. And some Canadian companies who appear to see Europe as one giant export market. Germany is just one of them. However, the German-Spanish connection is interesting for several reasons: The two most interesting markets globally right now from both a strictly medical perspective with a clear pathway to much broader acceptance as it transitions into some kind of recreational reform, are Spain and Germany. While the former has not signed up for full-boat medical acceptance, the recent independent assertion by the Catalonian government that they would formalize the cannabis club system is seen here as one more step towards the inevitable. So are ongoing and significant Spanish medical cannabis trials.
This move also gives Canopy and Spektrum something else: access to much cheaper Spanish labour and production. This means that no matter where they grow their crops in Europe, or process them, the company now has a two-country supply system for a multi-country medical market that is just waking up. And that is highly valuable right now.
It gives Canopy direct market entry into several European states, with federally approved, medical grade cannabis and medical products. Those who are coming to the rest of Europe from a Spanish base only, will not at this juncture meet strict medical growing requirements for the German market for starters. On the Spanish side of things, this also means that cannabis clubs might be pressured to stop growing their own (at least outside of Catalonia) and rely on more corporate entities to actually grow and process the plant.
What Does This Mean For Euro Industry Development?
Canopy, strategically, has been at the forefront of interesting strategic plays in the global industry for at least the last 18 months to 2 years. They have eschewed the American market (unlike other Canadian competitors) in lieu of other game elsewhere. However their current expansion strategy, geolocationally, has clearly also been at least 12 to 18 months ahead of just about everyone else.
The cross-country chessboard game is also something that other Auslander (foreign or international) companies are clearly trying to play, particularly in Europe. This is true of both actual cannabis production and distribution entities as much as tech. The hop-scotching of both Leafly and Weedmaps across the continent in search of a business strategy that makes sense is just another face of this. Advertising rules in Europe, including online, and especially for cannabis, are a lot different from say, California state law.
However what Canopy appears to be doing is establishing both a brand and production presence in a way that guarantees not only European entry, but potentially dominance in the medical market as the market here continues to expand and open up.
What they are also doing with this announcement is telling the German government, for one, that they can supply patients in the EU with EU-sourced product, even if not grown or produced in Germany itself. This alone will help keep prices down as German cannabis production gets underway over the next several years.
It will also help Canopy deal with what is expected to be at least supply pressure as of next year as the Canadian recreational market gets underway. There is a very good chance that Spanish grown cannabis might end up not only in the rest of Europe but will also be shipped back to Canada if the supply problems there are severe enough.
Whatever the end result, this is an interesting alliance, and coming at an interesting time for not only the German cannabis industry, but a regional market as well. And further, it is also clearly a play with not only hemispheric implications but global ones.