Just weeks ago, the first voluntary cannabis product recall occurred under California’s new regulations. According to an article on MJBizDaily.com by John Schroyer, the recall for their vaporizer cartridges affects almost 100 dispensaries in California.
Bloom Brands, the company issuing the voluntary recall, mentioned in a press release that batches sold between July 1-19, 2018 were contaminated with the pesticide Myclobutanil and therefore does not meet the Bureau of Cannabis Control (BCC) standards. Below is an excerpt from the press release:
We are working closely with the BCC to remedy this issue and expect clean, compliant products to be back on shelves in three weeks…. At Bloom, we are continuing to work with the BCC and other partners to ensure that the space is properly regulated and safe for all customers. Transparency and safety remain our top concerns and we will provide updates as additional information becomes available. We apologize for any concern or inconvenience this serious misstep has caused. We thank you for your continued trust and confidence in our products.
Then, just days later, Lowell Herb Co. issued a voluntary recall on their pre-rolls. First reported by MJBizDaily.com, it appears the products initially passed multiple lab tests and was cleared for retail sales. Weeks after the batch passed tests, a laboratory reversed its decision, saying the products failed to pass the state’s testing standards. The contaminant in question was not mentioned.
The CCIA post calling out the BCC
Many seem to think these recalls are a product of the BCC’s unrealistic expectations in their lab testing rules. In a Facebook post days ago, the California Cannabis Industry Association called out the BCC for their unworkable rules. “The BCC has set testing standards that are nearly impossible to meet,” reads the post. “As a result recalls like this will be the norm and the industry will suffer a bottleneck in supply. Testing standards need to be realistic, not impossible.”
Thomas Jefferson University’s Lambert Center for the Study of Medicinal Cannabis and Hemp announced recently that it is co-sponsoring the third annual JAZ Tank Challenge: CannaVATION Edition.
Jefferson Innovation’s 2018 JAZ Tank Challenge: CannaVATION Edition is currently accepting submissions of innovative business models for a chance to compete on October 3, where finalists will each present their business ideas in a 10-minute pitch. Winning submissions could get one free provisional or utility patent application and business and clinical consulting services. The competition will be accepting submissions through August 20, 2018.
Finalists will compete for a $10,000 grand prize, legal support and business consultation services. According to the announcement, in addition to the grand prize winner, up to two other teams could win $5,000 in financial support, one free provisional or utility patent application and consulting services as well.
Zoe McKinley, director of entrepreneurship and social impact initiative at the Lambert Center
According to Zoe McKinley, director of entrepreneurship and social impact initiative at the Lambert Center, the competition is designed to have a national focus, not just on the Pennsylvania cannabis industry. “We are excited to shine a spotlight on Pennsylvania, and Thomas Jefferson University specifically, as a hub for research in medical cannabis, but like the competition, the Lambert Center has a national and even international focus,” says McKinley. She says this is also the first year that the JAZ tank is exclusively focused on cannabis.
Jefferson’s Chief Innovation Officer, Dr. Rose Ritts, notes “the competition is about creating a platform for emerging concepts to get a toe-hold on the path to potential commercialization. Anything that will improve patient access or outcomes …or improve the industrial hemp market in the U.S. is definitely of interest,” says Ritts. “We welcome companies to jump into the Challenge, and we also welcome investors or anyone thinking about getting into this space to be in the audience for our event on October 3.”
Dr. Rose Ritts, Jefferson’s Chief Innovation Officer
The challenge is an annual healthcare startup competition, where new businesses with particularly innovative ideas and technology solutions for the legal cannabis space submit their business models to a panel of judges for review. “This event will bring together the most inventive minds to pitch their solutions to stakeholder problems in the still-emerging medical and medicinal cannabis and industrial hemp industries,” reads the announcement. The Lambert Center is seeking applicants in a wide variety of business areas, including patient access, product design, plant science, information management, horticultural technology, sustainability, transportation, security, workforce training, community outreach, banking and public education.
Lambert Center Director Charles Pollack, MD sees the massive growth potential of the legal cannabis industry. “At our Center we are dedicated to identifying new approaches to developing cannabinoid-based therapies that help patients with various debilitating symptoms and diseases,” says Pollack. “Our JAZ Tank Challenge may identify the next great idea in medicinal cannabis.”
Through the Lambert Center for the Study of Medicinal Cannabis and Hemp, Jefferson is the first major university in the US to provide a comprehensive academic resource for the medicinal, medical and industrial applications and business of cannabis and hemp. The Lambert Center, the first of its kind in academia, provides “expert-developed, unbiased information to clinicians and patients about medical cannabis and cannabinoid-based therapies,” according to their website. They want to “support the development of entrepreneurial and socially responsible business and clinical approaches within the emerging medical cannabis industry and explore and develop new ways to use hemp in medical, industrial, and consumer products,” reads the website.
McKinley mentions they are looking for creative approaches to solving problems in the medical cannabis and industrial hemp industry. “These could be anything from new products or supply chain innovations to patient support tools to energy management systems that lower the environmental impact of grow facilities,” says McKinley. “We are hoping to see companies that have already launched, or are ready to very quickly.” The third annual JAZ Tank Challenge: CannaVATION Edition is accepting submissions through August 20. Click here for more information.
After a year of embarrassing missteps and revelations, along with two well-run advocacy campaigns by the parents of children with drug-resistant epilepsy, the British government is finally throwing in the towel on medical cannabis.
Sadly, politics rather than science has driven the pace of British cannabis legalizationIn the last week of July, a mere two weeks after announcing his review of the issue against mounting domestic pressure and outrage in the media, Sajid Javid, the home secretary, announced that cannabis medications will be rescheduled by the fall, allowing doctors to prescribe them more widely.
“Fall,” it should be noted, is not only when the Canadian government moves ahead with its own fully recreational market, but also when the German bid respondents need to file their paperwork to participate in the country’s first grow bid, Round II.
A Political Embarrassment Beyond Brexit
Sadly, politics rather than science has driven the pace of British cannabis legalization, just like it has in other places. However the UK is one of the best examples of how far medical knowledge has outstripped the pace of political change, and in this case, exposed bare the banal reason.
News broke this summer, as two families mounted a highly successful battle in the public for medical access, that the Prime Minister herself has personally profited from a status quo that is only now slowly going to change.
How and why?
Theresa May, Prime Minister of the UK Image: Annika Haas, Flickr
It was bad enough in May that the publicly anti-pot reformer Victoria Atkins, the cabinet level British drugs minister, was married to the managing director of British Sugar, the company with the exclusive right to grow cannabis in the British Isles. British Sugar is also the sole cultivator for GW Pharmaceuticals, the only company with the license to produce cannabis medications in the UK (and export them globally). In June, however, it emerged that Prime Minister Theresa May’s husband, Phillip May, is employed by Capital Group– an investment firm that is also the largest shareholder in GW Pharma. This is against the backdrop of news that broke earlier this year that GW Pharma had made the UK the single largest exporter of cannabis-based medicine annually. Globally. Even more than all of the Canadian firms combined currently exporting to Europe and beyond. Even as the drug is largely denied to British residents.
You don’t even have to be British to think the entire situation is more than a bit of a sticky wicket.
Vested, If Not Blueblood Interests
This development also came to light right as GW Pharma’s newest focal epilepsy drug faltered to failure in Eastern European trials and as Epidiolex, the company’s drug for certain kinds of childhood epilepsy, was given the green light in the U.S. by the government as the “first” cannabis-based medication to be allowed for sale in America.
No one has yet defined exactly what kind of cannabinoids will be allowed to be prescribed in the UK come fall, but here is the most interesting development of all that still hangs over the British Isles like stale smoke: Will competitors to GW Pharma be allowed to sell their products to medical customers in the UK or will this new opening for patients just create more of a monopolized windfall for one company whose profits, at least, lie in “pharmatizing” the drug rather than creating greater access to the raw plant or its close derivatives? And those profits flow to women (and men) with the greatest political control over the development of the industry in the country.
Is This Really A “Legalization” Victory?
In the short term, no matter how limited, the answer is actually yes. Rescheduling the drug is a step that has not even been taken in the U.S., and will serve, medically, to reset the needle if not the debate about the circumstances under which cannabis should be used for patients.
It will also move the punishment discussion in a way that still has not happened in places like Germany where, technically, the drug has not yet been decriminalized even though doctors are prescribing it and public health insurers cover the costs for increasing numbers of patients. Large numbers of Britons, just like everywhere else, are incarcerated every year or obtain black marks on their records for mere possession that in turn can affect lives.
Finally, it will put recreational reform in the room, even if still knocking at the door. This discussion too has been gaining in popularity over the past year in particular as reform moves elsewhere. Like Germans, like Canadians and like Americans, reform in Colorado and Washington set loose a global revolution, which will clearly not be stopped.
Even if in places like the UK, it is still moving far slower than it should be. For political and business reasons, not driven by science.
The press release says this makes EVIO Labs Massachusetts one of only a few operating and accredited testing laboratories serving the state’s medical cannabis industry. With recreational sales coming shortly to the state, EVIO is preparing for a higher demand in their lab testing services. “We are very proud of all of the teams’ hard work that resulted in this advanced accreditation,” says James Kocis, lab director of EVIO Labs Massachusetts. “With the state-mandated laboratory regulations, EVIO upholds the high standards of testing and plays a pivotal role in ensuring consumer safety and confidence in the states burgeoning marijuana market.”
According to Adam Gouker, general manager at A2LA, EVIO Labs Massachusetts, based in Southborough, MA, is the first cannabis laboratory they accredited in the state. “A2LA is excited to expand our cannabis accreditation program into yet another state, promoting the value of independent third-party accreditation to support quality products in the industry,” says Gouker. “Having the opportunity to work with a prominent name in the industry such as EVIO Labs and assess their exceptional Massachusetts laboratory has been an additional bonus.”
According to the A2LA press release, by achieving ISO/IEC 17025 accreditation, EVIO Labs Massachusetts demonstrates that they “have management, quality and technical systems in place to ensure accurate and reliable analyses, as well as proper administrative processes to ensure that all aspects related to the sample, the analysis, and the reporting are standardized, measured, and monitored.” It also requires that personnel are competent to perform each analysis.
The National Cannabis Industry Association (NCIA) announced earlier this week the release of two white papers at their Cannabis Business Summit in San Jose, California.The first white paper, dedicated to cannabis testing policy, offers recommendations for state’s addressing cannabis testing, advising them on how to write rules for the testing market.“As wonderful as cannabis is, we’ll face a crisis together as an industry way too soon. When it happens, the key will be how we respond to it,” says Moss.
The NCIA Policy Council is like a think tank for helping for and shape state and federal level policy related to cannabis. Kurshid Khoja, principal at Greenbridge Corporate Counsel and member of the Policy Council, says this release of the testing policy recommendations demonstrates how we can help shape policy on the state level. “As both an NCIA Board member and a member of the Policy Council, I am really excited about the Council’s work,” says Khoja. “Somewhat under the radar, the Policy Council is establishing itself as the think tank for the cannabis industry. On topics ranging from tax policy to pesticides to international competition, the Policy Council is churning out quality papers to raise awareness and educate policy makers in DC. With the release of its testing policy recommendations this week, the Policy Council is demonstrating that it could also help shape policy on the state level.”
The second white paper is meant to provide guidance to businesses dealing with crisis communications. The manual describes best practices in crisis communications, showing businesses how to identify and avoid potential public communications issues in the cannabis industry.
Jeanine Moss, Crisis Manual Subcommittee Chair of NCIA’s Marketing & Advertising Committee, says the creation of a crisis manual is meant to preempt problems we might face soon in the cannabis industry. “As wonderful as cannabis is, we’ll face a crisis together as an industry way too soon. When it happens, the key will be how we respond to it,” says Moss. “That’s why we think it is so important for NCIA members to have an easy and practical guide that can not only help protect businesses during a crisis, but also the industry as a whole. This manual will help businesses prevent problems, keep issues from spiraling out of control, and share positive messages during times of stress.”
C-45 – or the Cannabis Act, passed overwhelmingly in the Senate by a vote of 52-29. Canadian Prime Minister Justin Trudeau has subsequently announced that the legislation will pass into law on October 17. The intent behind the legalization effort was to cripple organized crime and protect minors.
Only one other country in the world has taken such a dramatic step – Uruguay.
Now what?
The Medical Discussion Is Just Getting Underway
While legalization advocates and the increasingly corporate industry have everything to celebrate, this does not necessarily change the other conversation on the ground – in fact it only strengthens it.
Clearly this is a blow against prohibition still in force just south of the border in the U.S. This move alone is also likely to drive the debate in an environment where California and other states are clearly thumbing their noses at the federal government and proceeding apace with its own (and largest) U.S.-based marketplace.
However, there is another topic floating around this conversation. If cannabis is “harmless” enough for recreational use, its use for medical purposes has become the third rail that is now driving the conversation in other places – most certainly Europe.In the meantime, Canadian firms are in an unparalleled position to enter global markets (as they have already begun to do) and set the tone and debate.
Here, full legalization is absolutely off the table as policymakers and scientists begin to seriously contemplate integration of cannabinoids into comprehensive health systems. This week’s dramatic announcement in the UK to that effect, which came the same day as the Canadian vote, is one indication of that. Germany’s own cautious foray into medical use is another. The change in the law last year mandating public health insurance coverage of the same has created a population of 15,000 patients in the last year with many more lining up to obtain it. This population of patients will reliably use more cannabis every month than even the most dedicated recreational consumer.
What Comes Next?
Four and a half years after Colorado took the plunge, the world of cannabis acceptance has clearly changed – and for good.
But what is the next step? Clearly the pressure is now on in the U.S. to consider rescheduling to at least a Schedule II if not Schedule III drug. Marinol, the synthetic version of the drug, became a Schedule III drug in 2010. Epidiolex, GW Pharma’s drug derived from cannabis, just received FDA approval too. GW Pharma is the only British company allowed to develop cannabinoid medications. Let’s see how long that flag flies in the new commonwealth, with Canada fast behind the UK now as the two compete for the title of largest canna exporter. Globally.
The drug war, in other words, is finally coming to close for cannabisHowever full legalization – even in the United States and most certainly in Europe – is at least several years away.
In the meantime, Canadian firms are in an unparalleled position to enter global markets (as they have already begun to do) and set the tone and debate. How they will position themselves – as medical pharmaceutical or recreational companies – is another discussion that is still unfolding. Particularly because cannabis is a hybrid substance. And further, it is not entirely understood (nor has of course it been studied) where cannabis stops becoming a drug. If a consumer uses CBD, for example, as part of a wellness routine but also heads off a more serious condition, is the use of the plant “medical” or “recreational?”
These are all questions now on the table. But at least they are.
The drug war, in other words, is finally coming to close for cannabis. But the horizons beyond that, widely unexplored, promise blue ocean opportunities for decades to come. And not “just” in recreational use, but in the amazing worlds of science, technology and medicine that now lie within reach.
According to a press release, the U.S. Food and Drug Administration (FDA) approved GW Pharma’s drug Epidiolex for the treatment of rare forms of epilepsy. Just a few months ago, news broke of a very encouraging FDA panel assessment, which indicated a positive outlook for the drug’s approval.
In the press release, FDA Commissioner Scott Gottlieb, M.D appeared to indicate an open willingness to explore the medical benefits of cannabis. “This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies,” says Gottlieb. “And, the FDA is committed to this kind of careful scientific research and drug development.” He went on to add:
Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients. Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug’s uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes. We’ll continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and work with product developers who are interested in bringing patients safe and effective, high quality products. But, at the same time, we are prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims. Marketing unapproved products, with uncertain dosages and formulations can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.
According to the press release, the drug was studied in three randomized, double-blind, placebo-controlled clinical trials with 516 patients who have either Lennox-Gastaut syndrome or Dravet syndrome, the two rare forms of epilepsy the drug is now approved to treat. Epidiolex is an anti-epilepsy drug, taken in a syrup form, with the main active ingredient being cannabidiol (CBD), and less than 0.1 % THC.
In a few short weeks, the regulations in California’s cannabis market will expand to include more laboratory testing. The previous exemption for selling untested product will be eliminated come July 1st, meaning that every product on dispensary shelves will have to be tested for a number of contaminants.
Pesticide testing, expanded residual solvent testing and foreign materials testing will be added come July 1st.
According to William Waldrop, chief executive officer and co-founder of EVIO Labs, the state is currently finalizing a revision to the existing emergency rules, which is designed to target the potential supply bottleneck situation. “To help alleviate the bottleneck, the state is eliminating the field duplicate test on every batch of cannabis or cannabis products,” says Waldrop. “This will give the labs additional bandwidth to process more batches for testing.” So one test per batch is the rule now and batch sizes will remain the same. This, of course, is contingent on the state finalizing that revision to the emergency regulations.
William Waldrop, chief executive officer and co-founder of EVIO Labs
In addition to that change, the state will expand the types of testing requirements come July 1st. New mandatory pesticide testing, expanded residual solvent testing and foreign materials testing are added in addition to the other tests already required.
With July 1st quickly approaching, many in California fear the rules could lead to a major market disruption, such as the previously mentioned bottleneck. Waldrop sees the elimination of duplicate testing as a preventative measure by the state. “It is a good move for the industry because it allows labs to test more batches, hopefully reducing the bottleneck come July,” says Waldrop. Still though, with only 26 licensed laboratories in the state as of March, testing facilities will have to meet higher demand, performing more tests and working with more clients.
EVIO Labs is preparing for this in a number of ways. They already have a lab in Berkeley and are working to expand their capacity for more analyses. In addition to their lab in Berkeley, the company is working to get three more locations operational as quickly as possible. “Right now, EVIO Labs is expanding through the identification of new market locations,” says Waldrop. “We have announced the acquisition of a facility in Humboldt and we are outfitting it for state-mandated testing. We have secured a location in LA, and licensing for LA just began as of June 1stso we are going through the local licensing process at this time. We are still moving through the licensing process for our facility in Costa Mesa as well.”
Labs will soon have to deal with higher demand, meaning more samples and more clients
“In the meantime, we have expanded capacity of personnel in our Berkeley facility to support our client base until these other locations come online,” says Waldrop. “We are refining our business, bringing on additional equipment and more resources.” While the rules haven’t been implemented yet, Waldrop says he’s seen an uptick in business with licensed operators requesting more testing for the new July 1st standards.
While some might feel a bit panicky about how the new standards could disrupt the market, Waldrop says his clients are looking forward to it. “Our clients are very happy with the proposed new rules, because it reduces the cost of testing per batch, which will inherently reduce wholesale costs, making cannabis more affordable for patients and recreational users.”
Pennsylvania’s medical cannabis program may be young, but the industry in that state is off to a burgeoning start. Back in 2016, the state legalized medical cannabis. In 2017, the PA Department of Health began accepting applications for licenses and announced the first 12 winning applications. On February 15th, 2018, medical cannabis became available for more than 17,000 patients that registered in the program.
In March of this year, Governor Tom Wolf announced two more dispensaries were approved to operate as well as another grower/processor licensee. At that time, the press release indicated more than 21,000 patients have registered to participate in the medical cannabis program.
Then in April, Governor Wolf announced Phase Two of their medical cannabis program, allowing the industry to grow even more. That allowed for 13 new grower/processor permits and 23 new primary dispensary permits, according to a press release, which moved the total up to 25 grower/processors licensees and 50 dispensary licensees.
On May 15th, Governor Wolf approved eight universities to participate in a groundbreaking program, allowing Pennsylvania to take the first steps towards clinical research for medical cannabis. This research program would be the first of its kind in the country, allowing research institutions to explore the drug. The excitement was put on hold, however, when a Pennsylvania judge halted the program with an injunction. A handful of growers and dispensary owners in PA filed suit to stop the program on grounds that it violated the original intent of the law. State Representative Kathy Watson from Bucks County, the author of the research program, called the suit “pathetic because it’s all about the money.” We’ll follow closely with any new developments as they come.
Steve Schain, Esq. practicing at the Hoban law Group
Steven Schain, Esq., senior attorney at Hoban Law Group, a global cannabis law firm, represents multiple cannabis-related businesses in Pennsylvania. He says the program’s roll out has been fast with solid growth. “Within two years of the legislation’s enactment, Pennsylvania’s medical marijuana program has exceeded expectations with controlled, sustainable and quality growth,” says Schain. “The Pennsylvania Department of Health established ambitious goals, which they met timely and created a statewide program servicing over 10,000 patients in record time. Looming ahead is New Jersey’s adult use program, the anticipated robustness of which could undermine vigorous sales in southeastern Pennsylvania’s marijuana-related businesses.”
On May 30th, Philadelphia welcomed their first medical cannabis dispensary, with a location opening up their doors to patients in Fishtown. Now reports are coming in that say more than 37,000 patients have registered to date, with over 16,000 who have received their ID cards and medical cannabis at a dispensary.
Even though the research program might be on hold for now, Pennsylvania’s medical cannabis program is growing at a fast pace. The market there has blossomed in just a few short months to a whopping 37,000-registered patients, according to a press release form Governor Wolf’s office. Some say an additional 200,000 patients could qualify. With the second phase in sight, it seems Pennsylvania is on track to become a hotbed for business and research, developing into a massive medical cannabis marketplace soon. Stay tuned for more updates.
“Your tomatoes are organic. What about your weed?” The language on their homepage is clear: Consumers should seek the same high standards in their cannabis just as they do with food.
Earlier in the month, The Cannabis Certification Council (CCC), a nonprofit that promotes organic and fair trade practices in the cannabis industry, announced the launch of their #WhatsInMyWeed campaign. The consumer education initiative is designed to draw parallels between what buying choices people make in food and cannabis.
The consumer-facing idea is to produce videos and ads that make people question the ethics and environmental sustainability of their cannabis, just as they do when purchasing organic, fair trade-certified produce. According to Amy Andrle, owner of L’Eagle Services in Denver and board member with the CCC, the campaign should benefit cannabis companies that produce ethical and sustainable products. “This campaign is long overdue and much needed to alert consumers about the quality of their cannabis and begin to reward producers of organic, fair trade, sustainable and other high quality and integrity products just as they are in other consumer categories,” says Andrle. “We believe the campaign and accompanying website will drive demand and increase transparency in the cannabis industry.”
According to the press release, the website has a listing of cannabis certifications currently available now, information about them and where consumers can find certified products. Companies can sign up for the #WhatsInMyWeed Pledge as well to let consumers know they produce clean products.
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