Tag Archives: market

Pennsylvania Medical Cannabis Program Blossoms

By Aaron G. Biros
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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.

Just weeks later after that announcement, the PA Department of Health adjusted their program to allow patients access to whole plant, dried flower and opened up more qualifying conditions. The qualifying conditions added to the list now include cancer remission therapy as well as opioid-addiction therapy, which are two very notable additions. According to an April 6threport, 28,508 patients and 2495 caregivers registered with the program.

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.

HACCP

Hazard Analysis and Critical Control Points (HACCP) for the Cannabis Industry: Part 4

By Kathy Knutson, Ph.D.
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HACCP

In Part 3 of this series on HACCP, Critical Control Points (CCPs), validation of CCPs and monitoring of CCPs were defined. When a HACCP plan identifies the correct CCP, validates the CCP as controlling the hazard and monitors the CCP, a potential hazard is controlled in the manufacturing and packaging of cannabis-infused edibles. The food industry is big on documentation. If it’s not documented, it did not happen. The written hazard analysis, validation study and monitoring of CCPs create necessary records. It is these records that will prove to a customer, auditor or inspector that the edible is safe. Here in Part 4, more recordkeeping is added on for deviation from a CCP, verification and a recall plan. 

Take Corrective Action When There Is a Deviation from a Critical Control Point

Your food safety team conducts a hazard analysis, identifies CCPs and decides on monitoring devices, frequency and who is responsible for monitoring. You create an electronic or paper record of the monitoring for every batch of edible to document critical limits were met. Despite all your good efforts, something goes wrong. Maybe you lose power. Maybe the equipment jams. Nothing is perfect when dealing with ingredients, equipment and personnel. Poop happens. Because you are prepared before the deviation, your employees know what to do. With proper training, the line worker knows what to do with the equipment, the in-process product and who to inform. In most cases the product is put on hold for evaluation, and the equipment is fixed to keep running. The choices for the product include release, rework or destroy. Every action taken needs to be recorded on a corrective action form and documents attached to demonstrate the fate of the product on hold. All the product from the batch must be accounted for through documentation. If the batch size is 100 lb, then the fate of 100 lb must be documented.

Verify Critical Control Points Are Monitored and Effective

First, verification and validation are frequently confused by the best of food safety managers. Validation was discussed as part of determining CCPs in Part 3. Validation proves that following a CCP is the right method for safety. I call validation, “one and done.” Validation is done once for a CCP; while verification is ongoing at a CCP. For example, the time and temperature for effective milk pasteurization is very well known and dairies refer to the FDA Pasteurized Milk Ordinance. Dairies do not have to prove over and over that a combination of time and temperature is effective (validation), because that has been proven.

I encourage you to do as much as you can to prepare for a recall.A CCP is monitored to prove the safety parameters are met. Pasteurization is an example of the most commonly monitored parameters of time and temperature. At a kill step like pasteurization, the employee at that station is responsible for accurate monitoring of time and temperature. The company managers and owners should feel confident that CCPs have been identified and data are being recorded to prove safety. Verification is not done by the employee at the station but by a supervisor or manager. The employee at the station is probably not a member of the food safety team that wrote the HACCP plan, but the supervisor or manager that performs verification may be. Verification is proving that what was decided by the food safety team is actually implemented and consistently done.

Verification is abundant and can be very simple. First, every record associated with a CCP is reviewed by a supervisor or manager, i.e. someone who did not create the record. This can be a simple initial and date at the bottom of the record. Every corrective action form with its associated evaluation is verified in the same way. When HACCP plans are reviewed, that is verification. Verification activities include 1) testing the concentration of a sanitizer, 2) reviewing Certificates of Analysis from suppliers, 3) a review of the packaging label and 4) all chemical and microbiological testing of ingredients and product. The HACCP plan identifies CCPs. Verification confirms that implementation is running according to the plan.

Verification is like a parent who tells their child to clean their room. The child walks to their room and later emerges to state that the room is clean. The parent can believe the word of the child, if the child has been properly trained and has a history of successfully cleaning their room. At some frequency determined by the parent, the room will get a parental visual check. This is verification. In the food industry, CCP monitoring records and corrective action must be reviewed within seven days after the record is created and preferably before the food leaves the facility. Other verification activities are done in a timely manner as determined by the company.

Food processing and sanitation
Product recalls due to manufacturing errors in sanitation cause mistrust among consumers.

Write a Recall Plan

In the food industry, auditors and FDA inspectors require a written recall plan. Mock recalls are recommended and always provide learning and improvement to systems. Imagine your edible product contains sugar, and your sugar supplier notifies you that the sugar is recalled due to glass pieces. Since you are starting with the supplier, that is one step back. Your documentation of ingredients includes lot numbers, dates and quantity of sugar.You keep good records and they show you exactly how much of the recalled lot was received. Next you gather your batch records. Batches with the recalled sugar are identified, and the total amount of recalled sugar is reconciled. You label every batch of your edible with a lot code, and you identify the amount of each affected lot and the customer. You have a press release template in which you add the specific information about the recall and affected lots. You notify every customer where the affected edible was shipped with a plan to return or destroy the edible. When you notify your customers, you go one step forward.

How would your company do in this situation? I have witnessed the difficulties a company faces in a recall when I was brought in to investigate the source of a pathogen. Food safety people in my workshops who have worked through a recall tell me that it was the worst time of their life. I encourage you to do as much as you can to prepare for a recall. Here are two good resources:

Please comment on this blog post below. I love feedback!

Cannabis Report

German Health Insurer Issues First Look at Impact of Medical Cannabis

By Marguerite Arnold
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Cannabis Report

If anyone (read Auslanders) had any illusions that the German take on medical cannabis was going to be casual or unscientific if not painstakingly documented, think again.

Techniker Krankenkasse (or TK as it is referred to by the locals) is one of Germany’s largest public health insurance companies. In other words, it is a private company that is required to provide so called “statutory” health insurance which covers 90% of Germans.

As such, they are also on the front lines now of the medical cannabis debate. Approximately one year after the new law requiring public health insurance companies like TK to reimburse cannabis claims went into effect, the company has just issued what would surely be a best-seller if it were being sold.All of the medical cannabis now being prescribed and reimbursed is coming from abroad.

The Cannabis Report, as it is titled, produced with the help of professors at the University of Bremen, is also the first of its kind. In its pages, along with the corporate summary produced for the recent press conference in Berlin, are several fascinating snapshots of what is going on.

By the numbers.

The Cannabis Report

For those who cannot understand German, this summary by Business Insider is quite educational. Here are the major takeaways: There are now almost 16,000 German patients who are receiving some kind of medical cannabis by prescription. From a doctor. These patients are also paying about $12 for their monthly supplies – even if they have to wait for reimbursement. This is in contrast to the 1,100 patients who managed to obtain cannabis by prescription and pay for it themselves before the law changed last spring.

Do the math and that is a 1,450% uptick. Add in the additional 15,000 left out of this report who are getting cannabis prescribed but their claims turned down, and that is an even more amazing story.

Cannabis ReportHere is the next obvious fact: All of the medical cannabis now being prescribed and reimbursed is coming from abroad. A significant amount is still coming from Holland. The rest? Canada.

For that reason, the cost of medical cannabis is a major concern, along with the medical efficacy of cannabis and the authors’ frustrations about dosing.

The most interesting takeaway? Chronic pain and spasticity arehigh on the list of prescriptions (MS is currently the only condition which is “on label” for cannabis). So is Epilepsy and AIDS. Most interestingly are the high numbers for ADD. This is also highly significant in a country where amphetamine prescriptions for the same are almost unheard of.

TK, like the other health insurers who have started to provide numbers, also approved approximately two thirds of the requests they received. And it has cost them $2.7 million. That bill will begin to reduce as Germany cultivates medical cannabis domestically. However, the tender bid, which now apparently includes 11 contenders, is still undecided, with growing apparently pushed off now until (at the earliest) sometime next summer.

The bottom line, however, in the report from Socium, a university-based think tank that focuses on social inequality, is that cannabis is a drug that should also be treated like any other medication. Even though study authors conclude that so far, they do not find cannabis to be as “effective” as other drugs, they clearly state that the drug does help patients.

An Equally Interesting Industry Snapshot

Flip to page 20, however, and the authors also confirm something else. The top companies providing medical cannabis to German publicly insured patients who are getting reimbursed are Bedrocan, Aurora andCanopy. Aurora’s brands clock in at the highest percentage of THC, although their German importer Pedianos, clearly offers a range of products that start at less than 1% and increase to 22%. MedCann GmbH (renamed Spektrum last year) is essentially providing the rest, and ranges of THC at least, that go from 5.4%-16.5%. They also provide the products with the highest percentages of CBD.

Page 20 of the Cannabis Report produced by TK
Page 20 of the Cannabis Report produced by TK

Unlike the other companies, Canopy’s “brands” are also showing up in ostensibly both medical and government reports (Houndstooth, Penelope, Princeton and Argyle). This is interesting primarily because the German government (and regulatory requirements) tends to genericize medications as much as possible.

Dosing, Impact, Results

The next page of the report is also fascinating. Namely a snapshot of what kind of cannabis is being prescribed and at what doses. Patients who are obtaining cannabis flower are getting up to 3 grams a day. Dronabinol, in stark contrast (which is still the only form of the drug many German patients are able to get), is listed at 30mg.

Unlike any corporate report so far, the study also discusses consumption methods (including, charmingly, tea). It is impossible to forget, reading this, how German and structured this data collection has clearly been. There are several fairly stern referrals to the fact that cannabis should not just be prescribed for “vague” (read psychological) conditions but rather aspecific symptomology (muscle spasms and severe pain).

There is also great interest in how flower differs from pills. And how long the effects last (according to the authors, effects kick in about 2-15 minutes after dosing and last for 4 hours). This is, of course, an accurate picture of what happens to just about every patient, in every country. What is striking, particularly to anyone with an American perspective, is how (refreshingly) clinical much of this basic data collection and discussion is.

And no matter how much the authors call for more research, they clearly have observed that cannabis can have positive, and in many cases, dramatic impacts on patients. According to the handy graphs which are understandable to English speakers, study authors find significant evidence that the drug significantly helps patients with severe pain and or muscle spasms – see MS and Epilepsy, AIDS patients with wasting syndrome and paraplegics (wheelchair bound individuals). Authors list the “strong possibility” that the drug can help with Tourette’s and ADHD. Fascinatingly, however, so far, German researchers are not impressed with the efficacy of the drug for Glaucoma. “Psychological” and psychiatric conditions are also low on the list.

Regardless, this is an important line in the sand. As is the clear evidence that cannabis has efficacy as medication.

The great German cannabis science experiment, in other words, is well underway. And further, already starting to confirm that while many questions remain, and more research is required, this is a drug that is not only here to stay, but now within reach of the vast majority of the population.

aurora logo

Aurora Expands Canadian (And Global) Footprint

By Marguerite Arnold
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aurora logo

With the summer season (and recreational reform) fast approaching and the continued growth of the European medical market, Canadian LP Aurora has continued to power forward with another corporate acquisition. This time, the firm is medical cannabis firm MedReleaf (TSE:LEAF). The price? $3.2 billion in stock.

Aurora shareholders will now own 61% of MedReleaf.

The firm has also, of course, solidified its place as a global leader in the cannabis space with production capacity of over 570,000 kilos of cannabis a year.This purchase will absolutely ensure that the company is in a strong position

According to a statement by chief executive Terry Booth, “Our complementary assets, strategic synergies and strong market positioning will provide us with critical mass and an excellent product portfolio in preparation for the adult consumer use market in Canada.”

It also does a bit more than that.

With the German cultivation bid in what appears to be at least a three to six month delay, exports, including from Canada, are the only real way into Europe’s largest cannabis market. And Aurora, with it’s on the ground partner, Pedianos, isright in the middle of it. This purchase will absolutely ensure that the company is in a strong position as the next level of cannabis reform begins to unfold particularly in Europe.

Cannabis Is SO Expensive!

In fact, per this report just produced by one of the leading German public health insurers, Aurora, via Pedianos, and MedCann (the company that became both Spektrum Cannabis and bought out by Canopy Canada), appear to be the two Canadian LPs supplying the vast majority of all reimbursed medical cannabis to German patients. Further the vast majority of product is still coming from Canada – not the satellite grow or production facilities now being built in Portugal (Tilray), Denmark (Aurora and Canopy), Spain (Canopy) or anywhere else in Europe where legal cultivations are being established.

Techniker Krankenkasse report
“The Cannabis Report” produced by Techniker Krankenkasse (TK) and the University of Bremen, p.20

However, this also makes for an expensive product here in Germany, land of the generic drug (and where most of them can be bought by consumers, with a prescription, at a regular pharmacy for about $12). In fact, this report was produced in part to underscore the still-evolving medical position on the use of medical cannabis and its efficacy. This highlights how much Germany’s import policy is now costing even public insurers.

What is even more intriguing about the TK report is that the Germans are clearly moving into new research territory. Sure AIDS, chronic pain and muscle spasms (in particular MS) are conditions for which the drug is increasingly being prescribed, but so is ADD. And research studies are now mushrooming around the country.

The Germans have engaged on the medical cannabis efficacy question. And while it is still unclear what doses and of what kind of cannabinoid, have yet to be standardized into protocols, such conversations are well on their way.

And Aurora is also, of course, right in the middle of them.

Another Aurora Acquisition

Given the importance and size of the German market, in particular, it is also no surprise to see another strategic Aurora acquisition coming less than a week after the announcement of this report in Berlin. Specifically, Aurora has also just sunk another 1 million in an investment in CTT– an Ontario-based firm leading the development of thin film wafers that can provide dose specific, smoke free delivery of medical cannabinoids.

The Teutonic cannabis market is clearly in the company’s sights. Not to mention absolutely driving investment and positioning strategy both at home and abroad.

Steven Burton
Soapbox

Why Traceability Is Crucial for the Cannabis Industry

By Steven Burton
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Steven Burton

The stage is set: cannabis legalization is rolling out around the world. With legalization comes regulations and smart companies will adapt to make new requirements work for them. In the end, our shared goal (as industry, consumers and government) is the same: provide safe, high-quality, reliable products. This is where traceability comes in.

If a cannabis product isn’t safe (cannabis is vulnerable to the same kinds of hazards as most food products), the reputation of the entire industry suffers. Earning public trust is the first step toward favorable government regulations. With upcoming decisions that will decide taxation and distribution, it’s more important than ever that cannabis producers can react quickly if recalls should occur – and that means taking traceability seriously.

Comprehensive Traceability for Cannabis Means More Than Legality

A crucial key to producing safe and high-quality cannabis products is detailed traceability. Many states require cannabis businesses to use systems like Metrc, a technology that uses RFID tags to track cannabis from seed to sale to ensure nothing is diverted to the black market. However, Metrc focuses only on the chain of custody, not on the safety or quality of the product.METRC logo

Ensuring a secure supply chain is only one piece of the cannabis puzzle. Public health hazards like toxic chemical contamination, mold growth and pathogenic contamination introduced by pests or improper employee handling need to be controlled in order to earn public trust and comply with regulations. State-mandated traceability systems don’t address these imperatives, so an effective safety technology that includes traceability, in addition to mandated systems like Metrc, is absolutely necessary to complete the cannabis picture.

Automation Technology Supports Cannabis Companies’ Growth and Helps With Audits

Cannabis professionals are aware of the regulatory scrutiny the industry is under and many have turned to automation technology to help stand up to this scrutiny, as well as collect and manage all the data necessary for compliance. Automating data collection pays off in several ways. For one, interconnected, real-time IoT technologies that are accessible to the entire facility 24/7 are giving cannabis businesses the tools they need to create the best possible products now, as well as providing them with the data they need to make their products even better. Since frequent audits are a part of the legalization transition, automation also makes preparing for audits and inspections a matter of minutes instead of days.

Ron Sigman, chief executive officer of marijuana compliance consulting firm Adherence Corp. and former investigator for the Marijuana Enforcement Division (MED) in Colorado, lists the most common violations for cannabis businesses that he found during more than 200 audits in an interview for Marijuana Business Daily. These violations include:

  • Metrc issues, especially accounting not matching inventory (too many plants or ounces of marijuana on the premises);
  • Security issues like lack of sufficient camera coverage;
  • Failure to upgrade licenses;
  • Improper or incomplete training of new employees.

Adopting safety and traceability concepts that the food industry developed over many decades can yield huge benefits for cannabis businessesA proper cannabis traceability technology mitigates these problems by providing notifications of inventory inconsistencies, certification expirations and more. Traceability for cannabis must be able to handle the complexities of procedures like terpene extraction and injection. With the rapid growth of the industry, it must be able to set targets and track actuals. It should track, not just cannabis plants and related derivatives, but also every other ingredient, material and packaging material used during production. There must be monitoring at each stage of production and a system in place to ensure all employee training is up to date. Preventative maintenance must be scheduled and tracked and hazards must be identified and controlled. In the event of an audit or recall, precise mass-balance calculations must be available to account for every gram of product, including non-cannabis ingredients like coconut oil and packaging materials like pouches and labels.

GMPDetailed traceability can make the difference between a cannabis business keeping their license or being shut down. “You have to make a diligent effort to stay compliant 365 days out of the year, because you never know when a regulatory agency is going to come knocking on your door,” says Sigman. Knowing exactly what went wrong when and where allows a company to make changes so failures don’t happen again.

Higher Standards Will Be Demanded

The standard sought by most in the cannabis industry is only GMP (Good Manufacturing Practice) certification, which is actually the lowest level of certification possible in food production. With the public demand for edibles and concentrates on the rise and major retailers scrambling for seats at the table, the demand for transparency from growers and manufacturers will increase. Cannabis companies will soon find that GMP compliance simply won’t be enough to earn trust and expand their market share, especially when it comes to edibles and concentrates.

SQF-Certified“Every day, patients express interest and assurance of wanting to know that the foods and medicines they consume are safe and of the best quality available,” says Lindsay Jones, president of Curaleaf Florida, the first medical cannabis company in Florida to achieve SQF Certification. Safe Quality Food (SQF) certification ensures a company meets the highest levels of safety and quality on a reliable basis. Curaleaf has set a new bar in the industry that others will be compelled to follow and they should be congratulated for their proactive vision.

Adopting safety and traceability concepts that the food industry developed over many decades can yield huge benefits for cannabis businesses, but it will be interesting to watch the technology evolve to accommodate the specific needs of retailers and consumers. Imagine a traceability system that ensures safety and quality while also tracking consistency and potency.

The Future of Cannabis Is Bright

The emerging cannabis industry is facing challenging hurdles on its path to widespread legalization and acceptance but the forecast is sunny – for companies who are prepared.

New Frontier Data CEO Giadha Aguirre De Carcer, explains that California’s “legal (cannabis) industry is forecast to grow from $2.8 billion in 2017 to $5.6 billion in 2020. That spending will be increasingly directed at products and retailers who understand and serve the market’s evolving tastes and preferences.” That includes implementing comprehensive traceability systems to deliver safe, quality product.

Epidiolex-GW

Epidiolex Gives GW Pharmaceuticals Boost In Global Markets

By Marguerite Arnold
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Epidiolex-GW

GW Pharmaceuticals scored a significant victory in the United States with its cannabis-based epilepsy drug Epidiolex in mid-April. The company received approval from a U.S. Food and Drug Administration (FDA) panel for its use in treating two forms of drug-resistant epilepsy.

The drug was granted “orphan drug” status in the EU a year ago.Will this be enough to move the conversation forward about cannabis as medicine in the United States? 

So what does the future hold for this drug and a company, which has visited this space before? Remember Sativex?. The Company now faces real competition from a raft of companies moving into this space from just about everywhere – both from Canada and of course Europe itself.

The FDA Might be on the Verge of Approving its First Cannabis-Based Drug

It is not like this is either the FDA’s or GW Pharma’s first discussion about the medical efficacy of cannabinoids. Sativex, a mouth spray containing THC, was never granted approval in the United States for the treatment of MS – although it received such approvals in Europe.

Epidiolex-GWIf the FDA approves Epidiolex (made from CBD), it will be the first cannabinoid-based drug approved in the United States by the federal agency.

Will this be enough to move the conversation forward about cannabis as medicine in the United States? What will happen in the EU?

A Divergent and Highly Different Drug Market

Will the FDA finally approve at least one form of a CBD-based drug? The chances are that Epidiolex might finally move the agency to approve. However,this is not, despite the hype that the company has made in the press about this, the first cannabinoid-based drug to be approved in the United States. It might be, however, the first drug based on actual natural cannabinoids rather than synthetic ones that it approves for some purpose. Both Cesamet and Dronabinol (or Marinol) are synthetic cannabinoid drugs approved for several conditions from chronic pain caused by chemo to Parkinson’s.

GW logo-2But those who are hoping that this drug approval might open the floodgates at the FDA for startersshould take a pew. While Sativex was not approved in the United States, it was made available after 2011 for MS patients, particularly in Germany, which has the highest rate of MS of any European country. The problem? It was just too expensive for most people to afford – since their insurance would not cover it. And doctors were even more resistant to prescribing than they are now. So even getting a prescription was almost impossible.

That conversation was different in Europe post-2013, and there were people who managed to get a doctor to write a prescription not to mention afford the eye-watering prices sans insurance coverage.

That said, given the choice between whole plant meds, most people still prefer bud cannabis to the spray variety. And in Europe right now, that is what is on the table.

What Will This Mean in the US vs Europe?

In the US, the first thing that FDA approval will mean is drug sales for only one branded drug. That is the cynicism at play here. Furthermore, it also neatly dodges the THC issue.

In Europe? Particularly Germany? This development is not likely to make much of a dent. GW is competing with every single Canadian producer with flower-based oil – and on both the medical and non-medical CBD front. That also now includes local producers. Further, this is a market which prizes genericized drugs over name brands. In France, the distribution of Sativex was held up, primarily because of the row over cost. And who would pay.

It is also unlikely that the FDA approval in the United States will change the discussion either in the US on a federal level – or in Europe.

The most important place this news already made a dent? GW Pharma’s stock price – at least temporarily. It is also a spot of good news the company really needs. In February, the company’s GWP42006 drug designed for focal seizures (drug resistant epilepsy) failed to outperform placebo results and wiped 5% off the company’s stock.

Cannabis Track Added to 2018 Food Safety Consortium

By Cannabis Industry Journal Staff
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The 6thAnnual Food Safety Consortium Conference & Expo has announced a series of talks focused on cannabis. In addition to the categories such as Operations, Detection, Compliance and Supply Chain, the Call for Abstracts now includes a fifth category in this year’s program: Cannabis Quality.

The Cannabis Quality series will feature presentations by subject matter experts in the areas of regulations, edibles manufacturing, cannabis safety & quality as well as laboratory testing. The Food Safety Consortium itself is hosted by our sister publication, Food Safety Tech, but the Cannabis Quality series will be co-hosted by Cannabis Industry Journal as well.

Rick Biros, President/Publisher, Innovative Publishing Co. LLC
Rick Biros, conference director of the Food Safety Consortium

Citing the need to address safety in a burgeoning market, Rick Biros, conference director, believes education is key to helping the cannabis industry mature. “As the cannabis industry evolves, so does the need to protect the consumer,” says Biros. “Just as we protect the safety of our food supply chain, it is important to educate the cannabis industry about protecting their supply chain from seed to sale. Through these educational talks, we want to help bridge that gap, hosting a forum for those in the cannabis industry to interact with food safety professionals.”

The 2018 Food Safety Consortium Conference & Expo will be held November 14–16 in Schaumburg, Illinois. The event is a top food safety conference that features Food Safety and Quality Assurance (FSQA) industry experts and government officials.

The conference focuses on food safety education and networking, providing attendees information on best practices and new technology solutions to today’s food safety challenges. Previous keynote speakers have included food safety leaders such as Stephen Ostroff, M.D., deputy commissioner for Foods and Veterinary Medicine, U.S. Food and Drug Administration and Frank Yiannis, vice president of Food Safety at Walmart and author of Food Safety Culture: Creating a Behavior-Based Food Safety Management System.

Before submitting an abstract, following are a few points to keep in mind:

  • The abstract should be about 300 words
  • Presentations will be judged on educational value
  • Don’t submit a sales pitch!
  • Presentation time is about 45 minutes—this includes a 10-15 Q&A session

To see the Call for Abstracts and submit a presentation for consideration, click here. The deadline for submissions is May 31, 2018. The conference will notify everyone who submits an abstract on the status of acceptance by June 15.

GreenRelief Logo

Green Relief Enters European Market Via Switzerland

By Marguerite Arnold
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GreenRelief Logo

It is old news that Canadian companies are entering the European market. And it is also no stop-the-presses flash that Germany is a big prize in all of this. But there are other Euro markets to watch right now. Switzerland is one of them.

Look for the Canadian influx here too.

One of the more interesting entrants this month? Green Relief – a Canadian LP with a really unique twist. They are the only company in the world to produce cannabis oil from flower grown with aquaponics. This unique method creates unbelievably “clean” cannabis with no pesticides – and no residue of them.

It also sets the company up for a really unique market opportunity on the ground outside Canada. Especially as they have now just announced a partnership with two Swiss companies– Ai Fame GmbH and Ai Lab Swiss AG. Both companies have been leading European pharmaceutical companies since the turn of the century. The idea is to leverage all three company’s intellectual capital with Green Relief’s additional and first international investment with an eye to the entire European cannabis market. Ai Fame specializes in cultivation, manufacturing, sales and distribution to both the food and medical sectors. Ai Lab Swiss AG operates as a laboratory and testing facility.Less than three weeks before Green Relief publicized their European announcement, there were also strategic developments afoot at home.

From this unique perch in the Swiss canton of St Gallen, the three companies are setting up to conquer Europe.

Why Is Switzerland So Strategic?

Switzerland has been on the legalization track since 2011. As of this date, the Swiss government began allowing adults to buy and use CBD-only cannabis. Shops were allowed to obtain licenses. A trickle of sales began. However, rather suddenly, as reform hit Europe, the craze took off. Last year, for the first time, the industry generated a significant amount of revenue (close to $100 million). That is $25 million for the government via taxes- just on CBD sales. Even more intriguing for those looking for market opportunity across borders? Less than a week ago, the German-based budget discount store Lidl just announced they were carrying smokeable CBD  – in Swiss grocery stores. The leap across the border is imminent.

That has opened up other conversations, including the “legalize everything” push that makes an awful lot of sense to the ever tax-aware Swiss. This is a push afoot just about everywhere across the continent, including, of course, just across the border in Germany.

GreenRelief LogoThe cities of Zurich and the cantons of both Winterthur and St Gallen (home of the Swiss companies behind the new venture with Green Relief) have already indicated that they will not pursue possession fines for those busted with 10 grams or less– no matter what kind and even of the THC variety.

Read between the lines, and it is clear that the cannabinoid conversation locally has begun to attract the Canadians. And not just because of the many opportunities of the Swiss CBD market – but the huge medical and THC German and European opportunities now opening beyond that.

No matter which way Green Relief and their new partners slice it, they are now in the game – and across Europe – with a unique new play and product, and further one set to enter both the medical THC and “consumer,” albeit still CBD, market now burgeoning.

A Cross Market Play

Here is the truly interesting part about this new announcement. Less than three weeks before Green Relief publicized their European announcement, there were also strategic developments afoot at home. Cannabis Growth Opportunity Corporation also just announced an investment in Green Relief. The share purchase agreement netted Green Relief $750,000 in both cash and common shares.

With this, Green Relief seems to have set sail on its European expansion. Look for more interesting turns to this developing saga soon!

A2LA Accredits First Rec Alaska Cannabis Lab

By Aaron G. Biros
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The American Association for Laboratory Accreditation (A2LA) announced recently the accreditation of The New Frontier Research (TNFR) laboratory to ISO/IEC 17025:2005. TNFR, based in Wasilla, Alaska, was previously evaluated by A2LA for competence and proficiency to perform the minimum tests required by Alaska.

TFNR is now the first recreational cannabis-testing laboratory in Alaska accredited to ISO/IEC 17025 standard. According to Roger Brauninger, A2LA biosafety program manager, this accreditation is a sign of attention to thorough science. “Cannabis testing laboratories that have gained ISO/IEC 17025 accreditation have demonstrated their competence and commitment to rigorous science,” says Brauninger. “In the greatly scrutinized recreational cannabis industry, we are pleased to have granted the first accreditation of its kind in Alaska.”

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Roger Brauninger, A2LA biosafety program manager

According to the press release, the ISO/IEC 17025 accreditation is the most significant third-party lab accreditation an organization can receive. The standard confirms labs have management, quality and technical systems designed for accurate and repeatable analyses, in addition to proper administrative processes for testing.

Jessica Alexander, technical director of the TNFR laboratory, says this is the first step in many to researching the medical properties of cannabis. “By achieving ISO/IEC 17025 accreditation, The New Frontier Research believes that it advances the cannabis industry as a whole so that we can conduct legitimate research to unlock the amazing potential that this plant has for development of more effective medicines to address problems like opioid dependence and pediatric seizures,” says Alexander.

Ex-Im Europe: The Face of the Current Cannabis Market

By Marguerite Arnold
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In the United States, the idea of transporting cannabidiol (CBD), let alone medical cannabis across state lines is still verboten. As a result, a patchwork of very different state industries has sprung up across the map, with different regulatory mandates everywhere. While it is very clear that California will set the tone for the rest of the United States in the future, that is not a simple conversation. Even in-state and in the present.

In the meantime, of course, federal reform has yet to come. And everywhere else, there is a very different environment developing.

In Canada, “territorial” reform does mean there will be different quality or other regulatory guidelines depending on where you are. The main difference between the territories appears to be at point of retail – at least for now. Notably, recreational dispensaries in the East will be controlled by the government in an ABC package store model. That will not be the case across all provinces however. Look for legal challenges as the rec market gets underway.

EU flagIn Europe, the conversation is already different – and based on the realities of geopolitics. Europe is a conglomeration of federally governed nation-states rather than more locally administered territories, supposedly under federal leadership and control (as in the US). That said, there is common EU law that also governs forward reform everywhere now, just as it hindered national drug reform until a few years ago on the cannabis front.

However, now, because European countries are also moving towards reform but doing so in very different ways in an environment with open borders, the market here is developing into one of the most potentially fertile (and experienced) ex-im markets for the cannabis plant anywhere. On both the consumer and medical fronts, even though these labels mean different things here than they do elsewhere.

The Drivers

Medical reform in Europe basically opens the conversation to a regulated transfer of both non and fully loaded narcotic product across sovereign national borders. This is already happening even between nation-states where medical (read THC infused) cannabis is not federally legal yet, but it is has been accepted (even as a highly restricted drug). This means that Europe has already begun to see transfer of both consumer and medical product between states. In the former case, this is also regulated under food and cosmetic safety laws.

Cannabis in this environment is “just another drug.”While a lot of this so far has been via the strategic rollout of the big Canadian LPs as they attempt to carve up European cannabis territory dominance and distribution like a game of Risk, it is not limited to the same.

Pharmaceutical distributors across Europe are hip to the fact, now, that the continent’s largest drug market (Germany) has changed the law to cover cannabis under insurance and track its issuance by legal prescription. So is everyone in the non-medical CBD game.

As a result, even mainstream distributors are flocking to the game in a big way. Cannabis in this environment is “just another drug.” If not, even more significantly, a consumer product.

Game Time

The race for Europe is on. And further, in a way that is not being seen anywhere else in the world right now. And not just in pharmacies. When Ritter Sport begins to add cannabis to its famous chocolate (even if for now “just” CBD) for this year’s 4/20 auf Deutschland, you know there is something fundamental and mainstream going on. Lidl – a German discount grocery chain that stretches across Europe, has just introduced CBD-based cannabis edibles – in Switzerland.

As a result of this swift maturation, it is also creating from the beginning a highly professional industry that is essentially just adding cannabis to a list of pharmaceutical products already on a list. Or even just other grocery (or cosmetic) items.

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Spektrum, Alcaliber and Canopy are part of some of the larger deals in Europe

In general, and even including CBD, these are also products that are produced somewhere in Europe. As of this year, however, that will include more THC from Portugal, Spain and most certainly Eastern Europe. It will also mean hemp producers from across the continent suddenly have a new market. In many different countries.

This means that the industry itself is far more sophisticated and indeed used to the language and procedures of not only big Euro pharma, but also mainstreamed distribution (straight to pharmacy and even supermarket chains).

It also means, however, understanding the shifting regulations. In general, the focus on ex-im across Europe is also beginning to standardize an industry that has been left out of the global game, on purpose, for the last 100 years. Medical cannabis, grown in Spain under the aegis of Alcaliber (a major existing opioid producer) can enter Germany thanks to the existing partnership with Spektrum and Canopy, who have a medical import license and source cannabis from several parts of Europe at this point. It also means that regular hemp producers, if they can establish the right brand and entry points, have a new opportunity that exists far outside of Switzerland, to create cross-European presence.

And all of this industry regulation is also setting a timeline, if not deadline, on other kinds of reform not seen elsewhere, anywhere, yet.