Tag Archives: regulations

September 26, 2016

California Poised to Make Huge Advances in Market Expansion and Regulation

By Chuck Epstein

California’s tradition of social and political experimentation has made it the national leader in areas ranging from environmentalism and social justice to technology. Now it is poised to make the same far-reaching transformations in the cannabis industry.

As one of the world’s top ten economies and the nation’s most populated state (having a population of 38 million), California could propel the decriminalized recreational cannabis industry to $6.5 billion in 2020, according to a report by ArcView Group and New Frontier.

At the same time, California is in the process of moving from state to local zoning control, as far as issuing the OK to become licensed, effective Jan. 18, 2018. This means collectives and dispensaries have to obtain local approval before they receive a state license. It also puts greater pressure on gray market operations to become licensed.

On the regulatory front, the state is also heading toward a historic vote in November 2016 in the form of Proposition 64. This will open up the customer base to all Californians. It has a similar licensing path as the medical regulations the Governor signed last year, except it allows vertical integration between growers and dispensaries, which is not allowed under the medical regulations, except in very limited circumstances.

“My bet is the demand will outweigh the supply for a while and the legal cannabis businesses that are licensed by the locals and have their supply chain in place will end up profiting,” says Andrew Hay of Frontera Accounting, a cannabis-focused CPA firm based in California under the umbrella of the Frontera business group.

A Huge Market Awaits

If the Adult Use of Marijuana Act passes and is enacted by 2018, the state’s legal cannabis sales are projected to hit $1.6 billion in their first year, the ArcView and New Frontier market report said. Even without the new expanded legislation and working amid a fractured medical cannabis regulatory environment, California now accounts for about half of all the legal cannabis sales nationwide, according to the report.

At the same time, the state is well positioned to capitalize on new technology and financing from Silicon Valley in terms of human talent, money and the applications of new technology in both the medical and recreational sectors. One driving force will come from the Adult Use of Marijuana Act, which mandates that 10 percent of sales tax collected on cannabis sales be re-directed towards medical research and drug abuse programs.

In addition, according to Marijuana Politics, the expected tax windfall is slated to be divided up among a variety of programs: $10 million to public universities, $10 million to business and economic development, $3 million to California Highway Patrol and $2 million for medical cannabis research at UC San Diego. The remainder will be divided between youth drug education and prevention (60%), environmental protection (20%) and law enforcement (20%).

This flow of new funds is expected to propel research into biomedical and applied research, as well as nutraceuticals, or products derived from food sources with extra health benefits in addition to the basic nutritional value found in foods. The driving new ingredients in these products will be derived from cannabis.

Consolidating the Recreational and Medical Markets

Californians will vote in November 2016 to legalize the sale of recreational cannabis. This vote will have serious repercussions since it could mean that the delineation between medical and recreational markets will disappear.

“Should California vote to legalize recreational use this November, we expect implementation of a combined regulated market as soon as 2018,” says Matt Karnes, founder of GreenWave Advisors. Karnes says a merged California market is significant, not only because of its sheer size (it represents about 55% of the U.S. market), but also because it “would mark the first state to implement regulations for a fully legal market without initial oversight of medical use purchases. This could serve as a catalyst for similar action in Nevada, Arizona, Massachusetts and Maine which will also vote to fully legalize cannabis this November.”

In the report, “Mid Year Update: The Metamorphosis of the U.S. Marijuana Market Begins,” the firm said it projects cannabis sales in the U.S. to hit $6.5 billion for 2016. The firm forecasts that by 2021, revenues should reach about $30 billion. This assumes that marijuana will be legal in all 50 states to various degrees. The firm also notes that this year’s election choices can potentially generate $4.2 billion in incremental retail revenues by 2018 and $5.8 billion by 2021.

The Impact on Branding, Music and Culture

As the nation’s culture manufacturing center for films, TV and music, the cannabis business is also expected to shape artistic direction for years to come. Jeff Welsh is a partner at Frontera, a business group that holds a suite of services including the Frontera Law Group, Frontera Advisors, Frontera Accounting and Frontera Entertainment, which is headquartered in Sherman Oaks with a specific focus on the cannabis industry. Welsh says he sees more partnerships between the cannabis industry and mainstream entertainment outlets. Welsh recently signed Chris Sayegh, the herbal chef who uses liquid THC to create elegant restaurant-quality food, in a deal with the United Talent Agency. This marks a cultural breakthrough that links the cannabis and culinary industries.

Because Los Angeles is the largest market, this cultural nexus is expected to contribute more new alliances between celebrity branding and cannabis products.

Luke Stanton, founder and managing partner of Frontera, also said less stringent regulations in the cannabis legal environment could find their way into the regulations and laws of other states that often adopt California laws as templates for their own state. “We have seen this happen in other areas, such as environmental and criminal justice, so it would not be surprising to see our state regulations and policies being enacted in states nationwide, and even in some countries outside of the U.S.,” Stanton says.

California has also been the site of innovative marketing efforts between cannabis patients and growers. The Emerald Exchange held in Malibu, was the first event in cannabis that allowed a direct conversation between Northern California cultivators and the Southern California patient community. According to Michael Katz of Evoxe Laboratories, a California cannabis product manufacturer, “Often the farmers don’t have a chance to really engage with patients, and we wanted everyone to be able to come together, discuss practices, provide information and ultimately support the entire ecosystem of the cannabis community.”

Caveats for Investors

While the California market looks very attractive, it may be the siren’s call for investors until issues related to finding solid companies and taxation are settled.

Since more operations will have to become fully compliant with state regulations, these businesses will face more significant expenses to meet security, taxes, licensing fees, accounting and reporting operations requirements. This could drive smaller operations out of business or force them to become more efficient.

In addition, California’s huge potential and changing regulatory environment is attracting large growers into the state that will compete with smaller, established operations. According to Jonathan Rubin, chief executive officer of Cannabis Benchmarks, these regulations affecting commercial growing vary greatly by municipality. For instance, Mendocino and Humboldt counties have enacted measures to protect local growers, while other counties have not, Rubin says.

Credit: https://www.cannabisbenchmarks.com — Credit: cannabisbenchmarks.com

In addition, cannabis wholesale prices have been falling due to changes in cultivation methods and variations in supply.

Andrew Hay, a CPA at Frontera Accounting, believes investors should make sure there is a solid plan behind any cannabis company investment. “I’ve seen significant money thrown behind ‘cannabis brands’ with no substance,” Hay says.

“In these cases, the winners are the growers, manufacturers, distributors and dispensaries that are licensed (or are in the process of getting licensed), who pay their taxes and have a successful track record. I wouldn’t invest until you see the underlying operational structure, their tax/regulatory compliance and financials that prove there have been sales,” he says.

Another major problem for investors lies in the IRS accounting regulations. “The biggest hurdle I see facing the California cannabis business is the IRS / IRC 280E, which only allows cost of goods sold deductions. Every cannabis business should be planning their operations around IRC 280E, as there is no way to legitimately survive in the cannabis industry without doing so,” according to Hay.

“IRC 280E is here to stay regardless of California legalization. It is up to the Federal government to fix this issue, which I don’t see happening any time soon. Every cannabis business should hire a CPA and business attorney that work well together to devise a cost accounting strategy to minimize IRC 280E and its impact. Without this, an investor’s profits can go up in smoke to the IRS,” Hay says.

September 21, 2016

Cannabusiness Sustainability

Dear Cannabusiness Community

By Olivia L. Dubreuil, Esq., Brett Giddings

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Dear Cannabusiness Community,

You may have read our two recent articles. We received so much positive feedback that Aaron Biros (editor-in-chief of Cannabis Industry Journal) has invited us to continue with our own column at CannabisIndustryJournal.com. We are very happy to launch this column, and we thought we would take this opportunity to introduce our project, our vision and ourselves so you can understand where we are coming from when you read this series of articles.

Brett and I both have a background in business sustainability and corporate responsibility. We both have backgrounds in management consulting, with a specific expertise in sustainability issues along the supply chain. We have been working together for almost nine months now on sustainability issues in the Bay Area. In May, we started to get interested in sustainability in the cannabis industry and before we knew it we were diving deep into research relating to the environmental, social and ethical impacts of the legal cannabis industry. It was actually difficult to find a lot of information, as the reign of prohibition still very much influences what is available.

In June, we attended the National Cannabis Industry Association’s conference in Oakland to open up the conversation with cannabis industry players and to find out about people’s attitudes and approach to sustainability. The results were overwhelmingly positive. Not only were we encouraged to launch a project, but also excited to discover that many of the speakers presenting at the conference referenced sustainability in one way or another when they talked about environmental impact awareness, social justice, ethics or about staying competitive when “big business” enters the market.

What started out as a side project quickly became the center of focus this summer when we decided to incorporate Project Polaris, a California non-profit, to deliver sustainability knowledge and expertise to the cannabis industry.

Our thinking is as follows:

Thinking about sustainability, means thinking strategically about business. As we forge a new and upcoming industry, let’s seize the opportunity to make it a sustainability-focused one! Let’s create generally accepted industry principles that fosters a positive image of the industry and teaches newcomers about best environmental and social practices. Let’s create a voluntary and industry-led socially responsible code of conduct for cannabis business owners and suppliers, helping the regulators, as they will be drafting all of the future regulations of the legalized cannabis market. Let’s do more research on the market and the consumer. Let’s develop clean and green alternatives to dirty processes or practices. Let’s elevate the discussion and create a model industry, one where short-term, large-scale, quality-lowering corporate interests are kept at bay.

With this vision in mind, we created Project Polaris because we believe that this is a real opportunity for the industry to be a role model for other industries (and educate legislators as well as drive public opinion in those states that are still under prohibition laws). We believe there is a real economic opportunity for those businesses that understand how to embed sustainability properly within their business model. Because we know that sustainability influences legislators in a positive way because it sheds a positive light on businesses.

In the upcoming months, we will continue to research and report on sustainability-related issues facing the cannabis industry, such as packaging, edibles, “organic” in cannabis, butane extraction versus CO2 extraction and so on. We also welcome questions from our readers. If you have a question, please post it in the comments section below.

We will also take this opportunity to call out to cannabis industry organizations, cannabis businesses, or cannabis related services and product suppliers to get in touch with us if they wish to find out how to integrate sustainability more concretely into their action plan. We are not planning on doing this alone, we are seeking partners to join us on this journey, and we want to partner with you on your journey to Cannabusiness Sustainability.

PS: We still have one seat open for the board of directors and would love to hear from you if you are interested!

September 6, 2016

Quality From Canada

The Devil is in the Detail – Changes to Canada’s Cannabis Regs to Encourage Patient Independence and Business Competition

By Tegan Adams, Elfi Daniel-Ivad MSc

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Canada’s new ACMPR was launched late last month on August 24^th. The key change that most notice is that Canadians may now again grow their own cannabis at home for medical purposes. In addition, more strict guidelines for product testing and labeling requirements for Licensed Producers (LPs) were released.

Short term pain for long term gain. While the combination of allowing patients to grow at home and more strict regulations for LPs may at first seem like a business disadvantage; overtime LPs will be thankful for the combination switch. Health Canada’s new requirements encourage a leveling of the playing field globally between LPs and large scale product manufacturers of pharmaceuticals, therapeutics and natural health products. The steps Health Canada is taking to regulate our producers, is exactly what they need to get ready for mass production that will be necessary for recreational markets, scheduled for release in Spring 2017.

Picture rows of Tylenol bottles on the shelf at your favorite pharmacy. Now picture rows of cannabis bottles on the shelf beside them. This is what medical cannabis will look like in Canada perhaps as early as 2018, if not sooner. With just under forty LPs on the map and a projected sales volume of modest billions, Canada’s LPs’ eyes are widening with dollar signs as they lube up their oil production and more to see what shelves in Canada will hold.

Curious to know more? Our regulatory department manager Elfi Daniel-Ivad is an expert in regulatory change. She has worked on close to 150 submissions for cannabis licensees in Canada and beyond. Here are a few key changes from her department’s overview to better understand.

MMPR	ACMPR (Updated)
No personal production or designated production available to patients (aside from that grandfathered in by MMAR).	Personal production and designated production available. Patients may grow 5 indoor plants OR 2 outdoor plants at any given time per gram prescribed to them.
Licensed Producers were not required to label THC or CBD amounts in dried cannabis, though most producers did for sales and educational purposes. Oils had to be labeled with THC and CBD amounts.	Licensed Producers must label their percent THC and CBD for dried and fresh cannabis products.
For the labelling of oils, the total quantity of THC, CBD and oil in a container had to be shown. Restrictions on THC allowed no more than 10mg/mL THC per capsule and no more than 30mg/mL THC per mL oil to be distributed.	In addition, oil labels must now include information on “carrier” oil and allergen information. Containers must be labelled with number of capsules, the net weight and volume of each capsule. .
No reference to validation of analytical testing methods.	Analytical testing must be completed using validated testing methods; confirming reliability and consistency in results for contaminants, disintegration, residues and THC, THC-A, CBD and CBD-A
Accredited labs can only test products as received from Licensed Producers.	In addition to Licensed Producers, patients growing their own or having a designated grower growing for them may also test their products at an accredited lab.

In addition to these changes, it is important to note that if an individual or company has an MMPR proposal already submitted they can now revise it to include oil production (previously, it was first dried bud only). If a company submits a new ACMPR proposal, they can include oil production on their application right away. Interested in submitting your own application? Or need help with one in the USA? Our regulatory department would be happy to answer any questions you might have about the process.

August 23, 2016

Quality From Canada

Hold on for Rec! Canada’s New ACMPR Program

By Tegan Adams

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Earlier this month, Health Canada, in a press release, gave a glimpse as to what the new Access to Cannabis for Medical Purposes Regulations (ACMPR) might look like. On August 11^th, they announced the new set of regulations would go into effect on August 24^th this week. Information presented was not shocking. Most Canadians had hoped and suspected that the announcement would include a provision for growing cannabis at home – and it did exactly that.

Essentially, the ACMPR expands accessibility of cannabis from our highly regulated 34 licensed producers (LPs) to include those authorized by their health care practitioner to access cannabis. Anyone with the appropriate medical documentation can now grow for him or herself at home, or designate a grower to do so for them. Health Canada also stipulated in the press release that “Storefronts selling marijuana [sic], commonly known as ‘dispensaries’ and ’compassion clubs’ are not authorized to sell cannabis for medical or any other purposes.” The regulatory body went on to add: “These operations are illegally supplied and provide products that are unregulated and may be unsafe. Illegal storefront distribution and sale of cannabis in Canada are subject to law enforcement action.”

There were a few curve balls in the announcement, including a statement issued that suggests commercial producers may be the only ones authorized to distribute seeds or plants to those growing for themselves or on behalf of another. It is unclear how the plant and seed sourcing aspect will be regulated and/or how that statement may impact LPs over individual producers. Restriction of strain availability and additional costs are examples of potential implications to individuals[1]. LPs therefore remain in control of the types of cannabis available on the market. It is unclear if this regulatory aspect will mean they can restrict access to strains they have on hand, or not, especially if they are popular for sales.

When the first glimpse of the ACMPR was released, we saw many LPs stock drop in price across the board, in some cases greater than 10%. It is not anticipated however that the ACMPR will cause any long-term negative effects on LPs stock price or profitability. The ACMPR was put in place merely to satisfy a court ruling on a deadline. The deadline was inconvenient, occurring around 9 months before the regulations governing recreational sales are meant to go in effect. It meant that Health Canada employees had to dedicate time to finding a Band-Aid solution up until recreational sales instead of focussing on recreational regulatory framework itself.

Recreational regulations are scheduled for release in 2017, and it is unclear when exactly they will begin. As they do begin to unfold it is projected that the production and sale of cannabis will remain highly regulated. LPs will remain the consistent quality source of supply. There have been multiple distribution models in discussion, including co-op retail ownership, pharmacy dispensary and liquor board models. While yes, those with medical documentation anticipate still being able to produce at home; it is unlikely this allowance will have any effect on the overall sales of LPs as the market unfolds. Alcohol and wine are good examples to compare the regulatory model to. While sure, any of us can do home brewing, odds are we would still like to purchase beer from commercial breweries. In both Vancouver and Toronto, property is very expensive. Higher percentages of the population are starting to live in apartments, condos and smaller homes. Many people working full time are not interested in growing their own cannabis and would prefer the variety of the marketplace. There are many reasons individuals will continue to purchase from LPs. As competition rises in the marketplace, so will efficiencies in production as producers become more familiar with growing practices. Canada is anticipating a drop in retail prices to be much more affordable than existing “black markets.” Cannabis will become commonplace on shopping corners and it will be a product that most will be able to afford.

June 15, 2016

Documentation & Compliance: A Q&A with Michael Shea, ConformanceWare

By Aaron G. Biros

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Cannabis safety throughout the supply chain requires active documentation tools for business owners to keep up with standards and regulations on the local and state level. Michael Shea, founder and president of AccessQMS and chief executive officer of Upshot’s ConformanceWare, provides consulting support across multiple industries with independent referral services to compliance professionals. With quality, safety and efficiency at top of mind, ConformanceWare’s design team developed the Medical Cannabis Series (MC Series™) to help cannabis business owners make the task of compliance easier. The documentation tools in the program are individually tailored to address needs in cultivation, processing, analyzing and dispensing.

The MC Series-Analyze Edition is currently in use at Canalysis Laboratories and NV Cann Labs, both operating in Nevada. According to Tara Lynn, chief executive officer at NV Cann Labs, the product helps them meet all of their documentation needs. “I appreciate all of the development using the MC Series- Analyze Edition and look forward to developing even more of a relationship through the years to come,” says Lynn. We sit down with Michael Shea to learn more about his product and how cannabis business owners can stay on top of regulatory compliance.

CannabisIndustryJournal: How will the MC Series help cannabis laboratories, cultivators, processors and dispensaries navigate regulatory compliance?

Michael Shea: To open a sustainable business involving cannabis goes beyond submitting applications, paying fees and focusing on profit alone. As laws adjust and tighter controls are put in place, more and more business owners are realizing what preserves and sustains their business is, in fact, compliance.

True sustainability is driven by forward thinking that values documenting and following best practices to ensure quality, safety and efficiency. Ambiguity concerning where to turn or how to correctly produce this documentation not only poses a difficult dilemma, it can put one’s investment at risk as well.

Finding a remedy for the situation begins with an expansion of perspective. Businesses will benefit most by actively working toward compliance from the onset. This approach eliminates having to face non-compliance and the enforcement that goes along with it.

MC Series™ is designed for this purpose and will greatly help businesses precisely document how their method of operation demonstrates full compliance with applicable laws and standards. Each MC Series™ edition is developed using Microsoft Word and Excel, which is then customized to mirror each organization’s processes, procedures and instructions.

Being user friendly, we have built in numerous hyperlinks for navigating and managing files and documents so that the documentation behaves like a website. This enables each user to access, edit, save and retrieve information instantly.

CIJ: How does your product utilize CMC’s, FDA, ISO, FOCUS, AHPA and EPA standards to help business owners?

Michael: Businesses handling cannabis are subject to strict regulations and are expected to show full compliance with regulatory protocols. Setting up your business correctly means playing by the rules and operating with the proper documentation and structural foundation.

By applying established best practices from the start, business owners will be able to minimize risk for investors, tighten efficiencies and quickly adapt to regulatory changes with minor adjustments. This serves two primary functions: Business owners will now have the protection they need and the means to promote their brand as a world-class operation.

Because laws surrounding cannabis are in such a state of flux and revision, what is most valuable to know is what technical documents lawmakers select for the purpose of writing regulations. Putting this knowledge to work, the MC series uses a variety of guidance documents designated by regulatory and standards bodies for best establishing compliance.

Developed with regulations in mind, each series edition accurately defines the scope of applicability required for your business model. Whether you’re a grower, processor, cannabis testing service or dispensary the MC series has a solution. It significantly helps business owners to achieve compliance by providing the required documentation with an operations framework.

MC series merges regulatory best practices with internationally accepted standards to deliver a complete solution with a very quick turnaround time. Designed to ensure public safety and protect human health, the MC series provides a much-needed tool that bridges the gap between compliance and profitability.

CIJ: How might you be ahead of the curve in looking toward a rescheduling or a schedule 2 cannabis framework?

Michael: Being ahead of the curve simply translates to knowing the regulatory landscape and what’s involved moving forward. When the goal is to legalize cannabis for its great many uses and benefits, public health and safety must come first. Now is the time for business owners to get serious and effectively address the process of legitimizing it.

As with anything available for consumption, standardization is the method and regulators have a long established process for putting controls in place to ensure the health and safety of consumers. We have a lot of experience in this area, and our MC Series™ is an exceptionally useful tool for people who don’t. It is our way of contributing to assisting and accelerating the process.

Essentially, we are saying to business owners, operate your business as if cannabis is already legal. Managing your operations in compliance to existing regulatory best practices will speak volumes to lawmakers. You will be effectively demonstrating to Federal and State governments that you understand the importance of regulations to ensure public health and safety and are making compliance top priority.

This will make your business fluid in relation to regulatory changes and prepare you for Schedule II and beyond.

CIJ: Why should business owners be proactive in navigating regulatory compliance with a documentation management system?

Michael: With so many regulations targeting the cannabis industry, it is hard to keep track of and adjust accordingly. Many business owners are getting excited about being involved and making a difference. Amidst all this enthusiasm, the importance of best practices is often times overlooked and prioritized for when business is good and finances improve.

At this point, business owners can no longer afford to position best practices for future use.

For businesses handling cannabis, taking a future stance will always increase risk.. This leaves you legally exposed to unforeseen costs and complications. More importantly, it will exponentially increase the potential for watching your investment, hard work and business be out paced by the competition, or even worse, closed down permanently.

Alternatively, being proactive will yield different results. Great benefits will come by adopting and following best practices to operate your business. In doing so, you now have an effective method to ensure quality, health and safety, environmental stewardship and sustainability. As a rapidly growing industry, these areas of discipline are absolutely critical for cannabis to reach its full potential and be fully accepted.

In many industries, legitimate and successful companies see best practices as simply part of doing business. Many see it as a tool that provides a useful roadmap for continually improving their operations and strengthening their position in the market.

When the legal obligations have been taken care of, success becomes a matter of setting realistic goals, planning well and delivering with impeccable timing. Operational performance can now be measured and improved for unhindered growth. Everyone involved or tied to your business is now on the same page and in areas of supervision, micromanagement is replaced with a documented system. Documentation should clearly define everyone’s roles and responsibilities, so that when errors occur, there are corrective action procedures available to fix them.

Editor’s note: For more information you may reach out directly to Michael Shea at 313-303-6763 or info@conformanceware.com

March 23, 2016

Quality From Canada

Quality Training in a GMP Testing Facility: 8 Steps to Get Employees Compliant

By Tegan Adams

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Eurofins-Experchem Laboratories is a Health Canada and FDA-accredited analytical laboratory with a regulatory support division. The laboratory carries out testing for many different sectors including pharmaceuticals, cosmetics, natural health products and medical devices. Starting in 2014, cannabis testing was incorporated into the mix. One reason our results so accurate is due to rigorous staff orientation and training method. Diligent staff training and monitoring is very important for success as a Good Manufacturing Practices (GMP) facility with a Drug Establishment Licence and Narcotics License. So what does that look like on the inside? Saif Al-Dujaili, our quality assurance manager, Sohil Mana, our vice president of operations, and I will provide some guidelines for developing training programs below.

Introductory Session: When any new employee starts an introductory phase, it begins with general admin, a facility tour, policy manual training, govt. legislation overview and health and safety training and orientation (WHIMS and Bill 168) specific to our lab. We record signatures on any pertinent forms for SOPs that the new employee will be using.
Standard Operating Procedures: Any new employee must read all related SOPs and is evaluated on their understanding of them through questionnaires/quizzes. SOPs are written for all equipment, instrumentation or process that is applied in the lab, to ensure consistency across operations.
Laws and Regulations: New employees must be familiar or familiarized with Good Manufacturing Practices and Good Laboratory Practices. Analysts are required to read all sections of the USP pertinent to their role, as decided by the quality manager and/or dept. head and a checklist is recorded on training.
Methods: Different methods are used to test products including Compendium or other published methods with organizations such as the Association of Analytical Communities (AOAC) and the American Chemical Society (ACS). Client Methods and house-developed methods are also used. If there is a change to any method, a change control form must be filled out and documented.
Documentation: Documentation is very important in a GMP lab. All data is recorded in a hard cover bound book and/or approved worksheets. Quality assurance data reviewers are responsible for ensuring all data is being recorded properly.
Sample Management: Employees are trained on sample management related to sample entry, how samples are distributed to analysts, turn-around time, and where finished projects are placed.
Training Forms: Everything an employee learns must be recorded and filed for records. Analysts must follow a training matrix on qualitative and quantitative testing methods. Recurrent training occurs each 3 years or less depending on the position the analyst holds. Any updates on GMPs, new instruments or equipment is ongoing and recorded. Experchem runs “ghost” samples through its laboratory to ensure compliance by employees at any given time. Employees are evaluated on their abilities to comply.
Ongoing Training: Once employees are up and running they also receive monthly training in the lab and an annual GMP training followed by a comprehensive quiz that must be passed for them to continue work.

Interested in learning more about cannabis testing in Canada and the US? Contact Tegan Adams, business development manager with Eurofins at teganadams@eurofins.com.

Editor’s Note: Eurofins-Experchem has helped submit over 150 MMPR applications to Health Canada and continues to work with 10 of the 27 licensed MMPR producers in Canada. Their regulatory affairs division has started working with companies applying to produce and distribute cannabis in those states, which are new to its sale and distribution. They offer services include writing SOPs, training staff and performing mock inspection audits.

March 22, 2016

Supreme Court Denies Challenge to Colorado’s Cannabis Laws: Industry Outlooks

By Aaron G. Biros

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The Supreme Court shut down a lawsuit on Monday brought by two states against Colorado for its recreational cannabis laws. Nebraska and Oklahoma brought the case to the Supreme Court, claiming that the recreational cannabis industry in Colorado is responsible for the illegal exportation of cannabis outside of Colorado. “Colorado has facilitated purchase of marijuana by residents of neighboring states by issuing licenses to an unusually high number of marijuana retailers perched on Colorado’s borders,” the two states told the court in a supplemental brief.

In that brief, the two states argue that Colorado’s cannabis industry led to more cannabis illegally crossing state lines. They argue because of that influx of cannabis, they spend more on law enforcement and state resources, which is a detriment to their citizens. The Supreme Court did not provide an explanation for why they refused to hear the case.

Many view this as a big win for the legal cannabis industry. “The Supreme Court has protected the will of the people today and I believe the court has demonstrated that it understands legal cannabis is a fundamental right,” says Andy Williams, president of Medicine Man, the largest cannabis dispensary in Denver.

Still others see this simply as business as usual. “While I’m pleased to see the Court reject the challenge to Colorado’s cannabis law, this decision isn’t really a win for cannabis advocates- it only maintains the status quo,” says Aaron Herzberg, partner and general counsel at CalCann Holdings, a medical cannabis holding company specializing in real estate and licensing. “We are struggling with diversion in California, so hopefully states will continue to be on track to create a more regulated and taxed environment where cannabis can be manufactured and sold through channels where it is safe and tested,” continues Herzberg.

Adam Koh, chief cultivation officer at Comprehensive Cannabis Consulting (3C), warns that the Court’s denial to hear the case is not necessarily an affirmation of state’s cannabis programs. “It is evident that some diversion is taking place, which of course is against the provisions of the Cole Memorandum,” says Koh. “In order to avoid being implicated in such activities, legally licensed cannabis businesses in Colorado should not take the SCOTUS decision as a signal to relax, but should instead work to make sure that inventory control and record-keeping protocols are in place and even exceed the standards required in state regulations.”

The fact alone that Nebraska and Oklahoma even brought the case to the Supreme Court means that diversion is a major issue facing the cannabis industry. “Only by going above and beyond in terms of compliance will this controversial industry make itself credible in the eyes of its detractors,” says Koh. Some cannabis industry leaders take it upon themselves to help guide rule makers in crafting standards.

Lezli Engelking, founder of the Foundation of Cannabis Unified Standards (F OCUS), believes the Cole Memo is currently the best guidance for states and business owners to follow by the federal government in regards to cannabis. “Gaping holes in cannabis regulations are glaringly identified via the pesticide issues and recalls recently,” says Engelking. “These issues showcase each state being in violation of the Cole Memo’s expectation that they will implement strong and effective regulatory and enforcement systems that address the threat to public safety, public health, and other law enforcement interests.”

The Supreme Court’s denial of the two states’ challenge to Colorado’s cannabis legislation suggests the federal government’s intentional avoidance of involvement in current state cannabis issues. The government’s inaction does not, however, indicate their support.

March 9, 2016

Nic Easley: How Far Have We Come?

By Cannabis Industry Journal Staff

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Nic Easley, chief executive officer at Comprehensive Cannabis Consulting (3C), delivered the keynote address at the first annual Cannabis Labs Conference, co-located with Pittcon. Easley begins with a discussion of the 2014 milestone where Colorado and Washington legalized recreational cannabis, opening the floodgates for a diverse range of products and business opportunities in quality and safety testing. With members of his team sitting on the Colorado Department of Agriculture’s Pesticide working group, they are working with industry leaders and regulators to comprehensively write the standards. “The industry gets regulated in 2014 in Colorado with a total of $2.7 billion in sales in the first year of the industry’s history,” says Easley. “We have this giant influx of business, but without process validation, good agricultural practices and proper SOPs, each state is left to fend for themselves to write regulations.”

March 9, 2016

Nic Easley Delivers Keynote at Cannabis Labs Conference

By Cannabis Industry Journal Staff

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Nic Easley, chief executive officer at Comprehensive Cannabis Consulting (3C), delivered the keynote address at the first annual Cannabis Labs Conference, co-located with Pittcon. Easley set the tone of the conference early on by identifying safety and quality concerns in the current cannabis marketplace. “We can choose to do business as usual or we can create a new model with outside industry expertise to help guide this industry forward responsibly,” says Easley. Noting the existing comprehensive standards in food and agriculture, Easley emphasized the value of the Cannabis Labs Conference in bringing that expertise to the cannabis space. “We have the guidance and expertise in this room alone to help move the cannabis industry forward out of the closet and into the sunlight,” adds Easley.

February 9, 2016

Quality From Canada

The Great Green North: Canada vs. US in Cannabis Regulations

By Tegan Adams

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A lot has been changing quickly in the world of cannabis across North America. While international drug treaties sit back and watch in horror, cannabis and cannabis-infused products have been popping up in households across Canada, on retail shelves and in private delivery services across the US. How each jurisdiction in North America accepts and regulates (or draws a blind eye) to the sale of cannabis is different depending on where you are located. Here are a few key distinctions between the current Canadian and US regulatory approaches to marijuana.

In Canada, cannabis is regulated at the federal level by Health Canada through the Marihuana for Medical Purposes Regulations, (MMPR). The MMPR allows persons to obtain dried cannabis for their own personal medical purposes or for another person for whom they are responsible. To obtain dried cannabis, a person must obtain a medical document from a physician, or nurse practitioner to register as a client with a licensed producer of their choosing. After registering as a client, they are able to order dried cannabis and possess up to a maximum of 150 grams at any one time, depending on the recommendation of their physician. More recently, in 2015, regulations allow the distribution of not only the dried form of cannabis but also their extracted forms.

In the US, at the federal level, cannabis is still 100% illegal. Public statements from the federal administration dictate that they steadfastly oppose legalization of cannabis and other drugs. They are concerned that legalization would increase the availability and use of illicit drugs, and pose significant health and safety risks to all Americans, particularly young people. At the state level, legalization laws are rapidly changing. The office of National Drug Control Policy lists 23 states (a rising number) and Washington DC that have passed laws allowing cannabis to be smoked for a variety of medical conditions. The state laws do not change federal regulation. Many local governments are creating zoning and other restrictions that prohibit dispensaries from operating in their communities. That being said, voters in Alaska, Colorado, Oregon and Washington state support legalizing the sale and distribution of cannabis to adults over 21. There are many differences in the regulation of marijuana within each state, municipality and within the country itself.

Internationally, Canada has a platinum reputation for delivering and regulating quality consumer products. Within the Canadian cannabis industry, many feel Health Canada’s regulatory regime is inaccessible, restricts production to large corporations and limits distribution channels. The average start up cost of even a small licensed facility is around $4-5M CAD. On top of the financial costs, production companies have to compete with the other 2000 or so applicants who have been waiting, in some cases up to two years, to hear back from Health Canada if they will succeed in the licencing application process. In response, Canada has seen many tolerances made to allow dispensaries to distribute marijuana at the municipal level, even though not allowed as per regulation.

Many Canadian dispensaries operate with professional policies and procedures including providing customers with access ID cards and offering physician consults. Vancouver became the first city in Canada to license and regulate marijuana dispensaries. The number of licenses within the city exceeds both Tim Hortons and Starbucks Franchises combined. Many dispensaries provide bar and café settings for people to enjoy a “bong shot” or café au lait infused with cannabis. Licensing dispensaries has become a great financial resource for the city, charging $30,000 CAD per licence. Vancouver’s dispensaries have been a topic of debate across all levels of government. The Health Minister asked Vancouver to shut the dispensaries down, while other municipalities have started to expand the same concept. The Royal Canadian Mounted Police (RCMP), Canada’s federal police force, has started raiding various dispensary locations. Part of the new Prime Minister, Justin Trudeau’s, political platform and claim to fame is to legalize cannabis recreationally across Canada. How the framework will unfold is still in the works and subject not only to local jurisdictional reform but also to international negotiations.