Tag Archives: product

emerald test retail

The Emerald Test Gets Record Lab Participation

By Aaron G. Biros
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emerald test retail

According to a press release released by Emerald Scientific, their spring Emerald Test had a 25% increase in participation over the fall 2017 test.

77 laboratories from 18 states and two foreign countries participated in the bi-annual Emerald Test, an inter-laboratory comparison and proficiency testing (PT) program. The program is a tool for labs to demonstrate their competence to existing clients, potential customers, regulatory agencies and accreditation bodies.

Overall, the company shipped 314 PT samples, with the majority in a hemp or hemp oil matrix. According to the press release, the new PTs including potency in hemp oil, STEC, Aspergillus Mold and Mycotoxins attracted a good deal of labs. “Many laboratories have been regular participants which speaks volumes about their commitment to quality assurance, regulatory compliance, and consumer safety,” says Ken Groggel, director of Emerald Scientific’s proficiency testing program. “The collegial attitude of open communication and shared experience increases our knowledge and ensures continued success for all involved. Our goal is to establish an industry benchmark for cannabis testing while providing valuable feedback to each laboratory’s quality assurance system.”

This marks the first time the Emerald Test used two potency PTs- the original in solution and a new hemp oil matrix. “Of the 62 labs that participated in the Potency PT, 48 took the PT in solution with 47 receiving an Emerald Badge,” reads the press release. “Another 23 labs took the PT in hemp oil, with 22 awarded an Emerald Badge. Nine labs took both PTs.”

39 labs took PTs in APC, Total Coliform, E. coli, Enterobacteriaceae and Yeast/Mold and 38 of those received the badge. 45 reported results for Salmonella and 42 of them were able to correctly identify the contaminated sample. 12 labs took the Aspergillus Mold PT and 11 of them were awarded the badge. 24 participated in the pesticides PT and 19 of them met criteria for the badge, while four of them did not report results.

The press release noted that the pesticides and residual solvents in hemp oil PTs were some of the more challenging tests in the spring program. 43 labs reported results for the residual solvents in hemp oil PT and only 31 received badges. The terpenes in hemp oil PT was also a challenging test where 21 labs participated and only 11 received the badge, marking the lowest passing rate of all the PTs.

The advisory panel for The Emerald Test consists of chemists, accreditation providers, laboratory owners, and other industry experts to keep it representative of industry needs. “The Emerald Test is the most comprehensive testing program in the world for the cannabis industry, but as the market grows more testing will be needed,” says Groggel. “We intend to continue introducing new proficiency tests while expanding the menu of matrix choices in response to laboratory requests and regulatory requirements.”

According to the press release, their fall program is open for enrollment until today. Testing begins in mid-October.

european union states

The Battle Over CBD Regulation Hits Europe

By Marguerite Arnold
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european union states

With all the attention on the pending regs for the recreational industry in Canada plus the huge medical market under construction in the EU, it is easy to forget the other cannabis discussion in the room right now. Namely CBD in commercial food ingredients and supplements. Battles in the beauty space, while surfacing, are still much less avidly fought.

As a result, edible CBD is also rapidly becoming (another) big green elephant in the room. Globally. Starting with all the changing rules about mostly medical use of cannabinoids in general.

This is underway, sort of, in the United States, driven by state regulations and consumer protection initiatives, but delayed on a federal level by the fact that CBD is still scheduled, like THC, as a Schedule I drug.

In Europe, however, this is already a different animal.

The regulatory hammer also appears to be coming down in strategic country markets, with strange hybrid fights and issues emerging as a result.

For example, as cannabis crops (designed for both markets) begin to flourish in Spain buoyed by both the clubs in Barcelona and the growth of legitimate medical and other kinds of cannabis cultivation across the country – and much of that for export, authorities are cracking down on a federal level about labelling of not cannabis bound for clubs, but the CBD used in edibles.

In the last month, CBD industry blogs are reporting that the Spanish government is sending both warning letters to distributors and the police are apparently taking products off of shelves directly.

For all the direct showdowns about the cannabis plant this year, not to mention CBD, including British children ending up in hospital, this has got to make the top five list.

A Brief Modern History Of CBD Controversies On The Continent

The current complications have their roots in both the regulation of medical cannabis, health supplements and what are called “novelty” food items.

The food issue has been cooking for several years and for botanicals and additives far from cannabidiol. This year, on January 1, however, the entire EU brought in a new directive about the use of certain plants in food which seems to be affecting the edible cannabis conversation all over the continent. That said, countries are interpreting the same at different speeds and with different enthusiasm.

The EU looks poised to hop on the legalization train

Switzerland (not a member of the EU) is actually the only country on the European continent where so far, things have gone relatively smoothly. Their lack of EU membership is actually why. This also does not mean they have overcome some of the larger problems inherent in this entire discussion, but, if things go to form, it will be relatively drama free.

That is not the case in other places.

For example, at the end of 2016, British authorities made a splash about medical labelling with the Medicine and Health Care products Regulatory Agency (MHRA) also leaving the entire edibles discussion in limbo. Technically, low strength CBD can be sold in the UK but it must be labelled as a food product if not specifically made for the medical market. That flap is likely to take off again with the direct competition now of not only Tilray but Namaste and the changing scheduling of cannabis in the UK to a Schedule II in October. See the recent furore over the “unauthorized claims” supposedly made by the nascent Cannabis Trades Association in meeting, lobbying if not “working” with local authorities. The organization has literally blossomed within the last 18 months to over 300 members and 1,200 sellers in part to figure out what exactly the rules are, as authorities grapple with changing times.

tilray-logoNow jump the channel to Spain. The international focus of late has not been just the medical cannabis now sprouting in greenhouses owned by established pharmaceutical companies, or that bound for semi medical use in Barcelona, but the entire CBD edibles discussion.

Why?

On some levels, it is clearly an attempt to continue to set less than grey rules for the Spanish cannabis industry, which even in the club scene is regulating. But beyond that, this fight is altogether more complicated, and far from just regional, or even just a Spanish conversation.

European Food Regulation Meets The Cannabis Industry

CBD in edible products will, according to European regulation, make it a novel food or “additive” – namely that products containing the cannabinoid have not been used “safely”. Translated into English that crosses cultural boundaries, this definition really means that the substance in question must have been part of a regulated federal procedure – for at least 25 years in any third country. As such, it will have to be tested and regulated accordingly.In other words, until the EU can move to classify CBD as a novel food, in Spain, CBD products on the market must be labelled “external use only.”

One does not have to be an industry analyst to know this clearly excludes all parts of the cannabis plant. Everywhere. This is why the situation now unfolding in Spain is all the more worrying for the industry across Europe.

In Spain at least, the crackdown appears to be on any food item containing cannabis, which, according to European-wide regulations, has yet to be classified as a “novel food.” Namely, a food product which has not been consumed in a significant degree in the EU before May 15, 1987. See the guide for new applicants here.

In other words, until the EU can move to classify CBD as a novel food, in Spain, CBD products on the market must be labelled “external use only.”

Where Does This Leave The CBD Industry Across Europe?

As any manufacturer or vendor in any EU country could technically be required to register their new food, this means that cannabis producers and distributors in Europe need to be on their toes for the next several years as the regulatory schemata is worked out. Bottom line? Expect as much hullabaloo over this sector of the market as other places (even if over other issues).Both producers and distributors could easily face labelling problems

Here is the critical take-away. Regulation is coming to the entire industry in Europe in a way unseen in both Canada and the U.S. and from a much more granular perspective.

What “reigns in Spain” in other words right now, is a wake-up call for CBD producers across the continent, even if not involved in the medical space. Not to mention both U.S. and Canadian producers (in particular) looking for profitable market entry strategies. Labelling and standards, in other words, are clearly on the way, and beyond the drawing board, for all cannabinoids, not just those of the “medical” kind.

In the meantime, edible CBD products in Europe and in every country are ripe for the institution of new guidelines that are, as yet, formalized. Both producers and distributors, therefore, could easily face labelling problems for all their CBD products and product lines for the next several years.

Massachusetts Regulators Crack Down On Pesticide Use

By Aaron G. Biros
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Earlier this month, the Massachusetts Department of Health sent a cease-and-desist letter to Good Chemistry, a Colorado-based brand operating in Massachusetts with a dispensary in Worcester and a cultivation facility in Bellingham. The letter claimed Good Chemistry used unapproved pesticides and must close their operations in the state.

goodchem.exter
A Good Chemistry dispensary in Colorado

According to a Boston Globe article, the company used three pesticides (approved for use on organic food products by the federal government) that cannabis regulators in Nevada, Oregon, Washington and Colorado have all approved for use in cannabis cultivation. Previously, Massachusetts has allowed a number of pesticides to be used on cannabis, but since last year when the state’s Department of Agricultural Resources took over regulating pesticide use on cannabis, they decided to ban all pesticides.

Representatives from Good Chemistry insist the compounds used were safe and that the state is singling them out when the practice is widespread in the industry. “These organic compounds are safe all over the country, and they’re safe in Massachusetts,” Jim Smith, a lawyer for Good Chemistry, tells the Boston Globe. “For the state to single out Good Chemistry for using an industry-standard practice is absolutely wrong. It’s not acceptable — and we’re not going to destroy the crop, because it poses no risk to public safety whatsoever.”

Matthew Huron, CEO of Good Chemistry
Matthew Huron, CEO of Good Chemistry

Good Chemistry even disclosed to the state that they would use those pesticides when they applied for a cannabis business license. According to Telegram.com, a local Worcester publication, Matthew Huron, chief executive officer of Good Chemistry, is asking the state to reverse their decision. “The Department of Public Health has the discretion to amend or rescind their order to allow us to make the cannabis we’ve cultivated available to patients in the Worcester community,” says Huron. “Patients have let us know that they really benefited from Good Chemistry’s wide selection of high quality cannabis strains, and they would like access to it again as soon as possible. We’ve asked the state to incorporate the research, analysis and experience that led other states like Colorado, Nevada, Washington and Oregon to determine that the use of these cultivation methods are best practices and helps create healthier, contaminant-free cannabis for patients and the industry as a whole.”

On September 5, the Department of Public Health allowed Good Chemistry to amend the cease-and-desist so they could sell products from other producers in the state. “Many of our patients rely on our medicine we grow specifically and we now are only allowed to sell third party product,” Huron told Telegram.com.

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Tilray Enters Both U.S. & UK Markets

By Marguerite Arnold
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Tilray has long been seen as one of the market leaders in the global cannabis space. They are strategically placed in several critical areas to continue to do well, and put up major competition for just about everyone else (including German market entry first Canopy, plus the other big players in both Canada and Europe) ever since. See Aurora, Maricann and Aphria, to name a few. On the EU front, they are also certainly giving Dutch Bedrocan (with not only existing government contracts, but a newly increased ex-im medical allowance across the open Schengen border) a run for its money. And appear to have broached a monopoly long held by GW Pharma in the UK. 

But first things first. Here is a brief list of accomplishments on the corporate CV so far.In the U.S., Tilray just scored a medical trial at the University of San Diego with a pill used to treat a nerve disorder.

Long (relatively speaking) before Europe was on the map for anyone but a couple of Canadian LPs, the company was exporting to Croatia (in 2016). Even the initial hiccups in delivery (a batch arrived in broken bottles), did not stop their foreign expansion plans. 

When the first German cultivation bid was due, the company also, at least according to their spokesperson in Berlin at the time, considered applying. However, by late summer last year, Tilray was actually the first to publicly tip their hands that not only were they bowing out of the German tender, but had rather decided to import to Germany from cheaper EU climes. See their production facilities in Portugal. Plus of course a mass distribution deal to German pharmacies via local distribution.

Then there is their social media presence on Leafly, which also competes with Weedmaps as both an information portal and dispensary finder in key markets (California and Canada). The German version of the website (Leafly.de), has created a reality, no matter where the server is located, of also connecting directly to patients in a market still finding its way. 

tilray-logoAdd all these elements together, and that puts the company behind it all in an unbelievably strong position to continue to gain both market access and market growth in multiple jurisdictions while carefully moving at literally the change if not bleeding edge of the law.

How much long term impact this will have, however remains to be seen. Why? The times are changing fast. And not everyone is following a policy of promotion timed around other large events (see Canadian recreational legalization and the timing of the company’s IPO). 

Here is another example: the company’s most touted recent double victory, on each side of the Atlantic. Why? This is a place where cannabis companies are starting to compete. And while notable, particularly in it’s timing, is clearly indicative of the next stage in the development of the legitimate medical cannabis industry– not just Tilray.

Trials As Market Entry Tools

Medical trials in both the United States and Europe right now (including the UK for now at least), are the best way for cannabis companies to enter and gain market share. In the U.S., Tilray just scored a medical trial at the University of San Diego with a pill used to treat a nerve disorder.

Last week, Tilray also announced that they had essentially become the first Canadian LP to successfully challenge GW Pharmaceuticals on its home turf in the UK, even if for now limited to one patient application at a time. That won’t last, nor will such a tight monopoly.From a medical point of view, it is a very positive sign, at least for now.

That cross-Atlantic connection is even more interesting, however, given U.S. market entry recently for GW Pharmaceutical’s product, Epidiolex. 

From a medical point of view, it is a very positive sign, at least for now. How it will end up in the future is anyone’s guess, including stock valuation. 

Most advocates, of course, still hope for a medical market where patients are not restricted from deciding between the whole plant, oils or even the pharmaceutical products they choose to take.

Tilray of course is also not the only large LP engaged in medical trials. They are going on all over Europe right now (even if not as well strategically publicized). Health Canada is also committing to trials in Canada over the next five years.

However, what this very clearly demonstrates is that the global medical market is now ripe pickings for companies who approach the entire discussion from a “pharmacized” product point of view. Even if that means in Europe, and including for Tilray, entering the German and other medical markets with flower, oils and medical products.

Packaging Design for Cannabis Products: How to Build Trust and Gain Customers

By Katie Lundin
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To sell more cannabis products, you must build trust with your customers. Design Shack Magazine explains: “Trust is a key component of user loyalty, and a reason why people come to your company or brand.”

If you don’t get your package design right, people might simply ignore your cannabis products.But building trust is a big challenge for new medical cannabis businesses. That’s where good design can help:“While a lot of trust comes from past performance and a brand’s track-record, it also comes from the design. How a website, poster or package looks can impact how users feel about it and whether they take the leap from casual looker to brand loyalist.”

For a cannabis health supplement business, the product packaging design is one of the most important ways to reassure consumers and build trust.

When a prospective customer first sees your product, they see the packaging before they can touch or see the product. Good product packaging can raise concerns or instill comfort and confidence in a potential buyer.

If you don’t get your package design right, people might simply ignore your cannabis products.

So, let’s take a look at what your business can do to create great product packaging designs that will win over the skeptics and gain customers.

Include the Right Content On Product Packaging

Designing packaging that inspires trust starts with including the right content.

Start by telling people exactly what’s inside your packaging. For example, specify what your product is (CBD Extract Oil vs. Full-Spectrum Hemp Oil Caplets), how much of it there is, a production lot number and a potency level.

Include any qualifiers that may reassure your customers – such as “Organic,” “Non-GMO” or “CO2-Extracted.”

Image courtesy of Kannabia Seed Company

Communicate this information in clean, concise language that shows you have nothing to hide. And, speaking of not hiding – include contact information for your business. Many businesses bury their contact info on their websites and packaging. Don’t do that.

People trust businesses that are transparent and easy to reach. Customers want to know that if they have a question or something goes awry with an order that they can get help.

Including your web address, support email and phone number is a powerful way to reassure clients that your business is legitimate and trustworthy.

And, no packaging is complete without branding elements to help customers identify who your business is and what you’re about. This should include your company’s logo, identifying brand colors and any other small visual elements your brand may use.

Finally, make sure to follow the FDA guidelines for dietary supplement labels.

Your content checklist for product packaging

  • Include the essential details
    • What’s inside?
    • How much?
    • What’s the potency and dosage?
    • When does it expire?
    • What’s the lot number?
  • Include reassuring qualifiers that your audience will value
    • Organic, CO2-Extracted, Full Spectrum, Contains Less Than 0.3% THC, etc.
  • Include your company’s contact info
    • Web Address
    • Customer Support Email
    • Customer Support Phone number
  • Include your visual branding elements
    • Logo
    • Tagline
    • Brand Colors
    • Small branded graphic elements

Keep the Packaging Design Simple

Clean, simple design is reassuring and inspires trust.

Image courtesy of Receptra Naturals

That’s because simple design makes it easy for customers to find what they need or want to know.

It’s easy to miss information in a cluttered design – and people know this.

People naturally mistrust the dense chunks of text at the bottom of many advertisements and product packages. On the other hand, clean, easy-to-read fonts and plenty of white space ensure that your audience can read your product packaging and find the information they want quickly without too much trouble.

With fewer words and graphics competing for attention, the important stuff naturally stands out. And, a simple design also sends the message that there are no hidden loopholes or secrets that may work against your customers.

Keep the Design Of Your Product Packaging Professional

It doesn’t matter how great your product is if your business comes across as unprofessional. And, for medical cannabis businesses, the bar for establishing professionalism is even higher than for most companies.

Keep these tips in mind to communicate professionalism and reliability.

Image courtesy of Sagely Naturals

Make sure your packaging is error-free

Mistakes don’t look professional. How many times have you wondered how an error could have passed through so many hands unnoticed that it made it onto the final version?

Consumers notice errors in your packaging design. They see typos and often, discover incorrect or misleading information. Errors make customers think that your business is incompetent. Or worse – they might think that your business is deliberately misleading them. Make sure you proof-read everything before your packaging goes to production.

Showcase Your Cannabis Products Well Against Competitors

People buying your cannabis products will have other options. Don’t ignore your competition and be sure to understand how other dietary supplements and medicine is packaged.

Want to build trust by encouraging consumers to group your CBD products with other trusted medical brands? Follow these tips:

  • Provide a list of ingredients and instructions for safe dosing and usage. People expect this from reputable medicinal brands. Your product packaging should dothis too. And, remember to follow the FDA’s labeling requirements for dietary supplements.
  • Incorporate a safety seal into your packaging design. You’ll notice that most medicines, vitamins, and supplements have a safety seal to protect the contents. Whether you opt for a shrink-wrapped seal over the lid or a foil seal under the cap, adding a safety seal shows that your product has not been tampered with and implies that it’s safe to use.

Incorporating these elements will create a mental link between your product and other trusted medicinal products.

Be authentic to your cannabis brand

Last, but not least, your packaging design must align with your brand. When consumers sense a disconnect between the brand identity they’ve come to identify with your business and the packaging design for your products, it creates discomfort.

Image courtesy of Direct Cannabis Network

But packaging that is in line with (or expands upon) the brand identity consumers have come to know will create comfort and trust.

Kevin Keating at PKG Brand Design explains:

Your brand’s packaging design must reflect your company’s story, product, and values. If your packaging claims a “simple” snack product with dozens of ingredients, consumers are going to be left with a disingenuous feeling about your products and company. By ensuring that your messaging, design, and visual impact is in line with your company and your consumer’s preferences, you can build instant trust.

So, ensure that your packaging design is consistent with your existing visual identity. This includes the name of your business or cannabis product, your cannabis business logo, website, and marketing design.

A united and cohesive visual brand presence looks professional and helps to build familiarity – which is key to developing trust. Ultimately, many people judge products based solely on the product packaging. That’s why it’s essential to make sure your product packaging sends the right message.

A Province-By-Province Look At Recreational Cannabis In Canada

By Marguerite Arnold
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Federal recreational reform is coming to Canada next month, the second country after Uruguay to take the plunge. For the first time in almost a century, in other words, cannabis is now about to be legal again.

The federal government will license and regulate the industry. However each province and territory (analogous to American states) will set the rules on distribution and sales. As a result, there is quite a bit of difference across the country with implications both for licensed producers (LPs) and consumers.

A quick guide to the general Canadian regulations broken down by Province.

Who Can Buy, Sell and Grow?

With two exceptions, the legal age of consent is 19, home growing of up to 4 plants is allowed across many provinces (with only Quebec, Manitoba and Nunavut banning the practice), and rules vary by province on both public and private consumption.

However what the industry is really looking at right now is where private enterprise will be allowed to flourish at the retail end of the industry. Private retailers will be allowed to operate in 7 provinces and territories where they will compete with government run outlets. In New Brunswick, Nova Scotia, Ontario, Prince Edward Island, Quebec and the Yukon, consumers will be required to shop in only government-run establishments.

Nunavut, with no licensed producers, will allow online sales only, even in a recreational market. This gives Tilray an instant advantage with their established online presence not only from the company website, but Leafly.However, the two largest provinces are also where the competition will be most intense nationally.

Power Provinces

One of the most interesting statistics to look at is mapping this information to the number (and size) of licensed producers in each province. For example, Ontario currently clocks in at 59 producers, British Columbia at 23, Quebec at 8 and Alberta at 6, while the Yukon, the Northwest Territories and Nunavut have none. Of these, Ontario and Quebec will not allow producers to sell direct to private establishments but rather mandate sales via government-run dispensaries.

Ontario is slated to become the largest of all provincial markets in the country with Quebec coming in second.

However, the two largest provinces are also where the competition will be most intense nationally.

Where The Big Dogs Lie

Even these statistics do not tell the entire story. The biggest producers (especially those engaged in international rather than just domestic production and distribution) are scattered all over the map. For example, Tilray is in British Columbia. This gives the company the unprecedented ability, via its online portal and information website, Leafly, to engage in direct sales to both patients (via online sales) and recreational users from its home base.

How this will shape regional sales figures once the rec market actually starts is uncharted territory.Aurora is in a similar situation as it is situated in Alberta.

Canopy is headquartered in Ontario, but has grow sites across the country, giving it wide market access, and has just been picked as one of four companies to begin recreational sales in Manitoba.

Aphria and MedReleaf headquarters are also both located in Ontario. But it is not necessarily where such producers are located which will determine market access. Ontario has opened the door to suppliers of all sizes, across the country.

Quebec, in contrast, has signed deals with Canopy, Aphria, Aurora, Tilray, MedReleaf and Hydropothecary with both Aurora and Hydropothecary expected to have large home-court advantage when it comes to branding. MYM Nutraceuticals, with a huge greenhouse in Weedon, Quebec, has now also signed the largest deal in Quebec (as of June). The company represents one of Canada’s largest greenhouses.Canopy_Growth_Corporation_logo

Prince Edward Island and Brunswick have followed a bit of a hybrid model, signing deals with both small local players and the larger national companies.

The interesting twist to the Canadian medical market (that does not exist in Europe for example) is that all licensed producers are allowed to sell directly to patients online. How this will shape regional sales figures once the rec market actually starts is uncharted territory.

Ontario, with 40% of the country’s population and home to more than half of Canada’s registered producers, is slated to become the country’s largest recreational market.

British Columbia, in contrast, is developing as a place where mom and pops can still thrive.

Epidiolex-GW

GW Pharma’s Enormous Price for Epidiolex

By Marguerite Arnold
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Epidiolex-GW

In a fascinating early August conference call with Seeking Alpha, British-based GW Pharmaceuticals finally revealed their retail price point for CBD-based drug, Epidiolex, as it goes into distribution in the U.S.

The drug is designed for the treatment of certain kinds of childhood epilepsy – although not all kinds. Also notable of course, is that GW Pharma’s “other” drug for treatment of resistant epilepsy failed in late stage trials in Eastern Europe earlier this year. It also knocked off 5% of the price of the company’s stock.The company is estimating it has a potential patient pool of between 25,000- 30,000 patients in the U.S.

British Advocacy Over Access And Pricing

The ineffectiveness of GW Pharma’s drugs for many patients (along with the cost charged for them) was responsible for pre-empting the entire access discussion in the UK this year. The mother of an epileptic British child tried to import a personal store of cannabis oil (produced by Canadian LP Tilray) only to have it confiscated at the airport this summer. Her son ended up in the hospital shortly thereafter.

The national uproar this caused pushed forward the country’s new medical cannabis policy– indeed drug rescheduling is due to go into effect in October. Conveniently, right as Epidiolex goes on sale in the U.S. (where cannabis remains a Schedule I drug).

The company is estimating it has a potential patient pool of between 25,000- 30,000 patients in the U.S.

Price Tags and Politics

What is the price of Epidiolex? $32,500 per patient, per year. If that sounds high, the company insists it is pricing the drug to be “in line” with other drugs for this segment of the market.

The majority of this cost will not be picked up by private health insurers but rather the federal governmentActually, according to industry analysis, this is about 70% more than the price of one comparable drug (Onfi), and slightly more expensive than Banzel, the two competing (non-cannabinoid based) medications now available in the U.S. for this market.

Here is the other (widely unreported) kicker. The majority of this cost will not be picked up by private health insurers but rather the federal government, which is also not negotiating with GW Pharma about that high price  (unlike for example what is going on in Europe and the German bid).

Why the difference?

Two reasons. The first is that Epidiolex has obtained “orphan drug” status (a medication for a disease that affects fewer than 200,000 patients in the U.S.) The second is that the majority of the insurance that will be picking up this tab is Medicaid. The patient pool will be unable to afford this. As a result, the bulk of the money will remit not from private insurance companies but rather federal taxpayers. And, unlike in say, Germany, none of this is pre-negotiated in bulk.

Epidiolex-GW
What is the price of Epidiolex? $32,500 per patient, per year.

Co-payments are expected to range from $5 to $200 per month per patient after insurance (read: the government) picks up the tab. This essentially means that the company plans to base participation at first at least on a sliding scale, highly subsidized by a government that has yet to reschedule cannabis from a Schedule I in the U.S.

Creating, in other words, a new monopoly position for GW Pharmaceuticals in North America.

A Hypocrisy Both Patients And The Industry Should Fight

The sordid, underhanded politicking that has created this canna monster is hardly surprising given the current political environment in both the U.S. and the U.K. right now. The people who benefit the most from this development are not patients, or even everyday shareholders, not to mention the burgeoning legitimate North American cannabis industry, but in fact highly placed politicians (like British Prime Minister Theresa May). Philip May, the PM’s husband’s firm is the majority shareholder in GW Pharma. Her former drugs minister (with a strong stand against medical cannabis) is married to the managing director of British Sugar, the company that grows GW Pharma’s cannabis stock domestically.

So far, despite a domestic outcry over this in the UK (including rescheduling), there has been no political backlash in the United States over this announcement. Why not?

Look To Europe For A More Competitive Medical Market

This kind of pricing strategy is also a complete no go in just about every other market – including medical-only markets where GW Pharma already has a footprint.

For example, German health insurers are already complaining about this kind of pricing strategy for cannabis (see the Cannabis Report from one of the country’s largest insurers TK – out earlier this year). And this in an environment where the government, in fact, does negotiate a bulk rate for most of the drugs in the market. Currently most German cannabis patients are being given dronabinol, a synthetic form of THC which costs far less.

GW logo-2On top of this, there are also moves afoot by the German government to begin to bring the costs of medical cannabis and medicines down, dramatically. And this too will impact the market – not only in Europe, but hopefully spark a debate in every country where prices are also too high.

The currently pending German cultivation bid for medical cannabis has already set an informal “reference” price of at most 7 euros a gram (and probably will see bid competitors come in at under half that). In other words, the government wholesale price of raw, unprocessed cannabis flower if not lightly processed cannabis oil is expected to be somewhere in the neighbourhood of 3-4 euros per gram come early next year. If not, as some expect, potentially even lower than that.

Processed Cannabis Medicine vs. Whole Plant Treatment

The debate that is really raging, beyond pricing, is whether unprocessed cannabis and cannabis oil is actually “medicine.” At the moment, the status quo in the U.S. is that it is not.

GW Pharmaceuticals, in other words, a British company importing a CBD-based derivative, is the only real “medical cannabis” company in the country, per the FDA. Everyone else, at least according to this logic, is placed in the “recreational camp.” And further, hampered still, with a lack of rescheduling, that affects everyone.

If that is not an organizing issue for the American cannabis industry, still struggling with the many issues inherent in the status quo (from insurance coverage and banking to national distribution across state lines) leading up to the midterms, nothing will be.

Soapbox

Are LED Grow Lights Worth It?

By Dr. Zacariah Hildenbrand, Robert Manes
8 Comments

There really is no question that Light Emitting Diodes (LEDs) work, but just how well do they work?

For the last 50+ years, indoor cannabis cultivators have used High Pressure Sodium (HPS) lights to illuminate their flowering crops. This technology was developed for, and is still used, as street lighting and there really hasn’t been a fundamental change to the output in the last half century.LED technology showed great promise to solve some of the primary drawbacks to the use of HPS technology for indoor cannabis cultivation. 

We are often asked why this technology was used to grow cannabis, and the answers are simple: 1) due to strict legislation and even stricter penalties for growing cannabis, growers wished to move their crops indoors, and, 2) there really hasn’t been another technology that would allow us to cheaply place 400, 600, or even 1000W of light on a crop. In addition, HPS technology is rich in certain frequencies of red light, which is so important to flowering crops. Unfortunately, HPS lamps have their drawbacks, such as high heat output and lack of other “colors,” along the lighting spectrum. In fact, up to 95% of light produced by an HPS lamp is emitted in the infrared range, which we perceive as heat.

Enter the Light Emitting Diode. LED technology showed great promise to solve some of the primary drawbacks to the use of HPS technology for indoor cannabis cultivation. The ability to manipulate spectrum, precision delivery of light, elimination of dangerous heat, and lack of substantive toxic chemical makeup are a few reasons to deploy LEDs. However, as with any new technology, there were some significant hurdles to overcome.

Early experimentation using Light Emitting Diodes (LEDs) to grow cannabis, suffice to say, did not go well.  Poor performance, misleading advertising and equipment failures plagued the first mass-produced LED grow lights. The aspect of poor performance can be blamed on several factors, but the most prominent are very low efficacy, in terms of light produced per Watt consumed, and incorrect application of spectrum (color) for horticultural purposes. Causes of “misleading advertising” was a mixed bag of dubious sales pitches and lack of understanding the technology and of horticultural lighting requirements. Additionally, there certainly were some quality control issues with LEDs and electronics equipment in general, especially from offshore manufacturers in China and Korea.

A plant in flowering under an LED fixture

That legacy of poor performance still has a partial hold on the current indoor cannabis cultivation industry. Many of the current “Master Growers” have tried LEDs at some point and for the various reasons mentioned above, reverted to HPS lighting. Some of this reluctance to embrace LEDs comes from unfamiliarity with application of the technology to grow better cannabis, while some can be attributed to stubbornness to deviate from a decades-long, tried-and-true application of HPS lighting.

Certainly, growing with LEDs require some changes in methodology. For instance, when using true “full spectrum” grow lights, more nutrients are consumed. This is caused by stimulation of more photoreceptors in plants. To further explain, photoreceptors are the trigger mechanisms in plants that start the process of photosynthesis, and each photoreceptor is color/frequency-dependent. True full spectrum LED systems fulfill spectrum shortages experienced with HPS technology. Anyone that grows with LEDs will at some time experience “cotton top,” or bleaching at the upper regions of their plants.  Increased nutrient delivery solves this issue.

As we continue to uncover the vast medical potential of cannabis, precise phytochemical composition and consistent quality will become all-important.While the industry is still saturated with confusing rhetoric and some poorly performing equipment, LEDs are gaining momentum in the cannabis market. LED efficacies have increased to levels far greater than any other lighting technology. Broad spectrum white and narrow-frequency LEDs in all visible (and some invisible to the human eye) colors are being produced with great precision and consistency. Quality control in manufacturing is at an all-time high and longevity of LEDs has been proven by the passage of time since their introduction as illumination sources.

As the world embraces LED horticultural lighting, probably the most encouraging news is that current and upcoming generations of cannabis growers are more receptive to new ideas and are much more tech-savvy than their predecessors. Better understanding of cannabis-related photobiology is helping LED grow light manufacturers produce lighting that increases crop yields and perhaps more importantly, cannabis quality. As we continue to uncover the vast medical potential of cannabis, precise phytochemical composition and consistent quality will become all-important.

Obviously, the indoor cannabis industry is expanding rapidly and this expansion raises deep environmental concerns. More power is being used for indoor lighting, and for the cooling required by this lighting. Power systems are being taxed beyond forecasts and in some cases, beyond the capabilities of the infrastructure and power companies’ ability to produce and deliver electricity.  Some states have proposed cannabis-related legislature to limit power consumed per square foot, and some are specifically requiring that LEDs be used to grow cannabis. While some business leaders and cultivation operators may groan at the acquisition cost and change in operating procedures when deploying LEDs, common sense states that it is imperative we produce cannabis applying the most environmentally friendly practices available.

How to Vet Suppliers in Cannabis Product Manufacturing

By Amy Davison
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The quality of your edible cannabis product can only be as reliable as the components that comprise it. The three types of components include active ingredients (such as CBD oil), packaging components  (such as the bottles that hold finished product) and inactive ingredients (such as coconut oil). When evaluating a potential supplier for these three areas, a risk-based method follows a vendor selection process that highlights critical ingredients and also adequately assesses excipients. With this approach, the vetting process for a supplier is based on the impact the potential ingredient or component will have on the quality and purity of the finished product.

Choose only those suppliers who can provide certification that the packaging components are food-grade or food-safeThere are three basic categories to guide vendor assessment. Is the supplier providing 1) a packaging component with product contact, 2) an excipient, or inactive ingredient, or 3) the active ingredient? Regardless of the category, due to the factious nature of cannabis, it is important to first verify with a vendor that it will sell its products to a company in the cannabis industry. Once that is determined, the evaluation process may begin.

Packaging Components

Sourcing validation is a critical initial step in the production process. (image credit: Lucy Beaugard)

Packaging components, such as bottles and caps, are considered primary packaging because they have direct contact with the finished product. Suppliers of the primary packaging must be able to provide assurance that their goods do not contain additives that are harmful to consumers. Therefore, choose only those suppliers who can provide certification that the packaging components are food-grade or food-safe. Reputable vendors will also be able to provide a certificate of compliance, also known as a certificate of conformance, which states that the component meets specifications required for that part. Many cannabis regulations require finished products to be sold in child-resistant packaging, so the supplier will need to provide child-resistant certification for the packaging components, if applicable.

Excipients

Excipients are ingredients that are added to a product for the purposes of streamlining the manufacturing process and enhancing physical characteristics such as taste and color. Some examples could include coconut oil, starch and alcohol. Though they do not have the same critical nature as active ingredients, their potential risk to a finished product is generally greater than that of a packaging component. As such, there are additional factors to consider for an excipient vendor. Verify with the supplier that it can provide the following documentation. While governing regulations may not require some information, the data included in these documents are important to ensure the quality of your finished product.

  • Certificate of Analysis (or, certificate of conformance), for each lot of material. The information on a certificate, including the tests performed, specifications and test results must be sufficient to determine if the material is acceptable for use in the product.
  • Allergen Statement. This statement is important to accurately include or disclaim allergens on the finished product label.
  • Residual Solvent Statement. Solvents are commonly used to bolster the manufacturing process for a material. In order to maintain acceptable levels of residual solvents in a final product, it is necessary to also consider the toxicity and level of each solvent in the raw material.
  • Heavy Metals Certification. Since metals pose a risk to consumer safety, it is important to know what amounts, if any, are being contributed to your product by raw materials.

Because changes in an excipient can impact your finished product, make every attempt to obtain a commitment from a supplier to notify you if changes are made to the excipient’s specifications.

Active Ingredients

Cannabis oil is the ingredient that, when the edible cannabis product is consumed, is biologically “active.” Thus, it is considered to be the active ingredient in cannabis products. Since cannabis oil has a direct impact on the quality of a product, it is critical that the oil supplier be appropriately evaluated. One of the main considerations for a cannabis oil supplier is whether the supplier is willing to host initial and periodic audits of its manufacturing facility. Such audits are crucial in assessing the capability of the vendor to comply with regulatory requirements and established procedures – can the supplier consistently provide quality material? The answer to this question is too important to risk for you and your customers.As anyone working in the industry has experienced, anything related to cannabis is placed under an unprecedented critical lens.

Additionally, verify the oil supplier will provide key documentation, such as that listed above for excipients, to support the quality and purity of the oil. And last but not least, ensure the information reported by the supplier is adequate to meet the requirements of your finished product.

Evaluation guidelines and criteria such as these should be added to standard operating procedures to ensure consistency and quality across all products. As anyone working in the industry has experienced, anything related to cannabis is placed under an unprecedented critical lens. The importance of consumer safety and bolstering industry integrity is paramount. Sourcing validation is a critical initial step in the production process that can directly impact a company’s success and longevity in the cannabis industry.

Basic Training for Employers and Employees in the Cannabis Industry

Basic Training for Employers and Employees in the Cannabis Industry

By Lindsay Engle
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Basic Training for Employers and Employees in the Cannabis Industry

The cannabis industry is evolving as more states begin to legalize; as the legalization of cannabis grows, the industry will need more well-informed dispensaries and dispensary employees.

Unfortunately, there are employees in dispensaries without proper training and some are put in positions to recommend specific strains to patients that may not be accurate. Getting proper training is important, no matter which cannabis job you want to pursue.

More Training Is Needed

Currently, there are no national standards for training dispensary employees, there is not even a licensing code. Therefore, it is important for owners to investigate state laws and understand legal minimums for worker education.

There are states, like Massachusetts, which requires a $500 fee for employee registration. There are other states that require cannabis employees receive a certain number of education hours on specific topics, like patient confidentiality.

Overall, more than fifty percent of cannabis dispensary staff has reported receiving some type of formal training and only twenty percent of staff members have received medical cannabis training.Basic Training for Employers and Employees in the Cannabis Industry

Dispensary staff should receive training on how and when to make appropriate suggestions to patients. Any successful dispensary owner will acknowledge that employee education pays off in reduced loss, increased sales and avoided fines. There are more benefits to employee training than just these and there are steps owners can take to ensure they are getting the most out of their business and employees.

Setting up a System

When a dispensary has protocols in place that show how the business operates, the company will have consistency and organization. No matter the task, all team members must follow specific procedural protocols.

Mostly, mistakes are made when steps are missed or misunderstood by new employees, but with proper and thorough training, this can be avoided. Owners should be investing in a POS software system that is straightforward; this will reduce training time and make it easier for new staff to be familiar with the system.Having budtenders that can educate and connect with the customers on a personal level is invaluable

Teaching budtenders to adopt a soft sell technique will be the most effective when it comes to increasing sales. Many customers seeking relief using cannabis are not going to respond to a hard sell technique, as this comes off pushy or aggressive.

There are going to be customers who are unsure of what products they want; theses customers will need guidance, and training employees to make suggestions based on what the customer is looking for is the best sales practice.

Having budtenders that can educate and connect with the customers on a personal level is invaluable; dispensaries that do this will have repeat customers.

More States Legalizing, More Dispensaries and More Employees

As the United States heads towards cannabis legalization, slowly but surely, we need to be prepared to train workers. When you have a dispensary that you have already spent millions of dollars on the application process, you don’t have time to be messing around with employees that are not serious.

There are many different options anyone in the cannabis industry can seek out to educate themselves more in the business.Those distributing cannabis must take their duties as seriously as pharmaceutical technicians, because in a sense that is what they are doing. They are giving information on the prescription or drug to a customer that is using it for an intended a purpose.

Cannabis users come in many different ages and aliments. It is important for budtenders and dispensary owners to understand the backgrounds of each customer to increase their up-sale potential.

While compassion isn’t something you can learn online or in a classroom, it is always a good idea to remind others to be compassionate. The budtender that asks the right questions, takes time with each patient to care for them and goes over practical products for the client will be the budtender with the most sales revenue.

Higher Learning

There are many different options anyone in the cannabis industry can seek out to educate themselves more in the business.

Some platforms are available online and are filled with important content that can teach you about different aspects of the cannabis plant and industry. These classes can prepare employees or owners for success.The most important training will be the training of patients

There are courses that can educate you in how to cook and healing with cannabis. You can also learn about laws on a state-by-state basis when you are enrolled in a cannabis-training program. The cannabis industry is large and growing; entrepreneurs, lawyers and caregivers can learn about the growing movement and expand their knowledge on this topic.

Patient Training

The most important training will be the training of patients, who will be navigating between the world of western medication and the new option of medicinal cannabis.

There are obviously many positive things that will come from the legalization of cannabis, one of the biggest being more options for pain management patients. There is a misconception that people are using medicinal cannabis as an excuse to get high; however, many patients in most states are over the age of 50.

In 2016, it was estimated that 650,000 Americans were using cannabis in compliance with the laws of their state. As legalization grows to a national level, we are going to need to be educating patients.

It is important for citizens to talk to their doctors about methods they believe will work best for them. It is necessary to communicate strains that are ineffective or unsatisfying. Keeping a cannabis journal is a good way to know what dose and strain you benefit from the most.

There are many ways patients can be educated in the cannabis industry, and dispensaries that encourage patient education will grow customer loyalty. The person who knows the facts and is confident in their information will be more successful than the person who guesses.

Be sure you, your staff and your customers know the laws, strains and can accurately answer questions about cannabis.