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.
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.
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.
Now 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.
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.
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.
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 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 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.
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.
On 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.
By Dr. Zacariah Hildenbrand, Robert Manes 13 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.
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.
In a previous article I discussed the elephant in the room for clients of laboratory services- the possibility of errors, inaccurate testing and dishonesty.
Now, I will explain how the current “smoke and mirrors” of distillation claims are impacting the cannabis industry in the recreational and medical areas. We have all heard the saying, “ignorance is bliss.” But, the ignorance of how distillation really works is creating misinformation and misleading consumers.
That is, just because a cannabis extract has been distilled, doesn’t mean it is safer.There have been reports of people claiming that “Distilled cannabis productsthat are Category 2 distillate are pesticide free and phosphate free, while Category 1 has pesticides and phosphates, but within acceptable limits”
The problem is that these claims of Category 1 and Category 2 cannot be proven just by saying they are distilled. Ignorance of the physical chemistry rules of distillation will lead to increased concentrations of pesticides and other organic contaminants in the supposedly purified cannabis distillate. That is, just because a cannabis extract has been distilled, doesn’t mean it is safer.
So, let’s look at a basic physical chemistry explanation of the cannabis distillation process.
First off, you must have an extract to distill. This extract is produced by butane, carbon dioxide or ethanol extraction of cannabis botanical raw material. This extract is a tarry or waxy solid. It contains cannabinoids, terpenes and other botanical chemicals. It will also contain pesticides, organic chemicals and inorganic chemicals present in the raw material. The extraction process will concentrate all of these chemical compounds in the final extract.
Now you are ready to distill the extract. The extract is transferred to the vacuum distillation vessel. Vacuum distillation is typically used so as to prevent the decomposition of the cannabinoid products by thermal reactions or oxidation. Under a vacuum, the cannabinoids turn into a vapor at a lower temperature and oxygen is limited.
Part of the vacuum distillation apparatus is the distillation column. The dimensions of this column (length and width) along with the packing or design (theoretical plates) will determine the efficiency of distillation separation of each chemical compound. What this means is that the more theoretical plates in a column, the purer the chemical compound in the distillate. (e.g. Vigreux column = 2-5 theoretical plates, Oldershaw column = 10-15 plates, Sieve plate column = any number you can pay for).
The temperature and vacuum controls must be adjustable and accurate for all parts of the distillation apparatus. Failure to control the temperature and vacuum on any part to the apparatus will lead to:
Thermal destruction of the distillate
Oxidation of the distillate
Impure distillate
Now, you can see that a proper distillation apparatus is not something you throw together from a high school chemistry lab. But just having the proper equipment will not produce a pure cannabis product. The physical chemistry that takes place in any distillation is the percentage a chemical compound that occurs in the vapor phase compared to the percentage in liquid phase.So, how can you produce a cannabis distillate that is clean and pure?
For example, let’s look at whiskey distillation. In a simple pot still, alcohol is distilled over with some water to produce a mixture that is 25%-30% ethanol. Transferring this distillate to an additional series of pot stills concentrates this alcohol solution to a higher concentration of 85%-90% ethanol. So, each pot still is like a single theoretical plate in a distillation column.
But, if there are any chemical compounds that are soluble in the vapor produced, they will also be carried over with the vapor during distillation. This means that pesticides or other contaminants that are present in the cannabis extract can be carried over during distillation!
So, how can you produce a cannabis distillate that is clean and pure?
Produce a cannabis extract that has lower concentrations of bad chemicals. Since a lot of the cannabis extracts available for distillation are coming from grey-black market cannabis, the chances of contamination are high. So, the first thing to do is to set up an extraction cleanup procedure.
An example of this is to wash the raw extract to remove inorganic phosphates. Then recrystallize the washed extract to remove some of the pesticides.
Make sure that the distillation apparatus is set up to have proper temperature and vacuum controls. This will limit production of cannabis decomposition products in the final distillate.
Make sure your distillation apparatus has more than enough theoretical plates. This will make sure that your cannabis distillate has the purity needed.
Finally, make sure that the staff that operates the cannabis distillation processes are well trained and have the experience and knowledge to understand their work.
Inexperienced or under-trained individuals will produce inferior and contaminated product. Additional information of extract cleanup and effective vacuum distillation can be obtained by contacting the author.
In the last four articles, I have outlined areas that impact your operations as they apply to laboratory quality programs. But this article will take a different path. It will focus on protecting your crop and brand along with any business that utilizes your crop, such as dispensaries or edible manufactures in the court of public opinion.
Now, the elephant in the room for cannabis companies is the difference between rules written by the state and their enforcement by the state. There are many anecdotal stories out there that can be used as case studies in identifying ways to protect your brand. Remember, consumers and the media caught them, not the regulators.
Cheating in the cannabis industry: growers, dispensaries, edibles manufactures, etc. This includes:
Finding laboratories that will produce results that the client wants (higher potency numbers)
Not testing for a particular contaminant that may be present in the cannabis product.
Selling failed crops on the gray or black market.
Claiming to regulators that the state rules are unclear and cannot be followed (e.g. So, give me another chance, officer)
So why should you be worried? Because, even if the state where you operate fails to enforce its own rules, the final end-user of your product will hold you accountable! If you produce any cannabis product and fail to consider these end-users, you will be found out in the court of public opinion by either the media or by the even more effective word of mouth (e.g. Social Media).
So, let’s take a look at some recent examples of these problems:
Each of these reports lists contamination by microbial stains or pesticides as being rampant within the California market whose products are used for medical or recreational use. Just imagine the monetary losses these cannabis businesses faced for their recalled cannabis product when they got caught. Remember, consumers and the media caught them, not the regulators.Institute a quality program in your business immediately.
How can you be caught? There are many different ways:
So, what should you do to produce an acceptable product and provide reasonable protection to your cannabis business? Institute a quality program in your business immediately. This quality program will include areas of quality assurance and quality control for at least these areas.
Growing
Processing or formulating
Shipping
Dispensing
Security
Training of staff
Laboratory services
Setting up and supporting these programs requires that your upper management impose both a rigorous training program and make employee compliance mandatory. Otherwise, your business will have an unreasonable risk of failure in the future.
Further information on preparing and instituting these types of quality assurance and quality control programs within your business can be found at the author’s website.
The 6thAnnual Food Safety Consortium Conference & Expo will feature an entire track dedicated to cannabis. As announced in May of this year, the Cannabis Quality series will feature presentations by subject matter experts in the areas of regulations, edibles manufacturing, cannabis safety & quality as well as laboratory testing.
The Food Safety Consortium is hosted by our sister publication, Food Safety Tech, and the Cannabis Quality series will be co-hosted by Cannabis Industry Journal. A number of cannabis-focused organizations will participate in the series of talks, which are designed to help attendees better understand the cannabis edibles market, regulations surrounding the industry and standards for manufacturers. Some highlights include the following:
Ben Gelt, board chairman at the Cannabis Certification Council (CCC), will moderate a panel where leaders in the edibles market discuss supply chain, production and other difficulties in manufacturing infused products. Panelists include Leslie Siu, Founder/CEO Mother & Clone, Jenna Rice, Director of Operations at Gron and Kristen Hill, MIP Director, Native Roots Dispensary, among others. “The Cannabis Certification Council believes consumer education campaigns like #Whatsinmyweed are critical to drive standards and transparency like we see in food,” says Gelt. “What better place to discuss the food safety challenges the cannabis industry faces than the Food Safety Consortium”
Radojka Barycki, CEO of Nova Compliance, will discuss the role of food safety in the cannabis industry and identify some biological and chemical hazards in cannabis product testing in her talk, “Cannabis: A Compliance Revolution.”
Cameron Prince, vice president of regulatory affairs at The Acheson Group, will help attendees better understand key market indicators and current trends in edibles manufacturing during his talk on November 15. “With the current trend of legalizing cannabis edibles, medicinal and recreational suppliers alike are looking to quickly enter the edibles market,” says Prince. “Understanding the nuances of moving to food production relative to food safety, along with navigating the food industry’s regulatory environment will be critical to the success of these companies.”
Tim Lombardo and Marielle Weintraub, both from Covance Food Solutions, will identify common pathogens and areas where cross contamination can occur for edibles manufacturers.
The Food Safety Consortium will be held November 13–15 in Schaumburg, Illinois (just outside of Chicago). To see the full list of presenters and register for the conference, go the Food Safety Consortium’s website.
Thomas Jefferson University’s Lambert Center for the Study of Medicinal Cannabis and Hemp announced recently that it is co-sponsoring the third annual JAZ Tank Challenge: CannaVATION Edition.
Jefferson Innovation’s 2018 JAZ Tank Challenge: CannaVATION Edition is currently accepting submissions of innovative business models for a chance to compete on October 3, where finalists will each present their business ideas in a 10-minute pitch. Winning submissions could get one free provisional or utility patent application and business and clinical consulting services. The competition will be accepting submissions through August 20, 2018.
Finalists will compete for a $10,000 grand prize, legal support and business consultation services. According to the announcement, in addition to the grand prize winner, up to two other teams could win $5,000 in financial support, one free provisional or utility patent application and consulting services as well.
Zoe McKinley, director of entrepreneurship and social impact initiative at the Lambert Center
According to Zoe McKinley, director of entrepreneurship and social impact initiative at the Lambert Center, the competition is designed to have a national focus, not just on the Pennsylvania cannabis industry. “We are excited to shine a spotlight on Pennsylvania, and Thomas Jefferson University specifically, as a hub for research in medical cannabis, but like the competition, the Lambert Center has a national and even international focus,” says McKinley. She says this is also the first year that the JAZ tank is exclusively focused on cannabis.
Jefferson’s Chief Innovation Officer, Dr. Rose Ritts, notes “the competition is about creating a platform for emerging concepts to get a toe-hold on the path to potential commercialization. Anything that will improve patient access or outcomes …or improve the industrial hemp market in the U.S. is definitely of interest,” says Ritts. “We welcome companies to jump into the Challenge, and we also welcome investors or anyone thinking about getting into this space to be in the audience for our event on October 3.”
Dr. Rose Ritts, Jefferson’s Chief Innovation Officer
The challenge is an annual healthcare startup competition, where new businesses with particularly innovative ideas and technology solutions for the legal cannabis space submit their business models to a panel of judges for review. “This event will bring together the most inventive minds to pitch their solutions to stakeholder problems in the still-emerging medical and medicinal cannabis and industrial hemp industries,” reads the announcement. The Lambert Center is seeking applicants in a wide variety of business areas, including patient access, product design, plant science, information management, horticultural technology, sustainability, transportation, security, workforce training, community outreach, banking and public education.
Lambert Center Director Charles Pollack, MD sees the massive growth potential of the legal cannabis industry. “At our Center we are dedicated to identifying new approaches to developing cannabinoid-based therapies that help patients with various debilitating symptoms and diseases,” says Pollack. “Our JAZ Tank Challenge may identify the next great idea in medicinal cannabis.”
Through the Lambert Center for the Study of Medicinal Cannabis and Hemp, Jefferson is the first major university in the US to provide a comprehensive academic resource for the medicinal, medical and industrial applications and business of cannabis and hemp. The Lambert Center, the first of its kind in academia, provides “expert-developed, unbiased information to clinicians and patients about medical cannabis and cannabinoid-based therapies,” according to their website. They want to “support the development of entrepreneurial and socially responsible business and clinical approaches within the emerging medical cannabis industry and explore and develop new ways to use hemp in medical, industrial, and consumer products,” reads the website.
McKinley mentions they are looking for creative approaches to solving problems in the medical cannabis and industrial hemp industry. “These could be anything from new products or supply chain innovations to patient support tools to energy management systems that lower the environmental impact of grow facilities,” says McKinley. “We are hoping to see companies that have already launched, or are ready to very quickly.” The third annual JAZ Tank Challenge: CannaVATION Edition is accepting submissions through August 20. Click here for more information.
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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.
