Patient numbers in Australia are going in only one way – up. As of last month, the Australian government reported that it had approved a record 3,594 cannabis prescriptions in October 2019 – or about twice as many as it had approved in only July.
As patient numbers have grown, plans have proceeded afoot Down Under to capitalize on the growing willingness in Australia to accept that cannabis is not only medicine – but can now be prescribed by regular GPs – as opposed to specialists. Not to mention exported to a global medical market suddenly looking for high quality product at affordable prices in far afield places.
Leafcann is one of the companies in that elite territory right now. The new approval by the government for the expansion of facilities to both produce and research cannabis will double the company’s facility somewhere in Adelaide (the location is not being disclosed for security reasons). The new facility will also be the first in the world to produce oil from plant genes and distribute the same to patients.
But they are not the only ones. According to the latest market report by Aussie-based Fresh Leaf Analytics, the numbers of patients domestically are set to jump dramatically again next year.
And as the Australian market mushrooms (indeed European farmers are fielding interest from distributors from the region lately), will the Aussies, rather than any EU-based rival, become the first real global competition to the Canadians first in the race on the flower front?
Don’t count on that. There are too many contenders now for quality cannabis all over Europe for low priced medical cannabis from Down Under to be able to do any more than secure a few early harvests. See the activities of Aphria in the UK for example. Or the proclivities of Lexamed and a few other distributors in Germany.
However, what this development clearly shows is that the Aussie market for oil is not only driving large and well-funded production at home, but also having a knock-on effect internationally.
Whatever else is going on, in other words, the Australians are not only gearing up to go big on the weed front domestically, but driving the market for oil just about everywhere. Starting with CBD.
Don’t Bet The Farm On Aussie Production
Looking at what is going on, in fact, by the numbers, it appears that the Australian market is getting going in ways impossible for their northern brethren. In part that has to do with both Australian federal and state legislation.
It also, when you look at the numbers, is still a market dominated by less than THC medical grade product – the vast majority of patients are still only receiving CBD and most of them in oil form. Australian cannabis bound for pharmacies is also so far clocking in far closer to European prices than Canadian – in part because Canadian companies can ship directly to patients. Australia is also following a European distribution model. And recreational is off the table for now (at least until New Zealand does it). In the meantime, the medical business is proceeding apace.
This means two things: CBD oil is going nowhere either in or outside Australia unless it is either GMP or Novel Food certified – and that takes cash up front. Regardless, will the Aussie market look financially like the salad days of Canada’s medical market? Do not count on it. The flameouts of public companies if not volatility of the public sector, not to mention the growing longevity of the legal biz is creating other paths to financing. Including the fact that most savvy investors at any rate understand that price sensitivity is in the room from the beginning.
So yes, there certainly have been and will continue to be large, well-funded, corporate Aussies – indeed that is the shape of the future just about everywhere. But don’t expect the corporate playbook to be the same as the ones played by the Canadians so far.
Microbial contamination on cannabis products represents one of the most significant threats to cannabis consumers, particularly immunocompromised patients who are at risk of developing harmful and potentially fatal infections.
As a result, regulatory bodies in the United States and Canada mandate testing cannabis products for certain microbes. The two most popular methods for microbial safety testing in the cannabis industry are culture-based testing and quantitative polymerase chain reaction (qPCR).
When considering patient safety, labs should choose a method that provides an accurate account of what is living on the sample and can specifically target the most harmful microbes, regardless of the matrix.
1. The Method’s Results Must Accurately Reflect the Microbial Population on the Sample
The main objective of any microbial safety test is to give the operator an indication of the microbial population present on the sample.
Culture-based methods measure contamination by observing how many organisms grow in a given medium. However, not all microbial organisms grow at the same rate. In some cases, certain organisms will out-compete others and as a result, the population in a post-culture environment is radically different than what was on the original sample.
One study analyzed fifteen medicinal cannabis samples using two commercially available culture-based methods. To enumerate and differentiate bacteria and fungi present before and after growth on culture-based media, all samples were further subjected to next-generation sequencing (NGS) and metagenomic analyses (MA). Figure 1 illustrates MA data collected directly from plant material before and after culture on 3M petrifilm and culture-based platforms.
The results demonstrate substantial shifts in bacterial and fungal growth after culturing on the 3M petrifilm and culture-based platforms. Thus, the final composition of microbes after culturing is markedly different from the starting sample. Most concerning is the frequent identification of bacterial species in systems designed for the exclusive quantification of yeast and mold, as quantified by elevated total aerobic count (TAC) Cq values after culture in the total yeast and mold (TYM) medium. The presence of bacterial colonies on TYM growth plates or cartridges may falsely increase the rejection rate of cannabis samples for fungal contamination. These observations call into question the specificity claims of these platforms.
The Live Dead Problem
One of the common objections to using qPCR for microbial safety testing is the fact that the method does not distinguish between live and dead DNA. PCR primers and probes will amplify any DNA in the sample that matches the target sequence, regardless of viability. Critics claim that this can lead to false positives because DNA from non-viable organisms can inflate results. This is often called the Live-Dead problem. However, scientists have developed multiple solutions to this problem. Most recently, Medicinal Genomics developed the Grim Reefer Free DNA Removal Kit, which eliminates free DNA contained in a sample by simply adding an enzyme and buffer and incubating for 10 minutes. The enzyme is instantaneously inactivated when lysis buffer is added, which prevents the Grim Reefer Enzyme from eliminating DNA when the viable cells are lysed (see Figure 2).
2. Method Must Be Able to Detect Specific Harmful Species
Conversely, qPCR assays, such as the PathoSEEK, are designed to target DNA sequences that are unique to pathogenic Aspergillus species, and they can be run using standard qPCR instruments such as the Agilent AriaMx. The primers are so specific that a single DNA base difference in the sequence can determine whether binding occurs. This specificity reduces the frequency of false positives in pathogen detection, a frequent problem with culture-based cannabis testing methods.
Additionally, Medicinal Genomics has developed a multiplex assay that can detect the four pathogenic species of Aspergillus (A. flavus, A. fumigatus, A. niger, and A. terreus) in a single reaction.
3. The Method Must Work on Multiple Matrices
Marijuana infused products (MIPs) are a very diverse class of matrices that behave very differently than cannabis flowers. Gummy bears, chocolates, oils and tinctures all present different challenges to culture-based techniques as the sugars and carbohydrates can radically alter the carbon sources available for growth. To assess the impact of MIPs on colony-forming units per gram of sample (CFU/g) enumeration, The Medicinal Genomics team spiked a known amount of live E. coli into three different environments: tryptic soy broth (TSB), hemp oil and hard candy. The team then homogenized the samples, pipetted amounts from each onto 3M™ Petrifilm E. coli / Coliform Count (EC) Plates, and incubated for 96 hours. The team also placed TSB without any E. coli onto a petrifilm to serve as a control. Figures 3 and 4 show the results in 24-hour intervals.
This implies the MIPs are interfering with the reporter assay on the films or that the MIPs are antiseptic in nature.
Many MIPs use citric acid as a flavoring ingredient which may interfere with 3M reporter chemistry. In contrast, the qPCR signal from the Agilent AriaMx was constant, implying there is microbial contamination present on the films, but the colony formation or reporting is inhibited.
This is not an issue with DNA-based methods, so long as the DNA extraction method has been validated on these matrices. For example, the SenSATIVAx DNA extraction method is efficient in different matrices, DNA was spiked into various MIPs as shown in Table 1, and at different numbers of DNA copies into chocolate (Table 2). The SenSATIVAx DNA extraction kit successfully captures the varying levels of DNA, and the PathoSEEK detection assay can successfully detect that range of DNA. Table 3 demonstrates that SenSATIVAx DNA extraction can successfully lyse the cells of the microbes that may be present on cannabis for a variety of organisms spiked onto cannabis flower samples.
As the legalization of cannabis continues to spread across the U.S., both THC and CBD products are rapidly growing in popularity, and we can expect that popularity to increase in the coming years. The cannabis industry alone is expected to account for nearly $16.9 billion in revenue this year.
Subsequently, there is a rising need among infused product manufacturers for sufficient filling machinery for CBD and THC products. These products, including CBD oil cartridges, require filling equipment that can provide quick turnaround, detailed parts and simple changeover and cleanup, among other factors. Let’s go over the different types of filling machinery used for these products.
Vial Filling Machines
For small vial packages made of glass, metal or plastic, vial filling machines are available. Often used for a variety of pharmaceutical products, they’re now suitable for filling liquid THC and CBD oil. Vial fillers are also often suitable for filling liquid products of varying viscosity levels, with either the installation of peristaltic pumps or volumetric filling stations.
Rotary fillers can also fill containers at high speeds and with quick turnaround, and are ideal for filling various types and sizes of containers made of materials such as plastic, metal or glass. A good rotary filler will be able to meet the demands of high-speed environments consistently and with accuracy.
Fixed or Variable Volume Cartridge Filling ToolsAs the industry develops more demand for high-quality filling and other types of equipment, more machines are likely to be manufactured or configured specifically with these types of products in mind.
Fixed and variable volume cartridge filling tools often feature a single-handed operation and are used to rapidly fill cartridges for THC and CBD oils used for vaping. With fixed volume fillers, you’ll be able to designate a specific and consistent volume, while variable volume models allow for different fill volumes for applications requiring versatility.
Automatic filling machines will be able to fill a large number of products at varying speed settings, without the need for manual operation. These machines can fill many different types of products with consistency that helps maintain optimal productivity. As with other fillers, automatic fillers are often customizable in a wide variety of configurations.
For concentrates, filling syringes are ideal in many cases. Many patients are in need of a specific dosage of oil, and a syringe can allow for accuracy through the inclusion of measurement indicators. Many dispensaries sell syringe units, so this type of packaging method is likely to continue to rise in popularity.
Other Types of Equipment for Liquid Cannabis Packaging
In addition to reliable filling systems, manufacturers should make sure every other aspect of their packaging lines is covered with high-quality equipment. Facilities will require a variety of conveyors to transport products from one end of the line to the other, cleaners to ensure that bottles or other containers are clean prior to filling, and labelers to apply custom labels to packaging, among other machinery.
With one or more of these types of liquid fillers in a facility, companies can maintain accuracy and efficiency throughout their operations when filling CBD or THC products. As the industry develops more demand for high-quality filling and other types of equipment, more machines are likely to be manufactured or configured specifically with these types of products in mind.
As cannabis reform finally begins to hit the UK, the same confusion, lack of standards and uneven application of the “law” reigns supreme.
Just like other places (notably Israel, the United States and Canada), in the early days after medical reform hits, the English situation is instructive if not reminiscent of other fights elsewhere – no matter how much individual stories may differ on the surface. Just like in Israel for example, sick children had to be hospitalized before anyone moved forward on reform.
Just like in the United States, Canada and Israel, the people who were able to get into the changing industry first and early had money and political connections.
And just like everywhere else, who survives and who gets hit with red tape, is largely a matter not of entrepreneurial savvy, but connections, inherited privilege, race, gender and of course, bank account. In a place like the UK, where “class” is still a valid force on its own (beyond access to money), this is already obvious. As a theme, it is one that is sadly, not over yet for too many in or affected by “the industry.”
There are still, per the estimates available, less than 100 legal patients in the UK. Those served by the NHS are also well aware of their “second class” status when it comes to healthcare. This one issue, after all, drove Brexit, and may yet cause it to fail, just on this one issue. Cannabis may be a side note in the debate. But it is also, by this time, clearly in the room.
A Chelsea Popup Shop Survives While A Brighton Eatery Fails To Open
In January, two graduates of Imperial Business School (a private, prestigious university in London) opened a “pop up shop” (kind of like a kiosk) in Chelsea. This is a part of the city frequented by Royals on the hoof, reality stars of a certain vintage, and a lot of highly priced real estate.
So far, with the predictable fawning press coverage, the almost too “cutely” named TheDrug.Store (which by its own admission is selling non-medical products) has been doing brisk business.
Meanwhile, in the historic if less slightly less elite but almost as expensive touristy seaside town of Brighton, The Canna Kitchen, a CBD eatery with the catchy slogan of “let food be thy medicine”, was closed by the police right before it was supposed to open at the end of May (although there is no mention of this or the negative press on the website, which despite having no telephone number, still allows visitors to “book a table.”) The owners, who also seem to be quite well-heeled millennials themselves, appear to be on the verge of “losing hundreds of thousands of pounds and laying off 15 staff,” to quote The Guardian story on the subject.
Never mind the irony that they also seem rather well positioned financially. Or that many, many more people, usually called poor patients, are still at risk of being hospitalized because they cannot get (or afford) their medication.
As the industry, such as it is, and patient rights group organize in earnest this summer, reform in the UK also hinges on whether and what the country decides to do in the fall.
And despite the huge disparities that exist in terms of who has access (let alone to entrepreneurial capital), or perhaps because of them, look for a healthy debate from patients about policy, access and fairness.
Products using hemp-derived cannabidiol (CBD) designed for pets is not a new concept; Companies have been marketing CBD pet products for quite some time now, making their way into pet stores across the United States. Some pet owners have embraced the trend, using CBD oil to calm pets down, help alleviate joint pain as well as inflammation, while others are understandingly skeptical when it comes to using novel remedies for their furry friends.
Researchers at the University of Pennsylvania’s School of Veterinary Medicine hope to find some answers to those questions, particularly regarding the efficacy of using CBD remedies for dogs. According to a press release, a team of researchers at University of Pennsylvania’s Veterinary Clinical Investigations Center will perform the first major double-blind clinical trial to study the effectiveness of CBD in treating joint immobility in dogs. The trial will be led by principal investigator Dr. Kimberly Agnello.
According to the press release, this is the largest trial for cannabinoid therapy in pets so far. The trial will include use of the CBD-infused pet product, Therabis’ “Mobility.” Therabis is a subsidiary of Dixie Brands, Inc., a large cannabis infused products company in markets across the United States. Here are some of the details on the clinical trial, shared through the press release:
Dogs known to be suffering from inflammation secondary to osteoarthritis will be studied to determine whether those who receive the Therabis supplement achieve better outcomes than untreated dogs. One group of dogs will receive the formula for a proprietary veterinarian-specific formula Therabis product; a second group will receive Cannabidiol alone which previous studies have shown may have benefit in osteoarthritic dogs; a control group will receive a placebo. Study designers are targeting inclusion of up to 20 dogs in each group. The design of this study will provide valuable data defining the synergistic potential of the additional ingredients in the Therabis formula.
According to Dr. Stephen M. Katz, co-founder of Therabis, they think the data from the trials will show a positive outcome for dogs using their products. “We are honored to have a Therabis product selected by the world-renowned experts at Penn Vet for their first major study of the effects of natural hemp oil to reduce joint pain in dogs,” Says Katz. “Our experience in my clinic has shown that cannabidiol (CBD) is an effective treatment in reducing inflammatory response. We have a passion for improving dogs’ quality of life, and we look forward to learning all we can about therapeutic methods to achieve this.”
The results from this clinical trial, to be published in an academic journal upon conclusion of the study, should be of great interest to the hemp industry. Brightfield Group estimates that the CBD-infused pet products market is a $199 million industry, expected to grow up to $1.16 billion by 2020.
A steep spike in demand has created a race to the finish line in the hemp industry, but marketing a CBD product before FDA regulations are in place can be tricky. However, there is plenty you can do now to set your CBD company up for success.Let’s look at how CBD brands can get their marketing ball rolling in order to stay ahead of the curve.
Start With How You’re Different
Despite being a new market to many consumers, the hemp industry is well established and highly competitive. Leaders such as Charlotte’s Web and CV Sciences (AKA Plus CBD Oil) are publicly traded, but the market remains extremely fragmented with small mom-and-pop shops winning out in their respective locales. The number of competitors is intense and growing. In late 2018, Congress gave hemp its blessing by including it in the farm bill. As a result, “the market will continue to grow at a fast pace,” says Steve St. Clair, CEO of Enerhealth Botanicals. CBD is now officially mainstream. With thousands of competitors, it is of utmost importance that brands pull away from the pack.
Brand strategy is something that CBD companies should outline now. How is your product different? Why would a consumer pick your brand over another? These questions can be defined by talking to your current customers, observing holes in the marketplace and understanding the key advantages you have over other companies.
Consider how messaging varies for Colorado Hemp Honey compared to Epidiolex. The first leads with messaging centered around not just the quality of their honey, but why honey is a great source of fuel, especially for athletes (“Bee your best”). The latter speaks directly to families with children who suffer from seizures (“Seizures are shared. So is Relief”). While Colorado Hemp Honey might put an emphasis on attending extreme sporting events, Epidiolex would find greater benefits in focusing their efforts elsewhere.
That same brand strategy can be used when considering product extensions. According to Heath Thomson, director of business development at CFH, knowing how your company serves its customers can guide you toward product development. “There’s booming demand for CBD across consumer demographics, use cases and product types. While this presents immense opportunity, CBD is not a cure-all and not every product type that is in development or new to the market is appropriate for medicinal or dietary supplement use cases,” says Thomson. “For example, many CBD suppliers/manufacturers are chasing water soluble CBD, but do we really need CBD enhanced water?”
Nail Your Brand Online
Armed with a brand strategy, it’s time to build something consumer facing: your website. Mass market retailers are beginning to launch their CBD programs; however, they have dozens of brands to choose from when it comes to building stock. Brands with an established presence, clear purpose and consistent brand identity will have a leg up on fly-by-night companies.
In marketing, a brand’s website is considered its digital headquarters. Investing in a clean website with clear communication is a must. A strong website will establish trust among consumers (and retail partners) and further communicate how your brand is different from the rest.
Beyond branding, e-commerce functionality is an important revenue driver. A consumer may feel self-conscious purchasing CBD in store (there is still quite a bit of stigma surrounding the product), but clicking “check out” in the privacy of their own home is easy.“Earned media is where companies can separate from the pack and become category leaders.”
Own Your Email List
When it comes to driving revenue, there is no replacement for email. Some marketers personally feel their inbox is too full and so they cringe at the thought of adding to the constant stream of media we all face. The stats are undeniable though: the ROI of the typical email program is 73%.
When it comes to email, you (the marketer) set the guardrails. Unlike with paid advertising, your account won’t be shut down simply due to the nature of your product. Even with a modest 20% open rate, you’re reaching far more consumers than on social media (where brands only get 1% organic reach), and in a much more meaningful way.
Build Your PR Strategy
Two weeks of trying to run an advertising campaign for a hemp company will teach you one thing: when it comes to CBD, paid media is a minefield. To date, Facebook, Google, Pinterest, and Amazon still do not permit promotion of CBD products on their platforms. As a result, brands must lean more heavily on earned channels, such as PR.
“Earned media is where companies can separate from the pack and become category leaders. Press is more than just free advertising when it comes to hemp or cannabis. Consumers want to know that what they’re putting into their body is safe, and with so much legal grey area they’ll be even more wary than with other supplements,” says James Clark, co-founder of Room 214. “News coverage – especially in the right publication – is like a seal of approval for your product and reaches audiences currently blocked by advertising.”
Leaders in the CBD industry already play a strong game when it comes to PR, but there’s plenty of room for more.
Prepare for Constant Change
This point cannot be stressed enough: over the next two to three years, everyone in the hemp industry needs to buckle up. The constant change in this ever-budding market means you must be ready to make quick turns and adjustments. This is even true in the exercise of writing this article, as every morning I wake up to news about new regulations in various states and motions from the FDA to hold hearings.
The impact constant change has on paid media is not to be underestimated. Over the course of just a few weeks, an advertising vendor may change their policies regarding hemp products. My team has seen this happen time and time again. They would spend a day getting a campaign rolling, see great success within a few days and then see the account had been suspended shortly after. While there are cannabis-specific advertising platforms such as Mantis, mainstream networks are still turning down hemp-based brands.
This sort of up-and-down movement requires patience, and a strong “try, try again” attitude. Applying the Dunkirk Marketing Model will help brands keep their eyes on the horizon while faced with these daily obstacles. With your focus on end goals, you must also be prepared for quick adjustments and split-second decisions.
Get Started Now
While CBD companies face far more obstacles than other CPG companies when it comes to promotion, your marketing should not take a back seat. How you build your brand today will position you to earn the trust of consumers tomorrow. Spend time building a solid foundation by getting to know your core customer. Outline a messaging plan and your brand’s positioning, and invest in owned and earned channels such as your website, email marketing and PR.
President Trump signed the Agriculture Improvement Act of 2018 (the Farm Bill) into law late in December of 2018, which removed hemp-derived cannabidiol (CBD) from the Controlled Substances Act in states that choose to regulate it. Wyoming Governor Mark Gordon signing HB0171 means that the state intends to regulate the cultivation and sales of hemp-derived CBD.
Scott McDonald with the Wyoming Department of Agriculture told Wyoming Public Media that once the bill is signed, the state has 30 days to show their plans for regulation to the federal government. “We were kind of hoping to get something in place this spring for this growing season,” McDonald told Wyoming Public Media. “But we’re not sure that’s going to happen or not. There’s some uncertainty there, so it might be next year.”
McDonald also discussed the next steps that the WY Department of Agriculture needs to take to follow through on the bill’s promises, including figuring out a way to distribute licenses to hemp farmers, licensing laboratories to test hemp, insuring it has less than 0.3% THC and implementing a remediation plan for when crops test above that threshold.
According to Charlotte Peyton, a consultant with 30 years of experience in FDA regulations and experience working in the hemp industry, it is important to keep in mind that as soon as products containing hemp-derived CBD are sold across state lines, the FDA maintains regulatory authority. “If you manufacture and sell hemp products inside of a state with a state mandated hemp program, you are legal and protected under state laws, but the minute you sell across state lines, it becomes the jurisdiction of the federal government and, more specifically, the FDA,” says Peyton.
The hemp industry is the marijuana industry’s half-sister. Both are variations of the plant Cannabis sativa and both were made illegal in 1937 with the passing of The Marijuana Tax Act. Despite this federal status, in recent years 33 individual states have legalized some type of medicinal marijuana use and 11 states now allow legal recreational marijuana within their borders. This prompted congress to modify the legality of hemp which was addressed in The Agricultural Act of 2014, but it only allowed hemp to be used for research purposes. The Agriculture Improvement Act of 2018 (known as the 2018 Farm Bill) that was signed into law on December 20, 2018 was a huge step forward for public access to hemp and hemp products. The 2018 Farm Bill legalized the growing of hemp in states with a state-mandated hemp program and removed hemp and its derivatives from Drug Enforcement Administration (DEA) Schedule I status. Schedule I drugs, substances, or chemicals are defined as drugs with no currently accepted medical use and a high potential for abuse. Some examples of Schedule I drugs are heroin, lysergic acid diethylamide (LSD), 3,4-methylenedioxymethamphetamine (ecstasy), methaqualone, and peyote. Consumers and the cannabis industry alike were very excited about this legalization of hemp…. but that was when the confusion began.
FDA & Hemp
Within two hours of the 2018 Farm Bill being signed, the Commissioner of the FDA, Dr. Scott Gottlieb, issued a statement reiterating the FDA stance on cannabis products and cannabidiol (CBD) in products for human and animal consumption: “Congress explicitly preserved the agency’s current authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and section 351 of the Public Health Service Act.” Currently the FDA only permits CBD products submitted as an Investigational New Drug (IND) Application as a pharmaceutical. There is only one such accepted CBD product, Epidiolex, manufactured by G.W. Pharma. All other CBD products are illegal for interstate shipment.
Every product for sale in the US which is either ingested or applied to a human or animal body has a regulatory category in the FDA. Hemp-derived CBD products will have to fit into one of those categories or it will not be legal. Many hemp manufacturing companies will argue with the illegality of CBD products, but it will get them nowhere. If you manufacture and sell hemp products inside of a state with a state mandated hemp program, you are legal and protected under state laws, but the minute you sell across state lines, it becomes the jurisdiction of the federal government and, more specifically, the FDA. Section 10113 of the 2018 Farm Bill states that (c) Nothing in this subtitle shall affect or modify:
(1) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.);
(2) section 351 of the Public Health Service Act (42 U.S.C. 262); or
(3) the authority of the Commissioner of Food and Drugs and the Secretary of Health and Human Services- ‘‘(A) under- ‘‘(i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.); or ‘‘(ii) section 351 of the Public Health Service Act (42 U.S.C. 262); or ‘‘(B) to promulgate Federal regulations and guidelines that relate to the production of hemp under the Act described in subparagraph (A)(i) or the section described in subparagraph (A)(ii).”
There is nothing unclear about this issue. The same 2018 Farm Bill that hemp manufacturing companies use to justify the legality of hemp and CBD products is the same bill that spells out the authority of the FDA in this matter.
The mission of the FDA is “to ensure the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.” The agency also is responsible for “the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.” Health or medical claims not supported by clinical proof will not be tolerated. An unsafe, unclean or untested product will also not be tolerated in the marketplace.
CBD Oil vs. Isolate
Then there is the matter of CBD as either a full spectrum oil vs. an isolate…Unlike marijuana flower which is a very popular product, hemp flower is very rarely sold at the retail level. Full spectrum oil is extracted from the plant, and depending on the solvent used, produces an oil with the same, or close to the same, naturally occurring chemicals from the plant. The oil therefore, includes all the cannabinoids present along with any terpenes, lipids or other compounds present in the plant. Full spectrum oil is a botanical extract and is a dark thick oil. Isolate is produced by separating the constituents of the full spectrum oil by molecular weights or boiling points to have very pure chemicals in the 95%+ purity range. CBD isolate is a white crystalline substance and bears the greatest resemblance to a synthetic raw material and at its purest form cannot be distinguished as coming from a plant in the dirt or a synthesized chemical. Epidiolex is produced from hemp isolate and was approved by the FDA as a pharmaceutical. Full spectrum hemp oil is a botanical extract, often as an ethanol extraction. Full spectrum oil bears the greatest resemblance to a botanical dietary supplement. It remains to be seen what the FDA will allow in the future.
The FDA has made it abundantly clear in numerous warning letters issued to the cannabis industry that drug claims (articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease) regarding CBD, oil or isolate, cannot be made without pharmaceutical approval of the Drug Facts (Epidiolex) lest there be enforcement consequence.
The labeling of other types of products are less clear. Dietary supplements are a category of foods with the FDA and as such both the labeling of dietary supplements and foods are dictated in 21 CFR 111, Food Labeling. Botanical dietary supplements frequently call out a chemical constituent within a particular botanical material or extract on the Supplement Facts Panel: Milk thistle seed extract containing standardized and labeled silymarin is such an example. Is this strategy acceptable for CBD with the FDA? What about “naturally occurring” CBD? Food claims are indicated in the Nutrition Facts, what can these be for CBD? Cosmetic product claims can only address articles intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body’s structure or functions. What is the purpose of CBD in a cosmetic?
FDA guidance would be very beneficial in all of these labeling areas, and there is hope. The FDA is promising public hearings this spring to discuss a path forward for having hemp food and dietary supplements. The FDA will ask for public comment and hopefully, there will be a lot of public comments provided to them. The public’s huge demand for CBD products will bear pressure on the FDA to at least listen and consider.
cGMPsRegulatory compliance will be difficult, and it will be expensive.
Those currently in the hemp manufacturing industry should pay attention and take the FDA seriously. If the FDA allows hemp products with CBD to be sold in the future, it will be the FDA who makes those regulations and those products will have to fit into an already existing FDA category: human food, animal food, dietary supplement, pharmaceutical or cosmetic. If you are a hemp product manufacturer, you must learn the applicable requirements for Current Good Manufacturing Practices (cGMPs) by hiring experienced FDA compliance personnel, and/or seeking out FDA regulatory consultants, to develop and implement a quality system accordingly:
21 CFR 117, Current Good Manufacturing Practice, Hazard Analysis, and Rick-Based Preventative Controls for Human Food
21 CFR 507, Current Good Manufacturing Practice, Hazard Analysis, and Rick-Based Preventative Controls for Food for Animals
21 CFR 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
21 CFR 210, Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General
21 CFR 211, Current Good Manufacturing Practice for Finished Pharmaceuticals
FDA Draft Guidance for Industry, Cosmetic Good Manufacturing Practice, June 2013
I believe in this industry and I am rooting for the pioneers who have taken all the risk thus far, but the level of denial of the FDA’s authority that I am hearing in the hemp industry community is disturbing to me because those companies will not manage the transition to a regulated future. Most don’t understand it and they don’t think it applies to them or their products. Regulatory compliance will be difficult, and it will be expensive. The hemp pioneers deserve to benefit from their labor and the risk they have taken. For those hemp product companies that do not think compliance is worth the effort or cost, there are many FDA-compliant human food, animal food, dietary supplement, pharmaceutical, or cosmetic companies that are waiting to take your business…
Editor’s Note: While Cannabis Industry Journal typically does not use the term ‘marijuana,’ the author here is speaking from a regulatory point of view and creates an important distinction. Peyton chose the word “marijuana” instead of “cannabis” because the FDA has chosen “cannabis” to refer to both marijuana and hemp.
Canapar SL, an Italian organic hemp producer has just announced it is breaking ground on what it is being billed as “Europe’s largest hemp processing facility.”
Located on Sicily, Canapar is already established as a manufacturer and processor of CBD oil and concentrates. On its roadmap already is to become a leader in the CBD-infused cosmetics, skincare and beauty industry with the additional benefit of bearing the “Made in Italy” imprimatur. In addition to the upscale export market of course, Italy is Europe’s fourth largest consumer of such products.
There has been much noise made about the CBD market in Europe, which even surprised experts by the end of year when it reached a magical 1-billion-euro sales cap.
However, things are not all smooth sailing on this front, no matter how much the market exploded. With the success of CBD, in Switzerland, Spain and beyond, regulators in Europe began looking at how the entire enchilada was regulated.
CBD isolates are falling into a very strange gray territory at the present across the continent. Why? As a plant extract, extracted CBD from cannabis absolutely falls into territory ruled “novel food” in the EU. In effect, what this means is that anything with CBD distillates that do not come from hemp, now requires an expensive licensing process to prove they are not harmful. In places like the UK, Spain and Austria, this became so contentious that police raided Spanish stores over health food products. The UK is now requiring tighter licensing and labelling for these products. Last December, the Austrians banned the entire industry. Take that, Switzerland!
CBD distillate made from hemp, however, seems, for now, to have survived this battle, which is why the strategic investment of Canopy last December was also so intriguingly timed. Why? It appears to be the loophole in the EU in which CBD producers will have to hang their hats until the broader CBD question is answered satisfactorily at both the UN and EU level.
Producing hemp distillate on the Italian island of Sicily also represents an interesting step for the entire cannabis industry as it develops in the country. There have been many efforts to legalize cannabis because this will then end the direct involvement of the Mafia. Perhaps the multi million investment from Canopy will be enough foreign capital to start to do the trick if not turn the tide.
But Won’t CBD Just Be “Rescheduled” By the UN?
There are many reasons why this is a strategic move for Canopy (if not producers moving in similar waters). Yes, CBD is likely to be descheduled by the UN at some point in the near future, but this still will not solve the larger question of “novel food” issues until the EU formally issues regulations on the same. Until then, EU will be a state by state hop for CBD, much as the United States has been so far. And will be, until that debate is settled across the EU at least, sourced from hemp.
With Italian food products export just behind things like cosmetics, Canapar is clearly moving into strategic and potentially highly lucrative territory.
Cannabis extraction has been used as a broad term for what can best be described as cannabis processing. A well-thought-out cannabis process goes far beyond just extraction, largely overlapping with cultivation on the front-end and product development on the back-end1. With this in mind, four pillars emerge as crucial capabilities for developing a cannabis process: Cultivation, Extraction, Analytics and Biochemistry.
The purpose and value of each pillar on their own is clear, but it is only when combined that each pillar can be optimized to provide their full capacities in a well-designed process. As such, it is best to define the goals of each pillar alone, and then explain how they synergize with each other.
At the intersection of each pillar, specific technology platforms exist that can effectively drive an innovation and discovery cycle towards the development of ideal products.Cultivation is the foundation of any horticultural process, including cannabis production. Whether the goal be to convert pigments, flavors or bioactive compounds into a usable form, a natural process should only utilize what is provided by the raw material, in this case cannabis flower. That means cultivation offers a molecular feedstock for our process, and depending on our end goals there are many requirements we may consider. These requirements start as simply as mass yield. Various metrics that can be used here include mass yield per square foot or per light. Taken further, this yield may be expressed based not only on mass, but the cannabinoid content of the plants grown. This could give rise to a metric like CBD or THC yield per square foot and may be more representative of a successful grow. Furthermore, as scientists work to learn more about how individual cannabinoids and their combinations interact with the human body, cultivators will prioritize identifying cultivars that provide unique ratios of cannabinoids and other bioactive compounds consistently. Research into the synergistic effect of terpenes with cannabinoids suggests that terpene content should be another goal of cultivation2. Finally, and most importantly, it is crucial that cultivation provide clean and safe materials downstream. This means cannabis flower free of pesticides, microbial growth, heavy metals and other contaminants.
Extraction is best described as the conversion of target molecules in cannabis raw material to a usable form. Which molecules those are depends on the goals of your product. This ranges from an extract containing only a pure, isolated cannabinoid like CBD, to an extract containing more than 100 cannabinoids and terpenes in a predictable ratio. There are countless approaches to take in terms of equipment and process optimization in this space so it is paramount to identify which is the best fit for the end-product1. While each extraction process has unique pros and cons, the tunability of supercritical carbon dioxide provides a flexibility in extraction capabilities unlike any other method. This allows the operator to use a single extractor to create extracts that meet the needs of various product applications.
Analytics provide a feedback loop at every stage of cannabis production. Analytics may include gas chromatography methods for terpene content3 or liquid chromatography methods for cannabinoids 3, 4, 5. Analytical methods should be specific, precise and accurate. In an ideal world, they can identify the compounds and their concentrations in a cannabis product. Analytics are a pillar of their own due simply to the efforts required to ensure the quality and reliability of results provided as well as ongoing optimization of methods to provide more sensitive and useful results. That said, analytics are only truly harnessed when paired with the other three pillars.
Biochemistry can be split into two primary focuses. Plant biochemistry focuses back towards cultivation and enables a cannabis scientist to understand the complicated pathways that give rise to unique ratios of bioactive molecules in the plant. Human biochemistry centers on how those bioactive molecules interact with the human endocannabinoid system, as well as how different routes of administration may affect the pharmacokinetic delivery of those active molecules.
Each of the pillars require technical expertise and resources to build, but once established they can be a source of constant innovation. Fig. 1 above shows how each of these pillars are connected. At the intersection of each pillar, specific technology platforms exist that can effectively drive an innovation and discovery cycle towards the development of ideal products.
For example, at the intersection of analytics and cultivation I can develop raw material specifications. This sorely needed quality measure could ensure consistencies in things like cannabinoid content and terpene profiles, more critically they can ensure that the raw material to be processed is free of contamination. Additionally, analytics can provide feedback as I adjust variables in my extraction process resulting in optimized methods. Without analytics I am forced to use very rudimentary methods, such as mass yield, to monitor my process. Mass alone tells me how much crude oil is extracted, but says nothing about the purity or efficiency of my extraction process. By applying plant biochemistry to my cultivation through the use of analytics I could start hunting for specific phenotypes within cultivars that provide elevated levels of specific cannabinoids like CBC or THCV. Taken further, technologies like tissue culturing could rapidly iterate this hunting process6. Certainly, one of the most compelling aspects of cannabinoid therapeutics is the ability to harness the unique polypharmacology of various cannabis cultivars where multiple bioactive compounds are acting on multiple targets7. To eschew the more traditional “silver bullet” pharmaceutical approach a firm understanding of both human and plant biochemistry tied directly to well characterized and consistently processed extracts is required. When all of these pillars are joined effectively we can fully characterize our unique cannabis raw material with targeted cannabinoid and terpene ratios, optimize an extraction process to ensure no loss of desirable bioactive compounds, compare our extracted product back to its source and ensure we are delivering a safe, consistent, “nature identical” extract to use in products with predictable efficacies.
Using these tools, we can confidently set about the task of processing safe, reliable and well characterized cannabis extracts for the development of world class products.
 Sweeney, C. “Goal-Oriented Extraction Processes.” Cannabis Science and Technology, vol 1, 2018, pp 54-57.
 Russo, E. B. “Taming THC: potential cannabis synergy and phytocannabinoid-terpenoid entourage effects.” British Journal of Pharmacology, vol. 163, no. 7, 2011, pp. 1344–1364.
 Giese, Matthew W., et al. “Method for the Analysis of Cannabinoids and Terpenes in Cannabis.” Journal of AOAC International, vol. 98, no. 6, 2015, pp. 1503–1522.
 Gul W., et al. “Determination of 11 Cannabinoids in Biomass and Extracts of Different Varieties of Cannabis Using high-Performance Liquid Chromatography.” Journal of AOAC International, vol. 98, 2015, pp. 1523-1528.
 Mudge, E. M., et al. “Leaner and Greener Analysis of Cannabinoids.” Analytical and Bioanalytical Chemistry, vol. 409, 2017, pp. 3153-3163.
 Biros, A. G., Jones, H. “Applications for Tissue Culture in Cannabis Growing: Part 1.” Cannabis Industry Journal, 13 Apr. 2017, www.cannabisindustryjournal.com/feature_article/applications-for-tissue-culture-in-cannabis-growing-part-1/.
 Brodie, James S., et al. “Polypharmacology Shakes Hands with Complex Aetiopathology.” Trends in Pharmacological Sciences, vol. 36, no. 12, 2015, pp. 802–821.
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