In Part 1 of this series we answered the question: What is “hemp”; and addressed some of the consequences of defining “hemp” as a thing. In Part 2, I will explore this topic in more detail and provide some commonsense definitions for several traditional hemp products based on a classification approach rather than separating “cannabis” from “hemp”.
Classifications, Specifications, and Test Methods – Establishing Market Protections for Hemp Products Through Standardization
Does making a distinction between “hemp” and “cannabis” make it easier to protect the interests of the seed and fiber markets?
On the face of it, this question seems obvious. Yes, it does.
Up to this point in history, the bifurcation of the cannabis plant into resin types and non-resin types has served to provide protections for the seed and fiber markets by making it easier for producers to operate, since the resins (the scary cannabinoids, namely d9-THC) were not involved. Today, however, the line in the sand, has been washed away, and “hemp” no longer only refers to non-resin producing varieties of the cannabis plant.
The structure of cannabidiol (CBD), one of 400 active compounds found in cannabis.
As more and more hemp marketplaces come online with varying limits for d9-THC the need for standardization becomes even more pressing. Without standardization, each marketplace will have its own requirements, forcing businesses looking to sell their products in multiple jurisdictions to comply with each region’s mandates and adds a significant level of burden to their operations.
Providing an internationally harmonized definition for hemp is an important first step but allowing the d9-THC limit to vary from jurisdiction to jurisdiction has some unintended (or intended) consequences (#NewReeferMadness). These discrepancies between legal marketplaces will inevitably lead to the establishment of global trade regions; where, if your product cannot meet the definition of “hemp” in that region, then you could effectively be barred from participating in it.
A process which has already started. Harmonizing around 0.3% is great for the US, Canada, and European Union, but what about other stakeholders outside of these markets?
And, at what point does the conflict of hemp from one region with a d9-THC content of 0.3% and hemp from another region with a d9-THC content of 1% being sold into the same market become a problem?
Perhaps a better long-term solution for protecting the market interests of “hemp product” stakeholders would be to establish specifications, such as identity metrics, total cannabinoid content, especially d9-THC, and other quality attributes which have to be verified using test methods for a product to be classified as “hemp”. This system of standards (classifications, specifications, and test methods) would allow for more innovation and make it significantly easier for cannabis raw materials that meet these specifications to find a use rather than being sent to the landfill. Bolstering advancements and opening the door for more market acceptance of the cannabis plant, its parts, and products.
An Alternative Approach to Defining Hemp
Below are some proposed definitions related to common terminology used in the hemp marketplace based on the concept that there are no hemp plants, there are only cannabis plants that can be classified as hemp, and hemp products are simply cannabis products that meet certain specifications to allow them to be classified and represented as hemp.
Hemp, n—commercial name given to a cannabis plant, its parts, and products derived therefrom with a total d9-THC content no more than the maximum allowable limit for the item in question. (Maybe not the best definition, but it makes it clear that not only does the limit for d9-THC vary from jurisdiction to jurisdiction it varies from product type to product type as well.)
Hemp flower, n—commercial name for the inflorescence of a cannabis plant that can be classified as hemp.
Hemp seed, n—commercial name for the seeds of a cannabis plant which are intended to be used to grow another cannabis plant that can be classified as hemp.
Hempseed, n—commercial name for the seeds of a cannabis plant which are intended to be used as food or as an ingredient in food.
Hemp seed oil, n—commercial name for the oils expressed from the seeds of a cannabis plant.
Hemp seed cake, n—commercial name for the solid material byproduct generated during the expression of the oil from the seeds of a cannabis plant.
Hemp flour/meal/dietary-fiber, n—commercial name for the powdered seed cake of a cannabis plant intended to be used as a food or as an ingredient in food with a protein content no more than 35% by weight.
Hemp protein powder, n—commercial name for the powdered seed cake of a cannabis plant intended to be used as a food or as an ingredient in food with a protein content between 35% and 80% by weight.
Hemp protein isolate, n—commercial name for the powdered seed cake of a cannabis plant intended to be used as a food or as an ingredient in food with a protein content above 80% by weight.
Hemp fiber, n—commercial name for the cellulosic-based natural fibers of a cannabis plant.
Hemp shives, n—commercial name for the hurd of a cannabis plant which have been processed to defined specifications.
Hempcrete, n—commercial name for a solid amalgamation of various aggregates and binders, typically comprised of the hurd (shives) of a cannabis plant and lime.
The d9-THC limits for each product were purposefully omitted because these specifications still need to be defined for each product type. Leaving the d9-THC limit up to each authority having jurisdiction, however, is not the answer. It is fine if you comply with a lower d9-THC limit and want to sell into a market with a higher d9-THC limit, but what do you do if you are above the limit for the market you want to sell into? For now, you lose out on potential revenue.
Hemp-derived CBD extract
I am not advocating that everyone starts selling “hemp” as “cannabis,” or vice versa, far from it. I am advocating for a more commonsense and inclusive approach to the marketplace though. One that would allow for the commercialization of materials that would normally be going to waste.
To me it is simply logical. There are no hemp plants, there are only cannabis plants that can be classified as hemp. There are no hemp products, there are only cannabis products that can be classified as hemp. In order for a cannabis product to be marketed, labeled, and sold as a hemp product, i.e. to be classified as a hemp, it would need to meet a set of specifications and be verified using a set of test methods first. But fundamentally the product would be a cannabis product being certified as “hemp”. And that is the shift in thinking that I am trying to get across.
The cannabis plant is an amazing plant and to fully capitalize on the potential of this crop we have to start allowing for the commercialization of cannabis raw materials that are not controlled by the UN Single Conventions, i.e. the seeds, stalks, roots, and leaves when not accompanied by the fruiting tops or the resin glands. Not to do so disenfranchises a significant number of stakeholders from participating in established legal avenues of trade for these goods. A concept proposed and endorsed the ASTM D37 in the published standard D8245-19: Guide for Disposal of Resin-Containing Cannabis Raw Materials and Downstream Products.
If you are stakeholder in the hemp marketplace, you may feel threatened by the idea of the market getting flooded with material, but how are the demands of the so called “green economy” going to be met without access to more supply? Organic hemp seed for food production is scarce but there is plenty of conventional hemp seed for the current demand, but what happens when hempmilk is positioned to displace soymilk in every major grocery store? To feed the growth of the human population and allow for a transition to a truly “green economy,” we need to ensure that the policies that we are putting in place are not excluding those looking to participate in the industry and disenfranchising stakeholders from burgeoning marketplaces, nor alienating a segment of the marketplace simply because their plant cannot be classified as “hemp”.
Natural cannabinoid distillates and isolates are hydrophobic oils and solids, meaning that they do not mix well with water. By formulating these ingredients using various technologies, companies like Caliper and Ripple have learned how to change the solubility properties of the cannabinoids. In addition, formulations can improve bioavailability and onset time of the cannabinoids.
Stillwater Brands is a cannabis formulation company based out of Denver, Colorado, leveraging proprietary technologies for solubilizing cannabinoids in water. Stillwater has a partnership with the Canadian company Green Organic Dutchman and will soon expand their THC line of products, Ripple, into Michigan. Their CBD product line, Caliper, is already sold nationally.
We spoke with Drew Hathaway, senior food scientist at Stillwater, about the Stillwater technology and aspirations for growth. Hathaway joined Stillwater in 2018 after engaging with them as a technical sales representative in his previous role at a food ingredients supplier.
Aaron Green: What trends are you following in the industry?
Drew Hathaway: I can mainly speak to the science side of the business since that’s where I operate, but I do have some insight into the marketing approach and some of the things we look at. We’re looking at traditional food and beverage trends, whether it’s beverage formats, with its unique ingredients that are going to be general flavor trends, which can definitely be very region-specific. One of the things we definitely look at, especially on the THC side, is dosage differences. What are people putting their dosages at? Are they doing a combination of cannabinoids or terpenes? Are they really using individual ingredients? I think that’s something that’s been fairly well established in the THC market, especially since you have the regulatory mandate of 10 milligrams THC being your max single dose.
Drew Hathaway, senior food scientist at Stillwater
When Stillwater first launched in 2016, our company started with lower dose products to provide microdose options. We focus all of our products on functional foods for consumers. It’s why we have three different options for every single one of our products. We have what we call the Pure 10 which is 10 milligrams of THC per serving. We have what we call the Balanced 5. That’s 5 milligrams THC, 5 milligrams of CBD. Then as well as our Ripple Relief, which is a 40 to one ratio of CBD to THC at 20 milligrams CBD and 0.5 milligrams THC. We provide a variety of options for people looking for different dosage levels. We have to look at all of those trends. Packaging trends are also high on our radar.
Aaron: How about flavors?
Drew: We recently launched additional SKUs for our Ripple gummies here in Colorado. We have four different options. We have a sour variety pack that contains sour watermelon, sour apple and sour peach. We also just launched peach cherry, kiwi apple and sour watermelon by itself — and all of those are at the five milligram THC per gummy dose. That aligns with the Pure 10 line as well. We also have been working on some new flavors for the 10 milligram THC quicksticks, which we’re looking to launch early next year. Then, like I mentioned earlier, we’re expanding into Michigan with the THC business, which has been a big goal for us and something that’s gotten a lot of effort behind the scenes.
Aaron: So Drew, how did you get involved at Stillwater?
Drew: I like to describe myself as a traditionally educated food scientist. I went to college and got my bachelor’s and master’s in food science and technology at Ohio State. And then I ended up at a really cool company that was a very large food ingredient supplier. I was technical support to sales for their team. Through that position, I covered the Colorado territory as well as California and I got to cover Stillwater as one of my customers providing technical advice on different products and ingredients that they were looking at. I got involved with Stillwater through that position, back in the early days when they were still trying to develop and figure things out. That would have probably been about four years ago. I was able to see from the sidelines and I was dealing with some other cannabis companies in the space here in Colorado at the time too.
I recognized very early on what they were trying to do by making cannabinoids water soluble and water compatible. It was not only extremely challenging, but also had a ton of potential if they were able to pull it off. At that point, they were still trying to figure out how this is going to work. How do we produce it? How do we sell it? How do we make sure that things are stable? Things of that nature. I got an inside look at Stillwater from the very start, back when there were really only a few people at the company. I would check in with them regularly as they needed help.
I always joked that they were my least important, most interesting customer and I mean that only because they were buying extremely small amounts of ingredients from us. From a sales perspective, naturally, my manager didn’t necessarily want me spending a ton of time working with them. From a personal interest perspective, I was like, “these guys are doing something really intriguing and if they can pull this off this has a ton of potential, so I want to help them however I can.”
I dealt with them in that sales capacity for about two years before they talked about expanding into the CBD space with the Farm Bill passing at the end of 2018. I recognized at that point that I think they had two scientists including Keith, our head of R&D, and I said “alright, that’s really ambitious. You probably need some help! I think it’s time for me to take the leap and see if you guys are interested in having me come on board.” Fortunately, they were and so I’ve been with the company a little over two years now.
Aaron: Can you explain at a high level what the Stillwater products do?
Drew: The base technology behind all of our products for Ripple and Caliper is essentially converting your fat-soluble cannabinoids, whether it’s CBD or THC, into a water compatible product in a process referred to as emulsification. What you’re essentially doing is taking CBD and THC containing oils, whether it’s a distillate or isolate, and you’re essentially breaking those fat droplets into extremely small droplets and then stabilizing them at that size. We make our own emulsion — the fat droplets are extremely small — then when you draw that down into a powder format and redissolve it into water, you are dispersing billions upon millions of fat droplets into your glass. Those droplets are evenly dispersed through the beverage so that you get the same amount of THC or CBD in your first sip that you get in the last sip. That’s really the core technology behind everything that we do.
Taking cannabinoids and making them water soluble is the base technology necessary in order to make something like a shelf-stable infused beverage. There’s no way that you’re going to take traditional distillates or cannabinoids and be able to make a beverage that is shelf-stable otherwise. It’s been really cool since joining Stillwater to learn and understand how that process changes the way that those cannabinoids are absorbed by your body. Emulsification changes things like the onset time, as well as the total amount of cannabinoids your body’s absorbing and using. That’s been something that’s super interesting to see through the clinical research that we’ve done with human participants through Colorado State University.
Aaron: Let’s say if you just take THC oil and put it into an infused product. What’s the difference between that and Ripple?
Drew: Some products formats, such as beverages, just aren’t possible with THC oil without an emulsification technology. As the old saying goes in science, water and oil just don’t mix. So, if you were to take a traditional THC distillate and try to add it to a beverage, that would just float on top as a big oil slick. When you took your first sip, you would essentially get all of the cannabinoids in your first gulp which not only makes precise or partial dosing impossible, but also would taste absolutely terrible. Emulsification makes those infused beverage products possible and stable over a normal one-year shelf life or potentially longer.
Emulsification also changes the way that your body absorbs those cannabinoids, which is something that we’ve definitely put a heavy emphasis on and have really been able to validate with clinical research. I think that’s one of our biggest differentiators versus our competitors. We’re definitely not the only ones in the water-soluble cannabinoid space, but from my understanding, I think we’re one of the few companies that have actually executed human-based clinical trials (vs rodents) through a third-party university and been able to prove that these cannabinoids are detected in your bloodstream as fast as 10 minutes after consumption. We measured those results directly against an oil-based control, where you’re not going to get a peak absorption until maybe 60 to 90 minutes after consumption. What this research found was that not only was our product absorbed much faster, but it also enabled a significantly higher amount of the cannabinoids to actually make it into the participants’ blood stream where it can be used by their bodies. We also found the type of food emulsifier makes a significant difference in absorption – not just emulsion size, counter to common belief.
We use the analogy, “It’s getting a better bang for your buck.” The main purchasing consideration for a lot of edibles consumers when you go to a dispensary is “what is my cost per 10 milligram dose of THC?” That’s one of their key purchasing parameters, especially for your lower budget customer. What’s great with Ripple is one milligram of THC consumed through our Ripple technology is not really equivalent to one milligram of an oil-based product and that your body is actually going to absorb a higher percentage of it. And therefore, you’re going to get more of an effect, whether you’re looking for a medical effect or whether you’re looking for more of a recreational therapeutic effect. It also improves the consistency of that experience. So, with oil-based products, you could have the same products multiple different times and based on what you recently ate, you might get a higher or lower absorption rate or a faster or slower absorption rate. It’s also in the consistency of the experience and I know that from our market research of our consumers of Ripple products here in Colorado since that’s been in the market for a few years now. That’s the number one reason why people really trust our brand is because they can count on getting a consistent experience every time for the same dose.
As we all know, with the THC market and edibles market being newer in general, that’s most people’s biggest fear, especially if you’re a new consumer of THC — you obviously don’t want to consume more than what you can handle as far as getting higher than you want to be or anything like that — So consistency is a really, really key aspect for us and something that I’m definitely proud that we can provide that for our consumers.
Aaron: What does your product look like when you dissolve it into a liquid – let’s say something clear? Is the resulting mixture clear or cloudy?
Drew: We do have liquid concentrates, especially in the Caliper side of things, but with our powders, it kind of billows in as a cloud when you add it to a clear liquid. You can almost think of it like when we pour creamer into coffee: you see the cloud expand and then slowly fill out the cup and then be fully mixed in. Whereas with our products if you pour it into clear water, and you’ll see this white cloud form and then disperse. The final solution is generally a little bit cloudy depending on how much water you add it to.“I’ve been fortunate to be the lead developer for those products for Caliper and for Ripple, and flavor work is definitely something that never gets old.”
Aaron: How are customers using your products?
Drew: For a long time, we’ve had a variety of products in the market, some of which are still in the market, and some of which we’ve pulled since then. The key product for us has always been the Ripple dissolvable powder. It’s an unflavored, unsweetened powder that comes in a little sachet packet that you can tear open just like you would any other product and add to really anything. With its water compatibility, there’s really not a single product that you can’t add it to. It’s been really cool to see through social media, and in general, consumer engagement is electric and is kind of viewed as a novelty. The initial reaction is “Oh, I can take this little powder, put it in my eggs and now I have infused eggs!” It’s been great to see the creativity that our consumers have. We’ve seen it put in such a wide variety of products that literally you can make anything into an edible. I think that’s one of the coolest aspects of that product and why it’s been so successful.
One of the things we did realize pretty fast is that for a lot of people, the convenience and the consistency of the experience was a main driver for why they were purchasing our products. A lot of our real consumers just take that packet apart, ripping it open and pouring it straight in their mouth. It’s the fastest and most convenient way to consume the products, pretty much anywhere. We dug into that with our more recent launch of Ripple Quicksticks. And then we added some flavor, we added a little bit of sugar and sweeteners to make it a consumer-friendly experience where you get a really enjoyable flavor. It’s still just as convenient to consume by just ripping the packet straight open and pouring it in your mouth.
Aaron: It sounds like there must have been some interesting internal product development testing!
Drew: Yeah, definitely. That’s a fun one. I’ve been fortunate to be the lead developer for those products for Caliper and for Ripple, and flavor work is definitely something that never gets old. It can be frustrating at times, it’s definitely not the easiest thing to do. We’ve looked at traditional berry flavors, citrus flavors, as well as weird, kind of out-there flavors, to see what we like and what we think will work with our consumers.
Aaron: What states do you operate in?
Drew: Currently, our Stillwater THC business only operates in Colorado. That’s essentially the genesis of all the companies (Ripple, Caliper) is Stillwater being here in Colorado. We’re excited to announce that we’re expanding to Michigan next year. That’s something that we’ve all been working pretty heavily on developing and getting ready to go. That will be our first expansion of the THC brand to a different state.
We do have a licensing and distribution agreement with The Green Organic Dutchman (TGOD) in Canada. They produce our products using the same technology up there and license also under the Ripple brand name. So, it’s great to see the presence that we’ve been able to expand up there.
Then with Caliper on the CBD side of things with Caliper Ingredients and Caliper Consumer. We operate nationwide for that based on the more recent rules with the 2018 Farm Bill. For me, especially working across all of those business units, it’s really interesting to see the different business approach between your target CBD consumers and your target THC consumers because they’re really different markets. There’s definitely some overlap, but you’re targeting a different demographic to a certain degree. We keep those decisions in mind when we’re choosing how to market and what flavors to use and what products to make. So that’s been really interesting for me to see the behind-the-scenes discussions.
Aaron: I saw on your website, you’ve got consumer options via the dispensaries. Do you work with any infused product manufacturers on a licensing basis or partnership basis?“I’m super excited to continue to see how the medical research will continue to evolve.”
Drew: I’d say the majority of them are definitely on the CBD side for Caliper, partly because the regulatory environment of CBD just is a little bit easier to kind of engage other customers and to sell products across state lines and things of that nature. We do have some partnerships with some of the companies here in Colorado. I’d say the main one that we’ve promoted externally is with Oh Hi infused Seltzers based out of Durango, Colorado. It’s been a great agreement where we provide our base technology via liquid Ripple formulation that they can then infuse into their seltzers. They’ve done a great job with those products and it’s definitely a partnership that’s been mutually beneficial.
Aaron: What are you personally interested in learning more about?
Drew: For me, the whole appeal of joining the industry was research. With prohibition and decades of those restrictions preventing true research there are so many unknown questions that still need to be investigated. I’m super excited to continue to see how the medical research will continue to evolve. I think we’ll get better clarity on the efficacy of individual cannabinoids versus different combinations and ratios of cannabinoids. The entourage effect is something that’s pretty heavily talked about in the industry. I do think there’s some research to support that. I also think there’s still way more unknowns than things that we actually know. So, I’m super interested in seeing how our understanding of everything will continue to improve over time.
I’d love to see the medical research eventually expand into what synergistic benefits exist between cannabinoids and other bioactive ingredients such as turmeric, catechins, antioxidants and other plant-based ingredients that have gotten a lot more interest through the medical research in the last decade.
Then one of the things I’m always excited about being on the science side of things is we’re still investigating the general compatibility of cannabinoids with various types of food and beverage products. That goes not only for ingredient interactions, but also factors like pH, water activity and moisture content. Even packaging definitely plays a role in cannabinoid stability for a variety of products. There’s also a variety of production processing technologies that still need additional investigation, whether you’re talking pasteurization, for beverages, or retort for canned products or newer technologies like high pressure processing (HPP). So, I think the most exciting thing for me, and the reason I was really willing and interested in joining the industry, is there’s so much to learn. I don’t think we’ll ever run out of things to explore. I think as an industry the better we conduct this research, the better off we’ll all be.
Aaron: That’s the end of the interview! Thanks Drew.
Due to quick progressions in legalization, today’s cannabis industry bears little resemblance to the industry of five years ago. As the cannabis space gains mainstream acceptance, it resembles more “traditional” industries closely. In turn, how we consume cannabis has changed dramatically within this novel legal framework.
A brief visit to a cannabis dispensary quickly illuminates just how much the industry has changed in the past few years.
Within the dynamic of modern cannabis, perhaps no vertical has seen the same advancements as cannabis extracts. It’s precisely the growth of the concentrate category that has given rise to the many branded products that define the legal market.
To give a clear picture of how advancements in extraction have stimulated the concentrate category’s growth, we put together this brief exploration.
Standards & Technology
Before legalization, the production of cannabis extracts was a shady affair done in clandestine and often dangerous ways. Especially concerning BHO (Butane Hash Oil), home-based laboratories have long since been notorious fire hazards. Even more, with a total lack of regulation, black-market extracts are infamous for containing harmful impurities.
In the few short years that cannabis has been legal in Nevada, Washington and other states, extract producers have adopted standards and technology from more professional arenas. By borrowing from the food and pharmaceutical industries, concentrate companies have achieved excellence undreamed of a decade ago.
Good Manufacturing Practices
One of the essential elements in the extracts vertical advancements is the adoption of good manufacturing practices. According to the World Health Organization website, “Good Manufacturing Practice (GMP) is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use.”
When adult-use cannabis was legalized in markets such as Colorado, cannabis companies were able to come out of the shadows and discuss GMPs with legit businesses. In doing so, they implemented professional controls on extract manufacturing in accordance with “quality standards” of state regulatory agencies.
Supercritical CO2 Extraction
As cannabis businesses adopted GMP from other industries, extract producers also embraced more sophisticated technology. Of these, supercritical CO2 has pushed the cannabis concentrates vertical into the future.
According to the equipment manufacturer Apeks Supercritical, “CO2 is considered to be a safer method of extraction because the solvent is non-volatile. The extract is purer because no trace of the solvent is left behind. It is also versatile and helps protect sensitive terpenes, by allowing cold separation.” By deriving methods from food production, supercritical equipment manufacturers have given cannabis companies a viable option for the commercial production of extracts.
Supercritical technology has helped push the concentrates vertical forward by providing a clean and efficient way to produce cannabis extracts. Nonetheless, supercritical CO2 equipment is highly sophisticated and carries a hefty price tag. Producers can expect to pay well over $100,000 for commercial supercritical CO2 extraction setup.
Products
Just as standards and technology have evolved in the cannabis extracts vertical, we have also seen products rapidly mature. Notably, the legal environment has allowed manufacturers to exchange ideas and methods for the first time. In turn, this dialogue has led to the development of new products, like isolates and live resin.
Isolates
Just as the name implies, isolates are concentrates made from a singular, pure cannabinoid. In today’s market, CBD isolates have grown increasingly popular because people can consume pure CBD without ingesting other cannabinoids or plant materials, including the legal 0.3% THC found in hemp.
Isolates are made by further purifying cannabis extracts in the process of purification, filtration and crystallization. As seen with other concentrates, isolates are used as the base for many cannabis products, such as gummies.
There is also growing interest in CBG isolate, which is another non-psychoactive cannabinoid when consumed orally.
Live Resin
The cannabis concentrate live resin has taken the industry by storm over the past few years. Live resin is a form of extract that is originally sourced from freshly harvested and frozen cannabis plants. The primary selling point behind this extract is the fact that fresh flowers produce much more vibrant aromas and flavors than dried cannabis. Interestingly, this pungency is tied to the preservation of terpenes in live resin.
Just a few of the dozens of various products types on the market today.
To make live resin, producers “flash freeze” fresh cannabis plants immediately after harvest. Valuable cannabinoids and terpenes are then extracted from the fresh, frozen plant material using hydrocarbon solvents. This whole process is done at extremely cold temperatures, ensuring no thermal degradation to the precious and volatile terpenes.
In lieu of these intricate steps to preserve the flower and extracts, live resin has continuously gained popularity. Namely because vaping with live resin is the best way to sample fresh cannabis terpene profiles in its most authentic fashion
It is amazing to see how much cannabis extracts have grown and progressed with legalization. Due to such amazing advancements in standards, technology, and products, the concentrates category has exploded on the dispensary scene. In today’s market, flowers have been largely sidelined in favor of concentrate-based products like gummies. These products now adorn dispensary shelves in beautiful packaging replete with purity and testing specifications.
It’s an often-overlooked fact that the purity standards of the legal extracts have made reliable cannabis brands possible in the first place. You cannot develop a cannabis brand without consistent products that customers can rely on; all things considered, it can be said that advancements in extraction have not only stimulated the concentrate category but the entire industry as we know it today.
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
The structure of cannabidiol, one of 400 active compounds found in cannabis.
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.
Product Labeling
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.
An excerpt of an FDA warning letter sent to a CBD company in November of 2017
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.
Imagine this: you are taking medication for cancer pain. One day, it works perfectly. The next, you feel no relief. On some days, you need to take three doses just to get the same effect as one. Your doctor can’t be completely positive how much active ingredient each dose contains, so you decide for yourself how much medication to take.
Doesn’t seem safe, right? It is crucial that doctors know exactly what they are prescribing to their patients. They must know that their patients are receiving the exact same dose of medication in their prescription each time they take it, and that their medication contains only the intended ingredients.
consistency is key to creating products that are safe for consumers.In the cannabis industry, lack of certainty on these important factors is a major problem for drug manufacturers as they attempt to incorporate cannabidiol (CBD), a compound found in cannabis that has no psychoactive effects but many medical benefits, into pharmaceutical drugs.
When using these compounds as medications, purity is essential. Cannabis contains a wide variety of compounds. Delta-9 tetrahydrocannabinol (THC) is the most well-known compound and its main psychoactive one1. Safety regulations dictate that consumers know exactly what they are getting when they take a medication. For example, their CBD-based medications should not contain traces of THC.
The cannabis industry greatly needs a tool to ensure the consistent extraction and isolation of compounds. In 2017, the cannabis industry was worth nearly $10 billion, and it is expected to grow $57 billion more in the next decade2. As legalization of medical cannabis expands, interest in CBD pharmaceuticals is likely to grow.
If compounds such as CBD are going to be used in pharmaceutical drugs, consistency is key to creating products that are safe for consumers.
CBD’s Potential
CBD is a non-psychoactive compound that makes up 40 percent of cannabis extracts1. It is great for medical applications because it does not interfere with motor or psychological function. Researchers have found it particularly effective for managing cancer pain, spasticity in multiple sclerosis, and specific forms of epilepsy3.
Figure 1: The chemical structure of cannabidiol.
Other compounds derived from cannabis, such as cannabichromene (CBC) and cannabigerol (CBG), may also be beneficial compounds with medical applications. CBC is known to block pain and inflammation, and CBG is known for its use as a potential anti-cancer agent1.
Along with these compounds that provide medical benefits, there are psychoactive compounds that are used recreationally, such as THC.
“It will definitely be an advantage to have cannabis-based medications with clearly defined and constant contents of cannabinoids,” says Kirsten Müller-Vahl, a neurologist and psychiatrist at Hannover Medical School in Germany.
Creating a Standard Through Centrifugal Partition Chromatography
To obtain purified compounds from cannabis, researchers need to use technology that will extract the compounds from the plant.
Many manufacturers use some sort of chromatography technique to isolate compounds. Two popular methods are high performance liquid chromatography (HPLC) and flash chromatography. These methods have their places in the field, but they cannot be effectively and cost-efficiently scaled to isolate compounds. Instead, HPLC and flash chromatography may be better suited as analytical tools for studying the characteristics of the plant or extract. As cannabis has more than 400 chemical entities4, compound isolation is an important application.
This method is highly effective for achieving both high purity and recovery.Although molecules such as CBD can be synthesized in the lab, many companies would rather extract the compounds directly from the plant. Synthesized molecules do not result in a completely pure compound. The result, “is still a mixture of whatever cannabinoids are coming from a particular marijuana strain, which is highly variable,” says Brian Reid, chief scientific officer of ebbu, a company in Colorado that specializes in cannabis purification.
Currently, there is only one method available to researchers that completely allows them to isolate individual compounds: centrifugal partition chromatography (CPC).
The principle of CPC is similar to other liquid chromatography methods. It separates the chemical substances as the compounds in the mobile phase flow through and differentially interact with the stationary phase.
Where CPC and standard liquid chromatography differs is the nature of the stationary phase. In traditional chromatography methods, the stationary phase is made of silica or other solid particles, and the mobile phase is made of liquid. During CPC, the stationary phase is a liquid that is spun around or centrifuged to stay in place while the other liquid (mobile phase) moves through the disc. The two liquid phases, like oil and water, don’t mix. This method is highly effective for achieving both high purity and recovery. Chemists can isolate chemical components at 99 percent or higher purity with a 95 percent recovery rate5.
“CPC is ideal for ripping a single active ingredient out of a pretty complex mixture,” says Reid. “It’s the only chromatographic technique that does that well.”
The Need for Pure Compounds
High levels of purity and isolation are necessary for cannabis to be of true value in the pharmaceutical industry. Imagine relying on a medication to decrease your seizures, and it has a different effect every time. Sometimes there may be traces of psychoactive compounds. Sometimes there are too much or too little of the compound that halts your seizures. This is not a safe practice for consumers who rely on medications.“It’s hard to do studies on things you can’t control very well.”
Researchers working with cannabis desperately need a technology that can extract compounds with high purity rates. It is hard to run a study without knowing the precise amounts of compounds used. Reid uses a Gilson CPC 1000 system at ebbu for his cannabinoid research. With this technology, he can purify cannabinoids for his research and create reliable formulations. “Now that we have this methodology dialed in we can make various formulations —whether they’re water-soluble, sublingual, inhaled, you name it —with very precise ratios of cannabinoids and precise amounts of cannabinoids at the milligram level,” says Reid.
Kyle Geary, an internist at the University of Illinois at Chicago, is currently running a placebo-controlled trial of CBD capsules for Crohn’s disease. This consistent isolation is helpful for his research, as well. “Ideally, the perfect study would use something that is 100 percent CBD,” says Geary. “It’s hard to do studies on things you can’t control very well.”
The State of the Industry
While CBD is not considered a safe drug compound under federal law in the United States6, 17 states have recently passed laws that allow people to consume CBD for medical reasons7. Half of medicinal CBD users solely use the substance for treatment, a recent survey found8. As the industry quickly grows, it is crucial that consumer safety protocol keeps pace.
In June, the US Food and Drug Administration (FDA) approved the first drug that contains a purified drug substance from cannabis, Epidiolex9. Made from CBD, it is designed to treat Dravet Syndrome and Lennox-Gastaut syndrome, two rare forms of epilepsy. FDA Commissioner Scott Gottlieb said in the news release that although the FDA will work to support the development of high-quality cannabis-based products moving forward, “We are prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims. Marketing unapproved products, with uncertain dosages and formulations can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.”
The industry should be prepared to implement protocols to ensure the quality of their CBD-based products. The FDA has issued warnings in recent years that some cannabinoid products it has tested do not contain the CBD levels their makers claim, and consumers should be wary of such products10. It’s hard to know when or if the FDA will begin regulating CBD-based pharmaceuticals. However, for pharma companies serious about their reputation, there is only one isolation method that creates reliable product quality: CPC.
National Institute on Drug Abuse. (2015, June 24). The Biology and Potential Therapeutic Effects of Cannabidiol. Retrieved from https://www.drugabuse.gov/about-nida/legislative-activities/testimony-to-congress/2016/biology-potential-therapeutic-effects-cannabidiol
Atakan, Z. (2012). Cannabis, a complex plant: Different compounds and different effects on individuals. Therapeutic Advances in Psychopharmacology,2(6), 241-254. doi:10.1177/2045125312457586
Gilson. (n.d.). Centrifugal Partition Chromatography (CPC) Systems. Retrieved from http://www.gilson.com/en/AI/Products/80.320#.WzVB2lMvyMI
Mead, A. (2017). The legal status of cannabis (marijuana) and cannabidiol (CBD) under US law. Epilepsy & Behavior, 70, 288-291.
ProCon.org. (2018, May 8). 17 States with Laws Specifically about Legal Cannabidiol (CBD) – Medical Marijuana – ProCon.org. Retrieved from https://medicalmarijuana.procon.org/view.resource.php?resourceID=006473
Borchardt, D. (2017, August 03). Survey: Nearly Half Of People Who Use Cannabidiol Products Stop Taking Traditional Medicines. Retrieved from https://www.forbes.com/sites/debraborchardt/2017/08/02/people-who-use-cannabis-cbd-products-stop-taking-traditional-medicines/#43889c942817
U.S. Food & Drug Administration. (2017). Public Health Focus – Warning Letters and Test Results for Cannabidiol-Related Products. Retrieved from https://www.fda.gov/newsevents/publichealthfocus/ucm484109.htm
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The cannabis plant is an amazing plant and to fully capitalize on the potential of this crop we have to start allowing for the commercialization of cannabis raw materials that are not controlled by the UN Single Conventions, i.e. the seeds, stalks, roots, and leaves when not accompanied by the fruiting tops or the resin glands. Not to do so disenfranchises a significant number of stakeholders from participating in established legal avenues of trade for these goods. A concept proposed and endorsed the ASTM D37 in the published standard D8245-19: Guide for Disposal of Resin-Containing Cannabis Raw Materials and Downstream Products.
