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Leaders in Infused Products Manufacturing: Part 2

By Aaron Green
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Cannabis infused products manufacturing is quickly becoming a massive new market. With companies producing everything from gummies to lotions, there is a lot of room for growth as consumer data is showing a larger shift away from smokable products to ingestible or infused products.

This is the second article in a series where we interview leaders in the national infused products market. You can find the first piece here. In this second piece, we talk with Mike Hennesy, vice president of innovation at Wana Brands. Mike started with Wana in 2014 after moving to Colorado and leveraged his science background to transition into product development and innovation where he has helped develop one of the best-known brands in Colorado.

Next week, we’ll sit down with Stephanie Gorecki, vice president of product development at Cresco Labs. Stay tuned for more!

Aaron Green: Thank you for taking the time today. Just to start off, can you walk me through how you got involved at Wana Brands?

Mike Hennesy: Thanks Aaron. I got involved in the cannabis industry pretty intentionally. After graduating college in 2012, I was determined to get involved. I moved to Colorado from the east coast. I’m originally from Virginia. I moved out here in 2013 and started with Wana in 2014.

Mike Hennesy, Vice President of innovation at Wana Brands

I got involved in the sales side of the business originally – as the company was just starting to emerge into the legal recreational market – and oversaw growth here at Wana during significant changes in the industry. Over time, my role transitioned into innovation and R&D where I am leaning on my background in science.

I now lead new product development and education as Vice President of Innovation, and I’m also completing a master’s degree in cannabis science and therapeutics.

Aaron: So, what does innovation mean to you?

Mike: Innovation for the cannabis industry is pretty unique and interesting. We are just beginning to unpack the pharmacopeia of the cannabis plant as well as starting to understand our own bodies endocannabinoid system.

Innovation spans from genetics of plants and how they are grown to how you deliver cannabinoids to the body and what different ratios and blends of cannabinoids and terpenes you are actually putting in there. So, innovation is not a one size fits all category for cannabis.

Aaron: Sounds like an interesting role! At Wana Brands, and in your role in innovation, how do you think about differentiating in the market with your products?

Mike: I would describe the way we perceive differentiation as going beyond simple developments, such as product forms or new flavors. We see the future of product development trending towards what active ingredients and in what ratios we are putting into products. For example, what kinds of cannabinoids and terpenes are we using? What kinds of drug delivery systems might we be harnessing? How do we put all of these ingredients and technologies into a product to make it more effective?

A simple way to think about all of this is: how is our product going to work better for the consumer? Because that is really the key here. Tasting great is important, but we are delivering a product that provides an experience. We want to continue to make a better experience and a better way for customers to enhance their life.

Aaron: I think that leads nicely into our next question, which is, when you’re thinking about creating a new product for the consumer, what’s your process for creating a new product?

Mike: We have a very full pipeline of new products, and many of these ideas come from networking and speaking with innovators and following the research and science for inspiration and direction. We take this information and start brainstorming as a team. We have a decade of experience in the cannabis space that provides us with a unique lens on how we apply new research to our product development.

From there, we build a product development pipeline of potential ideas and start to prioritize, looking at the feasibility of each of these ideas and their market readiness. Sometimes we have a great idea for a product, but a lack of consumer knowledge may mean we don’t move forward with launching.

Aaron: Can you expand a bit on what you mean by education and how you guys think about education to the end consumer?

Mike: Since product innovation must move with consumer knowledge and cannabis is so new, education is critical. We have a very robust education platform with topics that range from cannabis 101 to the endocannabinoid system, to lessons on terpenes and CBD, as well as trainings on our products themselves. We have both bud tender-facing and consumer-facing trainings. The consumer trainings are on our website, and bud tender trainings are hosted through dispensaries.

Aaron: Is that training electronic training or written material?

Mike: Both, but the primary platform is online in the form of interactive training courses. We also have printed flip book training material in dispensaries and offer in-person presentations, but with the pandemic, we’ve been heavily leaning on the online training content.

Aaron: Alright. So, we’re going to take a different direction here on questions. From your perspective, at the innovation level, can you walk me through your experience with your most recent product launch?

Mike: Most recently, we launched the line of Wana Quick Fast-Acting Gummies. I am extremely excited and proud of this line. They have absolutely exploded in popularity!

The idea for these products started a few years ago as we were learning cannabinoids are not very bioavailable. This means most of the cannabinoids that you consume from an edible do not end up in the bloodstream. Edibles also have a delayed onset and undergo a conversion of THC in the liver, called first pass metabolism, that gives a heavier sedating high. This slow onset and difference in effects with edibles can be a turn off for some consumers, leading us to the idea of developing a fast acting gummie that works differently.

It was about two years of research looking at technologies developed by pharma and nutraceutical companies to improve bioavailability and bypass first pass metabolism. We started looking into nano-emulsions and encapsulation of cannabinoids that help with bioavailability and reduce the onset time. These technologies envelop the cannabinoids like a disguise that tricks the body into absorbing the oily compounds more easily. The encapsulation bypasses the liver and is absorbed into the bloodstream quickly, so their effect starts within five to fifteen minutes. Since they are not processed in the liver, they deliver delta-9 THC instead of 11-hydroxy-THC, giving an effect I describe as a “smoker’s high.”

We trialed and tweaked many technologies before we landed on one that is truly effective and worked with our line of gummies. With this revolutionary technology inside, we then crafted delicious flavors and a new triangular shape to differentiate them from our classic gummies. Because they take effect so quickly and only last about three hours, we thought the Quick Fast-Acting Gummies were the perfect product to use during happy hour. So, we have Happy Hour inspired flavors like Pina Colada, Strawberry Margarita and Peach Bellini.

We launched in March, and already right now, these SKUs in Colorado are #4, #7 and #11 out of all edibles sold in Colorado. And overall, Wana produces eight out of the ten top SKUs in Colorado. That’s according to BDSA, so a pretty impressive achievement!

Aaron: Okay, great, I’d say so! The next question here goes deeper in the supply chain. How do you go about sourcing for the ingredients?

Mike: I am going to start with the cannabis side of things. As I mentioned earlier, cannabis is unique. It is not just one ingredient. It’s many different compounds like the cannabinoids THC, CBD and others, but also terpenes and other beneficial compounds. To make the most effective edibles we partner with growers that care about their genetics, how they are growing, and how they are extracting to create high quality cannabis extracts.

We also understand terpenes are so important in the entourage effect, and that different terpene blends synergize with cannabinoids to produce different effects. Some can be energizing while others are more relaxing. Wana has innovated the terpenes we use by formulating proprietary blends of thirty terpenes or more that replicate indica, sativa and hybrid strains.

We did this by strain hunting the best cannabis in each class and analyzing the strains to understand their profiles. Then using organic, botanically derived terpenes, we build blends in the ratios they are found in the plant and reintroduce them into our edibles. This means Wana edibles match the terpenes that you will find in cannabis, unlike other products that just use distillates where the terpenes are degraded and lost in extraction. This also means we can replicate these blends with our partners in other states, so when you consume a Wana indica or sativa product you’re going to have the same terpene blends and the same experience and feeling every time.

Beyond cannabis and terpenes, we are extremely selective in all of our ingredients. And in the near future we’re implementing an optimized recipe that is all-natural, with no high-fructose corn syrup, as well as moving towards organic ingredient sourcing.

Aaron: Can you give me an example in your role of a challenge that you run into frequently?

Mike: I think that is the exciting thing about working in R&D and new products: there is always a new challenge. I guess I would say if you are not making mistakes, you are not really trying to push the envelope in product development.

We are working with plant matter, terpenes and encapsulation technologies, things that don’t always taste good, and putting them all into edibles. That means we frequently run into the challenge of figuring out how to put the right ingredients for effect in a product, but still make it taste delicious. We are very selective in what ingredients we use and how we’re introducing them to make sure the product still tastes good. We oftentimes come across a great technology—such as a terpene blend or a quick onset delivery system—that does the job, but is not optimal for a gummie recipe, such as the resulting consistency or taste.“These developments are all heading in the direction of delivering consistent repeatable experiences for consumers, which is what I see as the future of cannabis.”

Aaron: Would it be correct to say that formulation is a common thing you run up against in terms of challenges?

Mike: Yes, especially because a lot of the ingredients and technologies we are working with are new. There isn’t a guidebook for how to incorporate encapsulated cannabinoids into a gummy, for example.

That’s the novel aspect of a lot of this: how do you take a terpene blend that’s designed to mimic the cannabis plant and put it in your gummies? What’s the right way to introduce it so they’re not degraded by heat? Formulating with cannabis is about problem solving, and is the backbone to what we do in R&D

Aaron: We’re getting towards the end of the conversation here. And these questions are more geared towards you individually. So, what trends are you following in the industry right now?

Mike: I’ve got to have my eyes on a lot of things. That’s how you innovate in this industry!

I would say No. 1 is still terpenes. We are already innovating there, but I think we’re just scratching the surface of where we’re going to go. I think terpenes are going to unlock a lot of potential in cannabis products in the future, and Wana is going to be innovating there, leading the pack.

Next is minor cannabinoids. Through decades of an illicit black-market, the genetics have skewed towards high THC strains, but the cannabis genome actually allows for many other cannabinoids to be formed. Through the right cultivation and breeding programs, we are going to see a lot more CBG, CBN, CBC, and even more rare cannabinoids like THCV and others.  These currently rare cannabinoids are going to be important for new product development as we learn more about their therapeutic effects.

Then there is continued innovation on delivery systems and bioavailability, functional ingredient blends and more natural products. These developments are all heading in the direction of delivering consistent repeatable experiences for consumers, which is what I see as the future of cannabis.

Aaron: Awesome. What are you interested in learning more about? This could be cannabis related or business related.

Mike: Well, fortunately, I am working on a master’s degree right now and so I get to learn a lot every day. I am most curious to see where science takes us with the endocannabinoid system. It was pretty much unheard of until a few decades ago, and now we understand that it interacts with almost every other system in the body. It is like missing the elephant in the room when you are talking about human biology. The amount of information that we’re going to unlock about how the ECS interacts and regulates our body is going to continue to revolutionize the industry There’s a lot more to be understood around how different compounds interact with the ECS and affect us, and I think we are going to learn how we can use it to tailor other products for  outcomes such as sleep, pain, anxiety, energy and focus.

Aaron: Just a clarification there. What are you working on for your master’s?

Mike: I’m getting a Master’s in Medical Cannabis Science and Therapeutics from the School of Pharmacy at the University of Maryland. It is the very first master’s level program of its kind, and is taught by doctors and pharmacists, so we discuss cannabis as a drug and how it effects the brain and the body. It has been really exciting and I’m looking forward to continuing learning more about this amazing plant!

Aaron: Okay, that concludes our interview!

Leaders in Extraction & Manufacturing: Part 5

By Aaron Green
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Cannabis extraction and manufacturing is big business in California with companies expanding brands into additional states as they grow. This is the fifth and final article in a series where we interview leaders in the California extraction and manufacturing industry from some of the biggest and most well-known brands.

In this week’s article, we talk with Kristen Suchanec, VP of Production at Island. Kristen converted her experience in traditional consumer packaged goods to cannabis to help create a brand that is sought after by many. The interview with Kristen was conducted on August 21, 2020.

Aaron Green: Good afternoon Kristen, I am glad we were able to put this interview together. I know you have been very busy!

Kristen Suchanec: I’m so sorry this took so long to actually work! Thank you for bearing with me. I’m happy we are able to talk.

Aaron: Great! I like to start off the conversation with a question that helps our readers get to know you a little better. So, Kristen can you tell me how you got involved at Island?

Kristen Suchanec, VP of Production at Island

Kristen: My background is in manufacturing and planning for consumer packaged goods. I had a friend of a friend and we were just at a happy hour and I asked what he was up to. He was actually our VP of Finance at Island and he handed me a box of pre-rolled joints. They were our Island Minis and I thought it was a great customer experience. I loved the brand and packaging which made it a consumer product versus, you know, this was a few years back where cannabis wasn’t necessarily commoditized or branded. I got really excited about that because I feel like cannabis should be traditional CPG and it should appeal to different people and it should have different brands that appeal to those different groups. So I literally just started a conversation. His brother is our founder and CEO and they needed someone to run production so that was my background and it all kind of lined up and I ended up being employee number five at Island!

Aaron: Wow, employee number five – awesome! OK, great. That is some nice background about how you got involved at the company. The next questions get into product development and manufacturing. The first question is: what’s your decision process for starting a new product?

Kristen: Yea, we are right now owning the lane between cultivation and distribution. So, getting those raw materials for whether it be concentrates or flower and then converting them into that final packaging for everything. So that is what we focus on and spend all of our time with automation and trying to make that process as efficient as possible.

When we’re looking at a new product we’re not necessarily creating a new extraction, we are really looking at the market and the end consumer and what people want. At Island we’ve really focused on vape, pre-roll and packaged flower. Those are the three categories we are working on right now. We are expanding and looking to move more towards vape and live resins and specialty concentrated products that we haven’t really had in our portfolio before. What we would like to do is make sure we have the capability to manufacture that and then take a look at where we think the market is going. We are trying to go in the flower, pre-roll and vape because that is where we spent so much of our time getting pieces of automation so not everything we are bringing in house is manual.

Aaron: Now when you say the capability to manufacture that are you talking about from a packaging perspective or…?

Kristen: Yes, so we won’t do any extraction on site. It’s getting distillate, shatter and flower and then we take that and convert that either into pre-rolled joint, a package of flower or any other final product. So, we are looking at automating that packaging piece.

Aaron: Got it. OK, so the next question — and I think you kind of touched on this as well — are you involved in manufacturing to the extent that you are manufacturing the packaging?

Kristen: Yes absolutely. My whole team’s manufacturing is based out of Oakland. That’s where we do all the conversion of products. I oversee that entire team and have been really involved in a lot of the equipment that we have sourced and iterations that we’ve gone through to make sure that we’re able to automate as much as possible. We’ve really focused on the issue of weighing the material. For our flower line everything is weighed and put into a jar, capped, sealed and labeled for it to come off our lines. We don’t have anyone in packing or anything like that. Our pre-rolls manufacturing is an automated machine where it actually weighs the flower before going into the cone so we’re not having to weigh after the fact and take into account the weight of the cone because that’s so variable so we know that the customer is getting consistency. Then for the vapes, it’ssame thing – the volumetric doses everything.

I have to give my credit to everyone on the floor who is doing the day to day, they find so many new solutions since they are the ones that are hands on.  I am really involved in what new equipment we need, what problems we are looking to solve and what’s causing our bottlenecks so we can continue to improve our process week over week and year over year.

Aaron: We’ll dig into some of those problems in a bit. What is your process for not just starting new product but for developing a new product?

Kristen: Yeah, absolutely. So, I think it’s really interesting to see where the market is going. What’s selling really well and especially over the past year pre rolls have been a huge growth platform for us. And especially now, we’ve seen some changes because of COVID as well. We have single joints. But then we have our Minis, which I’ve mentioned before, which are half gram joints. We’re seeing sales on those actually increased because I think people are sharing joints as people want individual things because of this pandemic.

When we go through this process, we’re really – again – we’re so focused on what the consumer wants, and what we think is going to add to our portfolio. Then when marketing and our product team comes to me, we really focus on our machinery, what we can do with it currently, and if we would need something additional. So,we’re excited about expanding into 510s right now. We’re looking at how we can automate the process of capping – we can fill right now, but not cap. And then we also take a look at packaging.

I think it’s a little different than creating like a whole new product, extraction or anything like that, but we were looking at more sustainable options for packaging for child resistance because we’re trying to move away from barrier bags as much as possible. We’re looking at, okay, how many stickers do we need to put on there? What is the labor time going into each piece of product? And again, how are we eventually going to get some consistency across product lines, etc.

So, it’s really taking all three of those components, making sure we’re getting out the customer that feels like they want. I’m having it either fit into our process or again, then go through and look at what automations meanand automation equipment investment you want to make for long term future investments.

Aaron: Are you developing new products internally, or are you relying on outside manufacturers for that?

Kristen: Not everything we do is internal. We have a big network of, you know, cultivators and extractors we work with, but we’re in the midst of getting our own cultivation and manufacturing in house by working with other companies. So with that we’re doing everything.

Aaron: Do you ever bring in external product development consultants for helping out with your processes?

Kristen: No, we don’t bring in consultants. But we have brought in another brand into our fold via a brand called Neutron Genetics. That is part of our overall portfolio. We work very closely with the founder because he has a lot of trade secrets, a lot of his own processes to make sure you’re getting the best product for that specific brand.

Aaron: In your product development, what does getting stuck look like to you?

Kristen: That’s a good question. I think one of the biggest challenges is working with the plant itself, because it’s not consistent and it’s not homogenous. You could get the same strain from the same cultivator, but it’ll be a different batch. It might be a little stickier or a little larger, etc. When you’re looking at traditional manufacturing and automation, you want consistency, homogenized liquids, same viscosity every time, and we don’t have that because the plant itself is natural and is going to have all these different expressions depending on the batch and how it was grown and how it was trimmed even.“I think it’s really the proper equipment, the proper training and then, again, continuing to evolve as a team.”

So, getting stuck means finding an off-the-shelf solution that might work for, you know, nuts and bolts or some kind of food production and then you’re going to have to convert it to actually work with the cannabis plant. So that’s what makes it so challenging, but also really exciting. In the bud, humidity and air can really throw off a manufacturing process which is really different than just doing beverages for example.

Getting stuck means really having to work with the plant concentrates specifically if you think about just the nature of those whether it be shatter, distillate or very sticky product. So again, working with machinery isn’t always what goes hand in hand. So, getting stuck is dealing with all those different formats and inconsistency using the same product day after day.

Aaron: It sounds like consistency is kind of a main topic here?

Kristen: Yeah, I think it depends on what product format we have. For example, about a year ago, we launched infused pre-rolls for Neutron where we’re putting flower, kief and shatter into a joint. So that’s going to perform differently on a piece of machinery than just straight flower.

I think it all depends on the product. Usually it happens when it’s in that machine, you’re trying to get a good flow and a good consistency. You want to have time studies, you know how long it takes to make each batch. But if a certain flower mix is performing differently, it’s getting the settings of the machine dialed, right? It’s also properly training personnel so people know how to react when things get going. Sometimes things get physically stuck in the machine as well, so to be able to react on that.

I think it’s really the proper equipment, the proper training and then, again, continuing to evolve as a team. So for our pre-roll machine, we are now on our third version of it, just because we kept running into the same roadblocks and I’m hoping that continues to evolve and we just continue to get better equipment year after year.

Aaron: I see, do you ever hire outside consultants when you do get stuck?

Kristen: We’ve worked closely with vendors. I will say that we’re not a machine shop or engineering firm. So we’re not the ones creating a lot of what we use on the floor. We’ve partnered with various vendors, which has been helpful, but we haven’t used external consultants.“When you see the huge potential and then see how much is taken out from illegal activity right now, it is frustrating to see.”

Aaron: Okay, now imagine that you have a magic wand and somebody can come in and help you. What does your magic helper look like?

Kristen: I could probably make a really long list if I’m focusing on just my manufacturing and everything! I think the next thing which we’re already thinking about that magic wand is how to get a perfectly rolled joint without having so much manual human touch to it. And like I said, we’ve really attached to that weighing problem. And we’ve seen solutions out there that you know, claim to twist and have that “perfect roll” and you don’t need to even touch it. But I think the biggest challenge there is it depends how well it’s packed. You know, you don’t want it too tight. You don’t want it too loose for that customer experience. So getting that quality, if I could wave a magic wand where I’m putting in, you know, paper on one side and out comes perfectly rolled joints, that would be my magic wand for sure. Okay, I think there’s a lot of solutions out there but to get that quality and that consumer experience that we want, I haven’t seen working practice yet.

Aaron: Okay, What’s the what’s the most frustrating thing you’re going through with the business right now?

Kristen: Again, that could be a long list! I think from a more macro-level, it’s definitely the competition with the illicit market and just how there’s not enough outlets for legal cannabis right now in the state of California. When you see the huge potential and then see how much is taken out from illegal activity right now, it is frustrating to see. We’re going to get this growth and projection of the right number of dispensary licenses and things like that are definitely a huge frustration as well as with the tax structure right now because it’s obviously contributing to people going to the illicit market.

Aaron: So what are you following in the market? And what do you want to learn more about?

Kristen: Yeah, I think that’s a great question. I think the thing I’m most excited about for the larger population isjust more research to come out about the actual attributes of the plant, or how different cannabinoids react together and can have different effects. How terpenes can affect the high, how things can be used and distantly, recreationally, etc. And really, hopefully evolve and move away from strictly some sativa, hybrid,indica classifications, and really be able to educate the consumer more about the plant so people can have a more a personal relationship to understand how cannabinoids or specific terpenes are going to give them a different effect. And again, I think that’s so interesting because it could be used for therapeutic reasons that people do consume cannabis or it could just make it a better experience for people who want to take this as an escape or a way to relax and everything. So I’m really excited because more research is going to be able to get done and we can really learn more about how all of these things interact in the body and then people can take it to a whole new experience and be more educated all around.

Aaron: Alright that’s the end of the interview Kristen! Nice chatting and meeting you!

Kristen: Alright, thanks Aaron!

Heavy Metals Testing: Methods, Strategies & Sampling

By Charles Deibel
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Editor’s Note: The following is based on research and studies performed in their Santa Cruz Lab, with contributions from Mikhail Gadomski, Lab Manager, Ryan Maus Technical Services Analyst, Laurie Post, Director of Food Safety & Compliance, and Charles Deibel, President Deibel Cannabis Labs.


Heavy metals are common environmental contaminants resulting from human industrial activities such as mining operations, industrial waste, automotive emissions, coal fired power plants and farm/house hold water run-off. They affect the water and soil, and become concentrated in plants, animals, pesticides and the sediments used to make fertilizers. They can also be present in low quality glass or plastic packaging materials that can leach into the final cannabis product upon contact. The inputs used by cultivators that can be contaminated with heavy metals include fertilizers, growing media, air, water and even the clone/plant itself.

The four heavy metals tested in the cannabis industry are lead, arsenic, mercury and cadmium. The California Bureau of Cannabis Control (BCC) mandates heavy metals testing for all three categories of cannabis products (inhalable cannabis, inhalable cannabis products and other cannabis and cannabis products) starting December 31, 2018. On an ongoing basis, we recommend cultivators test for the regulated heavy metals in R&D samples any time there are changes in a growing process including changes to growing media, cannabis strains, a water system or source, packaging materials and fertilizers or pesticides. Cultivators should test the soil, nutrient medium, water and any new clones or plants for heavy metals. Pre-qualifying a new packaging material supplier or a water source prior to use is a proactive approach that could bypass issues with finished product.

Testing Strategies

The best approach to heavy metal detection is the use of an instrument called an Inductively Coupled Plasma Mass Spectrometry (ICP-MS). There are many other instruments that can test for heavy metals, but in order to achieve the very low detection limits imposed by most states including California, the detector must be the ICP-MS. Prior to detection using ICP-MS, cannabis and cannabis related products go through a sample preparation stage consisting of some form of digestion to completely break down the complex matrix and extract the heavy metals for analysis. This two-step process is relatively fast and can be done in a single day, however, the instruments used to perform the digestion are usually the limiting step as the digesters run in a batch of 8-16 samples over a 2-hour period.

Only trace amounts of heavy metals are allowed by California’s BCC in cannabis and cannabis products. A highly sensitive detection system finds these trace amounts and also allows troubleshooting when a product is found to be out of specification.

For example, during the course of testing, we have seen lead levels exceed the BCC’s allowable limit of 0.5 ppm in resin from plastic vape cartridges. An investigation determined that the plastic used to make the vape cartridge was the source of the excessive lead levels. Even if a concentrate passes the limits at the time of sampling, the concern is that over time, the lead leached from the plastic into the resin, increasing the concentration of heavy metals to unsafe levels.

Getting a Representative Sample

The ability to detect trace levels of heavy metals is based on the sample size and how well the sample represents the entire batch. The current California recommended amount of sample is 1 gram of product per batch.  Batch sizes can vary but cannot be larger than 50 pounds of flower. There is no upper limit to the batch sizes for other inhalable cannabis products (Category II).

It is entirely likely that two different 1 gram samples of flower can have two different results for heavy metals because of how small a sample is collected compared to an entire batch. In addition, has the entire plant evenly collected and concentrated the heavy metals into every square inch of it’s leaves? No, probably not. In fact, preliminary research in leafy greens shows that heavy metals are not evenly distributed in a plant. Results from soil testing can also be inconsistent due to clumping or granularity. Heavy metals are not equally distributed within a lot of soil and the one small sample that is taken may not represent the entire batch. That is why it is imperative to take a “random” sample by collecting several smaller samples from different areas of the entire batch, combining them, and taking a 1 g sample from this composite for analysis.


References

California Cannabis CPA. 12/18/2018.  “What to Know About California’s Cannabis Testing Requirements”. https://www.californiacannabiscpa.com/blog/what-to-know-about-californias-cannabis-testing-requirements. Accessed January 10, 2019.

Citterio, S., A. Santagostino, P. Fumagalli, N. Prato, P. Ranalli and S. Sgorbati. 2003.  Heavy metal tolerance and accumulation of Cd, Cr and Ni by Cannabis sativa L.. Plant and Soil 256: 243–252.

Handwerk, B. 2015.  “Modern Marijuana Is Often Laced With Heavy Metals and Fungus.” Smithsonian.com. https://www.smithsonianmag.com/science-nature/modern-marijuana-more-potent-often-laced-heavy-metals-and-fungus-180954696/

Linger, P.  J. Mussig, H. Fischer, J. Kobert. 2002.  Industrial hemp (Cannabis sativa L.) growing on heavy metal contaminated soil: fibre quality and phytoremediation potential. Ind. Crops Prod. 11, 73–84.

McPartland, J. and K. J McKernan. 2017.  “Contaminants of Concern in Cannabis: Microbes, Heavy Metals and Pesticides”.  In: S. Chandra et al. (Eds.) Cannabis sativa L. – Botany and Biotechnology.  Springer International Publishing AG. P. 466-467.  https://www.researchgate.net/publication/318020615_Contaminants_of_Concern_in_Cannabis_Microbes_Heavy_Metals_and_Pesticides.  Accessed January 10, 2019.

Sidhu, G.P.S.  2016.  Heavy metal toxicity in soils: sources, remediation technologies and challenges.   Adv Plants AgricRes. 5(1):445‒446.

Dr. Ed Askew
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Distillation Of Your Cannabis Extract: Ignorance Is Not Bliss

By Dr. Edward F. Askew
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Dr. Ed Askew

In a previous article I discussed the elephant in the room for clients of laboratory services- the possibility of errors, inaccurate testing and dishonesty.

Now, I will explain how the current “smoke and mirrors” of distillation claims are impacting the cannabis industry in the recreational and medical areas. We have all heard the saying, “ignorance is bliss.” But, the ignorance of how distillation really works is creating misinformation and misleading consumers.

That is, just because a cannabis extract has been distilled, doesn’t mean it is safer.There have been reports of people claiming that “Distilled cannabis productsthat are Category 2 distillate are pesticide free and phosphate free, while Category 1 has pesticides and phosphates, but within acceptable limits”

The problem is that these claims of Category 1 and Category 2 cannot be proven just by saying they are distilled. Ignorance of the physical chemistry rules of distillation will lead to increased concentrations of pesticides and other organic contaminants in the supposedly purified cannabis distillate. That is, just because a cannabis extract has been distilled, doesn’t mean it is safer.

So, let’s look at a basic physical chemistry explanation of the cannabis distillation process.

  • First off, you must have an extract to distill. This extract is produced by butane, carbon dioxide or ethanol extraction of cannabis botanical raw material. This extract is a tarry or waxy solid. It contains cannabinoids, terpenes and other botanical chemicals. It will also contain pesticides, organic chemicals and inorganic chemicals present in the raw material. The extraction process will concentrate all of these chemical compounds in the final extract.
  • Now you are ready to distill the extract. The extract is transferred to the vacuum distillation vessel. Vacuum distillation is typically used so as to prevent the decomposition of the cannabinoid products by thermal reactions or oxidation. Under a vacuum, the cannabinoids turn into a vapor at a lower temperature and oxygen is limited.
  • Part of the vacuum distillation apparatus is the distillation column. The dimensions of this column (length and width) along with the packing or design (theoretical plates) will determine the efficiency of distillation separation of each chemical compound. What this means is that the more theoretical plates in a column, the purer the chemical compound in the distillate. (e.g. Vigreux column = 2-5 theoretical plates, Oldershaw column = 10-15 plates, Sieve plate column = any number you can pay for).
  • The temperature and vacuum controls must be adjustable and accurate for all parts of the distillation apparatus. Failure to control the temperature and vacuum on any part to the apparatus will lead to:
    • Thermal destruction of the distillate
    • Oxidation of the distillate
    • Impure distillate

Now, you can see that a proper distillation apparatus is not something you throw together from a high school chemistry lab. But just having the proper equipment will not produce a pure cannabis product. The physical chemistry that takes place in any distillation is the percentage a chemical compound that occurs in the vapor phase compared to the percentage in liquid phase.So, how can you produce a cannabis distillate that is clean and pure?

For example, let’s look at whiskey distillation. In a simple pot still, alcohol is distilled over with some water to produce a mixture that is 25%-30% ethanol. Transferring this distillate to an additional series of pot stills concentrates this alcohol solution to a higher concentration of 85%-90% ethanol. So, each pot still is like a single theoretical plate in a distillation column.

But, if there are any chemical compounds that are soluble in the vapor produced, they will also be carried over with the vapor during distillation. This means that pesticides or other contaminants that are present in the cannabis extract can be carried over during distillation!

So, how can you produce a cannabis distillate that is clean and pure?

  • Produce a cannabis extract that has lower concentrations of bad chemicals. Since a lot of the cannabis extracts available for distillation are coming from grey-black market cannabis, the chances of contamination are high. So, the first thing to do is to set up an extraction cleanup procedure.
    • An example of this is to wash the raw extract to remove inorganic phosphates. Then recrystallize the washed extract to remove some of the pesticides.
  • Make sure that the distillation apparatus is set up to have proper temperature and vacuum controls. This will limit production of cannabis decomposition products in the final distillate.
  • Make sure your distillation apparatus has more than enough theoretical plates. This will make sure that your cannabis distillate has the purity needed.
  • Finally, make sure that the staff that operates the cannabis distillation processes are well trained and have the experience and knowledge to understand their work.

Inexperienced or under-trained individuals will produce inferior and contaminated product. Additional information of extract cleanup and effective vacuum distillation can be obtained by contacting the author.

Radojka Barycki picture

Food Safety: Do You Know What Is In Your Water?

By Radojka Barycki
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Radojka Barycki picture

Water is essential for life and it is an important part of agriculture and food manufacturing. Water has many uses in the cannabis industry. Among the most common uses are irrigation, ingredient/product processing and cleaning processes.

Water can be the carrier of pathogenic microorganisms and chemicals that can be transferred to food through agriculture and manufacturing practices. Poor quality water may have a negative impact in food processing and potentially on public health. Therefore, development and implementation of risk management plans that ensure the safety of water through the controls of hazardous constituents is essential to maintain the safety of agricultural and manufactured food or cannabis products.

Chemicals can enter the water stream through several sources such as storm water, direct discharge into fields and city water treatment plans.Although there no current regulations regarding the water used in cannabis cultivation and processing, it is highly recommended that the industry uses potable water as standard practice. Potable water is water that is safe for drinking and therefore for use in agriculture and food manufacturing. In the United States, the Environmental Protection Agency (EPA) sets the standards for water systems under the Safe Drinking Water Act (SDWA.)The regulations include the mandatory levels defined as Maximum Contaminant Levels (MCLs) for each contaminant that can be found in water. Federal Drinking Water Standards are organized into six groups: Microorganisms, Disinfectants, Disinfection Byproducts, Inorganic Chemicals, Organic Chemicals and Radionuclides. The agriculture and food manufacturing industry use the SDWA as a standard to determine water potability. Therefore, water testing forms part of their routine programs. Sampling points for water sources are identified, and samples are taken and sent to a reputable laboratory to determine its quality and safety.

Microbiological Testing

Petri dish containing the fungus Aspergillus flavus
Petri dish containing the fungus Aspergillus flavus.
Photo courtesy of USDA ARS & Peggy Greb.

Determining the safety of the water through microbiological testing is very important. Pathogens of concern such as E. coli, Salmonella, Cryptosporidium parvum and Cyclospora sp. can be transmitted to food through water. These pathogens have been known to be lethal to humans, especially when a consumer’s immune system is compromised (e.g. cancer patients, elderly, etc.) If your water source is well, the local state agency may come to your facility and test the water regularly for indicator organisms such as coliforms. If the levels are outside the limit, a warning will be given to your company. If your water source is the city, regular testing at the facility for indicator microorganisms is recommended. In each case, an action plan must be in place if results are unfavorable to ensure that only potable water is used in the operations.

Chemical Testing (Disinfectants, Disinfection Byproducts, Inorganic Chemicals, Organic Chemicals and Radionuclides) 

Chemicals can enter the water stream through several sources such as storm water, direct discharge into fields and city water treatment plans. Although, there are several regulations governing the discharge of chemicals into storm water, fields and even into city water treatment plants, it is important that you test your incoming water for these chemicals on a regular basis. In addition, it is important that a risk assessment of your water source is conducted since you may be at a higher risk for certain components that require testing. For example, if your manufacturing facility is near an agricultural area, pesticides may enter the surface water (lakes, streams, and rivers) or the aquifer (ground water) through absorption into the ground or pollution. In this case, you may be at higher risk for Tetrahalomethanes (THMs), which are a byproduct of pesticides. Therefore, you should increase the testing for these components in comparison to other less likely to occur chemicals in this situation. Also, if your agriculture operation is near a nuclear plant, then radionuclides may become a higher risk than any of the other components.

GMPFinally, in addition to the implementation of risk management plans to ensure the safety of water, it is highly recommended that companies working in food manufacturing facilities become familiar with their water source to ensure adequate supply to carry on their operations, which is one of the requirements under the 21 CFR 117. Subpart B – Current Good Manufacturing Practices (cGMPs) for food manufacturers under the Preventive Controls for Human Foods Rule that was enacted under the Food Safety Modernization Act in 2015. Also, adequate supply is part of the Good Agricultural Practices (GAP) The EPA has created a program that allows you to conduct a risk assessment on your water source. This program is called Source Water Protection. It has six steps that are followed to develop a plan that not only protect sourcing but also ensures safety by identifying threats for the water supply. These six steps are:

  1. Delineate the Source Water Protection Area (SWPA): In this step a map of the land area that could contribute pollutants to the water is created. States are required to create these maps, so you should check with local and/or state offices for these.
  2. Inventory known and potential sources of contamination: Operations within the area may contribute contaminants into the water source. States usually delineates these operations in their maps as part of their efforts to ensure public safety. Some examples of operations that may contribute to contaminants into the water are: landfill, mining operations, nuclear plants, residential septic systems, golf courses, etc. When looking at these maps, be sure that you verify the identified sources by conducting your own survey. Some agencies may not have the resources to update the maps on a regular basis.
  3. Determine the susceptibility of the Public Water Source (PWS) to contaminate sources or activities within the SWPA: This is basically a risk assessment. In here you will characterize the risk based on the severity of the threat and the likelihood of the source water contamination. There are risk matrices that are used as tools for this purpose.
  4. Notify the public about threats identified in the contaminant source inventory and what they mean to the PWS: Create a communication plan to make the State and local agencies aware of any findings or accidents in your operation that may lead to contamination of the PWS.
  5. Implement management measures to prevent, reduce or eliminate risks to your water supply: Once risks are characterized, a plan must be developed and implemented to keep risks under control and ensure the safety of your water.
  6. Develop contingency planning strategies that address water supply contamination or service interruption emergencies: OSHA requires you to have an Emergency Preparedness Plan (EPP). This plans outlines what to do in case of an emergency to ensure the safety of the people working in the operation and the continuity of the business. This same approach should be taken when it comes to water supply. The main questions to ask are: a) What would we do if we find out the water has been contaminated? b) What plan is in place to keep the business running while ensure the safety of the products? c) How can we get the operation back up and running on site once the water source is re-stablished?

The main goal of all these programs is having safe water for the operations while keeping continuity of the business in case of water contamination.

Schebella, Celia photo

Designing the Perfect Cannabis Edible in California

By Celia Schebella
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Schebella, Celia photo

Are you a product designer in the edible cannabis market? Well, you live at the intersection of the food and pharmaceutical industries and need to know both worlds, utilizing best-practice product development principles, regardless of which industry you are working in. In the cannabis industry, this means knowing your chemistry principles, food science, food safety, Good Manufacturing Practices (GMPs, applicable to the food industry) along with the more intense records and documentation requirements of the pharmaceutical industry.

California is the most recent state to implement legal recreational cannabis. It is estimated to deliver $7.7B in sales by 2021, including a reduction of medical use cannabis and an uptake of adult recreational use. How often do you live at the inception of such a potentially enormous market? Not often, so product developers, here is an opportunity. However, with that opportunity comes the responsibility. A recent emergency legislation adopted by the California Cannabis Safety Branch states:

Operational Requirements Licensees must have written procedures for inventory control, quality control, transportation, security and cannabis waste disposal. Descriptions of these procedures or Standard Operating Procedures (SOPs) must be submitted with the annual license application. Cannabis waste cannot be sold, must be placed in a secured area and be disposed of according to applicable waste management laws. Good manufacturing practices must be followed to ensure production occurs in a sanitary and hazard-free environment, cannabis products are contaminant free and THC levels are consistent throughout the product and within required limits. Extractions using CO2 or a volatile solvent must be conducted using a closed-loop system, certified by a California-licensed engineer. Volatile, hydrocarbon-based solvents must have at least 99% purity. Finally, volatile solvent, CO2 and ethanol extractions must be certified by the local fire code official.

Part of this emergency legislation for all California cannabis product manufacturers is the newly published GMP requirements, which appear to be a combination of food, supplements and HACCP requirements. Helpful resources to learn more about this new California emergency legislation impacting cannabis product manufacturers can be found at the California Manufactured Cannabis Safety Branch with the details of the emergency cannabis regulations.

Once developers have decided on a product, research and education to develop a good understanding of the regulatory environment is a must. For example, in order to develop compliant cannabis edibles, compliance with state, and in some cases local regulations, for food and cannabis must be met. Proactive compliance is a big part of designing a successful product in the most efficient manner.The attention to detail here will create a safe and satisfying experience for consumers as they receive a consistent product every time.

As a product developer you must first know the incoming cannabis plant characteristics to determine what type of cannabinoids they contain to determine what types you wish to source. This requires a strong and well documented  supplier program that can identify reliable suppliers of high purity and consistent cannabis raw materials, the same principles that are typically required of food manufacturers. When looking for examples of credible ingredient supplier programs, looking at those used by the food industry is a good start. Make sure supplier management programs apply to all the raw materials and direct-contact packaging that you plan to use in your new product.

Once reliable sources of raw material have been secured, the next challenge is to conduct periodic tests of cannaboids levels found in your incoming cannabis. With this information, you need to adjust blending amounts to reflect the correct cannaboid dose in the finished ready-to-eat (RTE) product. Like any other medicinal product, the active ingredient dosage will directly impact the effect on the consumer, thus it is important that you, the manufacturer, are completely aware of the exact cannaboid levels in your incoming ingredients, your blending amounts and your final product levels. This will require a robust either in-plant or commercial laboratory testing program. There is a great deal of technology and chemical analyses available to help dose the product accurately. This must also include robust testing and verification steps. If a consumer of your product were to over-consume from “normal” consumption rates of your cannabis-based food product, the liability, both financial, civil, ethical and criminal would fall on your company. The attention to detail here will create a safe and satisfying experience for consumers as they receive a consistent product every time.

design your products with commercial manufacturing viability in mindOnce regulatory responsibilities for manufacturing and marketing a cannabis-based food product have been met, so that you may sell a compliant and consistent product, it is time to add some creative juices and make the product interesting and enjoyable to consumers. With cannabis edibles, for example, explore what sort of food is appealing to consumers. Consider when, where and with whom your potential customers would be eating that food. Evaluate the best packaging design and size to suit the occasion. Ensure the packaging is child resistant yet practical for adult consumers. And above all manufacture a food that is delicious. Curiosity will attract your customers for the first time but quality and consistency will keep them coming back.

Product developers are usually fantastic at developing great lab scale products, but part of a developer’s job is to ensure that the design and manufacturing process is scalable for consistent and compliant commercial manufacturing. So design your products with commercial manufacturing viability in mind. Try to minimize the number of ingredients whilst still making a consumer-desirable product. Finally, rationalize your ingredients across your portfolio to avoid overcrowding the warehouse and risking expired ingredients.

If successful, your consumers will desire your product, your compliance team will be satisfied, your manufacturing partners will be thankful, the State of California will determine that you are fully compliant and your sales team’s job will have great business and professional success. In the end, you will have developed and launched a successful legacy product!