Tag Archives: lab

Mitigating Counterfeiting in the Cannabis Industry

By Norbert Korny
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According to projections, counterfeiting and piracy could reach $2.3 trillion in the US alone, bringing the economic cost to $4.2 trillion globally by 2022. The pandemic made the billion-dollar problem even worse. Products that you directly ingest or place in contact with your body have become a target for counterfeiters introducing some serious side effects.

More than 70% of the CBD products purchased at unlicensed CBD shops in the Los Angeles area failed after-market laboratory testing according to the SC Labs report brought by the United Cannabis Business Association (UCBA). More than half of the tested samples labeled as hemp or hemp-based did not qualify as hemp. Perhaps the biggest concern is the level of contamination which in some cases, were several hundred times the allowed limit.

With the rise of synthetic cannabinoid agonists, some of them having a structure similar to THC, it is hard to keep track of the complete list. The majority of these chemicals are produced in Asia without standards or regulations. The most extreme case has been a version of synthetic cannabis laced with rat poison that led to several deaths.

Last year in Florida, synthetic THC was to blame for daily emergency calls to Poison Control. Poisoning cases linked to counterfeit cannabis edibles tripled between 2019 and 2020.

Vaping is growing rapidly in popularity. An illicit market has emerged and with it a rise in Vaping-Associated Pulmonary Illness (VAPI). Over a hundred cases have been reported in California contributing to over a thousand reported cases nationwide. 

Consumers pay a harsh and unnecessary price with their health, risking long-term damage or even death. If you don’t know the source, it is very difficult to identify counterfeit cannabis products. Still, some telling points can help you identify the fakes:

  • Authentic-looking products available at dubious prices perhaps bought at a gas station or a convenience store.
  • Packaging that matches a reputable brand, without the brand’s logo and missing required details such as an amount of CBD and THC per serving.
  • Missing laboratory testing information
Authentic-looking counterfeits can have labeling that mimics a brand’s look, but could be missing key information.

Legitimate product manufacturers and brand owners suffer financial losses, as well as something even more precious – trust and reputation.

Essential elements of a brand protection program

Are you running a business in the cannabis industry? It is your top-quality product the customers want and not some third-rate knockoff. How can you provide your customers with the means to verify that their product is genuine? Let’s weigh several methods.

1. Provide images and videos of an authentic item on your website

Pros:

  • Customers can visually compare the details of the product.

Cons:

  • Customers need to know your website and navigate to a specific page with product details. You need to capture several details of the product.

2. Label each item with a unique product code. Optionally use a hologram image as an additional anti-forgery

measure

Pros:

  • Customers can verify a single product code instead of several visual details.

Cons:

  • You must be able to generate unique product codes and maintain a database of these codes for later verification.
  • You need to implement a solution for customers to authenticate their product codes.

3. Use a product number authority like ProdNum to issue and validate unique QR product codes for you

Validating a product using QR Code

Pros:

  • Customers don’t need to retype an alphanumeric product code, merely scan a QR code with a camera to get instant verification.
  • The manufacturer doesn’t need to implement and maintain a custom solution.

Cons”

  • You need to arrange printing of the QR codes on the package or stickers you will attach to each product.

The inevitable drawback of a profitable cannabis business is the fact it attracts counterfeiters. Businesses and customers joining forces in the never-ending battle against counterfeiting is a winning scenario for both.

Innovations in Dosing Technologies: Getting an Accurate Hit, Every Time

By Michael Sassano
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Cannabis products and medicines are progressing rapidly, eating away at the market share of smokable flower. Currently, the general adult use cannabis market is split in three, in order of popularity: cannabis flower, vaporizers and ingestible products like edibles or capsules. In the medical market, flower is increasingly being replaced by alternative methods of delivery – and the same trend is now starting to be seen in the adult use market.

This is to be expected to some extent. Initially, only flower was available to medical cannabis users. On top of not everyone feeling comfortable with smoking, inhaling a combustible substance into the lungs is not the healthiest consumption method for those already suffering from a serious illness.

In the present day, there are new alternatives to smoking that come without the risk and actually have additional benefits. For example, there are now much more precise ways to measure your cannabinoid intake than weighing out the flower you’re about to burn. As technology develops, there is an expectation that – despite flower sales being fairly stable last year – we will see continued incremental growth in the non-flower category, especially on the medical side.

Oral Cannabinoid Delivery

Thankfully for those who want to use non-smokable products, there are a growing number of alternative oral products that are currently available in the market or are under development.

Some of the many infused products on the market today.

Cannabis edibles might be the first products to come to mind when you think about non-smokable products – but for many medicinal users, these are actually a fairly unpopular option. While having a cannabis-infused brownie or gummy might be quite discreet compared to smoking a joint, the need for patients to take in extra sugar or extra calories every time they need to take their medicine can be off-putting. Additionally, tradionally infused edibles can take between one to three hours to feel as the body needs time to digest.

Cannabinoid capsules or pills have recently emerged as an equally discreet alternative to edibles. These pills come in many forms, including hard capsules containing ground cannabis flower, softgel capsules containing measured doses of cannabis extract, and gelatin-free alternatives. Though these pills, like edibles themselves, do come with a relatively long onset time.

Cannabinoid capsules

Pills and edibles are also both affected by first-pass metabolism. This means that the active cannabinoids will be processed through the digestive system and the liver before passing onto the brain or the other organs. During this process, some amount of CBD or THC will likely be broken down by the body before it can make its effect felt, leading to inaccuracies between the labelled dose of a product and the active dose that reaches the brain or target area in the body.

To avoid these problems with first-pass metabolism, some have turned to use sublingual cannabis oils and tinctures. By placing a measured dose of oil under the tongue using a dropper, this theoretically allows for the fast absorption of THC or CBD into the bloodstream without the product being processed by the digestive system. However, in practice, these sublingual tinctures need to be held under the tongue for around ten minutes before they are fully absorbed. This is fairly difficult to do without accidentally swallowing some amount of the tincture, and so this still introduces some amount of uncertainty with dosing.

Fast-Acting Absorption

Fast-acting absorption techniques and nano emulsions are also gaining in popularity. Nanotechnologies and techniques have been developed by many firms, and boast claims of increasing absorption through the digestive system in order to effectively double the volume of cannabinoids absorbed into the body. Nano emulsions are also promising, which come with claims of up to four to five times more improved absorption. Such technologies rely on cannabis oils being immiscible with water-based substances, and process these cannabis oils in such a way that they become nanoscale droplets suspended in a larger mixture. Because of their size, these small pockets of cannabis oil are able to be absorbed rapidly through the gastrointestinal tract and into the bloodstream.

A drink additive, made by Splash Nano, that uses nano emulsion technology

Older liposomal and newer nano-liposomal combinations have also boasted similar claims. Liposomes are commonly used as a novel drug delivery system for pharmaceutical products to facilitate the absorption of drugs into the body, and the adaption of such techniques for the cannabis sector is also intended to dramatically improve the absorption of cannabinoids into the bloodstream. Given the marketing of these products, it can become confusing to know which is the best. The only way to know for sure is to have either a breath or blood analysis to see which style works and is best for the individual consumer.

As manufacturers progress from flower and basic products, the largest brands and more advanced medical companies are all producing ingestible products with fast absorption methods and additives. The difference is pronounced and significant enough that consumers and patients are starting to demand fast absorption products. As the market becomes more educated, you can expect that the market for fast absorption ingestible products will greatly outpace the older, more basic formulations. Of course, some emulsion additives will increase the operating costs for businesses, but over time, this difference will likely be fairly minimal.

Microencapsulation to boost cannabinoid absorption

Microencapsulation is another new method for producing drugs with high bioavailabilities, and the technique has recently made headlines in the cannabis industry.

Using a technique known as ionic gelation, or ionotropic gelation, scientists are able to trap drugs inside nano- or microscale capsules. These tiny capsules are robust enough to be able to protect the active drug ingredient–which in this case would be CBD or another cannabinoid–against the harsh environment of the gastrointestinal tract without necessarily limiting bioavailability.

The structure of cannabidiol (CBD), one of 400 active compounds found in cannabis.

Unlike the other oral dosing methods, cannabinoid microcapsules are not yet a commercially available product. However, there is early research indicating that this drug delivery technology could be a significant step forward in terms of improving cannabinoid bioavailability and absorption.

Published in the journal PLOS One, a new study from a team of Australian scientists reports that CBD microcapsules used in combination with a permeation-modifying bile acid can boost the peak concentration of CBD reaching the brain by 300 percent. These peak concentrations of CBD in the body also happened much earlier with the CBD microcapsules than with regular CBD oil, reflecting a faster absorption by the body.

This improved absorption and bioavailability addresses many of the limitations seen with traditional oral cannabinoid delivery. However, there is still potentially a very long road before these microcapsules are approved for general use in humans, making them an unrealistic option at present.

Metered Dose Inhalers

So far as innovative cannabis dosing technology that is currently available on the market goes, metered dose inhalers lead the way. Making up one-third of the market share, these devices are easy to use, discreet and are far less invasive than burning cannabis flower.

A metered dose inhaler by MÜV

Heating and vaporizing a purified cannabinoid also exposes the user to fewer potentially harmful combustion products than smoking flower. Using vapes, manufacturers are also able to adjust the formulation of vape oils in order to deliver a truly consistent product. This can help the consumer to truly measure their intake of beneficial cannabinoids.

Vaporizers for general adult use are very common now and come in many forms and flavors. Until recently though, there were very few vaporizers that met the specific needs of the medical market, like being able to deliver very controlled doses of cannabinoids. Now, innovation in the sector has led to a number of companies developing special metered dose inhalers for this purpose. These devices use smart technology to only heat and vaporize a pre-set controlled dose of cannabis oil from their compatible cartridges, allowing for intake to be tracked more precisely. This is different from regular vapes, where the amount inhaled can vary depending on how deeply a person inhales, or other environmental factors.

Recently, Syqe Medical received approval from Health Canada for their metered dose cannabis vaporizer. There is already a similar registration for approval in the US and Europe that looks promising for similar devices.

Recreational acceptance of products, like these high-tech vaporizers, drives up spending on innovations that would otherwise just be novel ideas. The cannabis industry has a wealth of creative talent, and with the market beginning to tear away from flower and towards novel and innovative products, like vaporizers and fast acting ingestible products, now is the time for the medical market to invest in this talent and follow the demand and the money.

New York Expands Medical Access, Prepares for Adult Use

By Cannabis Industry Journal Staff
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Now entering its sixth year of medical cannabis legalization, the Empire State is well on its way to expanding the market considerably. When New York first legalized medical cannabis, it had some of the strictest rules in the country. Dispensaries needed to have pharmacists and doctors with special training on staff, they couldn’t sell flower and there was a very small list of qualifying conditions for getting a cannabis prescription.

While New York legalized adult use cannabis back in March of 2021, the actual market is still probably about a year away from launching. The bill immediately decriminalized possession up to certain amounts and set up the Office of Cannabis Management (OCM), New York’s regulatory body now overseeing the medical, adult use and hemp markets.

Over the past six years since the state legalized medical cannabis, the rules have eased incrementally, with more licenses awarded, more doctors participating, more qualifying conditions approved and a larger variety of products on dispensary shelves. Back in 2017, they added chronic pain to the list of qualifying conditions, which was seen as a big effort at the time for expanding patient access.

Just a few weeks ago on January 24, 2022, the Office of Cannabis Management, dropped all qualifying conditions. That means patients with more common ailments and really any type of condition, like anxiety or sleep disorders, can get a prescription for cannabis.

“Launching the new patient certification and registration system and expanding eligibility for the Medical Cannabis Program are significant steps forward for our program,” says Chris Alexander, executive director of the OCM. “We will continue to implement the MRTA and ensure that all New Yorkers who can benefit from medical cannabis have the access they need to do so. It’s important for New Yorkers to know that even as we shift the medical program to the OCM, your access will not be disrupted and the program will continue to expand.”

New York City
Image: Rodrigo Paredes, Flickr

In addition to dropping qualifying conditions, the state took a number of other measures to increase access and allow the market to expand further. For example, dispensaries can now sell flower, more physicians like dentists, podiatrists and midwives can participate, the OCM removed the patient registration fee and they increased the amount of cannabis patients can purchase at a time.

Beyond the medical market, New York is making strides in launching their hemp program as well as preparing for the eventual launch of the adult use market. Back in November, the state’s Cannabis Control Board approved new regulations for the hemp program, establishing standards for manufacturing, lab testing, packaging and labeling.

On the adult use front, delays are the name of the game. According to a publication called The City, delays to launch the new market have been made worse by former Governor Andrew Cuomo’s resignation following sexual harassment allegations. They say the state might not see the launch of the adult use market until early 2023 at best. Decisions on licensing, standards and rules are to be made by the Cannabis Control Board, a five-member commission tasked with overseeing the OCM. So far, the Board has not addressed a timeframe for when they will begin adult use sales.

2022 Infused Products Virtual Conference: February Program

By Cannabis Industry Journal Staff
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2022 Infused Products Virtual Conference: February Program

Sponsored by Columbia Laboratories

Click here to watch the recording

Agenda

cGMP Certification: What it is, Can you get it, and What does it take

  • Kim Stuck, Founder & CEO, Allay Consulting

Kim Stuck, a former cannabis regulator for Denver Department of Public Health and Environment now turned compliance consultant for the cannabis industry will be sharing her experiences and discussing quality assurance in cannabis when it comes to cGMP Certification. She will be explaining what cGMP is and:

  • How it fits in the cannabis industry
  • What the steps are to gaining cGMP Certification
  • Tips on how to be successful in the certification process.

TechTalk: Columbia Laboratories

  • Jessa Youngblood, Food & Beverage Market Coordinator II, Hardy Diagnostics

From Idea to Product: How to Launch an Edible 

  • Katherine Knowlton, Founder, Happy Chance
  • Kalon Baird, Founder & COO, Splash Nano

Learn everything you need to know about launching an edible product from two experts currently doing just that. Attendees learn about finding a niche, quality, the supply chain and the retail ecosystem.

Food Safety for Infused Edibles

  • Steven Gendel, Ph.D., Gendel Food Safety

This presentation takes a deep dive into current regulatory programs, why standardization is crucial, the importance of food safety in edibles, the importance of the ingredient supply chain and some shortcomings in current regulations.

Why Are Infuser Licenses Tricky?

  • Sumer Thomas, Director of Regulatory Operations, Canna Advisors
  • Brian Harris, Project Manager, Canna Advisors

Attendees of this session will learn:

  • Learn how being in the middle of the supply chain complicates everything
  • What is different about capital requirements
  • How team member requirements are make-or-break for your success

Click here to watch the recording

2022 Cannabis Labs Virtual Conference: January Program

2022 Cannabis Labs Virtual Conference: January Program

Sponsored by Hardy Diagnostics and Bio-Rad.

Click here to watch the recording

Agenda

What does Lean Mean to the World of Cannabis Testing?

  • Rob Radke, President, Method Testing Labs

In this session, Rob Radke delves into the world of Lean management, how Lean process implementation can enhance quality in a lab setting, what it means for customers and why it is unique and effective in the cannabis industry.

TechTalk: Hardy Diagnostics

  • Jessa Youngblood, Food & Beverage Market Coordinator II, Hardy Diagnostics

How Cannabis Labs Can Prepare for Accreditation?

  • Renee Delauter, Cannabis Program Manager, A2LA

Learn when to apply for your lab’s accreditation, what to expect during your ISO/IEC 17025 audit and find guidance on how to approach deficiency findings.

TechTalk: Bio-Rad

  • Helen Fong, Product Manager, Food Science Division, Bio-Rad

The Challenges and Benefits of National Standardization for Hemp Testing

  • Dillon Burns, Lab Manager, Infinite Chemical Analysis Labs

This presentation takes a deep dive into current hemp regulatory programs, why standardization is crucial and some shortcomings in current regulations.

R&D Lab Testing: Ensuring Success with Results

  • Christian Sweeney, President, Sonoma Labs

Attendees of this session will learn:

  • How R&D lab testing can help you
  • Prepare for compliance batches
  • Successfully launch new products
  • Amp up your quality control

Click here to watch the recording

A Conversation with the Founders of Veda Scientific: Part Two

By Aaron G. Biros
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This is the second piece in a two-part conversation with the founders of Veda Scientific, CEO Leo Welder and CSO Aldwin M. Anterola, PhD. To read part one, click here.

In part one, we chatted about their backgrounds, their approach to cannabis testing, their role in the greater industry and how they came into the cannabis industry.

In part two, we’re going down a few cannabis chemistry rabbit holes and realizing that what we don’t know is a lot more than what we do know. Join us as we delve into the world of volatile compounds, winemaking, the tastes and smells of cannabis, chicken adobo and much more.

Aaron: Alright so you mentioned the GCxGC/MS and your more advanced terpene analysis. How do you envision that instrument and that data helping your customers and/or the industry? 

Leo: Some of the things that we envision will help is a better understanding of what compounds and what ratios will lead to desirable outcomes, things like better effects, aroma and flavor. By better understanding these things it’ll help the industry create better products.

I have a personal connection to this. My wife has some insomnia and she’s always had to take various forms of OTC pharmaceuticals to help with sleep. She tried using a 1:1 vape pen and it was a miracle worker for her for several months. The local dispensary had a sale on it, and she bought some extra. Unfortunately, even though she used it the same way as before, she got very serious anxiety, which obviously didn’t help her sleep. Every time she used the vapes from this same batch, she felt the same extreme anxiety. Sadly, she now had a lot of this product that she couldn’t use because it kept her awake rather than helping her sleep, so she went back to trying other OTC solutions. That’s a problem for both consumers and the industry at large. If people find something that works and provides a desired effect, they need to be able to rely on that consistency every time they purchase the product, leading to similar outcomes and not exaggerating the problem. That’s why I think consistency is so important. We’re taking two steps forward and one back when we have inconsistent products. How do we really grow and expand the availability of cannabis if we lose trust from our consumer base? What a lab can do and what we can do is provide data to cultivators and manufacturers to create that consistency and ultimately allow the market to expand into other demographics that are currently wary and less tolerant of that variance.

Vials of cannabis samples being prepped for collaborative research with the CESC

On a similar note, we have been having a lot of discussions with the CESC [Clinical Endocannabinoid System Consortium] down in San Diego. They are an advanced cannabis research group that we have been working with for over a year. We’ve started looking at the idea of varietals. To be more specific, because I’m not a wine connoisseur, varietals are the pinot noirs, the cabernets and sauvignon blancs of the industry. In the cannabis industry, consumers have indica and sativa, though we still argue over what that concept really means, if anything. But for the sake of argument, let’s say we have this dichotomy to use as a foundational decision tool for consumers- call it the red and white wine of the cannabis industry. How inaccessible would wine be if we just had red or white? Imagine if you went to a dinner party, really liked the wine you were drinking, and the host could only tell you that it was a red wine. You can’t go to a wine store and expect to find something similar to that wine if the only information you have is “red.” At a minimum, you need a category. So that’s what varietals are, the categories. The data that we can produce could help people in the industry who identify and establish the varietals based on their expertise as connoisseurs and product experts to find what those differences are chemically. Similarly, we’re also looking at appellation designations in California. So, we want to help provide tools for farmers to identify unique characteristics in their flower that would give them ability to claim and prove appellation designation.

Aldwin: The GCxGC/MS allows us to find more things besides the typical terpene profile with 20 or 40 terpenes. It allows us to go beyond those terpenes. The issue sometimes is that with a typical one-dimensional GC method, sure you could probably separate and find more terpenes, but the one dimension is not enough to separate everything that coelutes. And it’s not just terpenes. Some terpenes coelute with one another and that’s why people can see this inconsistency. Especially if you use a detector like an FID, we can see the compound limonene on the chromatogram, but there’s another terpene in there that is unknown that coelutes with limonene. So, this instrument is helping us get past the coeluting issue and solve it so that we know what peaks represent what terpenes.

The other bonus with our GCxGC/MS is that the coeluting compounds that were masked behind other terpenes are now revealed. There is a second dimension in the chromatogram where we can now detect some compounds in cannabis that would be hiding behind these large peaks if it were just a one-dimensional GC. Besides terpenes, we’ve found esters, alkanes, fatty acids, ketones, alcohols and aldehydes, as well as thiols. The terpenes are so plentiful in cannabis that these other compounds present at lower levels cannot be seen with just one-dimensional GC. There are just so many compounds in cannabis that the ones in small amounts are often masked. My analogy to highlight the importance of these minor compounds is like a dish; I am from the Philippines and I like chicken adobo. My father does it differently from my mom and someone else will do it differently in a different region. The base of the sauce is vinegar and soy sauce, but some people will do it differently and maybe add some bay leaf, garlic, pepper, or a touch of another spice. It’s still chicken adobo, but it tastes differently. Just like in cannabis, where yes, you have the same amount of THC in two different plants, but it’s still giving you a different experience. Some people say it’s because of terpenes, which is true in a lot of cases, but there are a lot of other volatile compounds that would explain better why certain dishes taste different.

2-D chromatogram showing four peaks separated by the GCxGC. With a traditional 1-D chromatogram, these peaks would coelute and not separate.

Leo: There’s been some recent developments too here that show it’s very significant. It’s like the difference between bland and spicy. And it could be the thiol. We identified a thiol in cannabis at the same time as other scientists reported an article that just came out on this subject.

Aldwin: Thiols are sulfur containing compounds that produce very powerful odors, giving cannabis the skunky smell. Skunks also produce thiols. It is very potent; you only need a little bit. It turns out that yes, that paper described thiols and we also saw them in our GCxGC/MS. These are the kinds of things that the GCxGC can show you. Those very tiny amounts of compounds that can have a very powerful impact. That’s one that we know for sure is important because it’s not just us that’s finding out that GCxGC can detect this.

Not everything is about THC or the high amount of the compounds in the flower. This paper and our concurrent findings indicated that the skunkier smelling strains contained very small amounts of thiols and you can recognize their presence quite readily. It’s not a terpene, but it’s producing a distinct flavor and a powerful smell.

Aaron: Okay, so why is this useful? Why is it so important?

Leo: I would say two things in particular that we know of that are issues currently, both related to scents. We mentioned this earlier. We do know that farmers with breeding programs are trying to target particularly popular or attractive scent profiles, whether it be a gas or fruity aroma. Right now, when they get the flower tested and review the terpene profile, it isn’t enough information to help them identify what makes them chemically distinct. We hear time and again that farmers will say their terpene profile is not helpful in identifying specific scents and characteristics. They are looking for a fingerprint. They want to be able to identify a group of plants that have a similar smell and they want a fingerprint of that plant to test for. Otherwise, you have to sniff every plant and smell the ones that are most characteristic of what they’re targeting. For larger operations, walking through and smelling thousands of plants isn’t feasible.

Once we can identify that fingerprint, and we know which compounds in which ratios are creating the targeted aroma, we can run tests to help them find the best plants for breeding purposes. It’s about reproducibility and scalability.

Another value is helping people who are trying to categorize oils and strains into particular odor categories, similar to the varietals concept we’ve been talking about. Currently, we know that when manufacturers send multiple samples of oils with the same or similar scent to be tested, the results are coming back with significantly different terpene profiles. There is not enough data for them to chemically categorize products. It’s not that their categories are wrong, it’s just that the data is not available to help them find those boundaries.

Those are two issues that we know from conversations with customers that this particular piece of equipment can address.

Aldwin: Let’s start from what we find, meaning if you are using the GCxGC/MS, we are finding more terpenes that nobody else would be looking at. We have data that shows, for example, that certain standards are accounting for 60% or so of total terpene content. So a large percent is accounted for, but there is still quite a bit missing. For some strains there are terpenes that are not in common reference standards. Being able to know that and identify the reason why we have different terpenes in here unaccounted for is big. There are other things there beyond the standard terpenes.

Dr. Anterola working with the GCxGC/MS

What excites me sometimes is that I see some terpenes that are known to have some properties, either medical or antibacterial, etc. If you find that terpene looking beyond the list, you’ll find terpenes that are found in things like hardwood or perfumes, things that we don’t necessarily associate with the common cannabis terpenes. If you’re just looking for the limited number of terpenes, you are missing some things that you might discover or some things that might help explain results.

Leo: It’s also absolutely necessary for the medical side of things. Because of the federal limitations, cannabis hasn’t been researched nearly enough. We’re missing a lot of data on all of the active compounds in cannabis. We are finally starting to move into an era where that will soon be addressed. In order for certain medical studies to be successful, we need to have data showing what compounds are in what plants.

Drs. John Abrams and Jean Talleyrand of the CESC launched the Dosing Project in 2016. They have been studying the impact of cannabis flower for indications such as pain mitigation and sleep improvement, and now more recently mood, and appetite modulation. They categorize the THC & CBD content as well as flower aroma into 3 cannabinoid and 3 odor profiles. They are able to acquire quite a bit of data about how odor correlates with the outcomes. Because they were initially limited in terms of underlying natural product content data, they contacted us when they found out we acquired this equipment in 2020, and have stated that they are certain the data we will now be producing will take their research to the next level of understanding.

Aldwin: For quality control you are looking at specific things that would reflect properties in cannabis. There should be a 1:1 correspondence between properties observed and what we are measuring. The current assumption is that the terpenes we are looking at will tell us everything about how people would like it, with regards to flavor and smell preference. But we know for a fact that the limited terpenes most labs are measuring do not encapsulate everything. So, it is important for QC purposes to know for this particular strain or product, which everyone liked, what is it in there that makes everybody like it? If you just look at the typical terpene profile, you’ll find something close, but not exact. The GCxGC/MS shows us that maybe there’s something else that gives it a preferred property or a particular smell that we can explain and track. In one batch of flower, the consumer experiences it a certain way, and for another batch people experience it another way. We’d like to be able to understand what those differences are batch to batch so we can replicate the experience and figure out what’s in it that people like. That’s what I mean by consistency and quality control; the more you can measure, the more you can see.

Aldwin: Speaking to authenticity as well, in a breeding example, some growers will have this strain that they grew, or at least this is what they claim it to be, but what are the components that make those strains unique? The more analytes you can detect, the more you can authenticate the plant. Is this really OG Kush? Is this the same OG Kush that I’ve had before? Using the GCxGC/MS and comparing analytes, we can find authenticity in strains by finding all of the metabolites and analytes and comparing two strains. Of course, there is also adulteration- Some people will claim they have one strain that smells like blueberries, but we find a compound in it that comes from outside of cannabis, such as added terpenes. Proving that your cannabis is actually pure cannabis or proving that something has added terpenes is possible because we can see things in there that don’t come from cannabis. The GCxGC/MS can be used as a tool for proving authenticity or proving adulteration as well.  If you want to trademark a particular strain, we can help with claiming intellectual property. For example, if you want to trademark, register or patent a new product, it will be good to have more data. More data allows for better description of your product and the ability to prove that it is yours.

Leo: One thing that I think is a very interesting use case is proving the appellations. It is our understanding that California rolled out a procedure for growers to claim an appellation, but with strict rules around it. Within those rules, they need to prove uniqueness of growing products in specific regions. The GCxGC/MS can help in proving uniqueness by growing two different strains in two different regions, mapping out the differences and seeing what makes a region’s cannabis unique. It’s valuable for growers in California, Oregon, Colorado to be able to prove how unique their products are. To prove the differences between cannabis grown in Northern California versus plants grown along the Central Coast. And of course, for people across the world to be able to really tell a story and prove what makes their cannabis different and special. To be able to authenticate and understand, we need to have more comprehensive data about properties in those strains. It could be terpenes, it could be esters or thiols. That’s what we’re excited about.

Aaron: From your perspective, what are some of the biggest challenges and opportunities ahead for the cannabis industry?

Aldwin: Getting ready for federal legalization is both a challenge and opportunity. A challenge because when it is federally legal, there will be more regulations and more regulators. It is also a challenge because there will be more businesses, more competition, that might get into the industry. It is opening up to other players, much bigger players. Big tobacco, mega labs and massive diagnostic testing companies might participate, which will be a challenge for us.

But it’s also an opportunity for us to serve more customers, to be more established at the federal level, to move to interstate commerce. The opportunity is to be ready here and now while other people are not here yet.

Another challenge and opportunity is education. Educating consumers and non-consumers. We have to realize and accept that cannabis is not for everybody, but everyone is a stakeholder, because they are our neighbors, parents or part of the medical establishment. It would be a disservice not to educate the non-consumers.

The medical establishment, they don’t have to be consumers but they need to know about cannabis. They don’t know as much as they should about cannabis and they need to know more, like how it could affect their patients for better or for worse, so they know how to help their patients better. There could be drug interactions that could affect the potency of other drugs. They need to know these things. Educating them about cannabis is a challenge. It’s also an opportunity for us to now come in and say that cannabis is here to stay and be consumed by more and more people, so we better know how to deal with it from a medical perspective.“This bucking bronco of a growth style will throw a lot of people off. We need to figure out what we can grab on to and ride out these waves.”

Law enforcement needs to be educated too. What THC level in the blood indicates impairment? It is still a challenge because we’re not there yet, we don’t have that answer quite yet. And it’s an opportunity to help educate and to find more answers for these stakeholders, so we can have regulations that make sense.

Leo: To Aldwin’s point, the biggest opportunity comes along with federal legalization as well as expanding the customer base beyond the traditional market. Since adult use was legalized in CA, we haven’t yet seen the significant expansion of the consumer population. We’re primarily seeing a legal serving of the market that already existed before legalization.

The reality is cannabis can be used in different ways than what we think of. We know it has medical benefits and we know it is enjoyed recreationally by people looking for high THC content and the highest high. But there is also this middle ground, much like the difference between drinking moonshine and having a glass of wine at dinner. The wine at dinner industry is much bigger than the mason jar moonshine industry. That’s really where the opportunity is. What’s the appeal to the broader market? That will be a big challenge, but it’s inevitable. It comes from everything we’ve talked about today, consistency in products, educating people about cannabis, normalizing it to a certain degree, varietals and appellations.

As an entrepreneur, I’m looking at this from a business perspective. Everyone talks about the hockey stick growth chart, but it is a very wavy hockey stick. I expect to see very significant growth in the industry for a while, but it will have a lot of peaks and valleys. It’ll essentially be whiplash. We are seeing this in California right now, with sky high prices in flower last year down to bottom of the barrel prices this year. We have to all figure out how to hang on. This bucking bronco of a growth style will throw a lot of people off. We need to figure out what we can grab on to and ride out these waves. The good ones will be fun and the bad ones will be painful and we know they are coming again and again and again. That’s the biggest challenge. People say ‘expect tomorrow to look a lot like today,’ but you really can’t expect tomorrow to look anything like today in the cannabis industry. Tomorrow will be totally different from today. We need to figure out, within all this chaos, what can we hang on to and keep riding the upward trajectory without getting thrown off the bronco.

Connecticut Seeks to Change Microbial Testing Regulations

As of now, there are only two cannabis testing labs in Connecticut. Last year, regulators in the state approved a request from AltaSci Labs to raise the testing limits for yeast and mold at their lab from 10,000 colony forming units per gram (cfu/g) up to 1 million. The other lab, Northeast Laboratories, has kept their limits at 10,000 cfu/g.

Connecticut state flag

According to CTInsider.com, that request was approved privately and unannounced and patients were notified via email of the change. Ginny Monk at CTInsider says patients enrolled in Connecticut’s medical cannabis program have been outspoken over safety concerns, a lack of transparency and little voice in the decision-making process.

Connecticut has a small medical cannabis market with roughly 54,000 patients in the program and they are in the midst of readying the launch of their adult-use market.

A yeast and mold test showing colony forming units

Following public outcry regarding the change at the recent Social Equity Council meeting, state regulators have proposed a change to microbial testing regulations. The new rule will set the limit at 100,000 cfu/g for yeast and mold and requires testing for specific forms of Aspergillus, a more harmful type of mold.

Kaitlyn Kraddelt, spokeswoman for Connecticut’s Department of Consumer Protection, the agency in charge of testing regulations for the state’s cannabis program, told CTInsider.com that they involved several microbiologists to develop the new rule. “These new standards, which were drafted in consultation with several microbiologists, will prohibit specific types of yeast and mold in cannabis flower that may cause injury when inhaled and allow 10^5 cfu/g of colony forming units that have no demonstrated injurious impact on human health,” says Krasselt.

The rule change is now undergoing a public comment period, after which the Attorney General’s office will get a review period. If approved, it’ll head to the legislature, where a committee has 45 days to act on it.

A Conversation with the Founders of Veda Scientific: Part One

By Aaron G. Biros
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Leo Welder, CEO of Veda Scientific, founded the business with Aldwin M. Anterola, PhD in July of 2019. A serial entrepreneur with experience in a variety of markets, he came to the industry with an intrigue for cannabis testing and analysis. After teaming up with Dr. Anterola, co-founder and chief science officer at Veda Scientific, they came together with the purpose of unlocking possibilities in cannabis. From the beginning, they set out with a heavy scientific interest in furthering the industry from a perspective of innovation and research.

Through discussing their clients’ needs and understanding their complex problems, the two realized they wanted to start a lab that goes well beyond the normal regulatory compliance testing. Innovation in cannabis looks like a lot of things: new formulations for infused products, better designs for vaping technology or new blends of genetics creating unique strains, to name a few. For the folks at Veda Scientific, innovation is about rigorous and concentrated research and development testing.

With the help of some very sophisticated analytical chemistry instruments, their team is working on better understanding how volatile compounds play a part in the chemometrics of cannabis. From varietals and appellations to skunky smells, their research in the chemistry of cannabis is astounding – and they’ve only begun to scratch the surface.

In this two-part series, we discuss their approach to cannabis testing, their role in the greater industry as a whole and we go down a few cannabis chemistry rabbit holes and find out that what we don’t know is a lot more than what we do know. In part one, we get into their backgrounds, how they came into the cannabis industry and how they are carving out their niche. Stay tuned for part two next week where we delve deep into the world of volatile compounds, winemaking, the tastes and smells of cannabis and chicken adobo.

Aaron G. Biros: Tell me about how you and your team came to launch Veda, how you entered the cannabis space and what Veda’s approach is to the role of testing labs in the broader cannabis industry. 

Leo Welder, CEO of Veda Scientific

Leo Welder: I’m an entrepreneur. This is my third significant venture in the last fifteen years or so. So, I was intrigued by cannabis legalization broadly, because it is such a unique time in our history. I was always interested in participating in the industry in some way, but I didn’t see where would be a good fit for me. I used to meet monthly with a group of friends and fellow entrepreneurs for dinner and discussions and one member started working on the software side of the industry. He mentioned the testing element of cannabis in one of our meetings. I latched on to that and was intrigued by the concept of testing cannabis. I began to research it and found the role that testing plays in the cannabis industry is really significant. I found out that regulators rely pretty heavily on labs to make sure that products are safe, labels are accurate and that consumers have some protections. So, I thought that this is a space that I thought I could really find a calling in.

So, from that point I knew I needed to find a subject matter expert, because I am not one. I have business skills and experience in some technical fields but I am not a cannabis testing expert by any means. So, with that I started to look at a few different markets that I thought may have opportunity for a new lab, and I came across Aldwin’s business; he had a cannabis testing lab in Illinois at that time. I reached out to him, talked to him about my vision for the space and his thoughts and his vision and we really started to come together. From there, we researched various markets and ultimately chose to approach Santa Barbara County as our first foray together into the cannabis testing market.

Aldwin M. Anterola: As Leo mentioned, he was looking for a subject matter expert and I am very much interested in plant biochemistry. Which means I like to study how plants make these compounds that are very useful to us. For my PhD [in plant physiology], I was studying how cell cultures of loblolly pine produce lignin. Our lab was interested in how pine trees produce lignin, which is what makes up wood. Wood comes from phenolic compounds. You’ve probably heard of antioxidants and flavonoids – those are phenolic compounds. After my PhD, I wanted to do something different so I decided to work with terpenes.

I picked a very important terpene in our field, an anti-cancer compound called Taxol, produced from the bark of the yew tree. You have to cut trees to harvest it. We have ways of synthesizing it now. But at that time, we were trying to figure out how the tree produces that terpene. Of course, I’m interested in any compound that plants make. My interest in terpenes led me to cannabinoids which turn out to be terpenophenolics, thus combining the two interests in my professional field.

Aldwin M. Anterola, PhD, Co-Founder and Chief Science Officer at Veda Scientific,

So that’s the scientific and intellectual side of why I became interested in cannabis, but practically speaking I got into cannabis because of a consulting offer. A company was applying for a cultivation license, wanted to have a laboratory component of their business in their application, and hired me to write that part of their application. I was very familiar with HPLC, and had a GC/MS in the lab. I also have a background in microbiology and molecular biology so I can cover every test required at that time, and I knew I could research the other analytical techniques if necessary.

So, they did not get the license, but I figured I’d take what I wrote, once I received permission, and set up an independent laboratory together. But it’s hard to run a lab and be a professor at the same time. Also, the busines side of running a lab is something that I am not an expert in. Fortunately, Leo found me. Before that, I really got excited about this new industry. The concept of cannabis being now accessible to more people is so interesting to me because of how new everything is. I wanted to be involved in an industry like this and help in making it safe while satisfying my curiosity in this new field of research. As a scientist, those are the things that excite us: the things we didn’t have access to, we can now do. It opens up a whole new room that we want to unlock. It was my intellectual curiosity that really drove me. This opened up new research avenues for me as well as other ventures if you will. How can I be more involved? I thought to myself.

SIU boasts an impressive cannabis program, thanks largely to Dr. Anterola’s work there.

Back in 2014, I introduced cannabis research to our university [Southern Illinois University] and set up an industrial hemp program, which was DEA-licensed I gathered faculty that would be interested in studying hemp and cannabis and we now have a whole cannabis science center at the university. I teach a course in cannabis biology and because I also teach medical botany to undergraduate students, I was able to introduce [premed] students to the endocannabinoid system. Anyway, I can go on and on.

Outside of that I became involved with the AOAC and ASTM, and became a qualified assessor for ISO 17025:2017. I have been a member of the American Chemical Society since 2000 but there were no cannabis related activities there yet until relatively recently. But when they had the new cannabis chemistry subdivision, I am happy to participate in there as well . There are many avenues that I took to begin dabbling with cannabis, be it research, nonprofits, teaching, testing and more. Cannabis has basically infiltrated all areas of what I do as an academic.

Leo: I read his resume and I was like this is the guy! So back to your question, what’s Veda’s role as a testing lab in this space? What are we trying to build? We spent a lot of time trying to figure out what we wanted to be in this space. We came to understand that labs are not the tip of the spear for the market; that would be the growers, the retailers and the processors. We are a support, a service. We see ourselves as a humble, but competent guide. We provide the data for the tip of the spear, the people pushing the industry forward with support, data and the services to make sure they have the tools they need to build these great companies and great products with good cultivation practices and more, leading everyone to the next level of the cannabis industry. Our job is to support innovation, to provide quality compliance testing, to of course ensure safety, while also providing great R&D to these innovative companies.

Aldwin: I’d like to add a bit to that thought. Okay so that’s who we are, but what are we not? Because as Leo said I had a testing lab before we met [Advanced Herbal Analytics]. From there, I approach it as safety testing, making sure that before it gets to the end consumer, we are sort of like gate keepers keeping consumers safe. That’s one side to it, but we are not the people who are trying to make sure that none of the products get to the market. For some, that’s how we’re treated as.

People often look at testing labs like the police. We are not the people trying to limit products to market. Our approach is not to find faults. There is another way of being a testing lab that is less about finding faults in products and more about finding uniqueness. What makes your product different? With this new approach, we are much more focused on helping the best products make it to the shelves.

Aaron: Given that all state licensed labs have to provide the same tests as the other labs in that state, how does Veda differentiate itself?

Leo: Location was the first thing. We picked Santa Barbara County intentionally. We knew that some of the biggest operators, some of the most forward-thinking innovators were setting up shop here. Looking down the road, not just this year or next year but very long term, we wanted to start building a great, sustainable company. We wanted to build a brand that those kinds of companies would be receptive to. Building better and greater products. There’s one other lab in the county and that’s it. Whereas there are clusters of labs in other parts of the state. Part of the draw to Santa Barbara for us was that it is such a small, tight-knit community. We have worked very hard to build relationships in our community and to understand their challenges, helping them however we can.

Location and relationships. Getting to know the challenges that different size customers face, be it our greenhouse customers versus outdoor customers, or large-scale operations versus smaller manufacturing operations, the challenges are all different. Some people care about turnaround times, some more about R&D. If we understand our client’s problems, then we can provide better service. We see ourselves as problem solvers. We lean heavily on our technical team members like Aldwin, who not only have tremendous amounts of experience and education, but also great networks to utilize when a customer needs help, even when it falls outside of our local expertise.

The GCxGC/MS instrument, used for Veda’s advanced R&D testing

Last but certainly not least is the advanced R&D testing that we do. When we first started, we started talking to farmers and manufacturers trying to understand their challenges. What data were they not getting? How would a testing lab better serve them? So, we started investing strategically in certain instruments that would allow us to better serve them. We’ll get into this later as well, but we invested in a GCxGC/MS, which allows us to get more visibility into things beyond the typical panels, like more terpenes and other volatile compounds including thiols and esters. We did that because we knew there is value in that. The data our customers were getting prior just wasn’t enough to put together really great breeding programs or to manufacture really consistent products, you know, to move toward that next level of innovation in the industry.

Aldwin: Leo mentioned advanced R&D and it’s basically the same approach that I mentioned before. It’s not just telling you what you can and cannot do. It’s about asking them what do you want to do and what do you want from a lab? If we have a problem, let’s see if we can solve it. That’s how the GCxGC/MS came into play because we knew there was a need to test for many terpenes and other volatile compounds. The common complaint we received was why two terpene profiles differ so much from each other, even from the same genetics.

This is something that would actually give the customer, the cultivator or the manufacturer: data about their product that they can actually use. For consistency, for better marketing and other reasons. We are trying to help them answer the questions of ‘how can I make my product better?’

You know, for example, clients would tell us they want something that has a specific taste or smells a certain way. Nobody is telling them what makes the flavor or smell. There is a need there that we can fill. We are trying to provide data that they, the customers, need so that they can improve their breeding programs or their formulations. Data they can use, not just data they need in order to comply with regulations. They would ask us what we can do. We listen to our customers and we try and help as best we can. We don’t know every answer. We are discovering there is a lot more to terpenes than what you can find on a traditional one dimensional gas chromatogram. Some of the terpene data that our clients had previously is not really actionable data, which is where the GCxGC/MS is helping us.


In part two, we delve deep into the world of volatile compounds, winemaking, the tastes and smells of cannabis and chicken adobo. Click here to read part two. 

Detecting Microbial Contamination in Cannabis

By Mike Clark
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Increasing cannabis use across the US has come with increased scrutiny of its health effects. Regulators and healthcare providers are not just concerned about the direct effects of inhaling or consuming cannabinoids, however, but also about another health risk: microbial contamination in cannabis products. Like any other crop, cannabis is susceptible to contamination by harmful pathogens at several points throughout the supply chain, from cultivation and harvesting to distribution. Many state regulators have set limits for microbial populations in cannabis products. Consequently, testing labs must adopt efficient screening protocols to help companies remain compliant and keep their customers safe.

Some of the pathogens common to cannabis flower include Aspergillus fungus species such as A. flavus, A. fumigatus, A. niger and A. terreus. Cannabis might also harbor harmful E. coli and Salmonella species, including Shiga toxin-producing E. coli (STEC). Regulations vary by state, but most have set specific thresholds for how many colony forming units (CFUs) of particular species can be present in a sellable product.

The gold standard method for detecting microbes is running cultures.

Growers and testing labs need to develop a streamlined approach to remain viable. Current methods, including running cultures on every sample, can be expensive and time-consuming, but by introducing a PCR-based screening step first, which identifies the presence of microbial DNA – and therefore the potential for contamination – laboratories can reduce the number of cultures they need to run, saving money and time.

The Risk of Aspergillus Contamination

Contamination from Aspergillus species can bring harm to cannabis growers and their customers. The state of Michigan is currently undergoing the largest cannabis recall in its history from Aspergillus contamination.

If contamination grows out of control, the pathogen can damage the cannabis plant itself and lead to financial losses. Aspergillus can also cause serious illness in consumers, especially those that are immunocompromised. If an immunocompromised person inhales Aspergillus, they can develop aspergillosis, a lung condition with a poor prognosis.

A Two-Step Screening Process

The gold standard method for detecting microbes is running cultures. This technique takes weeks to deliver results and can yield inaccurate CFU counts, making it difficult for growers to satisfy regulators and create a safe product in a timely manner. The use of polymerase chain reaction (PCR) can greatly shorten the time to results and increase sensitivity by determining whether the sample has target DNA.

Using PCR can be expensive, particularly to screen for multiple species at the same time, but a qPCR-based Aspergillus detection assay could lead to significant cost savings. Since the average presumptive positive rate for Aspergillus contamination is low (between 5-10%), this assay can be used to negatively screen large volumes of cannabis samples. It serves as an optional tool to further speciate only those samples that screened positive to comply with state regulations.

Conclusion

Overall, screening protocols have become a necessary part of cannabis production, and to reduce costs, testing labs must optimize methods to become as efficient as possible. With tools such as PCR technology and a method that allows for initial mass screening followed by speciation only when necessary, laboratories can release more samples faster with fewer unnecessary analyses and more success for cannabis producers in the marketplace.

2021 Cannabis Labs Virtual Conference: December Program

By Cannabis Industry Journal Staff
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2021 Cannabis Labs Virtual Conference: December Program

Sponsored by ANAB, Hardy Diagnostics and MilliporeSigma.

Click here to watch the recording

Agenda

Cannabis Laboratory Accreditation Panel

  • Tracy Szerszen, President & Operations Manager, PJLA
  • Mohan Sabaratnam, Vice President, IAS
  • Kathy Nucifora, COO, COLA
  • Chris Gunning, General Manager for Accreditation Services, A2LA
  • Aaron Biros, Editor, CannabisIndustryJournal.com

In this session, the panel answers attendee questions related to ISO 17025:2017 accreditation for cannabis testing labs. Learn some of the common challenges labs face when seeking accreditation and learn about sampling protocols, security issues, statements of conformance, calibration and much more.

TechTalk: ANAB

  • Melanie Ross, Technical Products Developer, ANSI National Accreditation Board

R & D Lab Testing: Ensuring Success with Results

  • Mark Carter, president of MC Squared Enterprises

Learn how R&D lab testing can help you, prepare for compliance batches, successfully launch new products and amp up your quality control.

TechTalk: MilliporeSigma

 

USDA’s Hemp Testing Rules Have Changed: Accelerate Your Lab’s Preparedness

  • Arun Apte, CEO, CloudLIMS

This presentation takes a deep dive into understanding the requirements for USDA hemp testing, the operational changes hemp testing laboratories need to make to comply with the new hemp testing rules and the regulatory compliance framework and quality standards the testing labs need to meet.

TechTalk: Hardy Diagnostics

  • Jessa Youngblood, Food & Beverage Market Coordinator, Hardy Diagnostics

Bringing a National Hemp Testing Panel to Market

  • Josh Wurzer, Co-Founder & President, SC Laboratories

Without clear direction from the FDA, states are filling the void by developing their own quality standards and testing requirements for hemp derived CBD products. Unlike their THC based counterparts, hemp derived CBD products are being sold across state lines raising the demand for a single testing panel that will be compliant in every state. Attendees will learn:

  • The current state of regulations nationally
  • The issues that hemp product manufacturers need to be educated on to ensure compliance,
  • The challenges labs face in offering customers a truly comprehensive panel.

Click here to watch the recording