Cannabis News

Colombian think tank Fedesarrollo sees export revenue from the cannabis industry bringing US$800 million by 2025 and hitting an average of $2.3 billion in a decade hence. Colombia exported $5 million in cannabis byproducts in 2020 and $8 million in the period from January to June 2021, according to Rodrigo Arcila, president of the Colombian Cannabis Association (Asocolcanna).

“The growth potential is enormous. I cannot provide an exact figure, but companies were awaiting this announcement to prepare their crops and organize their business plans,” Arcila told CBT.

Executives from Clever Leaves, a cultivator, manufacturer and distributor listed on the Nasdaq, said exports of dried flower represent more than 50% of the world market for medicinal cannabis and participating in this segment will increase the country’s exports.

Julian Wilches, co-founder and director of Clever Leaves’ public affairs, said Colombia was one of Latin America’s pioneers of regulating production and exports of derivatives, but the export of flower will allow the expansion of the portfolio of products and services—generating greater opportunities and better prospects for the integral development of the industry.

READ MORE: Northern Swan Fully Integrates Colombia’s Clever Leaves

“The countries of the region have been updating their regulations, such as Peru, Ecuador, Mexico and Brazil, precisely to gain competitiveness. Colombia’s response was to be at the forefront and we are ready to serve this new segments,” Wilches said.

In Germany’s retail market, dried flower represents 53% of sales. It’s a country that represents 75% of the European market for medicinal cannabis and which currently depends entirely on imports. Likewise, the share of dried flower in Canada represents 73% of the units sold, while in the U.S. it is estimated to be above 60% of total sales, according to the team at Clever Leaves, citing a study published by Health Canada.

The company—with 18 hectares fully in production in the central province of Boyacá and a sophisticated laboratory in Tocancipá, located north of Bogotá—has invested US$70 million since 2018 in Colombia, and the market will tell how much they will have to invest more to expand into exports of flower, Wilches added.

In this “Leaders in Cannabis Testing” series of articles, Green interviews cannabis testing laboratories and technology providers that are bringing unique perspectives to the industry. Particular attention is focused on how these businesses integrate innovative practices and technologies to navigate a rapidly changing landscape of regulatory constraints and B2B demand.

PathogenDx is an Arizona-based provider of microbial testing technologies. Since their inception in 2014, they have broadened their reach to 26 states in the US. In addition to cannabis product testing, PathogenDx also provides technologies for food safety testing, environmental testing and recently started offering human diagnostics testing to support COVID-19 response efforts.

We interviewed Milan Patel, CEO and co-founder of PathogenDx. Milan founded PathogenDx as a spin-off from one of his investments in a clinical diagnostics company testing for genetic markers in transplant organs. Prior to PathogenDx, Milan worked in finance and marketing at Intel and later served as CFO at Acentia (now Maximus Federal).

Aaron Green: What’s the history of PathogenDx?

Milan Patel: PathogenDx was effectively a spin-off of a clinical diagnostics company that my partner Dr. Mike Hogan, the inventor of the technology, had founded when he was a professor at the University of Arizona, but previously at Baylor Medical College back in 2002. I had invested in the company back then and I had realized that his technology had a broad and wide sweeping impact for testing – not just for pathogens in cannabis specifically, but also for pathogens in food, agriculture, water and even human diagnostics. In the last 14 months, this became very personal for every single person on the planet having been impacted by SARS-CoV-2, the viral pathogen causing Covid-19. The genesis of the company was just this, that human health, food and agricultural supply, and the environment has and will continue to be targeted by bacterial, fungal and viral pathogens impacting the safety and health of each human on the planet.

We founded PathogenDx and we pivoted the company from its original human organ transplant genetics market scope into the bigger markets; we felt the original focus was too niche for a technology with this much potential. We licensed the technology, and we repurposed it into primarily cannabis. We felt that achieving commercial success and use in the hands of cannabis testing labs at the state level where cannabis was first regulated was the most logical next step. Ultimately, our goal was and is to move into markets that are approved at the federal regulatory side of the spectrum, and that is where we are now.

Green: What year was that?

Patel: 2014.

Green: So, PathogenDx started in cannabis testing?

Patel: Yes, we started in cannabis testing. We now have over 100 labs that are using the technology. There is a specific need in cannabis when you’re looking at contamination or infection.

In the case of contamination on cannabis, you must look for bacterial and fungal organisms that make it unsafe, such as E. coli, or Salmonella or Aspergillus pathogens. We’re familiar with recent issues like the romaine lettuce foodborne illness outbreaks at Chipotle. In the case of fungal organisms such as Aspergillus, if you smoke or consume contaminated cannabis, it could have a huge impact on your health. Cannabis regulators realized that to ensure public health and safety there was more than just one pathogen – there were half a dozen of these bugs, at a minimum, that could be harmful to you.

The beauty of our technology, using a Microarray is that we can do what is called a multiplex test, which means you’re able to test for all bacterial and fungal pathogens in a single test, as opposed to the old “Adam Smith” model, which tests each pathogen on a one-by-one basis. The traditional approach is costly, time consuming and cumbersome. Cannabis is such a high value crop and producers need to get the answer quickly. Our tests can give a result in six hours on the same day, as opposed to the two or three days that it takes for these other approved methods on the market.

Green: What is your business model? Is there equipment in addition to consumables?

Patel: Our business model is the classic razor blade model. What that means is we sell equipment as well as the consumables – the testing kits themselves.

The PathogenDx technology uses standard, off-the-shelf lab equipment that you can find anywhere. We didn’t want to make the equipment proprietary so that a lab has to buy a specific OEM branded product. They can use almost any equipment that’s available commercially. We wanted to make sure that labs are only paying a fraction of the cost to get our equipment, as opposed to using other vendors. Secondly, the platform is open-ended, meaning it’s highly flexible to work with the volumes that different cannabis labs see daily, from high to low.

One equipment set can process many different types of testing kits. There are kits for regulated testing required by states, as well as required environmental contamination.

Green: Do you provide any in-house or reference lab testing?

Patel: We do. We have a CLIA lab for clinical testing. We did this about a year ago when we started doing COVID testing.

We don’t do any kind of in-house reference testing for cannabis, though we do use specific reference materials or standards from Emerald Scientific, for example, or from NCI. Our platform is all externally third-party reference lab tested whether it’s validated by our external cannabis lab customers or an independent lab. We want our customers to make sure that the actual test works in their own hands, in their own facility by their own people, as opposed to just shrugging our shoulders and saying, “hey, we’ve done it ourselves, believe us.” That’s the difference.

Green: Can you explain the difference between qPCR and endpoint PCR?

Patel: The difference between PathogenDx’s Microarray is it uses endpoint PCR versus qPCR (quantitative real time PCR). Effectively, our test doesn’t need to be enriched. Endpoint PCR delivers a higher level of accuracy, because when it goes to amplify that target DNA, whether it’s E. coli, Salmonella or Aspergillus pieces, it uses all the primer reagent to its endpoint. So, it amplifies every single piece of an E. Coli (for example) in that sample until the primer is fully consumed. In the case of qPCR, it basically reaches a threshold and then the reaction stops. That’s the difference which results in a much greater level of accuracy. This provides almost 10 times greater sensitivity to identify the pathogen in that sample.

The second thing is that we have separated out how the amplified sample hybridizes to the probe. In the case of our assay, we have a microarray with a well in it and we printed the actual probe that has the sequence of E. coli in there, now driving 100% specificity. Whereas in the qPCR, the reaction is not only amplifying, but it’s also basically working with the probe. So, in that way, we have a higher level of efficiency in terms of specificity. You get a definite answer exactly in terms of the organism you’re looking for.

In terms of an analogy, let’s take a zip code for example which has the extra four digits at the end of it.  In the case of endpoint PCR, we have nine digits. We have our primer probes which represent the standard five digits of a zip code, and the physical location of the probe itself in the well which serves as the extra four digits of that zip code. The analyte must match both primary and secondary parts of the nine-digit zip code for it to lock in, like a key and a lock. And that’s the way our technology works in a nutshell.

Endpoint PCR is completely different. It drives higher levels of accuracy and specificity while reducing the turnaround time compared to qPCR – down to six hours from sample to result. In qPCR, you must enrich the sample for 24 to 48 hours, depending on bacteria or fungus, and then amplification and PCR analysis can be done in one to three hours. The accuracies and the turnaround times are the major differences between the endpoint PCR and qPCR.

Green: If I understand correctly, it’s a printed microarray in the well plate?

Patel: That’s correct. It’s a 96-well plate, and in each well, you’ve now printed all the probes for all targets in a single well. So, you’re not running more than one well per target, or per organism like you are for qPCR. You’re running just one well for all organisms. With our well plates, you’re consuming fewer wells and our patented foil-cover, you only use the wells you need. The unused wells in the well plate can be used in future tests, saving on costs and labor.

Green: Do you have any other differentiating IP?

Patel: The multiplex is the core IP. The way we process the raw sample, whether it’s flower or non-flower, without the need for enrichment is another part of the core IP. We do triplicate probes in each well for E. Coli, triplicate probes for Salmonella, etc., so there are three probes per targeted organism in each of the wells. We’re triple checking that you’re definitively identifying that bug at the end of the day. This is the cornerstone of our technology.

We were just approved by the State of New York, and the New York Department of Health has 13 different organisms for testing on cannabis. Think about it: one of the most rigorous testing requirements at a state level – maybe even at a federal level – and we just got approved for that. If you had to do 13 organisms separately, whether it’s plate culture or qPCR, it would become super expensive and very difficult. It would break the very backs of every testing lab to do that. That’s where the multiplexing becomes tremendously valuable because what you’re doing is leveraging the ability to do everything as a single test and single reaction.

Green: You mentioned New York. What other geographies are you active in?

Patel: We’re active in 26 different states including the major cannabis players: Florida, Nevada, California, Arizona, Michigan, New York, Oklahoma, Colorado and Washington – and we’re also in Canada. We’re currently working to enter other markets, but it all comes down to navigating the regulatory process and getting approval.

We’re not active currently in other international markets yet. We’re currently going through the AOAC approval process for our technology and I’m happy to say that we’re close to getting that in the next couple of months. Beyond that, I think we’ll scale more internationally.

I am delighted to say that we also got FDA EUA federal level authorization of our technology which drives significant credibility and confidence for the use of the technology. About a year ago, we made a conscious choice to make this technology federally acceptable by going into the COVID testing market. We got the FDA EUA back on April 20, ironically. That vote of confidence by the FDA means that our technology is capable of human testing. That has helped to create some runway in terms of getting federalized with both the FDA and the USDA, and certification by AOAC for our different tests.

Green: Was that COVID-19 EUA for clinical diagnostics or surveillance?

Patel: It was for clinical diagnostics, so it’s an actual human diagnostic test.

Green: Last couple of questions here. Once you find something as a cannabis operator, whether its bacteria or fungus, what can you do?

Patel: There are many services that are tied into our ecosystem. For example, we work with Willow Industries, who does remediation.

There’s been a lot of criticism around DNA based technology. It doesn’t matter if it’s qPCR or endpoint PCR. They say, “well, you’re also including dead organisms, dead DNA.” We do have a component of separating live versus dead DNA with a biomechanical process, using an enzyme that we’ve created, and it’s available commercially. Labs can test for whether a pathogen is living or dead and, in many cases, when they find it, they can partner with remediation companies to help address the issue at the grower level.

Another product we offer is an EnviroX test, which is an environmental test of air and surfaces. These have 50 pathogens in a single well. Think about this: these are all the bad actors that typically grow where soil is – the human pathogens, plant pathogens, powdery mildew, Botrytis, Fusarium – these are very problematic for the thousands of growers out there. The idea is to help them with screening technology before samples are pulled off the canopy and go to a regulated lab. We can help the growers isolate where that contamination is in that facility, then the remediation companies can come in, and help them save their crop and avoid economic losses.

Green: What are you most interested in learning about?

Patel: I would prefer that the cannabis industry not go through the same mistakes other industries have gone through. Cannabis started as a cottage industry. It’s obviously doubled every year, and as it gets scaled, the big corporations come in. Sophistication, standards, maturity all help in legitimacy of a business and image of an industry. At the end of the day, we have an opportunity to learn from other industries to really leapfrog and not have to go through the same mistakes. That’s one of the things that’s important to me. I’m very passionate about it.

One thing that I’ll leave you with is this: we’re dealing with more bugs in cannabis than the food industry. The food industry is only dealing with two to four bugs and look at the number of recalls they are navigating – and this is a multi-billion-dollar industry. Cannabis is still a fraction of that and we’re dealing with more bugs. We want to look ahead and avoid these recalls. How do you avoid some of the challenges around antimicrobial resistance and antibiotic resistance? We don’t want to be going down that road if we can avoid it and that’s sort of a personal mission for myself and the company.

Cannabis itself is so powerful, both medicinally as well as recreationally, and it can be beneficial for both consumers and industry image if we do the right things, and avoid future disasters, like the vaping crisis we went through 18 months ago because of bad GMPs. We must learn from those industries. We’re trying to make it better for the right reasons and that’s what’s important to me.

Green: Okay, great. That concludes the interview. Thank you, Milan.

Patel: Thank you for allowing me to share my thoughts and your time, Aaron.

As an experiential marketer that works with a lot of vice-oriented brands, I’ve always been fascinated by the story of the rise of spirits in the US – a history marked by ingenuity in the face of heavy restrictions, clashing social norms, crime and political ideals. Since then, those same qualities have emerged in the story of cannabis and how, against all odds, it has recently begun to push its way into the mainstream. But on the path to legalization, cannabis can also learn a lot from the spirits industry about what not to do.

For example, when laws governing the spirits industry were written in the post-Prohibition 1930s, the federal government wanted to create an equitable landscape. So, they created a 3-tier system – manufacturers or importers must sell to wholesalers, wholesalers must then sell to retailers and retailers sell to us. They figured that keeping manufacturing interests separate from wholesale and retail interests would keep any large company from owning an entire supply chain, muscling out smaller competitors.

In theory, it’s not a bad idea. Imagine the consequences of massive companies like Diageo or AB InBev using their money to pay bars and liquor stores to only stock their brands and not competitors. Add on the Tied House Laws, which basically says an entity in one of the three categories cannot have an ownership stake in any of the others, and you get a seemingly even-handed marketplace.

In truth, it makes it almost impossible to be disruptive or for new brands to break through. Other industries have innovated by cutting out the middleman and selling direct-to-consumer – something that simply cannot happen in alcohol (minus the wineries and distilleries that can sell direct out of their tasting rooms). Also, now distributors are so consolidated that there are only one or two big distribution companies in each state. So, as a company trying to bring a new product to market, you have to get into one of these highly selective and competitive distributors if you are going to be successful – a challenging ask for a small, independent brand.

Protection racket

Now, imagine that same challenge coming to the cannabis space. With legalization around the corner, the adult use (as opposed to medical use) cannabis industry could easily look like alcohol in the rules that will be set up.

Right now, adult use manufacturers can sell their products to dispensaries directly. Some use a distributor, but there is no nationwide mandate to – which is probably for the best. If a distributor isn’t a requirement, it forces brands to offer something new to differentiate themselves. It will spark innovation, rather than add an extra profit margin that will get rolled into the final price – a price that is already higher than it should be due to the murky federal legal status. Adding complexity and cost will only make it harder to compete with the illicit market. For the industry to grow, costs for illicit cannabis can’t be lower than its legal counterpart.

Of course, we are in the nascent stages of legalization here and we’ve come a long way culturally and technologically since the 30s. But remember, the rules governing alcohol were written nearly 100 years ago along with the passage of the 21st amendment repealing prohibition. Startlingly, those laws haven’t changed that much since they were written, so any mistakes made now in dealing with the cannabis industry could last for a long time.

A new way forward

What the cannabis industry needs is a new model for the adult use/recreational space, keeping some of what exists in the alcohol industry but without ever mandating use of a distributor – the middle tier. This would mean keeping Tied House Laws in place and applying them to cannabis so that a manufacturer could never hold an interest in a retailer, while still allowing them to sell directly to dispensaries and to consumers. Currently, some states allow for vertical integration, which would change under Tied House Laws.

This should be pretty simple, since most states are already separating licenses by type of activity (manufacturer, retailer, etc.) and it would promote competition while bringing the widest array of products possible to each consumer. Also, it would prevent any behemoths from squeezing out the up and comers.

Of course, some retail license allowances could be considered on a case-by-case basis. For example, I would carve out an exception that growers/manufacturers could sell direct to consumers through a single “tasting room” at their brand home. This is similar to the operations of microbreweries, distilleries and wineries. It would encourage education for consumers, and provide great opportunities for brands to show why their products are better or unique.

Given the technology and logistics solutions available to businesses in a 21st century economy, mandated distributors create a sometimes-unnecessary barrier to an already efficient supply chain. If mandated, prices will inflate to cover added margin, thus making it harder to bring consumers over from the legacy market to the legal one. I’m not against the idea of a distributor – they can add tremendous value, but the mandate would seriously curtail industry growth.

Direct-to-retail and direct-to-consumer sales are necessary for the economic health and growth of the industry. Without this, using alcohol as a cautionary tale, at some point the middle tier cannabis brands will inevitably begin to wield an outsized amount of power. We are living at a time where innovation is going to be the key to explosive growth in the cannabis industry, so it’s important to do everything possible to let the market find its way without falling into a century-old trap.

In a long-awaited announcement, Colombia authorized exports of dried cannabis flower for medical purposes. For businesses in the country, it’s a move that increases the growth potential of the nascent cannabis industry.

Colombia had approved a regulatory framework in July 2016 governing the production, distribution, sale and export of seeds—as well as products like creams and other derivatives based on cannabis—but had prohibited the export of dried cannabis flower, fearing that such a move would allow diversion of legal cannabis products into the illicit marketplace.

The new decree, 811, issued July 23, modifies an earlier law that regulated the commercialization of medical cannabis, Justice Minister Wilson Ruiz said.

The new decree also allows manufacturers to produce goods such as oils, extracts,  textiles or food containing “non-psychoactive cannabis”—so long as they are limited to biomass containing less than 1% of THC. (Colombia does not make distinctions between “cannabis” and “hemp,” as in other countries, but rather uses the “psychoactive” nomenclature at the 1% THC content threshold.).

Colombia President Ivan Duque signed a decree ending “the ban on the export of dried flower” in an event organized at a facility owned by Clever Leaves, one of the 18 multinationals that grows medicinal cannabis in Colombia.

“Colombia starts to play big, and with this decree we are putting ourselves at the forefront in terms of regulatory competitiveness, at least in Latin America and the Caribbean,” he said, noting that the country is no longer only working in a pharmaceutical market. “We are opening the space to do much more in cosmetics … [including] food and beverages and even textiles,” the president said.

Duque’s office estimates that the global market for medicinal and industrial cannabis may be worth US$62 billion by 2024. National and international companies have invested US$250mn in Colombia to develop this industry.

Colombia, one of the world’s largest cannabis producers in the 1960s and 1970s, and the world’s biggest supplier of cocaine, continues to change the country’s drug policy.

With the regulation followed by a new resolution that will regulate how the dried flower should be produced, Colombia joined other counties in the region that have authorized exports of dried flower, said Jon Ruiz, director of the consultancy firm CannCons and former CEO of the cannabis companies Pharmacielo and Medcann. Notably, Colombia will have a competitive advantage against Ecuador, a neighboring nation with similar geographic conditions, which only authorized exports of non-psychoactive dried flower, he said 

The resolution is expected to be ready in two months, Ruiz said. The Ministry of Justice will continue to be responsible for issuing licenses for seeds for the cultivation of cannabis plants. Meanwhile, the National Food and Drug Surveillance Institute (INVIMA) will issue the licenses for derivatives.

Until recently, dried flower produced in Colombia was only allowed to go into the Free Trade Zone for transformation for derived products such as cannabis extracts or oils.

Advantages

In a long-awaited announcement, Colombia authorized exports of dried cannabis flower for medical purposes. For businesses in the country, it’s a move that increases the growth potential of the nascent cannabis industry.

Colombia had approved a regulatory framework in July 2016 governing the production, distribution, sale and export of seeds—as well as products like creams and other derivatives based on cannabis—but had prohibited the export of dried cannabis flower, fearing that such a move would allow diversion of legal cannabis products into the illicit marketplace.

The new decree, 811, issued July 23, modifies an earlier law that regulated the commercialization of medical cannabis, Justice Minister Wilson Ruiz said.

The new decree also allows manufacturers to produce goods such as oils, extracts,  textiles or food containing “non-psychoactive cannabis”—so long as they are limited to biomass containing less than 1% of THC. (Colombia does not make distinctions between “cannabis” and “hemp,” as in other countries, but rather uses the “psychoactive” nomenclature at the 1% THC content threshold.).

Colombia President Ivan Duque signed a decree ending “the ban on the export of dried flower” in an event organized at a facility owned by Clever Leaves, one of the 18 multinationals that grows medicinal cannabis in Colombia.

“Colombia starts to play big, and with this decree we are putting ourselves at the forefront in terms of regulatory competitiveness, at least in Latin America and the Caribbean,” he said, noting that the country is no longer only working in a pharmaceutical market. “We are opening the space to do much more in cosmetics … [including] food and beverages and even textiles,” the president said.

Duque’s office estimates that the global market for medicinal and industrial cannabis may be worth US$62 billion by 2024. National and international companies have invested US$250mn in Colombia to develop this industry.

Colombia, one of the world’s largest cannabis producers in the 1960s and 1970s, and the world’s biggest supplier of cocaine, continues to change the country’s drug policy.

With the regulation followed by a new resolution that will regulate how the dried flower should be produced, Colombia joined other counties in the region that have authorized exports of dried flower, said Jon Ruiz, director of the consultancy firm CannCons and former CEO of the cannabis companies Pharmacielo and Medcann. Notably, Colombia will have a competitive advantage against Ecuador, a neighboring nation with similar geographic conditions, which only authorized exports of non-psychoactive dried flower, he said 

The resolution is expected to be ready in two months, Ruiz said. The Ministry of Justice will continue to be responsible for issuing licenses for seeds for the cultivation of cannabis plants. Meanwhile, the National Food and Drug Surveillance Institute (INVIMA) will issue the licenses for derivatives.

Until recently, dried flower produced in Colombia was only allowed to go into the Free Trade Zone for transformation for derived products such as cannabis extracts or oils.

Advantages

In a long-awaited announcement, Colombia authorized exports of dried cannabis flower for medical purposes. For businesses in the country, it’s a move that increases the growth potential of the nascent cannabis industry.

Colombia had approved a regulatory framework in July 2016 governing the production, distribution, sale and export of seeds—as well as products like creams and other derivatives based on cannabis—but had prohibited the export of dried cannabis flower, fearing that such a move would allow diversion of legal cannabis products into the illicit marketplace.

The new decree, 811, issued July 23, modifies an earlier law that regulated the commercialization of medical cannabis, Justice Minister Wilson Ruiz said.

The new decree also allows manufacturers to produce goods such as oils, extracts,  textiles or food containing “non-psychoactive cannabis”—so long as they are limited to biomass containing less than 1% of THC. (Colombia does not make distinctions between “cannabis” and “hemp,” as in other countries, but rather uses the “psychoactive” nomenclature at the 1% THC content threshold.).

Colombia President Ivan Duque signed a decree ending “the ban on the export of dried flower” in an event organized at a facility owned by Clever Leaves, one of the 18 multinationals that grows medicinal cannabis in Colombia.

“Colombia starts to play big, and with this decree we are putting ourselves at the forefront in terms of regulatory competitiveness, at least in Latin America and the Caribbean,” he said, noting that the country is no longer only working in a pharmaceutical market. “We are opening the space to do much more in cosmetics … [including] food and beverages and even textiles,” the president said.

Duque’s office estimates that the global market for medicinal and industrial cannabis may be worth US$62 billion by 2024. National and international companies have invested US$250mn in Colombia to develop this industry.

Colombia, one of the world’s largest cannabis producers in the 1960s and 1970s, and the world’s biggest supplier of cocaine, continues to change the country’s drug policy.

With the regulation followed by a new resolution that will regulate how the dried flower should be produced, Colombia joined other counties in the region that have authorized exports of dried flower, said Jon Ruiz, director of the consultancy firm CannCons and former CEO of the cannabis companies Pharmacielo and Medcann. Notably, Colombia will have a competitive advantage against Ecuador, a neighboring nation with similar geographic conditions, which only authorized exports of non-psychoactive dried flower, he said 

The resolution is expected to be ready in two months, Ruiz said. The Ministry of Justice will continue to be responsible for issuing licenses for seeds for the cultivation of cannabis plants. Meanwhile, the National Food and Drug Surveillance Institute (INVIMA) will issue the licenses for derivatives.

Until recently, dried flower produced in Colombia was only allowed to go into the Free Trade Zone for transformation for derived products such as cannabis extracts or oils.

Advantages

Like any other natural product, the biomass of legal cannabis can be contaminated by several toxic agents such as heavy metals, organic solvents, microbes and pesticides, which significantly influence the safety of the end products.

Let’s just consider the toxicological effects. Since cannabis products are not only administered in edible forms but also smoked and inhaled, unlike most agricultural products, pesticide residue poses an unpredictable risk to consumers. One example is the potential role of myclobutanil in the vape crisis.

Unfortunately, federal and state laws are still conflicted on cannabis-related pesticides. Currently, only ten pesticide products have been registered specifically for hemp by the U.S. Environmental Protection Agency. So, the question arises what has to be done with all pf the high-value, but also contaminated cannabis, keeping in mind that during the extraction processes, not only the phytocannabinoids get concentrated but the pesticides as well, reaching concentrations up to tens or hundreds of parts per million!

Currently, there are three different sets of rules in place in the regulatory areas of Oregon, California and Canada. These regulations detail which pesticides need to be monitored and remediated if a certain limit for each is reached. Because the most extensive and strict regulations are found in Canada, RotaChrom used its regulations as reference in their case study.

To illustrate that reality sometimes goes beyond our imagination, we evaluated the testing results of a THC distillate sample of one of our clients. This sample contained 9 (!) pesticides, of which six levels exceeded the corresponding action limits. The most frightening, however, regarding this sample, is that it contained a huge amount of carbofuran, a category I substance. It is better not to think of the potential toxicological hazard of this material…

The CPC-based purification of CBD is a well-known and straightforward methodology. As the elution profile on the CPC chromatogram of a distillate shows, major and minor cannabinoids can be easily separated from CBD. At RotaChrom, this method has been implemented at industrial-scale in a cost effective and high throughput fashion. In any case, the question arises: where are the pesticides on this chromatogram? To answer this, we set ourselves the goal to fully characterize the pesticide removing capability of our methodologies.

Our results on this topic received an award at the prestigious PREP Conference in 2019. The ease of pesticides removal depends on the desired Compound of Interest.

Here is a quick recap on key functionalities of the partition chromatography.

• Separation occurs between two immiscible liquid phases.
• The stationary phase is immobilized inside the rotor by a strong centrifugal force.
• The mobile phase containing the sample to be purified is fed under pressure into the rotor and pumped through the stationary phase in the form of tiny droplets (percolation).
• The chromatographic column in CPC is the rotor: cells interconnected in a series of ducts attached to a large rotor
• Simple mechanism: difference in partition

Let’s get into the chemistry a bit:

The partition coefficient is the ratio of concentrations of a compound in a mixture of two immiscible solvents at equilibrium. This ratio is therefore a comparison of the solubilities of the solute in these two liquid phases.

The CPC chromatogram demonstrates the separation of Compounds of Interest based on their unique partition coefficients achieved through a centrifugal partition chromatography system.

CPC can be effectively used for pesticide removal. About 78% of the pesticides around CBD are very easy to remove, which you can see here:

In this illustration, pesticides are in ascending order of K_d from left to right. CBD, marked with blue, elutes in the middle of the chromatogram. The chart illustrates that most polar and most apolar pesticides were easily removed beside CBD. However, some compounds were in coelution with CBD (denoted as “problematic”), and some compounds showed irregular K_d-retention behavior (denoted as “outliers”).

If pesticides need to be removed as part of THC purification, then the pesticides that were problematic around CBD would be easier to remove and some of the easy ones would become problematic.

To simulate real-world production scenarios, an overloading study with CBD was performed, which you can see in the graph:

It is easy to see on the chromatogram that due to the increased concentration injected onto the rotor, the peak of CBD became fronting and the apparent retention shifted to the right. This means that pesticides with higher retention than CBD are more prone to coelution if extreme loading is applied.

To be able to eliminate problematic pesticides without changing the components of the solvent system, which is a typical industrial scenario, the so-called “sweet spot approach” was tested. The general rule of thumb for this approach is that the highest resolution of a given CPC system can be exploited if the K_d value of the target compounds fall in the range of 0.5-2.0. In our case, to get appropriate Kd values for problematic pesticides, the volume ratio of methanol and water was fine-tuned. Ascending mode was used instead of descending mode. For the polar subset of problematic pesticides, this simple modification resulted in an elution profile with significantly improved resolution, however, some coelution still remained.

In the case of apolar pesticides, the less polar solvent system with decreased water content in ascending mode provided satisfactory separation.

Moreover, if we focus on this subset in the three relevant regulatory areas, the outcome is even more favorable. For example, myclobutanil and bifenazate, dominant in all of the three regulatory regions, are fully removable in only one run of the CPC platform.

Based on these results, a generic strategy was created. The workflow starts with a reliable and precise pesticide contamination profile of the cannabis sample, then, if it does not appear to indicate problematic impurity, the material can be purified by the baseline method. However, if coeluting pesticides are present in the input sample, there are two options. First, adjusting the fraction collection of the critical pesticide can be eliminated, however the yield will be compromised in this case. Alternatively, by fine-tuning the solvent system, a second or even a third run of the CPC can solve the problem ultimately. Let me add here, that a third approach, i.e., switching to another solvent system to gain selectivity for problematic pesticides is also feasible in some cases.

In review, RotaChrom has conducted extensive research to analyze the list of pesticides according to the most stringent Canadian requirements. We have found that pesticides can be separated from CBD by utilizing our CPC platform. Most of these pesticides are relatively easy to remove, but RotaChrom has an efficient solution for the problematic pesticides. The methods used at RotaChrom can be easily extended to other input materials and target compounds (e.g., THC, CBG).

The explosive, unregulated growth of delta-8 tetrahydrocannabinol (THC) is coming with a dangerous consequence: Poison control centers across the country are reporting a rise in calls from those who have ingested the cannabinoid. 

At least four states have issued public warnings regarding the cannabinoid, according to local news reports: Michigan, West Virginia, Virginia and North Carolina.

So far this year, as of July, the North Carolina Poison Control Center reported 157 cases related to delta-8, according to the Winston-Salem Journal. Virginia is reporting “dozens” of calls this year.

The rise in calls can be attributed to a number of factors, from the market’s lack of standards to delta-8’s accessibility to minors.

But perhaps the most concerning cause for an increase in delta-8 poison center calls is due to mislabeling–in some cases, consumers hoping to buy these products may be purchasing unregulated, illegal cannabis without knowing.

“This is part and parcel for what happens when you have an unregulated market,” says Jonathan Miller, general counsel for U.S. Hemp Roundtable. 

Mislabeling Plays a Role

A recently published report shines a light on just how prominent mislabeling is in the industry.  Leafreport.com, a peer-reviewed watchdog website for the cannabidiol (CBD) industry, found that more than half of the 38 products it tested had illegal levels of delta-9 THC. In addition, only 32% had the advertised amount of delta-8. The rest were off by 10.7% to 102.7% from the label.

And Wayne State University, based in Michigan, reports that law enforcement agencies in Michigan have seized delta-8 products that were falsely labeled as CBD products.

Lev Spivak-Birndorf, Ph.D., chief science officer at PSI Labs, a Michigan-based cannabis testing lab, says the mislabeling of these products could be linked to the risks associated with producing delta-8, as byproducts can be left during the process of converting it from CBD or delta-9 THC.

For example, when labs extract cannabis to make other oils, it’s a more straightforward process, as there are already established and known solvents and methods, like butane or ethanol extraction, that labs can use to remove byproducts, Spivak-Birndorf says.

“But once you get into the process of converting CBD into delta-8, it’s called chemical synthesis,” he says. “You’re essentially taking one molecule and performing a chemical reaction that’s causing it to change into another molecule via that reaction.”

There are several standard operating procedures (SOPs) that can be used to extract delta-8; however, there are many “variables in terms of what can be left over in the product and how dangerous the substance is that labs use to catalyze that reaction and make it occur at a speed that’s acceptable for production,” he says.

PSI Labs has not yet conducted extensive research into what type of contaminants can be found in delta-8 products due to costs; however, the laboratory has brought in off-the-shelf delta-8 products from places like vape shops and gas stations for testing, and they’ve discovered discrepancies in the products.

“We often find that some of [the products] are very pure delta-8, but still contain traces of delta-9 that are technically above the legal 0.3% THC limit,” he says. “It’s just a mixed bag, and that’s what I think is so risky about it, is that it’s very uncontrolled in terms of these processes, where one product could be pretty genuine to its label, but another one might be very different.”

RELATED: Understanding Delta-8-THC: Where Does It Come From?

Allison Justice, Ph.D., CEO of The Hemp Mine, previously told Hemp Grower that in the delta-8 extraction process, the final distillate ends up being 60% to 70% delta-8 and roughly 2% to 6% delta-9. Suppose a company wants to make a compliant product with the U.S. Department of Agriculture’s (USDA’s) final rule on hemp. In that case, they will then run the distillate through extensive chromatography to remove the delta-9 or dilute it down to ensure it’s under the 0.3% THC limit, she said.

But Spivak-Birndorf says PSI Labs has found off-the-shelf delta-8 products that contain 20% delta-9, as well as a significant amount of CBD, meaning that whatever reaction pathway they chose, they didn’t finish it and left it “half-cooked,” he says.

“This raises lots of questions about what residual other byproducts might be in [the delta-8 products] that are sort of not familiar cannabinoids, but maybe harmful substances, like heavy metals, which can often be used in these processes,” he says.

Spivak-Birndorf says PSI Labs has come across many delta-8 vapes over the 0.3% THC limit; however, he thinks the real risk with mislabeling is with edibles. 

“Once you eat [the edible], that’s how much you eat, and you really can’t go back from there. So, that’s where testing is absolutely critical,” he says. “You really need to test things in a fashionable manner to make sure that there’s nothing wrong with your process. Other packaged and ready-made goods go through many good manufacturing practices (GMPs) and Food and Drug Administration (FDA) guidelines before they get to the shelf. In the cannabis industry, a lot of that stuff is non-existent or just catching up.”

Spivak-Birndorf says there is a need for third-party, end-product testing on a batch basis to ensure the products are correctly dosed before hitting shelves because there are not many regulated delta-8 testing and measurement practices in place.

“All of this is an important part of a good manufacturing practice of what goes into all the packaged goods we consume,” he says. “And so really, it should be implemented for delta-8 or delta-9, just like anything else.”

“There’s no reason to limit ourselves in terms of the cannabinoid toolbox,” he adds. “Whether it’s naturally occurring, semi-synthetic or even synthetic, it’s very important to know exactly what we’re dealing with and what quantities we’re dealing with if we want to avoid unknown adverse reactions and keep people as safe and healthy as possible.”

Minors the Main Victims

According to the Wayne State University report, in a nearby state, there were two reported cases of severe adverse reactions to delta-8 in children who ingested their father’s edibles purchased at a vape shop.

The report says that because delta-8 products are packaged in similar forms of CBD, teens and young children have a higher risk of using the compound accidentally. “THC use in children can cause low blood pressure, difficulty breathing, severe sedation, coma, and psychological effects. Long-term effects in children are not known,” the report says.

According to the National Capital Poison Center, because delta-8 products are largely unregulated, “the packaging may not be child-resistant and may contain cartoon-like images or other features that may be appealing to children.”

On its website, the National Capital Poison Center offers this anecdote: “A 3-year-old boy was brought to an Emergency Department after eating an unknown amount of delta-8 THC gummies belonging to his mother. The gummies were packaged in a container with a twist-off top, and the boy was able to open the container by himself. The child experienced vomiting but was eventually released from the hospital. His mother was cited for child abuse and neglect.”

Market Regulation Needed

Spivak-Birndorf says there is an increased need for regulation, as it is difficult to trace where these unsafe delta-8 products are coming from.

“While some of these companies have an online presence and show current testing and are actually responsible, for every one of those, there’s probably, and I would guess, numerous [companies] that are flying by night and just not checking their work,” he says. “Or they’re not concerned about quality control checks for their product, which they should have. So, definitely without that regulatory push to do all that stuff, it’s unrealistic to think that [everyone] is just going to take that upon themselves.”

As previously reported by Hemp Grower, Michigan has recently joined numerous other states in regulating delta-8, as Gov. Gretchen Whitmer signed legislation into law July 13, prohibiting businesses from selling delta-8 products without proper licensing from the Michigan Marijuana Regulatory Agency, and the products must be tracked and tested like any other cannabis product. 

Additionally, “the new law also bars businesses without state cannabis licenses from producing and selling any other potentially intoxicating cannabis compounds,” Hemp Grower previously reported.

And in late April, Hemp Grower reported that Washington’s Liquor and Cannabis Board (LCB) issued a policy statement, stating that “Delta-8 THC, as well as derivatives, extracts, cannabinoids, isomers, and CBD isolate from hemp or other sources that are genetically or chemically altered into compounds may not be produced or processed in LCB licensed facilities, and may not be sold in licensed marijuana retail stores.”

However, this does not necessarily mean delta-8 is outright banned in the state, as the LCB’s notice “was only an interpretation of the law as it relates to the legal cannabis market,” Hemp Grower reported.

Washington and Michigan are just two of nearly 20 states that have already regulated the cannabinoid. According to Hemp Grower, 15 states have issued bans on delta-8, while six additional states have pending legislation to regulate the cannabinoid and related THC isomers. 

Miller says the U.S. Hemp Roundtable has been working with states on developing laws that regulate delta-8 under the cannabis market because of its psychoactive properties. So far, Michigan, Oregon and New York have passed similar laws.

“I would very much hesitate buying a delta-8 product” in the current market, Miller says. “I would only buy things available in a dispensary that have been proven to undergo the same type of testing [as regulated cannabis].”

Not Just Delta-8

Delta-8 isn’t the only cannabinoid responsible for an uptick in poison center calls this year.

As of June 30, the American Association of Poison Control Centers (AAPCC) reported that poison control centers across the country had managed 2,158 cases in 2021 related to CBD. This is nearly on par with the 2,226 calls placed the entire year in 2020.

For perspective, in June 2020, poison control centers handled 181 cases related to CBD; in June 2021, that number jumped to 423.

The AAPCC offers this explanation on its website for the increase in calls: “…[S]ome products contain more CBD than what is on the label, more THC than labeled, or other chemical compounds/drug ingredients that are not listed at all. Consumers have no way of knowing whether the product is contaminated with other chemicals and drugs or labeled correctly.”

© Chart Courtesy of The American Association of Poison Control Centers

Miller points out that CBD is “a safe compound, and study after study have demonstrated its safety.” But without clear regulations or even guidance on how to produce CBD products, it’s possible the products contributing to poison control center cases don’t comply with GMP safety standards, Miller says.

“The challenge is that we’re in an unregulated marketplace,” he says. “These kinds of problems are hopefully going to spur Congressional action that will pass bills to develop a regulatory structure.”

Miller adds that the Hemp Access and Consumer Safety Act moving through the U.S. Senate would require the U.S. Food and Drug Administration to develop a regulatory pathway for CBD to be used in food, beverages and dietary supplements.

You can reach your local poison control center by calling the Poison Help hotline: 1-800-222-1222. To save the number in your mobile phone, text POISON to 797979.

Cannabis testing is important for both operators and consumers, but there are some differences in what is important to each group. Obviously, safety and efficacy are important to both. Cannabis is primarily tested for safety reasons to ensure that consumers are receiving a product that is safe to consume and accurately labeled. In addition, consumers may look for a potency they’re used to consuming or a certain terpene profile that gives them a desired effect. Cannabis operators, on the other hand, use testing results to improve their processes and to monitor product quality versus state specific regulatory requirements that could cause their products to pass or fail.

What cannabis operators need to understand about cannabis testing results

Historically, there was an education gap on the side of the operators when it came to interpreting results. The regulated cannabis industry is still quite new and cannabis operators were initially focused on getting products to market. While there was always a focus on regulatory compliance and safety, the same level of quality control that existed in other regulated industries like food production seemed to lag. That has changed as operators have become more sophisticated and are hiring experts skilled in interpreting results and quality control. For a laboratory, hiring scientists with a regulatory background offers the operators the experience needed to ensure they’re getting accurate results that are easy to understand. This has led to more meaningful collaboration between labs and operators who work together to understand what test results mean to their processes and business operations.

A common problem is that some operators see testing as just a speed bump. This doesn’t have to be the case. Third-party testing is an integral part of getting safe products to consumers. Businesses need to find a lab that understands their objectives and knows how to support the manufacturing and production cycles. Establishing a testing protocol with a lab will help ensure that there are no surprises and that products can be tested and sold as quickly as possible.

Now that operators and labs are speaking the same language, the challenge becomes translating that information into a consumer-friendly format. Consumers don’t necessarily need (or want) to explore the minutiae of every tested analyte, but they can easily grasp high level results in the form of charts and graphs. Translating the testing results into an easy-to-digest format allows consumers to better understand the products they are buying.

What are the main components of test results cannabis businesses should look for?

The first and most obvious results to look for is what was tested and if any tests delivered a failing result. A failing result is determined by comparing the tested values against the state requirements. If a product has failed testing in any area, operators will need to work with the lab and their internal teams to determine exactly what the issue is and if it can be rectified. Failing of any state required test (pesticide, microbial, metals, ….) means the product cannot be sold in its current form. Depending on the state, failing results may be required to be confirmed by another lab, processed further to remove the failing contaminants or destroyed. The production cycle to grow, process and manufacture cannabis products can take anywhere from 120 to 160 days with many different processes and handlers. Despite attempts to control all the variables that impact final product quality, failing tests do occur.

Once businesses have passed the state-required testing, the remaining tests are focused on product characteristics including potency and terpene profile. The potency of a product measures the levels of cannabinoids and influences both production and marketing decisions. Lower potency flower may be extracted for distillate products while higher potency flower will demand a higher price and will most likely be sold as flower or processed into concentrate products. Cannabinoid profiles go well beyond just CBD and THC. Understanding the full cannabinoid profile of a product is an important factor in how it can be marketed, and how it will be used.

The terpene profile of a product is also quickly becoming just as important to medical and adult use consumers. Terpenes play a major role in the effects that consumers experience with cannabis products. In the past, consumers relied heavily on strain names to purchase products that they believed would give them the effects that they were looking to achieve. Moving forward, we believe that consumers will be more interested in a product’s terpene profile given the strong influence that terpenes have on effects. In states like Nevada, cannabis businesses put terpene profiles on their product labels and cannabis consumers are starting to select products based on terpenes rather than raw potency numbers.

What is the most important factor in cannabis testing results?

Trust is the most important factor when testing cannabis. Operators need to trust that their lab is providing consistent, accurate and timely results. Consumers need to be able to trust what they read on the certificate of analysis, and they ultimately need to trust that the products they buy will deliver the effects that they expect.

The easiest way for businesses to increase trust in their products and testing results is transparency. When there is transparency from the testing lab to the business and customers, it will help build trust and establish a brand for the long term.

Another important aspect of this process is ensuring businesses share the right information with consumers and educate them as to what it means to them. Information overload, without explanation, will only lead to confusion. It’s important to educate employees, especially those interfacing with customers, on how to interpret and explain test results in a way that consumers can understand.

It can be challenging to translate highly technical test results into consumer-friendly language but being able to do so will enable businesses to build a stronger relationship with customers. This isn’t something that businesses need to figure out by themselves. Rely on your trusted lab partners to help design and deliver easy to understand, consumer friendly certificates of analysis. Consumers want to be educated and understand what is in their products, and how the products will work for them. Trust, transparency and education will help cannabis operators strengthen relationships and continue to grow their business.

The explosive, unregulated growth of delta-8 tetrahydrocannabinol (THC) is coming with a dangerous consequence: Poison control centers across the country are reporting a rise in calls from those who have ingested the cannabinoid. 

At least four states have issued public warnings regarding the cannabinoid, according to local news reports: Michigan, West Virginia, Virginia and North Carolina.

So far this year, as of July, the North Carolina Poison Control Center reported 157 cases related to delta-8, according to the Winston-Salem Journal. Virginia is reporting “dozens” of calls this year.

The rise in calls can be attributed to a number of factors, from the market’s lack of standards to delta-8’s accessibility to minors.

But perhaps the most concerning cause for an increase in delta-8 poison center calls is due to mislabeling–in some cases, consumers hoping to buy these products may be purchasing unregulated, illegal cannabis without knowing.

“This is part and parcel for what happens when you have an unregulated market,” says Jonathan Miller, general counsel for U.S. Hemp Roundtable. 

Mislabeling Plays a Role

A recently published report shines a light on just how prominent mislabeling is in the industry.  Leafreport.com, a peer-reviewed watchdog website for the cannabidiol (CBD) industry, found that more than half of the 38 products it tested had illegal levels of delta-9 THC. In addition, only 32% had the advertised amount of delta-8. The rest were off by 10.7% to 102.7% from the label.

And Wayne State University, based in Michigan, reports that law enforcement agencies in Michigan have seized delta-8 products that were falsely labeled as CBD products.

Lev Spivak-Birndorf, Ph.D., chief science officer at PSI Labs, a Michigan-based cannabis testing lab, says the mislabeling of these products could be linked to the risks associated with producing delta-8, as byproducts can be left during the process of converting it from CBD or delta-9 THC.

For example, when labs extract cannabis to make other oils, it’s a more straightforward process, as there are already established and known solvents and methods, like butane or ethanol extraction, that labs can use to remove byproducts, Spivak-Birndorf says.

“But once you get into the process of converting CBD into delta-8, it’s called chemical synthesis,” he says. “You’re essentially taking one molecule and performing a chemical reaction that’s causing it to change into another molecule via that reaction.”

There are several standard operating procedures (SOPs) that can be used to extract delta-8; however, there are many “variables in terms of what can be left over in the product and how dangerous the substance is that labs use to catalyze that reaction and make it occur at a speed that’s acceptable for production,” he says.

PSI Labs has not yet conducted extensive research into what type of contaminants can be found in delta-8 products due to costs; however, the laboratory has brought in off-the-shelf delta-8 products from places like vape shops and gas stations for testing, and they’ve discovered discrepancies in the products.

“We often find that some of [the products] are very pure delta-8, but still contain traces of delta-9 that are technically above the legal 0.3% THC limit,” he says. “It’s just a mixed bag, and that’s what I think is so risky about it, is that it’s very uncontrolled in terms of these processes, where one product could be pretty genuine to its label, but another one might be very different.”

RELATED: Understanding Delta-8-THC: Where Does It Come From?

Allison Justice, Ph.D., CEO of The Hemp Mine, previously told Hemp Grower that in the delta-8 extraction process, the final distillate ends up being 60% to 70% delta-8 and roughly 2% to 6% delta-9. Suppose a company wants to make a compliant product with the U.S. Department of Agriculture’s (USDA’s) final rule on hemp. In that case, they will then run the distillate through extensive chromatography to remove the delta-9 or dilute it down to ensure it’s under the 0.3% THC limit, she said.

But Spivak-Birndorf says PSI Labs has found off-the-shelf delta-8 products that contain 20% delta-9, as well as a significant amount of CBD, meaning that whatever reaction pathway they chose, they didn’t finish it and left it “half-cooked,” he says.

“This raises lots of questions about what residual other byproducts might be in [the delta-8 products] that are sort of not familiar cannabinoids, but maybe harmful substances, like heavy metals, which can often be used in these processes,” he says.

Spivak-Birndorf says PSI Labs has come across many delta-8 vapes over the 0.3% THC limit; however, he thinks the real risk with mislabeling is with edibles. 

“Once you eat [the edible], that’s how much you eat, and you really can’t go back from there. So, that’s where testing is absolutely critical,” he says. “You really need to test things in a fashionable manner to make sure that there’s nothing wrong with your process. Other packaged and ready-made goods go through many good manufacturing practices (GMPs) and Food and Drug Administration (FDA) guidelines before they get to the shelf. In the cannabis industry, a lot of that stuff is non-existent or just catching up.”

Spivak-Birndorf says there is a need for third-party, end-product testing on a batch basis to ensure the products are correctly dosed before hitting shelves because there are not many regulated delta-8 testing and measurement practices in place.

“All of this is an important part of a good manufacturing practice of what goes into all the packaged goods we consume,” he says. “And so really, it should be implemented for delta-8 or delta-9, just like anything else.”

“There’s no reason to limit ourselves in terms of the cannabinoid toolbox,” he adds. “Whether it’s naturally occurring, semi-synthetic or even synthetic, it’s very important to know exactly what we’re dealing with and what quantities we’re dealing with if we want to avoid unknown adverse reactions and keep people as safe and healthy as possible.”

Minors the Main Victims

According to the Wayne State University report, in a nearby state, there were two reported cases of severe adverse reactions to delta-8 in children who ingested their father’s edibles purchased at a vape shop.

The report says that because delta-8 products are packaged in similar forms of CBD, teens and young children have a higher risk of using the compound accidentally. “THC use in children can cause low blood pressure, difficulty breathing, severe sedation, coma, and psychological effects. Long-term effects in children are not known,” the report says.

According to the National Capital Poison Center, because delta-8 products are largely unregulated, “the packaging may not be child-resistant and may contain cartoon-like images or other features that may be appealing to children.”

On its website, the National Capital Poison Center offers this anecdote: “A 3-year-old boy was brought to an Emergency Department after eating an unknown amount of delta-8 THC gummies belonging to his mother. The gummies were packaged in a container with a twist-off top, and the boy was able to open the container by himself. The child experienced vomiting but was eventually released from the hospital. His mother was cited for child abuse and neglect.”

Market Regulation Needed

Spivak-Birndorf says there is an increased need for regulation, as it is difficult to trace where these unsafe delta-8 products are coming from.

“While some of these companies have an online presence and show current testing and are actually responsible, for every one of those, there’s probably, and I would guess, numerous [companies] that are flying by night and just not checking their work,” he says. “Or they’re not concerned about quality control checks for their product, which they should have. So, definitely without that regulatory push to do all that stuff, it’s unrealistic to think that [everyone] is just going to take that upon themselves.”

As previously reported by Hemp Grower, Michigan has recently joined numerous other states in regulating delta-8, as Gov. Gretchen Whitmer signed legislation into law July 13, prohibiting businesses from selling delta-8 products without proper licensing from the Michigan Marijuana Regulatory Agency, and the products must be tracked and tested like any other cannabis product. 

Additionally, “the new law also bars businesses without state cannabis licenses from producing and selling any other potentially intoxicating cannabis compounds,” Hemp Grower previously reported.

And in late April, Hemp Grower reported that Washington’s Liquor and Cannabis Board (LCB) issued a policy statement, stating that “Delta-8 THC, as well as derivatives, extracts, cannabinoids, isomers, and CBD isolate from hemp or other sources that are genetically or chemically altered into compounds may not be produced or processed in LCB licensed facilities, and may not be sold in licensed marijuana retail stores.”

However, this does not necessarily mean delta-8 is outright banned in the state, as the LCB’s notice “was only an interpretation of the law as it relates to the legal cannabis market,” Hemp Grower reported.

Washington and Michigan are just two of nearly 20 states that have already regulated the cannabinoid. According to Hemp Grower, 15 states have issued bans on delta-8, while six additional states have pending legislation to regulate the cannabinoid and related THC isomers. 

Miller says the U.S. Hemp Roundtable has been working with states on developing laws that regulate delta-8 under the cannabis market because of its psychoactive properties. So far, Michigan, Oregon and New York have passed similar laws.

“I would very much hesitate buying a delta-8 product” in the current market, Miller says. “I would only buy things available in a dispensary that have been proven to undergo the same type of testing [as regulated cannabis].”

Not Just Delta-8

Delta-8 isn’t the only cannabinoid responsible for an uptick in poison center calls this year.

As of June 30, the American Association of Poison Control Centers (AAPCC) reported that poison control centers across the country had managed 2,158 cases in 2021 related to CBD. This is nearly on par with the 2,226 calls placed the entire year in 2020.

For perspective, in June 2020, poison control centers handled 181 cases related to CBD; in June 2021, that number jumped to 423.

The AAPCC offers this explanation on its website for the increase in calls: “…[S]ome products contain more CBD than what is on the label, more THC than labeled, or other chemical compounds/drug ingredients that are not listed at all. Consumers have no way of knowing whether the product is contaminated with other chemicals and drugs or labeled correctly.”

© Chart Courtesy of The American Association of Poison Control Centers

Miller points out that CBD is “a safe compound, and study after study have demonstrated its safety.” But without clear regulations or even guidance on how to produce CBD products, it’s possible the products contributing to poison control center cases don’t comply with GMP safety standards, Miller says.

“The challenge is that we’re in an unregulated marketplace,” he says. “These kinds of problems are hopefully going to spur Congressional action that will pass bills to develop a regulatory structure.”

Miller adds that the Hemp Access and Consumer Safety Act moving through the U.S. Senate would require the U.S. Food and Drug Administration to develop a regulatory pathway for CBD to be used in food, beverages and dietary supplements.

You can reach your local poison control center by calling the Poison Help hotline: 1-800-222-1222. To save the number in your mobile phone, text POISON to 797979.