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Biros' Blog

Judge Dismisses Claims in Vaping Illness Lawsuit

By Aaron G. Biros
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In September of 2019, Charles Wilcoxen fell seriously ill after vaping cannabis oil from a cartridge. Just days after he began experiencing symptoms he was hospitalized and later diagnosed with lipoid pneumonia, the mysterious lung illness now known as EVALI associated with the 2019 vape crisis.

Wilcoxen spent three days in the hospital and ever since he was diagnosed, he has been unable to exercise, return to work full time or even play with his daughter. Attorneys for Herrmann Law Group representing Wilcoxen filed a product liability lawsuit, Wilcoxen v. Canna Brand Solutions, LLC, et al., in Washington State Court, naming six cannabis companies as defendants: Canna Brand Solutions, Conscious Cannabis, Rainbow’s Aloft, Leafwerx, MFused and Janes Garden.

This image came from the complaint filed, alleging that Mr. Wilcoxen believes this was a CCELL product.

This case was allegedly the first lawsuit in the wake of the 2019 vape crisis. The Vanderbilt University Law School Blog has a very comprehensive post on this case that has the original complaint and a lot of information on the lawsuit.

Canna Brand Solutions, the primary defendant named in the complaint, is a packaging supplier and distributor for CCELL vaping products (heating elements, pens and batteries) in the state of Washington. The complaint alleges that Wilcoxen believes he used a CCELL vape. CCELL is a Chinese company, which makes it notoriously difficult to pursue legal action against them, hence why Canna Brand Solutions was listed as a defendant instead.

On August 31, 2020, Judge Michael Schwartz dismissed all claims against Canna Brand Solutions. “All claims asserted by Plaintiff against Canna Brand in the above-mentioned matter shall be voluntarily dismissed without prejudice and without costs or fees to any of the parties to this litigation,” Judge Schwartz says in the dismissal. Judge Schwartz dismissed the case without prejudice, meaning it could be brought to the court again should the plaintiff’s attorneys decide to do so.

With the allegations against Canna Brand Solutions focusing on CCELL products, it seems that the case was dismissed largely due to a lack of evidence connecting exactly which product resulted in the illness, as well as the lack of culpability for a distributor of products they did not manufacture.

These are the vape cartridges that Mr. Wilcoxen purchased

Daniel Allen, founder and president of Canna Brands Solutions, claims that the product mentioned in the complaint did not come from his company. “We stand by our high quality and customizable CCELL vaporization products,” says Allen. “We feel vindicated in this case by the judge’s decision, which shows the claims against our company and products were completely unfounded from the beginning.”

He also added that the quality and safety of the products they distribute is their highest priority. “The product in question involved in this case did not come from Canna Brand Solutions,” says Allen.

Wilcoxen’s illness and subsequent long-term lung injury is extremely unfortunate. Thousands of people have been hospitalized and 68 deaths have been confirmed by the CDC. The CDC is still calling the illness EVALI (e-cigarette, or vaping, product use-associated lung injury). According to the CDC, there is no real known cause of EVALI, but they have found that vitamin E acetate is “strongly linked” to the outbreak. Knowing that, it is entirely possible that Mr. Wilcoxen’s illness was a result of one of the cannabis products he consumed, just most likely not anything that came from Canna Brand Solutions. A closer look at the contents with an independent lab test of the THC oil he consumed could shed some more light on what exactly caused the illness.

I would venture to guess that one of the products he consumed did have vitamin E acetate. Because the case was dismissed without prejudice, it could be brought to the court again if, say, Mr. Wilcoxen’s attorneys were to obtain more evidence, such as an independent lab report showing vitamin E acetate in the contents of one of the products he consumed. If Mr. Wilcoxen’s attorneys can figure out which product actually contained vitamin E acetate, perhaps the lawsuit could get a second shot and Mr. Wilcoxen could have a greater chance at getting some long-overdue and much-deserved restitution.

Navigating the Cannabis Industry in the Current Climate

By Serge Chistov
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All major industries took a hit during the COVID-19 pandemic, but in many states, cannabis dispensaries were labeled as essential, which has allowed the industry to continue with some alterations. The impact now will come from what innovations and improvements the industry can leverage going forward.

From changes to protocols and buyer behaviors to supply chain disruptions, there were many new hurdles for the industry in addition to the ones cannabis businesses already faced, such as funding. But the silver lining could be that businesses within the cannabis industry become less of a specialty and more ‘every day’ than ever before.

The effects of the pandemic on the cannabis industry

Overall, the industry has fared well, in part thanks to its distinction as an essential service in states where cannabis is legal. It’s possible states made this decision for the same reason that alcohol businesses were deemed essential in most places: hospitals are not equipped during pandemic times to take care of people who are being forced to detox or those suffering from anxiety because they don’t have access to their legal drug of choice.

In a multitude of ways, cannabis businesses have adapted to bring calm in a storm while at the same time making manufacturing adjustments to meet the CDC guidelines. For example, there is more attention placed on individually pre-packaged products for single use; something that is less sharable as an experience but eminently practical.

Another area that has shifted a little is in the limiting of the exchange and interaction between business owners and staff relative to the customers. It’s all in the aim of mitigating the risk of exposure, but it has changed the dynamic in many cannabis businesses. This is the new normal for the time being and the industry has adapted well.

Ultimately, retail cannabis businesses today are no different than the retail of candy, cigarettes or alcohol. Certainly, segments of the industry have still struggled. Lack of tourism and the curbside/take out circumstances at dispensaries took their toll. But without the opportunity to still conduct business in some capacity, 50-60% of all operators would have gone out of business. Plus, as many people use cannabis to offset medical symptoms, including pain management, there is a legitimate need for cannabis to be available. The pandemic has provided the opportunity for many who might not have tried it before to give it a chance to help them medicinally.

Behaviors have changed, including those of buyers

Driven by consumer interests, many dispensaries have adapted to provide curbside pickup options, delivery of online orders and more. That has meant that the customer also needs to be more knowledgeable about cannabis: the experienced consumer knows what they like and want and can make their choices at a distance. Someone who is new to cannabis use might find navigating the choices and options a little more difficult, without the help of experienced staff. The breadth of material online and the ability of some dispensaries to share content that helps the consumer to make choices, in the absence of walking around the dispensary, have been additional tools at the disposal of businesses.

That said, the cannabis industry today is not a vastly different one: it is adapting to the new rules and new reality. Whether this way of doing business—at a distance—is a temporary or permanent solution will be dependent upon what federal and state regulators dictate in the months ahead, but there is likely to be ongoing demand for being able to order online and keep social distance protocols in place.

An interesting example is the Ontario Cannabis Store (OCS) in Ontario, Canada. This is a government run shop that has retail as well as a robust online presence, with free delivery during the pandemic. This has facilitated an increase in new customers, which had already jumped, post legalization. People who might have felt uncomfortable going into a dispensary can still learn about cannabis online and order it, from the relative comfort and safety of their sofa.

Supply chain disruptions and the cannabis industry

The industry has long been focused on overseas suppliers. With the arrival of the pandemic and restrictions on obtaining products from other countries, supply chains have been disrupted for many cannabis businesses. That has forced many to shift their supply chains to more local manufacturers, in North and South America.

In the long run, this should have a positive impact for the industry, so that despite the short-term disruption to the supply chain, which is having an impact on the industry as a whole, there could be an upside for local producers, growers and manufacturers. It will take time to know how this will all play out.

Funding and other issues for the cannabis industry

For a new cannabis startup in these times, the key will be what it has always been for any business, just to a greater degree: due diligence. Companies that want to open a cannabis business, whether during the pandemic or not, need to evaluate the opportunity as one would any investment. It’s all about the numbers: data for the industry as a whole and specifically from competition. These days, that data is widely available and more and more consultants and investors have expertise in this industry. “Overall, there is more interest in the industry than ever before”

It’s vital to be extremely well versed, particularly for businesses that are relatively new in the industry, because the single biggest issue for many has and will continue to be funding and investment. The cannabis industry is no different than any other business, except for the fact that it is a specialty business. With that comes the need to look for funding among investors who have some knowledge or appreciation for the industry.

Some of the key concerns traditional investors will have include:

  • Regulatory differences from state to state: since cannabis is still illegal at the federal level, there can be an array of hurdles at state and local level that make cannabis businesses trickier to work with.
  • There are religious based/morality issues for some lenders in dealing with the industry. These aren’t dissimilar from issues with other industries such as adult entertainment and gaming. It’s also fair to point out that, morality aside, these industries have thrived in the last several decades.

So, while traditional banking institutions will often deal with the proceeds from the cannabis industry, including allowing bank accounts for these businesses, there is far less of a chance that they would invest in a cannabis business, for fear of risking their license. They can even go so far as to refuse to include income from a cannabis business in the determination of a loan application.

There are more unique lending or investing groups that either specialize in cannabis or are starting to open their books to specialize in cannabis. Overall, there is more interest in the industry than ever before, as it becomes normalized in American society: more participants and more insiders of the industries that are willing to invest in the right idea.

Will legalization be more likely in the future?

The fact that cannabis businesses and dispensaries have been deemed essential services during the pandemic, where they legally operate, has shed new light on the relevance of these businesses and the advantages of more widespread legalization.“Consumers will help drive the innovations as they demand clean consumption methods”

In fact, the pandemic has normalized a lot of new behaviors, including the acceptable use of cannabis to help with stress and anxiety. People are, perhaps thanks to staying at home more, doing the legwork to understand how cannabis could be useful to them in managing their stress. The medicinal benefits of cannabis have long been researched and understood: consumers are coming into the fray to express their interest in it, which can only fuel the possibility of more widespread legalization.

Add to this the fact that the cannabis industry is a growth industry. There are companies and jobs that aren’t coming back, post-pandemic. There is an opportunity to grow the cannabis industry to the general benefit of many, both as business owners and employees. The revenue generated from taxation following legalization would also benefit many state coffers. Federal level legalization would be the panacea to eliminate the mixed message, state by state regulation that currently exists.

Opportunities for innovation, moving forward

As more and more people become interested in the industry, and as cannabis use is normalized within society through legalization, the opportunities for the industry can only expand.

For an industry that started on the simple concept of smoking cannabis, the advances have already been legion: edibles, nanotechnology-based formulations for effective, clean consumption and many more innovations.

In a world that increasingly sees smoking as a negative, for the obvious impact to lung health, there are so many opportunities to grow the industry to find consumption methods that are safe and still deliver the impact of the inhaled version.

Here again, consumers will help drive the innovations as they demand clean consumption methods. The technology is available to make this possible; it only takes innovation and education to find the best ways to move this industry forward.

As legalization expands—and particularly if it is dealt with at the federal level—the industry will be able to capitalize on existing infrastructure for manufacturing and distribution, allowing new businesses to grow, get funded and thrive in the new normal.

How Barcode Labeling Improves Traceability & Security

By Travis Wayne
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One of the biggest challenges that cultivators, processors and distributors face in doing business is the requirement to track the product at every step in the production process, from seed to sale. When you add the wide range of label sizes and requirements across the supply chain, labeling can feel overwhelming. While business systems such as METRC, BioTrack, MJFreeway and others are key, integrating accurate and secure barcode labeling with those systems will streamline the end-to-end process while meeting traceability requirements. Here are some things to consider, no matter what role in the cannabis supply chain you play.

Cultivation: Where Tracking and Labeling Starts

Cultivation is where the tracking process begins – integrating barcode labeling METRC, BioTrack, MJ Freeway from the start will streamline the end-to-end process

It’s crucial to implement accurate labeling processes from the beginning, whether growing for a customer or your own vertically integrated operation. The cannabis industry is faced with strict labeling regulations for a variety of cannabis products. Start with a labeling system that can integrate with METRC, BioTrack, MJ Freeway or other seed to sale software solutions. Your barcode labeling solution should also include label approval requirements, so you have role-based access and transparency with label changes and print history in case of issues or recalls. Whatever cannabis labeling regulations your business faces, label design software helps you create compliant cannabis labels throughout the supply chain, from grower to consumer.

Radio Frequency Identification (RFID) Labeling

Select regulations require growers to leverage RFID technology to track the location of the plants in their grow houses. RFID technology also enables accurate real-time inventory analysis and helps reduce manual labor costs, as well as errors that can occur with manual counting. To accurately encode RFID tags with variable plant data, be sure you are using a barcode labeling system that can enable easy RFID tag encoding that integrates data from all your business systems. Fastening RFID tags to plants across your grow house floor enables quick and easy location tracking, and RFID reading removes the need for a manual line of sight and allows hundreds of tags to be read at the same time, speeding up shipping and receiving.

Lab Testing

After a plant is cultivated, a certain percentage is sent to a lab to be tested to ensure its proper strain, weight and compound makeup. After your product has been lab tested, leverage the data from your certificate of analysis to accurately display on your cannabis product labels, including:

  • Pass/fail chemical testing
  • Final date of testing & packaging
  • Identification of testing lab
  • Cannabinoid profile & potency levels
  • Efficiently display lab testing results on product labels with the use of a QR code for the consumer to review the independent lab’s certificate of analysis

Processing and Production: Tracking and Labeling After the Plant Has Been Harvested

A lot of information needs to go on a cannabis label. Whether you’re producing pre-rolls, packaged flower, edibles, beverages, topicals or cartridges, your labeling software must have the capability to create a wide variety of label sizes with barcodes that encode a large volume of data, while also being fully compliant and showing consumer appeal.

Your cannabis labeling software should do the following for you:

  • Support database integration to populate variable data from METRC, BioTrack, and other systems
  • Import high-resolution artwork and leverage with dynamic barcodes and variable data
  • Contain barcode creation wizards for 1D & 2D barcodes
  • Automate weigh & print
  • RGB/CMYK color matching
  • Feature secure label approval processes, label change tracking and print history
  • Offer WYSIWYG (What You See is What You Get) printing
  • Automatically trigger printing directly from scales and scanners when cannabis is weighed
Automatically integrating data with your barcode labeling software improves regulatory compliance, security and reduces manual processes that can lead to labeling errors

Integrate labeling with your seed to sale software solution to automatically trigger label printing by an action in your seed to sale system or by monitoring a database. By integrating your label printing system with your seed to sale traceability system, you can expect to minimize errors, increase print speeds and maximize your ROI. Your business system already holds the variable data such as product names, license number, batch or lot codes, allergens, net quantity, cannabis facts, warning statements and more. By systematically sending this data to the right label template at the right time, labeling becomes an efficient and cost-effective process.

Distribution: labeling for consumer and industry demands

The ability to manage and distribute inventory efficiently is critical in the cannabis market. Warehouses and distributors need to ensure proper storage, handling and traceability of product, from the warehouse to the truck.

Leverage your labeling software to easily create:

  • Packaging labels
  • Shipping labels
  • Case & pallet labels
  • Inventory labels

If you use the same data for your documents and labels, consider moving document printing into your label design software for greater efficiency. An advanced label creation and integration software enables label and document printing standardization by allowing multiple database records to be on one file. That means when new documents or labels come into your database, your software can seamlessly integrate.

Dispensaries can benefit from integrated seed to sale labeling for traceability, speed to market

Whether you’re a small outlet or a large dispensary, you benefit from integrated barcode labeling that starts from the beginning of the process. How? When barcode labeling software is integrated with seed to sale software, product is fully traced throughout the entire process, from tagging each plant at cultivation to identifying the consumer at point of sale, and accurately communicating that data back to METRC, BioTrack and other critical systems. Some dispensaries do package raw flower onsite, which many times means manually weighing, recording and entering the weight on the label, which is a time consuming and error-prone process. Integrating weigh and print functionality with barcode software enables dispensaries to use the action of weighing raw flower to automatically trigger the label print job. The variable weight is then accurately and automatically populated on cannabis flower package labels, creating an accurate and efficient on-demand labeling process for dispensaries. With efficient labeling processes, time spent creating, correcting, approving and printing labels will be reduced, getting product on the shelves faster.

A2LA Accredits Viridis Laboratories

By Cannabis Industry Journal Staff
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In a press release published this week, the American Association for Laboratory Accreditation (A2LA) announced they have successfully accredited Viridis Laboratories to ISO/IEC 17025:2017.  Viridis Labs, based in Lansing, Michigan, gained their license to operate as a cannabis testing facility back in April 2020.

“Our company is incredibly proud of achieving this milestone of ISO/IEC 17025 accreditation through A2LA’s rigorous assessment program,” says Greg Michaud, CEO of Viridis Labs. “The choice to partner with A2LA was a simple one due to their international reputation as a global leader in accreditation programs. Additionally, their partnership and certification program through the American’s for Safe Access strengthens our accreditation further and helps solidify Viridis as Michigan’s premier cannabis testing laboratory.”

CBD Watchdog Finds Beverage Labeling Inaccuracies

By Cannabis Industry Journal Staff
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According to a press release published in late August, CBD watchdog Leafreport found a large number of inaccuracies when testing CBD-infused beverages on the market today. Leafreport conducted independent lab testing on 22 different CBD-infused beverages and found more than half of the products had less CBD than the label claimed. To be specific, 12 out of the 22 products tested contained less CBD than advertised.

Canalysis Laboratories, the lab contracted to conduct the testing, found two of the products didn’t even contain any CBD. 18 of the beverages had CBD levels with a label claim variance greater than 10%. 14 of the beverages had CBD levels with a label claim variance greater than 40%. Only 4 of the beverages achieved an ‘A’ letter grade for coming within 10% of their advertised CBD levels.

According to Lital Shafir, head of product at Leafreport, the CBD beverage market is a bit tricky, largely due to product formulation issues. “This is in line with our expectations because CBD beverages are difficult to formulate and contain relatively small amounts of CBD, which means that variations of even a few milligrams can have a big effect,” says Shafir. “The CBD industry is completely unregulated and there have been many cases of companies selling products that contain little to no CBD. That’s why third-party testing is important for brands in this industry.”

Interestingly, this report did not find a positive correlation between a company’s reputation and their product’s test results. The full study can be found here. Leafreport is an independent, peer-reviewed website dedicated to increasing transparency in the CBD marketplace.

Leaders in Extraction & Manufacturing: Part 4

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

In this week’s article we talk with Michael Schimelpfenig, head of R&D and BHO extraction manager at Bear Extraction House. Michael worked in the cannabis space for about five years prior to landing his role at Bear, having spent several years in the hills of Humboldt County. The interview with Michael was conducted on August 3, 2020.

In next week’s piece, we sit down with Kristen Suchanec, vice president of Production at Island. Stay tuned for more!

Aaron Green: Good morning Michael and thank you for taking the time to chat with me today!

Michael Schimelpfenig: Thanks, excited to be here!

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

Michael Schimelpfenig, head of R&D and BHO extraction manager at Bear Extraction House.

Michael: You know, I actually landed my role at Bear through a job search on LinkedIn. I had been working in the traditional market for five years and was getting tired of the irregular paychecks and general uncertainty of working in that market. You know, too many helicopter buzzes and all that. I felt like the risk vs reward just wasn’t there. I like Northern California and knew I wanted to find something up in Humboldt County where I had been fortunate to get experience out in the hills. After I applied on LinkedIn, I was contacted in twenty-four hours. I had an interview twenty-four hours after that and the next day I had a job! It’s been a big change going to a legal company. The possibilities are lightyears beyond what you can do in the traditional market. Lots of resources and equipment available that just aren’t there in the traditional market.

Aaron: Fascinating! I spent a week up on Humboldt last year and it is beautiful up there. The next questions will be focused on product development and manufacturing. What is your decision process for starting a new product?

Michael: We get feedback from a lot of different places. Sometimes a new product idea is coming from our CEO, Per. He comes to me with new ideas and asks if we can do something. Often it will start with a general question. Is it possible with the given capabilities? Is it scalable? Some of our new product ideas are based on market input and then others are based on employee input. Sometimes we have pre-existing ideas and just need to sit down to formalize them. Here at Bear we have the capability of making a lot from a little input.

We’re always playing with ideas. We have lively R&D meetings each week where we throw ideas around. Take byproducts from a product development run for example. Maybe it’s not a byproduct, but maybe a separate new product altogether! Sometimes we’ll start off wanting to make something and, in the process, create something unexpected that we are then able to turn into a product. Creating new products is just as important as improving optimizations. Ideas come from all over the place.

We focus these ideas through the R&D committee. Common questions include: How do we develop the product? What are the costs? Is it marketable? We have to view things from an economic standpoint and we wont proceed until we can figure out what the product can be and what we can make money from. Our R&D committee is made up of our COO, Jeff, our lead extractor, our oven room manager and our post-production manager who focuses on product separation. When we kick a new project off It all takes lots of scheduling and coordination.

Aaron: Are you developing new products internally?

Michael: We do 100% in-house product development and manufacturing. We are formalizing and creating a more focused approach to R&D and are bringing in some academics now. They are young minds with backgrounds in organic chemistry and thermodynamics. This is important because it’s the science behind the process that helps to generate the products. We believe the added talent should help to provide some grounding to the R&D. Before we made a lot of products by accident. The ultimate goal is uniform manufacturing and that requires an understanding of molecular processes.

Aaron: Answer the next question however you like. What does being stuck look like for you?“If a product isnt behaving the way we expect, we will do testing to determine cannabinoid and terpene levels to gain better understanding.”

Michael: Well, there are a couple ways to get stuck. Sometimes you can get stuck with a limited product portfolio. A year and a half ago all we made was live resin. Now we have different levels of live resin and six different vape carts. If you are not changing and developing new products, you are stuck.

When the web of production stops going that is definitely what I consider getting stuck. You can get stuck if sourcing material is difficult to find or cost prohibitive. We will pivot and adjust manufacturing material if that happens. We are also exploring best avenues for sourcing high quality trim and working with farmers to specifically grow strains and exotic genetics. But overall, getting stuck happens. Being stuck, on the other hand, is a lack of creativity.

Aaron: If you get stuck is it usually the same place? Or is it different each time?

Michael: We have redundancies for equipment and components. If we are getting stuck in the same place it is usually due to a lack of source material. Sometimes we get material that degrades prior to extraction. It’s a matter of contacting supplier to coordinate with them on the best approach forward. If a product isnt behaving the way we expect, we will do testing to determine cannabinoid and terpene levels to gain better understanding. In the end, sometimes we just have to pivot to other products with things we have.

Aaron: Thanks for that. Now, imagine you have a magic wand that can take care of your issues. What does your magic helper look like?

Michael: My magic helper would be someone to help with reporting. Someone that can take care of METRC indexing and preparing final R&D reports. Like a magic data processor. Someone to handle the minutiae.

Aaron: Whats most frustrating thing you are going through with the business?

Michael: There’s never enough time! We continue to manufacture at full capacity all the time. With that demanding of a schedule it can be difficult to manage time between day-to-day processes and being able to look at bigger picture.

Aaron: Now for our final question: What are you following in the market and what do you want to learn about?

Michael: I’m following the guys out there that are heavy into crystallization. There are some huge THCA diamonds coming from East Coast Gold. I would like to know what their solution is. What is their magic liquid and process? I am a big fan of diamond growth. You can grow extremely pure isolates that way. We grow our own diamonds and have had them tested greater than 99.99% THCA. I think high level purity THCA from diamonds is preferred versus distillate. There is a difference in the smoke between them too. Having a process for making large quantities of diamonds would open us up to sticking our foot in edibles and topicals too. There is control that comes with having a purity level like that. Dosage is difficult without it. I am also interested in improving extract purity and isolating terpenes. I like solvent-less products. It means it came from a high-quality source. I would be just as happy smoking good flower as concentrate derived from the same flower.

Aaron: Alright that concludes our interview! Thank you again for the time today, Michael!

Michael: Thank you.

Shimadzu & Front Range Biosciences Announce Partnership

By Cannabis Industry Journal Staff
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According to a press release, Shimadzu Scientific Instruments and Front Range Biosciences (FRB) announced a partnership where they will establish the FRB Hemp Science Center of Excellence. The center will focus on genetics, biobanking, breeding and analysis, all with Shimadzu instrumentation. The center will host scientists performing chemical and genetic analytical research to “support the development of new hemp varieties for the production of cannabinoids, terpenoids and other compounds for medical and wellness applications; lipid, wax and protein ingredients for food and cosmetics applications; and fiber for industrial applications.”

Dr. Jon Vaught headshot
Dr. Jon Vaught, CEO of Front Range Biosciences

Located at FRB’s new headquarters in Boulder, CO, the new center will allow for collaborative efforts between researchers from the public and private sectors like academic, nonprofit and government agencies. The center will expand FRB’s collaboration with the University of Colorado at Boulder. Researchers at other institutions can apply for grants to support students, postdoctoral candidates and other researchers at the new center.

Dr. Jonathan Vaught, CEO of FRB, says they’re honored to work with Shimadzu and their instrumentation. “Front Range Biosciences is honored to partner with the world-class team at Shimadzu. Combining their innovative and proven cannabis and hemp analytical instrumentation solutions with our next-generation breeding program, we will be well positioned to continue advancing the industry with data-driven science so we can harness the incredible potential of this versatile plant for therapeutic, wellness, nutrition and industrial applications,” says Dr. Vaught. “We are confident that with Shimadzu’s cutting-edge technology, we will be able to drive forward-thinking solutions in this growing industry to better serve farmers, producers and consumers.”

CBD You in Court: Consumer Class Actions Involving Hemp-Derived CBD Products

By David J. Apfel, Nilda M. Isidro, Brendan Radke, Emily Notini, Zoe Bellars
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Consumer demand for products containing cannabidiol (CBD) is on the rise across the country, with industry experts estimating that the market for CBD products will reach $20 billion by 2024. This boom in consumer demand has outpaced the regulatory framework surrounding these products. While the 2018 Farm Bill decriminalized hemp, it left much up to individual states and preserved the FDA’s jurisdiction over dietary supplements, foods and cosmetics. The FDA has not yet issued any specific rulemaking for CBD products.

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

Against this background, it is not surprising that consumer class actions regarding hemp-derived CBD products are flourishing. Over the past year alone, the plaintiffs’ bar has filed approximately twenty putative class action lawsuits against manufacturers of hemp-derived CBD products. The cases are primarily in federal court in California and Florida, with additional cases in Illinois and Massachusetts. Plaintiffs challenge the marketing and advertising of a variety of CBD products, including oils, gummies, capsules, creams, pet products and more.

The cases so far follow a familiar pattern seen in prior consumer class actions, especially in the food and beverage industry. Read on to learn what plaintiffs have claimed in the CBD lawsuits, how companies are defending their products, and how best to position your hemp-derived CBD products in light of lessons learned from past litigation.

What These Lawsuits Are Claiming, and How Companies Are Defending Their Products

In most of the recent CBD lawsuits, plaintiffs claim either that: 1) product labels over- or understate the amount of CBD in the products; and/or 2) the sale of CBD products is inherently misleading to consumers because the products are purportedly illegal under federal law. Regardless of which theory underlies the claims, plaintiffs typically frame their claims as consumer fraud, false advertising, breach of warranty, unjust enrichment, and/or deceptive trade practices.

Just some of the many CBD products on the market today.

In most cases, defendants have filed motions to dismiss seeking to have the cases thrown out. In these motions, defendants argue that plaintiffs’ claims are “preempted” by the Federal Food Drug and Cosmetic Act (FDCA), and that only the federal government can enforce the FDCA. Some defendants have additionally argued that if the court is not prepared to dismiss the claims as preempted, the doctrine of “primary jurisdiction” applies. This means that the issues raised regarding CBD are for the FDA to decide, and the cases should be stayed until the FDA finalizes and issues rules on products containing hemp-derived CBD. Many defendants have also advanced dismissal arguments for lack of standing, claiming that the individuals bringing the lawsuits are trying to sue for conduct that never harmed them personally (e.g., because they never purchased a particular product), or will not harm them in the future (e.g., because plaintiffs have stated they will not buy the product again). The standing arguments often apply to particular claims or products within the lawsuit, rather than to the lawsuit as a whole.

Current Status of the Cases

Of the approximately twenty consumer class actions filed over the last year, about half remain pending:

  • Five have been stayed pursuant to motions filed by defendants;
  • Two have motions to dismiss pending;
  • One has a pending motion to vacate a default judgment against defendants;
  • One was filed earlier this month, and defendant’s deadline to respond has not yet elapsed.

FDAlogoTo date, none of the cases (currently pending or otherwise) has proceeded to discovery, and no class has yet been certified. That means that no court has yet determined that these cases are appropriate to bring as class action lawsuits, rather than as separate claims on behalf of each individual member of the putative class. This is significant, because plaintiffs’ ability to achieve class certification will likely influence whether these CBD lawsuits will continue to be filed. Consumer fraud cases like these typically do not claim any physical injury, and the monetary damages per individual plaintiff are relatively low. As such, the cases often are not worth pursuing if they cannot proceed as class actions.

Of the cases that are no longer pending, all but two were voluntarily dismissed by plaintiffs. While the motivation behind these dismissals is not always announced, approximately half of the voluntary dismissals came after defendants filed a motion to dismiss, but before the court had ruled on it. One Florida case was mediated and settled after the court denied defendant’s motion to dismiss.1 A California court spontaneously dismissed one matter (without the defendant having filed any motion) due to a procedural defect in the complaint, which plaintiffs failed to correct by the court-imposed deadline.2

Early Outcomes on Motions to Dismiss 

Of the thirteen motions to dismiss filed to date, only five have been decided. So far:

  • No court has dismissed a case based on federal preemption grounds. Courts have either deferred ruling on preemption, or denied it without prejudice to re-raising it at a later time.
  • Four courts have stayed cases based on primary jurisdiction.3
  • Only one court has denied the primary jurisdiction argument.4
  • Standing arguments have been successful in three cases,5 and deferred or denied without prejudice to later re-raising in the other two cases.6 However, the standing arguments applied only to certain products/claims, and were not dispositive of all claims in any case.

These rulings show a clear trend towards staying the cases pursuant to primary jurisdiction. In granting these stays, courts have noted that regulatory oversight of CBD ingestible products, including labeling, is currently the subject of FDA rulemaking, and that FDA is “under considerable pressure from Congress” to expedite the publication of regulations and guidance.7

Any label claims need to meet FDCA regulations and applicable FDA guidance.

Plaintiffs may be recognizing the trend towards primary jurisdiction as well, since there is now at least one case where plaintiffs agreed to a stay after defendant filed a motion to dismiss asserting, among other things, primary jurisdiction.8 But some plaintiffs are still resisting. For example, in the first case to have been stayed plaintiffs have since filed a motion to lift the stay. The motion—which was filed after the case was reassigned to a different judge—argues that primary jurisdiction does not apply, and that the FDA’s recent report to Congress suggests no CBD-specific rulemaking is forthcoming.9 The motion is pending.

Lessons Learned From Food Industry Consumer Class Actions

The motions to dismiss that have been filed to date in CBD-related class actions follow a tried and true playbook that has been developed by defense counsel in other food and beverage industry class actions. For example, the primary jurisdiction arguments that have been gaining traction in the CBD consumer class actions are very similar to primary jurisdiction arguments that were successful years earlier in cases involving the term “natural” and other food labeling matters.10

Similarly, the standing arguments that have succeeded in the early motions to dismiss CBD consumer class actions followed similar standing arguments made years earlier in food and beverage class actions.11

Work with reputable labs to ensure the potency stated on the label is accurate

The preemption arguments that have largely been deferred in CBD consumer class actions to date could become a powerful argument if and when the FDA completes its CBD rulemaking. The preemption defense has been particularly effective when the preemption arguments focus on state law claims that require defendants to omit or add language to their federally approved or mandated product labeling, or where plaintiffs otherwise seek to require something different from what federal standards mandate.12 These arguments could be particularly compelling once the FDA issues its long-anticipated rulemaking with respect to CBD products.

Until then, primary jurisdiction will likely continue to gain traction. The FDA’s comprehensive regulatory scheme over food, dietary supplement, drug, and cosmetic products, combined with the FDA’s frequently-expressed intention to issue rulemaking with respect to CBD-products, and a need for national uniformity in how such rulemaking will interface with state requirements, converge to make primary jurisdiction especially appropriate for CBD-related class actions.13

How to Best Position Your Products

Until the FDA issues its long-awaited rulemaking regarding CBD products, companies can take the following steps to best position their products to avoid litigation and/or succeed in the event litigation arises:

  • Work with reputable labs to ensure the amount of CBD stated on product labeling and advertising is accurate;
  • Ensure that the product is manufactured according to appropriate current Good Manufacturing Processes (cGMPs);
  • Ensure that any claims made on product labeling and/or in advertising are consistent with FDCA requirements and applicable FDA guidance to date – for example, if the product is a dietary supplement, avoid making express or implied claims that it can cure or prevent disease;
  • Maintain a file with appropriate substantiation to support any claims stated in product labeling and advertising;
  • Work with legal counsel to stay abreast of developments in federal and state laws applicable to hemp-derived CBD products, and how any changes might impact potential class action defenses; and
  • If a lawsuit arises, work with legal counsel to develop a strategy that not only resolves the current litigation as efficiently as possible, but also positions the company strategically for any future consumer claims that may arise.

References

  1. Final Mediation Report, Potter v. Potnetwork Holdings, Inc., 1:19-cv-24017-RNS, (S.D. Fla. July 30, 2020).
  2. Court Order, Davis v. Redwood Wellness, LLC, 2:20-cv-03273-PA-JEM (C.D. Cal. Apr. 10, 2020).
  3. Electronic Order, Ahumada v. Global Widget LLC, 1:19-cv-12005-ADB (D. Mass. Aug, 11, 2020); Memorandum and Order, Glass v. Global Widget, LLC, 2:19-cv-01906-MCE-KJN (E.D. Cal. June 15, 2020); Order Granting in Part Defendant’s Motion to Dismiss and Staying Remaining Causes of Action, Colette et al. v. CV Sciences Inc., 2:19-cv-10227-VAP-JEM (C.D. Cal. May 22, 2020); Order on Motion to Dismiss, Snyder v. Green Roads of Florida LLC, 0:19-cv-62342-AHS (S.D. Fla. Jan. 3, 2020).
  4. Order on Motion to Dismiss, Potter v. Potnetwork Holdings, Inc., 1:19-cv-24017-RNS, (S.D. Fla. Mar. 30, 2020).
  5. Order Granting in Part Defendant’s Motion to Dismiss and Staying Remaining Causes of Action, Colette et al. v. CV Sciences Inc., 2:19-cv-10227-VAP-JEM (C.D. Cal. May 22, 2020); Order on Motion to Dismiss, Potter v. Potnetwork Holdings, Inc., 1:19-cv-24017-RNS, (S.D. Fla. Mar. 30, 2020); Order on Motion to Dismiss, Snyder v. Green Roads of Florida LLC, 0:19-cv-62342-AHS (S.D. Fla. Jan. 3, 2020).
  6. Electronic Order, Ahumada v. Global Widget LLC, 1:19-cv-12005-ADB (D. Mass. Aug, 11, 2020); Memorandum and Order, Glass v. Global Widget, LLC, 2:19-cv-01906-MCE-KJN (E.D. Cal. June 15, 2020).
  7. Order on Motion to Dismiss at 12, Snyder v. Green Roads of Florida LLC, 0:19-cv-62342-AHS (S.D. Fla. Jan. 3, 2020).
  8. Minute Entry, Pfister v. Charlotte’s Web Holdings, Inc., 1:20-cv-00418 (N.D. Ill. Aug. 11, 2020).
  9. Plaintiff’s Motion to Lift Stay, Snyder v. Green Roads of Florida LLC, 0:19-cv-62342-AHS (S.D. Fla. July 13, 2020).
  10. See, e.g., Astiana v. Hain Celestial Grp., Inc., 905 F. Supp. 2d 1013 (N.D. Cal. 2012), rev’d on other grounds, 783 F.3d 753 (9th Cir. 2015); Taradejna v. Gen. Mills, Inc., 909 F. Supp. 2d 1128 (D. Minn. 2012).
  11. See Miller v. Ghirardelli, 912 F. Supp. 2d 861, 869 (N.D. Cal. 2012) (holding that the named plaintiff lacked standing where the products purchased by the putative class members were not “substantially similar” enough to those purchased by the named plaintiff); Colucci v. ZonePerfect Nutrition Co., No. 12-2907-SC, 2012 WL 6737800 (N.D. Cal. Dec. 28, 2012) (finding one of two named plaintiffs lacked standing because, even though the other named plaintiff (his fiancée) purchased the nutrition bars for him, he himself did not purchase any of the bars); Veal v. Citrus World, Inc., No. 2:12-CV-801-IPJ, 2013 WL 120761 (N.D. Ala. Jan. 8, 2013); Robinson v. Hornell Brewing Co., No. 11-2183 (JBS-JS), 2012 WL 6213777 (D.N.J. Dec. 13, 2012) (holding that there was no Article III standing because the named plaintiff had testified and stated in written discovery that he would not purchase the product in the future).
  12. See, e.g., Turek v. Gen. Mills, Inc., 662 F.3d 423 (7th Cir. 2011); Lam v. Gen. Mills, Inc., 859 F. Supp. 2d 1097 (N.D. Cal. 2012); Veal v. Citrus World, Inc., No. 2:12-CV-801-IPJ, 2013 WL 120761, at *9-10 (N.D. Ala. Jan. 8, 2013).
  13. See, e.g., Astiana v. Hain Celestial Grp., Inc., 905 F. Supp. 2d 1013 (N.D. Cal. 2012), rev’d on other grounds, 783 F.3d 753 (9th Cir. 2015); Taradejna v. Gen. Mills, Inc., 909 F. Supp. 2d 1128 (D. Minn. 2012).

Iridium Consulting & Ionization Labs Launch New Partnership

By Cannabis Industry Journal Staff
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According to a press release published today, Iridium Consulting and Ionization Labs announced the launch of their new partnership for in-house R&D testing. The partnership will launch a new series of in-house potency testing solutions, aimed at increasing accuracy and speed for cannabis companies looking to improve their product quality, while also simplifying the testing process.

Ionization Labs, based in Austin, Texas, has a “Cann-ID Potency Testing Solution” that uses an integrated, proprietary software for cannabinoid analysis. That testing solution allows growers and producers to measure potency in-house. Iridium is providing the service as part of their consulting offering for the cannabis and hemp industry, starting with clients based in California.

“We are delighted to add the Ionization Labs service to our list of offerings for cannabis and hemp clients” says Aaron Green, partner and co-founder at Iridium Consulting. “We have seen a lot of technologies on the market for cannabis R&D potency testing and no other solution provides comparable accuracy, efficiency and ease of use.”

Sponsored by Agilent

Agilent Introduces New eMethods & Consumables Kits

By Cannabis Industry Journal Staff
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Sponsored by Agilent

Agilent Technologies just announced a new line of products for cannabis testing labs. Their newest tool, Agilent eMethods, are downloadable, plug-and-play instrument methods that “establish reliable efficient protocols with an end-to-end workflow that addresses the different testing needs, and offers guidance on sample preparation, consumables, and supplies.”

Those eMethods give labs a complete analytical system configuration for automating testing, sample prep, separation and detection, along with data processing and reporting abilities. The tool is designed with startup labs in mind, given how tedious developing new testing methodology can be.

According to Monty Benefiel, vice president at Agilent and general manager of the Mass Spectrometry Division, the new tool should give some labs a head start when it comes to method development. “The fledgling market of cannabis and hemp testing has an urgent need for solutions that help ensure efficiency as well as regulatory compliance,” says Benefiel. “Our new tool—Agilent eMethods—along with the Cannabis and Hemp Potency Kit and Cannabis Pesticide and Mycotoxin Kit gives labs a head start in establishing testing procedures, increasing productivity and profitability, and greatly reducing risk.”

In addition to the new eMethods, the company is also rolling out their newest consumables kits: The Cannabis and Hemp Potency Kit and the Cannabis Pesticide and Mycotoxin Kit. These are designed to help labs set up and simplify analyses for complex matrices. They include all the consumables necessary to perform each test and come with step-by-step instructions.