Tag Archives: results

By Cannabis Industry Journal Staff

Canadian cannabis giant Tilray (NASDAQ:TLRY) announced its fiscal second quarter of 2022 results last week. The company reported net revenue of $155 million in Q2 which was an increase of 20% year over year. Tilray attributed these gains to its expansion in verticals that include alcohol as well as hemp-based wellness.

Despite an uptick in sales, Tilray’s gross margin reduced by 7% to $32.8 million as the Canadian cannabis market continues to wrestle with oversupply issues resulting in lower-priced products. Alternatively, Tilray claimed its cost-reduction program is running ahead of schedule and it expects to save $100 million by 2023, up from its earlier forecast of savings of $80 million.

Tilray reported a net income of $6 million in Q2, compared to a year-ago loss of $89 million. The fiscal second quarter was also the 11th consecutive quarter where Tilray reported an adjusted EBITDA. This figure stood at $13.8 million in Q2.

Tilray stock rose by 15% in the two trading days following its Q2 results.

What impacted Tilray in Q2 of fiscal 2022?

Tilray explained its Q2 results were solid as it has successfully built a cannabis and lifestyle brand. Further, the company continues to benefit from its scale, global distribution capabilities as well as operational excellence allowing it to increase sales and maintain profitability despite macro-economic headwinds.

Last year, Tilray completed its merger with Aphria making the combined entity the largest cannabis producer in Canada in terms of market share and sales. Tilray maintained its leadership position in the country despite market saturation and rising competitive challenges.

The company enjoys strong brand recognition and is focused on ensuring an adept pricing environment. It also believes marketing adjustments will allow Tilray to aggressively capture market share going forward.

Germany is the largest medical cannabis market in Europe where Tilray has a 20% share. It’s well-positioned to capture the adult use cannabis market as well in Europe, if and when cannabis is legalized in this region.

Tilray, similar to most other producers aggressively acquired companies in the past. Its acquisition of the U.S.-based SweetWater Brewing and Manitoba Harvest provides it a foothold in the world’s largest cannabis market. These two companies have invested in product innovation to enhance awareness and distribution.

Further, SweetWater and Manitoba Harvest are profitable and provide Tilray an opportunity to launch THC-based products in the U.S. when pot is legalized at the federal level.

What next for TLRY stock?

During its earnings call, Tilray disclosed its new parent name called Tilray Brands. It reflects the company’s evolutions from a Canadian licensed producer to a global consumer packaged goods company with a leading portfolio of cannabis and lifestyle CPG brands.

Tilray aims to post annual sales of $4 billion by 2024 which is quite optimistic given analysts expect revenue to grow to $980 million in fiscal 2022 and $1.2 billion in fiscal 2023. In order for Tilray to reach its lofty goals, it will have to acquire other licensed producers resulting in shareholder dilution.

Germany is expected to legalize marijuana at the federal level, making it the largest country to do so in terms of population. Tilray already has an EU GMP-certified facility operating in Germany which can increase production capacity to accommodate demand from the adult use segment.

Bottom Line: Is Tilray Stock a Buy Post Fiscal Q2 Results?

While Tilray’s stock gained pace, following its Q2 results, investors should understand that it was estimated to report revenue of $171 million in the quarter. Despite the cost synergies enjoyed by Tilray, the adult-use market in Canada is crowded as well as highly fragmented and should consolidate in the upcoming years which will allow companies to improve the bottom line.

Tilray stock is valued at a market cap of $3.2 billion which suggests its forward price to sales multiple is over 3x. Unlike most cannabis producers in the U.S. Tilray continues to post an adjusted loss making it a high-risk bet at current multiples.

July 27, 2021

The Importance of Understanding Cannabis Testing Results

By Josh Reed

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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.

OGanalytical instruments. — Consumers can easily grasp high level results in the form of charts and graphs

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.

EVIO labs photo — 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.

May 5, 2021

Lab Shopping: Highlighting the Need for Checks and Balances in Cannabis

By Josh Swider

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Cannabis, we have a problem. Legalizing adult use cannabis in California caused the demand for high-potency cannabis to increase dramatically over the last several years. Today, many dispensary buyers enforce THC minimums for the products that they sell. If smokeable flower products don’t have COAs proving the THC levels are above 20% or more, there is a good chance many dispensaries won’t carry them on their shelves. Unfortunately, these kinds of demands only put undue pressure on the industry and mislead the consumer.

Lab Shopping: Where the Problems Lie

Lab shopping for potency analysis isn’t new, but it has become more prevalent with the increasing demand for high-potency flower over the last couple of years. Sadly, many producers submit valid, certified COAs to the California Bureau of Cannabis Control (BCC), which show two to three times the actual potency value.

At InfiniteCAL, we’ve purchased products from dispensary shelves and found significant discrepancies between the analysis we perform and the report submitted to the BCC by the producer. So, how can this happen? Several factors are creating the perfect storm in cannabis testing.

Problems with Potency

Many consumers still don’t understand that THC potency is not the only factor in determining quality cannabis, and they are unwittingly contributing to the demand for testing and analysis fraud. It is alarming for cultivation pioneers and ethical labs to see producers and profit-hungry testing facilities falsifying data to make it more appealing to the unaware consumer.

Basically, what’s happening is growers are contacting labs and asking, “I get 30% THC at this lab; what can you do?” When they see our COA reporting their flower tested lower than anticipated, they will go to another lab to get higher test results. Unfortunately, there are all too many labs that are willing to comply.

I recently saw a compliant COA that claimed that this particular flower was testing at 54% THC. Understanding cannabis genetics, we know this isn’t possible. Another product I reviewed claimed that after diluting an 88% THC distillate with 10-15% terpenes, the final potency test was 92% THC. You cannot cut a product and expect the potency to increase. Finally, a third product we reviewed claimed 98% total cannabinoids (while only looking at seven cannabinoids) with 10% terpenes for a total of 108% of the product.

These labs only make themselves look foolish to professionals, mislead laymen consumers and skirt under the radar of the BCC with basic mathematical errors.

The Pesticide Predicament

Frighteningly, inflating potency numbers isn’t the most nefarious testing fraud happening in the cannabis industry. If a manufacturer has 1000 liters of cannabis oil fail pesticide testing, they could lose millions of dollars – or have it retested by a less scrupulous lab.

As the industry continues to expand and new labs pop up left and right, cultivators and manufacturers have learned which labs are “easy graders” and which ones aren’t. Certain labs can miss up to ten times the action level of a pesticide and still report it as non-detectable. So, if the producer fails for a pesticide at one lab, they know four others won’t see it.

In fact, I’ve had labs send my clients promotional materials guaranteeing compliant lab results without ever receiving a sample for testing. So now, these companies aren’t just tricking the consumer; they are potentially harming them.

An Easy Fix

Cannabis testing is missing just one critical factor that could quickly fix these problems – checks and balances. The BCC only needs to do one of two things:

Verifying Lab Accuracy

InfiniteCAL also operates in Michigan, where the Marijuana Regulatory Agency (MRA) has already implemented a system to ensure labs are maintaining the highest testing standards. The MRA will automatically flag all COAs which test above a certain percentage and require the product to be retested by multiple labs.

Labs are required to keep a back stock of material. So, when test results come back abnormally high from Lab A, then Labs B, C and D are commissioned to retest the material to compare data. If Lab A reports 40% THC, but the other labs all report 18%, then it’s easy to see Lab A has made an error.

Secret Shopping

By simply buying products off the shelves and having them blind-tested by other labs, it would be simple for the BCC to determine if the existing COA is correct. They already have all the data in Metrc, so this would be a quick and easy fix that could potentially solve the problem overnight.

For example, at InfiniteCAL, we once purchased 30 samples of Blue Dream flower from different cultivators ranging in certified COA potencies from 16% to 38%. Genetically, we know the Blue Dream cultivar doesn’t produce high levels of THC. When we tested the samples we purchased, nearly every sample came back in the mid-teens to low 20% range.

Labs Aren’t Supposed to Be Profit Centers

At InfiniteCAL, we’ve contacted labs in California where we’ve uncovered discrepancies to help find and flush out the errors in testing. All too often, we hear the excuses:

“If I fix my problem, I’ll lose my clients.”
“I’m just a businessman who owns a lab; I don’t know chemistry.”
“My chemist messed up; it’s their fault!”

If you own a lab, you are responsible for quality control. We are not here to get rich; we are here to act as public safety agents who ensure these products are safe for the consumer and provide detailed information about what they choose to put in their bodies. Be professional, and remember you’re testing for the consumer, not the producer.

May 15, 2020

Moving Towards Greater Competency in Cannabis Testing

By Ravi Kanipayor

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While legalization of recreational cannabis remains in a fluid state in the United States, the medical application of cannabis is gaining popularity. As such, the diversification of pharmaceutical and edible cannabis products will inevitably lead to increased third party testing, in accordance with Food and Drug Administration (FDA) mandates. Laboratories entering into cannabis testing, in addition to knowing the respective state mandates for testing procedures, should be aligned with Federal regulations in the food and pharmaceutical industries.

In 2010, the American Herbal Products Association (AHPA)¹ established a cannabis committee with the primary objective of addressing issues related to the practices and safe use of legally-marketed cannabis and cannabis-related products. The committee issued a set of recommendations, outlining best practices for the cultivation, processing, testing and distribution of cannabis and cannabis products. The recommendations for laboratory operations sets some basic principles for those performing analysis of cannabis products. These principles, complementary to existing good laboratory practices and international standards, focus on the personnel, security, sample handling/disposal, data management and test reporting unique to laboratories analyzing cannabis samples.

As local and federal regulations continue to dictate medical and recreational cannabis use, many will venture into the business of laboratory testing to meet the demands of this industry. Thus, it is not surprising that cannabis producers, distributors and dispensaries will need competent testing facilities to provide reliable and accurate results. In addition, our understanding of cannabis from an analytical science perspective will derive from test reports received from these laboratories. Incorrect or falsified results can be costly to their business and can even lead to lawsuits when dealing with consumer products. Examples of fines and/or suspensions related to incorrect/false reporting of results have already gained coverage in news media. This sets up the need for the cannabis industry to establish standardized protocols for laboratory competency.

The international standard, ISO 17025 – ‘General requirements for the competence of testing and calibration laboratories’ – plays an important role in providing standard protocols to distinguish labs with proven quality, reliability and competency. The industry needs to rely not only on the initial accreditation received, but also on the ongoing assessment of the labs to ensure continuous competency.

Receiving accreditation involves an assessment by an International Laboratory Accreditation Cooperation (ILAC) recognized accrediting body, which ensures that laboratories have the competency, resources, personnel and have successfully implemented a sound quality management system that complies with the international standard ISO/IEC 17025:2017. This ISO standard is voluntary, but recognized and adopted globally by many industries for lab services. Cannabis companies can ensure that the test services they receive from accredited laboratories will meet the requirements of the industry, as well as the state and federal regulatory agencies. The International Organization for Standardization (ISO) is an independent, non-governmental organization with over 160 memberships of national standards bodies, and all with a unified focus on developing world-class standards for services, systems, products, testing to ensure quality, safety, efficiency and economic benefits.

ILAC is a non-profit organization made up of accreditation bodies (ABs) from various global economies. The member bodies that are signatories to the ILAC Mutual Recognition Arrangement (ILAC MRA) have been peer evaluated to demonstrate their competence. The ILAC MRA signatories, in turn, assess testing labs against the international standard, ISO/IEC 17025 and award accreditation. Accreditation is the independent evaluation of conformity assessment in accordance with the standard and related government regulations to ensure the lab carry out specific activities (called the ‘Scope’) impartially and competently. Through this process, cannabis industry stakeholders and end users can have confidence in the test results they receive from the labs.

Understanding the principles of accreditation and conformity to ISO standards is the beginning of the ISO 17025 accreditation process. Similar to other areas of testing, accreditation gives cannabis testing labs global recognition such that their practices meet the highest standards in providing continuous consistency, reliability and accuracy.

Many government agencies (state and federal) in the US and around the world are mandating cannabis testing laboratories to seek accreditation to ISO/IEC 17025:2017, in an effort to standardize their practice and provide the industry with needed assurance. Conformance with the standard enables labs to demonstrate their competency in generating reliable results, thereby providing assurance to those who hire their services.

Testing of cannabis can be very demanding and challenging given that state and federal regulations require that the performance and quality of the testing activities must provide consistent, reliable and accurate results. Hence, labs deciding to set up cannabis testing will have to take extra care in setting up a laboratory facility, acquiring all necessary and appropriate testing equipment, hiring qualified and experience staff and developing and implementing test methods to ensure the process, sample throughput, data integrity and generated output are continuously reliable, accurate and meet the need of the clients and requirements of the regulatory bodies. This demands the lab to establish and implement very sound quality assurance program, good laboratory practices and a quality management system (QMS).

Some expected challenges are:

Standardization of test methods and protocols
1. Since there is no federal guidance in standardization of test methods and protocols for cannabis testing in US, it is challenging for laboratories to research and validate other similar, established methods and gain approval from the local and state authorities.
Facility
1. Cannabis testing activities must be physically isolated from other testing activities for those labs conducting business in other areas of testing such as environment, food, mining, etc.
2. Microbiological testing requires additional physical isolation within the testing facility, maintaining sterility of the environment, test area and test equipment.
Equipment
1. The test equipment such as Chromatographs (GC/LC), Spectrometers (ICP-MS, ICP-OES, UV-Vis), and other essential analytical instruments must meet the specifications required to detect and quantify and statistically justify the test parameters at the stipulated concentration levels. That means the limit of detection and limit of quantitation of each parameter must be well below the regulatory limits and the results are statistically sound.
2. Calibration, maintenance and operation of analytical equipment must be appropriate to produce results traceable to international standards such as International System of Units and National Institute of Standards and Technology (SI and NIST).
Staff
1. The qualification and experience of the staff should ensure standard test methods are implemented and verified to meet the specifications.
2. They should have a sound understanding of the QA/QC protocols and effective implementation of a quality management system which conforms to ISO/IEC 17025:2017 standard.
3. Staff should be properly trained in all standard operating procedures (SOPs) and receiving schedule re-training as needed. Training should be accurately documented.
QMS
1. The QMS should not only meet the requirements of ISO 17025, but also be appropriate to the scope of the laboratory activities. Such a system must be planned, implemented, verified and continuously improved to ensure effectiveness.

Finally, stakeholders should seek expert advice in establishing a cannabis testing lab prior to initiating the accreditation. This can be achieved through a cyclic PLAN-DO-CHECK-ACT process. Labs that are properly established can attain the accreditation process in as little as 3-5 months. An initial ‘Gap Analysis’ can be extremely helpful in this matter.

IAS, an ILAC MRA signatory and international accrediting body based in California is one such organization that provides training programs for those interested in attaining accreditation to ISO/IEC 17025:2017. It is a nonprofit, public-benefit corporation that has been providing accreditation services since 1975. IAS accredits a wide range of companies and organizations including governmental entities, commercial businesses, and professional associations worldwide. IAS accreditation programs are based on recognized national and international standards that ensure domestic and/or global acceptance of its accreditations.²

References

American Herbal Products Association , 8630 Fenton Street, Suite 918 , Silver Spring, MD 20910 , ahpa.org.
International Accreditation Services, iasonline.org.

April 23, 2020

How to Streamline Labeling from Seed to Sale in The Time of COVID-19

By Travis Wayne

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As if the cannabis industry doesn’t regularly go through enough rapid change, with COVID-19, cultivators, processors and dispensers of all sizes are trying to do more with less. Lower operational headcount and unpredictable production volume, along with a rapidly-changing supply chain – make eliminating manual steps a necessity. Labels include barcodes or various barcode symbologies to help companies manage inventory, identify products and ultimately ensure that the right products get to the right customers at the right time. By eliminating manual steps in your labeling environment, you can address these issues through automation, scalability, efficiency and accuracy: benefits that will last through the pandemic and position you well for the recovery period.

Automation

Automation of many kinds is being implemented from seed to sale including barcode label printing automation. Integration of labeling software and seed to sale traceability systems including METRC, BioTrack, Leaf Data and others enables streamlined barcode label data population and high-volume label printing to counteract the decreasing operational headcount and eliminate manual touchpoints.

Print automation can be defined as “a centralized technology that replaces the manual process of triggering a print job within a labeling environment.” Look for a labeling software solution that allows you to:

- Completely automate your label printing process
- Print to a greater number of printers
- Initiate printing directly from any business system

Integrating your label printing system with your seed to sale traceability system can minimize errors, increase print speeds and maximize your ROI.

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.

Scalability

One of the most important considerations for cannabis cultivators, processors and dispensers is to invest in solutions that can grow and pivot quickly as the business changes. Whether you are responding to temporary requirements or changes, or your business needs to scale up quickly to respond to a spike in demands as a result of COVID-19 or to prepare for coming out of this pandemic. Whatever your needs are, think about short-term and long-term goals for sustainable business solutions. Scalability includes:

Printing to a greater number of printers

As needs and automation requirements change, and your printer inventory has the possibility of increasing, make sure your labeling design software can be licensed per simultaneous user, with cost-effective, multi-user networking licenses. That way, you don’t run the risk of paying for more printers as you grow or going over budget with each additional printer.

Print documents and labels from the same application

If you use the same data for your documents (like order receipts, bills of materials or packing lists) and labels, moving document printing into your label design software makes sense logistically. 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.

Efficiency and accuracy

In a time where responding to the changing market needs to happen very quickly, where costs are being scrutinized and when errors cannot happen – you need to set up your labeling environment to have high levels of accuracy and control. With increased accuracy you will reduce waste, eliminate returns due to mislabeled product, efficiently track product and gain more efficiencies that will save you money and time.

Cutting manual steps out of the process

Removing manual steps in your printing process is a sure-fire way to gain efficiency and accuracy in your labeling environment. Look for labeling software features that allow you to add variable data from a device to your labels automatically, which limits the human interaction with your labels and in turn helps minimize human errors. Other efficiencies include:

On-demand color labeling streamlines efficiency and accuracy across a wide variety of labeling needs.

Increased print speed within your labeling environment
Reduced label waste
Collection of data from several devices such as:
- Scanners
- Scales
- Keyboards

On-demand color labeling

On-demand labeling is specifically helpful in the cannabis labeling world because of all the regulations you must comply with. Each state has its own regulations, which means each label throughout the cannabis supply chain must be compliant with whichever state they are located. With on-demand labeling, cannabis companies print labels as needed and make changes as they go without the risk of wasting obsolete pre-printed label stock. This is beneficial as pre-printed labels often have large minimum order quantities. On-demand labeling also helps companies maintain better control of their own branding and graphics.

With on-demand labeling, label information can be populated by using pre-approved label templates in order to save you time with the variations of cannabis labels. This gives you the ability to print the specific label you need without having to waste your pre-printed label stock, or spend time switching out your pre-printed label stock in your printer.

Cannabis cultivators, processors and dispensers are faced with many obstacles during these challenging times due to COVID-19 – ensuring workers are safe, keeping operations at 100% capacity with potentially fewer people, creating contingency plans that may be changing daily. In an environment that is changing very quickly, consider how labeling solutions can evolve. You may also need to lean more on your partners than you ever have in the past.

January 9, 2019

Sequoia Analytical Labs Caught Falsifying Results

By Aaron G. Biros

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Last month, Sequoia Analytical Labs admitted that they falsified hundreds of pesticide tests for batches of cannabis products. The Sacramento-based laboratory faked data on 22 different pesticide tests for more than 700 batches over a period of four months.

According to a notice posted on Sequoia’s website, the skewed results were originally found due to a “faulty instrument” but “it was further discovered” that the lab director knew about it and was fraudulently posting the results in order to hand out certificates of analysis. The lab director in question has since been fired and Sequoia voluntarily relinquished their state license.

Joe Devlin, Sacramento’s chief of cannabis enforcement, told KCRA3 News “We’re going to be taking a look at suspending or possibly revoking their permit.” He followed that up with saying that California needs more testing labs. “The shortage of labs has really created a bottleneck in the supply chain across the state,” says Devlin. There are only 43 licensed laboratories in the state of California as of this time, and just three of those are in Sacramento.

The Bureau of Cannabis Control (BCC), the regulatory authority overseeing the cannabis testing market in California, has not commented on this story, but they did reach out to distributors who had sent batches to Sequoia for testing. “Any cannabis goods from these batches, returned by consumers to the retailer, must be destroyed,” reads the BCC letter. “Any cannabis goods returned from a retailer’s inventory or remaining in your inventory may be destroyed, or may be re-sampled and re-tested after obtaining approval from the Bureau. Any cannabis goods from these batches may not be released to a retailer without re-sampling and re-testing.”

Sequoia Analytical Labs posted two notices on their homepage, one was a letter to their clients informing them of the fraud and the other is that BCC letter to distributors doing the same. “Management and ownership were horrified to learn about this severe breach of a very important safety regulation,” reads the notice. “We have voluntarily surrendered our license to do COA testing to the BCC while we make the required corrections. We are already hard at work making the needed changes to the instrument and revamping procedures so that we may get our license reinstated January 1.”

As of today, the lab’s license has not been reinstated.

December 11, 2018

Soapbox

Dishonest Potency Testing In Oregon Remains A Problem

By Kelly O’Connor

9 Comments

Oregon, we have a problem.

Anyone with a search engine can piece together how much THC certain strains produce and what their characteristics are. Oh wait- there’s an app for that… or dozens, I lose count these days.

Nefarious lab results are rampant in our communityLet’s take one of my favorites, Dutch Treat; relaxing, piney and sweet with a standard production of 18-25% THC, according to three different reviews online. So, did I raise an eyebrow when I saw Dutch Treat on Oregon shelves labeled at 30% THC? Did I take it in to an independent, accredited lab and have it tested for accuracy? You bet your inflated potency results I did! The results? Disappointing.

Nefarious lab results are rampant in our community; it is hurting every participant in our industry affected by the trade, commerce and consumption of recreational cannabis.

“I have had labs ask me what I want my potency numbers to look like and make an offer,” says David Todd, owner and operations manager of Glasco Farms, a craft cannabis producer in central Oregon. “It’s insane- I want to stand behind my product and show through scientific fact that I produce a superior flower.”

But without enforcement of lab practice standards, producers are being pressured to play dirty. In her third year cultivating at a two-tier recreational cannabis farm, a producer who wished to remain anonymous sent me an email about the pressures she is up against to produce high THC strains:

“The only sure way to get my product on the shelf at a profitable price is with THC 25% or above. Not a lot of strains have that potential, but the market has plenty with 28% to 32% floating around so I have to go with the same labs as the rest of the independent farmers to get the best numbers I can. The lab I use … return(s) good numbers.”

Those “good numbers,” aka high THC %, are the driving force of sales. A strain tests at 20% THC and it sells for $1,000/lb. Then it tests at 25% THC, and sells for $1300/lb. You produce cannabis for sale- this is your business. And labs are telling you that they can manipulate samples and reports to make you more money. Everyone else is doing it. If you don’t, your product isn’t “good enough” to sell. What do you do?Labs should operate ethically.

It’s a vicious cycle perpetuated by lies, lack of enforcement resources, coercion and undereducation. We are all responsible. Yet, ask who the source of the problem is and everyone points fingers across the circle.

The consumers are uneducated about cannabis and only focus on THC. The dispensaries and budtenders should be educating them. Producers should take a stand and use an honest lab. Labs should operate ethically.

I repeat: Oregon, we have a problem.

It’s time to stop living in a land where Dutch Treat is hitting 30% THC. It’s time for everyone to demand auditing and ethics.

Laws have been set forth on how to sample, prep, test and report analyses for cannabis to ensure fair commerce, consumer health and public safety. But there’s a clear need to blind test the different labs, and for unbiased, third-party research and development.

As federal eyes turn to the Oregon to investigate black market activity, regulatory bodies are tightening their grip on licensees to maintain legal validity and avoid shut down.

The time to demand change and integrity is now.The crack-down began on August 23, 2018, when the OLCC investigated several prominent producers’ practices. Black market distribution incurred the harshest penalty; the OLCC revoked their wholesale license due to multiple violations.

“We want good compliant, law-abiding partners as OLCC marijuana licensees,” says Paul Rosenbaum, OLCC Commission Chair. “We know the cannabis industry is watching what we’re doing, and believe me, we’ve taken notice. We’re going to find a way to strengthen our action against rule breakers, using what we already have on the books, and if need be working with the legislature to tighten things up further.”

Trends in METRC data lay the foundation for truth, and it’s time to put it to use. “The Cannabis Tracking System worked as it should enabling us to uncover this suspicious activity,” says Steven Marks, OLCC Executive Director. “When we detect possible illegal activity, we need to take immediate steps …”

Potency fraud might not be at the top of the list for investigation, but labs and producers are breaking the law, and there will be consequences. ORELAP and OLCC have the right to investigate and revoke licenses of labs that are falsifying data and consumers can file claims with the Department of Justice.

The time to demand change and integrity is now.

August 23, 2018

From The Lab

Quality Plans for Lab Services: Managing Risks as a Grower, Processor or Dispensary, Part 5

By Dr. Edward F. Askew

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Protection in the Court of Public Opinion

In the last four articles, I have outlined areas that impact your operations as they apply to laboratory quality programs. But this article will take a different path. It will focus on protecting your crop and brand along with any business that utilizes your crop, such as dispensaries or edible manufactures in the court of public opinion.

Now, the elephant in the room for cannabis companies is the difference between rules written by the state and their enforcement by the state. There are many anecdotal stories out there that can be used as case studies in identifying ways to protect your brand. Remember, consumers and the media caught them, not the regulators.

Cheating in the cannabis industry: growers, dispensaries, edibles manufactures, etc. This includes:

Finding laboratories that will produce results that the client wants (higher potency numbers)
Not testing for a particular contaminant that may be present in the cannabis product.
Selling failed crops on the gray or black market.
Claiming to regulators that the state rules are unclear and cannot be followed (e.g. So, give me another chance, officer)

So why should you be worried? Because, even if the state where you operate fails to enforce its own rules, the final end-user of your product will hold you accountable! If you produce any cannabis product and fail to consider these end-users, you will be found out in the court of public opinion by either the media or by the even more effective word of mouth (e.g. Social Media).

So, let’s take a look at some recent examples of these problems:

Each of these reports lists contamination by microbial stains or pesticides as being rampant within the California market whose products are used for medical or recreational use. Just imagine the monetary losses these cannabis businesses faced for their recalled cannabis product when they got caught. Remember, consumers and the media caught them, not the regulators.Institute a quality program in your business immediately.

How can you be caught? There are many different ways:

Consumer complaints to the media
Secret shopper campaigns (more to come on that in the next article)
Media investigations
Social media campaigns

What are the effects on your business? Product recalls such as these two to hit the California market recently.

So, what should you do to produce an acceptable product and provide reasonable protection to your cannabis business? Institute a quality program in your business immediately. This quality program will include areas of quality assurance and quality control for at least these areas.

Growing
Processing or formulating
Shipping
Dispensing
Security
Training of staff
Laboratory services

Setting up and supporting these programs requires that your upper management impose both a rigorous training program and make employee compliance mandatory. Otherwise, your business will have an unreasonable risk of failure in the future.

Further information on preparing and instituting these types of quality assurance and quality control programs within your business can be found at the author’s website.

August 7, 2018

From The Lab

Quality Plans for Lab Services: Managing Risks as a Grower, Processor or Dispensary, Part 4

By Dr. Edward F. Askew

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In the last three articles, I discussed the laboratory’s responses or defenses used to reply to your questions about laboratory results that place stress on the success of your business. The Quality Control (QC) results can cause this stress if they are not run correctly to answer the following questions:

Are the laboratory results really true?
Can the laboratory accurately analyze sample products like my sample?
Can the laboratory reproduce the sample results for my type of sample?

Now let’s discuss the most important QC test that will protect your crop and business. That QC sample is the Matrix Sample. In the last article in this series, you were introduced to many QC samples. The Matrix Sample and Duplicate were some of them. Take a look back at Part 3 to familiarize yourself with the definitions.

The key factors of these QC sample types are:

Your sample is used to determine if the analysis used by the laboratory can extract the analyte that is being reported back to you. This is performed by the following steps:
1. Your sample is analyzed by the laboratory as received.
2. Then a sub-sample of your sample is spiked with a known concentration of the analyte you are looking for (e.g. pesticides, bacteria, organic chemicals, etc.).
3. The difference between the sample with and without a spike indicates whether the laboratory can even find the analyte of concern and whether the percent recovery is acceptable.
4. Examples of failures are from my experiences:
  1. Laboratory 1 spiked a known amount of a pesticide into a wastewater matrix. (e.g. Silver into final treatment process water). The laboratory failed to recover any of the spiked silver. Therefore the laboratory results for these types of sample were not reporting any silver, but silver may be present. This is where laboratory results would be false negatives and the laboratory method may not work on the matrix (your sample) correctly. .
  2. Laboratory 2 ran an analysis for a toxic compound (e.g. Cyanide in final waste treatment discharge). A known amount of cyanide was spiked into a matrix sample and 4 times the actual concentration of that cyanide spike was recovered. This is where laboratory results would be called false positives and the laboratory method may not work on the matrix (your sample) correctly.
Can the laboratory reproduce the results they reported to you?
1. The laboratory needs to repeat the matrix spike analysis to provide duplicate results. Then a comparison of the results from the first matrix spike with its duplicate results will show if the laboratory can duplicate their test on your sample.
  1. If the original matrix spike result and the duplicate show good agreement (e.g. 20% relative percent difference or lower). Then you can be relatively sure that the result you obtained from the laboratory is true.
  2. But, if the original matrix spike result and the duplicate do not show good agreement (e.g. greater than 20% relative percent difference). Then you can be sure that the result you obtained from the laboratory is not true and you should question the laboratory’s competence.

Now, the question is why a laboratory would not perform these matrix spike and duplicate QC samples? Well, the following may apply:

These matrix samples take too much time.
These matrix samples add a cost that the laboratory cannot recover.
These matrix samples are too difficult for the laboratory staff to perform.
Most importantly: Matrix samples show the laboratory cannot perform the analyses correctly on the matrix.

So, what types of cannabis matrices are out there? Some examples include bud, leaf, oils, extracts and edibles. Those are some of the matrices and each one has their own testing requirements. So, what should you require from your laboratory?

The laboratory must use your sample for both a matrix spike and a duplicate QC sample.
The percent recovery of both the matrix spike and the duplicate will be between 80% and 120%. If either of the QC samples fail, then you should be notified immediately and the samples reanalyzed.
If the relative percent difference between the matrix spike and the duplicate will be 20% or less. If the QC samples fail, then you should be notified immediately and the samples should be reanalyzed.

The impact of questionable laboratory results on your business with failing or absent matrix spike and the duplicate QC samples can be prevented. It is paramount that you hold the laboratory responsible to produce results that are representative of your sample matrix and that are true.

The next article will focus on how your business will develop a quality plan for your laboratory service provider with a specific focus on the California Code Of Regulations, Title 16, Division 42. Bureau Of Cannabis Control requirements.

June 20, 2018

Top 10 Common Findings Detected During Cannabis Laboratory Assessments: A Guide to Assist with Accreditation

By Tracy Szerszen

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With the cannabis industry growing rapidly, laboratories are adapting to the new market demand for medical cannabis testing in accordance to ISO/IEC 17025. Third-party accreditation bodies, such as Perry Johnson Laboratory Accreditation, Inc. (PJLA), conduct these assessments to determine that laboratories are following relevant medical cannabis testing standard protocols in order to detect potency and contaminant levels in cannabis. Additionally, laboratories are required to implement and maintain a quality management system throughout their facility. Obtaining accreditation is a challenge for laboratories initially going through the process. There are many requirements outlined in the standard that laboratories must adhere to in order to obtain a final certificate of accreditation. Laboratories should evaluate the ISO 17025 standard thoroughly, receive adequate training, implement the standard within their facility and conduct an internal audit in order to prepare for a third-party assessment. Being prepared will ultimately reduce the number of findings detected during the on-site assessment. Listed below is research and evidence gathered by PJLA to determine the top ten findings by clause specifically in relation to cannabis testing laboratories.

PJLA chart — The top 10 findings by clause

4.2: Management System

Defined roles and responsibilities of management system and its quality policies, including a structured outline of supporting procedures, requirements of the policy statement and establishment of objectives.
Providing evidence of establishing the development, implementation and maintenance of the management system appropriate to the scope of activities and the continuous improvement of its effectiveness.
Ensuring the integrity of the management system during planned and implemented changes.
Communication from management of the importance of meeting customer, statutory and regulatory requirements

4.3: Document Control

Establishing and maintaining procedures to control all documents that form the management system.
The review of document approvals, issuance and changes.

4.6: Purchasing Services and Supplies

Policies and procedures for the selection and purchasing of services and supplies, inspection and verification of services and supplies
Review and approval of purchasing documents containing data describing the services and supplies ordered
Maintaining records for the evaluation of suppliers of critical consumables, supplies and services, which affect the quality of laboratory outputs.

4.13: Control of Records

Establishing and maintaining procedures for identification, collection, indexing, access, filing, storage and disposal of quality and technical records.
Providing procedures to protect and back-up records stored electronically and to prevent unauthorized access.

4.14: Internal Audits

Having a predetermined schedule and procedure for conducting internal audits of its activities and that addresses all elements that verify its compliance of its established management system and ISO/IEC 17025
Completing and recording corrective actions arising from internal audits in a timely manner, follow-up activities of implementation and verification of effectiveness of corrective actions taken.

5.2: Personnel

Laboratory management not ensuring the competence and qualifications of all personnel who operate specific equipment, perform tests, evaluate test results and sign test reports. Lack of personnel undergoing training and providing appropriate supervision
Providing a training program policies and procedures for an effective training program that is appropriate; identification and review of training needs and the program’s effectiveness to demonstrate competence.
Lack of maintaining records of training actions taken, current job descriptions for managerial, technical and key support personnel involved in testing

5.4: Test and Calibration Methods and Method Validation

Utilization of appropriate laboratory methods and procedures for all testing within the labs scope; including sampling, handling, transport, storage and preparation of items being tested, and where appropriate, a procedure for an estimation of the measurement of uncertainty and statistical techniques for analysis
Up-to-date instructions on the use and operation of all relevant equipment, and on the handling and preparation of items for testing
Introduction laboratory-developed and non-standard methods and developing procedures prior to implementation.
Validating non-standard methods in accordance with the standard
Not completing appropriate checks in a systematic manner for calculations and data transfers

5.6: Measurement Traceability

Ensuring that equipment used has the associated measurement uncertainty needed for traceability of measurements to SI units or certified reference materials and completing intermediate checks needed according to a defined procedure and schedules.
Not having procedures for safe handling, transport, storage and use of reference standards and materials that prevent contamination or deterioration of its integrity.

5.10: Reporting the Results

Test reports not meeting the standard requirements, statements of compliance with accounting for uncertainty, not providing evidence for measurement traceability, inaccurately amending reports.

SOP-3: Use of the Logo

Inappropriate use of PJLA’s logo on the laboratories test reports and/or website.
Using the incorrect logo for the testing laboratory or using the logo without prior approval from PJLA.