Tag Archives: laboratories

Advancing Knowledge and Expertise in the Cannabis Testing Industry

By Greg Kozadjian, MBA ,BSc.
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The cannabis laboratory testing market has undergone a lot of changes in the past ten years. With those growing pains so common in such a new industry, come plenty of challenges driven by market dynamics, new regulations and scientific advancements.

Julie Kowalski, a cannabis testing consultant at JA Kowalski Science Support, has seen these changes firsthand. For twelve years, she worked at Restek as a senior chemist, helping to provide expertise and develop analytical solutions for their cannabis testing partners. She also worked as chief scientific officer for Trace Analytics, a cannabis testing lab in Spokane, Washington. Between being an advisor, consultant, trainer and accreditation assessor, she wears many different hats in the space. We sat down with Kowalski to learn more about the evolution of the marketplace, the importance of product safety and some of the common challenges that labs face.

Greg Kozadjian: Tell us a little about yourself and how you came to be working as a consultant in the cannabis and hemp testing industry?

Julie Kowalski, Owner of JA Kowalski Science Support

Julie Kowalski: I began working on gas chromatographs when I was about 20 years old, added liquid chromatography to my repertoire in my early 20’s, and have been in the lab nearly every day since then.

My consulting business launched in early 2020 after I received numerous requests from my network for help and advice regarding cannabis testing. I am passionate about helping people, talking science, and promoting growth and innovation in the cannabis industry.

Speaking with individuals and businesses who potentially received conflicting advice or felt somewhat overwhelmed by the complex and rapidly evolving cannabis industry, I realized I could help. So, I decided to utilize my experience and knowledge to promote trust and expertise within the cannabis industry and champion science over profit.


Kozadjian: Why do you think it’s crucial to test cannabis and hemp-based products in today’s market?

Kowalski: The way I look at it is that cannabis and hemp-based products are like any other product in that the consumer has the right to have some assurance that these products are safe, and that the labeling information is accurate.

Then, there are the increasing number of people seeking to use cannabis for medicinal reasons. Again, the industry should be able to assure them that the products they are using are safe to help them with their health issue.

Kozadjian: How has the market evolved over the last five years to meet the current testing regulations, and which of those regulations focus more on the safety of cannabis and hemp-based products?

Kowalski: In the past five years, more states have been coming online domestically. So, we are dealing with a regulatory environment where different states may have different regulations, a situation that will continue to exist for the foreseeable future. There have been efforts on the regulatory side, if not to coordinate efforts directly, to at least connect and communicate, and hopefully, out of those communications comes increased coordination.

I am hopeful that scientists, myself included, can do our part and provide additional data and information about testing that works, testing that doesn’t work, and that the regulators will consider and incorporate much of that information into changes in current and future regulations.

It is important to note that many state agencies were put in the position of creating a regulatory system that they were perhaps not familiar with, or accustomed to doing, particularly from the testing standpoint. There are no federal programs to model against, so programs are being developed from scratch and need to address all aspects of the market. It is a complicated task. It made sense to borrow from similar existing markets, but there is now the opportunity to use what we have learned to improve regulations.

For example, adopting certain criteria and practices from environmental, food, and agricultural testing was a great place to start. Now, we better understand some of the unique challenges associated with cannabis testing, it is time to set our fit-for-purpose best practices.

I hope that we, as an industry, can increasingly provide more data to help guide the regulators so that their goals are achieved and based on a growing body of data. I am optimistic that there will be much more interaction and coordination between regulators and scientists. This would greatly help with some of the struggles some cannabis labs are feeling in the current market.

Kozadjian: What are some of the challenges that testing labs face?

Kowalski: The cannabis and hemp-based products market is competitive with multiple sources of pressure. A definite challenge has been the gold rush mentality. Folks want to enter the cannabis business, and establishing a testing lab is attractive and perhaps perceived as more comfortable because it is not directly growing or producing a product.

There is a burden to set up a lab and open as quickly as possible because while the lab is being set up no money is being made. It can be stressful, and sometimes shortcuts are taken while developing technical programs. These shortcuts can ultimately cause disruption, stress, and risk. I saw this ten years ago, I saw this five years ago, and I am still seeing it now. I am still waiting for people to come into the industry with more realistic expectations of what it takes to establish functional technical programs and laboratories.“There are fundamental knowledge gaps that this market as a whole needs to address.”

Inadequate technical programs resulting from poorly vetted and insufficiently validated methods do not function well in the real world, changing regulations, as well as changing matrices, can result in chaos in the lab. A lab will fight fires daily if it does not plan for and build well-vetted, robust methods. Unfortunately, I have seen many new testing labs rush through development, and then when they open their doors for business, they realize their methods do not function properly.

Daily, they may be faced with deciding whether they should pass a sample batch because technically, it did not meet the criteria, but the client is waiting. Or labs constantly needing to retest may lose confidence in their ability. This is a high-stress situation, and quite a few labs are probably operating in this mode in the market right now. Substandard testing is becoming riskier as we see scrutiny, mainly due to test lab shopping increasing. I do want to make it clear and be fair to point out that the economics of cannabis testing is challenging. Pricing in most markets is too low to allow high-quality testing.

Kozadjian: How do you think this testing era will evolve in the next five years?

Kowalski: I think we will start to see more involvement and recognition of standards organizations like the AOAC, USP, ASTM. They have existed and have been working for at least a few years, and now are publishing methods, guidance documents, and providing education. That will be very helpful, and I invite testing labs to join in and participate in these efforts. Your voice is critical. We need more knowledge in the market, whether it is knowledgeable people entering the market, or people currently in the market who are willing to invest the time to learn analytical chemistry, for example. There are fundamental knowledge gaps that this market as a whole needs to address.

Brooke Butler, Simplifya
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Five Reasons Everyone in Cannabis Should be Using RegTech

By Brooke Butler
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Brooke Butler, Simplifya

As the cannabis industry continues to grow, regulations will only get more onerous and complex, and enforcement will ramp up. In order to survive, it’s imperative for cannabis business owners and the ancillary companies that support them – such as banks, insurance agencies, law firms and marketers – to keep on top of regulations.

Due to cannabis’ fractured regulatory environment, confounding state and local laws, and the fact that regulations are constantly changing, keeping track of it all can nearly seem impossible at times. But companies don’t need to reinvent the wheel and handle compliance on their own.

There are a host of tools on the market today that can help cannabis related businesses (CRBs) streamline their operations. RegTech solutions can drastically reduce the challenges of navigating compliance, saving companies significant time and money so they can focus on their core competencies. Here, let’s take a look at five of the main reasons everyone in the cannabis ecosystem should seriously consider adopting RegTech solutions today.

1. Simplify the Complex

The heart of RegTech solutions is taking out the guesswork when tackling compliance while mitigating risk. Besides there being a vast number of regulations that vary by state, they’re also not easy to understand – they’re really written for lawyers, can be hundreds of pages long, and don’t offer implementation guidance. Thankfully through RegTech, operators and ancillary companies are alerted when regulations change and are given easy-to-follow implementation and remediation guidelines that can be as easy as checking a box.

Beyond just simplifying compliance, RegTech can substantially increase operational efficiency.

As the cannabis industry has been rapidly growing and maturing, we’ve been seeing a major uptick in M&A activity – M&A activity tripled in the sector from 2020 to 2021 – and with each new state a company enters, comes a host of new regulatory challenges. When expanding to a new state, RegTech solutions provide updates in real time, making sure, for example when you expand to Ohio, it’s not at the expense of complying with regulations in your core market of Illinois. Also, from an operations strategy perspective, RegTech solutions can be incredibly useful in helping companies decide what markets to pursue, as they can offer regulatory snapshots that compare tax laws, average margins, consumer segments, product stipulations, marketing restrictions and more. Thus besides simplifying compliance, RegTech can substantially increase operational efficiency.

Since cannabis is such a highly regulated industry, there are a ton of documents an operator has to keep on hand and be able to produce in a moment’s notice. Through RegTech, operators can store and organize all documents that are applicable to them electronically. So, when an inspector comes into a dispensary for a surprise inspection, rather than sweating bullets and digging through six filing cabinets trying to locate say a visitor log from three years ago, using RegTech a manager can quickly search records electronically, download and print the needed document, pass the inspection and go back to work.

2. Save Costs by Streamlining Compliance

While adopting RegTech solutions has a cost, the cost savings companies yield from RegTech way exceed the investment. RegTech providers have teams of dedicated analysts constantly tracking regulations and providing updates, making it so companies don’t need to hire much more costly lawyers to track regulations and amend policies and procedures. Rather, they can tap into RegTech solutions and leverage decades of experience and lean on the best regulatory experts in the field, while saving a lot of money.

RegTech providers have teams of dedicated analysts constantly tracking regulations and providing updates,

Just to give a small example of the cost savings RegTech can provide, on average a CRB spends over $20,000 to produce a new SOP package when using an attorney and nearly $8,000 when updating an SOP package using an attorney. Compare that to Simplifya’s fully customizable SOP package, where a CRB spends on average less than $1,600 to produce a new SOP package and less than $650 to update an SOP package – a 92% savings.

When considering costs, it’s important to think holistically and anticipate potential problems that could come up. One of the biggest pain points for companies starting up operations or entering new markets is complying with confusing tax codes – no industry is taxed to the degree cannabis is, and it’s easy to lose sight of tax obligations when planning operations. Unanticipated withholding requirements can create serious cash flow problems. RegTech solutions clearly outline requirements, as well as track updates, which help companies plan operations and expansion plans and prevent nasty tax surprises from creeping up, and they’re a much cheaper alternative to hiring tax lawyers.

While there are tremendous growth opportunities in cannabis, the industry is also facing significant headwinds, including the high cost of capital, supply and demand misalignments, and shrinking margins, and as we head towards recession, cost efficiency will become more and more important. Not only can RegTech help companies survive by helping ensure they stay compliant and don’t get fined or even shut down for breaching regulations, they also help companies run more efficiently and save major costs on operations.

3. Hold Your Employees Accountable

In addition to using RegTech to stay on top of compliance, it can be a powerful HR tool as well. Companies can utilize RegTech platforms to make and track assignments and tasks for employees. If you’ve already spent the time and money to create SOPs, RegTech tools are essential to making sure they’re actually being followed correctly. 

As many cannabis companies are expanding rapidly and bringing new employees into their fold – particularly those that are engaging in M&A – it can be difficult to get employees up to speed and following SOPs. RegTech automation and tracking solutions help flatten the learning curve and ensure employees are completing tasks on time, boosting efficiency and preventing problems that may arise – and if problems do arise, the tools help pinpoint where and when for efficient remediation. And if you’re an MSO or a SSO with multiple locations, RegTech allows employers to keep track of their dispersed employees without having to be in 10 places at once. This holds employees accountable for their actions for smooth operations while reducing growing pains.

4. Identify Issues Before They Become an Issue

The most compelling reason for having strict regulations in the cannabis industry in the first place is to protect consumer and patient health. Given the long, brutal history of cannabis prohibition, where lies and misconceptions about cannabis consumption being “dangerous” were perpetuated in the mainstream, the last thing the industry needs is people consuming products that are in any way contaminated. If you skirt the rules and manage to put out compromised products without a regulator catching and dinging you first, consumers may get sick. This can lead to a recall and tarnish a brand’s reputation. Competition is steep in this industry and even one incident can be irrecoverable. If consumers have reason to believe you’re not putting out consistent, safe products, they’ll buy from your competitor instead.

RegTech helps companies track all processes and procedures so that they can spot problems before they occur and ensure nothing dangerous makes its way to the public, which in turn shields brand reputation. Also, it’s important to note – in the cannabis ecosystem, every company you work with has to be licensed. If you work with an entity that’s not, you are very liable. Tracking licensing information is burdensome, especially for retailers and ancillary businesses like lenders and insurers who work with many vendors. Luckly, RegTech providers have already done the heavy lifting, pulling APIs into state databases and creating tracking systems of licenses that make it easy for companies to ensure every entity they work with is operating with a valid license. This saves companies from having to hire people to track licensing information on a weekly or even daily basis, which can be very costly, and more importantly, keeps them compliant and prevents slip ups that could jeopardize consumer and patient health. 

5. Looking Towards the Future, Regulations will Only Become more Complex – Only the Compliant Will Survive

A common misconception people have about the cannabis industry is thinking that federal policies like SAFE banking will be a catch-all to their banking woes, opening up the floodgate to institutional investment. The fact of the matter is, however, SAFE banking would be ineffective without RegTech. Cannabis companies need to demonstrate reliability and a history of compliance in order to attract investors and accumulate capital, and they do this through using RegTech platforms. Conversely, financial institutions also use RegTech to verify licenses, ensure legitimacy and assess lending risks based on the locations in which their borrowers operate. After SAFE banking is finally enacted, since larger institutional investors have so much on the line, they’re going to be particularly careful and only invest in those companies that can comprehensively demonstrate a history of compliance. This will also be the case for major CPG companies looking to acquire cannabis companies – they’ll want companies that have used RegTech to show compliance and optimize operations, since those companies will be more trustworthy and transitioning them under new management will be easier. In every major industry other than cannabis, RegTech solutions have been adapted. This is where cannabis is headed, and the companies that adopt solutions and demonstrate compliance will come out ahead.

Cannabis companies need to demonstrate reliability and a history of compliance in order to attract investors and accumulate capital

The other major misconception some people have about the cannabis industry is that once cannabis is legalized on a federal level, state and local regulations will somehow just go away, so current RegTech solutions may become ‘obsolete.’ This couldn’t be further from the truth. In no world is there going to a federal legalization system that says states can no longer create their own rules around cannabis. Think about the alcohol or gambling industries. Alcohol and gambling are federally legal, but every state – and even some counties and cities within those states – can have very different rules. Federal legalization will just mean additional regulations will be piled on and thus RegTech will only become more important.

While many companies in the cannabis space have already adopted RegTech solutions, there are still many others that have taken a reactive rather than proactive approach towards compliance. When major legislation like SAFE banking or federal legalization is approved, there will be a paradigm shift and RegTech will be deemed more essential quickly. Those who have implemented RegTech will have distinct advantages. To survive and thrive in the industry going forward, it’s prudent to proactively handle compliance and adopt RegTech solutions today.

Scenes From The 2022 Cannabis Quality Conference & Expo

By Cannabis Industry Journal Staff
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PARSIPPANY, NJ, October 17-19, 2022 – The Cannabis Quality Conference & Expo (CQC) took place in New Jersey last week. The agenda featured three tracks of educational talks, panel discussions, keynotes and breakout sessions.

Highlights from the 2022 CQC

At this year’s event, the conference featured three different keynote presentations, each on different days as well as Lunch & Learn sessions, led by Matthew Anderson, CEO of Vanguard Scientific. He sat down with two experts in cannabis law for interviews during the lunch hour on Tuesday, October 18.

Investigations & Enforcement: A Former Federal Prosecutor’s Perspective

  • Matthew Anderson spoke with Barak Cohen, Chair of the Cannabis Industry Group at Perkins Coie, to discuss federal investigations, Justice Department prosecutions and white-collar offenses.

Compliance is Key: Best Practices for Your New Jersey Cannabis Business

  • Anderson interviewed Casey Leaver, Director of Regulatory Compliance at Vicente Sederberg, to discuss compliance culture, quality controls, New Jersey regulations and more.
Commissioner Maria Del-Cid Kosso takes the stage on Monday

The conference began on October 17 with a keynote presentation led by Commissioner Maria Del Cid-Kosso of the New Jersey Cannabis Regulatory Commission. Commissioner Del Cid-Kosso highlighted the progress the state has made so far with respect to cannabis legalization as well as their goals for the future of the state’s new market.

On the second day of the CQC, Toi Hutchinson, President & CEO of The Marijuana Policy Project, kicked things off with an inspiring keynote discussion where she discussed racial disparities in the industry, social equity, progress and reform efforts.

What People Are Saying About The 2022 CQC

Below are some testimonials we found from this year’s event:

Toi Hutchinson delivers her keynote presentation on Tuesday

“What set the Cannabis Quality Conference apart from many others was the intentionality and focus on high value substance from the presentations.”

“Once again, excellent panels today at the CQC here in Jersey! Have I mentioned how much I love to learn? This industry is forever evolving and being able to observe and watch it roll out from infancy in New Jersey has been tremendous.”

“What an informative and motivating event!”

“I feel fortunate to have been in attendance for such inspiring, informative and REAL discussions being had by industry experts from all across the country.”

“It was so great to listen, meet and speak with so many industry influencers!”

Coming Soon For 2023

After a successful event in New Jersey, the conference begins its planning for next year. The Cannabis Quality Conference & Expo will be returning to New Jersey in 2023. Stay tuned for important announcements, like the dates and location, coming soon.

Scenes From The 2022 CQC

Below are some snapshots of what this year’s CQC had to offer.

About Cannabis Industry Journal

Cannabis Industry Journal is a digital media community for cannabis industry professionals. We inform, educate and connect cannabis growers, extractors, processors, infused products manufacturers, dispensaries, laboratories, suppliers, vendors and regulators with original, in-depth features and reports, curated industry news and user-contributed content, and live and virtual events that offer knowledge, perspectives, strategies and resources to facilitate an informed, legalized and safe cannabis marketplace.

About the Cannabis Quality Conference & Expo

The Cannabis Quality Conference & Expo is an educational and networking event for the cannabis industry that has cannabis safety, quality and regulatory compliance as the foundation of the educational content of the program. With a unique focus on science, technology, safety and compliance, the “CQC” enables attendees to engage in conversations that are critical for advancing careers and organizations alike. Delegates visit with exhibitors to learn about cutting-edge solutions, explore three high-level educational tracks for learning valuable industry trends, and network with industry executives to find solutions to improve quality, efficiency and cost effectiveness in the evolving cannabis industry.

ASTM Debuts New Standards for Cannabis

By Cannabis Industry Journal Staff
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Earlier this month, ASTM International announced that the D37 cannabis committee has approved four new standards for the cannabis industry. Just a few days ago, the same organization announced the development of a new standard that will be published soon.

According to a press release, the four new standards that are already approved will help those working in the cannabis space, as well as regulators and consumers. The four new approved standards are as follows:

  • D8375: This standard provides a method to establish cannabinoid content in cannabis and hemp samples. ASTM member Garnet McRae says, “the standard will help ensure products are labeled properly in jurisdictions where they are legally produced and sold.”
  • D8399: This standard “will aid laboratories in analyzing cannabis and hemp samples to establish pesticide concentration levels – or lack thereof – to ensure products meet regulatory requirements within appropriate jurisdictions,” reads the press release.
  • D8442: This standard aids stakeholders in the cannabis supply chain with quality control measurements. It provides a method for testing terpenes and cannabinoid levels using gas chromatography.
  • D8469: This one provides a new metals testing method for cannabis using inductively coupled plasma mass spectrometry (ICP-MS).

David Vaillencourt will be discussing standards and more at the Cannabis Quality Conference on October 17. The fifth standard that ASTM International announced this week is D8439. This one is designed “to support sound and reproducible research” by providing specifications for medicinal-use cannabis flower. ASTM member David Vaillencourt says it will help establish consistent testing for safety and quality. “With a fragmented cannabis industry marketplace, there is no common set of requirements around reporting cannabinoids and terpenes, which are the primary constituents that are linked to therapeutic benefits,” says Vaillencourt. “This lack of consistency harms public health and prevents evaluation of product safety and efficacy across jurisdictions. This standard provides a solution to this problem.”

Ask the Experts: Ensuring the Validity of Cannabis Lab Testing

By Cannabis Industry Journal Staff
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Cannabis testing laboratories are one of the major players in the industry for protecting public health. Ensuring that laboratory test results are reliable and valid requires a multipronged approach involving method validation, proficiency testing and performing frequent reviews of equipment and processes.

Cannabis testing laboratories often use a variety of different methods to conduct proficiency testing. Laboratories can either participate in programs run by ISO/IEC 17043-accedited proficiency testing providers or through intralaboratory comparison. Comparing different instruments, methods, technologies against pre-defined criteria is a must when validating methods for a specific type of test and ensuring the competence of the laboratory.

Beyond proficiency testing, there are a number of other stopgaps at a laboratory’s disposal for ensuring valid results, like using accredited certified reference materials, performing checks on measuring equipment frequently, reviewing reported results and retesting retained items. All of that and more is outlined in the ISO/IEC 17025:2017 standard, section 7.7.

labsphoto
What good is a test result if you cannot attest to its validity?

There’s a lot that goes into making sure laboratories provide valid results, much of which is detailed in the accreditation process. For more information, we sit down with Keith Klemm, senior accreditation manager for ANSI National Accreditation Board to learn about laboratory accreditation, method validation and other certifications and credentialing available in the cannabis industry.

Q: Why is method validation important for cannabis test methods? 

Keith Klemm: Because cannabis production, testing, and sales is regulated by each individual state, there are very few standard methods for testing cannabis and cannabis-derived products. Non-standard methods or methods developed by the laboratory must be validated to ensure the methods are fit for their intended purpose. What good is a test result if you cannot attest to its validity? There would be no confidence that the results are accurate. Additionally, while organizations such as ISO, AOAC and ASTM are developing standard methods for use in the laboratory, the wide range of products and matrices being tested require modifications to standard methods. Standard methods used outside their intended scope must also be validated, again to ensure the method remains fit for the intended purpose.

Q: We’re pretty familiar with laboratory accreditation. What other accreditations are available in the cannabis industry?

Klemm: Accreditation programs are available for product certification and personnel credentialing, in addition to laboratory accreditation. ANAB’s product certification program was launched in 2020 and is based on the requirements of ISO/IEC 17065. The program combines the requirements of this standard with specific scheme requirements to attest to the competency of certification bodies who then certify products within the scheme. Two schemes are in development specific to the cannabis industry: Cannabis Safety and Quality (CSQ) and PurityIQ. For personnel credentialing, a new Cannabis Certificate Accreditation Program (C-CAP) was developed and is based on ASTM D8403, Standard Practice for Certificate Programs within the Cannabis and Hemp Industries. It also includes any additional state Responsible Vendor Training requirements.

Q: What are the steps to becoming an accredited cannabis testing laboratory, product certification body, or C-CAP organization?

Klemm: The process begins with a request for quote. The organization prepares for the initial assessment by implementing the requirements of the applicable standards, regulatory requirements, and scheme requirements. ANAB believes in a partnership approach to accreditation with a focus on customer needs while ensuring accreditation requirements are met. Once the organization is ready, an initial document review is performed. The accreditation assessment is then performed on-site by technically skilled and knowledgeable assessors. If any nonconformities are encountered, the organization provides a response with cause and corrective actions. Once all nonconformities are resolved and technical review is completed, a scope of accreditation and certificate are provided to the organization. The technical review may vary depending on the accreditation that is being sought, but the general process of accreditation is the same. After accreditation is achieved, the organization moves into a cycle of surveillance and reassessment as defined by the accreditation program and any scheme requirements.

About Keith Klemm

Keith Klemm is a graduate of Manchester University with a B.S. in Biology.  Keith is an experience laboratory director and operations manager with 30 years’ experience in the laboratory environment and has worked as a senior accreditation manager for ANSI National Accreditation Board for the past five years.

Keith’s areas of expertise include:

  • Microbiological assays for food, medical device, and environmental test matrixes.
  • Environmental chemistry of water and wastewater.
  • Biocompatibility testing of medical devices.
  • ISO/IEC 17025:2017
  • AOAC International – guidelines for food laboratories program requirements
  • 21 CFR Part 58, GLP program requirements
  • EPA NLLAP program requirements
  • AAFCO program requirements
  • FDA ASCA Pilot program for Biocompatibility
  • Michigan Cannabis Regulatory Agency program requirements
  • ISO 20387 Biobanking

Bad Actors in CBD: How to Distinguish Quality Products From the Rest

By Joseph Dowling
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The success of reputable cannabis and CBD brands has inspired an influx of inexperienced and disreputable competitors in the market. These so-called “bad actors” in CBD advertise products that are not manufactured under current Good Manufacturing Practices (cGMP), which help to ensure that all products are consistently produced and controlled according to specified quality standards. cGMP helps guard against risks of adulteration, cross-contamination and mislabeling to guarantee product quality, safety and efficacy.

Joseph Dowling, Author & CEO of CV Sciences

CBD products without cGMP regulations are often inaccurately labeled and deceiving to consumers. In fact, in a test of over 100 CBD products available online and at retail locations, Johns Hopkins Medicine found significant evidence of inaccurate, misleading labeling of CBD content. The prevalence of such brands not only reduces consumer confidence in CBD but also limits the growth of the sector as a whole. Fortunately, CBD consumers and retailers can easily discriminate between a well-tested, reputable brand and inferior bad actors with a few straightforward, minimum requirements to look out for when selecting a product.

Why are “bad actors” a problem for consumers and the industry?

Bad actors in CBD sell products that are not produced under cGMP conditions and are typically not tested by third-party laboratories to ensure identity, purity, quality, strength and composition. This means they are not verified for contaminants, impurities, label claims and product specifications. This frequently results in misleading advertising with inaccurate levels of cannabinoids or traces of compounds not found on the label, like THC. To combat this, the FDA issues warning letters to actors that market products allegedly containing CBD—many of which are found not to contain the claimed levels of CBD and are not approved for the treatment of any medical condition. Still, bad actors manage to slip through the cracks and deceive consumers.

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

Bad actors that put anything in a bottle and make unsubstantiated medical claims hurt the reputable operators that strive to create safe and high-quality products. It is easy for consumers to be drawn to CBD products with big medical claims and lower prices, only to be disappointed when the product does not produce the advertised results. Inaccurately labeled products may contain unexpected levels of cannabinoids, including ingredients that consumers may not intend to ingest, like Delta-9 or Delta-8 THC. Along with unexpected levels of THC, many CBD products available now are not as pure as advertised, with one in four products going untested for contaminants like microbial content, pesticides, or heavy metals.

Further, inaccurate labeling of products and their compounds also prevents consumers from establishing a baseline impact of CBD on their bodies, leaving them vulnerable to inconsistent future experiences. Such a poor experience can turn consumers off to the category as a whole, drawing their trust away from not only the bad actors but also the reliable, reputable brands on the market. The saturation of the market with these disreputable brands delegitimizes a category that has only just begun to break down the stigmas, creating stagnation rather than growth as consumers remain wary of low-quality products.

How can consumers identify bad actors in CBD?

There are several simple ways to identify a bad actor among CBD products and make certain that both consumers and retailers purchase quality, reliable and safe brands in legitimate sales channels. To start, consumers should avoid all CBD products that are marketed with unsubstantiated medical claims. This is a significant area of abuse, as brands that relate any form of CBD product to a disease state, like cancer, should not be trusted. The science to support such medical claims has not been completed, yet, product marketing is years ahead of the evidence to support such claims. Unsupported medical claims could also mislead consumers that may need more serious medical intervention.

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

Additionally, consumers must review the packaging, which should include nutrition information in the form of a supplement fact label. The label should include the serving size, number of servings per container, a list of all dietary ingredients in the product and the amount per serving of each ingredient. All labels should include a net quantity of contents, lot number or batch ID, the name and address of the manufacturer, and an expiration or manufacturing date. These signs of a reputable brand are easy to look for and can save consumers from the trouble of selecting the wrong CBD product.

What to look for when selecting a CBD product

With this in mind, products from reputable, tested brands can be identified by a few key factors. Reputable CBD companies are already compliant with the FDA regulations on nutritional supplements, including a nutritional or supplement fact panel on the packaging—just like vitamins. The information in this panel should include all the active cannabinoids in the product, both per serving and package. Clear potency labeling allows consumers to confidently select products that suit their needs and understand the baseline impact of CBD concentration on their bodies, thus helping them to tailor their experience with thoughtful product selection.

Reputable brands also include a convenient QR code on the packaging, linking the product to a certificate of analysis that details the testing results to demonstrate compliance with product standards and label claims. In terms of specific ingredients, consumers should be skeptical of high concentration levels of “flavor of the month” minor cannabinoids, which are often associated with unsubstantiated medical claims. Current scientific research has set its focus on major cannabinoids like CBD and Delta-9 THC, leaving additional research necessary for understanding minor cannabinoids. Minor cannabinoids are typically included in full spectrum products at concentrations found naturally in the cannabis plant, which is a safer approach to consuming CBD until more research is completed.

Consumers should not let the existence of unreliable, untrustworthy brands curtail their confidence in the CBD sector—there are many high-quality, safe and trusted brands on the market. With a knowledgeable and discerning eye, consumers and retailers can easily select top-quality CBD products that millions of consumers have found to improve many aspects of their health and well-being. Looking ahead, clear federal regulations for CBD products that require mandatory product registration, compliance with product labeling, packaging and cGMP will be crucial in weeding out bad actors and will allow compliant companies to gain consumer trust and responsibly grow the CBD category.

Commissioner Maria Del Cid-Kosso to Keynote CQC

By Cannabis Industry Journal Staff
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PARSIPPANY, NJ, October 17, 2022 – The Cannabis Quality Conference & Expo (CQC) just announced the newest addition to the event’s agenda. Commissioner Maria Del Cid-Kosso of the New Jersey Cannabis Regulatory Commission will deliver a keynote presentation at 1:00 PM EST on Monday, October 17.

Commissioner Maria Del Cid-Kosso of the New Jersey Cannabis Regulatory Commission

Commissioner Del Cid is an inaugural commissioner of the NJ Cannabis Regulatory Commission, the government body overseeing regulating the state’s new cannabis industry. Prior to being appointed by Governor Phil Murphy in February of 2021, she was the Director of Policy and Legislative Services at the New Jersey Department of Health. She was awarded the Union County Women of Excellence Award in Government, the Hazel Frank Gluck Award from the Eagleton Institute of Politics, Urban League of Union County Young Professionals Award in Government, and has been recognized as Insider NJ’s 2021 Top 6 Millennial; Insider’s 100 Cannabis Leaders; Insider’s 50 under 30; and Insider’s Top 100 Millennials (2018, 2019, and 2020).

Following Commissioner Del Cid’s keynote presentation, a panel discussion on The Future of East Coast Cannabis: Social Equity, Justice & Legalization will take place in the afternoon. Following that will be a panel on The Standardization State of the Union: Science-Based Resources for Driving Cannabis Safety with an overview of the New Jersey cannabis marketplace to end the first day.

The second day will kick off with a Keynote titled Centering Equity in Cannabis Policy, Quality & Business with Toi Hutchinson, President & CEO at Marijuana Policy Project. Other agenda highlights include:

  • The State of the State: An Update on New Jersey Legalization by Steven M. Schain, Esquire, Attorney at Smart-Counsel, LLC
  • Tri-State Cannabis: Pro Tips for Winning Applications by Sumer Thomas, Director of Regulatory Affairs and Russ Hudson, Project Manager at Canna Advisors
  • Navigating Cannabis Testing Regulations for Multi-State Operations by Michael Kahn, President & Founder of MCR Labs
  • Keynote by Edmund DeVeaux, President of the New Jersey Cannabusiness Association
  • A Guide to Infusion Technology | Design Experiences that Inspire and Innovate with Cannabis Ingredients by Austin Stevenson, Chief Innovation Officer at Vertosa
  • Valuable Analysis Ahead of Asset Acquisition by Matthew Anderson, CEO of Vanguard Scientific

Registration options are available for in-person, virtual and hybrid attendance.

Event Hours

  • Monday, October 17: 12 pm – 6:30 pm (ET)
  • Tuesday, October 18: 8 am – 5:45 pm (ET)
  • Wednesday, October 19: 8 am – 12 pm (ET)

Cannabis industry professionals also interested in the food industry can attend the Food Safety Consortium, which begins on Wednesday, October 19 – Friday, October 21.

About Cannabis Industry Journal

Cannabis Industry Journal is a digital media community for cannabis industry professionals. We inform, educate and connect cannabis growers, extractors, processors, infused products manufacturers, dispensaries, laboratories, suppliers, vendors and regulators with original, in-depth features and reports, curated industry news and user-contributed content, and live and virtual events that offer knowledge, perspectives, strategies and resources to facilitate an informed, legalized and safe cannabis marketplace.

About the Cannabis Quality Conference & Expo

The Cannabis Quality Conference & Expo is an educational and networking event for the cannabis industry that has cannabis safety, quality and regulatory compliance as the foundation of the educational content of the program. With a unique focus on science, technology, safety and compliance, the “CQC” enables attendees to engage in conversations that are critical for advancing careers and organizations alike. Delegates visit with exhibitors to learn about cutting-edge solutions, explore three high-level educational tracks for learning valuable industry trends, and network with industry executives to find solutions to improve quality, efficiency and cost effectiveness in the evolving cannabis industry.

The Cannabis Quality Conference & Expo Brings Education, Networking to New Jersey

By Cannabis Industry Journal Staff
No Comments

PARSIPPANY, NJ, October 17-19, 2022 – The Cannabis Quality Conference & Expo (CQC) heads to New Jersey October 17-19 this year. The agenda features three tracks of educational talks, panel discussions, keynotes and breakout sessions.

At this year’s event, the conference will debut two new features of the program: Lunch & Learn sessions and Happy Hour Roundtables. Matthew Anderson, CEO of Vanguard Scientific, will sit down with two experts in cannabis law for interviews during the lunch hour:

Investigations & Enforcement: A Former Federal Prosecutor’s Perspective

  • Matthew Anderson will interview Barak Cohen, Chair of the Cannabis Industry Group at Perkins Coie, to discuss federal investigations, Justice Department prosecutions and white-collar offenses. This Lunch & Learn will take place 12:00 to 12:25 PM on Tuesday, October 18.

Compliance is Key: Best Practices for Your New Jersey Cannabis Business

  • Matthew Anderson will interview Casey Leaver, Director of Regulatory Compliance at Vicente Sederberg, to discuss compliance culture, quality controls, New Jersey regulations and more. This Lunch & Learn will take place 12:35 to 1:00 PM on Tuesday, October 18.

Following the conference agenda on Monday, October 17 and Tuesday October 18, attendees are invited to join the cocktail reception for Happy Hour Roundtables. From 4:45 to 5:45 PM, subject matter experts will be available to chat, answer questions & offer guidance on the following topics:

  • Regulatory Compliance: Jason Thomas, Precision Quality & Compliance
  • Banking, Finance & Real Estate: Steve Schain, Esq., Smart-Counsel LLC
  • Licensing: Russ Hudson & Sumer Thomas, Canna Advisors
  • Certifications & Controls: Tyler Williams, CSQ
  • Compliance Solutions: Doug Plunkett & Zach Cicconi, ProCanna
  • Standards in Cannabis: David Vaillencourt, The GMP Collective
  • Social Equity & Justice: Ernest Toney, BIPOCANN

The conference will begin with a panel discussion on The Future of East Coast Cannabis: Social Equity, Justice & Legalization. Following that will be a panel on The Standardization State of the Union: Science-Based Resources for Driving Cannabis Safety with an overview of the New Jersey cannabis marketplace to end the first day.

The second day will kick off with a Keynote titled Centering Equity in Cannabis Policy, Quality & Business with Toi Hutchinson, President & CEO at Marijuana Policy Project. Other agenda highlights include:

  • The State of the State: An Update on New Jersey Legalization by Steven M. Schain, Esquire, Attorney at Smart-Counsel, LLC
  • Tri-State Cannabis: Pro Tips for Winning Applications by Sumer Thomas, Director of Regulatory Affairs and Russ Hudson, Project Manager at Canna Advisors
  • Navigating Cannabis Testing Regulations for Multi-State Operations by Michael Kahn, President & Founder of MCR Labs
  • Keynote by Edmund DeVeaux, President of the New Jersey Cannabusiness Association
  • A Guide to Infusion Technology | Design Experiences that Inspire and Innovate with Cannabis Ingredients by Austin Stevenson, Chief Innovation Officer at Vertosa
  • Valuable Analysis Ahead of Asset Acquisition by Matthew Anderson, CEO of Vanguard Scientific

Registration options are available for in-person, virtual and hybrid attendance.

Event Hours

  • Monday, October 17: 12 pm – 6:30 pm (ET)
  • Tuesday, October 18: 8 am – 5:45 pm (ET)
  • Wednesday, October 19: 8 am – 12 pm (ET)

Cannabis industry professionals also interested in the food industry can attend the Food Safety Consortium, which begins on Wednesday, October 19 – Friday, October 21.

About Cannabis Industry Journal

Cannabis Industry Journal is a digital media community for cannabis industry professionals. We inform, educate and connect cannabis growers, extractors, processors, infused products manufacturers, dispensaries, laboratories, suppliers, vendors and regulators with original, in-depth features and reports, curated industry news and user-contributed content, and live and virtual events that offer knowledge, perspectives, strategies and resources to facilitate an informed, legalized and safe cannabis marketplace.

About the Cannabis Quality Conference & ExpoCannabis Quality Conference & Expo logo

The Cannabis Quality Conference & Expo is an educational and networking event for the cannabis industry that has cannabis safety, quality and regulatory compliance as the foundation of the educational content of the program. With a unique focus on science, technology, safety and compliance, the “CQC” enables attendees to engage in conversations that are critical for advancing careers and organizations alike. Delegates visit with exhibitors to learn about cutting-edge solutions, explore three high-level educational tracks for learning valuable industry trends, and network with industry executives to find solutions to improve quality, efficiency and cost effectiveness in the evolving cannabis industry.

2022 Cannabis Labs Virtual Conference: September Program

By Cannabis Industry Journal Staff
No Comments

2022 Cannabis Labs Virtual Conference: June Program

Sponsored by Millipore Sigma

Click here to watch the recording

Agenda

Combating Laboratory Shopping

  • Michael Kahn, President & Founder, MCR Labs

In this session, Michael Kahn discusses:

  • Economics of lab shopping
  • Effects of lab shopping on public health
  • Creating incentive for honest testing and labeling

TechTalk: Millipore Sigma

  • Dr. Stephan Altmaier, Sr. Manager, Merck KGa Darmstadt

AOAC: Why Third-Party Accreditation Matters More than Ever

  • Anthony Repay, Laboratory Director, Method Testing Laboratories

Attendees will learn about the history the AOAC, the role of third-party accreditations in Cannabis microbiology testing and how to seamlessly integrate into your existing processes to enhance consumer safety. 

The Evolution of the Hemp Testing Market: An Introduction

  • Mikhail Gadomski, Principal Chemist, Deibel Laboratories

Attendees of this session will learn:

  • What is the Difference Between Hemp and Cannabis?
  • What are Natural and Synthetic Psychoactive Cannabinoids; THC 9, CBD, THC 8, THC 10, THCO, etc.?
  • Status of Federal and State Testing Regulations

Cannabinoid Extraction Efficiency for Potency Analysis: An In-Depth Look of Multiple Techniques

  • Melinda Urich, LC Solutions Scientist, Restek

Attendees of this session will learn:

  • The importance of extraction efficiency.
  • Variables to consider when choosing a sample preparation technique.
  • Understanding which technique is best for your testing lab.

Click here to watch the recording

Soapbox

Fly By Night: Do Your Gummies Take the Red-Eye?

By Douglas Rohrer
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The global vitamin supplement market is projected to grow at 6.2% compound annual growth rate (CAGR) to $71.37 billion by 2028 with the most rapid growth now occurring in the gummy vitamin segment. Gummy supplements are expected to have the fastest CAGR at 12.6% to exceed $33 billion by 2028. Initially developed for youths, gummies are now preferred by all age segments as an alternative to tablets, capsules and pills.

As one might expect, cannabidiol (CBD) gummies are also projected to grow rapidly at a 30.7% CAGR to $13.9 billion by 2028. In terms of actual number of CBD gummies produced last year, a rough estimate would be at least 1.7 billion. For perspective that equates to 53 gummies produced every second, 24 hours a day, 365 days per year. One might reasonably ask, “So where do all these gummies come from?” and “Who makes them and under what conditions and quality assurance standards?”

There is no short answer to these questions nor confidence that all cannabinoid gummies are manufactured with adherence to a minimum set of safety and quality standards. Gummy recipes and ingredients are readily available online and there is no shortage of hobbyists who make small batches for family, friends and to sell at retail pop-ups and farmers’ markets. There are a number of well-known brands that started out in home kitchens and garages. In terms of production scale, on the other end of the spectrum are companies like Bloomios, Inc. (OTCQB: BLMS), that operates a 51,000-square-foot Current Good Manufacturing Practices (cGMP) compliant facility in Florida.

The Hobbyists

A variety of CBD products on the market today

For the hobbyist producer, they often begin to scale out of their home kitchen and take over part of their garage or basement and while the entrepreneurial spirit is admirable, most consumers wouldn’t be comfortable with their pharmaceuticals, supplements or even grocery items being manufactured under these conditions which often lack:

  • Rigorous sanitary practices
  • Measures to mitigate contaminants entering the production areas
  • Quarantine, chain-of-custody audit and testing of active ingredients used in production
  • Standardized and rigorous quality assurance testing of finished product
  • Certificate of Analysis (COA) for active ingredients in finished product for certainty of dosage levels
  • Labeling and packaging standards to ensure product information and volumes are correct
  • Batch record data collection, retention and audit procedures.

However, the hobbyists constitute only a very small fraction of gummy production today, and they typically take great pride in their work and show a high degree of care in production practices. Thus, when demand begins to outpace the artisanal home production capacity, many growing brands turn to contract manufacturers to assist with scaling the production side while the brand focuses on the sales, marketing and distribution side of the business. This is an ideal solution as high quality product can be produced at volume in cGMP facilities which enhances the consumer experience, confidence in the product and further grows brand value. This is a best-case scenario of small emerging brands that care deeply about their reputations and their customers’ experience scaling production and growing responsibly.

The Opportunists

The real underbelly of commercial gummy production is characterized by the pure profit seeking producers that set up semi-permanent production lines in flex-industrial spaces not suitable for food handling, with limited buildout for isolation of each production stage. This process includes: materials storage, weight/measures prep, ingredient mixing, molding, dehydration, coating, sorting and filling, labeling and finish packaging. Lacking cGMP compliant facilities and practices, they neglect or fail entirely to maintain batch records, COAs or chain-of-custody practices and have limited ability to address defective product once in the stream of commerce. Let’s refer to these manufacturers as the “Opportunists.”

Opportunists see the current cannabinoid gummy market for what it is. It is an emerging market really taking form only since the 2018 Farm Bill legalized hemp derived cannabinoids. As such it is very much in its “gold rush” phase with many of the participants having just entered the sector. Many participants have adopted ad hoc practices with no standardization and no explicit federal oversight because the FDA has yet to acknowledge any cannabinoids under its generally regarded as safe (GRAS) standard.

FDAlogoIn addition, the FDA has excluded CBD products from the dietary supplement definition of the Food, Drug and Cosmetics (FD&C) Act. Under the FD&C Act, if a substance is an active ingredient in a drug product that has been approved or has been authorized for investigation as a new drug, then products containing said substance are excluded from the definition of dietary supplement. So far cannabinoid gummy demand has continually outstripped supply supporting attractive margins and with little oversight. The Opportunist mindset has focused on maximizing profits while they can before regulation increases costs, compresses margins and reduces profits.

The Opportunists have more cover to seek profit maximization as opposed to incurring the cost of setting up cGMP facilities and adhering to rigorous standards due to the fact that the brands consumers recognize are often manufactured by one or more third-party contract manufacturers. Some brands also want to maximize near-term profits and manufacturers with a lower cost structure can more effectively compete on price as opposed to quality.

As demand surges, some brands will supplement their third-party cGMP produced product with additional product sourced from Opportunists and “recycle” the valid COAs from their cGMP product without the cGMP manufacturer or consumers even knowing. With lax regulatory oversight, these brands are inclined to look the other way on their contract manufacturer’s production practices so long as the large volume orders are delivered on time and at lower cost.

GMPFor gummies produced by Opportunists, if there are product defect issues, the consumers likely won’t be able to rely on the batch record data and purported COAs linked to/from QR codes on the container, many of these COAs have been recycled from legitimate batches or simply doctored up and reproduced rather than generated on a per batch basis. There is limited to no audit trail and recalls are unlikely to be effective, if even initiated. A refund is the most likely solution a consumer has which leaves perhaps a much larger run of defective product in the market still unaddressed. Moreover, brands that suffer reputational harm due to quality issues can simply launch a substitute brand with a similar look through its same distribution channels and maintain much of its market share.

Best Practices

If today’s CBD gold rush sounds much like the Wild West, you would be correct. However, as more consumers become aware of cannabinoids’ health and wellness benefits in addition to the recreational uses, this larger and more diverse consumer base is raising the bar and demanding more transparency and certainty on manufacturing practices than ever before.

americana dummies
A roughly estimated 1.7 billion CBD gummies were produced last year

How are the leading cannabinoid nutraceutical manufacturers proactively addressing consumers’ desire for high quality, rigorously tested products manufactured in accordance with standards already imposed on mainstream nutritional supplement and prepared food manufacturers? Although the answer may be simple, the implementation and ongoing compliance is not.

The answer is voluntary adoption and compliance with the same regulations applicable to non-cannabinoid dietary supplement manufacturers. Given that the FDA has not recognized cannabinoids as dietary supplements quite yet, certain aspects of dietary supplement regulation can’t be adhered to such as notifying the FDA of structure/function claims as new products are brought to market or notice of new dietary ingredients. On the other hand, many of the regulations can and should be adhered to by cannabinoid nutraceutical manufacturers to ensure its safe, transparent orderly growth.

Chief among the FDA requirements that Bloomios and other leading manufacturers adhere to are:

  • Register with the FDA as a food handling and production facility.
  • Adopt Current Good Manufacturing Practices for dietary supplements which establishes uniform standards needed to ensure quality throughout the manufacturing process and verification of the identity, purity, strength and composition of their products.
  • Undertake at least annually an independent third-party cGMP audit of their facility and procedures.
  • Comply with Code of Federal Regulations (21 CFR 101.36) supplement label requirements to ensure that the ingredients list is accurate, and the content matches the amount declared on the label among other disclosures.

The most significant challenge in adopting all of the above best practices is cGMP facility qualification and ongoing compliance. The cGMP standards require specific facility build-out features, equipment, and of course standard operating procedures. There are significant additional costs to bring a cGMP facility on-line, additional time and required experienced personnel that can implement the operating procedures and recertification every time a production line’s configuration is changed or augmented with additional equipment.

Bloomios annual cGMP audit was conducted in August and over 130 specific requirements were evaluated and graded. While Bloomios passed the audit and evaluation, what is of far greater significance is that cGMP practices become part of a company’s culture so that these high standards are maintained year-round and not rushed into practice just for the audit.