On this month’s episode, we are joined by Otha Smith III, the CEO and founder of Tetragram. We discuss Otha’s history in the industry as both a patient and an entrepreneur, obstacles he’s overcome, exciting research endeavors, and more.

Noid Knowledge, Ep 6: Tetragram: How Patient Data Is Powering Research

We’re highlighting the talented female experts presenting at the upcoming 2022 Cannabis Science Conference West on May 18-20 in Long Beach, California

Cannabis Science Conference Honors the Wisdom of Women

Check out the Cannabis Science and Technology April Issue!

What are current good manufacturing practices (cGMP) certification and why get it? 

Why cGMP Certification Matters in the Cannabis Industry

This study focuses on a step-by-step optimization of commercial scale preparative HPLC purification of cannabinoids, specifically cannabidiol, starting with stationary reversed-phase screening, followed by method optimization

Development, Optimization, & Process Performance for Chromatographic Purification of Cannabinoids

CannMed held their 2022 annual conference in Pasadena, California from May 3–5. The event, fully in person, included a full-day medical practicum workshop, dozens of exhibitors, and thought-provoking keynote presentations in the four focus areas of medicine, science, cultivation, and safety. Attendees and presenters had the chance to network and mingle at the VIP dinner and the cocktail hour. Several presenters and guests were interviewed throughout the conference the at the CannMed Coffee Talk Lounge, including Megan L’Heureux, Group Editorial Director for 

A few interesting talks to note included the presentation by Jaime Brambila of Grace Health and Wellness titled “Raising Awareness: The Successful Implementation of Natural Plant Based Medicines Used as Adjunct Therapies with Standard Treatments for Metastatic Breast Cancer.” Brambila shared his wife, Nicole DiMonda’s, personal journey through cancer treatment and the success she had with medical cannabis and psychedelics. At the end, DiMonda shared a passionate statement about how this industry helped save her life. DiMonda and Brambila have partnered with several universities and research groups to expand their experience into clinical trials for others.

In addition, Dr. Marion McNabb of the Cannabis Center of Excellence highlighted some of the initial findings from her healthcare provider study in which her company surveyed healthcare professionals across the country on their knowledge and interest surrounding medical cannabis. The study is still open to healthcare providers through August 2022. Some of Dr. McNabb’s initial findings include:

354 healthcare providers responded, the majority of whom were nurses

42% of respondents also reported using medical cannabis themselves

37% believe cannabis can be a first line treatment

Alongside presentations on the medical aspects of cannabis, there were also many talks on the latest advancements in cultivation, testing, extraction, and research. Seth Crawford, co-founder of Oregon CBD, explained in his keynote address, “Cannabis 2022: The Golden Age of Discovery?” the methods of selective breeding of certain hemp plants on his farms, plus the potential innovations these seeds and plants can provide to farmers and researchers.

Grace Bandong, Scientific Strategy Leader for Contaminants for Eurofins Food Integrity and Innovations, gave another keynote presentation titled “Risk Based Hazards Analysis: A Tool for Building a Comprehensive Analytical Testing Program.” Bandong’s presentation explained how to create an effective yet economical risk-based framework of analysis of products, plus an explanation of the unexpected threats that hazards such as mycotoxins, heavy metals, and pesticides can pose to products.

For more information on CannMed or to learn more about the talks and speakers from this year’s event, please visit: 

https://cannmedevents.com/cannmed-schedule/

Articles

CannMed held their 2022 medical practicum and science conference in Pasadena, California from May 3 – 5.

CannMed’s 2022 Conference Further Promotes Mission to Inspire Science, Community, and Hope

On June 14–15, 2022, Natoli Engineering Company will be offering a two-day seminar called “Tablet Press & Tooling: Applied Learning Experience” at their headquarters in St. Charles, Missouri. The seminar will reportedly teach students best practices for tablet press operation and maintenance. The course, which is offered a few times each year, is fully comprehensive, and provides students with the latest knowledge, research, and technology in tablet compression tooling. Supervisors, quality assurance and quality control personnel, and maintenance technicians at any stage are encouraged to attend.

Assembly and disassembly of all main components of a rotary tablet press

Relationships among maintenance, inspections, operations, and troubleshooting

On June 14–15, Natoli Engineering Company, a manufacturer of tablet compression tooling, is offering hands-on training on how to sharpen skills in tablet press setup, operation, and maintenance procedures.

Natoli Engineering Company Schedules New Two-Day Seminar Training for Tablet Press Operation and Maintenance

Have you ever found a foreign object in your food, or woken up not feeling too good from the previous days’ food? Each year in the United States, 1 in 6 people get sick from foodborne disease, 128,000 are hospitalized, and 3000 on average die. In the United States, we have seen large recalls involving listeria in cantaloupes, salmonella in peanut butter, metal pieces in ground beef, and, more recently, cannabis recalls because of potentially unhealthy levels of molds, yeasts, pesticides, and heavy metals.

In the cannabis industry there seems to be a misconception that your company will never have a recall in its lifetime, or that there isn’t any possibility that it will ever happen to you. In reality, all wholesale food companies and cannabis companies experience at least one or multiple recalls during their lifetime. It isn’t about 

. And when it happens, how will your company handle it? If your company is prepared and has good protocols in place, then you can prevent a recall or make it far less detrimental to the company if you happen to go through one.

In efforts to protect consumers, the Food and Drug Administration (FDA) as well as local and state regulatory authorities publish product recalls to notify consumers of confirmed and potentially contaminated products. The recall could stem from your own product or an outside manufacturer; think of in-house manufactured ingredients, out-of-house added ingredients, or primary packaging. What to expect from a recall may differ from state to state, but the overall process is similar to the FDA’s. We hope to clarify what to expect during a recall and how this can prepare you for dealing with this type of situation.

Keep in mind that a recall is not always your company’s fault, but that doesn’t mean that your company isn’t the one that has to deal with it or be the one announced in the press releases and bulletins when it does. We see this a lot when a company isn’t protecting itself by testing all products (yes, again) before using them in their products. This means all ingredients including cannabis products. As much as I hate to say it, certificates of analysis (CoAs) aren’t always telling you the truth, so we always recommend conducting your own third-party testing for new vendors for at least a few months before trusting CoAs. These kinds of precautions could save you millions down the line, even though there is a cost associated with extra testing.

We also see this when companies are using white labelers to create their products. If your company name is on the containers being recalled, then it's your brand that is affected negatively by it. Unfortunately, you don’t always have control of what is happening in a white label facility, so we highly recommend routine third-party food safety audits or making sure the company has current good manufacturing practices (cGMP) certification before engaging with them. You have to protect your brand at all costs, and be wary of taking someone’s word for being “compliant” or for being cGMP certified. Stating that you are “complaint” really doesn’t mean anything since there isn’t anyone checking to see if you are staying compliant with cGMP standards. If a company really is cGMP certified, they should be able to easily supply you with an actual, up-to-date certification. Please do not take anything at face value. I have seen the worst of it – ask for proof of everything.

The very early steps of a recall start with determining the need for a recall.You may conduct a voluntary recall on your own or you may receive a notification that your product is at fault, which could also lead to a recall. This could include a simple consumer complaint, consumer social media post, hospital visit, or worse…death. No matter the origin, your product could be the linking connection to the complaints.

Let’s say a regulatory authority notifies you that your product is the common source of illness. What is next? You must quickly identify which products are associated with the complaints. Maybe a common ingredient, common manufacturing date, equipment, staff, packaging material, or so on. You will need to be able to identify which products are included in the recall. Let us hope your traceability is on point! Having a strong product traceability program will expedite identifying which products need to be recalled and which consumers need to be notified. If traceability is not in place, the recall could expand past the identified product to include “any and all” products.

Once the product is identified, you must contact and notify any consumers, wholesalers, and distributors to whom the product was sold. This could include contact via phone call, mass email correspondence, social media posts, press releases, and the most profound is the FDA publishing the recall on a national level. Expect product returns, reimbursements, and disposals for the recalled product.

After publishing the recall and receiving returned product back, what’s next? An investigation must be conducted on the recalled product to determine the root cause for the incident. This root cause will help determine how to best move forward.Once investigated, a corrective action must take place. You may choose to rework the product or you may choose to dispose of the product. Either decision must be based on science and have a clear path of documentation. Adhering to a corrective action preventive action (CAPA) plan is key to correcting the impacted product and ensuring it doesn’t happen again.

You’re not done just yet; the next step is preventing this from occurring again. Understanding the root cause of the nonconforming product will reveal options for preventing a similar disruption in the future. Perhaps an ingredient was purchased from an unapproved supplier, a product failed testing or was not tested, equipment malfunctioned, sanitizer chemical was too concentrated, and so on. The list goes on and on.

A recall is never ideal, but you can control how smoothly a recall flows. Remember to work with your local or state government regulatory agencies when conducting a recall. Additionally, you can prepare for potential recalls by promoting current good manufacturing practices throughout the facility, utilizing an approved supplier program, applying a CAPA plan, consumer complaint and non-conforming operating procedures, and have a complete recall plan in place. 

Kim Stuck is the CEO and founder of Allay Consulting. Direct correspondence to: 

In the cannabis industry there seems to be a misconception that your company will never have a recall in its lifetime, or that there isn’t any possibility it will ever happen to you. In reality, all cannabis companies experience at least one or multiple recalls during their lifetime. It isn’t about if it will happen, it’s more of a when. And when it happens, how will your company handle it?

What to Expect with Product Recalls 

Sarah Ahrens, Founder and CEO of True Labs For Cannabis

Can you tell us about your background? What are the main reasons you chose to start True Labs for Cannabis LLC (TLC)?

 Before entering the cannabis industry, I had a successful career in sales, but if I were to start my career over again, I think I would have become a research scientist. My interest in cannabis and being a part of a new market, combined with my interest in science, led me to land on the idea of starting a cannabis analytical testing laboratory.

Beyond my professional background and interests, though, lies a personal passion for quality. Transparency and integrity are rooted in my DNA. I want to know what goes into the products that I buy for myself and my family. I’m health-conscious—I read all the ingredient labels and buy organic as much as possible. So, it was easy for me to see how I could help bring safety and transparency to the New Jersey cannabis market. It’s not a coincidence that TLC also stands for “tender loving care.”

Did you face any unique challenges as the first woman-owned testing laboratory on the East Coast?

There are challenges associated with starting any business, but it has been a big benefit and a differentiator to be the first certified woman-owned cannabis testing laboratory on the East Coast. It feels good to be the first, but I certainly hope I’m not the only woman-owned laboratory for long. We need more women leaders in cannabis and in testing.

There have been challenges I’ve faced as a female entrepreneur, though, and particularly when it comes to access to capital. Being in the cannabis industry has its own banking and capital restrictions but combine that with the fact that less than 3% of investor capital goes to women-owned businesses, securing funding becomes a really steep hill to climb. It has certainly helped that I have a lifetime career in sales, but most female entrepreneurs are not so lucky. There’s a lot more the industry could do to break down gender barriers when it comes to financially supporting women business enterprises (WBEs).

What has been the most unexpected or rewarding experience you’ve had since starting TLC?

There have been several already. It feels special to blaze a trail by being the first certified woman-owned cannabis testing laboratory on the East Coast. I also never expected to play a big advocacy role, but it is so important in a market that is just getting started. It has been a great experience to develop a louder voice to stand up for consumer safety and robust testing standards. It is also amazing how small this industry can get so quickly, and how there are very few degrees of separation between people in cannabis—it starts to become a very large family.

But hands-down, the most rewarding experience has been to see my dream of starting this business become a reality. On that note, I must give a shout out to our Chief Science Officer, Dr. Carl Christianson. He has been the best partner and scientific leader I could have ever imagined, and True Labs would not be where we are today without him and his guidance.

Why is it important to note that your laboratory has been “built from the ground up?” What sorts of challenges did your team face while building this laboratory?

At True Labs, we are dedicated to our craft: cannabis testing. Being 100% focused on servicing one industry allows us to continuously innovate, offer a wider array of industry-specific testing, and increase efficiencies. Our scientific leadership team has more than 18 years of cannabis testing experience! That is very hard to find in a new market.

We’ve built our lab in a way that fits our values and ideals, with integrity threaded throughout our processes. We are using advanced technology and instrumentation as the cornerstone of the state-of-the-art facility we set up. So, we are not just taking someone’s cookie cutter approach to turning around a profit, but we are purpose-driven and truly focused on being trusted partners for our customers. We also want to be a reputable source of knowledge and insight for consumers.

As far as challenges go, we’ve experienced what you would typically see for any startup business, namely timeline delays for various reasons and added and unexpected costs, although we’ve had some pleasant surprises with cost reductions and savings as well.

Tell us about what a typical testing process looks like (or will look like) at TLC. What unique challenges does cannabis pose in standard testing laboratories?

The reality is that a typical testing process is non-existent. The variety of sample types and evolving regulations, combined with the push to continually improve upon our own procedures, make this a truly dynamic environment.

When a sample comes in the door, the first challenge is ensuring that we gather as much information about the sample as possible, helping us determine the best way to prepare it for testing. These questions range from sample type, added ingredients, and the stability of the sample. From there, we assess the types of tests requested or required, as this will influence the workflow. Once we have all the information and the right plan in place, it is then all about an efficient plan to obtain the necessary data points, ensuring that we are utilizing the proper controls and continually monitoring the integrity of our processes.

After gathering these data, everything is triple checked, and finally the data set is aggregated into a usable report, or certificate of analysis (CoA), for our customer. At True Labs, we make sure to back this up with any additional support required to read, interpret, or understand the CoA.


How important is the CoA you provide for cannabis products tested in your laboratory?

Extremely important. Without a CoA, there is no proof that products were tested and no insight into what substances and contaminants were identified and quantified. A CoA is like a report card, in that it details whether you are passing or failing, and for the latter, it details how you’re failing. However, the CoA is just a representative document meant to summarize all the work that went into generating that data. The most important thing we can do as a lab is make sure this is presented clearly and concisely, making the information accessible and usable for every consumer.


What do you think consumers need to understand about CoAs? Are there any good resources for people to learn how to read a CoA?

It is not easy for a consumer who has no experience reading CoAs and has not been given a tutorial on doing so, to understand what they are looking at. Sure, the phytocannabinoid profile or terpene profile should be easy enough to understand, but the measurements used do not always translate into a consumer’s understanding of product potency. True Labs published a 

guide on how to read a certificate of analysis

Why is it important to your facility to offer testing services above and beyond those currently required and regulated by the state of New Jersey?

True Labs is designed to be a “one stop shop” for all cannabis related testing needs. While most of our business will come from compliance testing based on the New Jersey testing regulations, it has been an important part of our business model to offer additional value-add services to our customers. We are not a compliance factory; we are a true partner to our customers and really want to help our customers enhance their business operations. As an example, if we can certify that a grow room is free of harmful contaminants prior to seedlings going in, it provides value for the cultivator and can save them serious headaches down the road. True Labs wants to be that trusted testing partner for producers at every step of their operations.


Now that New Jersey has fully legalized cannabis, how much demand do you anticipate seeing on the testing side?

The demand for third-party testing in New Jersey has been trickling in as the market gets up and going. There are several reasons for this. The testing market is in this interim limbo state. Labs are just starting up, with only a few operational, and so the New Jersey Cannabis Regulatory Commission is hesitant to require all operators to go through a third-party lab for testing. Testing with a third-party lab is optional right now. As more labs come online, and as more of the newly licensed cultivators and manufacturers start planting, harvesting, and producing, there will be a huge demand for third party testing.

In the same sense, it is hard to see how New Jersey can have a big legal market without product testing. We have a state lab that has been conducting the medical cannabis testing, but they do not have a microbial assay and they only test the first batch of a cultivar in the first year it is grown. You can essentially say that no testing is really happening in New Jersey. To have a legal cannabis market, you must ensure the health and safety of consumers. Once the Commission requires producers to test with third-party labs, there will be a ton of demand.


Can you explain the practice of “lab shopping”? How can the industry combat it?

Lab shopping is a nasty habit that has creeped up in various markets. Essentially, it is when a producer selects or switches to a lab that can give the producer the results they are looking for. Typically, this is in the form of THC potency or passing contaminated product. It is gaming the system.

Unfortunately, there are labs out there that will bend or dismiss their morals and are willing to risk their entire business by tweaking methods or data so that the producers get the desired results, not the honest results. Thankfully, though, there are ways a market can combat this.

The first step is awareness. Luckily, the New Jersey Cannabis Regulatory Commission is very aware of this issue and has some processes set up to prevent it from happening. There are a few methods to prevent lab shopping, including having a state-run lab to verify testing results and do spot-checks, such as a secret shopper approach. The state can also require round-robin proficiency testing program among all the labs in the state, which essentially verifies results each lab gets on the same sample. Finally, the state can require that labs are certified under a third-party system, like ISO 17025.

Obviously, there are legitimate reasons for a business to choose a different testing lab to partner with, but these reasons should focus on the integrity of data, the efficiency of generating reports, and the customer service of the lab. The manipulation of data is something that should not be tolerated in our industry. Our hope and expectation is that bad actors will be identified and removed from the equation as the industry continues to grow and mature.

How do consumers’ buying trends affect what is tested, such as terpenes?

What I see happening in New Jersey is probably not too dissimilar from every other state, in that what consumers want, need, or are buying doesn’t translate up to the regulators. This is likely because there really aren’t any consumer advocacy associations to pool voices together.

It is also a reason why businesses in the cannabis market need to be vocal and advocate for consumers. Typically, the health and safety targets are covered by regulation, but innovative new products are market driven. With these new product classes, the need for additional testing targets may arise.

At True Labs, we have built an operation capable of providing a range of techniques in anticipation of this challenge. In addition, our team brings a diverse set of experiences to the table, helping us partner with our clients to support the creation and innovation of new product classes.

You are working on creating testing guidelines that are the “best of the best.” Can you tell us more about the process of creating these guidelines (who else is working on them, how do you plan to get them approved at a higher level)?

Every organization needs an association—a way to pool voices and stand up for what you believe in. Therefore, I started the Laboratory Testing Committee under the New Jersey CannaBusiness Association (NJCBA), which I am now chairing. We have pulled together labs starting up in New Jersey, as well as various other experts in physical and biological sciences, medicine, public health, or similar.

Before the committee formed, several of our members had been collaborating informally to create a guidance document for the New Jersey Cannabis Regulatory Commission on what New Jersey’s testing standards should be. The testing standards proposed were developed by holistically looking at best practices throughout the US and reasonable testing standards both from states with existing cannabis markets that have some excellent testing regulations, as well as from various national and international standards organizations. Now that we are formally grouped in the NJCBA committee, we are providing the Commission with additional related documentation detailing specific aspects of testing which support our original guidance and working to ensure the formation of a robust cannabis testing industry. We do our best to communicate these advanced scientific regulatory recommendations in a clear and logical way, helping the Commission and consumers alike see the importance and benefit of these recommendations.

What do you think are the most important factors for the guidelines you’re working on?

In the guidelines we have created, we have strived to maintain a balance between operational practicality and product safety, while maintaining the integrity of the testing market. It is important that we do not overburden testing labs or producers, and even more important that we ensure consumer safety.

Product safety is 

 differentiator for the legal cannabis market. The key to creating guidelines is making sure that we have several expert voices working together, while doing our best to hear the needs and concerns from the other impacted areas of the industry, all supporting the same goal of product safety. There is no perfect regulatory platform, but we aim to develop one focused on health and human safety, while maintaining fairness in an emerging market.

How can other interested parties get involved with developing testing guidelines?

Reach out to me! The NJCBA Laboratory Testing Committee is interested in working with any person or business who has an interest in ensuring consumer safety and upholding the integrity of the testing market. The more perspectives we bring into the conversation, the more robust our testing guidelines can become. We are also happy to share what we have already developed, as we want it to be critically reviewed. Feedback is a gift.

How do you envision the future of the cannabis testing industry in New Jersey? And in the northeast as a whole?

There remains a lot of work that needs to be done within the testing ecosystem. As I mentioned, regulations need to be honed, the market is in a growth stage that will ultimately stabilize, and during the next two years or so, labs will be adapting in real time as regulatory bodies and producers alike grow with this industry. As the maturation of the market starts to materialize, labs will be embedded as an integral part of the supply chain, and more traditional operating challenges should become the focus, from increasing efficiency, bringing the newest technologies into our operation, and providing the best customer service.

What goals or new projects are you working on for TLC?

Right now, we are all hands-on deck with the anticipation of the New Jersey cannabis market opening and expanding. We are eager to support this initial phase of the market and are currently focused on preparing our lab to be ready to operate efficiently at these early stages. Beyond this, we already have ideas for which projects come next, although I am not going to publicly reveal what those are yet (smiling).

Is there anything else you’d like to add?

Starting a business in the cannabis industry is not for the faint-hearted—it takes grit and determination. Some days it is really, 

 hard, but there is a quote I love that has helped to pull me through: “If your dreams don’t scare you, they’re not big enough.” It is a reminder to keep moving forward despite your fears that want to hold you back, and to keep reaching for bigger goals. I am really excited about the potential for the New Jersey cannabis market, and just as excited to have True Labs play a critical role from the beginning.

Visit the True Labs for Cannabis LLC website

https://www.truelabscannabis.com/blog/how-to-read-a-certificate-of-analysis

Cannabis testing laboratories play an important role in ensuring consumer safety and quality throughout the industry. These laboratories face many challenges—from the variety of samples in the industry to changing regulations and testing requirements and everything in between. In this interview, Sarah Ahrens, Founder and CEO of True Labs for Cannabis LLC, explains her philosophy and approach behind building her cannabis analytical testing laboratory in New Jersey. She also covers current developments in the cannabis testing industry and what needs to be done to ensure it has a transparent and productive future that benefits producers and consumers alike.

A Focus on Safety, Integrity, and Innovation: One Cannabis Laboratory Strives to Exceed Standard Testing Practices and Client Relations

How did you get involved in the cannabis industry?

 While cannabis has been used in some form or another for centuries, the science of cannabis is still in its infancy. So as a scientist, I was attracted to this dynamic and fascinating field from the beginning. When I joined the company, Shimadzu was already established as the leader in analytical solutions for the cannabis industry, and my boss, Dr. Bob Clifford, was a recognized authority in that market. He mentored me to become the Market Manager for Cannabis at Shimadzu Scientific Industry. And I’m very grateful and excited to serve in this role to help advance cannabis science.

At Cannabis Science Conference West, you are presenting two talks. Can you give us a little preview of your talk for the hemp track titled “Starting with the Roots - the Many Uses of Hemp”?

 Hemp is a remarkable and very versatile plant and has been cultivated by humans for thousands of years. We all know about the benefits from the flower in terms of CBD. In my talk, I will highlight how the other parts of the hemp plant are being used to produce everyday products like clothes and shoes and paper. And, of course, as the title indicates, the health benefits of the hemp root. All this in the context of solutions for the quality control of these products.

What will your analytical talk titled “Delta Dawn - the Next Generation of Cannabinoids?” focus on?

 The drop in value of CBD combined with the Hemp Farm Act have created a situation where CBD is chemically converted to different THC isomers. In my talk, I describe the chemistry of this conversion and the need to develop advanced analytical techniques (for example, LC–MS) to detect and identify the various “Delta X” isomers of THC.

What are you most excited to learn at the Cannabis Science Conference?

 In addition to learning about the latest hemp and cannabis research, I am most excited about the new Psychedelics Track.This is such a hot new field that deserves a lot of attention.Right now, I know just enough to be dangerous and I’m hoping to learn more about the different types of psychedelics so I can become useful and make meaningful contributions towards the analytical aspect of Psychedelics.

Can you explain what tetrahydrocannabinol (THC) isomers are and why it’s important to learn more about them?

 Isomers are defined as having the same molecular formula but different arrangement of the atoms.THC isomers differ in the position of a double bond within one of its rings.While that may seem like an insignificant difference, the receptors in our bodies are remarkably sensitive to even the slightest difference in molecular structure.Which means a person could have a different physiological reaction to, for example, the newer delta-8 THC isomer than the more widely studied and understood delta-9 THC.Remember that delta-9 THC is the predominant isomer occurring in cannabis plants. So, as more of the synthetic THC isomers (like delta 8) enter the cannabis consumer market, we need to understand how they affect the human body and assure that they are safe to consume.

What is the best method for measuring cannabinoids and terpenes found in hemp?

 For cannabinoids, the best and most widely used technique is high performance liquid chromatography (HPLC). There are dedicated instruments, for example, the Hemp Analyzer from Shimadzu, that make this analysis easy and accurate.Terpenes are volatile compounds, so they are best analyzed by gas chromatography–mass spectrometry (GC–MS).Both headspace and liquid Injection are commonly used, depending on the actual sample and specific analytes.

In the cannabis industry, do you think there should be a uniform set of rules and regulations?

 Absolutely!As cannabis consumption—both medicinal and recreational—becomes more mainstream, it is important to have a consistent set of rules and regulations across the entire country. I look at it as an extension of Food Safety. The FDA establishes guidelines and regulations to assure that the food we eat is safe. We need similar FDA guidelines and regulations to assure that any cannabis product at any dispensary anywhere in the country is safe to consume.

What would you like to see change in the cannabis industry in the next 5 years? How about in the hemp industry?

 The big change I would like to see is managing the cannabis industry on a federal level.One of my focal points in cannabis science is “food safety”, that is, making sure cannabis products are safe to eat or smoke. To achieve that from an analytical perspective, we simply cannot have 50 different lists of pesticides or residual solvents. We need consistency across the entire country—one set of federal regulations and standards for every cannabis testing lab in the country.

As for the hemp industry, I’d like to see extended use of other parts of the hemp plant.I will elaborate more on this in my talk, but CBD from the flower is like the proverbial tip of the iceberg.The seeds and roots offer excellent health benefits.And the stalk is a “greener” alternative to crops like cotton (for fabrics) and trees (for paper).However, to help make hemp a more viable option for these products, regulators would have to relax the arbitrary rule of <0.3% THC.Raising that limit to, for example, 1.5%, could prevent an entire hemp harvest from having to be destroyed.And much like with cannabis, this would have to be a federal, nationwide regulation change.

Are there any other talks at the Cannabis Science Conference that you’re looking forward to hearing?

 As always, there are a lot of great speakers talking about relevant and interesting topics.The one I look forward to the most is the Keynote presentation by Professor Richard van Breemen talking about his groundbreaking research on certain cannabinoids blocking the Coronavirus from entering our cells.This could be a game changer on how we deal with Covid-19.

Is there anything else you would like to add?

 I like CSC because it offers the most relevant, interesting, and current cannabis and hemp science and research.My favorite part, though, is the Canna Boot Camp.It is such a fun and educational and interactive event.I would highly recommend the Canna Boot Camp to anyone new to the cannabis industry, or anyone looking for some close up, hands-on experience with any aspect of cannabis science, from cultivation to nutrients to sample prep to analysis to compliance.

The science of cannabis is in its beginning stages and has a large opportunity for growth advancement. Market Manager for Cannabis for Shimadzu, Eberhardt Kuhn, Ph.D., will be presenting two talks for both the hemp and analytical tracks, “Starting with the Roots - the Many Uses of Hemp” and “Delta Dawn - the Next Generation of Cannabinoids?” If you are interested in exploring hemp or cannabidiol (CBD) and other cannabinoids, check out both of these presentations to learn more! In this interview, Kuhn also discusses his interests in the cannabis industry and other presenters at the Cannabis Science Conference (CSC) West taking place in Long Beach, California from May 18–20, 2022.

CSC West: Dr. Eberhardt Kuhn Looks to Advance Cannabis and Hemp Science

What first led you to get involved in the cannabis industry?

: My background is in environmental laboratory quality assurance. When the cannabis industry started to emerge, I found cannabis laboratories were often lacking the rigor of quality control and the documentation to support it. Emerging industries are always exciting.

Your presentation for the Cannabis Science Conference West is called “Importance of Quality Control in Cannabis Laboratories.” What inspired you to present on this topic? What are you most excited to share?

: Quality control is important no matter the matrix—air, water, or cannabis. I have found that laboratory personnel are so often in the weeds, pun intended, they lose sight of the overarching purpose of analyzing quality control samples. I am excited to share a basic understanding of quality control as it pertains to cannabis analyses. I believe better quality data is the result.

Who will benefit most from your presentation and why?

: Laboratory management, supervisors, and analysts can benefit from my presentation. No matter how experienced one is, it is always nice to get back to basics every so often.

What kind of important information do you hope attendees will gain from your presentation that they wouldn’t know otherwise?

: I would hope attendees will gain a deeper understanding pertaining to the “why” of running quality control samples. Each type provides different information concerning sample preparation, instrument conditions, and contamination.

Do you face any unique challenges with your work in quality control and consulting in the cannabis industry?

: Emerging industries will always have those in a rush to the finish line. Sometimes corners are cut for the sake of speed. There has been a drastic improvement over the years but there remain some laboratories in need of a little guidance and help.

What do you hope to see change in the future with analysts’ approaches to quality control in cannabis laboratories?

: I hope to see continual improvement in cannabis laboratories. The data should be well-defined and of known and documented quality. Analysts working in cannabis laboratories should continue to build their skill sets and general knowledge of the chemistry behind the tests.

What are you most excited to learn at Cannabis Science Conference West?

: I’m excited to learn about new technologies and methods for testing cannabis products. The science is evolving rapidly with advanced ways of performing separations and analyte detection.

: Thank you for this opportunity. I’m excited to present and attend.

Cannabis Science Conference West, taking place May 18-20 in Long Beach, California, is quickly approaching. The two-day agenda is packed with exciting speakers from around the country. In this preview, we hear from Dr. Tony Francis, Principal, SAW Environmental. Dr. Francis is also an IAS instructor and assessor and a fully qualified National Environmental Laboratories Accreditation Conference (NELAC) assessor in organic and inorganic chemistry, microbiology, cryptosporidium, radiochemistry, solids, aqueous, tissue, and air. Here he shares some insights into his talk, “Importance of Quality Control in Cannabis Laboratories,” scheduled for Friday, May 20 from 9:30 – 10:00 am. We hope to see you there!

Quality Control in Cannabis Laboratories: A Cannabis Science Conference West Preview with Dr. Tony Francis

Recently, Medicare Plans, a patient support center that helps provide resources for understanding Medicare, conducted a survey of current Medicare recipients on their opinions of Medicare coverage for medical cannabis treatment and products (1). The survey was conducted online with 1250 Americans ages 65 and over surveyed. It covered topics such as past and current cannabis use, political affiliations, and how much patients spent on cannabis products per month. Medicare Plans released their survey results this month.

Some of the most prominent findings, according to Medicare Plans, included:

1 in 5 Medicare recipients currently use medical cannabis

23% have used medical cannabis in the past

66% of Medicare recipients “strongly agree” or “agree” that Medicare should cover medical cannabis

59% of those who support Medicare coverage for medical cannabis say it's because it can be effective where other treatments fail

38% of Medicare recipients who use medical cannabis do not want Medicare coverage because they fear it will increase the price

Medicare Plans pointed out that currently the use of medical cannabis is legal in 37 states, four territories, and the District of Columbia. However, because cannabis is both illegal at the federal level and, in most cases, not approved by the US Food and Drug Administration (FDA), health insurance does not pay for it. Medicare Plans also noted that with the recent passing of the Marijuana Opportunity Reinvestment and Expungement (MORE) Act in the House of Representatives, the question of whether insurance should cover medical cannabis may soon need to be addressed.

To see the survey results in detail, please visit: 

https://www.medicareplans.com/1-in-5-medicare-recipients-use-medical-marijuana/

Medicare Plans, a patient support center that provides resources for better understanding Medicare, recently conducted a survey about the idea of Medicare coverage for medical cannabis treatment and products. Here are some highlights from their results.

Medicare Plans Releases Survey Results Regarding Medical Cannabis Coverage

Recently, we published an article about a new commission in the United Kingdom (UK) researching how to become a global leader in cannabinoid innovation (1). Now, in another step forward, the Food Standards Agency (FSA) has released a list of permitted cannabinoid products in the UK.

The UK has become the first country to regulate the market for safe, orally consumed legal cannabis extracts, following the recent release of the FSA’s public list of cannabinoid products permitted for sale to consumers. Products designed to be inhaled, such as vapes, or applied to the skin, including cosmetics and massage oils, are not included on the list. Publication of the list follows two years of close cooperation between the FSA and the Association for the Cannabinoid Industry (ACI), the UK’s cannabinoid sector trade body. According to the press release, full authorization is expected in 2023 (2,3).

“The FSA public list represents a major milestone for the UK’s CBD [cannabinoid] category. It demonstrates the progress the sector has made to meet compliance requirements and creates greater regulatory certainty which, in turn, will increase levels of consumer trust, encourage investment in the sector, and promote innovation,” said Steve Moore, ACI founder, in the press release (2,3). “ACI is immensely grateful for the work that our members and the FSA have put in to take this momentous step.”

The ACI is working in tandem with Trading Standards, a government authority that protects consumers (4), to enforce the new rules immediately, with any company offering unlisted cannabinoid products for sale facing possible action by its officers. Businesses selling cannabinoid products, including supermarkets, convenience stores, health food stores, pharmacies, online retailers, cafés, and restaurants, have been urged to check their current stock against the list to ensure they are compliant. ACI has also launched a new website, 

, to serve as a reference point enabling consumers, retailers, health practitioners, and enforcement authorities to verify whether a product is being sold legally.

“The release by the Food Standards Agency of the list of cannabinoid products permitted for sale to consumers in England and Wales is an important milestone for the cannabinoid sector in the UK. We welcome the release,” said Jeremy Willcocks, Partner at law firm Arnold & Porter. “Cannabinoid foods on the list can now be sold legally in England and Wales. Other cannabinoid food products need to be removed from sale. Today’s announcement brings welcome legal certainty which will encourage investment in the cannabinoid foods sector.The ACI has played an important role in this process and we congratulate the ACI for its terrific work.”

The UK’s market for consumer cannabinoid products was worth £690 million in 2021, according to ACI estimates—more than double the level of sales recorded in 2019, when the market was valued at £314 million. The UK is now the world’s second largest market for consumer cannabinoids, behind only the US.

https://www.cannabissciencetech.com/view/a-new-commission-formed-in-the-united-kingdom-plans-to-publish-recommendations-on-how-the-uk-can-become-a-global-leader-in-cannabinoid-innovation

https://aci.prezly.com/press-release-embargoed-until-12pm-bst-31-march-2022

https://www.food.gov.uk/news-alerts/news/food-standards-agency-takes-next-step-to-regulate-cbd-market

https://en.wikipedia.org/wiki/Trading_Standards

The United Kingdom (UK), the first country to formally regulate the market for consumer cannabinoid products, recently released a list of cannabinoid product legally permitted for sale.

United Kingdom’s Food Standards Agency Releases a Public List of Legally Permitted Cannabinoid Products for Consumers

Cannabis companies are consistently under-regulated when it comes to health and safety, so many companies have been taking this part of their business into their own hands to produce consistent and safe products and to later be able to function under federal guideline. One of the ways companies are doing this is to become current good manufacturing practices (cGMP) certified. Even though to me and to some others this is an obvious, good thing to do, people still ask me, “what is cGMP certification and why should I get it?” It takes a lot of time, it’s hard work, and can be expensive to become cGMP certified, so why should we even be interested in going through all the heartache for something that isn’t yet required?

There are many reasons that receiving a cGMP accredited certification can benefit your cannabis company, and I decided to write the blog this month about those reasons. Here, I will explain those reasons and then concisely outline the steps of becoming certified. If this is something in your 2022 goals for your company, hopefully it will get you in the mindset and give you an idea of what to expect.

Current good manufacturing practices (cGMPs) are a set of standards that were created by the US Food and Drug Administration (FDA) under the authority of the Federal Food, Drug, and Cosmetic Act. The standards cover manufacturers of food, dietary supplements, cosmetics, medical devices, and prescription drugs. cGMP requires a systematic quality approach to manufacturing, including the development and implementation of procedures and documentation for the design, monitoring, and control of all manufacturing processes. cGMP certification is specific to the facility, which means each production facility will need their own certification. This quality management system helps to ensure products are made consistently and reliably to product specifications for identity, strength, quality, and purity.Not only does cGMP help businesses prevent hazards such as contamination or errors, but it also ensures that products are safe for consumers every time. Most large retailers (such as Walmart, CVS, and so forth) require this certification prior to selling products.

Positive brand recognition is always a good thing when producing products.This is probably the number one reason why potential clients call me wanting the cGMP certification in the first place. They want to be able to brand their products as cGMP certified, and many other cannabis or hemp companies won’t buy or sell products that weren’t made in a cGMP certified facility. This is the trend and the way I see it; it will continue to be in the industry from now on.Consumers are far more likely to buy a product that they know is safe and held to a standard that has been audited. Being able to put on your branding, website, and product stands that you are a cGMP certified company makes a lot of difference when it comes to consumers and ingredient buyers. It also lets consumers know that you aren’t just in this to make money, but you care about the people who are using your products. It helps consumers trust your brand and want to continue buying it, and that’s the goal, right? Especially right now when there are oh so many brands that obviously are in it just for the money grab and seem not to care. Doing this will set your company apart from the others.

Product safety when it comes to cGMP certification is one of the key factors. cGMP requirements are based on current FDA regulations and revolve around making your product as safe as possible for human consumption. This is not only showing consumers that you care about them, but it is also a huge risk mitigator when it comes to liability and regulatory fines. Not only that, but it seriously reduces the likelihood that you will have to go through a recall or dispose of products due to a contamination oversite. Announcing to the world that you messed up and potentially (or actually) harmed some of your customers is a huge black eye on not only your brand, but the industry as a whole. Having good food safety practices in place can make or break a company. Don’t be the last company to be up to par with food safety–you may very soon regret it.

Worker safety, or Occupational Safety and Health Administration (OSHA) regulations, is very important and most people aren’t thinking about them yet, but you should be implementing them now if you can. cGMP certification is one way to get a start toward being OSHA compliant. All cGMP requirements from an accredited certifying body have requirements for documentation, training, and logs of some (but not all) OSHA standards. I would say that 90% of the companies in the cannabis industry that I consult with have no OSHA documentation in place in their facility other than the informative poster on the wall. The documentation that cGMP requires is also required by OSHA, and is the perfect place to start on the path to having complete worker safety compliance. Many of our clients will finish up their cGMP certification and then have Allay Consulting finish out all their OSHA required documentation and training as well. Once companies have a couple OSHA items in place, I think company leaders see how important it is to protect their employees and decide it’s a good idea to become fully complaint. Also, OSHA is one of the highest fining departments in the US and if there is a complaint, they have jurisdiction to investigate in all cannabis facilities, so having anything in place will help lower those fines if a visit does happen. 

Media opportunities are a paramount way to show how your company shines. Press releases and articles about the company usually happen when you have something to talk about. This is a great opportunity to brag about your accomplishments and you deserve to! Becoming cGMP certified or having any other accredited certification for health and safety is not easy. You should be posting the certification on the website, getting articles in media outlets, doing podcasts, and obviously putting out a press release. These tactics have greatly helped other companies we have worked with after certification is received. You should have pride in your company’s accomplishments, and when you actually have an accomplishment like this you should be talking about it.

Most of our clients are on a long-term certification path that consists of first receiving cGMP certification, then International Organization for Standardization (ISO) 9001, and then ISO 22000. This will be the way of the world. The longer hemp and cannabis are on the market, the more these kinds of regulations and certifications will be required. Eventually all will be federally legalized, and not only will you be dealing with all state and local regulatory factions, but that will all be topped by the FDA and OSHA as well. Receiving these certifications will make the federalization transition practically painless, because most of what is required by the FDA will be already addressed and implemented in your facilities. Companies that aren’t thinking about the big picture, and aren’t even thinking about becoming compliant with these standards, eventually will be paying the price. The reason we set our clients on this path is because there is evidence that ISO 22000 will be required for international commerce to most other countries, much the same as many wholesale foods. The Canadian government is even thinking about requiring all their cannabis facilities to be compliant to this standard, and that ideal will probably spread to other countries, including the US. Without these certifications, you will seriously be limiting your future growth potential. Our goal is to help our clients be as successful as possible. Being compliant and getting certified is a cornerstone of success in this industry. Someday storefronts and ingredient buyers won’t even work with you without these kinds of safety assurances in place. Anyone who is falling behind won’t be around long enough to make their mark.

Becoming cGMP certified can be a long and tedious process that doesn’t happen overnight, and the regulations for each certifying body are different and must be followed perfectly in all documentation and training requirements. There are many reasons why getting cGMP certified in the cannabis or hemp industry is a smart thing to do. Becoming compliant with federal regulations such as the FDA and OSHA can save you hardships and money. Receiving brand recognition for a job well done and for going above and beyond is always a good thing, and all of the outgoing media can only help you find new consumers for your brands. The true take away I want to leave you with is simple: If you want to build a quality brand that is going to last longer than a few more measly years, then you will need this. The industry is changing, and people want products they know are safe and consistent. This is the way you prove that. 

 is the CEO and founder of Allay Consulting. Direct correspondence to: 

What are current good manufacturing practices (cGMP) certification and why get it? It takes a lot of time, it’s hard work, and can be expensive to become cGMP certified, so why be interested in something that isn’t yet required?

Could you tell us about your background and what first inspired you to start CBD American Shaman? What makes your company unique? Where did the name come from?

 Growing up around entrepreneurs set me on the path to entrepreneurship. CBD American Shaman began from a calling to try to help my uncle who was terminally ill. Although I kind of stumbled into this business, once I decided to follow this calling, things moved fast. The name is tied to the intention to help people feel better, like a shaman does.

The main goal of CBD American Shaman has—and always will be—to help people feel better. We’re also always trying to bring the latest science and technology to the cannabis industry. One of the things we always say about our business is “nature enhanced by science.” We stand out in the industry because we place a huge emphasis on education. Educating our customers so they know how to best use what they’re purchasing and getting them the right dosage for their needs is super important to us.

Can you tell us about the entire process of the formation of your cannabidiol (CBD) products from seed to sale? How do you ensure constant quality and safety?

 We started with manufacturing oil in the beginning, expanded into extraction, and now grow our own hemp. We test any soil our plants are grown in for insecticides and heavy metals, and we continue testing throughout the development process: we test the plant materials while they’re growing and cured, we test the oil when it’s extracted, and we retest the finished products.

CBD American Shaman is reportedly the nation’s largest brick and mortar CBD retailer. What sorts of challenges have you had to overcome in the past and currently to reach that status?

 There have been so many challenges, and new challenges arise daily. It builds true resilience!Some of the challenges we’ve faced in the past include legal issues on a state-by-state basis as well as federally (before the federal government made CBD legal), plus the time and work we put in lobbying at federal and state levels to bring about change. Another challenge is banking–everything from getting a bank account to getting a business credit card to advertising. Advertising is a gray zone–some will work with you while others will not. While running and scaling any business is challenging, a business in this industry is infinitely harder.

Tell us about your use of nanotechnology to enhance hemp’s health-supporting effects and to increase the bioavailability of CBD.

 We actually sort of backed into it! I realized early on that the bioavailability of CBD oil is so low that you must use a high dosage, which makes it really expensive. The high price point made this product unavailable to the people who really needed it. But if you increase bioavailability, you get more efficacy from a smaller amount. Then more people can have access to it, it works better, and it even manifests differently sometimes. The best example I can think of is when we started working with cannabigerol (CBG). We initially were digging into CBG for its gut health properties, but once we used nanotechnology on CBG it resulted in helping gut health and providing a burst of clean energy.

Tell us about what a customer can expect with an in-store and online buying experience. How do you provide education and guidance?

 The in-store experience for our customers revolves around education and creating an inviting experience. We believe it’s necessary to educate our customers because even our great products are useless if they’re not being utilized properly. We prioritize each customer and make the time to teach, but also support them while using our products. We’re in it for the long run! We want to create relationships with our customers, which creates returning customers. We are also working on automated kiosks which will provide a self-guided learning track giving customers the option to choose.

Each store is designed to be a warm, inviting, and comfortable environment conducive for learning and encouraging customers to open their minds. It always comes back to education so we can best teach our customers how to use our products and ultimately set them up for success.

Our online experience differs in that we’re not able to provide as much education as we’d like for the time being (we’re exploring how we can improve this). We offer as much description and background as possible on each product, but it’s challenging to properly relay our message with so many Food and Drug Administration (FDA) regulations that hinder what we can and cannot say.

What types of products do you offer for pets and why?

 We have CBD tinctures, water-soluble CBD, and CBD treats for dogs, cats, and horses. People love their pets.If we can help provide some relief for any discomfort pets are experiencing, we’re definitely going to help.

How does your Compassionate Care program help your customers?

 CBD American Shaman offers ongoing discounts for those who really need our products but don’t have access. We offer these ongoing discounts to those who are low-income, and for veterans through the company’s Compassionate Care Program.

Can you tell us about your recent expansion into selling medical cannabis products?

 We started in Oklahoma first with a dispensary and moved into manufacturing and growing. Next, we bought licenses in Missouri for manufacturing. We’re essentially doing the same things in the tetrahydrocannabinol (THC) space as we’ve done in the CBD world, so all that education and experience has been an easy segue into the medical marijuana industry. The medical marijuana business itself is easier at times because there are more defined lines about what we can and cannot do. This means we’re not spending as much time and energy trying to make certain things happen that are often an uphill battle (as with the CBD industry). For example, I know I can’t advertise on TV.

What is the most important thing consumers should know about hemp and about CBD?

 Hemp needs more credit–it can be used to create supplements to make your life better and make you feel better, as well as create great replacement products for materials that aren’t environmentally friendly. I’d also love for people to recognize and experience how great CBD is! It’s an amazing cannabinoid that enables the body to operate the way it was designed to work because it works with the body’s endocannabinoid system.

What is special about the hemp plant? How have you used it to make a gentler impact on the environment?

 The hemp plant is very environmentally friendly by nature. It gives back to the soil, you don’t need to use insecticides because the terpenes naturally deter insects, and it uses far less water than cotton and other plants. About 

 are needed to grow enough cotton for one pair of blue jeans–this statistic is astonishing (1). There are so many things that aren’t good for the Earth, such as cotton and plastic, that we can replace with hemp. 

Tell us about your work as part of the Board of Directors for US Hemp Roundtable. What have you seen accomplished and what is the organization currently working towards?

 The biggest thing was the 2018 Farm Bill, which made CBD and hemp officially federally legal after 81 years of prohibition–that’s the biggest lift of all time! And on an ongoing basis, the organization is still working for federal approval on different levels, such as a bill to Congress that proposes removing CBD from the FDA’s authority so it can finally be named a dietary supplement. If this were passed, it means the FDA would have no power over it. Additionally, we’re always facing issues at a state level. The organization’s main goal is to ensure quality, legal products are being created nationwide that are safe for customers.

Why is It important to be certified by the US Hemp Authority?

 It's a very thorough inspection–it means you’re doing everything above board and have good manufacturing processes for all supplements. That’s exactly why you don’t see many companies with it, because unfortunately not many work at that high quality level the US Hemp Authority requires.

What are you most hoping to see in the cannabis and hemp industries in the next few years?

 Normalization–an adult conversation around marijuana. It’s far less damaging than tobacco and alcohol, yet we can deal with those. This would comprise decriminalizing, legalizing, and allowing businesses in this industry to operate as a normal industry, meaning normal banking and other needs like that.

https://www.the71percent.org/industrial-water-usage/

Cannabidiol (CBD) has been a hot topic for several years now and it seems like you can buy CBD almost anywhere. As a consumer, how do you know that the CBD at your local drug store is the same quality at a cannabis or hemp retail store? Education is key to knowing the difference and finding a top-notch product. In this interview, Vince Sanders, founder and president of CBD American Shaman, discusses his company’s approach to cannabis retail, their main motivators for success, and his plans for continual expansion in the cannabis industry. 

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