Tag Archives: laboratory

Michigan Shuts Down Cannabis Testing Lab

By Aaron G. Biros
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In a state where cannabis testing labs are already hard to come by, one lab just got their license suspended, bringing the total number of testing labs in Michigan from six down to five.

According to the Detroit Free Press, last week, Michigan’s Marijuana Regulatory Agency (MRA) filed a formal complaint against Iron Labs, based in Walled Lake, “for, among other things, finding marijuana that tested above the legal limit for various contaminants but not reporting those test results in the state’s tracking system. The lab allegedly also didn’t report edibles that tested above the state’s potency limit for THC, the psychoactive substance in marijuana that produces a high.”

The formal complaint filed by the regulatory body said that Iron Labs lacks “integrity, moral character and responsibility or means to operate or maintain a marijuana facility.” While no reports of health issues associated with products tested by Iron Labs have surfaced, the state is still urging patients to reconsider using products tested by the lab in question.

In a statement last week, MRA Executive Director Andrew Brisbo said he wants his agency to focus on protecting patient and consumer safety. “It is imperative that our licensees follow the rules and laws, especially regarding the testing of medical marijuana product,” says Brisbo. “We are intensely focused on making sure that the marijuana product in the regulated industry meets established safety standards.”

Because the issues are still under investigation, the regulatory body will not comment on how much cannabis is potentially contaminated and how much of the market has been using Iron Labs as an analytical testing partner.

Andrew Kline, Director of Public Policy at NCIA, to Speak at 2019 Cannabis Quality Conference & Expo

By Cannabis Industry Journal Staff
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EDGARTOWN, MA, Aug. 6, 2019 – Innovative Publishing Co., publisher of Cannabis Industry Journal, has announced that Andrew Kline, Director of Public Policy at the National Cannabis Industry Association (NCIA), will serve as the keynote speaker at the 2019 Cannabis Quality Conference & Expo on October 2. The Cannabis Quality Conference & Expo (CQC) takes place October 1-3 in Schaumburg, IL (just outside Chicago). The CQC is an educational and networking event for cannabis safety and quality solutions. Serving the Midwest market with a unique focus on science, technology and compliance, the CQC enables attendees to engage in conversations that are critical for advancing careers and organizations alike.

Andrew Kline, Director of Public Policy at NCIA

To see the agenda for the CQC and registration pricing, click here.Kline’s keynote talk is titled “The Business of Cannabis: Why Public Policy Matters.” It will feature two discussions: First, a general update on public policy and government relations with respect to the cannabis industry. Second, Kline will discuss how cannabis should be regulated at the federal level once legalization happens.

Kline joined NCIA’s leadership team in April of this year and began his work with the organization swiftly. He led a coalition of CBD and hemp businesses to prepare public comments and testimony for the purpose of educating and influencing FDA rule-making. Prior to working with NCIA, he served as President of the National Association of Cannabis Businesses (NACB), the first self-regulatory organization for the cannabis industry.

Before joining the NACB, Kline was Special Counsel for the Federal Communications Commission’s (FCC) Enforcement Bureau where he was responsible for high-profile investigations and public policy negotiations affecting the telecommunications, internet, cable and satellite industries. He also served as Chief of Staff and Senior Advisor for Intellectual Property Enforcement in the Obama Administration.

Andrew Kline will be delivering the keynote talk on October 2. To learn more about the Cannabis Quality Conference & Expo, click here. 

Stillwater Labs Accredited to ISO/IEC 17025

By Cannabis Industry Journal Staff
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The American Association for Laboratory Accreditation (A2LA) announced earlier this month the accreditation of Stillwater Laboratories, Inc. to ISO/IEC 17025. Based in Olney, Montana, Stillwater Labs is the first laboratory A2LA has accredited to the ISO 17025 standard in the state. 

According to a press release, Stillwater is also the first in the state to go through a dual assessment, a new program put in place Fall of 2018. Both ISO/IEC 17025 accreditation and Americans for Safe Access (ASA) Patient Focused Certification were obtained by the lab. Stillwater achieved the recently updated ISO 17025:2017 accreditation.

“Stillwater Labs is honored to achieve ISO/IEC 17025:2017 accreditation” says Dr. Ron Brost, laboratory director Stillwater. “Quality methods are the cornerstone of our operations, and accreditation through the A2LA has been a valuable developmental process. We used the opportunity to refine, clarify, and tune our systems in order to bring world-class analytics to our clients in Montana. We look forward to continuing to drive advanced technologies coupled with excellent customer service through ISO/IEC 17025 best practices.” 

Keeping Your Environment Clean: Preventative Measures Against Contamination

By Jeff Scheir
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For years we have heard about and sometimes experienced, white powdery mildew when growing cannabis. It is a problem we can see, and we have numerous ways to combat it. But now more and more states are introducing regulatory testing on our harvests and they are looking for harmful substances like Escherichia coli., Aspergillis Fumigatus, Aspergillis terreus, …  just to name a few. Mycotoxins, mold and bacteria can render a harvest unusable and even unsellable- and you can’t see these problems with the naked eye. How much would it cost you to have to throw away an entire crop?

You bring in equipment to control the humidity. You treat the soil and create just the right amount of light to grow a superior product. You secure and protect the growing, harvesting, drying and production areas of your facility. You do everything you can to secure a superior yield… but do you?

Many of the organisms that can hurt our harvest are being multiplied, concentrated and introduced to the plants by the very equipment we use to control the growing environment. This happens inherently in HVAC equipment.

Your air conditioning equipment cools the air circulating around your harvest in a process that pulls moisture from the air and creates a perfect breeding ground in the wet cooling coil for growth of many of the organisms that can destroy your yield. As these organisms multiply and concentrate in the HVAC system, they then spew out into the very environment you are trying to protect at concentrated levels far greater than outside air. In effect, you are inoculating the very plants you need to keep safe from these toxins if you want to sell your product.

The cannabis industry is starting to take a page from the healthcare and food safety industries who have discovered the best way to mitigate these dangers is the installation of a proper UVC solution inside their air conditioning equipment.

Why? How does UVC help? What is UVC?

What is Ultraviolet?

Ultraviolet (UV) light is one form of electromagnetic energy produced naturally by the sun. UV is a spectrum of light just below the visible light and it is split into four distinct spectral areas – Vacuum UV or UVV (100 to 200 nm), UVC (200 to 280 nm), UVB (280 to 315 nm) and UVA (315 to 400 nm). UVA & UVB have been used in the industry to help promote growth of cannabis.

What is UVC (Ultraviolet C)?

The entire UV spectrum can kill or inactivate many microorganism species, preventing them from replicating. UVC energy at 253.7 nanometers provides the most germicidal effect. The application of UVC energy to inactivate microorganisms is also known as Germicidal Irradiation or UVGI.

UVC exposure inactivates microbial organisms such as mold, bacteria and viruses by altering the structure and the molecular bonds of their DNA (deoxyribonucleic acid). DNA is a “blue print” these organisms use to develop, function and reproduce. By destroying the organism’s ability to reproduce, it becomes harmless since it cannot colonize. After UVC exposure, the organism dies off leaving no offspring, and the population of the microorganism diminishes rapidly.

Ultraviolet germicidal lamps provide a much more powerful and concentrated effect of ultraviolet energy than can be found naturally. Germicidal UV provides a highly effective method of destroying microorganisms.

To better understand how Steril-Aire UVC works, it is important to understand the recommended design. Directed at a cooling coil and drain pan, UVC energy destroys surface biofilm, a gluey matrix of microorganisms that grows in the presence of moisture. Biofilm is prevalent in HVAC systems and leads to a host of indoor air quality (IAQ) and HVAC operational problems. UVC also destroys airborne viruses and bacteria that circulate through an HVAC system and feed out onto the crop. HVAC cooling coils are the largest reservoir and amplification device for microorganisms in any facility.

For the most effective microbial control, UV germicidal Emitters are installed on the supply side of the system, downstream from the cooling coil and above the drain pan. This location provides more effective biofilm and microbial control than in-duct UVC installations. By irradiating the contaminants at the source – the cooling coils and drain pans – UVC delivers simultaneous cleaning of surface microorganisms as well as destruction of airborne microorganisms and mycotoxins. Steril-Aire patented this installation configuration in 1998.

The recirculating air in HVAC systems create redundancy in exposing microorganisms and mycotoxins to UVC, ensuring multiple passes so the light energy is effective against large quantities of airborne mycotoxins and cleaning the air your plants live by.

Where are these mycotoxins coming from?

Aspergillus favors environments with ample oxygen and moisture. Most pre-harvest strategies to prevent these mycotoxins involve chemical treatment and are therefore not ideal for the cannabis industry.

Despite the lack of cannabis protocols and guidelines for reducing mycotoxin contamination, there are some basic practices that can be utilized from other agricultural groups that will help avoid the production of aflatoxins and ochratoxins.

When guidelines are applied correctly to the cannabis industry, the threat of aflatoxin and ochratoxin contamination can be significantly reduced. The place to start is a clean air environment.

Design to win

The design of indoor grow rooms for cannabis is critical to the control of airborne fungal spores and although most existing greenhouses allow for the ingress of fungal spores, experience has shown that they can be retrofitted with air filters, fans, and UVC systems to make them relatively free of these spores. Proper designs have shown clearly that:

  1. Prevention via air and surface disinfection using germicidal UVC is much better than chemical spot treatment on the surface of plants
  2. High levels of air changes per hour enhance UVC system performance in reducing airborne spores
  3. Cooling coil inner surfaces are a hidden reservoir of spores, a fertile breeding ground and constitute an ecosystem for a wide variety of molds. Continuous UVC surface decontamination of all coils should be the first system to be installed in greenhouses to reduce mildew outbreaks.

UVC can virtually eliminate airborne contaminants

Steril-Aire graphic 4

Steril-Aire was the first and is the market leader in using UVC light to eliminate mold and spores to ensure your product will not be ruined or test positive.

  1. Mold and spores grow in your air handler and are present in air entering your HVAC system.
  2. Steril-Aire UVC system installs quickly and easily in your existing system.
  3. The Steril-Aire UVC system destroys up to 99.999% of mold/spores.
  4. Plants are less likely to be affected by mold…with a low cost and no down time solution.

It’s time to protect your harvest before it gets sick. It’s time to be confident your yield will not test positive for the contaminants that will render it unusable. It’s time to win the testing battle. It’s time for a proper UVC solution to be incorporated throughout your facilities.

Kentucky Gets Its First Accredited Cannabis Testing Lab

By Aaron G. Biros
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Fouser Environmental Services LTD, a laboratory based in Versailles, Kentucky, became the first cannabis testing laboratory accredited in the state last week, according to a press release. The American Association of Laboratory Accreditation (A2LA) announced the lab’s successful accreditation to ISO/IEC 17025:2017.

“We congratulate Fouser Environmental Services on becoming the first cannabis testing laboratory accredited in the state of Kentucky. Their completion of this milestone in such a timely manner through the A2LA accreditation process is a testament to their hard work and commitment to quality”, says Adam Gouker, A2LA General Manager. “A2LA realizes the vital role that accreditation plays in the cannabis industry to support compliance with regulatory requirements, and we are thrilled to see that our service has been adopted in a new state. We look forward to our continued relationship with Fouser Environmental Services in the provision of their accreditation needs.”

Fouser Environmental Services has been an environmental testing lab in Kentucky for more than 30 years. A statement by the lab in the press release says they want to support the hemp industry as it continues to grow in Kentucky. “It is our great honor to be the first A2LA ISO/IEC 17025:2017 accredited laboratory for cannabis testing in the Commonwealth as we continue to strive to perform accurate analysis and release reliable data to the growing hemp industry within Kentucky and throughout the country,” reads the press release.

Food processing and sanitation

Key Points To Incorporate Into a Sanitation Training Program

By Ellice Ogle
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Food processing and sanitation

To reinforce the ideas in the article, Sanitation Starting Points: More Than Sweeping the Floors and Wiping Down the Table, the main goal of sanitation is to produce safe food and to keep consumers healthy and safe from foodborne illness. With the cannabis industry growing rapidly, cannabis reaches a larger, wider audience. This population includes consumers most vulnerable to foodborne illness such as people with immunocompromised systems, the elderly, the pregnant, or the young. These consumers, and all consumers, need and deserve safe cannabis products every experience.

GMPSanitation is not an innate characteristic; rather, sanitation is a trained skill. To carry out proper sanitation, training on proper sanitation practices needs to be provided. Every cannabis food manufacturing facility should require and value a written sanitation program. However, a written program naturally needs to be carried out by people. Hiring experienced experts may be one solution and developing non-specialists into an effective team is an alternative solution. Note that it takes every member of the team, even those without “sanitation” in their title, to carry out an effective sanitation program.

Sanitation is a part of the Food and Drug Administration’s Code of Federal Regulations on current Good Manufacturing Practices (GMPs) in manufacturing, packing or holding human food (21 CFR 110). Sanitation starts at the beginning of a food manufacturing process; even before we are ready to work, there are microorganisms, or microbes, present on the work surfaces. What are microbes? At a very basic level, the effects of microbes can be categorized into the good, the bad, and the ugly. The beneficial effects are when microbes are used to produce cheese, beer or yogurt. On the other hand, microbes can have undesirable effects that spoil food, altering the quality aspects such as taste or visual appeal. The last category are microbes that have consequences such as illness, organ failure and even death.In a food manufacturing facility, minimizing microbes at the beginning of the process increases the chance of producing safe food.FDAlogo

Proper sanitation training allows cannabis food manufacturing facilities to maintain a clean environment to prevent foodborne illness from affecting human health. Sanitation training can be as basic or as complex as the company and its processes; as such, sanitation training must evolve alongside the company’s growth. Here are five key talking points to cover in a basic sanitation training program for any facility.

  1. Provide the “why” of sanitation. While Simon Sinek’s TEDx talk “Start with why” is geared more towards leadership, the essential message that “Whether individuals or organizations, we follow those who lead not because we have to, but because we want to.” Merely paying someone to complete a task will not always yield the same results as inspiring someone to care about their work. Providing examples of the importance of sanitation in keeping people healthy and safe will impart a deeper motivation for all to practice proper sanitation. An entertaining illustration for the “why” is to share that scientists at the University of Arizona found that cellphones can carry ten times more bacteria than toilet seats!
  2. Define cleaning and sanitizing. Cleaning does not equal sanitizing. Cleaning merely removes visible soil from a surface while sanitizing reduces the number of microorganisms on the clean surface to safe levels. For an effective sanitation system, first clean then sanitize all utensils and food-contact surfaces of equipment before use (FDA Food Code 2017 4-7).
  3. Explain from the ground up. Instead of jumping into the training of cleaning a specific piece of equipment, start training with the foundational aspects of food safety. For example, a basic instruction on microbiology and microorganisms will lay down the foundation for all future training. Understanding that FATTOM (the acronym for food, acidity, temperature, time, oxygen and moisture) are the variables that any microorganism needs to grow supplies people with the tools to understand how to prevent microorganisms from growing. Furthermore, explaining the basics such as the common foodborne illnesses can reinforce the “why” of sanitation.

    Food processing and sanitation
    PPE for all employees at every stage of processing is essential
  4. Inform about the principles of chemistry and chemicals. A basic introduction to chemicals and the pH scale can go a long way in having the knowledge to prevent mixing incompatible chemicals, prevent damaging surfaces, or prevent hurting people. Additionally, proper concentration (i.e. dilution) is key in the effectiveness of the cleaning chemicals.
  5. Ensure the training is relevant and applicable to your company. Direct proper sanitation practices with a strong master sanitation schedule and ensure accountability with daily, weekly, monthly and annual logs. Develop sanitation standard operating procedures (SSOPs), maintain safety data sheets (SDS’s) and dispense proper protective equipment (PPE).

Overall, sanitation is everyone’s job. All employees at all levels will benefit from learning about proper sanitation practices. As such, it is beneficial to incorporate sanitation practices into cannabis food manufacturing processes from the beginning. Protect your brand from product rework or recalls and, most importantly, protect your consumers from foodborne illness, by practicing proper sanitation.

A Case for Digital Cultivation Management in the Cannabis Industry

By Allison Kopf
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The steady destigmatization and legalization of medical and recreational cannabis at the state level continues to propel a large and fast-growing industry forward. In 2018, the legal cannabis industry grew to $10.4 billion in the U.S., employing more than 250,000 people according to New Frontier Data. 

The mass production of anything that humans consume is invariably accompanied by an increased concern for safety and accountability—especially in the case of cannabis, which the federal government still deems a Schedule I substance. Each U.S. state has its own mix of laws based on the will of its voters, spanning the spectrum from fully legal to fully illegal.  

While the mix of legality in states can be hard to keep up with, all states with any form of cannabis legalization have one thing in common: the need to regulate this new industry. Last year, the federal government issued a Marijuana Enforcement Memorandum that allows federal prosecutors to decide how to prioritize enforcement of federal marijuana laws, so states are at risk.

If you are a public official involved in state cannabis regulation, or anyone involved in the supply chain from cultivator to dispensary, chances are you are using some kind of seed-to-sale tracking technology to monitor things like plant inventory, sales volume, chain of custody—and to hedge against federal encroachment by having a legitimate form of accountability.

Mandatory Request For Proposals (RFPs) issued by states for compliance solutions have spawned an entire sub-industry of seed-to-sale tracking, and point-of-sale hardware and software vendors, with large multi-million dollar contracts being awarded. Metrc’s RFID (Radio Frequency Identification) plant and packaging tags are gaining wide usage, and 11 states plus DC have adopted the technology.

While states are taking the right steps to keep their legal cannabis industry legitimate and accountable, there is actually a major gap that existing systems don’t cover: cultivation management. Most of the existing RFPs and platforms focus on the post-harvest side of the business (processing, packaging, distribution) and may have some cultivation management capability, but are not geared for the cultivation operation, which is where a lot of the risk actually lies for both growers and state regulators. 

As a state official or a cultivator, what could be more damaging to business than a massive product recall—especially after the product has been distributed and consumed? This is the fastest way to get shut down or audited by the state as a grower or invite federal investigation if you’re a state. And these recalls cost growers millions of dollars and possibly their license. There is massive risk involved by not addressing the cultivation side.

PlantTag
A plant tagged with a barcode and date for tracking

With current tracking systems, it’s possible to see where the product came from in the event of such a recall, but nearly impossible to pinpoint and see what actually happened and when the recall happened. This makes it almost impossible to stop the same problem in the future and puts consumers at unnecessary risk.

The reason most seed-to-sale systems are difficult for growers to use is because they were designed for regulators to address the most obvious regulatory questions (are growers abiding by the law? Who is selling and buying what and how much? Is the correct tax amount being levied?). They were not designed for growers and in many cases, cultivation teams are using two systems—their own ERP and/or spreadsheets and seed-to-sale tracking mandated by regulators.

This means there is a huge missing link in data that should be captured during the cultivation process. In many cases, growers are tracking crop inventory during the growth stage with pen and paper, or at best, in Excel. Cultivators need a tool designed for them that helps both run better operations and identify hazards to their crop health before it’s too late, and regulators need complete traceability along the supply chain to reduce risk to consumers.

To fill this critical data gap, there is a strong case for states in their RFPs and ongoing regulatory capacity, to adopt and encourage cultivators to use Cultivation Management Platforms (CMPs) alongside any existing seed-to-sale and ERP solutions for complete traceability.

As more states move to legalize medical and recreational cannabis, mitigating risk as part of a larger regulatory framework will only become more important. Adopting and using a CMP empowers growers to focus on not just tracking data, but making that data accessible and functional for growers to drive efficiency and profits all while ensuring security and regulatory compliance in this rapidly evolving industry.

European Cannabis Week Kicks Off First Year In London

By Marguerite Arnold
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Hold your hats and book your seats! The Limeys, no matter what they are doing on Brexit, are getting organized on the cannabis front. A unique coalition of “home-grown” as well as cross-European, American and Canadian industry insiders are already making travel plans for London during the last week of June.

Unlike Trump’s recent visit to the British capital, however, they are likely to meet nothing but enthusiasm if not a growing understanding in the British populace at large that the Great Green Cannabiz Has FINALLY Landed.

Now the question is getting the entire industry mainstreamed (just on the medical side).

On the CBD “recreational” discussion, the entire enchilada is still being formed and reformed. A high-end CBD “pop up” shop opened in a ritzy part of London in January while a more crunchy CBD restaurant in the seaside town of Brighton was shuttered right as it planned to open. Just another innocent victim in all the fuss about novel food still working its way through the entire British conversation (as it is elsewhere in Europe, including most recently Germany and Italy), certainly, but hopefully one of the last.

However, for that very reason, enthusiasm is already high as organizers continue to add events even three weeks out.

What Is On The Agenda?

Check the event website for details and scheduling. There is also a lot that is not on the official website, but has clearly been organized around it. That includes a patient advocacy and policy formation gathering on Thursday being organized by the United Patients Alliance and other events not on the “official” ECW list (or website) but clearly all with the goal of networking, interacting and gaining ground (such as the internationally organizing Cannabis Tech Society).

The first two days are reserved (at least during the day) for Cannabis Europa – the “other” major European cannabis business conference that got its start in 2018 in London. Earlier this year, the event was also held to a standing room only audience in France. Organized by two of the leading cannabis consultancies in the UK who are making a clear play towards both North America and Europe- Prohibition Partners, and Hanway Associates, the event is primed to bring together those in the international industry curious about changing times and opening opportunities not only in the UK but across Europe.

The rest of the week, events are spread out across the city (and are already selling out). Of note on Wednesday is an investors conference as well as an introduction to the growing ranks of British doctors (one hopes for the future of nascent doctor training programs everywhere across Europe, without borders), even if nascent at the moment, who are joining the medical cannabis crusade.

Thursday’s planned events also include a focus on connecting women in the industry to investors – particularly of the medical kind – and MedPayRx’s third pilot to market workshop (Unveiling The Digital Prescription). It will also include a ground-breaking seminar about cannabis certification for doctors at King’s College (long known for its critical studies about the supposed connection between cannabis and a host of nasty mental illnesses and conditions starting with schizophrenia).

There is also a round of private parties, events, industry soirees and more that are invite only. However, as with most cannabis industry events, showing up and tagging along is one of the best ways to network and meet people.

It will be a busy week, for sure.The entire cannabis debate is absolutely hitting in this space in the UK in a way that it has not in other places

Why Is This Significant?

The British are finally kicking off their version of “the industry.” That said, problems abound, including of the kind seen in places like Germany, with the added whiff of further disruptions thanks to a still-pending Brexit. On the healthcare discussion at least, it is hard to find a fan of the NHS in the ranks of average cannabis patients (who are still struggling to get their numbers over 100 for the entire country six months after Schedule II prescriptions were authorized). However, it is also equally hard to find anyone in the ranks of the chronically ill at least, who would welcome a more U.S. style approach to healthcare provision – even if they can avail themselves of private healthcare coverage. That is just 10% of the population.

The entire cannabis debate is absolutely hitting in this space in the UK in a way that it has not in other places (including Germany). This is, beyond Brexit discussions, in part a testament to the creakiness of the British system, although the German one at present also leaves a lot to be desired.

Nobody wants an “American” system. And the Canadians in the room are also dealing with the problem that so far, Canadian public health insurance does not cover medical cannabis either.

Like it or not, this is also a theme that colors cannabis politics in Europe as much as the industry does not know how to channel and harness it. The Green Vest movement is certainly alive and well in the UK. Nor should it be underestimated. And that resentment at the moment also is hitting some of the biggest industry players who are the only ones allowed market entry where it counts (the regulated ones including medical).

On the CBD front, despite assurances by activists as late as last year, and certainly overflowing enthusiasm about the potential of this market, novel food still applies.

Where the conversation will certainly get interesting is the ability to distribute through online pharmacies (unlike in Germany where this is still verboten– and for all drugs, not just cannabis). But even here, don’t look for the UK to become just another Amazon outlet. New rules, including GDPR, still affect the UK and will continue to do so no matter what happens in the fall. This has to do with what is called “trusted nation” status that affects regulatory issues including pharmaceuticals but also financials (which is why the idea of the UK sailing off entirely on its own or as an American subordinate state is also ludicrous).

Not to mention of course, that supply and demand has yet to be effectively linked anywhere in Europe.

Cannatech, beyond distribution platforms, will also become more of a focus in climate change conscious Europe.

And of course, with a focus in London, there will be a much greater opportunity for both the concentration of specialty equity and the industry itself (in English) that will impact issues across the continent.

In a nutshell, in other words, the week-long events in London (held in conjunction with an equally interesting gathering now coalescing in Berlin just the weekend before) is proof positive that not only is the European cannabis industry in the middle of another seismic year, but the British and German movements are connecting, coordinating, cooperating, and driving change both at home and elsewhere across the region.


Disclaimer: European Cannabis Holdings and Prohibition Partners are sponsors of MedPayRx and a business relationship exists between them.

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Biros' Blog

FDA Public Hearing On Hemp: What You Need To Know

By Aaron G. Biros
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Folks from around the country and the world tuned into the U.S. Food & Drug Administration (FDA) website as they held a public hearing on Friday, May 31. Manufacturers and suppliers asked the FDA to regulate CBD like food or dietary supplements, while the FDA seemed to want more evidence on the safety of CBD products before giving the greenlight.

Background On The HearingFDAlogo

For the uninitiated, after President Trump signed the Farm Bill into law back in December 2018, Scott Gottlieb, now former director of the FDA, issued a statement the same day the Farm Bill passed, clarifying the FDA’s regulatory authority. In the statement, Gottlieb explained that Congress preserved the FDA’s authority to regulate products containing cannabis and its constituents under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

In April 2019, around the same time he resigned from the FDA, Gottlieb issued another statement, acknowledging the quickly growing industry throughout the country and total lack of federal regulatory guidance. This time around, Gottlieb laid out a handful of steps that the FDA plans on taking to address regulations around hemp and cannabidiol (CBD). Those included scheduling the public hearing for May 31, where written and oral public comments were submitted by stakeholders, sharing “their experiences and challenges with these products [hemp and CBD products], including information and views related to product safety.”

That statement also announced the formation of an internal agency working group to “explore potential pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed; including a consideration of what statutory or regulatory changes might be needed and what the impact of such marketing would be on the public health.”

Fast-forward to May 31, the day of the public hearing, and all eyes in the industry focused on what all these stakeholders had to say to the FDA about CBD. The day started off with about two hours of oral comments, each speaker had roughly two minutes to deliver their thoughts.

Karen Howard, CEO of the Organic and Natural Health Association, speaks about the quality of CBD products 

Oral Comments

Industry stakeholders representing cannabis businesses sang much of the same tune, clamoring for wise regulations on safety, testing, banking and interstate commerce, among other standards. NCIA Policy Director Andrew Kline’s comments included running through five major positions of the industry trade organization representing CBD companies. Those included recommending the FDA act quickly in setting up regulations, stressing the massive economic impact of the industry, saying that CBD products are generally safe, clamoring for voluntary, consensus-based standards and informing consumers of any potential risks. “The bottom line is this – an overwhelming preponderance of evidence indicates that cannabis and cannabis-derived compounds present minimal health and safety concerns,” Kline told the folks at the FDA. “Time is of the essence. Hemp-derived CBD products are in very high consumer demand and the industry is eagerly awaiting FDA’s regulatory framework for these products. We strongly recommend that FDA act quickly to clarify the regulatory environment because there is significant confusion in the market.”

Anna Williams, representing the American Association for Laboratory Accreditation (A2LA), stressed the importance of testing for contaminants and adulterants as well as advocating for national standards on lab testing, instead of the state-by-state network of different standards.

Patients & Public Safety

After industry stakeholders had their chance to speak, the FDA allowed a group of advocacy organizations representing patients time to speak. That included representatives for the Alzheimer’s Association and the American Epilepsy Society, both of which were hesitant to throw their full support behind CBD as medicine. Kevin Chapman with the American Epilepsy Society said he wants to see clear warning labels, testing standards, more clinical trials and more studies before the group is ready to form a position on using CBD as medicine. Keith Fargo with the Alzheimer’s Association supports clinical trials to study it more, but thinks CBD is risky for patients without serious evidence of efficacy. A representative from the Tuberous Sclerosis Alliance also echoed similar concerns. They want to see labeling of drug interactions on labels of CBD products.

One section of the oral comments included discussions about patients, public safety and retailers/distributors.

After those comments, some organizations had the chance to speak followed by comments from retailers and distributors. Patrick Bird, owner of PMB BioTek Consulting, spoke on behalf of AOAC International, where he primarily discussed public safety. He said they want cannabis products to be regulated with food safety in mind, asking for FSMA to apply to hemp products. They want to adequately ensure product safety with things like mandating HACCP plans, recall readiness, saying hemp products should be treated just like food products.

Retailers & Distributors

Peter Matz, representing the Food Marketing Institute, the trade association for the supermarket industry, said that regulatory ambiguity is a serious issue that needs addressing. “There is mass confusion in the marketplace for the public, suppliers, retailers and state regulators,” says Matz. “Demand for CBD products in human and animal use is growing rapidly. ¼ of American have already tried it. We are fielding questions from companies seeking clarity regarding the current federal regulatory framework.” He added, what many others also mentioned, that the FDA needs to move swiftly to provide a pathway to regulation.

State Regulators

Next on the docket came presentations from state government entities, including state departments of agriculture, followed by healthcare professionals. The state regulators that spoke mentioned a lot about food safety, standards, testing regulations, GMPs and things like that to protect consumer safety. “Currently states are struggling with the lack of sound scientific research available in CBD and long-term health impacts,” said Pam Miles, representing the Virginia Department of Agriculture.

The docket for state regulators delivering presentations

One interesting aspect on their talks however was telling the FDA just how large their markets have gotten already and how they need guidance on how to regulate markets in their own states. Joseph Reardon, with the North Carolina Department of Agriculture, said they already have about 600 farmers growing hemp and thousands of processors working with the product in their state. “We urge the FDA to resolve the statutory issues improperly establish a legal pathway for CBD products to enter the market place,” Reardon commented. He also asked that the FDA extend the written comment period from July to August. “We are simply looking for a regulatory framework on the extraction, production and reconstitution of CBD or cannabinoid related products.”

Healthcare & Research

Healthcare providers, and physician testimony also echoed a lot of the same concerns, including the lack of research done, concerns about effects on at-risk populations and concerns about use as ingredients in dietary supplements and food. Some of the presentations also highlighted the room for nefarious activity in an unregulated marketplace. Some went as far as to mention cases where they found CBD vape juices with DXM in it (the active ingredient in cough syrup), CBD products found to contain THC, as well as synthetic cannabinoids responsible for drug overdose deaths. Some advocates in the hemp and CBD community have equated these arguments similar to reefer madness.

The major takeaway from this hearing is that everyone wants to see more data. Researchers and healthcare providers want to study the efficacy of CBD used in medicine, regulators want public safety information, patient advocates want to see data about effects on at-risk populations, trade organizations want data to back up label claims and the FDA wants to see just how safe CBD really is.

Arizona To Implement Mandatory Lab Testing

By Aaron G. Biros
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Good news came to patients using medical cannabis in Arizona earlier this week: Lawmakers in Arizona unanimously passed SB1494 through the state’s House and Senate, the bill requiring mandatory lab testing for medical cannabis products. Arizona Governor Doug Ducey is expected to sign the bill and has ten days to do so.

Arizona Governor Doug Ducey

When Governor Ducey signs the bill into law it will mark the first time since the state legalized medical cannabis in 2011 that a measure to protect patient safety via lab testing will be implemented. According to the bill, beginning November 1, 2020, all cannabis products shall be tested prior to sales “to determine unsafe levels of microbial contamination, heavy metals, pesticides, herbicides, fungicides, growth regulators and residual solvents and confirm the potency of the marijuana to be dispensed,” (Page 6, Section 36-2803).

The bill requires dispensaries to provide test results to patients immediately upon request. Dispensaries need to display a sign notifying patients of their right to see “certified independent third-party laboratory test results for marijuana and marijuana products for medical use,” according to the text of the bill (Page 7, Section 36-2803.01).“There will have to be some serious planning, but other states have achieved this and we can too.”

Under the new bill, the Arizona Department of Health Services will adopt rules to certify and regulate labs, establishing requirements like health and safety protocols, mandatory quality assurance program and standards, chain of custody and sampling policies, adequate records, accreditation, proficiency testing, among other requirements (Page 6-7, Section 36-2803).

Ryan Treacy, co-founder of the Arizona Cannabis Laboratory Association (ACLA) and CEO/Founder of C4 Laboratories, says this is a major turning point for Arizona’s cannabis industry. “We have been devoid of regulations with regard to testing the entirety of the program since it was legalized; This will be a significant change,” says Treacy. “Now patients can make sure they are getting a safe and clean product and getting exactly what they paid for.”

For those in the know when it comes to cannabis testing in the United States, the new requirements will look very similar to other states with testing requirements. One particularly unique aspect of the new program, however, is the establishment of a “Medical Marijuana Testing Advisory Council,” made up of stakeholders representing different interests in Arizona’s cannabis industry. Members of the council will include representatives from dispensaries, labs, cultivators, concentrate producers, edibles producers, as well as registered patients, caregivers, a representative from the Arizona Department of Public Safety, a licensed health care provider and “any other members deemed necessary by the director,” reads the text of the bill (page 16, Section 36-2821).

Ryan Tracy, co-founder of the ACLA and founder/CEO at C4 Labs.

“Other states like California have complained about detection limits, while Arizona is taking a unique approach with an advisory council with stakeholders in the cannabis industry,” says Treacy. “So that when the Department of Health Services promulgates rules, they are taking into account the challenges in the cannabis industry specifically. We have a chance to do this right and avoid pitfalls we’ve seen in other states.”

One problem worth mentioning for Arizona’s cannabis industry: Dispensaries have not been required to test products for patients since medical cannabis was legalized back in 2011. That means many producers could be very used to operating procedures that don’t account for lab testing. With mandatory lab testing, some producers may be behind the curve when it comes to mitigating contamination.

According to Treacy, this could disrupt the supply chain a little bit. “When testing becomes mandatory in November 2020, dispensaries will need a full panel of tests performed on their samples,” says Treacy. “With the entire market now required to complete a full panel in depth analysis on each product, product testing will become a more time-consuming stop in the supply chain. So companies will need to work that into their plan to meet regulation requirements to prevent a bottleneck and maintain patients’ access to their cannabis medicine.”

Arizona has a chance to prevent that type of bottleneck seen in states that implemented testing requirements, like California for example. “When you have a habitual history of not testing products, it can be very hard to change, which adds to Arizona’s challenges,” says Treacy. “We need to make sure this does not affect access for patients and the ability of the industry to continue to flourish and grow.”

While Treacy thinks the transition will be difficult for some, it’s absolutely necessary for Arizona’s patients to access clean and safe medicine. “There will have to be some serious planning, but other states have achieved this and we can too.”