STIIIZY Expands by Opening 44th Retail Store

By Cannabis Industry Journal Staff
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The STIIIZY Hawthorne grand opening marks the company’s ninth retail store launch in the past year — proving how the brand recognizes the growing demand and is answering the call to bring its quality products to consumers by scaling its operations in licensed states with a successful expansion strategy.

  The U.S. cannabis brand STIIIZY is expanding its footprint with the opening of its newest retail location in Hawthorne, CA on April 12th. As the brand’s 44th dispensary, the new storefront is located at 12831 Crenshaw Blvd, Hawthorne, CA.
  Perfectly located on Crenshaw Blvd at El Segundo Blvd, STIIIZY Hawthorne is a convenient stop for South Bay locals and tourists alike. Designed for the modern cannabis consumer, STIIIZY Hawthorne provides a sleek, welcoming environment and a knowledgeable team ready to help its customers find the perfect product for their needs. For seasoned aficionados or those who are new to the cannabis scene, the STIIIZY Hawthorne dispensary offers an extensive selection of premium products, including world-class flower, innovative concentrates, delicious edibles, and state-of-the-art accessories.
  The STIIIZY Hawthorne grand opening marks the company’s ninth retail store launch in the past year — proving how the brand recognizes the growing demand and is answering the call to bring its quality products to consumers by scaling its operations in licensed states with a successful expansion strategy.
  “STIIIZY Hawthorne is more than just a dispensary, it’s a hub for cannabis culture in the South Bay. As we continue to expand and establish our brand’s presence across the map, it’s especially meaningful to continue this growth within our home state of California—where it all started,” said Tak Sato, President at STIIIZY. “With our roots here, every California store we open reinforces our deep connection to the local communities that have supported us from the beginning. Now with 44 operating stores, we are dedicated to bringing STIIIZY to more markets statewide and beyond.”

Positioning Cannabis Companies for Success in 2025: Navigating Risks and Staying Competitive

By Jay Virdi
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The cannabis sector faces a multifaceted landscape marked by economic challenges, shifting regulations and market volatility. Thriving in this environment requires industry businesses to move beyond reactive measures, embracing forward-looking risk management strategies. By adopting comprehensive mitigation plans and maintaining proactive vigilance, cannabis companies can stay competitive and flourish in 2025.

Building resilience against climate risks

The cannabis industry is particularly vulnerable to climate change, with outdoor growers at risk from droughts and wildfires, and supply chains disrupted by hurricanes and floods. Events like the Eaton and Palisades wildfires, two of the most destructive fires in Los Angeles history, underscore the urgency for climate preparedness.

To mitigate these challenges, businesses must adopt comprehensive climate resilience measures. Innovative insurance products, such as parametric coverage, can provide financial protection where traditional insurance falls short. Catastrophe modeling tools offer insights into potential risks, enabling targeted infrastructure investments such as improved irrigation systems and reinforced facilities. Collaborating with brokers can help companies identify vulnerabilities and create plans to sustain long-term stability.

Strategic M&A and addressing profitability challenges

As profitability pressures mount, increased licensing has intensified competition, even as active operations decline. Mergers and acquisitions (M&A) have emerged as a crucial growth strategy, enabling stronger companies to expand and offering struggling businesses a path to exit.

However, these transactions come with inherent risks. Detailed due diligence is vital to uncover hidden liabilities, such as compliance issues or unresolved debts. Protections like Directors & Officers (D&O) coverage and runoff policies can shield stakeholders from unforeseen risks associated with acquisitions.

Beyond M&A, maintaining profitability requires robust risk management practices. Cannabis companies should emphasize organizational resilience by instituting business continuity plans and testing for potential disruptions like supply chain failures, cyber threats and natural disasters. Embedding these strategies into their operations will help stabilize margins, mitigate risks and seize emerging opportunities in 2025.

Elevating workforce benefits in a maturing Industry

As the cannabis industry evolves, workforce satisfaction and retention are critical priorities. High employee turnover and increasing unionization underscore the importance of offering competitive benefits.

Cannabis companies can enhance employee retention by developing data-driven benefits programs that cater to worker needs. Analyzing workforce demographics and preferences enables businesses to design personalized packages that improve employee satisfaction. Consulting with benefits advisors can help implement cost-effective, multi-year strategies to enhance offerings without straining budgets. Captive insurance options may also provide financial flexibility while boosting benefit quality.

Mitigating risks in R&D

Innovative products like cannabigerol (CBG) derivatives and THC-infused beverages offer significant growth potential but come with heightened risks, including regulatory hurdles, liability concerns and product recalls. For instance, hemp-derived THC beverages have leveraged regulatory loopholes to enter the market, yet insurers remain wary of covering these products due to compliance uncertainties.

Managing R&D risks requires a holistic approach. Conducting thorough risk assessments for new products, from development through market launch, is essential. Comprehensive liability insurance can safeguard companies against legal and financial fallout. Partnering with expert brokers allows businesses to evaluate exposures and secure tailored insurance solutions, fostering innovation while minimizing potential risks.

Key strategies for 2025

To succeed in a competitive, risk-filled market, cannabis businesses should focus on these four strategies:

  1. Finance risks strategically: Economic and climate-related challenges make tailored insurance essential. Assess risk exposures and collaborate with brokers to develop financial resilience plans.
  2. Approach expansion cautiously: Entering new product categories presents growth opportunities but also involves risks. Work with seasoned brokers to navigate regulatory and liability considerations.
  3. Optimize employee benefits: Data-driven, customized benefits can attract top talent and improve workforce retention in a competitive labor market.
  4. Maintain broker collaboration: Regular communication with brokers helps identify emerging risks and prepares businesses for policy renewals, ensuring optimal coverage and cost management.

The road ahead

The cannabis industry stands at a pivotal juncture in 2025, where adaptability and resilience will be key to success. By investing in tailored insurance, robust continuity strategies and workforce-focused solutions, cannabis businesses can navigate uncertainties and excel in an ever-evolving market.

Don’t Reinvent The Wheel: A Tour of ASTM Standards for Cannabis and Hemp – Part 2

By David Vaillencourt, Bethany Moore
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In our previous article, we delved into the foundational ASTM International standards that are shaping the cannabis and hemp industries. We explored the first true universal symbol for cannabis, water activity controls, and Hazard Analysis and Critical Control Points (HACCP) standards. As we continue this journey, we turn our attention to four additional ASTM International standards that are pivotal for ensuring public health and safety and streamlining operations for cannabis and hemp operators. These include standards on conducting a product recall, Corrective and Preventive Action (CAPA), how to establish a Quality Management System (QMS), and management responsibilities in an effective cannabis business. In this article, we speak with experts who contributed a significant amount of time and knowledge in shaping these standards, including Trevor Morones of Control Point Consulting, Cary Black of CK Black Group, and Steven Cooper of Quality Initiatives LLC.

Recall/Removal Procedures: Ensuring Swift and Safe Actions

When seven people died from taking unknowingly contaminated TYLENOLⓇ in 1982, it was the swift actions of Johnson & Johnson in initiating a costly but prudent recall that salvaged their reputation. Since then, numerous companies in the food, beverage, and pharmaceutical industries have been subjected to recalls. The reality is, that even the most robust processes are susceptible to human error or unforeseen circumstances. And in that worst case scenario, having a tested recall plan in place is critical to be able to respond efficiently, minimize harm to consumers, and maintain brand trust. The ASTM standard for recall/removal procedures provides just that; a structured approach to swiftly and effectively remove potentially harmful products from the market. Imagine a cannabis producer discovers that a batch of edibles has pieces of metal shavings in it. With this standard implemented, this company would have the ability to immediately initiate a recall, contact the distributors and retailers that received the product to remove the product from shelves and notify consumers. Within hours, the potentially dangerous product is no longer available, and public safety is safeguarded. This swift action not only protects consumers but also helps maintain the company’s reputation for quality and safety.

Cary Black, ASTM Fellow, ASQ CQE, PCQI, and Principal Consultant for CK Black Group, Inc., and Technical Contact for the ASTM standard ‘D8220-20 Standard Guide for Conducting Recall/Removal Procedures for Products in the Cannabis Industry’ said, “Effective recall procedures provide the final fail-safe for consumer safety. As in the food industries, the supplement industries, the pharmaceutical industries, cannabis industry must hold the same capability to effectively, quickly, and efficiently recall products that have been determined to be a risk for consumers. For an efficient recall program, there is a vetted series of protocols that have been employed to quickly recall adulterated products. From forming the recall team and maintaining clear and accurate traceability records from your raw materials, your inventory, and shipping to your customers; all these elements come together to create a seamless series of steps to initiate an effective recall when needed.

For an effective recall program, not only should the proper elements be in place for a recall, additionally there should also be provisions for conducting mock recalls to allow the recall team to practice the efficacy of their record keeping and procedural implementation.

Any supplier of cannabis products for human or animal consumption is required by all authorities having jurisdiction to a program in place and the ability to quickly recall adulterated products.”

CAPA (Corrective and Preventive Action): Proactive Problem Solving

As we stated above, even the most robust processes are susceptible to human error or unforeseen circumstances. Wouldn’t it be nice if there was a way to prevent those mistakes from ever happening again? Enter Corrective and Preventive Action (CAPA). A foundational tried and true component of every quality management system is that it is designed to identify the true root cause of a mistake, implement a corrective action, and verify the effectiveness of the corrective action to prevent the recurrence of such a mistake. Even better, CAPA is a tool to prevent the occurrence of problems before they occur in the first place. The ASTM CAPA standard guides operators in systematically addressing problems to avoid recurrence, leading to streamlined operations and enhancements to overall product quality and consistency. In the example above where the cannabis edibles producer has identified contaminated products and recalled the products from shelves, the next natural step would be to become proactive about ensuring that it does not occur again. That’s one of many examples where the CAPA standard steps in and provides a valuable solution.

Trevor Morones, Control Point founder and Chair of ASTM’s Cannabis Subcommittee on Personnel Training, Assessment, Credentialing (D37.06), who was involved in developing the ASTM CAPA standard D8299, said, “Implementing effective corrective action processes within an organization yields substantial benefits. Proactively preventing recurring incidents is key, but the commitment to continuous improvement is equally crucial. Open and effective communication with all involved parties is not just essential; it’s a way of showing that everyone’s input is valued and included in identifying and implementing the best solutions. Moreover, embracing ASTM standards can greatly enhance an organization’s competitive edge in the marketplace.”

Kara Lavaux, CP-FS, CQA, Compliance Consultant for Allay Consulting, said, “To build on what Trevor said, a CAPA plan is a hard-working component of a quality management system. CAPA works for times when you need to react to an issue, and for times when you have the foresight to prevent a future issue. The key to an effective CAPA program is learning to shift the focus away from the symptom of the issue and instead focus attention and action on the root of the issue. It’s the root of the issue that needs a corrective action, which will result in both the correction of the symptoms and the prevention of the issue in the future. In the example above of distributed edibles with mold contamination, the issue (risk to the public) was “fixed” by completing a quick recall of the products. But this correction does not prevent the issue from occurring again in the future. If we do not put control measures in place to prevent the mold on the edibles, we could continue distributing moldy edibles and will continue conducting reactionary recalls to protect consumers. Opening a CAPA and doing a deep dive into what caused the mold will reveal the root issue that needs to have a corrective action. Is it a water activity issue with the recipe, or perhaps a handling issue during packaging, or perhaps a storage issue at the dispensary? The CAPA investigation will reveal the root cause. Fixing the root cause leads to continual improvement of the process and prevents the issue from recurring.”

Establishing a QMS for Consumer Products: Foundation of Quality

In the 1980s, manufacturers discovered the value of implementing a Quality Management System (QMS) to provide a high level of confidence both internally and to their customers that their products would deliver on the quality and consistency that they were expected to meet. Forty years later, being certified to having an effective quality management system is one of the most basic requirements of companies engaging in global trade. The ASTM standard for establishing a QMS for consumer products lays the groundwork for comprehensive quality management in the cannabis and hemp industries. For example, when a company is launching a new line of products, a QMS provides the structure to develop and document the process for everything from ingredient sourcing to final product testing. This ensures that when this production line is scaled and commercialized, the process will be validated to provide the confidence needed that consumers will receive a safe and consistent product time and time again. Additionally, companies with a QMS will more easily be able to adapt to regulatory changes and stay in line with compliance requirements.

Cary Black, author of the ASTM standard, ‘D8222-21a Standard Guide for Establishing a Quality Management System (QMS) for Consumer Use of Cannabis/Hemp Products’ said, “Having a functional QMS is typically the first set of requirements for governing the manufacture and distribution of products. For products consumed by humans or animals a functional QMS sets the base for practices aligned with GMP. For most authorities having jurisdiction, relative to products that are consumed by humans or animals, a QMS supporting GMP compliance is required.

A functional QMS additionally provides the platform for a system that not only drives regulatory compliance, but also adjusts to and supports continuous improvement efforts, provides systems for manufacturing and distribution, and can foster increased productivity, improve efficiencies, incorporate risk management approaches, and ultimately ensure the safety of the products to its consumers.

The more participants within the Cannabis industry embrace the value of implementing a functional QMS, the more sustainable their manufacturing and product lines will become and the closer they will be to a risk management approach that aligns with most GMP requirements for cannabis products consumed by humans or animals.”

Management Responsibilities in Managing a QMS: Leadership and Accountability

You don’t have to be a retired Navy SEAL to understand the significant influence that leadership has when it comes to building a successful organization. Effective quality management requires strong leadership and clear responsibilities. The ASTM standard for management responsibilities in managing a QMS (D8398) outlines the roles and duties of management in developing, implementing, and maintaining an effective quality system. The symbiotic relationship between leadership and employees is crucial to fostering a culture of excellence. Ensuring that management is allocating the appropriate resources, providing adequate training, and regularly reviewing the system is paramount for employees to feel supported and confident in their understanding of how their roles are part of the bigger picture of maintaining high standards. And when employees have clear roles and responsibilities with the requisite support, businesses succeed. Research from Gallup has shown that companies with engaged employees benefit from 40% less quality defects and are more than 20% profitable compared to peer organizations with low employee engagement.

Steven Cooper, President of Quality Initiatives LLC, and author of this standard, emphasized the importance of leadership demonstrating support of quality and safety and how it can impact the entire company in the long term. “When I was involved in writing this standard, my main focus was to target the CEO or other top management of a company, or someone who is looking to start a company. My standard is intended for these types of people to help them simply understand some of the basic requirements to do things right and to ensure they get off on the right foot toward product quality. Most of the other standards written for GMP are rather long documents intended for a quality professional, and my document is specifically targeting someone who needs to capture the basic top-line requirements without spending a lot of time trying to understand an extensive detailed GMP requirements document. Ultimately, it’s easy for management to give lip service in saying “quality is important” but how do they get serious? How does an employee do their job to feed the need to satisfy quality requirements? What role does the employee have in the quality management system? And that’s where management needs to ensure a good understanding of the employees, which is achieved by training and follow through, but also by setting an example. And by that, I mean that the first time there is a quality problem, what does management do? Do they ignore it? Do they say it costs too much to fix? Are they serious? And that message really has to be very carefully delivered ot the employees so they are not only aware of the need for quality, but they have an appreciation of the importance. That can only be delivered by management walking the walk, not just talking the talk. 

As an example, a company can say they care about quality. They can hang posters and have meetings, but in one incident I observed, it wasn’t until there was a safety incident where someone could have been seriously injured or worse, and a mistake was made, at that moment, the reaction by management was critical. Did they just have a meeting to talk about it? Nope. The VP of Operations shut down the facility for three days, which is difficult to do when the company is demanding product, and customer orders are waiting to be filled, money on the line, etc, but when that decision was made, it sent a very serious message to all of the employees in the factory about the importance of quality. After that, the respect and appreciation for safety rose to a much higher level, and probably remained there for many years, all because of that one incident and the way management reacted. They walked the walk, not just talked the talk. They didn’t just take shortcuts to get the product out the door. 

Shaping The Industry

As the cannabis and hemp industries continue to evolve, the marketplace is going to get more competitive and only those with a high bar of quality, and the data to prove it, wil succeed.These four ASTM standards—recall/removal procedures, CAPA, establishing a QMS, and management responsibilities in QMS—are invaluable resources for operators to implement to not only maintain regulatory compliance, but ensure a future of success. By adhering to these standards, operators not only safeguard public health but also streamline their processes and build a stronger, more trustworthy industry.

In our next article, we will explore additional ASTM standards that are paving the way for innovation and excellence in the cannabis and hemp sectors. Stay tuned as we continue to highlight the standards that are shaping the future of this dynamic industry.

Call to Action: If you are a professional in the cannabis and hemp industries, consider joining ASTM and contributing to the development of these crucial standards. Together, we can build a safer and more efficient industry.

For more information on ASTM standards and how they can benefit your operations, visit https://www.astm.org/get-involved/membership.html.

IICPS universal symbol

Don’t Reinvent the Wheel: A Tour of ASTM Standards for Cannabis – Part 1

By Bethany Moore, David Vaillencourt
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IICPS universal symbol

In the realm of consumer safety, minimum standards form a critical safety net that allows businesses and regulators alike with necessary guidelines. From our food and medicines, railroad tracks to bicycle helmets, crayons to cribs, standards are everywhere. Knowing where the lanes are and how to move inside of them provides the structure needed to guide manufacturers forward. And the cannabis and hemp industry is no exception. Why would it be?

In this series of articles, we will explore specific ASTM International standards that have already been developed and published by its Committee on Cannabis (commonly referred to by its Committee designation number – D37). With a frustrating lack of federal clarity, states are increasingly adopting these standards directly into their rules — and for good reason! These standards have gone through an extensive and rigorous process of achieving consensus, adhering to the principles set out by the World Trade Organization to reduce technical barriers to trade. These principles cover openness, balance, and transparency, and are one of many reasons why ASTM standards are confidently adopted into regulations by the US Federal Government. It is no wonder state regulators are increasingly leaning into those standards with confidence when creating rules and regulations for operators in the cannabis industry.

There are numerous benefits to standards adoption, including taking the guesswork out of the “how,” and streamlining operations, particularly when companies wish to scale up and expand. To provide color and context to the fuzzy world of standards, we will include insights from ASTM committee members who were involved in the hands-on process of standards development, including Kim Stuck of Allay Consulting, Dr. David Nathan of D4DPR (Doctors For Drug Policy Reform), and Dr. John DeVries.

“ASTM has been around for over a century, and it is common practice for governments to adopt the standards that have been written by their committees. It takes so much time and effort to put together standards to create safe and consistent products that it just makes sense for governments to adopt already written standards from a trusted source such as ASTM rather than spending the time and money writing a set of their own that will most likely mirror the ASTM standards. The cannabis standards that we have been developing since 2017 have also been written by experts in the industry so that no corner of the industry will be left unregulated,” said Kim Stuck of Allay Consulting, a strategic partner of The GMP Collective, and a participating member of the ASTM D37 Cannabis Committee.

“The process that ASTM uses has been proven to create the most well-rounded and consistent standards, and I am proud to be a part of the process,” Stuck continued. “ASTM International plays a pivotal role in the cannabis industry by providing comprehensive, science-based standards that guide the production, testing, and distribution of cannabis products. The development and implementation of these standards ensure consistent quality, safety, and efficacy across the industry, fostering trust among consumers, regulators, and industry stakeholders.”

HACCP Systems

The same program that was developed by the US Army, NASA, and Pillsbury to keep astronauts from getting sick in outer space is arguably one of the best standards for any cannabis operator to implement in their own operation. The Subcommittee on Quality Management Systems (D37.02) realized and did just that, developing the HACCP System standard, which provides general guidance for implementation in order to prevent, control, or minimize hazards (biological, chemical, or physical) to an acceptable level. The standard can be accessed by anyone with an active ASTM membership, or purchased individually for just $63. As of publication, this standard has been adopted in 3 states, including Oklahoma where it is recommended, New Mexico where it is required for medical applications, and Colorado, which is required as of July 2024 for growers who want a microbial-reduced testing allowance.

“Regarding the specific HACCP (Hazard Analysis and Critical Control Points) standard I was involved in developing, its application in the cannabis industry establishes a proactive approach to identifying, evaluating, and controlling potential hazards throughout the production and distribution process. This standardization is vital for ensuring product safety, quality assurance, and compliance with regulatory requirements.

“HACCP helps the industry minimize risks and prevent contamination, leading to safer products for consumers. By implementing these standards, businesses can provide greater transparency and build consumer confidence in their products. This, in turn, supports the industry’s growth and fosters a safer marketplace while also mitigating risk and preventing costly recalls and fines.

“Regulators and lawmakers rely on such standards because they offer a structured and consistent framework for assessing safety and quality in the industry. Having robust, science-based standards like HACCP helps establish clear benchmarks for producers to meet, ensuring consumer safety and facilitating effective regulation and enforcement. By adhering to these standards, the cannabis industry can gain legitimacy and support from both regulators and consumers,” added Stuck.

Universal Symbol

The most symbolic standard published by the D37 Cannabis Committee is just that: a valuable consumer-facing symbol recommended for use on the packaging of any consumer product that may contain a level of intoxicating cannabinoids. The symbol can be stamped onto edibles like gummies and chocolate, and/or included on packaging. The standard solves an issue that came out of the patchwork regulatory systems from state to state, where each state, upon rolling out rules and regulations, essentially made it up as they went along, developing their own symbols due to not being able to point to a universal standard. This symbol now exists, paving the way for a streamlined process as new states legalize cannabis for medical or adult use.

Dr. David Nathan, Founder and Past President of D4DPR, was a key leader in the development of this standard which is already in adoption across multiple states. “The International Intoxicating Cannabinoid Product Symbol (IICPS) is a harmonized, universal cannabis product symbol that was developed and approved as consensus standard ASTM D8441 by ASTM International through a unanimous vote of over 200 professionals and experts from the public and private sectors. The National Technology Transfer and Advancement Act (NTTAA) mandates federal use of consensus standards, so the IICPS is poised to become the national cannabis product symbol when cannabis is legalized at the federal level,” Dr. Nathan said. The standard can be accessed through ASTM membership or purchased for a fee of $55.

Since its introduction in 2022, the IICPS has already been incorporated into the universal symbol of four U.S. states: Montana, South Dakota, New Jersey, and Vermont, and has been proposed in recent rulemaking in the State of Arkansas. Several other states are currently considering its adoption,” Dr. Nathan explained.

IICPS universal symbol
Above: International Intoxicating Cannabinoid Product Symbol (IICPS)

In 2023, 22 organizations representing public health, social justice, patient, consumer, and industry advocacy groups signed an open letter to regulators in the United States and around the world supporting universal adoption of the IICPS. If all states where cannabis is legal were to adopt this new standard moving forward, the result would be a significant time and cost savings in the long-run for companies who wish to expand across state lines. The symbol is clear, recognizable, and adheres to international interpretations based on color, shape, and other symbology factors. These factors were evaluated by a robust consumer research study to verify the effectiveness and intent of the symbol which was discussed in a webinar available on demand here.

To understand the impacts of many of the current symbols used in different states, written testimony submitted to the New York Office of Cannabis Management titled “A Symbolic Failure of Cannabis Regulation,” provides a colorful example. In it, Dr. Nathan states the following:

“The OCM symbol requires four-color printing, which is expensive. In a regulatory space intended to right the wrongs of the failed War on Drugs, the OCM symbol creates a barrier to entrepreneurs from historically oppressed communities who lack the capital to invest in costly packaging.

“The OCM symbol also violates numerous consensus standards, which are technical specifications issued by standards organizations like NIST, ASTM, and ISO. They are developed in an open environment to ensure public safety and promote best practices through collaboration by expert volunteers in the public and private sectors. Standards organizations have flourished since the 19th century, and their standards apply to everything from airplanes to zippers.”

Water Activity Controls

Dr. Jonathan DeVries, who provides food science services in regulatory and litigation matters, was the technical contact involved in developing the first two ASTM cannabis standards — developed to control water activity in cannabis flower that directly impacts both safety and quality of the product.

Dr. DeVries explained: “The first two methods adopted by ASTM committee D37 on Cannabis were ASTM D8196 Standard Practice for Determination of Water Activity (aw) in Cannabis Flower and ASTM D8197 Standard Specification for Maintaining Acceptable Water Activity (aw) Range (0.55 to 0.65) for Dry Cannabis Flower Intended for Human/Animal Use. During the early life stages of ASTM D37, cannabis growers, processors, and users stressed the importance of controlling the water activity of cannabis flower for safety and quality. All involved were generally aware that if the water activity was too high, microorganism growth, particularly mold, would damage the flowers rendering them unsafe (to say nothing of unpalatable). Similarly, cannabis flower that had a water activity that was too low (i.e the cannabis was too dry) could lead to dissatisfaction by the ultimate consumer because of handling losses due to fragility, loss of terpenes due to volatiles losses due to high burn temperatures during smoking, and unduly harsh characteristics of the smoke.” Both of those standards can be accessed through ASTM membership or purchased for a fee.

“Controlling the water activity to this range also is very logical during analysis, regulation, and commerce. Cannabis, properly dried and cured, then controlled to water activity 0.55 to 0.65 will exhibit very little variation in weight due to moisture change (controlling to a water activity range is typically more effective than controlling moisture directly) or loss or key volatiles that are part of the cannabis experience.

“As the technical contact for ASTM D8196 and D8197, I was always impressed with the ASTM processes, and of course, I was also impressed by the eagerness and willingness of those involved in providing safe, high-quality cannabis to be engaged in the process and share their extensive knowledge and experience to produce the optimum standard to meet the need.”

A Collaborative Effort

With more than 50 standards produced and published by the D37 Committee on Cannabis at ASTM, and another 50 more currently in development, there’s great opportunity to take the guesswork out of everything from Quality Management Systems, to Devices & Appliances, to Personnel Training, Assessment & Credentialing, and everything in between.

Stay tuned for the evolution of this article series, where we will explore more of these standards in order to understand their impact on ensuring consumer safety and streamlining what has been a chaotic patchwork of imperfect regulations and practices across the industry. By embracing standardized protocols and best practices, stakeholders can enhance transparency, build trust with consumers, and foster a more robust and sustainable cannabis market. Through collaboration and adherence to these evolving standards, we can pave the way towards a safer and more accountable cannabis and cannabinoid industry for all.

upstate elevator supply co logo

VT’s 1st Delta-9 Beverages Are Here to Socialize

By Cannabis Industry Journal Staff
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upstate elevator supply co logo

Upstate Elevator Supply Co., a Vermont based manufacturer of cannabis-infused products, has expanded its product line with beverages and gummies infused with fast-acting, hemp-derived Delta-9 THC created with nano-emulsified hemp extract.

The new Delta-9 beverages are sold in 12-ounce cans with either 1 or 5 milligrams of Delta-9 THC balanced with ratios of CBD. They come in four unique flavors, including Passion Fruit Seltzer, Green Mango Seltzer, Zesty Lime Ginger Ale, and Orange Pop Soda.

Cannabis Industry Journal had a quick call with Ryan Chaffin, Director of Business Development at Upstate, to learn more about their new Delta-9 beverage launch.

CIJ: What were the regulatory hurdles Upstate needed to deal with to launch the new products?

Chaffin: The biggest regulatory hurdle in selling all hemp-derived products continues to be the lack of cohesive federal regulation. Brands are forced to navigate a patchwork system of state regulations that are constantly evolving. Upstate Elevator continues to advocate for federal regulation to provide much-needed oversight in the industry and to best protect consumers.

CIJ: What testing has Upstate done for quality and safety?

Chaffin: Upstate Elevator Supply products are tested using ISO certified labs to ensure potency, consistency, and quality in every batch. All of our raw hemp ingredients are tested for pesticides, heavy metals, mycotoxins, and bacterial and fungal contaminants to maintain the maximum level of safety. We like to say that our commitment to the safety, quality, and purity of our products is emblematic of the great state of Vermont, where we’re from.

CIJ: What are Upstate’s plans beyond VT?

Chaffin: Upstate Elevator is partnering with distributors throughout New England and the Midwest to sell its Delta-9 THC beverage and gummies. Minnesota is an especially exciting market because it has the most robust regulatory framework in the country to provide safe access to hemp-derived products. We look to expand upon our portfolio of Delta-9 beverages and gummies in the coming months.

Jay Virdi

Navigating the Cannabis Industry: Risk Management for Profitability

By Jay Virdi
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Jay Virdi

The cannabis industry is growing and changing at an unprecedented pace, creating immense profit potential and putting a spotlight on the array of risks for those in the arena.

Understanding the current and emerging trends across the industry is essential for companies looking to maximize profitability while managing risk effectively. It’s important to take a proactive risk management approach to help mitigate potential losses and safeguard your people, property and profitability. Here are three steps to do just that.

Step One: Attract and Retain the Right Talent

Attracting and retaining top talent in any industry has become more challenging than ever. Employees now wield significant power and are often regarded as the new customers. They crave more flexibility in work arrangements and have reevaluated their benefit expectations in light of the COVID-19 pandemic.

To address these challenges, cannabis businesses should consider doing the following:

  • Compare current benefit offerings with those in competing industries
  • Present unique and appealing options to attract and retain talent
  • Maintain effective communication to ensure employees are aware of the benefits offered
  • Leverage industry expertise to guarantee the long-term sustainability of your benefits program

A multi-year strategy will include policies and procedures that consider cost management, HR advocacy, health and performance for employees, and leverage HR benefits technology to engage it all. Employee communication will be key to attaining buy-in from teammates.

Step Two: Protect Your Property

To protect your place of business, implement a multifaceted risk management approach by establishing physical, administrative and compliance controls.

Physical controls include investment in security technology (including cyber), locks, gates, lighting, cameras, access controls, guards and patrols to safeguard your building and inventory.

Administrative controls center around the development of security policies, procedures, staff awareness training, de-escalation techniques, threat reporting and conflict management programs to help safeguard your team.

Compliance controls involve the development of a system to stay organized, updated and in compliance with state-specific regulations and licensing, including environmental considerations for cultivation and pollution concerns.

Step Three: Consider Your Insurance Coverage

In the United States, legal recreational marijuana is currently available in 24 states; 38 states and the District of Columbia have approved its use for medical purposes. Though legal access to cannabis is on the rise across the country, many carriers are still not providing the coverage the cannabis industry needs because federal law still maintains that the use, sale and/or distribution of the substance is illegal.

A lack of experienced professionals to underwrite the risks associated with the cannabis industry is another issue. While many are still not underwriting in this space due to legal and reputational risks, the supply of insurance available to the cannabis sector is steadily increasing between 80% and 100% a year.

For those that do write cannabis insurance, there’s a host of losses and exclusions that must be considered prior to purchasing coverage. Common losses include fire and employee theft, water damage or pollution from operations, and product contamination recall. Common exclusions include criminal acts and health hazard exclusions; more specifically this includes onsite consumption, vape and general cannabis exclusions. 

To mitigate these risks, it’s crucial to partner with an insurance provider that understands the complexities of the cannabis industry and will help you navigate any exclusions. A broker with industry-specific knowledge is a must to ensure the right coverage with the right limits.

All cannabis operations should consider obtaining coverage to offload risk via the following policies:

  • Commercial general liability
  • Management liability
  • Product liability and product recall
  • Property and crop insurance
  • Equipment breakdown insurance
  • Business auto insurance
  • Care, custody and control coverage for distributors
  • Workers’ compensation

Looking Ahead

The cannabis industry is rapidly evolving, and with it comes both opportunities and risks. To achieve profitability and minimize potential risk exposures, adopt a proactive risk management approach that addresses the needs of your employees, protects your property

and enhances profitability. Cannabis executives also should develop a robust business continuity plan to ensure their operations can withstand unforeseen disruptions, such as product safety lawsuits and mergers or acquisitions.

Understanding the common risks and insurance coverage exclusions, as well as staying informed about emerging trends and regulatory changes, is vital for success in this dynamic sector. By combining strategic risk management with the right insurance coverage, your cannabis business can thrive in a growing and competitive market.

GMPC at NoCo Hemp

Highlights from NoCo Hemp Conference Panels: How did we get here, and where are we going?

By Bethany Moore, David Vaillencourt
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GMPC at NoCo Hemp

At the 10th Annual NoCo Hemp Conference and Expo, held in beautiful Estes Park, Colorado this year, educational panels included a wide array of topics covering both the fiber and industrial potentials of hemp products as well as the plant’s supplemental and dietary applications. Our attention was focused on consuming the policy and regulatory discussions held throughout the day on Thursday, April 11. The panels brought together “prominent stakeholders and thought leaders to explore the ever-evolving regulatory framework, innovative research initiatives, and the imminent implications of the upcoming 2024 Farm Bill for the hemp industry.” The day of panels brought together economists, prominent lawyers, regulatory health experts, and more. The array of speakers could be perceived to have disparate interests whereas, throughout the day, each panel brought valuable perspective and insights with a common theme: the need for collaboration and minimum standards for market certainty.

GMPC at NoCo Hemp
GMPC with Gillian Schauer at the 10th Annual NoCo Hemp Conference and Expo.

Keynote Panel

Kicking off the event on the main stage was a keynote address by Beau Whitney of Whitney Economics, addressing the economic outlook of the industry. Some key takeaways from his remarks included observations on the difficulty of market strategies due to constantly changing rules, prompting investors to have a “wait and see” approach to the industry. Currently, pricing has stabilized for cannabinoid biomass, and there is an overall increase in production for hemp fiber and grain, though more acres of hemp growth are needed to keep up with demand. The U.S. cannabinoid market boasts more than $28 billion potential, with cannabis sitting at a similar dollar amount. The illicit market, however, is estimated to hold $79 billion of the market. Whitney also noted that companies that intend to pursue the global market should do so by preparing for GMP/GAP certification.

ASTM Standards

The next panel heeded the call for the need for the development of minimum standards for consumer safety, as emphasized in the previous panel. The panel featured various experts who are involved in ASTM, including The GMP Collective CEO and Founder David Vaillencourt, along with Darwin Millard of TSOC, Alex Escher of Hemp Hollow Consulting, and Hunter Buffington of Agriculture Policy Solutions. Escher noted that there is not a one-size-fits-all protocol for testing hemp, but that safety is paramount in all applications. He offered a specific example of health and safety issues related to toxic dust concentration and pointed to a national story where an employee suffered fatal health issues while working in a cultivation facility. Occupational safety and health issues apply to the hemp and cannabis industry just like any other industry, and in-house safety protocols need to be central to every operation. Vaillencourt emphasized the importance of collaboration in creating viable and relevant market solutions, allowing collaboration between various stakeholders including biologists, chemists, economists, lawmakers, regulators, and more. He also encouraged further participation in ASTM International, a global standards organization that develops and publishes voluntary consensus technical standards for a wide range of materials, products, systems, and services. One way for participants to get involved is to become a member of ASTM and join the D37 Committee on Cannabis, and attend the upcoming USP-ASTM Workshop on Cannabis Medicine Quality happening in June in Philadelphia, Pennsylvania during the June Committee Week. Buffington, also an ASTM member, noted that the D37 Committee is collaborating with other non-cannabis committees to leverage information and expertise from other industries. Truly, there is no need to reinvent the wheel. Millard, who chairs multiple D37 subcommittees, says that the only way to commercialize the plant is through standards. Laws beget regulations, and this is where standards become the “meat on the bone.” A lack of industry-accepted standards will prevent market adoption, he warns. Each of these panelists have rolled up their sleeves at the table of standards development, and they all echoed the invitation for more industry operators and stakeholders to get involved in ASTM and join the collaborative effort.

Buffington noted that hemp currently boasts more than 27,000 uses, and Vaillencourt emphasized the trillion-dollar market potential of the plant. “How do we go from today at a billion-dollar economy to the future trillion-dollar economy? We do that through the development of standards,” says Vaillencourt. Given that Congress has already directed federal regulators through the National Technology and Transfer Advancement Act to defer to standards that represent a balance of interest and filter out bias through the rigorous consensus voting process, all stakeholders interested in seeing a viable marketplace with safe products must pull up their seats to the ASTM table and participate in the standards creation process.

ASTM Darwin Panel Noco Hemp
ASTM Panel with David Vaillencourt and Darwin Millard at the 10th Annual NoCo Hemp Conference and Expo.

3-Pillar Vision for the Future

After the lunch break, the second keynote speaker, Rod Kight of Kight Law, offered his vision for cannabis reform, including a 3-pillar approach to regulating hemp and cannabis, noting that “what’s good for hemp now is good for cannabis tomorrow.” The first pillar emphasizes strict control of access to minors, which includes age-gating and possible parental consent for minors. He also stated that this includes non-intoxicating products as we still don’t have the data to understand the effects on developing brains. The second pillar underscored the importance of Quality Control and noted that GMP standards are objective quality standards that prevent contaminants and protect consumer safety. The third pillar addresses proper labeling and marketing, which should be informative and standardized. He emphasized the importance of transparent disclosure to consumers based on objective national standards rather than state-specific standards and should include all other relevant quality standards. “All of this requires a federal-level solution,” Kight noted. 

Regulatory State of the Union

In the next panel session, attendees heard a presentation on the 2024 regulatory “State of the Union” for the hemp plant. Panelists included Michelle Bodian of Vicente LLP, Jonathan Miller of U.S. Hemp Roundtable, Beau Whitney of Whitney Economics, and moderator Joy Beckerman of Hemp Ace International. The panel opened up with an icebreaker, asking panelists what they would like to see more of in the hemp industry. Bodian’s response pointed to the need for more definitions of hemp, in all of its forms, including the plant and its derivatives. Whitney noted that the current state of hemp creates confusion for regulators and law enforcement, and the lack of federal guidance creates problematic patchwork issues, creating heavy costs associated with aligning to various state rules. This ripple effect of keeping up with these costs can mean businesses close, employees lose their jobs, and states lose out on tax revenues, further underscoring the need for Congress to enact a new framework.

Lawmakers and Regulators Perspective

As the afternoon progressed, the next panel took the stage to address a regulatory path forward. Speakers included Rod Kight of Kight Law, Gillian Schauer of CANNRA, Tami Wahl, and Tyler Klimas of Leaf Street Strategies. Schauer began by explaining that CANNRA is a non-partisan, non-advocacy group with a focus on education, and that members of the organization include specific states and government agencies with the goal of learning from each other. She also provided clarity on the role of regulators, which is to implement the regulations that were passed in the ballot measures and to protect consumer safety while stabilizing businesses and not letting “one bad actor tank an entire industry.” She notes that at times, many aspects of the laws can become too scientifically dense for lawmakers and regulators who lack a scientific background. While discussing how the cannabinoid market can come together or overlay with current regulations, she underscored the need for more data, as well as standardized manufacturing, processing, and testing. Kight offered praise to CANNRA for attending the event and being present to listen and learn from the industry itself. He noted the crossroads we have come to, where hemp and cannabis are being marketed through two separate paths that have almost become at war with each other. “Now is the time to move forward,” he urged. Wahl emphasized the importance of product standards and data and the need for real-time data to ensure consume safety. “It is up to the brand holder to ensure their product is safe,” she said. As the panel wrapped up, Schauer pleaded for industry stakeholders to interact with regulators productively, and emphasized the distinction between who passed the law versus who has been tasked to enforce it. She noted the discouraging reality of regulators being harassed and receiving death threats, which she herself has also sadly experienced. (The GMP Collective webinar held on April 24, 2024 on bridging the regulatory gaps and challenges can be attended live on Zoom or the recording can be accessed on our YouTube channel.)

Bethany Moore, David Vaillencourt, and Alena Rodriguez at NoCo Hemp
Bethany Moore, David Vaillencourt, and Alena Rodriguez at the 10th Annual NoCo Hemp Conference and Expo.

FDA Fireside Chat

In the final panel session of the day, attendees sat in on a fireside chat with Patrick Cournoyer, Senior Science Advisor at the FDA, and Garrett Graff, Managing Attorney at Moye White. The conversation began by clarifying the distinction between what was laid out in the language of the Farm Bill versus the authority the FDA holds. Cournoyer noted that the “Drug Preclusion Clause” creates one of several barriers that prevent cannabis and hemp from being included in food and dietary supplements, and underscored the importance of consumer safety in both the immediate, as well a need for high assurance that consumers will be safe consuming a substance over the long term. Cournoyer explained that the FDA CBD Policy Working group, established in 2019, which also opened a public docket for feedback and comment, found that CBD and CBD products should not be considered food or dietary supplements. Scientific studies found that high levels of CBD consumption can have negative interactions with certain drugs, interferes with the metabolization of caffeine, and can contribute to liver toxicity and reproductive issues. Based on these findings, safeguards should be put in place as we continue to seek a path forward. Cournoyer emphasized that the goal of the FDA is to be solutions oriented, provide technical assistance upon request, and that they want to hear from stakeholders as they continue to wade through these complex issues.

Overall, the day of panel discussions underscored the importance for industry stakeholders, consumers, and government entities to keep the lines of communication open and flowing as we continue to find the balance between the existing and future marketplace while ensuring consumer safety. Although cannabis and hemp have historically been seen as completely separate lanes, we now know that this is not the reality any longer. For example, how can non-cannabinoid areas of the industry like hempcrete production for building materials collaborate with hempseed producers of a nutritional product or livestock food? In what ways can we continue to truly “free the plant” in all of its 27,000 uses? As the complexities of both the cannabis and hemp industries begin to align and merge through clearer definitions of use and application, it becomes clear that we must all understand the various lanes we’re in and how to navigate the future together. The 10th Annual NoCo Hemp Conference offered a platform for these discussions to take place as this important and complex conversation continues to evolve. We look forward to seeing the results of these conversations go beyond the educational panel stage and into the day-to-day workings that will ensure our industry continues to not only survive, but thrive. 

Dede Perkins
Cannabis Coaching & Compliance

Be ready! How to Prepare for a State Cannabis Inspection

By Dede Perkins
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Dede Perkins

If you’re a licensed cannabis operator and you don’t make peace with state and local inspectors visiting your facility, clipboard or tablet in hand, you’re in for a long and likely bumpy road. All kinds of authorities will want to inspect your cannabis operation and facility. There will be state regulatory inspections, inspections driven by insurance and banking partners, local code officials, OSHA, EPA, and more. On average, cannabis operators are visited one to two times each year for state inspections, one time for insurance purposes, and one time for banking purposes. Depending on the reason for the visit, cannabis operators can expect inspectors to be onsite for varying amounts of time — an hour if the inspection concerns insurance, banking, or local codes (electrical, mechanical, plumbing, fire suppression and alarm systems); depending on the license type, two to four hours for a preoperational inspection, and four hours when OSHA comes to call. If an inspector shows up unannounced in response to a complaint or possible violation, be prepared for a four- to eight-hour stay.

In this article, we will focus on how to prepare for the three types of state regulatory inspections: pre-operational, unannounced, and renewal. However, the basics of preparing for a state regulatory inspection apply to all inspections. To begin, let’s define the reason behind each type of state regulatory inspection and highlight the most common items you’ll need to provide/show the inspector.

Pre-operational

Every licensed operator must pass a state pre-operational inspection before opening for business. In most states, the regulator assigned to the licensee will provide instructions on what to expect and the requirements to pass the inspection. Preparing ahead of time and showing the inspector that you and your staff take compliance and safety seriously will go a long way toward making the inspection speedier and smoother, which of course means you can start making money sooner.

At a minimum, to pass your pre-operational inspection, you need to have an organized binder or software program with all required documentation. Depending on your state, you will likely need:

  • Floor plans
  • Training plans
  • Standard operating procedures (SOPs) to:
    • Track inventory to prevent diversion and inversion
    • Store and display inventory
    • Control access to areas where cannabis is displayed or stored
    • Check IDs to prevent underage purchases
    • Maintain a safe and sanitary facility
    • Handle all facility operations
    • Handle adverse events
  • Security systems
    • Alarms, surveillance cameras
    • Safe and timely storage of video recordings
    • Equipment maintenance procedures
  • MSDS sheets for chemicals used during operations, if applicable
  • Administrative requirements such as insurance policies, surety bonds, corporate documentation, management and other legal contracts

In addition to reviewing required documentation, the inspector will tour your facility to ensure submitted floor plans are accurate and the building, security equipment and controls, signage, lighting, and access control are all compliant, and your license is displayed in a readily visible location.

Surprise/Unannounced Inspection

If an inspector shows up unannounced to your cannabis facility, it’s likely in response to a tip of non-compliance or complaint(s) from a customer or neighboring business.

To prepare for the unexpected, it’s best to be organized. Set up compliant systems to manage your operations before you have a problem. Have an organized binder or software program with all required documentation to prove you are proactive and your operations are compliant.

Set up a system to track the following:

  • Sales and inventory records
  • Employee onboarding; training documentation
  • Security equipment and system maintenance
  • Opening and closing procedures
  • Sanitation and safety for people and products
  • Environmental impacts, odor mitigation
  • Advertising, marketing campaigns
  • Packaging and labeling procedures and protocols
  • Mandatory testing results, product certificate of analysis (COAs)
  • Chain of custody documentation
  • Access control for employees, visitors, and to ensure underage individuals are not able to purchase cannabis or cannabis products
  • Administrative requirements

Ask your regulatory representative if there is a checklist you can use to ensure your operations are compliant, so you’ll always be prepared — even for a surprise inspection.

Renewal Inspection

The purpose of a renewal inspection is threefold. They are designed to ensure:

  • You’re doing what you said you’d do in your original license application.
  • Your procedures remain compliant, and your recordkeeping is in order.
  • You haven’t changed your facility or operations without first obtaining state approval.

License renewal applications are often time-consuming and challenging, especially if you haven’t set up a compliance system with an organized binder or software portal where information is readily available. To prepare for your renewal inspection, you’ll need everything listed in the pre-operational and surprise inspections as well as required annual reports such as your company’s diversity, community, and environmental impacts.

How to Prepare for All State Inspections

There are a few best practices that will help you impress your state inspector and ultimately avoid deficiency notices and fines. With a little preparation, you will feel confident and be able to greet your cannabis inspector with a smile and welcoming demeanor, which will set the tone for a pain-free inspection.

The first thing to do is to set up easily accessible and accurate recordkeeping systems as early in your business lifecycle as possible. Make sure facility managers or shift leads know where to find and how to share state-required documentation.

Ed Windbigler, Director of Internal Operations at Fawn River Cultivation Company in Michigan said, “I normally have all the administrative requirements pre-printed — visitor logs, color photos from 30 days earlier, background checks, SOPs, etc., all ready for the state inspector.”

The second is to maintain a clean and safe facility. Regularly walk through your facility and ensure that it, and all equipment in it, is clean, and that product is correctly displayed and stored. Ensure your license is displayed in a prominent location.

The third is to talk with your staff and let them know you prioritize compliance and an inspection is not a reason to panic. Appoint one person (or one in each area of the facility if your facility is large) to show the inspector around and respond to any questions or requests for information. Let your staff know what to expect. Make sure they know the regulations that apply to their position, where to find their department’s standard operating procedures, how to alert management if they witness a non-compliant activity or part of the facility, how to respond to a threat such as theft (co-worker or customer), altercation or aggressive behavior, fire, or natural disaster. Consider role-playing so employees can get comfortable with the types of questions an inspector may ask.

When asked how he prepares employees for an inspection, Windbigler, who has implemented a regular system of internal audits said, “We really don’t have our employees do anything differently. Our internal audits normally catch any issues early on.”

Fourth, walk through your facility with an eye toward security. Andy Shelley, former Oregon cannabis inspector and founder/CEO of CannXperts, a cannabis compliance consulting firm, suggests having an employee walk through the site while another monitors the surveillance. Adjust cameras or install additional cameras to cover blind spots. Check that surveillance recordings are stored in a manner that complies with state requirements. Ensure areas of the facility that contain cannabis or cannabis products are properly access-controlled. Check that facility visitor logs are complete and compliant with the regulations.

“I would say, consistently, the state inspectors will focus more attention on surveillance and security above everything else. You want to make sure those systems are rock solid. We train one or two onsite employees to check the systems daily and weekly and then we perform a complete compliance inspection on those systems during our audits,” said Shelley.

Jacob Lawson, Compliance Specialist, and Sarah Stalker, Director of Compliance at JARS in Arizona, said, “We focus equally on all aspects of compliance including but not limited to security, inventory, safety, and sanitation. We expect the state to always look at all aspects of compliance.”

And fifth, regularly audit your facility, staff, and operations to identify areas of weakness or non-compliance. Some states publish checklists that inspectors use when visiting a facility; if yours does, use it! Consultants and operational platforms often have their own checklists based on state rules and regulations. If you have an existing relationship, see if they have a resource you can use to prepare for your inspection.

Shelley advises, “Check everything, then double-check everything and then check it all again. There is no better way to test your compliance systems than having fresh eyes inspecting you a couple of times a year. We rotate our inspectors, so they aren’t going to the same facility twice in a row; so even we are putting fresh eyes on a client’s operations each time. Complacency can destroy an otherwise healthy company.”

Here’s to compliant cannabis facilities, and safe, life-changing cannabis and cannabis products. You’ve got this!

The Guardians of Consumer Safety: The Role of GMPs in Cannabis and Hemp

By David Vaillencourt, Bethany Moore
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Over the past century, numerous pivotal concepts have emerged, shaping the course of society and enhancing our collective well-being. Among these, Good Manufacturing Practices (GMPs) stand out as a beacon of assurance for product safety and consumer protection. Prior to the establishment of GMPs, industries such as pharmaceuticals operated in a murky landscape where products were peddled from wheeled carts as “miracle elixirs,” often containing undisclosed and potentially harmful ingredients. Labeling requirements were lax, production methods were shrouded in mystery, side effects were unknown, and the true efficacy of these concoctions was questioned.

Here in the United States, because of a previous lack of GMPs, there have been several major incidents over the years which have had catastrophic consequences. Poor controls for safety in the production of food, pharmaceuticals, supplements, medical devices, and more resulted in thousands of deaths and/or other medical issues. In 1938, three decades after the Pure Drug Act, Congress passed the Federal Food, Drug, and Cosmetic Act (FDCA), which formally established the FDAs authority to protect public health.

Take ‘snake oil’ for instance, a term evoking deceptive practices or fraudulent schemes. The original Chinese concoction was made using the oil from Chinese Water Snakes which helped relieve sore muscles and inflammation. When American salesmen got ahold of the recipe, they attempted to use rattlesnake oil, which does not have the same properties as the Chinese Water Snake. By the time the recipe was tested, it was shown to contain alcohol and opium, but no real snake oil. This illustrates the dangers of unregulated products and the importance of standards like GMPs in ensuring product integrity and consumer safety. Without proper oversight, consumers are vulnerable to misleading claims and potentially harmful substances, underscoring the necessity of stringent manufacturing practices in all industries, including cannabis.

In reviewing several examples in history where tragedies resulted, we can go back as far as 1906 when tainted and misbranded food and drugs led to widespread illness and death until basic standards were established for product safety and labeling. Speaking of the turn of the century, if you haven’t read “The Jungle” by Upton Sinclair, put it on your reading list. It is one of the most influential books in American history, as it details the unsanitary conditions of the meat industry before GMPs and is directly responsible for Congress passing some of the first food safety laws.

Safety standards
Chairlift safety standards in the 1960s.

Some of you may be old enough to remember back in 1982 when seven people died after ingesting cyanide-laced Tylenol capsules. This led to the introduction of new industry standards, including tamper-evident packaging and heightened safety measures for over-the-counter medications.

Even in modern times, recalls of contaminated meats and produce serve as stark reminders of the ongoing importance of stringent safety measures. These recalled food products not only pose serious health risks but also incur significant financial losses and damage to the brand reputation of the companies involved. To further underscore the importance of these safety measures, in 1994 Congress authorized the FDA to implement GMP guidelines for dietary supplements through DSHEA (Dietary Supplement Health and Education Act). However, GMP guidance for dietary supplements was not released until 2007.

“There are a lot of examples where failure to implement GMPs creates safety problems.  Many food recalls and FDA warning letters report problems with pest control, worker sanitation, cleaning and sanitation, employee practices, and other GMPs,” says Steve Gendel, Ph.D., an expert on food safety and consultant at The GMP Collective. (Gendel also serves as the Technical Contact for the cannabis GMP standard that was recently balloted at ASTM.) “One example of the problems caused by inadequate GMPs is the recent announcement that Family Dollar Stores pleaded guilty to a federal felony and must pay a $41 million fine for failure to control rodents in a warehouse. This follows a massive recall of hundreds of products that passed through that warehouse.”

In addition to criminal liability and hefty fines, a brand that fails to maintain the standard levels of safety and sanitation is not posing risks to customers and employees alike; it can also suffer long-term damage to reputation in the public eye, creating a public relations nightmare. In a blog by Rootwurks in August 2023 titled “It’s All About The Consumer,” Dr. Kathy Knutson, another food safety expert and consultant at The GMP Collective, states, “There can be brand damage through consumer litigation if any harm is caused. There can be regulatory action including fines and recalls. In the food industry, the average cost of a recall is $10 million.” For cannabis products, the most common types of recalls involve contamination of products containing Aspergillus, Salmonella, mold, heavy metals, and certain pesticides.

GMP triangle
The GMP Triangle

The cannabis industry, once relegated to the shadows of illegality, is now emerging into a legitimate marketplace. However, as it gains momentum, it faces numerous challenges, including the imperative of ensuring product safety, consistency, and regulatory compliance. Adopting and adhering to GMPs will be essential for the industry to establish marketplace trust, safeguard consumer health, and thrive in a competitive landscape. “The California Cannabis Commission lists 13 recalls for cannabis products from January 2022 through February 2024. Of these, nine were related to problems that could have been controlled by GMPs and/or good cultivation practices,” added Gendel.

Today, while there is no national requirement for Good Manufacturing Practices in the cannabis industry, over a dozen states currently require some form of GMP for cannabis operators — and for good reason. When implemented effectively, GMPs are good for businesses and good for consumers. They reduce the risk of costly product failures and recalls. They provide employees with the tools and guidance needed to carry out their duties — safely and efficiently. Whether it is preventing mold and pests through effective sanitation programs or verifying that equipment purchased works as intended, day in and day out GMPs truly are simply Good Practices and the absolute bare minimum that any business owner and consumer alike should demand of their operation.

The potential risks to human health aren’t limited to cannabis products alone. Vaporizers and other related devices represent a crucial aspect of safety to consider. As the cannabis industry transitions from illegality to legitimacy, ensuring product safety, consistency, and regulatory compliance becomes paramount. GMP adoption is crucial for establishing marketplace trust, safeguarding consumer health, and thriving in a competitive landscape.

Whether it’s the spices and herbs in your kitchen, medicines in your medicine cabinet, or the food in your refrigerator, GMPs have been recognized as the global minimum best practices that have helped our planet feed, nourish, and protect the nearly 8 billion people on our planet. In conclusion, the importance of GMPs spans all industries, safeguarding consumers and businesses alike. The cannabis industry’s embrace of GMPs signals a commitment to excellence and underscores the vital role these practices play in fostering a safe and reputable marketplace now and in the future.

Navigating the Future: A Glimpse into ASTM Committee Week and the Blueprint for Cannabis and Hemp Standards

By Bethany Moore
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In mid-January, against the backdrop of Kentucky’s renowned reputation for fast horses and whiskey, dozens of experts, advocates, operators, and regulators dove headfirst into the heartbeat of innovation and regulation at the ASTM Committee Week. It was my very first time attending, and I waded right into the deep end of the pool.

For those unfamiliar, ASTM International (formerly known as American Society for Testing and Materials) was originally established in 1898 and is one of three major standards development organizations (along with ANSI and ISO) and has been developing and publishing voluntary consensus technical standards in just about every category of materials, products, systems, and services you can think of. One of the oldest ASTM standards literally keeps the trains running on time – a standard for guiding steel rails. And as of just a few years ago in 2017, cannabis, the new kid on the block, joined the party.

I was also a new kid at the ASTM Committee Week conference, however the ASTM International organization provided training in advance with plenty of resources to understand the process, including online training, videos, and a warm welcome at the new member orientation meeting.

At first, the concept of developing standards through consensus seemed daunting, but soon was all demystified as the knowledgeable and helpful ASTM staff members explained the process with full transparency. Much like getting a bill passed on Capitol Hill, it can be a long process that includes debate, clarification, negotiation, and revision before finally becoming a published standard.

Instead of this process being ushered along by elected members of Congress, ASTM Committee members are volunteers from various stakeholder parties including major universities, state and federal government agencies, and public health organizations, as well as for-profit companies including multi-state operators and testing labs.

The atmosphere was charged with the collective determination to shape the future of the cannabis and hemp industries. While the legality remains an intricate puzzle in the United States, the global committee has members from over 30 countries, and the strides made during this event are monumental steps towards international standards that will chart the course for a thriving and harmonized industry.

Alena Rodriguez, co-founder of the non-profit S3 Collective, has been immersed in the world of ASTM standards for several years. Rodriguez states, “As an active member and the Chair of the Laboratory Subcommittee of ASTM’s D37 Committee on Cannabis, I am driven by the belief that standards are foundational to improving the world. Engaging in the development of global consensus standards for the cannabis and hemp industry offers an unparalleled chance for stakeholders like myself to ensure our voices are heard. I believe D37 is the most accessible standards development organization and provides individuals with a significant opportunity to influence our industry’s future. By sitting together at the table with industry operators, ancillary operators, scientists, consumers, and regulators from nearly 40 countries, we are collaboratively establishing the minimum practices necessary for safety and quality assurance. Our goal is for ASTM D37 standards to be referenced or adopted in regulations worldwide. Considering there are already over 6,000 references to ASTM standards within the U.S. Code of Federal Regulations alone for other industries, it seems within reach. Developing standards is ultimately about safeguarding our communities while ensuring the integrity of our marketplace, and I am proud to contribute to this vital effort.”

At the heart of this endeavor lies a profound understanding – the work we’re doing today isn’t just about compliance or even best practices; it’s about crafting the language of future legalization and regulation that can stand the test of time and can often streamline complex industry issues while creating a safer marketplace. Take, for instance, the International Intoxicating Cannabinoid Product Symbol (IICPS), identifying consumer products that contain intoxicating cannabinoids. In the past, each state conjured its own symbol, leading to a chaotic landscape for consumers and operators alike. The ASTM Committee, however, is rewriting this narrative. It instills order, creating a universal symbol that transcends state boundaries and eases the burden on operators adjusting to non-standardized symbols.

Darwin Millard, also known as the Spock of Cannabis, is another active member of the ASTM D37 Committee and is the chair of D37.08 (Personal/Household-Use Cannabis Devices and Appliances) and co-chair of D37.04 (Processing and Handling). ​​”ASTM International’s technical committee D37 on Cannabis is one of the only true unbiased forums where stakeholders of all types from around the world can participate in shaping the marketplace in which they partake. Through an established 125-year-old accredited process, the volunteer members of ASTM D37 work to create technically accurate market-relevant consensus standards. Much like a participatory democracy, the ASTM process can take time, but it builds a more robust and usable document. The D37’s committee week is an excellent opportunity to see all this in action, and witness firsthand how competing interests can come together to produce something that will benefit everyone, not just a few,” Millard shares.

During my immersion into the ASTM Committee Week, I found myself navigating a labyrinth of subcommittee meetings, each a melting pot of ideas and insights. The Strategic Planning and Government Liaison Task Group unfolded an ever expanding strategy, showcasing the intricate dance between planning and government collaboration. I also sat in on the Security and Transportation Subcommittee, where members explored the nuances of cannabis delivery services, addressing concerns for driver safety and product security.

The ASTM Committee space offers a unique opportunity for the government, whose goals include protecting public health, and the industry, to speak freely about issues of importance to both sides.

Equally captivating was the Terminology Subcommittee, a lexicon for the cannabis and hemp industry. Its mission: to establish a shared language, a Rosetta Stone for common terms. Even days later, I find myself tethered to the 5-page glossary it produced – a testament to its utility.

The symphony of subcommittee meetings included a crescendo of topics: Devices and Appliances, Sustainability, Quality Management Systems, Industrial Hemp, and a harmonious collaboration in the Joint Initiative Group on Vaporizer Product. The process, adhering to Robert’s Rules of Order, is deliberate, ensuring every voice is heard as documents move through the ASTM balloting process. It’s a meticulous journey, but one that ensures the standards being crafted are thorough and considerate of all perspectives.

David Vaillencourt, Vice Chair of the D37 Committee on Cannabis, has been rolling up his sleeves with this work since its formation in 2017: “I will never forget attending D37’s first Committee meeting over 6 years ago and witnessing the caliber of discussion taking place between heads of trade organizations, government officials, and technical experts from industry. For over a century, ASTM has proven that its process fosters collaboration between stakeholders that are typically in opposition publicly, because of the shared goal – to create a functioning marketplace that adequately protects consumers without impeding innovation and trade. As I enter my 2nd elected term as Vice-Chair, the time invested as a volunteer continues to pay dividends in the knowledge, relationships, and strategic insight. The members of ASTM D37 have quickly become my second family. Whether it’s a heated debate on the floor or talking about our kids or pets and our hobbies, at the end of the day, I know that we are all connected by our shared vision to make the world a better place through creating a minimum safety and performance standards for all things cannabis.”

To my fellow colleagues in the cannabis and hemp industry, I extend an invitation. Consider joining ASTM, become a part of the D37 Committee on Cannabis, and claim your seat at the table where these crucial standards for our industry’s future are being forged. This isn’t merely about compliance; it’s about piloting the plane while it’s already in the air. This is our chance to occupy the pilot’s seat and guide the trajectory of an industry we hold dear.

Let’s seize this opportunity to lead the way forward together.