With demand for THC and CBD distillate products steadily increasing on a global scale, it’s never been a better time to be a cannabis cultivator, processor, or product formulator. When entering these industries, an often overlooked yet critical step in the planning process is choosing the right cannabis extraction solution.
What are your options for cannabis extraction?
Depending on the amount of cannabis biomass you plan to process each year and the type of distillate you are trying to produce, you have three main options for meeting your extraction needs. You can:
Partner with a mobile extraction lab company to extract at your facility without having to build your own lab
Build your own fully-compliant extraction lab at your facility
Hire a 3rd party processor (often called a “toll-processor”) who can manage extraction for you at their facility
Is a mobile cannabis extraction lab right for you?
A mobile extraction lab is a fully-certifiable clean room that has been retrofitted with ready-to-use extraction equipment. Built off-site to GPP, cGMP, and EU GMP standards, they are delivered and installed at your facility, staffed and operated on contract by the partner company. They allow for scalable production and help you avoid some of the pitfalls and obstacles of building your own extraction lab, keeping you focused on cultivation, product development, and sales & marketing.
Mobile labs allow you to extract at your own facility without having to build your own lab, outlay a large capital expenditure (CAPEX), or use a lot of floor space. You can leverage the expertise of the best engineers whose main priority is to create labs that produce the highest-quality distillate. Labs can be operational at facilities anywhere in the world within 4-6 months, and remove the burden of selecting the right extraction process and sourcing the right equipment.
Mobile extraction lab partners are a great fit if you’re processing 50,000 lbs. to 2 million lbs. of biomass each year and want to outsource the lab CAPEX and ongoing staffing, SOPs, maintenance and upgrades to a trusted partner. These labs can also be incredibly useful if you want to test the market for new products, or want to expand into isolate or THC-free products through remediation and separation processes.
[Check out this video of an extractX mobile lab being delivered to one of their partner’s facilities.]
Should you consider building your own cannabis extraction lab?
If you have your products perfected, biomass sourced, and have a strong existing customer base, building your own extraction lab may be the right decision. If you’re processing over 1 million lbs. of biomass each year and have the facility space and financing secured, building your own lab can put you in a very competitive position in this emerging market.
It’s important to understand that building an extraction lab is no small undertaking. You’ll need to hire engineers to design the right process and source the right equipment for your needs. You’ll need to meet regulatory requirements and hire experienced staff. The entire process can take 12-24 months (or more) and cost $3 million to $7.5 million before you’re able to start processing, depending on the size of the lab and type of distillate you’re producing.
Building the lab is also just the beginning. Since the extraction industry is evolving so rapidly, new technology is constantly emerging that continues to improve production efficiencies and distillate quality. If you’re willing to commit to the massive undertaking of building your own lab, you must also be willing to commit to the ongoing compliance certifications, maintenance, and upgrades required each year to ensure your lab is keeping up with advancements in the industry.
When is toll-processing a good option?
When processing smaller amounts of cannabis biomass (less than 50,000 lbs. per year), a toll-processor may be your best option. A toll-processor is a company that has built a large-scale extraction lab which they rent out to other companies. You would be able to load your cannabis biomass onto a truck, deliver it to the toll-processor, and then receive your distillate back from them.
It’s crucial that you ensure this contractor is operating a fully-compliant facility, following GPP, cGMP, or EU GMP standards. You should check their references, certifications, and quality assurance promises before engaging with them, as you could be held responsible for the quality and contents of the processed distillate. Based on their capture rate and processing costs, you can gauge whether the toll-processor is right for you, or if you need to seek out another partner.
This option is great for small cultivators and processors as it allows you to avoid the major costs of building your own lab, and helps you get to market quicker and test the market viability of your products. It’s important to consider that challenges can occur if there are production delays, transportation issues, or issues with quality control.
Weighing your options
Image caption: [Since high-quality cannabis distillate has never been in higher demand, selecting the right extraction option is crucial to the success of your business.]
When examining these three extraction options for your business, it’s important to consider the immediate and future goals of your company. Do you hope to expand your production capacity over the next few years? How quickly are you trying to get to market? Do you have the resources and technical expertise to go it alone?
These are just a handful of questions to consider when exploring which extraction solution is right for you. Thankfully, the emerging industry is constantly creating new options to meet your needs.
A pioneer in integrated marketing technologies, Albert established his first successful business in 1986 and went on to build a solid track record as an entrepreneur that helped shape the digital industry. A talented leader whose business ranked among Canada’s fastest growing companies for several years running, Albert has assembled the strong management team that will drive extractX business forward. His keen business development approach has resulted in early adoption of extractX labs in global markets.
extractX Ltd. designs, builds, and operates turnkey pharma-grade hemp and cannabis extraction laboratories at facilities anywhere in the world. These fully mobile, purpose-built facilities fit into established industrial-scale operations and scale to meet the needs of cannabis and hemp cultivators and producers. Labs require no lab CAPEX to install, and produce the highest-quality THC and CBD distillate while meeting all GPP, cGMP, and EUGMP requirements and standards.
Equity Member Spotlight: Exspiravit LLC
This month, NCIA’s editorial department continues the monthly Member Spotlight series by highlighting our Social Equity Scholarship Recipients as part of our Diversity, Equity, and Inclusion Program. Participants are gaining first-hand access to regulators in key markets to get insight on the industry, tips for raising capital, and advice on how to access and utilize data to ensure success in their businesses, along with all the other benefits available to NCIA members.
Tell us a bit about you, your background, and why you launched your company.
My name is Michael Webster, and I am the Founder & Managing Member of Exspiravit LLC, a licensed Michigan cannabis company. I earned a bachelor’s degree from the Harvard Extension School in Liberal Arts, and a master’s degree in Composition and Rhetoric from New York University. As a native New Yorker, I tried to wait patiently for cannabis legalization at the state level, but Michigan represented a unique entry point to the regulated market.
Like many NYC kids, my introduction to cannabis occurred at an early age. It was part of the local culture. However, it wasn’t until my late teens that I indulged. And it was even later, when my mom – a fierce cannabis advocate – was diagnosed with breast cancer, that I was introduced to the medicinal benefits of cannabis. I went on to write my graduate thesis on this very topic. From there, I embarked on my cannabis career path.
I launched Exspiravit for a myriad of reasons, not the least of which was to access a burgeoning market that held such promise for the creation of generational wealth. But as a frontline victim of the war on drugs – a simple possession charge of less than a gram of cannabis that temporarily derailed my academic pursuits – I saw an opportunity to educate and destigmatize this amazing plant, that, up until about 80 years ago, had been a staple commodity in human society.
What unique value does your company offer to the cannabis industry?
We are currently deploying our Cannabis Event Organizing license for consumption events throughout the state of Michigan – both large and small – while we raise capital for the build-out of our solventless extraction lab. We believe in clean plants and derivatives and are working closely with the Cannabis Certification Council on securing the “made with organic flower” seal. The event organizer license has proven the perfect complement to our other ventures, as it has allowed us to redefine what “an event” really is, and to take our show on the road. We also offer consultancy to other social equity and small operators, with a focus on regulatory compliance, helping to share what we’ve learned on our journey.
What is your goal for the greater good of cannabis?
When it comes to our company values, Exspiravit advances a unique position on social equity. For far too long, social equity has been considered a gift or non-transactional offering. We at Exspiravit believe equity – social or otherwise – is earned and therefore OWED. Most current social equity initiatives in the cannabis industry broadcast messages of handouts and favors. This is the wrong message. When accessing the equity in your home, or other assets, neither you nor the bank treats those transactions as gifts. Social equity represents a debt owed from those who have weaponized their racial or class privilege to monetize a commodity market that was built on the willful destruction of black, brown, poor white, and otherwise marginalized communities. Debts are owed. Debts are to be paid. And their payment represents the satisfaction of an obligation and not a benevolent gesture.
Quite the opposite, those tapping equity are claiming what is rightfully theirs. Again, equity is earned, accrued, developed, and owed, but certainly not to be asked or begged for. Exspiravit plans to use its voice to correct this adversely impactful interpretation of social equity, in hopes of realigning access to resources in the regulated cannabis sector. In addition to our work on the social equity front, Exspiravit’s goal for the greater good of the cannabis industry is to advance the for-purpose market. We believe that flower and euphoria only represent the tip of the iceberg when it comes to products and outcomes. We envision an ultra-specific and ultra-targeted market that features purpose-driven derivatives for a highly informed consumer.
What kind of challenges do you face in the industry and what solutions would you like to see?
Like many social equity cannabis operators, accessing capital has been our greatest challenge. And this challenge is intrinsically linked to our greatest criticism of social equity initiatives –- the lack of social equity funding. For social equity applicants, the process can be grueling. And for those of us who make it through to licensure, being greeted on the other side by predatory investment opportunities exacerbates our challenges. Social equity initiatives MUST feature a robust social equity fund. Without it, social equity operators are being positioned for failure. Diversion of existing tax revenue or special taxes levied against large and multi-state operators can easily address these challenges. Too, we would like to see more collaboration than competition. Regulated cannabis markets should be rolled out in ways that foster greater opportunities to collaborate. Support for collectives, and other similar strategies, are low-hanging fruit when it comes to solutions.
Why did you join NCIA? What’s the best or most important part about being a member of the Social Equity Scholarship Program?
We joined the NCIA for a variety of reasons. Firstly, it was accessible. Through its outreach, the NCIA met us where we were and provided us a robust package of resources that weren’t intended to lure us into paid membership, but rather to help us stand up and be able to recognize the benefits of such association. You can’t effectively inform a starving, homeless, injured person until you have fed, housed, and rendered aid to them. And that appears to be the NCIA’s philosophy – meet the immediate, pressing needs of social equity operators, positioning them to then effectively and efficiently access industry resources. The perfect example of this strategy is NCIA’s decision to offer one year of complimentary membership to social equity operators, including access to the national and regional conventions. The value here, to one’s first year of operation, is immeasurable. These events have provided the opportunity to forge important and lasting connections with other industry stakeholders that have made all the difference for us. Without question, we would not be enjoying such forward progression without the genuine efforts of the NCIA.
The PACT Act Final Rule Has Been Released Prohibiting the Mailing of Cannabis/Hemp Vaporization Products. Is Your Business Ready?
By Rachel Kurtz-McAlaine, NCIA’s Deputy Director of Public Policy
After months of delay, the United States Postal Service (USPS) has released its FINAL rule enforcing the Prevent All Cigarette Trafficking (PACT) Act, effective October 21, 2021, and unfortunately, they are indeed applying it to cannabis/hemp vaporization products. The PACT Act has now made it extremely difficult for anything related to vaporization to be mailed, either business to business (B2B) or business to consumer (B2C). Your business could be affected even if you are not mailing out products. Although this is a massive burden on the cannabis/hemp vape industry, there are ways to deal with it. NCIA remains vigilant in making sure the federal government understands this unnecessary hardship to the industry, and making sure our members are fully educated on this issue.
What is the PACT Act?
The Prevent All Cigarette Trafficking (PACT) Act went into effect June 29, 2010, applying strict regulations to the mailing and taxation of cigarettes and smokeless tobacco products, effectively banning the mailing of cigarettes unless authorized by an exception. With the rise of e-cigarettes, especially their popularity among youth, Congress decided that vaporization products should be included in those provisions. On December 27, 2020, Congress modified the definition of “cigarettes” to include Electronic Nicotine Delivery Systems (ENDS), broadly defining ENDS to include nearly all vaporization products, regardless if they contain nicotine or are used for nicotine. Specifically:
“(1) any electronic device that, through an aerosolized solution, delivers nicotine, flavor, or any other substance to the user inhaling from the device; and (2) any component, liquid, part, or accessory of an ENDS, regardless of whether sold separately from the device.”
When the USPS issued their notice of proposed rulemaking, they received more than 15,700 comments, with many expressing frustration with the broad interpretation of ENDS, so the USPS delayed issuing FINAL rules while it considered the practical application to the unique cannabis and hemp industries. NCIA was proud to submit comments with a broad coalition and to issue an action alert to get our members to express their concerns.
In the meantime, the USPS issued a guidance document (“April 2021 Guidance”) (86 FR 20287) to help prepare businesses for the final rule and what documentation will be needed to apply for an exception. The exceptions include:
Intra-Alaska and Intra-Hawaii Mailings: Intrastate shipments within Alaska or Hawaii;
Business/Regulatory Purposes: Shipments between verified and authorized tobacco-industry businesses for business purposes, or between such businesses and federal or state agencies for regulatory purposes;
Certain Individuals: Lightweight, non-commercial shipments by adult individuals, limited to 10 shipments per 30-day period;
Consumer Testing: Limited shipments of cigarettes sent by verified and authorized manufacturers to adult smokers for consumer testing purposes; and
Public Health: Limited shipments of cigarettes by federal agencies for public health purposes under similar rules applied to manufacturers conducting consumer testing.
18 U.S.C. 1716E(b)(2)-(6). These exceptions are the ONLY way to mail these products moving forward. Unfortunately, the USPS was not accepting applications for exceptions until the final rule was published, but now that it has been published, it is time to apply for an exception.
FedEx and UPS have already banned delivering these products, so they are out as an alternative.
How can it affect me?
If you manufacture, sell, or buy vapor products, you will be affected. Manufacturers and distributors who use the mail to get their products to stores for resale (B2B) will have to apply for an exception through the USPS Pricing and Classification Service Center. If you are a business receiving these products, you will have to work with the business that mails it to you to be included in their exception as a recipient. If you are a retailer who delivers vaporization products to consumers via the mail, such as online retailers (B2C), you will also need to apply for an exception. If you buy the end products as a consumer, expect an increase in price because of the extra costs placed on the suppliers.
What should I do?
If your business has ANYTHING to do with the manufacture, delivery by mail, or retail of cannabis/hemp vaporization products, including liquids, batteries, empty cartridges, etc., you should get familiar with this final rule that is in effect as of October 21, 2021. The USPS spends the time addressing potential issues or suggestions from the comments it received, so any questions of why they did something are probably answered there.
You will also want to read the guidance document the USPS issued in the Spring that details if you qualify for an exception and how to apply for it. This will require cooperation between the mailer and the recipient, so make sure you are working with your supplier/retailer to get all the necessary information.
What is NCIA doing?
NCIA remains committed to making sure our members understand all of the legal ramifications and how to continue operations despite this rule. We continue to work with our coalition partners to better understand the effects and best practices, and will share with you as much information as possible to ease the transition via blog posts and webinars.
Take A Survey: U.S. Cannabis Industry Sentiment and Business Conditions
NCIA chief economist and his cannabis economics firm, Whitney Economics, are collaborating with NCIA to conduct a national survey of businesses and stakeholders in the U.S. cannabis industry. Below, please find a link to the Survey of U.S. Cannabis Industry Sentiment and Business Conditions. It examines the key issues facing the industry including what you are experiencing when doing business in the industry. The survey seeks to investigate what is working and what can be improved from the perspective of businesses and stakeholders in the cannabis industry.
The goal of the survey is to tabulate ancillary business and cannabis operator opinions on the state of the U.S. cannabis market. Responses are confidential and will be kept anonymous.
Your participation and insights will help policymakers understand the issues that face the industry from your perspective. The survey takes between 4–5 minutes to complete. Please complete the survey by Sunday, October 31.
As we make our way closer to 2022, the world is also entering a new paradigm for the cannabis industry. Due to advancing global legalization efforts, cannabis use is gaining mainstream acceptance for the first time in history. With these shifting perspectives also comes the rapid deterioration of traditional stereotypes.
Today, cannabis is not only widely regarded as a legitimate medicine, but many people also look to it as a performance tool. To this end, the endorsement of the herb by pro athletes, media icons, and high-powered executives has again turned our conceptions of cannabis on its head.
With such rapidly shifting perspectives, we are witnessing a monumental moment in time where propaganda is being replaced with factual evidence. As things evolve, active people are not only endorsing legalization, but many swear by cannabis as a performance tool.
Indica and Sativa
The more places that legalize cannabis around the world, the more opportunities we have to study cannabis in controlled settings. As our knowledge expands, so does our ability to use specific compounds in cannabis to aid particular activities.
In the early days of legalization, broad terms such as “Indica” and “Sativa” were used to describe just about every attribute of cannabis – including both product descriptions and psychoactive effects. To this end, Indicas are widely accepted as calming, while Sativas are known to be energetic.
Terpenes & Strains
While the effects of Sativas and Indicas are still widely accepted across the industry, we are also beginning to see a much more nuanced approach to cannabis consumption. Especially when it comes to performance, a more granular perspective of cannabis is necessary.
To maximize the performance benefits of cannabis, it’s critical to understand the constituent parts of the cannabis flower. By understanding the effects of different strains and cannabinoids, and terpenes, people can better choose the right products for their performance needs.
Notable cannabinoids and terpenes and their effects:
Tetrahydrocannabinol (THC): Cannabinoid that provides energy and focus during activities helps boost creativity. Pain reliever after physical activity.
Cannabidiol (CBD): Cannabinoid that relieves anxiety before and during performances. Pain reliever and anti-inflammatory agent after physical activity.
Cannabigerol (CBG): Cannabinoid, which promotes motivation and stimulates pleasure. Pain reliever and anti-inflammatory agent after physical activity.
CLS Holdings’ own City Trees developed several popular products based on the effects of certain cannabinoids and terpenes. Their Calm, Relief, Rest, and Energy distillate vape cartridges offer simplified shopping experiences for new cannabis consumers. By building product messaging around the effects of the products, they help people understand exactly what they are purchasing.
Physical & Mental Performance
While a detailed assessment of the compounds found in cannabis can go a long way, you must also account for your specific performance needs when finding the right cannabis product. Depending on how your body and mind react with cannabis, you can utilize it to help with physical activities and cerebral pursuits.
Whether you are interested in feeling more energized for your workout routine or getting the creative juices flowing for a writing assignment, there is likely a cannabinoid and terpene combination to suit your needs.
Olympic gold medalist snowboarder Ross Regalati swears by cannabis during both training and competition. The famous Canadian snowboarder feels cannabis “improves concentration” and is great for training because flowers are both “fat-free and calorie-free.” While no longer a professional snowboarder, Regaliti is still a world-class athlete. Today, his choice cannabis strain for exercise is the Sativa-dominant hybrid Bruce Banner.
The famous female vocalist Alanis Morisette swears by cannabis as part of the creative process. In an interview with High Times, she states, “As an artist, there’s a sweet jump-starting quality to [marijuana] for me… So if I ever need some clarity… or a quantum leap in terms of writing something, it’s a quick way for me to get to it.” Morisette can utilize the right cannabis product for her needs and push through creative boundaries and explore new territories.
Tips for Finding the Perfect Fit
While studying different terpene profiles and cannabinoids is a great way to learn about the effects of cannabis, you also need to consider your physiology. Notably, a cannabis product that works well for one person won’t necessarily do the same with another.
For example, if you are an introverted, anxiety-prone person, using an energetic strain like Diesel for a social situation might not be a good idea. In this case, a mellow Indica CBD hybrid like Cannatonic might be just what you need to feel relaxed and engaged. Yet, a naturally extroverted person would likely enjoy an energetic strain for social situations and need the CBD hybrid to wind down at the end of the day.
If you aren’t sure what cannabis products will work for you, we recommend visiting a credible dispensary with well-trained budtenders. Once you have sound recommendations, always start small when experimenting with new cannabis products. With a bit of careful trial and error, you will likely discover cannabis products that can help you with anything from enhancing your workout to stimulating your sex life.
Summary
Having been on pain management therapies since the age of 17 for my Kyphosis, I now rely solely on concentrated cannabis extracts to manage my pain and keep my Activities of Daily Living at peak performance. Being diagnosed at 17, I was prescribed 1x Hydrocodone per day to manage my pain. By the time I graduated from Pharmacy School, I was taking 18 pills a day (540/month) to manage my pain and the side effects of other medications. It’s been 8 years since I’ve taken a prescribed medication and cannabis and cannabis products have replaced every medication that I was on prior. I’m grateful and humbled to be a key member of a team that produces the very own products I use to manage my health and wellness.
Looking back just a few short years to the genesis of legal cannabis, it’s remarkable to see how far we have come. In the industry’s early days, people didn’t have the luxury to match a specific cannabis product to a particular performance need. Not only was our knowledge of cannabis not sophisticated enough to accomplish this task, but Good Manufacturing Practices (GMPs) were still lacking in the early days.
As our knowledge of cannabis continues to expand, so does our ability to make informed decisions on the products we use. Whether you are a trail runner who enjoys a Sativa before you head to the mountains, or a musician who likes to settle into practice with hybrid flowers, some careful study will lead you to the right products for your performance needs.
During this period of rapid change, it’s exhilarating to see negative stereotypes of lazy cannabis users finally being upended. Even more, it’s incredible to witness pro athletes, high-powered executives, and famous artists not only advocate for legalization but openly promote cannabis as a performance tool.
Dr. Monaco is the Director of Laboratory Operations forCLS Holdings’ newly opened approximately $4 million laboratory, and is responsible for all day-to-day operations inside the North Las Vegas facility. Dr. Monaco brings over 8 years of licensed & regulated cannabis experience, starting back in 2012 when medical marijuana first opened in Arizona, he has held numerous positions, with escalating responsibilities year over year. He graduated from the University of Arizona College of Pharmacy, in Tucson, Arizona, with a Doctor of Pharmacy in 2010.
Video: NCIA Today – Friday, October 8, 2021
NCIA Deputy Director of Communications Bethany Moore checks in with what’s going on across the country with the National Cannabis Industry Association’s membership, board, allies, and staff. Join us every Friday here on Facebook for NCIA Today Live.
How Sweet It Is… Contemplating Cannabis Confections
by Rachel Kurtz-McAlaine, NCIA’s Deputy Director of Public Policy
Have you ever had a bad experience eating edibles? Someone gave you a homemade brownie, you ate it, and they were like, “You weren’t supposed to eat the whole thing!” There are many people who won’t eat edibles at all because of past negative experiences. Maureen Dowd’s now infamous column about her harrowing experience eating too much of an edible was from an infused chocolate bar she bought from a licensed retail facility in Colorado. That didn’t do much to help the scary reputation of edibles.
Dowd’s article quoted Andrew Freeman, Colorado’s Director of Marijuana Coordination at the time: “There are way too many stories of people not understanding how much they’re eating. With liquor, people understand what they’re getting themselves into. But that doesn’t exist right now for edibles for new users in the market.” To imply that liquor is somehow safer was disingenuous and dangerous. In the seven years since this article was written, it’s clear that the alarmist predictions about cannabis edibles aren’t coming true, but I just read an article about another fraternity pledge that died recently from alcohol poisoning.
However, Dowd and Freeman were both correct that as the responsible cannabis industry that we are, we should be educating our consumers on the potential harm from overconsumption (e.g. extreme discomfort) and how to properly titrate. While we know it’s not as dangerous as it’s made out to be, happy customers make for repeat customers. We have gotten more sophisticated as an industry in the last seven years with things like labeling, dosage, and consistency, but there is so much potential for more innovation and refinement.
I consider edibles to be one of the best things to come out of the legal, regulated cannabis marketplace, and they’re gaining in popularity. According to BDSA, the edibles market grew 39% over the past year, and with good reason: people prefer the healthier aspect of eating to smoking, it’s more discreet, and it’s consistent. For some people it’s like eating a gummy vitamin or dietary supplement. There is also a trend toward micro-dosing, especially if the edible is so tasty it should be enjoyed in larger quantities, and playing with ratios between THC, CBD, and other cannabinoids. People can pay attention to their bodies and discover what amount works best for what they’re trying to achieve.
I was honored to speak recently at the American Association of Candy Technologists’ 2021 Technical Seminar. They were incredibly friendly people, and I’m not just saying that because they gave me enough candy it reminded me of trick or treating in that good neighborhood where there are a ton of kids and all the houses are decked out and you come home with a huge bag full of candy. They were genuinely nice! We played trivia and roasted s’mores in the evening. It felt like the summer camp every kid dreamed of going to.
They were also extremely interested in learning more about the cannabis industry. NCIA was invited to speak through one of our common members, Clara Food Technology, who provides expertise in making better cannabis edibles through science. In fact, most of the people I met who were interested in the industry weren’t planning on starting their own edible company, but providing the industry with some pretty incredible food science expertise that can only make the industry better as a whole. Cool things like making sure candy doesn’t get too hard or stick together, the ingredients are properly mixed so they’re consistent throughout, ramping up production with new systems and machines, and staying shelf-stable.
People who are entering the edibles market should absolutely find one of these food science consulting companies from the start to help avoid costly errors. Edible companies should have a food science consultant on hand, or even on staff, to elevate the quality and consistency of the products, and bring fresh ideas.
If you’ve been hesitant, take another look at edibles and the value they bring to the cannabis industry. We’ve come so far since the Dowd article, but the potential is limitless.
Committee Blog: Don’t Wipe Out – Riding the Wave of Cannabis Standardization
Staying ahead of the quick rollout of state, national, and international cannabis regulations is a huge and complex challenge. The patchwork of more than three dozen (and counting) different state regulatory regimes remains disconnected as cannabis remains federally illegal as a Schedule I drug. The framework of regulations and standards that guides allied sectors such as Foods, Dietary Supplements, Pharmaceuticals, or Tobacco is just beginning to take shape. Where do you look for guidance? How do you choose how to invest, how to design your operation, and how to produce?
There are a number of considerations and industry-relevant organizations to become familiar with when looking to conduct business in the cannabis space. In doing so, businesses can operate more successfully and mitigate risk. Risk should not be underestimated – many cultivation and manufacturing facilities will fall seriously short of the expectations of agencies such as the Federal Food and Drug Administration (FDA), Occupational Safety and Health Administration(OSHA), the Environmental Protection Agency (EPA), if risk, both business and consumer health and safety, is not considered upfront. Market pressures will build quickly as brand-savvy companies with significant capital and operational expertise enter the field. One way to avoid wiping out – is looking to national and international standards, guidelines and regulations already in place. For a comprehensive list of relevant standards regulatory bodies, refer to our recent blog post here.
As standards continue to be developed by industry experts for adoption by regulators, businesses can be empowered to run their operations with more predictability and reliability knowing that they demonstrate compliance with approved industry guidelines. Laboratories will have access to valid test methods and reference materials. Equipment specifications will require globally accepted certification marks or labels (such as CE or UL) which ensures safety and longevity of operations.
What is the cost of not adhering to established standards?
A simple batch loss can easily exceed tens of thousands of dollars of lost product, let alone the damage to your brand, labor costs surrounding rework, and relationships with your clients. Crop and batch losses due to subpar equipment sourcing, processes that are not validated, and worse – risk of fines or losing your license are all symptoms of a business lacking standardization.
Credible standards – they are data-driven, go through a rigorous and transparentprocess. In most cases, these standards were developed with input and guidance from federal and international regulatory agencies.
Here is the snapshot today. Read it fast, because it may be out of date next month:
The NCIA has several relevant committees sharing best practices and developing guidance for our industry.
ASTM International, one of the oldest and most recognized Standards Development Organizations (SDO) formed Committee D37 on Cannabis in 2017, and has already approved over 25 standards that provide guidance on key areas such as:
AOAC International, another 100+ year old SDO has a Cannabis Analytical Science Program (CASP) where cannabis standards and methods have also been developed – principally in the area of product standard method performance requirements (SMPRs) and methods of analysis such as:
You don’t have to put your business at risk of wiping out! The resources that NCIA Committees continue to create have your best interest in mind. Stay tuned to ensure you have the latest resources and guidance!
Video: NCIA Today – August 20, 2021
Deputy Director of Communications Bethany Moore checks in with what’s going on across the country with the National Cannabis Industry Association’s membership, board, allies, and staff. Join us every Friday on Facebook for NCIA Today Live.
Committee Blog: Safety – Terpene Limits in Cannabis Manufacturing
by NCIA’s Cannabis Manufacturing Committee
From the taste of your fruits and vegetables to the aroma that travels from trees and flowers in bloom, terpenes are the organic compounds that play a vital role in the flavors and smells we experience daily. Terpenes are common ingredients that are used in many industries such as food, cosmetics, tobacco, and pharmaceuticals. Therefore, the information on the safety of terpenes in these industries can be used for determining the safe use of terpenes in a wide range of product applications.
Terpenes are currently being introduced into a variety of adult-use and medical cannabis preparations across the U.S. and hemp-CBD markets around the world for both flavor and functional purposes. Much research has been and still is being conducted on the therapeutic effects of terpenes and their synergistic effects when used in conjunction with cannabinoids. The strong research background supports the benefits of infusing terpenes into cannabis extracts, both in reference to endogenous terpenes found naturally in the plant and those terpenes that have been added back into preparations from other botanical sources. Therefore, almost every manufactured cannabis product contains a percentage of terpenes. However, the clear lack of understanding of the full potential of the terpene profiles, and misuse of these volatile, fragile compounds bring up various misconceptions regarding terpene safety versus their efficacy in creating an elevated user experience.
As terpenes make a significant contribution to the quality of cannabis products, which varies from one consumption method to the other, it is highly important to utilize the most advanced knowledge regarding terpenes in order to maximize their potential while maintaining product safety.
Inhalation
Bioavailability
Terpenes are a naturally occurring constituent in resin cannabis extracts. Terpenes have been incorporated into vaporizable formulations in the form of pre-filled cartridges. These terpene formulations are designed to produce specific effects based on the creator’s intentions, or the terpenes are simply reintroduced to mimic the source material since the extracts are often refined to the point that they have little or no taste (i.e., lost their original essence).
Inhalation of these volatile molecules leads to quick absorption of the compounds via the lungs and directly into the bloodstream. The high solubility of monoterpenes in the blood and hydrophobic medium suggests a high respiratory uptake and accumulation in fat tissues (Falk 1990a). This was confirmed by recent studies of uptake and elimination of a-pinene and 3-carene in humans (Falk 1990b, Falk 1991b). The bioavailability range via inhalation of alpha pinene, camphor and menthol has been studied and reported to be 54-76% (Kohlert 2000) which is relatively high compared to oral bioavailability. Therefore, terpenes via inhalation are an efficient route of administration which allows low dosage of terpenes.
General Guidelines
When examining terpene infusion, the points below should be taken into consideration:
From accumulated knowledge within the cannabis industry and considering terpenes’ natural ratios in cannabis (1 – 5%) and data on safety, it is suggested not to exceed a concentration of 10% in the final product.
As terpenes are volatile molecules, the final terpene-infused product is recommended to be used only with adjustable temperature vaporizers such that the oil will not be heated to high temperatures to prevent unnecessary heat-derived toxin production.
Aerosol testing for the final product is recommended to test for heavy metals leaching into the vaporizable product.
Terpenes are recommended to be used within their defined expiration date labeled on the suppliers’ bottle. The final vaporizable product must be tested in a certified lab under the requirements of the authority having jurisdiction to make sure it meets all quality and regulatory requirements.
Terpene Limits
By using position papers such as the ANEC Position Paper on E-cigarettes and e-liquids, suggestions regarding terpene limits can be made for cannabis inhalable products. It is important to mention that the final decision on added terpene amounts and determination of product safety is the sole responsibility of the manufacturer based on their assessments, internal procedures, and local regulations.
The following numbers are the suggested infusion percentage of specific terpenes in E-liquid. This suggestion was calculated by using DNEL (Derived No Effect Level) levels in inhalation as well as frequency of puffs a day.
On average, E-liquid users take 500 puffs a day (ANEC position paper), whereas cannabis users take around 9 puffs a day. Therefore, the suggested terpene limit percentage in cannabis inhalables may be higher than E-liquid due to the lower daily usage.
Substance
Suggested Terpene Limit in E-liquid According to ANEC
Linalool
0.34%
Menthol
7.8%
Beta Pinene
0.7%
Alpha-Terpineol
1.1%
Geranyl Acetate
7.4%
Carvone
0.14%
Ingestion
Bioavailability
Terpene presence in foods of plant origin and in herbs with functional properties has led to further exploration of their bioavailability following oral consumption. The research on terpenes’ bioavailability is commonly done through medicinal plants since they are subjected to digestion within the mouth and stomach before accessing the small intestine. Bioavailability through oral ingestion is affected by mechanical actions, enzymatic actions, and different pH conditions, Transformations into usually more water-soluble and more readily excreted in the urine compounds affect this process as well. These transformations appear mainly in the liver, but also in the gastrointestinal tissue, lungs, kidneys, brain, and blood (Furtado 2017) Several studies have shown that terpenes consumed orally are absorbed through the gastrointestinal tract and are bioavailable as soon as 0.5 h after intake, reaching their peaks between 2 and 4 h (Furtado 2017, Papada 2018).
General guidelines
Terpenes are commonly used as flavor ingredients and their usage guidelines are clear when used in foods, such as the FEMA values table below. However, when terpenes are used for therapeutic purposes, the suggested dose in food is not fully researched, and the balance between flavor and functionality is still yet to be determined. Basing the dosing according to flavor guidelines is a good place to start. Upper limits should be defined by safety limits such as the DNEL values table found below. It is important to use natural, Food Grade terpenes that are backed up with certificates of analysis and are safe to ingest.
Terpene Limits
The Flavor and Extract Manufacturers Association of the United States (FEMA) has developed an innovative program utilizing the GRAS concept to evaluate the safety of flavoring substances. The FEMA GRAS program began in 1959 with a survey of the flavor industry to identify flavor ingredients then in use and to provide estimates of the amounts of these substances used to manufacture flavors. This database provides information on all ingredients that have been determined to be “generally recognized as safe” under conditions of intended use as flavor ingredients. According to The FEMA GRAS assessment – aromatic terpenes used as flavor ingredients are ubiquitous throughout the food chain; and therefore, not surprising that they serve as effective flavoring ingredients.
The below table presents the average maximum usage levels of terpenes used as flavors in several product types as provided by FEMA.
Product
Lime Terpenes
Average Max (ppm)
Orange Terpenes
Average Max (ppm)
Grapefruit Terpenes
Average Max (ppm)
Limonene Average Max (ppm)
Myrcene Average Max (ppm)
Linalool Average Max (ppm)
Beverages, Nonalcoholic
750
1,550
500
31
4.4
7
Beverages, Alcoholic
1,000
1,000
1,000
NA
NA
50
Chewing Gum
20,000
20,000
20,000
2300
NA
200
Hard Candy
5,000
5,000
5,000
49
13
400
Soft Candy
5,000
5,000
5,000
NA
NA
10
ppm is an abbreviation for “parts per million” and it also can be expressed as milligrams per liter (mg/L) or in a percentage where 10,000 ppm is 1%. For example, the maximum suggested infusion for orange terpenes in chewing gum is 2%, where the suggested infusion in hard candy is 0.5%.
*Point of thought*: Since terpenes in the cannabis industry are mostly infused in cannabis-based products, the frequency of usage of such products is lower than regular food products.
Additional safety data can be gathered from reviewing reports from governmental agencies such as European Chemicals Agency (ECHA). The following data about the DNEL (Derived No Effect Level) in the category of General Population was collected from ECHA website. These numbers may be used as a guideline for maximum daily intake via oral administration:
Substance
DNEL (Derived No Effect Level)
Calculated Daily DNEL for 70kg subject (mg/day)
Linalool
0.2 mg/kg bw/day
14
Menthol
4.7 mg/kg bw/day
329
Beta Pinene
0.3 mg/kg bw/day
21
Alpha-Terpineol
no hazard identified
no hazard identified
Geranyl Acetate
8.9 mg/kg bw/day
623
Carvone
69.4 µg/kg bw/day
4,858
For example, a 70 kg person consumes a 1g cookie that is infused with 1% Pineapple Express terpene formulation and Linalool constitutes 10% of the formulation, then there will be overall 10mg of terpene formulation in the cookie, out of the 10mg there is 0.1mg of Linalool which doesn’t exceed the DNEL level.
Topical
Bioavailability
Terpenes are lipophilic, small, and nonpolar molecules that are considered to be the largest group of natural fragrances. Terpenes can easily penetrate the skin and enhance transdermal delivery (Aqil 2007) and can potentially aid cannabinoid transdermal delivery. Terpenes are also known to have several dermal benefits including anti-inflammatory (Maurya 2014), wound healing (d’Alessio 2014) and anti-acne (Yuangang 2010). Terpene bioavailability via transdermal delivery ranges between 3-12% depending on the type of terpene, medium and application (Brain 2007, Gilpin 2010). Following topical application, maximum plasma levels of terpenes are reached within 10 minutes (Kohlert 2000).
General guidelines
While some terpenes are known as dermal irritants, the severity of the irritation may depend on their concentration. These should not be used on any inflammatory or allergic skin condition and should always be appropriately diluted. The oxidation of terpenes can increase risk of causing skin reactions because the oxides and peroxides formed are more reactive. This can be seen with (+)-limonene, δ-3-carene and α-pinene and arise due to the formation of oxidation products, some of which are more sensitizing than the parent compound. For this reason, proper storage of terpenes is required to preserve their effectiveness and decrease the risk of adverse reactions.
The table below lists commonly known allergenic terpenes, and for this reason, should be declared on the packaging or in the information leaflet if the concentration of these allergenic fragrances is higher than the permissible concentration of 0.01% in shower gels and baths (rinse-off products) and higher than 0.001% in body oils, massage oils and creams (leave-on products)
Allergenic Terpenes
Citral
Citronellol
Eugenol
Farnesol
Geraniol
Isoeugenol
D-Limonene
Linalool
Terpene Limits
The International Fragrance Association (IFRA) defines which compounds represent a potential allergy risk and determines their maximum concentration to produce safe cosmetic products. IFRA also issues recommendations for the safe use of fragrance ingredients, which are published in the IFRA Code of Practice and its guidelines. In the below table, there can be found specific infusion recommendations for specific terpenes.
Substance Name
Restriction Limits in the Finished Product (%) according to IFRA:
Lip Products
Body Lotion, Cream & Oils
Hand Sanitizer & Hand Cream
Body Wash
Citronellol
2.20%
12.00%
3.20%
24.00%
Citral
0.11%
0.60%
0.15%
1.20%
Farnesol
0.21%
1.20%
0.29%
2.30%
Eugenol
0.45%
2.50%
0.64%
4.90%
Geraniol
0.85%
4.70%
1.20%
9.20%
Alpha Bisabolol
0.42%
2.40%
0.60%
4.60%
Testing of terpenes in dermal products can be achieved safely by making a sample product with terpene formulation infused at 0.5% to 5% concentrations in petrolatum. Patch testing can be a useful technique to detect and avoid skin reactions.
As the cannabis industry scales and more states legalize for adult-use, the demand for consumable cannabis products increases. To keep up with the demand, manufacturing facilities have to not only scale, but stay ahead of the curve as far as conserving resources, constantly innovating facility design to meet regulations and third-party compliance, e.g., ASTM Cannabis Certification Program and Good Manufacturing Practices (GMP).
Here are a few areas of environmental, product quality, and worker impacts to consider when planning for the future of your manufacturing facility.
Energy
As with any manufacturing facility, cannabis manufacturers pull power from shared electrical grids, meaning there is increasing pressure to reduce energy usage as they scale their operations. There are many design strategies for facilities to consider, whether they retrofit or build new, to reduce environmental impacts and position their operation for a sustainable future. One example for the cannabis industry is to recapture and repurpose heat generated from the processing equipment used for manufacturing products. Another example is incorporating climate control technologies to reduce the amount of energy required in extreme environments. More and more energy companies are starting to incentivize cannabis operations to reduce their energy usage and offer guidance on how to do so. Furthermore, regulators are beginning to enforce energy usage requirements for manufacturing facilities.
There are many ways to reduce your facility’s energy usage from efficient lighting to control system maintenance and making sure your odor and emissions control systems are designed to your facility’s specific emission load and mechanical design. Whenever possible, installing cloud-based smart systems with the ability to capture energy usage and system maintenance data will help to improve your facility’s energy efficiency. More areas of impact and best management practice guidance can be found in the NCIA’s Environmental Sustainability Report, released in October 2020.
Air Quality
Manufacturers of Infused Products, or MIPs, are Colorado’s manufacturing facilities, which is one example of a market segment facing regulatory enforcements for air quality control. The large-volume use of solvents for extraction leads regulators to monitor the volatile organic compounds (VOCs) emitted from the use of these solvents, as VOCs are contributors to low-level ozone formation, poor air quality, and public health issues. These solvents are also potential contributors to water contamination if wastewater is not discharged properly from the facility and are consequently on the radar for regulators to tightly monitor. The EPA states “the main concern indoors is the potential for VOCs to adversely impact the health of people that are exposed. While VOCs can also be a health concern outdoors, EPA regulates VOCs outdoors mainly because of their ability to create photochemical smog (or low-level ozone) under certain conditions.”
Luckily, smart technology such as cloud-based platforms using the Industrial Internet of Things (IIoT) for control equipment is increasingly being installed in manufacturing facilities, allowing for the collection and monitoring of facility data, such as emissions. Furthermore, the same technologies that are used for odor mitigation, such as molecular filtration systems (aka carbon scrubbers) also remove VOCs in the facilities’ air space from both the products and the solvents in the facility. The ability to prove this removal to regulators with real-time data will help reduce facilities’ contributions to VOC emissions when regulators require reporting.
Worker Health & Safety
In addition to environmental impacts from VOCs, along with other emissions inside of a cannabis manufacturing facility, there is also the issue of indoor air quality and worker health. There is not a lot known about the potential impacts of the processing of cannabis on indoor air quality. What is known is that terpenoids that are emitted in the cultivation and processing of cannabis can contribute, through a series of atmospheric reactions, to the production of known air pollutants. Terpenoids, such as monoterpenes (C10H16) and sesquiterpenes (C15 H24), are highly reactive compounds with atmospheric lifetimes ranging from seconds to hours. These compounds on their own are non-toxic. However, the atmospheric reactions they participate in can result in a range of low volatility products that create aerosols or ozone. These two compounds have clear implications for indoor air quality and thus occupational health.
Uncertainty remains as to the extent of the formation of these pollutants since previous studies have been hampered by a lack of reliable data and are predicated on conditions and practices prevalent in illicit operations. Given that the methods employed in these illegal operations are driven by different needs, the methods currently used in legalized facilities may produce vastly different conditions. This speaks to the urgent need for rigorous new scientific research and evaluation to aid this new industry and relevant regulatory bodies in assessing the current occupational environmental threats of marijuana processing and provide solutions to mitigate those impacts.
Quality by Design
The competitive licensing process, regulatory requirements, and lack of knowledge on scaled cannabis production has contributed to facilities that were not designed to properly ensure control of environments, the process flow that minimizes risks of cross-contamination and the adequate storage for the many types of raw materials, work in process, and final products. The result is an inefficient operation that may have been spared significant Capital Expenses (CapEx), but requires significant Operational Expenses (OpEx) to maintain.
The concept of Quality by Design (QbD) was first developed by the quality pioneer Dr. Joseph Juran.It posits that quality should be designed into a product and recognizes that most quality issues are a result of poor initial design. It is supported by long-standing evidence that increased testing does not necessarily improve product quality.
Currently, there is an overarching emphasis on final product testing as the determinant of whether cannabis products are safe for release into the marketplace. This has pitted labs, regulators, and producers against each other, leading to accounts of lab shopping, exclusive contracts, and other nefarious activities. This approach does not serve anyone, and is in stark contrast with the concept of Quality by Design.
Transitioning from a Quality Control Approach to Quality by Design
Transitioning from our current processes into a proactive Quality by Design approach requires an understanding of Good Manufacturing Practices or GMPs.The first set of GMPs for finished pharmaceuticals were established for enforcement by the United States FDA in the Federal Register in 1963. Since then, GMPs have been created for and adopted globally for nearly all products that can be consumed or applied for human and veterinary use –- categorized under dietary supplements, food, cosmetics, and of course, pharmaceuticals. GMPs represent the minimum sanitary and processing requirements to ensure safe and consistent products. Consider the road map and cross-over between major FDA cGMP (current Good Manufacturing Practices) by industry sector.
GMP regulations are written by the FDA and adopted in the code of federal regulations under the authority given to the FDA by various laws. Almost all of these regulations are performance standards. There are dozens to potentially thousands of substantially different products regulated under each category of GMP standards. It is up to each manufacturer to ensure their unique processes meet the GMP standards. In this way the regulations are flexible yet force all manufacturers to operate with a minimum level of rigor that includes programs that proactively mitigate risks that can lead to product failures and cannot be controlled simply through final product testing. They take a holistic approach to facility operations, starting with the facility culture, design, layout, placement, and selection of equipment, along with ongoing training, supplier qualification, environmental monitoring, and executive commitment.
The current status quo of manufacturing facility design has been built on a quality control approach. Most facility owners believe cannabis will be assigned a cGMP category based on the final product type and have been trying to build compliant facilities under this assumption. Some States have incorporated by reference the federal GMP regulations. However the competitive application process and focus on final product safety via testing has created an environment in which facility owners feel compelled to do as much if not more than the other facilities in order to meet regulator expectations and all focus is on the final product, not the process. In order to win the application, businesses want to look ‘better’ than the other applicants so they tack on as many hazard controls as they can think of. This has given regulators unrealistic expectations as to the best practices required to operate responsibly. Instead of quantifying hazards by collecting data and making informed decisions as to how to best eliminate risks, facilities are simply copying hazard controls they have seen used in other industries with hopes they meet the regulators’ expectations of what a GMP facility looks like. This culture of adding as many hazard controls as possible is a quality control approach focused on the final product, not a Quality by Design approach focused on the process. As a result, envelope in an envelope style facilities in which the manufacturing process is entombed in layers of energy and resource consuming hazard controls are commonplace.
There are other ways of designing compliant facilities; ways that could be more efficient and use less energy and resources. With a Quality by Design approach, these options become explorable. With quantified hazards the process can be approached holistically and significant design questions asked, e.g.. how much energy goes into the outer envelope and how much product quality/safety is gained from that?
In the Southwest deserts, there is consideration given to opening canopy/atrium style extraction spaces that would use less energy while providing the safety of unconstrained open atmosphere ventilation. The important question to ask when considering alternative facility designs is – How much energy/resources goes into containing human contamination versus the likelihood and the actual consequences? Perhaps manufacturing facility workers can wear long sleeves, pants, and hair restraints and that will be sufficient versus wearing a full body gown?
Quantification of Risks
Quantifying the processes and proven hazards of the cannabis manufacturing industry will allow for more informed design and operational choices versus prescriptive solutions that may potentially over-mitigate the risks and possibly introduce additional risks. Moreover, this data would provide validation that the design and operational choices made are in fact the best practices. Instead of scrambling to follow each standard in a quality control approach, Quality by Design considers the whole process, how the 10 principles of GMP standards apply and focuses on finding the most efficient strategies to eliminate risks.
A Way Forward
Training is vital for the manufacturers to know the next steps and why they are critical for the future of cannabis extraction and post-processing. Knowledge is required to put valuable technology, tools, and equipment in place with the least operational downtime. Further, it is necessary to accept guidance from verified knowledgeable support, such as from a vetted supplier. Lastly, risk mitigation education is necessary to highlight the reality of long-term savings and sustainability versus the common short-sighted tendency for immediate cost savings, which can result in significant consequences for a business such as TerrAscend Canada’s 2021 recall of infused gummies due to mold contamination.
Member Blog: The Hidden Gem of Licensing and Endorsement Deals in Cannabis
Sitting here on July 14, 2021, the Senate Majority Leader of the United States Chuck Schumer just introduced legislation to (among other things) federally legalize cannabis. Yet, despite the Senate’s official entrance into the path to legalization, many states, businesses, and importantly here, athletes and celebrities, or “talent,” continue to behave as if legalization has already occurred. Side note – it has in many states!
Talent throughout the country have engaged in a variety of licensing and endorsement deals within the cannabis industry, ranging from Martha Stewart, Keith Haring, Bob Marley, Seth Rogan, Berner, Travis Scott, Rick Ross, “Sugar” Sean O’Malley, Jonathan Adler, to Gary Payton. A common theme among talent newly entering the space seems to be a default to the plant itself, i.e., partnering with cannabis producers to either endorse or license intellectual property (“IP”) to create cannabis strains and products. Here, I would like to first describe what licensing and endorsement deals are and then discuss a hidden gem of the cannabis licensing and endorsement space. That is, talent partnering with cannabis ancillary businesses, meaning, businesses that sell cannabis accessories and products but do NOT ‘touch the plant.’
Before I dive into a discussion of cannabis accessories, it is important to quickly outline “licensing and endorsement deals.” At a high level, a licensing deal is the process of an individual granting another party the right to use his or her name, image, and likeness, for a particular purpose, in exchange for certain consideration (payment). For example, publicly-traded cannabis accessory distributor Greenlane (NASDAQ: GNLN), where I serve as the Associate General Counsel, has remitted consideration to the owner of the artist Keith Haring’s IP, to use images of his artwork on a line ofsmoking accessories. A licensing deal allows an owner of IP to capitalize on its value by finding the right partner who can harness the IP in a way to create a profitable outcome. It allows an IP owner to find a partner with the production and distribution capacity and operational know-how that an IP owner likely does not possess. In a licensing deal, the end consumer is often under the impression that the end product is coming directly from the IP owner, which can add huge value to the talent’s brand; whether the talent is alive or deceased. This perception for the end consumer can be different with endorsement deals where there is usually a clear delineation between the talent and brand.
An endorsement deal is where talent is used to create awareness for a particular product or service; this can be seen in commercials, Instagram or Twitter posts, and public appearances. Unlike a pure licensing deal, an endorsement deal will commonly make it clear that the product being endorsed is not coming from the talent directly, but that he or she is merely promoting the underlying product in exchange for consideration. Nevertheless, despite the distinction, licensing deals and endorsement deals often merge into one and the same. For instance, Greenlane’s cannabis accessory house brand and retail arm Higher Standards did a licensing and endorsement deal with UFC MMA fighter “Sugar” Sean O’Malley. In this deal, Higher Standards secured a license to use Sugar Sean’s IP to create alimited-edition water pipe and promote this water pipe using his IP on all of its promotional mediums. As part of the deal,Greenlane also caused Sugar Sean to promote the Higher Standards brand on his social media platforms through a select number of posts and mentions. This is a prime example where talent and brands will often dip their toes into a deal that incorporates both a licensing and endorsement component.
So, now that I have established what a licensing and endorsement deal looks like, I want to shift to a discussion of the benefits of working with cannabis accessories. For clarity, cannabis accessories can include rolling trays, roach clips, rolling papers, vaporizers, water pipes, jars, grinders, lighters, packaging, and in certain cases, clothing. So, why should talent focus on licensing and endorsement deals with cannabis accessories?
Cannabis accessories can allow for a unique form of creative control for talent. Talent can create a product from scratch, like an ashtray, jar, or water pipe, and have a direct impact on the structural design. Additionally, accessories can be sold in a plethora of different locations. Unlike cannabis products, accessories can be found in department stores, headshops, smoke shops, convenience stores, clothing stores, and upscale interior design boutiques. In addition to the broad array of available doors, accessories can also allow certain talent to enter the cannabis space in a way that more closely aligns with their primary non-cannabis-focused brand. A great example of this is Greenlane’s licensing deal with iconic designer Jonathan Adler. It would be impossible for Jonathan Adler to partner with a plant-touching product and still be able to sell those products in his stores throughout the world. By partnering with Greenlane, Jonathan Adler is able to enter the cannabis space while maintaining his traditional brand and his ability to sell theseproducts in his interior design boutiques.
An additional appeal of the cannabis accessory space is timing, flexibility, and speed. While talent could quickly endorse an already developed and cultivated cannabis strain or other plant-touching product, the process could be timely. In contrast, to go back to the Sugar Sean example, Greenlane and Sugar Sean were able to move swiftly and nimbly to promote a line of water pipes for a launch in direct correlation to an upcoming fight. The deal moved quickly and highlighted the maneuverability and flexibility of working with accessories. Often, a template or mold for a product is already developed, with the talent’s unique branding and direction the last piece of the puzzle. For plant-touching products, talent may want to be a part of the cultivation process; focused on taste and effect on consumers. This process will usually take a bit more time and can present far more variables and regulatory concerns and limitations.
Ultimately, there are fascinating and innovative deals to be made for both plant-touching and non-plant-touching products, but moving forward, I believe the hidden gem of cannabis endorsement and licensing deals is with the non-plant-touching cannabis accessories.
Dan Shapiro is the Associate General Counsel at Greenlane Holdings, Inc. (NASDAQ: GNLN), one of the largest global sellers of premium cannabis accessories and CBD products. Prior to joining Greenlane, Dan worked at CAA in the Sports Business & Legal Affairs division. Dan is the Founder and Inaugural Chair of the Cannabis Division of the American Bar Association Forum on Entertainment and Sports Industries and a member of the National Cannabis Industry Association’s States Regulations Committee.Dan is a member of the New York Bar and Authorized House Counsel in Florida, and holds a JD from Cardozo Law School where he served as the President of the Cardozo Sports Law Society, and a BA from The George Washington University.
Member Blog: Why Cannabis Accessories are the Future of Corporate Gifting
Cannabis, CBD, and hemp companies are giving out cannabis-themed promotional gifts – but they’re not the only companies to follow this trend.
The stigma against cannabis is slowly disintegrating. And the more mainstream cannabis gets, the more companies are establishing themselves as open-minded and unique by using cannabis as a part of their marketing and business strategy.
A decade ago, cannabis and hemp were still niche topics. Few people outside the industry could’ve predicted that we’d now be living in a world where cannabis was so widely accepted. CBD can now be found in most health stores, there’s bipartisan support for cannabis legalization, and the world’s biggest celebrities have their own CBD and cannabis lines.
While we still have a long way to go in terms of breaking down stigma and advocating for reasonable cannabis laws, it’s clear that we’re getting somewhere. One thing that demonstrates this is the fact that many companies are aligning their brands with cannabis – even those that aren’t in the industry.
CBD, in particular, is gaining more mainstream interest. This popularity is partly because CBD is non-intoxicating and doesn’t carry the same level of stigma. As a result, health stores and pharmacies -– including chains like Walgreens and CVS – are selling CBD. Even Sephora, one of the U.S.’s most popular beauty stores, now stocks CBD-infused skincare products.
It’s not just huge corporate businesses that are embracing cannabis: smaller businesses are, too. At-home beauty spas use CBD-enriched serums. Local health stores stock CBD oil. Little bakeries are offering edibles. Small clothing companies are creating sustainable garments using hemp. While this proximity to cannabis might’ve been shunned years ago, these businesses are now simply keeping up with demands, staying on-trend, and experimenting with the now well-known benefits of cannabinoids.
It’s clear that, as our society moves away from cannabis stigma, cannabis is becoming a signifier for open-mindedness. Brands that embrace cannabis, CBD, and hemp products show that they’re in touch with the latest trends and informed about the science-backed benefits of these products. This establishes those companies as modern, progressive, and youthful.
As a branded merchandise company, we know that corporate gifts, promotional items, and branded apparel say a lot about a company. When someone orders branded goods for their business, they choose items that align with their business’s values, brand, and target market.
Just as with regular gifting, corporate gifting says a great deal about the giver. When you give someone a gift, they’ll think of you whenever they see or use it. The same goes with corporate gifting and branded items: companies give out items that they want us to associate with their brand. If you want to know how a company sees itself, take a look at what they’re willing to put their name on.
As such, branding merchandise companies, like our own, have access to interesting insights. We can tell what’s trending based on what the most innovative and exciting brands are gifting their clients, staff, and partners. Gift-giving is something of a litmus test when it comes to industry trends.
And what’s trending now is cannabis. More and more companies – including those outside of the industry – are excited to put their names on cannabis-related items, such as grinders, storage products, and rolling papers.
When we decided to establish a category for our cannabis-specific merchandise, we expected cannabis companies to be our main clients. We didn’t expect companies outside the industry to be interested in those same items, but we were wrong.
It seems to be that more and more brands want to align themselves with the cannabis industry, even when they don’t directly offer cannabis-related goods or services. Edgy new clothing companies and innovative start-ups alike might use cannabis-specific promotional items to show that they’re forward-thinking companies that rebel against outdated, traditional concepts.
The other side of gifting is that you expect the recipient to actually use their gift. This is why time-tested promotional items, such as branded pens and tote bags, continue to be brand favorites. The more often someone uses your gift, the more likely they are to think positively of you, so it makes sense to choose functional items instead of white elephants.
In the same way, the popularity of branded cannabis accessories is a reflection of how widespread and accepted cannabis use is. Nowadays, cannabis use is tolerated more than ever before, and CBD is a household name. Companies that use cannabis-related promotional items are saying something about their target market: their intended audience is cool with cannabis.
Two decades ago, young starlets who were “caught” using cannabis were the subject of scandal. This year, Academy Awards nominees were given a compensatory gift bag that included luxury cannabis vaporizers. Part of the assumption of giving gifts here is that people will be excited to use what they receive, and the exact same principle applies to promotional items.
Up until recently, you’d never have seen CBD-infused items on a Mother’s Day gift guide. But in 2021, the world’s approach to cannabis and hemp is far more permissive, especially since more people are now informed about the potential health benefits of cannabinoids. We’re at the point where cannabis and CBD items aren’t just something you’d buy yourself: you can gift it to others because you think they’ll like it, too.
In many ways, corporate gifting and promotional merchandise can tell us a lot about branding trends. The growing popularity of cannabis-specific branded items is a reflection of how society is becoming more and more tolerant of – and excited about – using cannabis, hemp, and CBD.
The fact that this once-disparaged plant is slowly being embraced by individuals and businesses alike is encouraging. It shows us that the stigma is slowly fading away – a sign that the industry is slowly gaining more and more support.
Dan Broudy is the CEO of rushIMPRINT, a marketing supply chain firm providing products and programs that stimulate sales, motivate employees, and strengthen corporate identity. rushIMPRINT serves companies and organizations throughout the USA and Canada.
As a finance and marketing expert with over 20 years of experience in the industry, Dan realizes the importance of having a recognizable brand. That is why he takes great pride in providing cost-efficient branded solutions using state-of-the-art technology. rushIMPRINT creates branded merchandise for the cannabis industry, such as grinders, storage solutions, rolling papers, personalized lighters and more – a unique offering for a growing industry. In addition, rushIMPRINT offers apparel, promotional products, signage, business cards and brochures to help you grow your business.
His current goal is to partner with dispensaries, distributors, labs, growers, cultivators, and vape shops to help them scale their businesses. Dan is excited to get involved in this revolutionary industry by assisting innovative cannabis and hemp brands.
Dan has an undergraduate degree in Psychology from Washington University in St, Louis. He also holds an MBA in Finance and Marketing obtained from the University of Miami Herbert Business School and is a Certified Franchise Executive (CFE).
Dan’s visionary perspective, enthusiasm, and exceptional organizational skills have earned him opportunities to work with brands such as European Wax Center, Blaze Pizza, TCBY, and Amazing Lash.
Committee Blog: The Asset We Wish We Knew Before 2020 – HACCP
Read on for insight and guidance for the vitally important topic of preventing, eliminating, or reducing microbial growth in cannabis edibles and packaging.
It all starts with the HACCP (Hazard Analysis Critical Control Point) Principles. Gather your team to share the five preliminary steps of HACCP and develop a plan (figure 1). This management system was launched by Pillsbury along with NASA and the U.S. Army for food safety in space exploration in the 1960’s. Quality, safety and efficacy is obtainable and sustainable with the HACCP discipline.
The objective is to PREVENT packaging from being a failure point and inhibit microbial growth in edible products. We know moisture (water activity), temperature, pH, and oxygen levels are primary microbial growth drivers.
HACCP is an asset, not an expense. Food is medicine for some, and cannabis products are medicine for many. Resin cannabis products (RCP) must be safe, consistent, and reliable products continuously. To generate those results, learn the HACCP mindset. Practice being an advocate with HACCP discipline displaying the actions written in the programs. It’s a system for cannabis safety that encourages operations to have Emergency and Business Continuity plans before disruptive events occur, e.g., natural disasters, pandemics, etc.
Resin cannabis product – Any product, whether finished or a work in progress, containing or comprised of cannabis flowers or resins or both and includes, but is not limited to, the cannabis flowers and resins themselves, extracts/concentrates/derivatives thereof, and preparations therefrom.
And can be further classified as Adult-Use or Medicinal-Use and subclassified as Topical-Use.
Creating such a plan is important because exposure to microbes may result in allergic symptoms such as sneezing, coughing, wheezing, nasal congestion, and watery or itchy eyes. Consumers using cannabis products as medicine, such as cancer patients on chemotherapy, are even more susceptible to harm caused by microbes. Thus, it is critical to ensure your products do not have microbial growth.
Effective HACCP management system ensures control. Empower your team through education and training on discipline of HACCP. Take the infused gummy recall from February 2021 as an example where cross-contamination, improper employee hygiene, and package permeability were failure points that led to loss of control. Lack of control during transport of the initially sterile packaging also contributes to contamination. Personal clothing worn by team members or visitors are also known sources of pathogenic fungus.
Best practice is to address preventive controls and reducing/mitigating risks. For example, consider installing two-way humidistatic control devices in packaging, such as desiccant packs, to maintain water activity (Aw) in acceptable ranges to mitigate microbial growth. Reducing moisture prevents powdery mildew caused by Golovinomyces Cichoracearum (figure 2).
A great resource to mitigate risks can be found in the ASTM D37; Standard Guide for Cleaning and Disinfection at a Cannabis Cultivation Center; Aw ASTM Standards for Cannabis Flower: D8196 – Standard Practice for Determining Water Activity in Cannabis Flower; and D8197 – Standard Specification for Maintaining Acceptable Water Activity Range for Dry Cannabis Flower.
Sanitary environments are critical from seed to sale.
Figure 2, Right. Powdery mildew development on leaves, stems, and flower buds of Cannabis sativa, caused by Golovinomyces cichoracearum. 2
Use the principles of HACCP to guide and maintain the integrity of your work. Each principle builds on the next to create a solid foundation to build and operate a safe and consistent management system. Establish storage conditions in your control and transport; determine the temperature and humidity for each product type (gummies do not tolerate heat, and certain ingredients are sensitive to humidity which could change the potency). This includes evaluating the stability of each of the ingredients when in final product form (how long do they remain potent).
Depending on the ingredients used, i.e., the formulation, gummies can take on or reject water. Most typically let out the water, then that water has nowhere to go (trapped in the packaging), and the product molds. This is why commercially produced gummies are coated in wax, literally to trap the water inside the product. Inadequate gummy formulations lead to water permeability; change in cannabinoid content is the least of the concerns.
General chapter 659 on Packaging and Storage requirements published by the USP (United States Pharmacopeia and the National Formulary, USP–NF)is a great resource. Though not all cannabis products may be for the medical market, using the standards of excellence from the USP is the best way to minimize product failure and help ensure consumer safety. Packaging 659 states that packaging materials must not interact physically or chemically with a packaged article in a manner that causes its safety, identity, strength, quality, or purity to fail to conform to established requirements.
Empower your cross-functional team to apply and implement HACCP through your organization. In doing so, you will have the discipline and tools to mitigate risks and prevent costly downtime. Your consumers benefit by having safer, consistent, and quality products. Finally, collect the data and share the story. We all need to drive improvement and produce safe consistent products for our consumers. HACCP systems are a tried-and-true tool to achieve this.
Please note that prerequisite programs such as current Good Manufacturing Practices (cGMPs) are an essential foundation for the development and implementation of successful HACCP plans. This article is intended to level up your current manufacturing processes and mitigate your exposure to potential recall or unsafe products in the marketplace.
The state of Nevada has always been a unique place to do business. Not only is its economy fueled almost entirely by tourism, but its population is located almost exclusively within a few key urban centers. These factors influence nearly every type of business opportunity in Nevada – including cannabis.
While Nevada’s economic and geographic constraints are unique in themselves, the type of tourist industry found here is one of a kind. Las Vegas is famously known as “Sin City.” It is a place where people flock from around the globe to indulge their vices, such as gambling and clubbing.
As a microcosm of Nevada itself, the Nevada cannabis industry has its own set of challenges and opportunities.
Overview of the Nevada Cannabis Industry
Nevada boasts both medical and adult-use cannabis markets. The state voted to legalize medical cannabis back in 2000, although their first medical dispensary did not open until 2015. While the medical cannabis space in Nevada began with a crawl, the adult-use industry has been quite different.
Nevada voted to legalize adult-use cannabis in late 2016, with the first adult-use dispensary opening mid-2017. Nevada has both medical and recreational dispensaries, although certain stores service both customer bases.
One of the more exciting facets of the Nevada cannabis market has to do with home cultivation. Its unique program allows people 21+ years old to grow at home if they live more than 25 miles from a dispensary. Nevada put these rules in place to accommodate citizens living in rural areas who cannot access dispensaries.
Since Nevada’s legalization, cannabis has become a big business. Here are some statistics for the 2019-2020 fiscal year in the Nevada cannabis industry:
Total Sales: $684,959,149.00
Cannabis Taxes: $105,180,947.00
Licensing & Application Fees: $5,212,557
Nevada sales are ahead of other new adult-use recreational markets such as Illinois and Massachusetts to put these numbers in perspective. Nevada falls short compared to more established industries such as Colorado and Washington, but it holds promise for massive growth.
What is Unique About the Las Vegas Cannabis Market?
The tourism industry in Las Vegas makes for a unique market. Adult-use market regulations coupled with the global renown of the city lead to an environment where out-of-state visitors greatly influence cannabis sales.
The structure of a cannabis market directly influences business opportunities. In medical cannabis, qualifying conditions and patient counts dictate potential market growth. Conversely, adult-use markets are only limited by people’s age.
The interesting thing about the Las Vegas market is that anyone over 21-years can legally purchase cannabis – this includes out-of-state visitors. According to the Las Vegas Conventions and Visitors Authority website, the city saw 42,523,700 visitors in 2019 alone. These people spent over $10 billion in Las Vegas that year. Within these billions of dollars in tourist money lies an excellent opportunity for adult-use operators in Nevada.
Another fact worth noting is that people flock to “Sin City” to partake in activities inaccessible in other U.S. states. Cannabis fits nicely into this package of taboo activities that can only be done in Las Vegas, NV.
Is it Hard to Open a Cannabis Business in Las Vegas?
While the tourist money in Las Vegas makes for a very intriguing adult-use market, it is not easy to acquire a cannabis business license. Unfortunately, Nevada has put a cap on the number of licenses available in the state, making it much more difficult to enter than other adult-use states like Colorado.
There are five types of business licenses in the Nevada cannabis industry:
Cultivation Facility
Distributor
Product Manufacturing Facility
Testing Facility/Laboratory
Retail Store
It’s worth noting that both the medical and adult-use markets offer these same business licenses. Similarly, the licensing cap in the state includes both verticals.
As of early 2021, the state of Nevada awarded 132 dispensary licenses. However, these licenses did not go to 132 different operators. Certain businesses acquired multiple licenses, with some able to open as many as seven retail stores. While Nevada has issued 132 retail licenses, there are only 80 dispensaries operational at this point.
The licensing situation in Nevada is frustrating for local investors and outside interests alike. Namely, because studies show that the Nevada economy could support as many as 1,283 more dispensaries than it has issued licenses for. Aggravation mounts with a lack of expansion opportunities in the area.
The state of Nevada only accepts additional cannabis business license requests during “application periods.” These short windows are scheduled by the Nevada Cannabis Compliance Board and stay open for just ten days. However, there has not been an application opportunity since 2018, and it doesn’t appear there will be one anytime soon. As such, it appears that plant-touching opportunities in Nevada are limited to current license holders.
Where is the Most Opportunity in Nevada Cannabis?
While many believe there is ample room for new players in the Nevada cannabis market, the state does not agree at this point. As a result, if you are looking to get involved in the Nevada industry, you are well-advised to look into ancillary business models instead of plant-touching businesses.
With such promise in the Nevada market, you can rest assured that those cannabis companies that have won licenses will be extremely busy. Ancillary operators can take advantage of this climate by developing models that operate in the business-to-business (B2B) vertical. To help plant-touching companies in Nevada, both product-based and service-based ancillary businesses could prove profitable. Examples of product-based companies include business management software and cultivation technology, while service-based businesses work in marketing, staffing, and consulting.
Opening an ancillary cannabis company in Nevada gives you the ability to enter the market by circumventing the licensing process. Even more, you don’t have to worry about application fees, compliance mandates, and other stressors faced by plant-touching companies. You also have the option to operate across state and national borders if you so desire.
Summary
There is no doubt that the Nevada cannabis industry is one-of-a-kind. While there is a good deal of excitement surrounding the market, many feel it hasn’t even come close to reaching its potential. To this end, the adult-use market in Nevada was only 1.5 years old when the COVID-19 pandemic struck. The financial blow of the pandemic was cataclysmic in Las Vegas, as the tourism industry dropped to 50% below average in 2020.
With the pandemic on the downswing in 2021, there is an unmistakable air of excitement across the globe. Some economists feel that we are about to enter a new “roaring 20’s” period, where people celebrate by spending travel money that was unusable during COVID-19. With this celebratory outlook on the near feature, there is no doubt Sin City will see its share of visitors. With the casinos and hotels full again, maybe we will finally see what the Nevada cannabis market can really do.
Dr. Monaco is the Director of Laboratory Operations for CLS Holdings’ newly opened approximately $4 million laboratory, and is responsible for all day-to-day operations inside the North Las Vegas facility. Dr. Monaco brings over 8 years of licensed & regulated cannabis experience, starting back in 2012 when medical marijuana first opened in Arizona, he has held numerous positions, with escalating responsibilities year over year. He graduated from the University of Arizona College of Pharmacy, in Tucson, Arizona, with a Doctor of Pharmacy in 2010.
Committee Blog: Future-Proofing Cannabis Manufacturing Processes – Part 2
by NCIA’s Cannabis Manufacturing Committee
Despite prohibition, the cannabis industry is not behind the curve of sustainability progress. While other industries were inventing modern Cloud-based quality control/distribution systems and making stuff out of plastic, cannabis producers were maximizing yields per watt and creating stronger concentrates in attempts to get the most out of their value streams while staying under the radar. Now all industries are racing towards a more sustainable future and the cannabis industry has the opportunity to show that it can be a good example, even a leader in sustainability. Regardless if it is in preparation for competition or regulation, now is the time to start building more sustainable, energy-efficient, and overall lower footprint businesses.
As the manufacturing branch of the cannabis industry paves its way into the future, the processes involved need to be made environmentally sustainable and best practices need to be shared and standardized to ensure product safety and industry longevity. Collecting and sharing data from manufacturing facilities is the ideal way to achieve these sector goals.
Environmental sustainability is a multi-discipline effort. Experts in engineering, emissions, air quality, worker health and legal matters should be relied on for educating and guiding businesses into a more sustainable future.
The Data Vacuum Is Holding Back Environmental Sustainability Advancements
While cultivation is one of the main focuses of the cannabis sustainability effort, manufacturing procedures are also prime targets for sustainable advancements. Due to the nature of the organic chemical processes used to produce consumables, some of the materials and practices could have a negative impact on both worker and environmental health if not addressed and handled properly. As a best management practice, regulated cannabis manufacturers typically operate closed-loop systems, which greatly reduce certain dangers, but this can require other more energy-intensive systems. As these relatively new processing techniques are being pioneered, we need more data to understand how they can be made more efficient and sustainable. For various reasons — such as intellectual property concerns — advancements in sustainable practices are often not shared and therefore not visible to potentially become a standard process that ensures product and consumer safety.
Cannabis Science Outpacing Regulations
The scientific improvements for manufacturing cannabis into consumer products in high demand have outpaced regulations. From process design and equipment to processing material sourcing, the manufacturing branch of the cannabis industry has much to offer the future of sustainable cannabis products. In many jurisdictions today, regulators have hastily opted for vertical, prescriptive regulations which have left many manufacturing operations without the leeway required to innovate more sustainable process strategies. Even more businesses with the legal leeway simply do not want to push the envelope in today’s regulatory climate. More forward-thinking, regulation-savvy equipment manufacturers have begun focusing on lower energy-use in their newer products as a selling point. The industry as a whole could be making progress much faster if regulators focused on performance standards for manufacturing facilities.
Strategies inspired by building and process heat recovery offer dozens of basic possibilities when it comes to implementation in a cannabis manufacturing facility. Using the energy released during solvent condensation for solvent evaporation is a prime example. Connecting liquid-cooled equipment with the building’s central plant system is another. These are big ideas that could be implemented in different ways with different efficiencies. Intelligent use of insulation, exhaust recirculation, odor mitigation, ventilation minimization, demand-control ventilation for providing makeup air, etc. could also make significant differences. Data collected from actual operating facilities experimenting with different strategies will be the best guide going forward in determining what the best energy saving strategies are.
Cannabis Extraction Processes and Air Quality
In an effort to prevent unnecessary Volatile Organic Compounds (VOC) emissions it is important to maintain proper solvent transfer and storage, perform extraction equipment inspections, and ensure a maintained inventory and handling of solvents on site are a part of a facility’s standard operating procedures. Best practice for extraction and post-processing dictates the use of butane, propane, CO2, ethanol, isopropanol, acetone, heptane, and pentane as solvents to encourage safe consumer products.
Carbon filtration is also the best management practice for controlling cannabis terpenes (VOCs) and odor emissions. It is important to install properly engineered molecular filtration systems (aka carbon scrubbers) that are sized appropriately for a facility’s ‘emission load’ and don’t exceed the maximum cfm rating for air circulation through the filter. To prevent VOC and odor breakthrough, it is imperative to inspect and conduct regular maintenance of HVAC systems and carbon filters. A standardized method for measuring the lifespan of carbon is by using a Butane Life Test, which equips manufacturers with the data to know how to manage their carbon replacement schedule effectively, minimizing unnecessary carbon waste. Additionally, processors can conduct air sampling to detect and measure VOC and odor levels in their facilities and the data can be used to validate the impact of control technologies further protecting worker and environmental health.
Proper VOC and cannabis odor control from manufacturing processes helps reduce community odor complaints and improve neighborhood relations. It also improves public and environmental health by reducing local ozone concentrations. Proper emissions control when running cannabis manufacturing processes and handling chemicals helps to shift the industry at large toward sustainable and environmentally conscious business practices.
Preparing Your Business for the Next Stage
Cannabis manufacturers are seeing big changes on the horizon. Increased legalization brings increased competition and inevitable M&A activity. Whether a business aspires to compete on the world stage or to be acquired in one of the coming green waves, there are actions that can be taken today to help cannabis manufacturers maximize their value to both customers and potential acquirers.
One of the most important assets a company can have — both to compete effectively and to attract purchasers — is intellectual property. Intellectual property, or IP for short, is the term for an intangible asset that has been afforded certain legal protections to solidify the asset into a commodity that can be bought, sold, and licensed. IP can have a negative connotation in some circles, mostly resulting from misconceptions in the law but also rooted in IP abuses by unscrupulous “trolls.” In reality, IP is an important tool to help companies protect their hard work and, when properly deployed, intellectual property can increase transparency into cannabis manufacturing processes and open new avenues of scientific advancement.
Intellectual property broadly covers a number of different types of rights. Patents protect new inventions like processes, machines, compositions of matter, ornamental designs, and plant genetics. Patents can grant relatively broad rights to these ideas, but with substantial additional costs and scrutiny.
Similarly, copyright can protect creative works, like writings, drawings, and sculptures. But many do not recognize that copyright can also protect compilations of data that have been creatively selected or arranged. Data and algorithm copyrights are relatively nascent, but they promise to play a large role in the intellectual property landscape of the future cannabis industry.
Another sect of intellectual property, trademarks, is all about protecting a brand: the names, logos, slogans, and overall look that tells customers that a good or service is from a particular company. Federal trademark registration is unavailable for federally illegal goods and services, but that does not mean that federal trademark protection is unavailable to cannabis brands. Many companies are using the zone-of-expansion doctrine baked into federal trademark law to set up registrations on related legal products (smoking/vaping devices, clothing, and even CBD edibles) that can be expanded to cover THC products when federally legal.
The nuances and requirements of these property rights — along with other IP rights like trade secrets and trade dress — are highly fact-specific, so involve a good IP attorney to guide your strategy from the start.
Towards A More Sustainable Future
Now is the time to start building more sustainable, energy-efficient, and overall lower carbon footprint businesses and the emerging legal cannabis industry is well-positioned to be the leader. If manufacturers are incentivized to safely share processing data directly or through emerging data collection and tracking platforms, the industry will make major advancements towards more environmentally sustainable practices. Environmental impact areas, such as air quality, energy, water, soil waste, and community all need to be considered by the manufacturing arm of the cannabis industry. Regulators can help push the industry forward by reducing negative impacts in these areas though focusing on performance standards for manufacturing facilities and their processes. Lastly, understanding that IP, including trademarks, can in fact increase transparency into cannabis manufacturing processes and open new avenues of scientific advancement will help position operators for M&A activity coupled with proper legal representation. These factors work together to protect the environment and communities, as well as future-proof manufacturing operations setting up the rest of the cannabis industry for longevity and federal legalization.
Member Blog: Sleep-Focused Brands Are Seeing Bottom Line Dividends
Nearly 40% of the nation’s top 100 CBD brands focus on need states. Chief among them is sleep, something the American Academy of Sleep Medicine (AASM) reports that 85% of Americans are falling far short of.
The 7.2 million sleep-related Google searches logged this past year provide ample evidence of interest. according to NBC News, which reports that 9 million Americans take prescription drugs to help them fall asleep.
Others prefer more natural solutions.
Nearly 11 million rely upon CBD and/or cannabis-based products to manage insomnia or sleeplessness, according to a 2021 report issued by High Yields Insights. Among them, almost 70% are women considered statistically more likely to suffer from insomnia.
YOUNG AND RESTLESS
Millennials are driving the bulk of market growth. Together, with a smaller percentage of Gen Z consumers, these severely stressed consumers represented 48% of the U.S. CBD market in the fourth quarter last year, according to High Yields Insights President Mike Luce.
Regardless of age or gender, brands like CBDfx are discovering that an ever-increasing number of their customers are using CBD to treat sleep-related issues. The Brightfield Group reports more than 58% of CBDfx customers purchased sleep products in the fourth quarter.
Collectively, 40% (4 in 10) of consumers, rely upon CBD to manage insomnia or sleeplessness, according to a recently issued High Yield Insights and InnovateMR 2021 sleep trend report.
FIGHTING FOR SLEEP
Growing pandemic-related uncertainty, anxiety, and associated sleep deprivation issues have kept sleep specialists like Colorado-based Pulmonologist Dr. Julie Whitaker, struggling to manage ever-increasing patient loads.
“We’re not seeing everyone we should,” says Dr. Whitaker, who sees the need to elevate the understanding of the importance of sleep, particularly among Americans.
The pandemic helped to elevate awareness of the importance of good sleep and has softened the momentum of the “sleep is for suckers” mantra, according to the pulmonologist.
CBD and cannabis brands are seeing significant growth, most notably among 25 to 35 year-olds. Although millennials dominate the growth trends, one brand reported moms 40 – 50 years of age are among its fastest-growing demographic.
Veterans, known to experience higher levels of insomnia (57% veterans) than the general population (30%), face elevated pandemic-related risks. Among veterans with Post-traumatic stress disorder (PTSD) or a traumatic brain injury (TBI), the rates are even higher — 93%, according to the Department of Veteran Affairs in San Diego.
Sleep specialists, like Whitaker, are particularly concerned about the stress levels in at-risk populations, particularly women- and veteran-headed households, whose support needs are more imminent.
When it comes to sleep, routines are important, according to the specialist who recommends patients develop healthy and consistent sleep routines, avoid consuming alcohol and OTC products known to disrupt sleep cycles, particularly antihistamines known to disrupt healthy sleep patterns.
CBD AND CANNABIS EFFICACY GROWING
In regard to other solutions, Dr. Whitaker says there’s “reasonable scientific evidence,” that CBD, particularly when combined with a small amount of THC, can help promote sleep.
Two in five working moms use cannabis, according to a newly minted survey released by San-Francisco analytics firm Lucky Analytics.
Women are helping cannabis brands like Ganja Goddess achieve record-breaking triple-digit sales growth. The cannabis company reports a 635% increase in its sleep lines last year, according to its SVP of Marketing Heidi Genrich.
Gummies provide a popular entry point, according to Incredible Edibles Brand Director Jessica Benchetrit, whose company helps make cannabis more accessible via entertaining and informative educational sessions.
“Consumers are looking for an enhanced sleep experience, says Benchetrit. “The majority (78%) are actively seeking out ‘indica-like’ edibles.
Incredibles’ Snoozzzeberry gummies climbed to the number one infused gummy product in the markets it sold in, during the fourth quarter of last year, according to BDS analytics reports.
REVEALING RESEARCH
A 2019 study published in the Journal of Alternative and Complementary Medicine, found cannabidiol (CBD) improved the sleep quality and reduced nightmares of 38% of the participants, all of whom had PTSD.
Joseph Maroon, M.D., a clinical professor and neurosurgeon at the University of Pittsburgh Medical Center who has researched the effect of cannabis on the brain, says that CBD has properties that could help some people sleep better. Most notably, he says, it appears to ease anxiety and pain, both of which can make it harder to fall asleep or stay asleep, according to a published statement in Consumer Reports.
“CBD is safe,” says Dr. Daniel Clauw, an internationally known pain expert and head of the University of Michigan Director of Chronic Pain and Fatigue Center, who frequently collaborates with the Arthritis Foundation on education efforts.
Among sleep associations, the American Sleep Association has indicated that cannabis may help induce sleep in people with insomnia, anxiety or post-traumatic stress.
A MEANINGFUL IMPACT
“People are interested in better ways to relax at the end of the day,” says Ginrich. “And they are increasingly concerned about safeguarding their well-being over the long term.
“Stress and anxiety are not going away, so products and rituals that help people sustainably manage these pressures are in high demand,” adds the Ganja Goddess Marketing Director.
We all have a role to play in helping put America’s sleep issues to bed.
Author Jackie Berg is the publisher of the Health Hub, a publication division of CBD Marketing Hub, as well as the publisher of TheHUB Detroit, TheHUB Flint and recipient of the Association of Women in Communications 2018 Vanguard award. To learn more CBD Marketing Hub, a cultivator of CBD and cannabis clients, visit its website or reach out at hello@cbdmarketinghub.com.
Committee Blog: National and International Standards & Regulatory Bodies Relevant to the Cannabis Industry
by NCIA’s Facilities Design Committee
The cannabis industry benefits from the accumulated knowledge and established standards developed by many of the organizations listed here. Understanding the regulatory ecosystem is essential for cannabis operators as well as for those who strive to shape the regulatory future of the cannabis industry.
Listed below are some of the major regulatory bodies and standards agencies that have some relevance to the cannabis industry.
The American Herbal Products Association (AHPA) was founded in 1982 to promote the responsible commerce of herbal products to ensure that consumers continue to enjoy informed access to a wide variety of herbal goods. Their seminal Herbs of Commerce (HoC) (first published in 1992) was officially incorporated by the US Federal Government into the Code of Regulations (21 CFR 101.4) establishing consistent naming of botanical ingredients for dietary supplements. With precedent for federal recognition, their active Cannabis Committee is actively paving the path for safe and consistent use of cannabis products.
The American Society of Agricultural and Biological Engineers (ASABE) is an educational and scientific organization dedicated to the advancement of engineering applicable to agricultural, food, and biological systems. ASABE develops standards through its standards committees. Relevant cannabis committees include:
ES-300 Energy Utilization & Application: Leads and coordinates the activities of ASABE in matters related to electro-technology as related to agriculture energy efficiency, electrical wiring systems, and electrical utility programs.
ES-310 Ag Lighting Group: Leads and coordinates the activities of ASABE in matters related to agricultural lighting systems (combined with ES-311 Electromagnetic Radiation Application for Plants)
The ASABE Standards Committee ES-311 X644 Working Group is developing Draft Standard ASABE X644 Performance Measures of Electromagnetic Radiation Systems for Plants.
ASABE Plants, Animals, and Facilities Systems (PAFS) Technical Community is working with ASHRAE (through its Plant and Animal Environment technical committee) to develop x653 related to HVAC and lighting for indoor plant growth without sunlight.
American Society of Heating, Refrigerating and Air Conditioning Engineers (ASHRAE) is a professional organization seeking to advance HVACR systems and design.
The ASHRAE Multidisciplinary Task Group coordinates technical activities related to the design of indoor plant production facilities and their HVAC&R systems and considers deliverables created by Technical Committees like:
Technical Committee 2.2 on Plant and Animal Environment (concerned with the relationships of environmental conditions and the growth, health, and reproduction of plants and animals).
Link to standards relevant to cannabis production:
Established in 1898, ASTM International formerly known as the American Society for Testing and Materials is a globally recognized leader in the development and delivery of voluntary consensus standards. Working in an open and transparent process and using ASTM’s advanced IT infrastructure, our members create the test methods, specifications, classifications, guides, and practices that support industries and governments worldwide. ASTM Committee D37 on Cannabis has 1,000 stakeholders from 30 countries working together to advance the industry by addressing quality and safety through consensus standards.
Examples of standards that have already been approved for the cannabis industry use include:
D8250 Standard Practice for Applying a Hazard Analysis Critical Control Points (HACCP) System for Cannabis Consumable Products
D8222 Standard Guide for Establishing a Quality Management System (QMS) for Consumer Use of Cannabis/Hemp Products
D8197 Standard Specification for Maintaining Acceptable Water Activity (aw) Range (0.55 to 0.65) for Dry Cannabis Flower Intended for Human/Animal Use
The Design Lights Consortium (DLC) is a non-profit organization that promotes high-quality lighting solutions in collaboration with utilities and others and establishes standards for different lighting types.
The European Hygienic Engineering & Design Group (EHEDG) was founded in 1989 as a non-profit consortium of equipment manufacturers, food producers, suppliers to the food industry, research institutes and universities, public health authorities, and governmental organizations.
The EHEDG mission is defined as:
“Raise awareness of hygienic engineering, develop guidance and solutions, and provide a platform to promote EHEDG expertise that facilitates networking between hygienic engineering experts from around the world.”
EHEDG actively supports European legislation, which requires that handling, preparation processing, and packaging of food is done hygienically using hygienic machinery and in hygienic premises according to the food hygiene directive, the machinery directive, and the food contact materials directive (see EC Directive 2006/42/EC for Machinery, EN 1672-2 and EN ISO 14159 on Hygiene requirements for the design of machinery). While EHEDG is European Initiative, the EHEDG Certification Logo is becoming more widely seen on food processing equipment sold in the US as a product differentiator, offering assurances of sanitary design, cleanability, sterilizability, and bacterial tightness. It is considered more stringent than other stamps or marks. Auditors or Regulators who might be inspecting a cannabis facility, if they understood this Certification Logo, should have an impression that the operator has invested in more hygienic equipment.
ENERGY STAR® is the government-backed symbol for energy efficiency. With oversight from the Environmental Protection Agency, this program certifies the energy usage and energy efficiency of products, homes, buildings, and industrial plants. By using a common set of metrics objectively applied across categories, companies and end-users can make comparative decisions based on energy efficiency.
In many localities, the use of ENERGY STAR® certified products or achieving certification for a building or industrial plant may qualify for rebates from local utility companies. Cannabis company eligibility to participate in these programs will vary depending on local laws, products in use, and rebates offered by local utility companies.
Founded by Thomas Edison in 1896 as the Lamp Testing Bureau and renamed to the Electrical Testing Laboratories (ETL) in 1904, ETL certifications demonstrate compliance to the requirements of widely accepted product safety standards, as determined through independent testing and periodic follow-up inspections by a Nationally Recognized Testing Laboratory (NRTL). The company is now known as Intertek.
The ETL Listed Mark indicates to distributors, retailers, and customers that a product has been tested by Intertek and found in compliance with accepted national standards. Acceptance of ETL certification varies by locality though it is widely recognized across the United States and Canada.
The U.S. Food and Drug Administration (FDA) oversees the safety of all food, drugs, medical devices, and cosmetics in the United States through the Federal Food, Drug, and Cosmetic Act of 1938. Despite the current status of cannabis as a Schedule I controlled substance, the guidance provided for analogous products, particularly current Good Manufacturing Practices (cGMPs) align with global best practices that industry can follow to ensure product quality and integrity as well as prepare for potential federal legalization. Resources on the current approval process and research pathways have been published by the FDA on their page: What you need to know about cannabis compounds, CBD, cannabidiol, products containing cannabis, scientific data, development & approval process, and much more!
Some states require compliance with The FDA Food Code in their cannabis regulations, but some reference 2013, some 2017. The next issue is expected in 2021. Be aware that The Food Code is for retail and foodservice segments of the industry. Many in the cannabis sector anticipate that when Cannabis is legalized at the federal level, FDA will apply the regulatory approach suitable to manufacturing, such as:
21 CFR 111 Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
21 CFR 117 Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
This is a very complex topic, and depending on how the sector for THC and CBD products evolve and how the products are sold and labeled. Other regulations may become relevant, such as:
21 CFR 211 Current Good Manufacturing Practice for Finished Pharmaceuticals.
The Global Food Safety Initiative (GFSI) is a private organization that oversees and approves different auditing platforms as meeting their criteria for safe food processing. This criterion provides a universal gold-standard of recognition to specific food safety audits. There are currently 10 global GFSI schemes that can award certifications. Cannabis eligibility for certification varies based on scheme and jurisdiction. Some states are requiring a GMP audit, “such as GFSI” in their cannabis regulations.
GLOBALG.A.P is a globally-recognized certification program that began as EUREGAP in 1997 to help the supermarkets in Europe address consumer concerns about the safety of agricultural practices and products. GLOBALG.A.P. is the world’s leading farm assurance program, with over 100 countries following the requirements of Good Agricultural Practices (G.A.P.). It focuses on globally accepted criteria for food safety, sustainable production methods, worker and animal welfare, and the responsible use of resources such as water, compound feed, and plant propagation materials. As of 2020, they have begun a feasibility assessment of bringing their G.A.P certification program to the cannabis industry. Cannabis and hemp businesses that are focused on cultivation of the plant would greatly benefit from incorporating these global best practices into their operation.
The Illuminating Engineering Society (IES) is a community of lighting experts seeking to improve the lighted environment by bringing together those with lighting knowledge and by translating that knowledge into actions that benefit the public.
The IES Horticultural Lighting Technical Committee researches and develops best practices for horticultural lighting using climate-based annual daylighting and electric lighting with lighting and shading controls, with a focus on greenhouses, vertical farms (plant factories), and building atria.
The committee produces Recommended Practices documents, including one for professional lighting designers who are tasked with horticultural lighting.
The International Organization for Standards (ISO) is an independent, non-governmental international organization with a membership of 165 national standards bodies that was established in 1946. Today, it has nearly 800 technical committees and subcommittees that manage the standards development process.
ISO standards focus on the business management of an organization and how information and data are reported and responded to. Some of the most common ISO standards relevant to the cannabis space are:
ISO/IEC 17025 – General Requirements for the competence of testing and calibration laboratories
The National Sanitation Foundation (NSF) originally brought together key stakeholders back in the 1940s to develop the first consensus standards for restaurant equipment sanitation. Public health inspectors liked what they saw, and began requiring product certification to NSF/ANSI standards. Currently, many states approach cannabis regulation from a foodservice perspective and the NSF Mark is desirable for equipment in the Cannabis processing room, such as sinks, rolling stock, dishwashers, and if available for cooking and packaging equipment. Even when cannabis is legalized at the federal level and the FDA regulates following Food Safety Modernization Act regulations from 21 CFR, the NSF Mark will continue to provide assurances of the sanitary design of much of the equipment used to produce Marijuana Infused Products (MIPS) However, after federal legalization, Certifications from the manufacturing perspective, such as 3-A or EHEDG, will become, most likely, more relevant.
With the Occupational Safety and Health Act of 1970, Congress created OSHA, the Occupational Safety and Health Administration, to assure safe and healthful working conditions for all workers by setting and enforcing standards. Additionally, OSHA provides training, outreach, education, and assistance. With steep fines that can exceed $50,000 for repeat violations, this commonly overlooked agency actively inspects cannabis facilities in all states. A free Guide to Worker Safety and Health in the Marijuana Industry was developed by a State of Colorado workgroup that cannabis businesses, regardless of state, can utilize.
Resource Innovation Institute is a non-profit research and advocacy organization providing guidance and data for cultivators and their project partners to use to optimize facilities for efficiency and productivity.
Cannabis PowerScore, RII’s resource benchmarking tool, is both a voluntary performance ranking system and in some jurisdictions where benchmarking is required PowerScore is also specified as a way to report energy and water information to regulators.
UL LLC (formerly known as Underwriters Laboratories) is a global safety certification company approved by the Office of Occupational Safety and Health Administration (OSHA) as a Nationally Recognized Testing Laboratory (NRTL).
The UL Listed seal means that the product has been tested by UL to nationally recognized safety and sustainability standards. Additionally, it has been found to be free from a reasonably foreseeable risk of fire, electric shock in a Division 2 environment.
U.S. Department of Agriculture (USDA) has had a significant impact on the cannabis sector through the 2018 Farm Bill, which provided authorization for the USDA to oversee the cultivation of cannabis containing no more than 0.3% THC (i.e. hemp / CBD biomass).
Additionally, the USDA would most likely be involved after legalization if Cannabis producers decided to launch Cannabis-infused meat products. So far this has not happened and the regulatory impact would be difficult to anticipate.
The U.S. Green Building Council (USGBC) is a non-profit organization that promotes high-performance buildings through the creation of voluntary certification systems for projects and credentialing programs for professionals.
The third-party green building certification Leadership in Energy and Environmental Design (LEED), is the most widely used green building rating system for commercial buildings.
The Green Business Certification Inc (GBCI), implements the LEED Accredited Professional (LEED-AP) program to support the construction of LEED-certified buildings.
The US Pharmacopeia, formed in 1820, is an independent, scientific, nonprofit public health organization devoted to improving health through the development of public standards for medicines, food ingredients, and dietary supplements, and related programs. Over 150 countries recognize the standards set by the USP, with more than 40 integrating USP standards into law. The USP formed a Cannabis Expert Panel in 2016 to support the industry with data-driven recommendations on cannabis quality attributes for human use. The 2020 paper on Cannabis Inflorescence for Medical Purposes: USP Considerations for Quality Attributes (Sarma et al., 2020) is available for download.
The International WELL Building Institute™ (IWBI™) has created the WELL Building Standard is a standardized metric for buildings, interior spaces, and communities seeking to implement, validate, and measure features that support and advance human health and wellness.
WELL was developed by integrating scientific and medical research and literature on environmental health, behavioral factors, health outcomes, and demographic risk factors that affect health with leading practices in building design, construction, and management.
Product safety isn’t an endpoint, it’s a journey. That’s what we told you in the 2021 series premiere, and it continues to hold true. In the last post, we revisited the Vaporizer Liquid Formulations portion of the NCIA’s policy council white paper to provide guidance to the industry. This time, we’re republishing the Vaporizer Delivery Devices section below. We’ve learned more about EVALI since its original publication, and while some of the specifics may be a little dated, the principles remain relevant to helping you understand vapor product safety.
Over the course of the next several months, we’ll bring you new content with the following working titles.
The Importance of Testing Vapor Products as a System
Edibles Stability – Microbial Growth Due to Insufficient Packaging
Terpene Limits Across Multiple Product Formats
So, while we wait with bated breath for this exciting new content, enjoy the excerpt below!
Excerpted from The Key To Consumer Safety: Displacing The Illicit Cannabis Market Recommendations For Safe Vaping. Access the full report and citations.
Background
While the technology used to vaporize cannabis extracts have been around for many years, advancements in vaporization technology and supply chains over the past decade have led to widespread adoption and growth of vaporization as a preferred method of cannabis consumption. Vaporizer devices offer the benefits of being discreet, allowing for metered consumption, and eliminating carbon associated with combusting cannabis flower. However, not all vaporizer devices are created equal and manufacturers should develop an understanding of the nuances of different vaporizer devices to ensure the delivery of a safe and high-quality experience. Aside from considering experiential qualities such as taste and the amount of vapor produced, manufacturers should consider at least the following three categories of issues that can present safety risks.
Physical Design Considerations
Vaporizer devices should be mechanically and electrically safe. This starts with relatively basic considerations that include ensuring the device is mechanically sound, does not leak alkaline or heavy metals, and is not configured in a manner that presents a safety hazard. In the early 2010s, there were many reported instances of vaporizer devices exploding. This was primarily due to improper electrical design and battery cell protection. Battery cells that are not protected from drawing current beyond their rated capacity or are allowed to drain too deeply present a safety risk. In fact, this risk led to the development of the UL 8139 standard for e-cigarette battery safety and the FDA recently relaxed its prohibition on e-cigarette battery changes in order to allow manufacturers to comply with this standard. UL 8139 is applicable to vaporizer devices and anyone who sources or develops a vaporizer device for the cannabis market should voluntarily comply.
Contamination by Hardware
Vaporizer device hardware should be tested for the presence of heavy metals. Currently, some manufacturers use Restriction of Hazardous Substances (RoHS) testing or rely on vendor representations that the components and materials being used are certified as FDA food-grade. The California Bureau of Cannabis Control mandated heavy metals testing standards for the three categories of cannabis products, including inhalable cannabis products, starting on December 31, 2018.
Vaporizer device hardware that comes into contact with cannabis formulation should also be free of other contaminants. It is important to consider both contaminants that could be immediately detectable in vaporizer devices as well as those that can be released or created over time. Vaporizer devices are designed using a variety of industrial manufacturing processes, some of which can leave residual oils, biological agents, or other substances in the device. It is important that device manufacturers clean incoming components, assemble them in a clean environment, then store and ship them in a manner that prevents re-contamination. Depending on the nature of the component, one or more of a cleaning bath or ozone treatment may be used for cleaning. After cleaning, assembly of vaporizer components should be performed in a cleanroom environment under appropriate current Good Manufacturing Practices (cGMP). Unfortunately, simply asking a device manufacturer whether it operates in such a manner is not sufficient to be certain that it does. There is no substitute for first-hand inspection of manufacturing processes. While it may not be practical for U.S.-based cannabis manufacturers to maintain a constant presence in the country of manufacture, it is possible to hire local agents who are skilled in audit practices and can perform unannounced inspections to verify that desired practices are implemented within the supply chain.
As noted above, hardware may also introduce contamination into the formulation over time, either through the process of leaching heavy metals or through chemical reaction. Leaching is a process whereby soluble constituents that may be present in materials dissolve into a formulation. A well-known example was the discovery that plasticizers present in certain plastic food and beverage containers were leaching and then being consumed. As a result, new types of plastics were developedfor improved food safety. Vaporizer components that contact cannabis formulations may present a similar issue and leaching may be tied to metals, ceramics, plastics, or other materials. In addition to leaching, certain materials may react with cannabis formulations, especially those with high terpene content which tends to be more volatile. Moreover, metal components in contact with formulations may be especially susceptible to leaching and lead to contaminants such as heavy metals in the formulation.
The good news is that it is possible to address this risk of leaching through the use of appropriate base materials and or plating. Base materials such as stainless steel are good candidates because of their low tendency to react with formulations. Plating other materials with corrosion-resistant metals is also possible; however, care must be taken to specify the right material and plating thickness while also ensuring the plating is not damaged during assembly.
With proper material selection and design, it is possible to reduce the risk of such contamination, including through conducting stability tests. In a stability test, a formulation is placed into the vaporizer device for a period of time, then removed and tested for contaminants. A good guide is to design the stability test to align with the desired shelf life of the product. That doesn’t necessarily mean the test needs to be as long as the rated shelf life. Typically, elevated temperature tests are used to determine stability and can cut the duration of the test to 50% or less of the desired shelf life. In addition, by taking measurements at intermediate intervals, stability can be better characterized and the point at which contaminants would exceed their respective limits can be projected.
Device Impact on Formulation: Control the Heat
The most fundamental, yet perhaps the most underappreciated aspect of vaporizer devices is how they vaporize cannabis formulations. Setting aside dry herb vaporizers, all liquid cannabis vaporizers basically work by bringing the formulation into contact with a hot surface in order to heat it and thus create vapor. While this may seem straightforward, there are a number of subtleties that affect the outcome. First, the temperature of the hot surface must be hot enough to heat the liquid, yet not so hot as to cause components of the formulation to degrade into byproducts that could be harmful. In fact, one study demonstrated how changing the voltage, and thus the temperature of an unregulated vaporizer device can affect the production of such degradants. While more advanced vaporizer devices attempt to control vaporization temperature by using heating elements made of specific materials that indirectly measure temperature and regulate the power delivered to the heating element, the majority do not.
Different formulations have different compositions and contain constituents that vaporize and degrade at various temperatures. This means that to fully control vaporization, the vaporizer device must be configured precisely to the requirements of the formulation in use. Second, many vaporizer devices do not heat uniformly. Rather, the heated surfaces heat unevenly, creating hot spots that can locally trigger thermal degradation. Temperature control circuits typically measure an average temperature and do not prevent such hot spots. Finally, the majority of vaporizer devices, whether they contain fiber wicks or ceramic, rely on capillary action to bring the formulation into contact with the heated area or surface. During a puff, capillary action is also what replenishes the formulation at the heated surface, and such capillary replenishment takes time. Depending on the viscosity of the formulation and the duration of the puff, a heated surface that was initially saturated with the formulation can become dry and hot during the course of a puff. Experienced users sometimes refer to this as a “dry hit,” which can be perceived when a cartridge runs dry or during a long puff. Dry hits can result in increased thermal degradation.
Armed with this understanding of the nuances of vaporizer devices, one can appreciate how the common business model of selling cartridges with a universal 510 threaded connection that can be used in conjunction with any number of batteries, any number of power settings, and filled with a variety of formulations makes it difficult to guarantee what is produced during vaporization. In order to understand and control the output of a vaporizer device, the system should be designed, configured, and tested as a whole; cartridge and battery, plus formulation. Closed systems with proprietary connectors and one-piece designs do not face the cartridge-battery mismatch challenge, but should still be tested in conjunction with the target formulation using a reasonable worst-case puff duration. And while new systems under development that employ non-contact heating methods may not present the same temperature control challenges, they too should be validated as a whole.
The Cannabis Manufacturing Committee (CMC) focuses on reviewing existing business practices and state regulations of concentrates, topicals, vaporizers, and edibles, ensuring the manufacturing sector is helping shape its destiny.
Member Blog: Growing Beyond THC – Terroirs and Terpenes Are The Future Of Premium Cannabis
I’m a serial entrepreneur and my roots in Napa Valley run deep. I’ve been a cultivator in this beautiful terroir for over 40 years, initially as a wine guy from a family of growers and makers, and now as the Co-Founder and CEO of a premium seed-to-sale cannabis company. I see a lot of similarities between wine and cannabis, comparisons that paint a bright, accessible, and profitable future for our industry.
Wine + Cannabis Offer Interesting Comparisons
Both are agricultural products that are highly regulated, though cannabis far more so given the industry is still in its infancy. 40 years ago, when my family started in the wine business they experienced similar business challenges, or as I like to call them – opportunities.
Like wine, cannabis comes in a variety of strains and formats. Also, like wine, cannabis is extremely well suited to the growing conditions of California’s terroirs, especially those where I live in Northern California. If you think about the wide variety of wine varietals – Cabernet, Pinot, Sauvignon Blanc, Rieslings, and so on – there is an even greater variety of cannabis strains – Lemon Sour Diesel, Double Chem OG, Budzilla, Bogota Berry, etc. There is something for every palette, which pre-legalization, I am not sure many people really paid attention to. This is all to say, that just as there are many different ways to enjoy wine depending on your tastes, your budget, or your intentions and preferences, the same is true for cannabis.
There’s so much more. If you’ve ever had a great wine or even a decent wine, you know that there are all these flavors and aromas that layer on each other and evolve over time, interacting in different ways to create this wonderful sensory experience that’s both about taste and smell. The same goes for cannabis. Premium cannabis is as complex as the most complex wine. Both wine and cannabis contain terpenes and it’s the variety of different terpenes in each of them that determines the flavors, aromas, and overall experience. Coming from wine, this is something I understand and I think as people explore cannabis without the stigma of prohibition, they will begin to seek out terpene-rich strains, just as they now seek out complex wine profiles – perhaps unknowingly given how wine is such a normalized product in today’s society.
Of course, there are obvious differences between cannabis and wine. The plants themselves are very different. One’s an annual plant and one’s a perennial vine. But, they both produce very similar compounds that make the sensory experience of their flower and fruit so much richer.
Let’s Talk Terpenes
You’ve probably been hearing a lot more about terpenes lately. They’re kinda the new ‘it’ thing in our industry. Terpenes are organic compounds in plants responsible for the unique smells and tastes of your favorite plants, flowers, and fruits. Most people don’t know this but with both wine and cannabis, most of what you think you’re tasting is actually what you’re smelling. It’s these terpenes that give your favorite wines and cannabis strains their signature scents.
Some of them overlap — there are some of the same terpenes in both cannabis and wine grapes like limonene and myrcene. And then there are some terpenes that are more unique to one plant or the other. But it’s the same compounds and so coming out of wine, it was such a natural thing for me to say, I’m not in this to build the strongest, highest-THC-get-you-wasted product. I wanted to develop something that honored the terroirs I’ve come to know and love. A premium product offering, with the same wonderful components of the wines I’ve been creating and the same rich variety of flavor profiles as the grapes I’ve been growing for all these years.
As chemicals go, terpenes offer delicate but very distinctive aromas but they are volatile and, if you’re not careful, will disappear quite quickly. You have to work to maintain them to keep them from evaporating from your flower as from your wine. Taking the time and care to capture and preserve these aromas and flavors that are truly unique to each strain and varietal makes for a much richer experience than the extreme high that some people chase, the cannabis equivalent of Night Train. With cannabis, quickly harvesting the flower and getting it into a temperature and humidity-controlled drying room helps maintain these volatile compounds as does the way you cure and store the flower after the initial drying. In wine, we preserve the terpenes with careful barreling and bottling.
The best way to enjoy terpenes is to use a flower vaporizer. Just heating it up enough to release everything without burning it and without burning rolling paper that covers up the subtle aromas of the terpenes.
Outdoor Growing Enriches the Final Product
The cannabis plant has been growing outside for millennia and our hypothesis at Napa Valley Fumé is that growing outdoors creates a wider range of terpenes and a richer, more nuanced consumption experience. A plant, like a human being, is a holistic entity, it’s a being of a sort. If you took a person — like in The Truman Show — and never let them outside, what would that do to that being?
In truth, we don’t really know what indoor growing does to the plant. But what I think is that these plants are meant to be grown outside. That’s where they do their best. They have to contend with elements that make them stronger, and other factors like pests, which over time create resistance, again making them stronger. They are also receiving full-spectrum sunlight that changes each day of the year. As the year goes on, the color spectrum starts to vary. It is bluer in the spring and redder in the fall. So while I get the efficiency of indoor growing, I believe that all of these environmental elements together with the heating during the day and cooling at night and the fact that different growing regions have different climates and terroirs, you get the best, most interesting plants when you grow outdoors.
Terroir: As Important to Cannabis as They are to Wine Grapes
Terroir is a great word because it’s not just about one element, it’s about everything in a given place. The altitude, the soil, the mineral content of the water, the directional exposure to the sun. In Napa where we’re based, the terroir is affected by the fog that comes up from the Bay. We measure the temperature days over the course of the whole growing season, assessing the total heat that the plant received. All of these things contribute to the terroir and the terroir informs and enriches the sensory experience of the resulting fruit and flower.
Plants, whether you’re talking about grapes or cannabis, will perform differently in different terroirs and will express themselves in different, nuanced ways. For me, this suggests a bright future for sun-grown cannabis with a wide variety of strains each displaying the unique signature of their terroir. The same seed grown across different terroirs expresses really differently, resulting in a distinct profile in the flower and an enhanced consumption experience.
Bottom Line: Terpenes, Terroirs, and Outdoor Growing Paint a Bright Future
This plant has so much to offer and is so expressive. While there’s a place for both indoor and outdoor, it seems to me that the most expressive form of this plant, with the most interesting aromas and flavors, comes when you grow in the full spectrum of sunlight outdoors. To attain the same rich variety in your cannabis experience as you do with wine, you want to do it outdoors, you want to tend them for the greatest terpene expression, you want to pick your strains at the beginning for that. Optimizing for terpenes doesn’t just have a flavor effect, it also shapes the psychoactive effect of the flower. The right terpenes and compounds can make the resulting high sleepier or more energetic, as well as providing other health benefits that are currently supported by anecdotal evidence and will likely be born out in the research that is currently underway.
As with the trajectory of the wine industry, we believe that educating consumers about terpenes and terroirs and offering them a wider variety of products and consumption experiences, will expand the category, creating a bright future for all of us. I’m excited and encouraged by articles like this one from Wine Magazine that suggest that we’re on to something.
Eric Sklar is an entrepreneur, Napa Valley vineyard owner and public official. He and his family have been growing grapes in Napa Valley for 40 years and he planted his first licensed cannabis garden in 2018. Eric is the CEO and co-founder of Napa Valley Fumé, LLC, a cannabis management and branding company that has launched brands such as LAKE GRADE with a few others in the works. He is also the co-founder of the Napa Valley Cannabis Association and the President of California Fish and Game Commission, a position he has held since 2016.
In 2005, Eric founded Alpha Omega Winery in Rutherford, CA and was managing partner until 2013. He’s held positions on the Board of the Napa Valley Vintners, as well as Napa Valley Vintners’ Community and Industry Issues Committee. In 1989, he founded Burrito Brothers’ Inc., a restaurant chain based in Washington, DC, which he sold in 1999. Eric was also an adjunct professor at Georgetown University’s School of Business where he taught courses in entrepreneurship, business strategy and marketing. He has held several other political positions including Assistant Press Secretary to Vice Presidential candidate Geraldine Ferraro in 1984.
Eric received a Bachelor of Arts degree in Political Science at the University of California at Berkeley in 1984, a Diploma in Business Studies at the London School of Economics in 1986, and a Master of Business Administration at Georgetown University in Washington, D.C. in 1997.
Committee Blog: Trust In Cannabis – Why It Matters More Now Than Ever
As a country, the U.S. is experiencing what can best be described as the “age of distrust.” While public distrust in institutions has been escalating for at least a decade, according to the annual Edelman Trust Barometer which has tracked trust in media, governments, businesses, and nonprofits since 2000. Social unrest and a global pandemic have escalated this distrust. Never has the public eyed institutions or businesses with such suspicion.
Meanwhile, in our industry, the vaping crisis of summer 2019 hit our industry below the belt, aided by some bad actors knowingly flooding the illicit market with products that couldn’t meet stringent state testing. That crisis created a crisis of confidence in the overall cannabis industry-leading it into a bleak period which was only partially buoyed by the declaration that dispensaries were considered “essential businesses” during the COVID-19 pandemic, pro-cannabis outcomes in both voting booths and Congress, many thanks to NCIA’s national and local efforts. By supporting NCIA, you’re signaling industry commitment and that you value growing trust within the industry.
Now, against the national backdrop of distrust and a COVID-19 vaccine that offers a glimmer of hope, it’s time to evaluate ourselves and our industry’s actions. Never has it been more crucial for all brands, but particularly our industry, to lean into actions and communications which consistently and powerfully earn the trust of investors and consumers. As an industry, we’re on an important precipice, what we do next will either ensure our credibility or tarnish it for years to come.
Consumers (and therefore investors) are looking at brands in a more holistic manner. Trust will be the single most valuable brand attribute.
Trust is defined on two spectrums: competence and ethics.
For CEOs, CMO’s, and experts in our industry, the time is now to act and communicate from a place of authentically aligned communications. This alignment will require hyper levels of empathy and a constant pulse on the state of affairs affecting your customers. Consumer behavior is in flux now.
The COVID-19 pandemic has changed consumers and now is the time for brands to align. According to the Edelman Barometer special report, Brands Amidst Crisis:
The role of brands in reflecting the consumer’s desire to be viewed as a tastemaker or trendsetter has decreased 9%
Up 38% is spending time with family
86% of consumers expect brands to solve both societal and personal problems, including proper treatment of employees and making product in a domestic market
The only values more important than trust to consumers are price and quality
Because consumer behavior is in flux, it’s never been more important to ensure internal and external values and communications align. Ironically, ensuring alignment supports the flexibility needed to respond quickly to changing behaviors or unexpected upheaval.
Aligned communications means we act internally and externally in a consistent and emotionally intelligent manner that earns trust. It’s not just good for our industry, trust in brands has very real bottom-line implications including increased sales, increased investor opportunities, and reduced customer acquisition costs. In fact, according to Edelman Trust Barometer, high trust consumers have 75% more brand loyalty.
Outstanding packaging and even quality products are the minimum expectations for today’s brands. But even those choices come under scrutiny from consumers if they don’t mirror consumer expectations and lifestyle. Therefore, earning trust starts at the very beginning. The earliest choices are powerful signals to consumers about brand values.
It isn’t enough to simply sponsor a campaign or align with a social movement. While those choices can be powerful quivers in your trust arsenal, it feels and sounds hollow when the brand is suddenly thrusting itself into a conversation without looking at itself first. Consumers are increasingly aware of “trust washing.”
92% of employees expect their employer’s CEO to speak up for issues ranging from income inequality to diversity and training for future jobs. An aligned trust-based strategy starts on the inside. Take a solid look at the ethos and ethics within your own company.
What are your company’s values?
What do you stand for?
How do you signal trust internally and how do you reward it?
Does your internal communication stand for your values?
The reason this internal step is critical is no matter what, your brand ethos is distilled into consumer interactions and communication, whether those communications are with dispensary workers or directly to the consumer, the experience will always stay with the brand. Imagine a dispensary worker making recommendations to a new-to-cannabis buyer, naturally, the dispensary worker has a huge amount of influence on the consumer’s impression of a new brand. And new-to-cannabis buyers are most likely to be loyal to their first brand, assuming the product meets expectations.
Personal experience is the number one way to build trust with consumers. 59% of customers say personal experience matters the most.
What consumer interactions signal trust?
How do you manage poor reviews?
How do you handle customer inquiries?
How does your owned media reflect not only your brand values but those of your customers?
Personal experience is absolutely about product experience and brand interactions. Brand interactions at events will take on more importance in cannabis. Consumers will want to engage in an experiential way with cannabis brands and it won’t be at cannabis events exclusively, consumers will expect to see cannabis brands in all the same places they see alcohol brands, even if sales and sampling aren’t available, which means experiences will need to be multi-sensory and strongly personal. Choose your experiences carefully based on your brand audience and ethos.
Earned media is second only to personal experience incredible trust-building. During the COVID-19 pandemic, trust in publications increased by 7%. Brands should look for opportunities in earned media that reflect their values. Branded content is another area where brands can use the credibility of publications.
Experts are still considered credible sources (52%) and they far surpass celebrities (35%) and influencers (36%). As you consider brand strategies in 2021, take a careful look at who you’re leveraging and what role they play. Choose your experts carefully and ensure they are fully vetted. NCIA’s Marketing and Advertising Committee is developing an “experts directory” of carefully vetted industry professionals, this will be a key resource not only to event organizers, but CEOs and CMOs looking for credible, authentic experts.
Our industry has so much to offer consumers, we provide very real opportunities for consumers to enhance their lives. We have been active on numerous social justice fronts from the very beginning. We may come from a historical place of rebellion, but often, even that rebellion came from a place of empathy and not just income. Consumers today are responding to companies who double down on trust and an aligned brand value system. There’s every reason to think the cannabis industry can do this better than anyone. Together, let’s lean into our values and seed trust not just in our companies, but in our industry.
*All statistics come from Edelman Trust Barometer 2020, unless otherwise noted.
Tara Coomans is the CEO of Avaans Media (formerly known as Primo PR), which has been working with hemp and THC brands and services since 2015 from startup through IPO. Founded in 2008, Avaans Media brings a digitally forward and purpose-driven perspective to public relations. Avaans Media is based in Los Angeles with clients and team members distributed around the country including Washington D.C., New York and Denver.
Coomans is on NCIA’s Marketing & Advertising (MAC) committee and leads the MAC Experts Directory subcommittee for 2021. Coomans is a frequent writer and speaker on public relations, marketing, and social media topics.
Valentine’s Day is coming. To some, it will be a wonderful day filled with candy and gifts and expressions of devotion. To others, it feels like an obligation designed to enrich greeting card companies, jewelry stores, and florists.
Whichever side of the fence you fall on, the fact is, this is one of the most important periods for retailers. According to the National Retail Federation, Valentine’s Day spending in 2020 totaled about $27.4 billion.
And with all this spending, brands really matter.
For instance, who wouldn’t want to get a silver or white gold necklace from Tiffany? Truthfully, it’s not that different from other necklaces on the market that are just a fraction of the price, but those don’t come with the Tiffany name and that iconic powder blue rigid box packaging.
The Unboxing Makes It Special
Beautiful packaging provides the foundation for companies to build a luxury brand and command higher prices in the marketplace. It’s how Harry and David can charge $40 for the box of 9 pears I received for the holidays.
I know their fruit is top of the line quality, but I just checked and I can get pears for about a buck each at my local Whole Foods. That’s more than just a bit of a difference!
What makes the price palatable and the product premium is the packaging.
Steve Jobs knew this and insisted that Apple products were always creatively packaged. “Packaging can be theater,” he said. “It can create a story.”
A beautiful package leaves a lasting impression. When a consumer has a hard time throwing away the box a gift came in, it’s a sign your brand is on the right track. How many of you kept the box your iPhone came in? I know I did and probably still have it.
Whether it is the precise fit of Apple’s packaging that makes you wonder how all those items fit so perfectly inside, or the fresh-off-the-farm feeling you get when opening a gift from Harry and David, luxury brands rely on premium packaging to help convey the idea that they are truly special and worth the higher price.
Cannabis Love
While Valentine’s Day isn’t as big a holiday in the cannabis world as 420, it does generate an impressive boost in sales.
Point-of-sale data from the cannabis software firm Flowhub and analytics company Headset found that Valentine’s Day spending increased among recreational consumers with sales jumping 20-32 percent over a typical day. Infused “mocktails” had the largest jump with sales rising 596 percent above normal.
Bath products and salts increased by 186 percent. Massage oil and lubricant sales rose by 88 percent.
Infused chocolates increased 33% and infused gummies rose 43%.
And the single most important factor in purchasing decisions, whether in the mainstream or the cannabis sector, is branding.
An article in Civilized said that cannabis products can be made exceptional and more valuable by communicating their distinctive properties through the branding process.
“Branding in the cannabis industry is what makes an agricultural product and the business that refines the plant more distinctive,” the article stated. “Branding creates an emotional connection, and when done effectively, branding can prevent products or services from failing.”
And with limited options to build a cannabis brand through traditional media, the packaging becomes even more vital to the product’s success.
The importance of packaging cannot be overstated. It is one of the strongest factors that influence a purchasing decision. It provides the first impression of the product to the consumer and it is the last thing they see before making their selection.
Not only can good quality packaging grab a consumer’s attention, but it can also communicate a brand’s messaging and convey key competitive differences. Conversely, some otherwise excellent products fail due to inferior packaging.
Therefore, it is vital that packaging is carefully designed so that it builds the brand, stimulates sales, conveys key messaging, and generates consumer loyalty.
So, this Valentine’s Day, whether you celebrate with cannabis or candy or not at all, remember that brands matter. People want gifts from the brands they know, trust, and aspire to own.
Personally, I am hoping to luxuriate in a tub filled with infused bath salts while opening a special little blue box (Jon, are you listening?).
Happy Valentine’s Day!
Kary Radestock, CEO, launched Hippo Premium Packaging in March 2016 offering an array of services to the cannabis market, including: Marketing Strategy, Brand Development, Social Media, Public Relations, Graphic and Web Design, and of course, Printing and Packaging. Radestock brings over 20 years of award-winning print and packaging expertise, and leads a team of the nation’s top brand builders, marketers and print production experts. Hippo works with businesses looking for a brand refresh or an entire brand development, and specializes in helping canna-business get their products to market in the most beautiful and affordable way possible. Radestock’s Creative Collective of talent and experts, allows her to offer world-class solutions to support the unique needs of the Cannabis Industry.
Committee Blog: The Language Of the Cannabis Industry – Developing A Commercial Manufacturing Glossary
The language of the cannabis industry is crude. It’s not that the cannabis industry relies on vulgar or offensive words, but rather that modern cannabis vernacular remains raw, unrefined, incomplete, and sometimes contradictory, even in mature markets. Perhaps most generously described as “imprecise” or “fluid,” the current lexicon is changing as quickly as the industry, but not always for the better. Consistent and universal terminology are hallmarks of strong industries. As the cannabis industry (including both high-THC “marijuana” and low-THC “hemp”) continues to grow and prove its legitimacy, it is critical that everyone is speaking the same vocabulary.
Defining the issue
Out of necessity, the language of the cannabis industry took root in the dark. Decades of prohibition followed by state-led regulation has resulted in a fractured vocabulary where terms-of-commerce have fuzzy boundaries. The current landscape of murky terminology can inject ambiguity into everyday transactions and, in the worst of circumstances, mislead consumers. As some industry terms coalesce in particular regions, for example, other terms take on different meanings around the country. It is not a problem unique to the cannabis industry, but with its regulatory history, rapid product advancements, and diverse consumer base, the NCIA’s Cannabis Manufacturing Committee (“CMC”) felt it time to start a conversation about the words that define the industry.
With legalization comes a mass-consumer base and new forums to joust for consumer attention. Retail shelves, product packaging, and commercial advertising are the new arenas where cannabis companies try to describe their product to consumers and differentiate their brands from others. Out of this scrum comes a new marketing jargon that can be difficult to decipher. Shatter, crumble, butter, wax, sauce, diamonds, distillate, isolate, broad-spectrum, full-spectrum, partial-spectrum… and that is just in one section of the dispensary. Indeed, a huge swath of cannabis consumers fall into the infrequent or casual consumer demographics for which these terms mean next to nothing.
What’s the problem?
This linguistic haze is felt acutely in the manufacturing link of the supply chain. Manufacturing is the relatively nascent segment of the industry that converts raw cannabis plants into various medical, adult-use, and industrial products. In just the past two decades, new technologies have produced a glut of new products, each of which needs to be called something. But those new terms have ambiguous definitions that are easy vehicles for confusion. And where confusion is prevalent, both consumers and companies suffer.
For many cannabis customers, trying to decode a dispensary menu is like reading in an alien language. They frequently must rely on budtenders and marketing materials to understand some products’ basic characteristics. And even if they manage to become fluent in one dispensary’s menu, they may still find it difficult to predict how that menu will translate to other retailers across the country. The lack of vocabulary standardization would be untenable in the food or beverage industries. In the cannabis industry, where patients may rely on specific products for medical treatment, consumers should have a uniform vocabulary to describe products.
That challenge is not limited to retail consumers. Language is critical to the smooth functioning of intra-industry business relationships. As in any other industry, cannabis business relationships are far more successful when the parties’ expectations are aligned. When a dispensary orders tens of thousands of dollars in shatter, crumble, distillate, and tincture, they have certain expectations about the products they will receive. Even experienced extractors, operators, and executives have different understandings of where some products end and others begin.
Ambiguity in the commercial arena can lead to big problems. Among the best-case scenarios, a miscommunication results in a dissatisfied customer. More serious disagreements may require costly replacement shipments or refused deliveries. Of course, if the stakes are high enough and both parties are adamant in their positions, a linguistic quarrel may become a courtroom duel. Some advertising litigation, such as for “Refined Live Resin” vape cartridges, is already working its way through the court system. When it comes to cannabis terminology, fuzzy boundaries are not a standard the industry should embrace. But leaving cannabis industry terminology to the mercy of courts and regulators also holds little appeal.
And so…
…the CMC set out to create a working glossary. The goal of this document is to get the industry on the same page with published terminology standards as best understood by the NCIA’s Cannabis Manufacturing Committee. These standards are intended to facilitate commerce within the cannabis industry by increasing consistency and decreasing confusion.
The CMC developed a list of the most common terms that are currently utilized in the manufacturing segment. While the committee included some broad terms applicable to the industry at large, the focus was on those terms that most directly relate to cannabis extraction and refinement. From that list of industry terms, the committee drafted definitions that attempt to capture how those terms are currently being used throughout the legal cannabis industries. The CMC then shared those draft definitions with as many practitioners as it could to get a broad selection of perspectives. Wherever possible, the CMC sought to be inclusive of regional variations and note instances where terms are exceptions to a generally understood meaning. But the CMC understands that neither this process nor any other is guaranteed to represent all corners of an increasingly complex industry.
The document is not meant to be the ultimate word on cannabis terminology, but rather a snapshot in time and the starting page for a discussion about what the words of the cannabis industry should mean. Importantly, these definitions are the CMC’s attempt to capture how the terms are currently used, not how they should be used. Indeed, there are several well-qualified bodies debating the future of cannabis nomenclature, including ASTM’s D37 committee and the Emerald Conference.
Along with publication of this glossary, the NCIA’s Cannabis Manufacturing Committee is inviting comments from the entire cannabis community. Your constructive comments are a crucial part of forming the vocabulary of an industry. The CMC’s intent is to revisit these definitions approximately every calendar quarter, adding, revising, and annotating as new terms are invented and meanings inevitably shift.
Paul Coble is the founder and CEO of Thalo Technologies, a veteran intellectual property attorney, Vice-chair of the NCIA’s Cannabis Manufacturing Committee, and Chair of the Nomenclature Subcommittee.
The CMC focuses on reviewing existing business practices and state regulations of concentrates, topicals, vaporizers, and edibles, ensuring the manufacturing sector is helping shape its destiny.
Committee Blog: Future-Proofing Your Business – 2021 Series Premier
The future is coming and the cannabis (marijuana and hemp) industry is uniquely positioned to offer innovative approaches to best management practices in its manufacturing sector. In 2021, the National Cannabis Industry Association’s Cannabis Manufacturing Committee formed a new group focused on addressing sustainable practices, legal protections, and policy considerations to future-proof your cannabis manufacturing business. The series, Future-Proofing Your Business, will consist of blogs, podcasts, and expert panel discussions focused on providing insight into the coming regulations, processes, facilities, and consumable products.
Extracts
With the coming vaping emissions and vape product potency regulations, the Future Proofing subcommittee will offer their expertise on what to expect and what manufacturers can do to support compliance and help protect the environment and public health. The outbreak of vaping-related respiratory illness in late 2019 demonstrated the damage a few bad actors can do in a marketplace where regulated and unregulated producers compete for consumer dollars. The committee will discuss these issues and more as manufacturers and regulators work together proactively to protect consumer health.
Processes
Manufacturing processes are evolving as the scientific understanding of cannabis consumables and their various effects and treatments deepens. In their efforts to protect environmental and worker health both inside and outside of the processing area, manufacturing best practices are changing. Regulators are also beginning to determine the standardization of these various processes in an effort to retain product quality without jeopardizing human and environmental health and safety. And new forms of competition will demand an increased focus on protecting intellectual assets. This second part of the Future-Proofing Your Business series will unpack sustainable manufacturing process design including software, equipment, and materials offering recommendations for regulatory approaches.
Facilities
Building on the processes deployed in the future of manufacturing cannabis (marijuana and hemp) products, facilities will also need to consider more efficient design strategies to reduce the use of energy & waste, increase product safety, and safeguard worker and community health. The rapid pace of energy efficiency technologies development for all utilities means most industries, not just cannabis, are playing catch up. Automation is redefining the best practices surrounding product and employee safety. Increasingly stringent testing standards are demanding greater care for waste and community health. The committee will offer their insights into the technologies and practices that are becoming popular in this multi-industry-wide push for sustainability.
Biosynthetic Manufacturing
The final topic to be addressed by the new Future-Proofing subcommittee in their 2021 series, will take a detailed look into the future of manufacturing techniques, specifically the use of biosynthetic manufacturing and how this will impact the industry. Tune in to learn more about bioreactors and their application for the concentrate market and genetic modification to cannabis (marijuana and hemp) consumable products.
Prepare to check out the first part of this integral Future-Proofing Your Business series brought to you by the Cannabis Manufacturing Committee.
Coming, February 2021.
Committee Blog: Future-Proofing Your Business – How Adopting Industry Standards Improves Your Bottom Line and Reduces Your Risks
By developing and adopting standards now, operators in the cannabis space can avoid unnecessary future expenses they might incur when needing to rework established facilities to meet upcoming federal standards or third-party compliance
Upton Sinclair’s The Jungle in 1905led to the Pure Food and Drug Act in 1906. The food sector has matured through additional governmental regulations, industry-led initiatives, consumer and trade guidelines and standards, and more recently, the Food Safety Modernization Act. Over one hundred years of progress helped to ensure what is arguably the safest food supply in the world. By comparison California, in 1996, 24 years ago, legalized Medical Cannabis. Since then, 36 states have legalized cannabis for medical or adult use. Confusingly, that is 36 different sets of regulations, none harmonized. And no consensus on how FDA will regulate cannabis when it is descheduled.
But investors and producers in the cannabis sector are seeking direction on how to future proof their businesses so they can manage the transition from fragmented state-level regulations to rigorous federal oversight. Developing and adopting cannabis industry best practices may be the greatest insurance available.
NCIA’s Facility Design Committee is one of the few groups beginning this effort. The group has representatives from operations, regulatory compliance, quality, equipment vendors, design and construction, and allied industries.
Standards can focus on several areas. Because the cannabis industry deals with substances that are ingested into the human body, standards that support consumer health and safety are paramount. Much of the current practice in the food sector, organized under the topic of current Good Manufacturing Practices (GMPs), can port over to Cannabis with some adjustments. These practices protect consumers and your brand. GMPs have, as a foundation, many aspects of facility and process design, but standards for these don’t yet exist. However, by developing and adopting standards now, operators in the cannabis space can avoid unnecessary future expenses they might incur when needing to rework established facilities to meet upcoming federal standards or third-party compliance. They also can control their own destiny, in effect, by establishing approaches that later can be considered as regulators write the rules in the future.
As operators themselves, a number of our committee members have felt the direct impact of product recalls due to a lack of clear delineation at the intersection of cannabis and food safety regulations. Depending on the scope of the recall, a company can be crippled by not properly understanding and adhering to a common set of standards across the industry, especially when concerning safe food handling practices and similar regulations that control consumable product manufacturing. For example, one of our committee members had to recall a batch of infused gummies because public health regulators used safe food handling regulations to determine that the gummies were exposed for too long in a potentially contaminated environment during the setting process. Had the operator adhered to standards commonly used in food production, they would have avoided the costly impact of the product recall. With nearly 15% of flower failing tests for yeast and mold in Colorado, the cannabis industry has become no stranger to costly recalls.
Standards not only minimize risk to the consumer and the business, but also improve quality and consistency. Improve employee NPS (Net Promoter Scores). Reduce cost and production downtime. Increase the inherent value of the business. And offer a brand message that increases sales.
Nearly all related industries follow best practices, known as cGMPS (current Good Manufacturing Practices), which can be adopted for our industry. If we look to examples from the food sector, you find mature and professional regulations at the federal level and experienced inspectors from USDA, FDA and state departments of Health or Agriculture, as well as global standards from the International Organization for Standardization (ISO) and the World Health Organization (WHO), initiatives from trade customers such as Global Food Safety Initiative (GFSI), equipment certifications from European Hygienic Equipment Design Group (EHEDG), NSF International, and 3-A Sanitary Standards. This constellation of resources is not yet published for the cannabis sector.
Join us in this exciting journey. Become involved, and stay aware of and ahead of the pending regulations. We don’t have 114 years to get this right!
The Facilities Design Committee (FDC) focuses on providing NCIA members and regulators a framework and information about facilities design options through which legal producers can plan for GMP level production as the market transitions from a state to a federally regulated industry.
Video: Member Spotlight – HAL Extraction
NCIA recently visited with our members HAL Extraction based in Golden, Colorado. While social-distancing with the team there, we learned more about their extraction rooms, booth, and labs, and how operators can get their cannabis extraction production facility up and running. The company’s Chief Engineer, Josh Gladfelter, gave us a tour and demonstration of the capabilities of their product offerings, while Sales Manager Emma Byrnes explained how the company works with customers to find solutions to their specific needs. As explained by the company’s President, Patric Galvin, HAL Extraction is focused on leading the way for industry’s safety standards, helping facilities achieve compliance, and the longevity of our industry. Learn more and take a tour in this NCIA member video spotlight.
Member Blog: GMPs – A Way Ahead for Hemp and CBD Firms
The hemp industry is the marijuana industry’s half-sister. Both are variations of the plant cannabis sativa and both were made illegal in 1937 with the passing of The Marijuana Tax Act. Flash forward to the Agriculture Improvement Act of 2018 (known as the 2018 Farm Bill) that was signed into law by Congress on December 20, 2018. One year later, The USDA issued interim regulations that entitled Establishment of a Domestic Hemp Production Program for the cultivation of hemp on October 31, 2019. Both were huge steps forward for public access to hemp and hemp products. FDA legalized the growing of hemp in states with a state-mandated hemp program and removed hemp and its derivatives from Drug Enforcement Administration (DEA) Schedule I status and the U.S. Domestic Hemp Program aims to approve cultivation plans issued by states and Indian Tribes.
Even so, then FDA Commissioner Scott Gottlieb issued a statement hours after the signing of the Farm Bill reiterating that “Congress explicitly preserved the agency’s current authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and section 351 of the Public Health Service Act.”
Still today, two years later and counting, FDA only permits CBD products submitted as an Investigational New Drug (IND) Application as a pharmaceutical and there remains only one such accepted CBD product, Epidiolex, manufactured by G.W. Pharma. All other CBD products are illegal for interstate shipment.
In-state production and sales may be a different story, provided that state has a mandated hemp program. In those cases, provided state law is followed, production and sales are legal and protected, but the minute products cross state lines, they become the jurisdiction of the federal government and, more specifically, the FDA. At least 47 states have enacted legislation to establish hemp production programs or allow for hemp cultivation research.
Section 10113 of The 2018 Farm Bill states that (c) Nothing in this subtitle shall affect or modify:
(1) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.);
(2) section 351 of the Public Health Service Act (42 U.S.C. 262); or
(3) the authority of the Commissioner of Food and Drugs and the Secretary of Health and Human Services- ‘‘(A) under- ‘‘(i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.); or ‘‘(ii) section 351 of the Public Health Service Act (42 U.S.C. 262); or ‘‘(B) to promulgate Federal regulations and guidelines that relate to the production of hemp under the Act described in subparagraph (A)(i) or the section described in subparagraph (A)(ii).”
The mission of the FDA is “to ensure the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.” As such, FDA categorizes every product for sale in the U.S. which is either ingested or applied to a human or animals into categories. That means hemp-derived CBD products will have to lawfully fit into one of those categories, however, while there has been positive movement towards the legal sale of hemp products on the USDA cultivation side, the FDA has authority over foods and dietary supplements, and the FDA’s position is that the addition of hemp/CBD to a food or dietary supplement is “violative.” In a Consumer Update statement revised on November 25, 2019, the FDA clearly stated that “it cannot conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food.”
That being said, FDA has indicated it would be open to review of safety data for submission of a cannabinoid as Generally Recognized as Safe (GRAS) for Food or as a New Dietary Ingredient (NDI) in a supplement as the lack of any federal regulation runs the potential of putting people at risk. That has sent the industry scurrying to design and initiate studies in the hopes of demonstrating levels of safety that meet FDA’s satisfaction.
In the meantime, those currently operating in states where hemp manufacturing is legal, must ensure Good Manufacturing Practices (GMPs) are adhered to closely. Should the FDA ever allow hemp products with CBD to be sold in the future, a manufacturer’s ability to demonstrate understanding and compliance with GMPs will be critical. Each FDA regulated industry has its own set of GMPs for the development and implementation of quality systems.
21 CFR 117, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food
21 CFR 507, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Food for Animals
21 CFR 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
21 CFR 210, Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General
21 CFR 211, Current Good Manufacturing Practice for Finished Pharmaceuticals
FDA Draft Guidance for Industry, Cosmetic Good Manufacturing Practice, June 2013
As the industry waits in the hopes that FDA will come on board with those states that have already legalized CBD’s use in products, it important to take the necessary steps to develop GMP protocols and quality systems as part of documented Standard Operating Procedures and record-keeping that those procedures are being followed, products are being tested and those tests are being validated.
Ensure as you begin to develop or strengthen your GMP programs that you do so with a full understanding of the requirements set forth in 21 CFR 111. Whether these programs are designed in-house or with the assistance of an outside consulting firm, ensure your GMPs are specific to your manufacturing procedures as opposed to a stock one-size-fits-all program. A reputable consulting firm with demonstrable expertise in FDA regulations and in helping to develop these GMPs is a good place to start, one that listens to your questions and concerns before providing you their stock answer. A good consulting firm can walk you through your unique processes.
Ensure your quality systems are robust and documented, including your demonstrations that your cGMPs are being followed.
Charlotte Peyton supports EAS Consulting Group CBD and hemp clients as well as that of dietary supplements and pharmaceuticals. As an independent consultant, she assists with projects ranging from startup through manufacturing and support. Her expertise includes quality, regulatory and management, method development, and method validation for FDA regulated drug, dietary supplement, and bioanalytical samples. She has extensive experience in writing validation protocols, reports, and SOPs and assists with implementation of stability programs and report writing for finished products.
EAS Consulting Group, a member of the Certified family of companies, is a global leader in regulatory solutions for industries regulated by FDA, USDA, and other federal and state agencies. Our network of over 150 independent advisors and consultants enables EAS to provide comprehensive consulting, training, and auditing services, ensuring proactive regulatory compliance for food, dietary supplements, pharmaceuticals, medical devices, cosmetics, tobacco, hemp, and CBD.
Committee Blog: Best Practices Guide – Allergen Labeling
Determining which edible to consume is an art all by itself. Making that choice when you suffer from food allergies often makes the decision all the more challenging.
Despite the continued federal illegality of cannabis, cannabis products are still obligated to abide by federal labeling requirements regarding the disclosure and identification of the presence of common allergens, including tree nuts (such as coconut and almonds), peanuts, fish, shellfish, dairy, soy, eggs, and gluten. Labels often do identify the presence of those ingredients and sometimes even the traces thereof. Although companies are seemingly committed to following federal requirements, there is still a continued absence of additional, more specific information that could help individuals with allergies make better-informed decisions when selecting their edibles.
A commitment to providing more information in labeling of common allergens not only helps consumers but also has the propensity to battle the stigma of cannabis as an underground and unregulated industry by embracing more advanced self-regulation and increased transparency. Additional information promotes transparency in the production and packaging processes, and provides valuable information to the discerning customer in addition to promoting better business practices. With roughly one in 20 adults allergic to peanuts or tree nuts, at least 5% of purchasers are directly impacted by the information related to the presence and management of nuts in a manufacturing facility.
In the marketplace today, common label designations include “may contain traces of,” “produced in a facility that also processes” or “produced on equipment that also processes.” Rarely is more information provided. Even though broad strokes disclosures satisfy federal requirements and limit legal liability, they do not do much to inform consumers suffering from allergies who could eat something produced with care, but cannot safely or comfortably consume food products that may contain traces of. With anxiety and paranoia, a potential consequence of cannabis overconsumption, the availability of more information about the presence of allergens on a label could possibly cure or temper an unwarranted freakout. More detailed information could even help avoid emergency room visits and the related trauma and anxiety from experiencing allergic reactions or the vestiges of one. No one enjoys the associated trauma and paranoia of hives in their mouth or wheezing while under the influence of an edible because they ate something that may contain traces of and actually did contain traces of the allergen.
The “may contain traces of” designation is good for the edible manufacturer at discharging potential liability, but it does not do much for consumers that are actually allergic to the items beyond sending the signal that if they consume the product, there is a possibly a legally identifiable amount present within the edible that could potentially trigger a severe allergic reaction. The language provides little information as to why there may be traces of the allergen. For the affected consumer, the business practices used to segregate common allergens or otherwise avoid cross-contamination or contact is what is critical for determining the likelihood and magnitude of the risk of any potential contamination, and therefore the risk presented by the consumption of an edible. This language, while good for insulation from liability, is not informative as to how the traces may have occurred and has the potential to be misleading and deter purchasers that would not be deterred if the label were more accurate at disclosing where in the production chain a potential trace of contamination could have occurred.
Manufacturers currently provide notice if there are “traces of,” or if equipment or a facility contains a common allergen, but they could go further. Four potentially more informative versions of “may contain traces of” or “made on the same equipment as other items that include…” or “made in the same facility as items that include” are:
Produced in a facility, but on separate equipment,
Produced on equipment, that processes INSERT ALLERGEN(S), but using best/reasonable business practices to segregate allergens in the production and storage process.
Produced on equipment, that processes INSERT ALLERGEN(S) where the facility produces products containing allergens on different days than products not containing INSERT ALLERGEN(S).
Produced in a facility that processes INSERT ALLERGEN(S) where the facility produces products containing allergens on different days than products not containing INSERT ALLERGEN(S). All production machinery is cleaned between the productions of different types of edible products.
Cannabis edibles product manufacturers could lead the charge on providing more informative allergen disclosures by promoting the use of more descriptive labeling practices. While such a move may cost fractions of a penny in ink and packaging real estate, the goodwill it could buy is invaluable. The loyalty of the allergy afflicted consumer (and the purchasers who care for or care about them) should not be understated. If a little extra print turns one in 20 customers into a lifetime brand patron, it is probably worth the rub.
Brandon Dorsky helps clients navigate the constantly evolving global marketplace in a variety of industries, providing strategic, seasoned counsel to facilitate growth, mitigate risk and seize opportunity in the cannabis, fashion, music, entertainment and media industries. Through a wealth of experience, contacts, enthusiasm, and commitment, clients receive carefully tailored legal and consulting services to accelerate their business’s success.
Committee Blog: What’s Up With Cannabis Standards?
by David Vaillencourt, The GMP Collective, NCIA Facility Design Committee
and Alena Rodriguez, Rm3 Labs, NCIA Scientific Advisory Committee
The cat is out of the bag despite the continued federal illegality of cannabis in the United States. A few years ago, the United States Pharmacopeial Convention (USP) recognized the need for standardization to address the safety and quality of cannabis used for medical purposes for the now estimated 3 million+ patients across the country. While the National Cannabis Industry Association (NCIA) does not develop standards and does not operate as a self-regulatory organization, it strongly supports the work being done by experienced standards-setting bodies. While NCIA lobbies for federal descheduling, the involvement of the USP and other organizations is another strong indicator of progress with respect to consumer and patient safety.
The USP is a nonprofit that humbly began with a small group of physicians on a brisk New Year’s Day in January of 1820. At the time, people would turn to their local apothecary for medications, where a druggist would mix together custom preparations from hand-collected plants and minerals. The types and quantities of these ingredients varied widely, with multiple names for the same medicine. Though sometimes not the fault of the physicians, it was not uncommon for the treatment to be worse than the disease. The USP rapidly evolved from a resource to an authority, when the importation of poor-quality medicines from Europe led to the Drug Importation Act of 1848. Tragic incidents of impurities and toxins in drugs over the years ultimately led to the 1938 Food, Drug and Cosmetic Act, in which Congress declared that certain medicines sold in the US must meet applicable USP quality standards. It should be noted that the USP included standards for cannabis preparations in the Pharmacopeia from 1851 until 1942.
Nearly 80 years later, the USP and several other internationally recognized groups are responding to the need to support the cannabis industry despite the quagmire of cannabis legality. Recently, the USP formed an expert panel of clinicians, scientists, and industry representatives from around the world resulting in a peer-reviewed article recently published in the Journal of Natural Products. The recommendations offered in this article (available here) provide a valuable foundation for the alignment of testing and quality attributes for cannabis flower. It is important to note that the USP published this information in a peer-reviewed article rather than a formal compendial monograph because of cannabis’ Schedule I status. Regardless, this article is another critical milestone towards standardization of the widely used plant, and it is only possible with support from individuals with knowledge of cannabis. Fortunately, there are established platforms that we as an industry can participate in and align with, known as Standards Development Organizations, or SDOs, that work closely with the USP to continue the advancement of our industry. In fact, many SDO efforts are referenced in the USP article.
ASTM International is one SDO that has responded favorably to industry and regulatory requests for assistance in standardizing cannabis. Founded in 1898 as the American Society for Testing and Materials, the group pioneered the standardization for the steel used to fabricate rails as frequent rail breaks across the fast-growing railroad industry plagued efficient transport of goods across the country between previously disconnected cities. Of the over 12,800 global standards published through ASTM’s rigorous consensus process, nearly one-third of them are codified within our federal regulations. ASTM Standards help ensure that the products in our lives can be depended on for safety, quality, and reliability.
The next time you wear a snowsport helmet, buy a crib for your child, use surgical gloves, pump gasoline, or get a new roof for your house, thank ASTM for creating the standards that help ensure that these items are safe. And lucky for us, now ASTM is focusing on cannabis standards.
In 2017, Committee D37 on Cannabis was formed, with subcommittees focused on developing test methods, cultivation best practices, quality assurance, processing and handling, security, and electronic devices. Today, over 800 members from 26 countries are actively contributing to the development of voluntary consensus standards. To date, more than a dozen voluntary consensus standards have been passed through the highly respected balloting process, providing specifications on water activity for cannabis flower, guidance on security plans, and many more. You can learn more about Committee D37 here and become a member here.
Another SDO is AOAC International, formerly known as the Association of Official Analytical Chemists. AOAC is a third-party, international association that establishes standard analytical methods and has been around since 1884. With the help of expert volunteers, AOAC ensures allOfficial Methods of Analysis (OMA) are highly scrutinized, scientifically sound, and defensible. OMA methods are recognized in the U.S. Code of Federal Regulations and are legally defensible in court globally.
AOAC created the Cannabis Analytical Science Program (CASP) to convene experts to discuss, develop, and validate cannabis testing standards. CASP is made up of five working groups: Microbiological Contaminants, Chemical Contaminants, Cannabinoids in Consumables, Training and Education, and Proficiency Testing. So far, CASP has published two First Action Official Methods for Cannabinoids in Cannabis sativa Dried Flowers and Oils (2018.10) and the Quantitation of Cannabinoids in Cannabis Dried Plant Materials, Concentrates and Oils (2018.11) and which are the first internationally recognized methods for potency in cannabis. They have also released several Standard Method Performance Requirements (SMPRs) that are developed through a voluntary consensus process, and prescribe the minimum analytical performance requirements for analytical methods during validation of the method. You can learn more about CASPhere and register to joinhere.
The work of USP, ASTM, AOAC, and others supports effective quality control of consumable products to promote public safety. These organizations create standards that are recognized by federal and state regulations across applicable consumable industries. Standards allow consumers to trust the products they buy have been subjected to thorough safety and quality controls that are the same no matter which state you buy the product in. Each organization has created an expert panel specifically for cannabis in order to help prevent uneven approaches to safety and quality. The efforts of USP, ASTM, AOAC, and AHPA directly relate toNCIA’s mission to promote the growth of a responsible and legitimate cannabis industry. With several thought leaders active both in NCIA and these organizations, it is imperative that moving forward we liaison with each other to ensure cannabis quality efforts are in alignment.
As NCIA says, “our industry is stronger, smarter, and more prosperous when we work together.”
Meet The Team: Clarissa Krieck – NCIA’s Director of Business Development
I was born and raised in the far south of Brazil, drinking yerba mate, listening to rock, going to the beach, and eating lots of BBQ! The war on drugs was fought hard in our streets, and we all remember the guns, the violence, that “social pain” growing up. I earned a business degree and relocated to the U.S. in 1999. Little did I know I was going to join a movement with the greatest mission, one much greater than you or I can grasp.
The West (and a Navajo rescue pup named Samba) stole my heart. Before cannabis, I led programs and teams working to bridge the digital divide through STEM education in Denver Public Schools for over 10 years. Colorado wowed me with its socially responsible libertarianism, vibrant third sector, and bravery to challenge the Union on unfair laws. Laws which later would personally affect me when I was diagnosed with cancer in 2011.
I felt extremely blessed to have access to regulated medicinal cannabis in Colorado. Edibles were instrumental in my healing and recovery. But it was not easy. Whether it was my medical team, my family, or my employer, I found myself educating my community constantly on the eminent scientific evidence behind the therapeutic properties of the plant.
I had been happily married to a U.S. diplomatic serviceman for nearly two decades. But when the Federales found out about my state-level medical marijuana registry, I was not given clearance to serve our country along his side. The conservative, globe-trotting lifestyle of the State Department did not allow for any access to cannabis. It became clear that I had to choose between my life and my marriage as the call to free cannabis from my home base in Denver spoke loud and clear. It was evident: I would have to fight for my birthright to heal myself. And I have never looked back!
After my divorce, I returned home from Warsaw, Poland, and immediately landed a job trimming bud in different medical centers. Between 2014-2016 I took a job as a sales representative with Bluebird Botanicals, one of the pioneers in the CBD and hemp space. I volunteered with the National Hemp Association (NHA) and the Hemp Road Trip and was truly blessed to work and learn alongside the greatest hemp professionals and activists. It was during this time I realized that hemp was going to be huge soon, and that THC was in need of some TLC.
I joined the board of Denver NORML from 2016-2018 as a volunteer, a flagship chapter that led the charge to lobby on behalf of consumers regionally and nationally on issues like social consumption, impairment, and access post adult market launch. Professionally, I led marketing and sales for Indo Expo Trade Show, a grower-centric cannabis trade show hosted in Denver and Portland every year. What a neat chance to build, support, and connect the emerging responsible industry!
In 2019 I proudly joined NCIA’s business development team to continue fighting and advocating for this most amazing industry we have built block by block. That’s right! We did not arrive here by parachute. We owe a great deal of gratitude to every activist, patient, mother, entrepreneur, policy official, and dreamer who refused to obey laws so unfair they border negligence. There is not a day in my life where I do not profusely thank the universe for this opportunity to represent the cannabis industry and to be a voice of change.
What came after my cancer was a series of countless blessings powered by a lot of hard work. Watching Dr. Mechoulam speak at the Inaugural Institute for Cannabis Research (ICR) Conference in Colorado, getting a private tour of the U.S. Capitol from now-Colorado Governor Jared Polis, leading policy reform and philanthropic work in Brazil, speaking to nearly 20,000 people at Hash Bash post adult market legalization in Ann Arbor, Michigan, ground zero for decriminalization… And the list goes on! Even when my retirement account was taken away in 2019 because I work in cannabis… that just fueled my fire more!
I always knew I would one day fight for justice when I was a little kid, but how could I have predicted that from something so disruptive, heavy, and terrible would bloom the most beautiful lotus flowers I could ever imagine? How is one to comprehend the many, often painful turns life takes, only to later arrive at the most fruitful of gardens? Ah! The mysteries of life! I will take every single one of them, accept them, and be grateful! All the way. Onward!
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