Member Blog: Colorado’s Evolving Cannabis Testing Regulations
Among the first two states to legalize and the first market to open, Colorado has had adult-use cannabis regulations in place for more than a decade now and helped set a standard for all the programs that came after it.
But Colorado’s testing regiment, like the industry, is ever evolving, with the state testing for additional pesticides beginning this year, for example. In addition, the state’s new “reduced testing allowance” could make the whole process easier for manufacturers in good standing.
Like many states, Colorado requires testing of the final product, be it flower, edible or pre-roll, which means not only must your flower be clean, but everything else you put into your products as well. In the case of pre-rolls, that means the paper used in the pre-rolled cones, as well as the filter tip.
The “big four” heavy metals (arsenic, cadmium, lead and mercury); and
Cannabinoid potency.
WATER ACTIVITY
Like every state, Colorado testing requires laboratories check for water activity because high amounts of moisture can create an environment with the potential for mold growth.
Any water activity above 0.70 Aw creates the conditions for mold to grow, which can be harmful if consumed, which is why Colorado caps water activity at 0.65 Aw in flower and pre-rolls.
PESTICIDES AND SOLVENTS
Colorado also requires testing for residual pesticides and other chemicals and has been slowly ramping up its required pesticide testing.
For example, on January 1, 2023, the state tested for a total of 13 different pesticides. By July 1, 2023, that number had increased to 28. But new regulations going into effect this year drastically increase that number.
Beginning July 1, 2024, state law requires labs to test cannabis products, including completed pre-rolls, for 99 different pesticides, each with their own actionable limits that can cause a whole batch to be destroyed.
Additionally, the state requires cannabis concentrate products, including those used in infused pre-rolls that combine flower with a concentrate for increased potency and flavor, to be tested for residual solvents.
The state requires testing and provides actionable limits for 13 specific solvents that can be used to make extracts and concentrates, as well as requiring “none detected” for “any other solvent not permitted for use.”
HEAVY METALS
The Centennial State also requires testing for the heavy metals mercury, cadmium, lead and arsenic. All four metals are toxic to humans, even at small doses, and can damage all the body’s vital systems, including pulmonary, reproductive and even the central nervous system.
Testing for heavy metals is especially important because cannabis plants are a well-known bio-accumulator that absorbs and collects heavy metals from the soil in which it grows.
For all inhalable products, including pre-rolls, the state sets the pass/fail actionable level at 1.5 parts per million (PPM) for mercury and arsenic, 0.5 PPM for cadmium and 1 PPM for lead.
MICROBIALS AND MYCOTOXINS
But while heavy metals are dangerous, they do not pose the greatest risk to human health among the testing. That distinction is reserved for microbials and mycotoxins.
Among the microbes – bacteria and fungus – for which Colorado requires testing are salmonella, Staphylococcus aureus and e coli. There is also a total yeast and mold limit.
Mycotoxins are a toxic compound produced by molds, such as Aspergillus, and can suppress the immune system and cause liver damage. Testing for mycotoxins help ensure cannabis products are safe for human consumption.
Colorado requires testing for two classes of mycotoxins, Aflatoxins and Ochratoxin A, each with an actionable limit of 20 PPM. Both have properties that can alter DNA and potentially cause the formation of cancer cells.
PRE-ROLL TESTING
But it’s not just the flower that needs to be tested in Colorado. Products must be tested in their final form, which means that pre-rolls, for example, must be tested after they have been packed, so the paper has to be as clean as the flower. And with no regulations or requirements on the testing of rolling papers themselves, several manufacturers have run afoul of the rules because of untested rolling papers or wraps. And testing by SC Labs, one of California’s licensed testing labs, found that 11% of rolling papers tested during a recent study would fail testing. So even if you are packing your own pre-rolls, it’s important to make sure the paper you choose is tested and clean.
Colorado has also had issues with this in the past, particularly in palm leaf wraps and blunts. In 2022, the states Marijuana Enforcement Division issued a recall for King Palm products due to unsafe mold and yeast levels found in the products.
“Take due diligence to make sure your product is viable,” says Custom Cones USA Compliance Manager André Bayard, noting that manufacturers should work with suppliers that are working to set industry standards. “Any one issue can be detrimental to your brand reputation.”
REDUCED TESTING ALLOWANCE
Recognizing the unique challenges and cost of testing, Colorado has introduced new reduced testing allowances, including one tailored for pre-roll cannabis products. This allowance enables cannabis manufacturers to submit composite samples for testing, rather than subjecting each individual batch of pre-rolls to separate testing.
For example, a manufacturer may achieve a Reduced Testing Allowance for contaminant testing for a specific product, like pre-rolls, if every production batch that it produced during at least a four- to eight-week period passed all contaminant tests. However, if those pre rolls are produced using different input materials, such as a different cannabis category (e.g. flower or trim), different wrapper materials, different processes or different equipment, they must get a separate Reduced Testing Allowance.
Additionally, effective July 1, 2024, to achieve or maintain a Reduced Testing Allowance for microbial contaminants, a cultivation facility must have a Hazard Analysis and Critical Control Point (HACCP) System in place. An HACCP must contain elements defined in ASTM D8250-19: “Standard Practice for Applying a Hazard Analysis Critical Control Points (HACCP) System for Cannabis Consumable Products” that addresses each product type for which a microbial contaminant Reduced Testing Allowance is sought.
It’s important to highlight that not all cannabis products qualify for this reduced testing allowance, and pre-roll manufacturers must meet specific criteria to be eligible for this exemption. For example, to get a reduced testing allowance for microbial testing, a company must maintain cleaning records and maintenance records.
Reduced testing allowances are valid for one year.
It’s a complicated program to be a part of, but well worth it for manufacturers who have their procedures locked in, as well as a supplier that also tests their pre-rolled cones and tubes to the highest standards to ensure passage of these important tests.
FINAL THOUGHTS
Colorado’s pre-roll cannabis testing regulations play a vital role in safeguarding public health and ensuring consumer confidence in the state’s legal cannabis industry. And from a business standpoint, a testing failure can be costly, especially for smaller businesses, and can follow a company and its products even after the issue is corrected.
Make sure your suppliers take the same care as you do to ensure passage of all required tests. And always ask for COAs.
Committee Insights | 7.13.23 | Know Your Hazards – Occupational Health and Safety Considerations in Cannabinoid Ingredient Manufacturing
NCIA’s #IndustryEssentials webinar series is our premier digital educational platform featuring a variety of interactive programs allowing us to provide you timely, engaging and essential education when you need it most.
In this edition of our NCIA Committee Insights series, originally aired on July 13, we were joined by members of NCIA’s Cannabis Manufacturing, Scientific Advisory and Hemp Committees for an in-depth discussion highlighting the occupational health and safety considerations to make during the manufacture of cannabinoids and provide recommendations for mitigating risk.
There is no mistaking that manufacturing cannabinoids is here to stay. It is more and more prevalent to see historically plant/naturally derived bulk ingredients being manufactured in a controlled environment in the lab or through innovative processes like precision fermentation. It is likely that bulk ingredient manufacturing of cannabinoids will go this route too.
For cannabinoids like HHC, that do not exist naturally in the plant or in high enough quantities to be commercially viable for extraction, it is most certainly the case that manufacture of these compounds will occur in the lab. To produce these compounds safely, we can luckily look toward existing regulations and occupational health and safety guidelines for producing novel ingredients for use in foods and non-foods.
Learning Objectives:
• Recognizing common occupational safety hazards associated with manufacturing cannabinoids and recommendation to mitigate these hazards
• Learning the different occupational safety considerations between isolation and purification of naturally occurring cannabinoids and the manufacture (synthesis) of cannabinoids in the lab
• Understanding the special safety considerations that processes like hydrogenation and others have and why these are critical to mitigating liability for your business
If you are a cannabis-related business, and are looking to accept credit cards, it is only possible to do so if you are selling a product that is defined as legal hemp by the 2018 Farm Bill.
The 2018 Farm Bill provides that:
“The term ‘hemp’ means the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.”
For the most part, it’s pretty cut-and-dry. Marijuana is a schedule 1 drug. Hemp is not. If your product has less than .3% Delta-9 on a dry weight basis, it’s not marijuana, it’s hemp. And since it’s hemp, it’s federally legal. And since it’s federally legal, it can be purchased with checks, credit cards, or debit cards. Hemp products are, reductively, as incendiary as a stick of butter.
Of course, there is the law and there is how acquiring banks—banks that offer merchant accounts—interpret the law. Across the U.S., there are hundreds of acquiring banks. Of those, only six or seven offer merchant accounts to hemp businesses.
That’s it, plus payment service provider Square.
The immediate problem for the few acquiring banks that have, laudably, said, “Yes,” to hemp is, “how do we distinguish products that are .3% Delta-9 or less (and therefore, yawningly legal) from those that are over .3% Delta-9 (and therefore, illegal as angel dust)?”
Enter the Certificate of Analysis, or COA, or lab report. While there is nothing in the law stating that COAs are required to prove that a product is within the federally legal limit, their role is sacrosanct during the boarding process. For every hemp-derived product, there must be a corresponding COA proving that the product being sold is hemp, and not marijuana.
Fortunately, there are labs across the nation. The U.S. Department of Agriculture website lists 85, as of May 2023. Manufacturers and businesses ship their samples to these labs. The labs run their tests and the COAs are issued.
Simple, right?
Not really.
There are no standards in place for these reports. No templates. Every laboratory’s COAs—while substantively providing the same information—look a little different. Furthermore, most bankers haven’t seen a lab report since high school chemistry, and you’ve got a recipe for confusion or misunderstanding (frequently both).
This COA, when it was initially presented to the bank, was rejected. To the underwriter, it was an open and shut case.
When the bank opened its door to offering acquiring to hemp businesses, its policy was to reject anything with greater than .3% Delta-9 by weight.
The top of this COA showed an instance of Delta 9 that read .189%. That passed muster, certainly. However, when he delved further into the analyte detail, he noted additional Delta-9 figures in excess of the .3% limit:
10.368 in the mg/unit cell
1.892 in the mg/g cell
It was not clear to the bank’s underwriter which of the two—per-unit or per-gram—corresponded with the by-weight percentage he was to be mindful of, but both were certainly over the .3% limit.
So, open and shut case: DECLINED
The salesperson that brought the merchant to this bank was surprised by the rejection. He hadn’t looked at the COAs very closely, but it seemed unlikely that this merchant had been selling products on her website that were in excess of .3% Delta-9.
Why? Because if the merchant had been selling products on its website in excess of .3% Delta-9, it would have been engaging in egregious felony drug trafficking. The salesperson doubted that was the case.
The salesperson did something he didn’t normally do: he took out his calculator.
He wanted to know why it read .189% Delta 9 at the top, but 10.368 in the analyte table. He noted the unit size at the bottom of the page was a gummy weighing 5.480g.
For the sake of simplicity, he multiplied that by 1000 to convert it to milligrams. That made it 5480 mg
Then he entered the onerous 10.368mg from the mg/unit figure in the analyte table and divided it by 5480mg. The resulting calculation netted the following total: .0018919.
Next, he converted it to a percent, and found that the result was .189%, which matched the figure at the top of the COA, exactly.
The next day, the salesperson presented the COA to the bank, with the markings and The Equation just as shown here.
It was an open and shut case: ACCEPTED
This situation is an example of why banks and credit unions unknowingly reject compliant hemp businesses from merchant processing solutions. As stated, a simple mathematical calculation was the difference between being accepted or rejected for necessary merchant processing services. Without proper merchant servicing not only are cannabis businesses’ profitability affected because they can only take cash; cash is also not as traceable or auditable as electronic transactions.
In general, businesses providing services to the cannabis industry are often challenged with disentangling legal risks with the benefits of their necessary services providing more transparency. With enhanced knowledge of the cannabis industry and its parameters, the cannabis industry will recognize a greater participation by all businesses necessary for the life of the industry thereby enhancing cannabis businesses’ likelihood to succeed but also enhancing the legitimacy and regulation of the industry.
Member Blog: Quality Over Quantity – Why Stronger is Not Always Better
by Andrew Kaye, Sweet Leaf Madison Capital
Over the last 15 years, cannabis has seemingly catapulted away from the days of schwag and dirt weed. Today, we are seeing THC levels well beyond percentages that were displayed in dispensaries 10 years ago when cannabis first became legal in certain states. Advancements in technology, a better understanding of growing cannabis, and strain cloning has allowed for growers and chemists alike to fine-tune the plant to offer more bang for our buck – but not everyone needs to blast off every time they light up, right?
Right.
Recently, there has been a shift in the way we approach cannabis use, especially for medicinal purposes – proper dosing is everything. These stronger strains that have been Frankensteined together to ensure a potent one-hit high making it nearly impossible to provide a controlled dose for someone just looking for a chill evening or relief from their chronic pain. Granted, these strains have their place among seasoned tokers, but for others who are novice cannabis enthusiasts or patients looking for a treatment, stronger does not necessarily mean better. More intention should be put toward partaking, and it is as simple as asking yourself a few questions: How do I want to feel? What do I want to do? Where am I going? What hurts? Who is part of the experience?
Realistically, when was the last time you went to the bar to enjoy a casual night out with friends and started throwing back tequila shots until your knees buckled?
Hopefully, you are not recounting a night where that happened, but if so, you can probably guarantee that you would not put yourself in that situation again, at least not right away. Be honest with yourself, answer the questions above and chat with budtenders to find the best solution for you.
Knowledge is Your Best Friend
For a lot of people entering dispensaries for the first time, they see these high THC numbers and equate it to a better high, but the reality is that cannabis potency can be attributed to more than the THC percentage. Terpenes, differing cannabinoids and other compounds found within the plant also play a major role in how strong the strain is and what effect it has on your body and mind. Think of the subtlety of wine versus the kick of jello shots.
This is why it is important to talk with budtenders to better understand which strain is going to work best for what you are seeking. The problem today is that dispensaries are experiencing high turnover rates, as 55% of budtenders who held jobs over the last year left within 12 months of starting, according to a Headset market report. Losing seasoned employees not only impacts the store itself, but customer service tends to take a hit (no, not that type of hit). Inexperienced budtenders might be rushed to the counter without proper training, leading to misguided direction and customers walking away with flower or edibles that will send them to space, or to a space that they did not intend to go. Again, there is nothing wrong with having highly potent strains, but making and distributing them comes with a responsibility toward customer and patient care. As more states migrate to adult use cannabis, many are abandoning the medical dispensary model and focusing on high-profit strains, not curative or palliative care. Dispensaries need to ensure they are properly onboarding and training new employees to provide the best service possible.
The Future of Cannabis
As science improves and technology becomes more refined, cannabis potency is going to continue to go up, but it also means that mid- and low-potency strains will get better. If you look at the craft beer industry, the days of high abv IPAs and stouts are slowly fading and more focus is being put on taste and balance.
Since 2014, there has been an almost “gold rush” mentality where growers were fine-tuning their product at a high rate to offer a better punch than their competitors, but in 2023, after nearly 10 years of legal cannabis, customers are looking to refine their tastes and highs.
For most, the quality of the strain is going to be far more beneficial than the quantity of THC, but at the end of the day it is all preference. So do yourself a favor the next time your supply is low and chat with budtenders – lean on their expertise and compare with your own research. Try different strains along the potency spectrum and really consider taste. No one consumer is the same; make your experience yours. The higher the price is not always the nicer the nice.
Andrew Kaye has been involved in all aspects of the financial services industry, as a fund portfolio investment manager, investment banker, family office investor and attorney. He has worked with start-ups on their first raise through global enterprises undertaking billion-dollar stock offerings, and has significant investment experience in the cannabis industry. Currently, Andrew works as Sweet Leaf Madison Capital’s Chief Commercial Officer. Lending his expertise toward the creation of middle market financing solutions for real estate and equipment financing needs in the cannabis space.”
“Sweet Leaf Madison Capital provides non-dilutive, asset-based lending solutions to the underserved middle market of the cannabis industry by originating real estate loans, equipment financing, securitized term loans, and more for entrepreneurs and businesses. The company is based in Denver, Colorado and has offices in New York City and West Palm Beach, Florida. To learn more or complete a loan application, visit Sweet Leaf Madison Capital online, or continue the conversation on LinkedIn, Twitter and Facebook.”
Andrew J. Kaye is Chief Commercial Officer of Sweet Leaf Madison Capital. He can be reached at akaye@sweetleafmadison.com.
Member Blog: The Importance of Genetic Studies for Identifying Plant Mutations
by Angel Fernandez, Joselyn Guadamuz, and Maria de Catarina of MyFloraDNA
The cannabis industry has experienced significant growth in recent years, highlighting the importance of quality control measures. One of them is the utilization of laboratory partners to ensure the genetic integrity of the products. However, the connection between cannabis and genetic studies is often underappreciated.
A genetic study or test is a type of analysis that is carried out on a tissue or cell to search for essential traits in the genetic material of the plant. The results obtained from these analyses can provide a lot of information that helps confirm or refute many theories.
In recent years, genetic studies of cannabis have played a crucial role in the industry by providing growers with more advanced tools and techniques. These studies have enabled growers to improve crop yields by identifying key traits and characteristics for reproduction. Furthermore, genetic testing has been instrumental in quickly and effectively detecting diseases that affect crops and identifying the gender of the plant well in advance of flowering, thus saving growers time and resources.
Even more, genetic testing also allows cannabis workers to detect changes or damages in the genetic material of their plants.
Plants, like all living organisms, have a complex genetic makeup that plays a crucial role in their growth and development. However, the genetic material of plants can be susceptible to mutations, which are changes in the DNA sequence that can occur naturally or be caused by external factors. These mutations can have varying effects on the plant, from having no impact to causing serious detrimental effects on its growth and development.
One of the main factors that can cause mutations in the genetic material of plants is found in controlled environments such as in vitro culture laboratories. In these environments, plants are exposed to chemicals and UV radiation that can cause mutations in their DNA. However, not all mutations are harmful to plants. For decades, scientists have been making changes to the genetic material of plants with the goal of improving crop quality and characteristics.
While controlled environments can cause mutations in the genetic material of plants, it’s also important to consider the impact of environmental factors in uncontrolled environments, such as outdoor crop plantations. Factors like air (oxygen) and sunlight (UV rays) are two of the main factors influencing mutations in the genetic material of plants. Because these two factors are part of the normal conditions in which a crop lives on a plantation, mutations can be expected to occur at some point in the growth process of plants.
The damage caused by these factors can not only generate simple changes in the genetic material of the plants but can also have serious detrimental effects on the plant, such as growth inhibition. Even subsequent cumulative damage to genetic material can not only prevent plant cells from dividing and growing but can seriously damage tissue and ultimately kill the plant.
Although some of these mutations can be subtle and go undetected, the composition of the plant could have changed at a molecular level, which may mean that, for example, in the case of cannabis, a mutation causes the cannabinoid content to be of poor quality or even non-existent, but to the naked eye the plant looks normal. This is why genetic and molecular studies have played a key role in this industry.
Additionally, if a grower obtains a particularly outstanding trait in their plant, the only way to obtain information on that trait and validate its function is through genetic studies, allowing them to obtain a genetic profile of the plant as proof that it is unique. These studies also work to detect unique, outstanding traits, such as high THC or CBD production in cannabis, which would not be possible without laboratory analysis, as these traits cannot be measured visually.
It is crucial for growers to have a good understanding of the genetic material of their crops in order to ensure that they are of good quality and to detect any mutations that may have a negative impact on the plant. Genetic and molecular studies play a vital role in this industry by providing growers with the necessary information to make informed decisions about their crops, and to ensure that the plants they grow are of the highest quality and free of mutations that could have a negative impact on the final product.
About MyFloraDNA: We are a genomic laboratory based in Woodland California, delivering modern genomics for the cannabis industry.
Our services include Trait detection (cannabinoid profile and sex/gender ID), Pathogen Detection, and Genetic Validation Services. We offer breakthrough solutions using the inner power of your plants.
Angel Fernandez, author. CEO & Co-Founder at MyFloraDNA. Member of the NCIA’s Scientific Advisory Committee. “It is time to fill in the gap between DNA Sciences and Agriculture. MyFloraDNA is willing to show the huge opportunities that exist for modern genetics in agriculture. Now, it is time for another agricultural revolution”.
Joselyn Guadamuz, co-author. Scientific Researcher and Content Writer at MyFloraDNA.
Maria de Catarina, editor. Public Relations Specialist at MyFloraDNA.
Member Blog: How to Prevent Pathogen Infections in Cannabis Gardens
One pathogencan spread through a garden and ruin everything that was going well.
A pathogen is “an organism causing the disease to its host, with the severity of the disease symptoms referred to as virulence.” (NCBI) There are different kinds of pathogens. These are the main three infecting cannabis crops:
Viruses (ex. Cannabis Cryptic Virus)
Viroids (ex. Hop Latent Viroid)
Fungus (ex. Botrytis)
Well, here are five recommendations approved by Dr. Angel Fernandez – Ph.D. in plant science with a complete background in cannabis genetics and genomics, CEO and Co-Founder of MyFloraDNA – The following recommendations will impede the spread of a pathogen in your cannabis garden so the next time you’re prepared for a worst-case scenario.
1. The first step: remove.
If a plant’s result comes out positive, it must be removed from the field or greenhouse as soon as possible, without exposing it directly to other plants.
2. Destroy.
Ironically, the best solution to avoid the destruction of your garden is to dispose of infected plants. If the infection is in a mother plant, remember to remove its clones from your growing facility and test them as fast as possible with your trusted genomic laboratory.
3. Don’t deny it, take action and prevent the spread.
If one plant is positive, assume the viroid is present in your field and extreme your prevention strategies.
Sterilize all tools used
Control your personnel and visitors
Do not jump from one plant to another without sterilizing your equipment
4. Don’t look away and take responsibility for your problem. Test regularly.
It doesn’t matter if other plants don’t return positives. Some pathogens remain dormant for weeks (like Botrytis or “bud rot”). Stay alert and test regularly.
5. Keep an eye on pests, they are pathogens’ best friends.
Control pests. One of the causes of quick pathogen propagation in Cannabis fields is pest infections, like Whiteflies.
How do you know if a plant is infected?
It might sound obvious, but pay attention to the symptoms. Anyways, the most effective way is by requesting RNA testing from your trusted genomic laboratory.
RNA testing for pathogen detection is the easiest way to detect infected plants. The results are obtained through the qPCR method, determining whether your samples are positive or negative for the pathogen you wish to detect.
Commonly known as Dudding Disease. HLV is a single-stranded, circular infectious RNA viroid (it is not a virus).
Symptoms during vegetative stage: stunted growth, outward growth, abnormal branching, small leaves, overlapping blades, brittle stems, chlorosis on the leaves (yellow leaves),
Symptoms during flowering stage: trichome reduction, dull smell, no terpenes or reduction of terpenes, reduction of cannabinoid production, smaller buds.
This mold is one of the most damaging fungi that can kill cannabis plants within a week. It can remain dormant for long periods of time before damaging your plant.
Symptoms: Brown, water-soaked spots on buds, chlorotic areas on stems, gray-brown mass of spores on buds, interveinal yellowing leaves showing necrosis, and smaller buds.
Fusarium is a devastating fungus pretty frequent on cannabis crops. Symptoms: wilts and bud, crown, and root rots, chlorotic leaves, stunted growth, plant death.
I am glad you kept reading until here and hope this guide helps you to keep growing healthy and safe cannabis plants!
Also, here are some interesting topics you may like when you click on them before you close this tab:
About MyFloraDNA: We are a genomic laboratory based in Woodland California, delivering modern genomics for the Cannabis Industry. \
Our services include Trait detection (cannabinoid profile and sex/gender ID), Pathogen Detection, and Genetic Validation Services. We offer breakthrough solutions using the inner power of your plants.
Marketing expert, with a portfolio of innovative and successful projects around the world. Native leader, resolutive and efficient. She brings creativity and proactivity to MyFloraDNA’s Marketing Department.
Editor: Felipe Cisternas
Member Blog: Cannabis Extraction – Creating a Competitive Advantage Through Data
As customers become more sophisticated and discerning about the fast-growing cannabis extract market, from vapes to dabs to infused pre-rolls, the need to routinely produce consistent, quality extracts at scale is becoming doubly important for processors. Compounding the issue, the potential for federal legalization will bring significant growth opportunities but also increased federal oversight, including the need for Good Manufacturing Practices (GMP) and other onerous standards that will challenge unprepared operators.
Future-Proof Extraction Operations Through Data
To overcome these twin challenges, processors should start developing (if they have not already) a framework to capture, review, and analyze data at every stage of production to produce consistent, quality, and compliant products.
That framework should examine every aspect of the extraction process, starting with the type of material harvested from farms, including how it is stored and handled, through to the final, packaged retail-ready product.
It should also be tied to specific goals and clear objectives. Capturing data simply to capture data within a given framework but without a clear idea of how that data will be used can lead to analysis paralysis, or worse, endless trial-and-error that wastes time and material, eating into expected profits.
Leverage Design of Experiments Methodology
Design of Experiments, or DoE, is a scientific methodology that can help guide processors in determining the key parameters they want to track and how those parameters interact. This starts with assertions that map to specific goals or objectives, such as investigating the yield of a specific terpene with the goal of blending it with a distillate-based vape cartridge. From here, processors can design and set up experiments with varying inputs from temperature to pressure, to biomass composition, all to understand how the yield of a specific terpene is influenced throughout a given process.
When these learnings are applied at production scale, the framework developed through DoE methodology provides a guide for creating consistent products, but also to better manage and rectify issues that may arise. With specific goals in mind, processors can then determine what data they need to capture and analyze.
The Four Steps of Data Capture
Step 1: Chemical Makeup – When selecting or determining what plant material to use for extraction, processors first must examine the chemical makeup of the cannabis biomass. This can include the profiles of cannabinoids, terpenes, and the fat/wax/water content.
The exact chemical makeup of cannabis biomass can be difficult to determine because of its nonhomogeneous nature. Imagine closing your eyes and selecting a random sample from a container of bulk biomass. Maybe you grab a sugar leaf or flower, high in THC-laden trichomes, or maybe you grab a fanleaf with little to nothing to contribute to a high-quality extract. The chemical composition will look significantly different depending on how one selects the sample. So it’s important to be cognizant of what and how biomass testing is conducted, and often a single sample isn’t the answer. Knowing the approximate chemical makeup of the feedstock material will guide the processor to determine what type of recipe they will use for extraction and post processing and, ultimately, what end products are most valuable for a given input.
Once the chemical makeup has been determined, the processor will know the inputs of the material, such as the associated THC, CBD, terpenes, etc. They can then use that data to determine what will (or should) come out of the extraction process at its conclusion. This is the mass balance of the production process. It is difficult or impossible to optimize any process if one doesn’t know exactly what goes in and what comes out. Of course, this is much easier said than done given the nonhomogeneous nature of biomass.
Step 3: Identify and Maintain Key Process Parameters – Depending on the recipe and desired end product as determined through the above steps, the extraction process will need to maintain specific temperatures, pressures, times, and flow rates, among other key variables, to ensure a consistent, quality product. This is where a DoE or other similar process can add significant value. Analytical tools, such as the DoE, can help determine what process parameters need to be precisely controlled, and what parameters can have looser controls or can be ignored altogether. Compliance comes into play here as well. The ability to track and record these key data points is crucial to achieving GMP compliance as well as creating a consistent product that customers expect.
Step 4: Post Process Review – In order to understand how recipe parameters affect the end product, the processor needs to know its chemical composition as well as the composition of any waste materials (e.g., biomass, fats, waxes), or impurities that have been filtered out. Capturing this data is vital as it offers the critical clues to why a particular batch did not turn out as planned, for example, so the processor can investigate potential causes and corresponding solutions.
Step 5: Recording Data Between Each Process – What happens between each process is nearly as important as what happens during the process. Storage conditions can have an impact on quality and consistency, issues that may not be readily evident within the data capturing during processing. Those data points to know, among others, may include monitoring the freezer temperature where biomass is stored, measuring the humidity of the environment, documenting when and how equipment is cleaned, or even tracking how long material sits between extraction and placement in a vacuum oven.
Decision Making Via Data Analysis
After the data is captured and analyzed, managers may need to enact decisions if the data shows deviations from the expected outcomes. For example, as part of post-production lab tests (step 4), are acetone traces appearing in the finished product? If so, the organization may need to change its equipment cleaning practices (step 5) to ensure unwanted trace chemicals are not seeping into finished products.
Although enacting a program to better capture, review, and analyze data can appear to be a daunting task, doing so will provide the processor a significant competitive advantage. Not only will it help ensure consistent production while future-proofing the organization against coming regulations, it may also enable processors to experiment with and develop novel or proprietary extracts derived from a repeatable, scientific method that can’t easily be replicated by competitors.
Jack Naito is President of Luna Technologies, where he oversees operations, strategic growth, and R&D for the company he co-founded in 2016. Jack entered the cannabis industry after time spent as a Materials, Process, and Physics Engineer for aerospace giant Boeing. Jack obtained an Economics and Business degree from Colorado College and a Master’s degree in Mechanical Engineering from the University of Washington.
Luna Technologies engineers state-of-the-art extraction equipment for cannabis processors. The meticulously designed, automated equipment empowers operators to process fresh-frozen or cured plant biomass with stress-tested hardware and built-in failsafes to foster a superior level of workplace safety while also lowering labor costs. Luna’s Earth-conscious engineering approach helps decrease energy consumption while setting the industry standard for safety, quality, consistency, and customization in support of creating clean, consistent cannabis concentrates with medical and social benefits. Learn more atwww.lunatechequipment.com.
Member Blog: How Can Hemp Businesses Better Self-Regulate?
The hemp industry is still in its early stages, especially when it comes to emerging products like delta-8 THC. While there is some regulation for hemp products, it’s much less than for legal cannabis, and this gives companies some freedom in terms of how they operate and what they do. For the most part, this is a good thing, but there is a downside too. Our report into the industry found that 76% of delta-8 THC products contained illegal quantities of delta-9 THC. This is terrible for consumers, but it also poses a risk to the industry: if you keep raising red flags, the government will eventually swoop in and take action. This is why self-regulation is a crucial concept for hemp businesses going forward.
Why Self-Regulate?
Self-regulation is crucial for hemp businesses because of the scrutiny the industry faces and to improve consumer confidence. Although CBD is generally accepted, this is especially important for companies selling something like delta-8 THC, which attracts more scrutiny because of its psychoactive nature. With states like Texas attempting bans on the substance and the findings of our report showing that the vast majority of products break legal limits for delta-9, the industry is in serious danger of attracting the attention of more lawmakers who may opt for an outright ban. In fact, there are already 18 states with some form of ban or restriction on the substance.
Jayneil Kamdar, PhD from InfiniteCAL Labs commented to us that: “The current delta-8 THC products on the market are very concerning because there is no regulatory body monitoring the safety of these products.”
In our report, we also found that companies tend to undercut customers on delta-8, that only 14% of companies perform substantial age verification checks and that two-thirds of companies don’t test their products for impurities.
It isn’t that self-regulation would be a cure-all, but if companies opt to act responsibly, it is much less likely that they will attract attention from lawmakers. In addition to this, though, self-regulation sends a strong message to consumers that you care about them and that they will get what they wanted when they buy your products. When this doesn’t happen,people will tell others about it.
The more the industry can mirror the regulations of regulated cannabis companies, the better things will go in the long run.
How Can Companies Better Self-Regulate?
However, “self-regulation” can’t just become a vague, catch-all term for generally responsible business practices: clear recommendations are essential in making this goal a reality. Luckily, our in-depth investigation of the delta-8 industry and other similar investigations into the CBD industry have revealed some key areas companies can focus on.
Provide Transparent Lab Reports with QR Codes
Lab reports are a vital part of building consumer trust, and you should ensure there is a QR code on the report so it’s easy for consumers to verify the report on the lab’s website.90% of CBD companies already do this, based on our industry analysis.
Offer a Lab Report for Every SKU
Many companies, however, only offer a COA for the base distillate, rather than every specific type of product it produces. If you sell vape cartridges, for instance, you should have a report available for each variation in flavor, strain, and potency.
Choose Credible Labs for Your Report
Not all labs are equal. If you get a report from a questionable or unknown lab, savvy consumers will still be wary of your product, and in some cases, the results may be unreliable. It’s best to choose a lab with a strong reputation, such as ProVerde, Anresco, SC Labs, InfiniteCAL, and CannaSafe.
Test for Impurities
With two-thirds of delta-8 companies not lab testing their products for impurities, this is a good way to stand out in the marketplace as well as good practice in general.
Verify Customer’s Ages
With most CBD companies not performing robust age verification checks, using a credible age verification system such asAgeChecker is a great step towards self-regulation. They stay up to date with FDA requirements, state laws, and merchant account policies, so you can set it up and then continue basically as normal. This is especially important for delta-8, but it’s also crucial for higher-strength CBD products too.
Label Your Products Accurately
What you claim on the label should be what’s in the product. Lab reports help you verify that this is the case.
Warning and Caution Labels
Only about 55% of hemp delta-8 companies use a warning label, but this is another key part of self-regulation. Suggested verbiage includes:
This product should be used with caution when driving motor vehicles or operating heavy machinery.
Use this product under the guidance of a physician if you have a medical condition, are pregnant or lactating.
Keep out of the reach of children.
This product was manufactured from hemp material that meets federal requirements for hemp products; however, consumption may be flagged by some drug tests.
This goes hand-in-hand with the above, but also, having your products that looklike a bag of Cheetos or anything along these lines is not a good look.
Avoid Medical Claims
Although many people opt to use delta-8 and CBD for medical purposes, if you’re selling the products, making medical claims that might not meet official organizations’ standards of proof is simply a terrible idea. Leave it to your consumers to determine.
Get Industry Certifications
Getting certified by an organization like theU.S. Hemp Authority is a great way to show your customers that you’re one of the responsible companies.
Conclusion
Self-regulation really just means taking a few basic steps to establish to both customers and politicians that you’re running a legitimate business which does what it claims to and is socially responsible. It might increase costs in the short-term, but over time and especially as consumer knowledge increases, it will pay off many times over. And the next time there’s a situation like what happened recently in Texas, the industry will have a much easier time defending its practices.
Lee Johnson is a writer at CBD Oracle who has been covering science, vaping, and cannabis for over a decade. He focuses on research-driven deep dives into topics ranging from medical uses for CBD to industry and user statistics, as well as general guides and explainers for consumers. He is a passionate advocate of both CBD and cannabis, and a strong believer in informed choice for consumers.
CBD Oracle is a consumer research company working to improve the safety and transparency of cannabis products, producing in-depth statistics on CBD and cannabis, detailed research pieces and analysis of social and legal issues.
Member Blog: Evaporation is Costing the Cannabis Industry Millions. Here’s Everything You Need to Know.
As cannabis ages, many of its therapeutic components degrade and transform into less effective compounds. Here’s everything you need to know about cannabis degradation, how the compounds are affected, and a few ways to restore products that have seen better days.
How long do cannabis and hemp buds stay fresh?
Cannabis is made up of various naturally occurring chemical compounds, including cannabinoids, terpenes, flavonoids, lipids, and fibers. Just like all organic materials, these components break down and degrade over time.
Think about your favorite fruits. Fresh oranges for example, will eventually rot as they age and their molecular compounds break down. When exposed to light, their outer layers start to spoil in a process known as photodegradation that causes discoloration and loss of flavor, vitamins, and proteins.
Further enzymatic chemical reactions occur and transform water, vitamins, and other molecules into different formations that can degrade even further with added heat or moisture loss. The oranges will lose their zesty aroma, sweet flavor and will be more susceptible to microbes, which will eventually cause the fruit to spoil. That said, dried fruits can be stored in a pantry for much longer before they’re no longer safe to eat as the “conditioning” or “curing” process can make them shelf-stable for up to a year.
Like dried fruits, cannabis and hemp undergo a curing process that helps to equalize the moisture content among the buds. This process reduces the risk of mold and spoilage while keeping the flower fresh, flavorful, and potent. Following this process correctly can keep cannabis and hemp flower “fresh” for 3-6 months or longer if stored properly. However, even with the most disciplined processes and practitioners, eventually, all organic materials begin to break down from exposure to the elements.
Much like our dried oranges example above, cannabis and hemp stored in suboptimal conditions are more susceptible to “rot” and can lose everything that makes them special. Light and temperature can contribute to the degradation of these natural features, but the biggest factor in terpene degradation is moisture content – or the lack of it. Moisture helps to preserve these compounds for prolonged periods of time.
What happens to the terpene profile and moisture content of cannabis and hemp over time?
On average, 12% of all cannabis and hemp biomass is moisture. As that moisture evaporates, it takes valuable terpenes and other essential oils with it leading to dry and brittle plant matter. Terpenes are naturally occurring chemical compounds found in plants that are responsible for their unique aromas and flavors. They also add and help preserve moisture. Cannabis and hemp contain an unparalleled profile of 100+ different terpene isolates that all evaporate at different rates based on temperature and humidity.
While live terpenes smell most potent during the flowering phase, terpene degradation starts immediately after the buds are cut from the stem. This happens because terpene oils, especially the most pleasant ones found in tiny amounts, tend to have low-temperature tolerance thresholds and evaporation levels. Once these terpenes have evaporated they will not be replaced by the living plant after cutting. This is why curing and storage is so important post-harvest. The curing stage allows for the terpene profile to mature but, even during this process terpene potency will continue to weaken.
When flower is stored below 50-55% RH (Relative Humidity) it leads to the fragile cannabinoid and terpene-rich trichomes to become brittle and break off. This lowers potency and causes the terpenes to evaporate with the remaining moisture content. The longer cannabis and hemp are stored in these conditions, the less potent, flavorful, and aromatic they become. On the other hand, going over 65% RH is in the danger zone of where mold can thrive and wreck a harvest with bona fide rot.
Who is affected by terpene and moisture degradation?
In short, terpene degradation affects everyone. Growers see the most significant profit loss as evaporation can take pounds and pounds of cannabis away from their final numbers in as little as 14 days. Dispensaries also see a loss of profit as the flowers dry during transit and while sitting on the shelf, making it so that they paid for more than what they actually ended up selling to their customers.
In the end, consumers are eventually the ones left holding the bag. Not only is the flower at its highest degradation stage by the time it gets into their hands but loss in weight can turn a pre-packaged 3.5g eighth into 3.15 grams or less.
The example in the graphic below outlines how moisture degradation affects both yields and profit.
How can you stop your cannabis from drying out?
Using orange peels and pieces of bread for rehydration used to be the norm in what feels like ages ago. In the more recent past, cultivators, dispensaries, and consumers alike have relied heavily on moisture-control products like Boveda brand or Boost brand humidity packs. These products can help to keep moisture in the 50-65% optimal range. However, they do have their drawbacks.
The humidity packs have a definite shelf life and in extremely dry conditions, they can’t keep up with the rate of evaporation – almost to the point where many claim they don’t actually work. While they can help maintain some moisture content, they can’t rehydrate buds that have gone below the 50% humidity threshold. This makes them closer to a moisture stabilizer of sorts than a moisture booster or replenisher. Beyond using the aforementioned “ancient ways” to rehydrate abused cannabis flower, these packs have been the only option available to the industry.
However, recently a new product on the market called the “Cure-Egg” has been making waves and has been proving invaluable when it comes to product reclamation and preservation. The Cure-Egg’s patented ergonomic design and utility works in a similar way to the hydration packs but boasts the ability to rapidly rehydrate biomass in a few days’ time while staying under the mold growth threshold.
In addition to its ability to quickly rehydrate cannabis and hemp flower it also comes with the added benefit of terpene infusion to counteract terpene loss. Oftentimes beautiful-looking flower is grown but it somehow misses the mark when it comes to the nose. This product could be a game-changer for farms, dispensaries or anyone sitting on older product that has lost its zing from prolonged storage or errors in production.
Users are quickly finding out that they can take less than premium flower destined for the world of “affordable pre-rolls” and easily turn them into a flavor and aroma-packed desirable product that doesn’t have to come at a discounted price. Time will tell if this product will become the next industry staple but one thing is for certain, innovative new products are definitely shaking things up.
Peak Supply Co provides the first true all in one solution providing terpenes, vape cartridges, package design and production, helping clients progress from starting creative to finished product.
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.
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!
Member Blog: “Food Safe” Gloves Cause Cannabis Recall
A pesticide-free cannabis producer and processor from Washington was recently forced to issue a recall after the chemical o-Phenylphenol (OPP), traced back to their “food safe” gloves, was found on its products. OPP, listed under California Proposition 65 as a chemical known to cause cancer, was found in the food-safe gloves they were using to handle their crop.
In a statement announcing the recall, the company said, “Nothing ruins your day like testing your product, confident it will be clean, only to find it contaminated with some crazy, toxic chemical. The gloves were the last thing we tested, we just never imagined something sold as food safe could transfer such nastiness. The discovery was just the beginning… recalls are costly in more ways than one.”
Why “food safe” gloves can cause a recall
After initial approval, non-sterile FDA compliant food grade gloves are not subject to ongoing controls to ensure the reliability and consistency of raw material ingredients or quality processes during manufacturing. Opportunity exists for glove manufacturers to use cheap raw materials which lower glove durability and can introduce toxic compounds, which can transfer not only to products handled but also to glove users.
Demand for lower costs from the end-user pressures glove manufacturers to sacrifice quality, and substitute other compounds to meet these demands. This can include increased levels of cyanide, fungicides, inexpensive phthalate plasticizers, or others on the Prop. 65 list of chemicals known to cause cancer.
Steve Ardagh, CEO of Eagle Protect, a specialist glove supplier explains, “People assume ‘food grade’ gloves are clean and toxin free, but that’s not necessarily the case. The actual FDA Compliance does not even require gloves to be tested clean or sanitary which surprises most people. Having tested 25 different brands of gloves, we’ve found everything from feces, fungicides, Staphylococcus, yeast, and mold,” says Ardagh, “due to putrid water sources and unhygienic manufacturing conditions.”
Recalls & brand reputational damage
Single-use gloves, even those FDA compliant, can be a risk to product recalls and brand reputation. Peer-reviewed scientific studies have identified harmful toxins and contaminants in and on single-use gloves. These “food handling” gloves pose risks for companies producing consumer products, especially in industries such as organics and cannabis whose products must be clean if tested.
Staff & consumer risks
In addition, staff wearing contaminated gloves are at risk of absorbing toxins, as are the consumers of products contaminated by gloves. The contaminants have often been identified as causing cancer, and reproductive and hormonal damage.
Mitigating glove contamination risks
Gloves are often purchased with little thought or foresight into their risks. Cost is commonly the determining factor in their procurement decision-making. However, sourcing gloves from established companies who partner directly with glove manufacturers to ensure consistent quality is essential for all cannabis companies. Gloves may seem trivial, but can cause fines up to $200,000, put consumers and staff at risk, and damage brand reputation.
This is especially important currently in the post-COVID world as the glove market is being flooded with counterfeit and reject quality gloves. The new glove suppliers, traders, and brokers who came into the COVID PPE space with little or no experience, with an intention to simply trade and make quick money, are now bailing out of their poor quality junk gloves and dumping them into the U.S. market. Consider the following before purchasing gloves:
Is your glove supplier reputable, with a long history of glove sourcing direct from the manufacturer and proven quality control processes in place?
Can your glove supplier ensure your glove quality is consistently high through documented factory audits, HACCP compliance certifications and quality processes?
Have you undergone a commercial trial of products prior to committing to purchasing to ensure glove quality is consistently high?
After establishing Eagle Protect as an industry leader in New Zealand, where the company supplies approximately 80% of the primary food processing industry, Steve Ardagh relocated with his family to the U.S. in January 2016 and launched Eagle Protect PBC. Steve brought with him Eagle’s values of providing products that are certified food safe, ethically sourced and environmentally better. Steve is driven to keep consumers safe, one high-quality disposable glove at a time, and has been instrumental in developing Eagle’s proprietary third-party Fingerprint Glove Analysis glove testing program.
Eagle Protect, the world’s only glove and PPE supplier to be a Certified B Corporation®. Eagle Protect supplies disposable gloves and protective clothing to the food processing, food service, cannabis, medical and dentistry sectors in both the U.S. and New Zealand.
Eagle is implementing a proprietary third-party glove analysis to ensure a range of their gloves are of consistent high-quality, and free from harmful contaminants, toxins, and pathogens.
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.
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.
One of the direst, yet infrequently discussed, issues in the cannabis industry is the lack of federal guidelines regulating pesticide use. Despite the adult-use cannabis market consistently expanding on a state-by-state basis, as long as the crop remains illegal on the federal level, much-needed national oversight will continue to be limited.
The more states that legalize under a national prohibition, the more varying and convoluted state-by-state crop management regulations may become. Meanwhile, without standards firmly set in stone across the country, some cultivators have turned to hazardous chemicals to control pathogens and preserve their crop yields. Such cultivation solutions can compromise the safety of staff, the environment and, of course, the consumers.
Health Hazards of Pesticides in Cannabis
Even when shopping at a licensed adult-use or medical dispensary, consumers today still cannot be 100 percent confident that the cannabis they are purchasing is completely safe and free of contaminants and unwanted components, such as pesticides, harmful microbials, heavy metals, and solvents. Emerging research from Colorado State University shows that contaminants in cannabis, including pesticides, “are imminent threats that directly impact public health and wellness, particularly to the immunocompromised and pediatric patients who take cannabis products as a treatment for numerous human disorders including cancer patients and those suffering from epileptic seizures.” With many consumers turning to cannabis for its health benefits, and because it’s a natural alternative to heavily processed pharmaceuticals, the cultivation process should honor cannabis’ medical use by being as safe and accountable as possible.
The pesticide issue is compounded when we think about how cannabis is often consumed: through inhalation. Additional research has shown that nearly 70 percent of the pesticides used in cultivation remain in the cannabis flower that consumers smoke.
Even when these same pesticides are permitted in other types of American agricultural industries, this is a global anomaly. More than 25 percent of pesticides used in the U.S. are banned in other countries.
Moving Towards a Pesticide-Free Flower
So how do we work towards a pesticide-free cannabis industry? Licensed businesses, regulators, and consumers need to band together to set standards and guidelines for pesticide use across each legal state, and eventually on a federal level.
In 2020, Arizona took a page out of Oregon’s playbook by establishing a regulatory agency and adopting Oregon’s standards for limiting pesticide use in cannabis, setting a prime example for inter-state collaboration and accountability. Measures also need to be taken to lower the cost of testing cannabis products for pesticides and contaminants. And, of course, we need to embrace more sustainability and environmentally-minded education, and emerging technologies.
While testing does not necessarily prevent contaminants during the grow process, frequent, reliable, and standardized testing can help ensure contaminated products don’t make it to market. Unfortunately, testing requirements continue to differ by state, with some being more lenient than others. For instance, certain states only test for certain types of microbials, while others allow companies and cultivators to cherry-pick samples. This makes it easier for companies’ products to meet compliance, however, doesn’t ensure that the final products available for purchase will be safe for the consumer. Looking ahead towards inevitable federal legalization, testing requirements need to be uniform across all legal markets.
However, cultivators shouldn’t wait for federal oversight to hold themselves to the highest possible standards. There are inexpensive testing procedures currently available that cultivators can adopt before sending their cannabis products to the lab, which can help to better ensure what they are doing is working and catch a problem before it starts.
There are also non-toxic crop management technologies available now, and in addition to seeking out vendors offering innovation-driven solutions to replace conventional pesticides, cannabis companies and their cultivators can embrace simple, preventative measures to minimize outbreaks of bio-contaminants. This includes controlling humidity at the grow site, plant spacing, adequate air circulation, and implementing a strict chain of custody throughout the supply chain. Successful prevention mitigates the temptation to turn to potentially toxic pesticides to eradicate contaminants.
While federal legalization looms, it likely won’t happen this year. Therefore, state regulatory agencies should continue to be prepared with comprehensive outreach plans to communicate their pesticide and testing regulations to cultivators and their companies, ensuring that industry participants are fully informed. Planning and communication also sets the stage for the industry to have tried and true standards already in place by the time federal legalization does come to fruition.
The good news is the cannabis industry has the potential to lead a paradigm shift towards a safer agricultural sector as a whole. In years past, the amount of information shared between cannabis and other agricultural industries was limited, cutting cannabis cultivators off from reliable best practices for cultivation and crop management. However, this is changing quickly. Cannabis is also pushing the envelope towards more sustainable practices, with more cultivation sites moving indoors and into greenhouses, complete with LED lighting and additional sustainable practices. Cannabis cultivators are becoming more cutting-edge and setting an example for the broader agricultural community. The industry should continue these forward-thinking approaches by embracing pesticide-free solutions on a broad, scalable level.
Carlos Perea is the CEO and Co-founder of Terra Vera, an agricultural technology company offering innovative solutions to replace conventional pesticides and increase product safety and consumer confidence within the agriculture industry. Carlos is a serial entrepreneur with a focus on the intersection of technology and social impact. Prior to founding Terra Vera, he formed MIOX Corporation, a technology company that treats water in a variety of applications and is distributed in over 30 countries. He is active as an advisor and board member with several early stage companies and social enterprises including YPO, where is he an active board member. Carlos has an MBA from the Stanford Graduate School of Business, and an BS in Mechanical Engineering from the University of New Mexico.
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.
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.
Member Blog: Augmented Reality CBD, Cannabis Product Labels – Entertainment Paves Path to Education
by Gary Paulin, VP of Sales and Client Services at Lightning Labels
Everyone loves good, entertaining stories. In part, their value lies in information — and education — sticking with recipients long after the storytelling has ended.
There’s a correlation in this to the value of Augmented Reality (AR) CBD and cannabis labels — which provide a novel, entertaining way to capture and keep audience attention. Along the way, product-makers have an opportunity to provide credibility-enhancing education about products, trends, quality control, and the like.
More than ever, consumers want to feel their products protect them. Likewise, cannabis and CBD manufacturer reputation and revenues hinge on consumers feeling safe using their products, and clear about proper (and improper) uses.
Augmented Realitybrings interaction and product labeling together, using smart device apps, and even your smart phone’s camera to create an enhanced user experience. When viewers download a related smartphone app and point it at the product’s label, they can see an array of different options including videos, 2D/3D content, social media sharing options, and content that enables seeing how products appear in the real world. A web-based interaction can be launched using your phone’s camera – just open your camera app and point it toward a QR code. In either case, the AR experience is initiated, and interacting with brand labels this way is fun, interesting, and can be extremely educational.
In many ways, it’s like hearing and seeing a story. When connected to useful, practical educational information, AR can fully address common and compelling consumer concerns at a time when fears about safety and health are at an all-time high.
In turn, this can assist manufacturers looking to gain another competitive edge when it comes to consumer awareness, preference, and sentiment. This further strengthens the labels’ role as the front door to product marketing and sales.
TrendHunter.com, dedicated to trend identification, notes that AR is gaining popularity in a variety of industries, ranging from food and beverage to cannabis. Regarding labels, the site notes: “The food and beverage industry adopts augmented reality-based labels… The use of AR in food labels is on the rise, with brands using such technology to both engage and educate their customers on the products they’re considering, or have already purchased. Such items cater to consumers’ continued interest in gamification, and add an element of interactivity that tends to be limited in product packaging.”
TrendHunter.com continues: “Though consumers tend to go online and research the details pertaining to products they purchase, the amount of information to sort through can be overwhelming. Thus, having brands do some of the work in relation to product education allows consumers the freedom to purchase in-person. With tech-integrations into labeling and packaging, this process is streamlined for consumers.”
Specifically targeting cannabis, TrendHunter.com emphasizes: “Virtual and augmented reality enters the cannabis space… The merging of augmented and virtual realities with the cannabis industry is on the rise as brands look to offer immersive experiences for connoisseurs and beginners alike. These platforms offer benefits like virtual product libraries and augmented package engagement — prioritizing both informative and creative experiences for viewers… For novice consumers, being informed about this emerging space is crucial in order to alleviate some of the apprehension they feel when they’re considering consuming a substance that was once attached with stigma and misinformation.”
Here are some hands-on, straightforward ways that AR-powered cannabis and CBD product labels can engage and educate consumers:
Show products being manufactured, establishing quality controls, purity and other credibility-building examples along the way;
Relate customer stories and reviews endorsing products, benefits and efficacy;
Address claims and controversies within the industry or involving the company itself;
Document complete tracking of products from seed to shelf, proving authenticity and quality control;
Provide ways (and encouragement) for consumers to interact with a brand via AR;
Offer easy social media sharing options, so that individual consumers can become brand information hubs via their networks.
Gary Paulin is VP of Sales and Client Servicesat Lightning Labels, a Denver-based custom label printer that uses state-of-the-art printing technology to provide affordable, full-color custom labelsand custom stickers of all shapes and sizes. Contact: sales@lightninglabels.com; 800.544.6323 or 303.481.2304.
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.”
Committee Blog: Cannabis Classification and the Role of Terpenes
Cannabis is thought to have originally been domesticated in the mountainous regions of Central Asia. As humans started exploring the world, they brought the plant with them, and the plant needed to adapt to the different climates in order to thrive. This gave rise to many of the cultivars (or “strains”) we deem as “landrace,” allowing some subspecies of the cannabis plant to naturally start propagating. Since plant breeding didn’t become en vogue for thousands of years until Gregor Mendel’s work with pea plants, these natural cultivars were able to gain great genetic fitness, as well as become genetically diverse from other landrace strains as they adapted to their specific, often isolated, environments analogously to the finches of the Galapagos Islands.
We are all familiar with indica and sativa. With growing popularity of plant breeding and creating crosses of indica-dominant and sativa-dominant strains, we have largely lost true landrace cultivars that are 100% one way or the other. Almost every strain sold in the modern market is a hybrid, featuring a mixture of indica-derived and sativa-derived genes. Did you know that indica and sativa designations focus more on the phenotype, or the observable characteristics (e.g. height, leaf shape/color, and branch formation), rather than genotype, the unique DNA sequence of an organism?
In cool and dry climates, the cannabis plant leaves are broader and there is less space between branches. This creates a shorter, more compact plant that is better able to retain heat and moisture. The broad leaves help maximize photosynthesis on the otherwise short-statured indica-dominant plants. If you instead look at a warmer climate, you will see the plants grow much taller and thinner. They grow up and out more so that they can easily dissipate the heat and moisture in these warmer regions. The branches of the sativa-dominant plants are also longer and the leaves have more nodes, though they are thinner than that of an indica plant. All of these characteristics may also help prevent mold growth on a sativa-dominant plant due to better air flow within the plant.
Since indica and sativa classifications are more likely to indicate landrace phenotypes and the climate in which the cannabis plant grew in, new methods of classification are being explored to better express to consumers and patients the effects of the cannabis or cannabis-infused product they are using. For example, Leafly launched a new way for their website to categorize cannabis strains that considers terpene profiles, rather than labeling them as indica, sativa, or hybrid. Since terpenes are produced in plants other than cannabis, a description based on terpene profiles is the most compelling option, as research can be done on the effects of terpenes produced by other sources. While the entourage effect in cannabis is likely important to its variable uses in medicine, more research is warranted to fully understand the effect.
Terpenes and Terpenoids
Terpenes are plant constituents that impart olfactory, gustatory, and medicinal properties to plants. These Volatile Organic Compounds (VOCs) are “Generally Recognized as Safe” by the FDA and are composed of repeating isoprene units arranged head-to-tail to create the over 200 terpenes known to be produced in the cannabis plant. These terpenes are found in other plants as well. Terpenes generally come in three varieties depending on how many isoprene units are used to construct them: monoterpenes are composed of two isoprene units, sesquiterpenes of three units, and diterpenes of four units.
The term “terpenoid” is often used interchangeably with the term “terpene.” The difference is terpenoids are modified terpenes that contain oxygen, while terpenes are hydrocarbons containing only hydrogen and carbon. This modification usually occurs through either the movement or loss of a methyl (-CH3) group or, more commonly in cannabis, through its interaction with oxygen during the drying/curing process. As such, “terpenoids” are more correctly used to describe smokable flower, whereas “terpene” is more accurate when describing the compounds when they are being produced by the living plant.
Terpenes have three main purposes: environmental adaptation, the repulsion and destruction of predators, and the attraction of pollinators. Monoterpenes, such as limonene and α-pinene, tend to predominate in the flower portion of plants and have been shown to repel herbivorous insects in Arabidopsis thaliana, often used as a model organism of the cannabis plant, due to their volatile aromatic properties. Sesquiterpenes, on the other hand, have a bitter taste and deter larger plant-eating organisms, due to their predominance in the leaves of a plant. The sticky nature of terpenes also helps to trap bugs as they move around on the plant. From the perspective of cannabis, humans have shown to be excellent pollinators as illustrated by the diverse cannabis strains available at your local dispensary.
Terpenes are strongly inherited from parent plants and are not often affected by environmental factors over the short term. Terpene profiles, therefore, can be used to help distinguish between indica-dominant and sativa-dominant classifications due to the ratio of individual terpenes’ stimulating or sedating properties. Below are descriptions of some of the most common and best-researched terpenes. The summation of sedating and stimulating terpenes produced by the plant will determine whether the net effect of consumption will have more “indica” properties or more “sativa” properties.
α-pinene is one of the most common terpenes found in nature occurring in pine trees as well as many common spices such as rosemary, basil, and dill. Along with its role as an insect repellant, it has also been shown to have anti-inflammatory properties. It has the ability to cross the blood-brain barrier and inhibits the breakdown of acetylcholine, a neurotransmitter which can stimulate cognitive functions. This will cause α-pinene to have more of a stimulating effect.
Limonene is another common terpene found in citrus fruits. It has been shown to help with anxiety and depression by increasing dopamine and serotonin levels in the brains of mammals. Limonene has also been shown to increase alertness as well as help with weight loss and relief of gastric distress.
β-myrcene is one of the most common terpenes found in cannabis, though it is also found in hops and mangos. It gives off an earthy aroma of cloves and has been shown to have pain-relieving and anti-inflammatory properties in mice. Due to its sedating effects, it was thought to be a reliable indicator of indica strains; however, recent studies have shown that this terpene is equally present in both indica and sativa strains. The sedating properties are responsible for the ”couch-lock” effect some people experience when consuming certain cannabis strains.
β-caryophyllene has a dual use in protecting plants from grazing species since it both attracts insect predators as well as repels grazing insects. It is commonly found in spices such as black pepper and oregano and has a spicy flavor. It can act as a gastro-protective agent and is helpful in fighting stomach ulcers. It has also been shown to help combat symptoms of opioid addiction, through a process called opioid sparing. β-caryophyllene selectively activates CB2 receptors, the cannabinoid receptor primarily found in muscle tissue as opposed to brain tissue which is generally high in CB1 receptors. Due to this, it has more physically sedating properties making it a common terpene found in more indica-leaning strains.
Linalool is a terpenoid alcohol commonly found in lavender. It is a highly sedating phytochemical that is coveted for its anti-anxiety properties. It also helps as an antidepressant since it assists in serotonin-receptor transmission. As an anti-epileptic, it helps to modulate motor movements, presumably due to its sedating properties. When applied topically, it has been shown to help heal skin burns as well as treat acne.
Through a combination of these terpenes and the other 200+ terpenes found in the cannabis plant, we get a balancing act between sedating and stimulating properties. And since everything is technically a hybrid now, the cannabis industry should strongly consider other ways to categorize different cultivars, rather than just indica or sativa, to better educate the consumer on its effects.
The Scientific Advisory Committee is comprised of practicing chemists and other scientific field professionals to advise other NCIA committees as they work to develop standards and guidelines for the various sectors of our industry, ensuring that any formal recommendations produced by other NCIA committees are scientifically sound, sustainable, and legitimate.
Webinar Recording: A Spring Federal Policy and Government Relations Update
In this webinar from the morning of Friday, March 27 at 10:00 AM MT, NCIA’s Director of Public Policy, Andrew Kline, presents an update focused on federal cannabis policy issues taken up by NCIA’s Policy Council, including vaping illnesses, highlights of the findings from the Illicit Market Summit, and comments to be submitted to the DEA and NIDA. We also explore the COVID-19 responses across the United States.
Michelle Rutter Friberg, NCIA’s Deputy Director of Government Relations, shares information about how to stay politically active on behalf of cannabis policy reform while still practicing physical distancing during the COVID-19 pandemic. We explore the impact that COVID-19 is having on small cannabis businesses, plus an update on the action and movement we’ve seen in Congress, including a recent letter sent regarding Small Business Administration loans for cannabis businesses.
Speakers
Michelle Rutter Friberg
Deputy Director of Government Relations, National Cannabis Industry Association
Michelle Rutter Friberg is deputy director of government relations for the National Cannabis Industry Association. Prior to working for NCIA, Michelle was a research analyst at a government affairs firm in Washington, D.C., where she analyzed and tracked legislation on numerous issues. Michelle graduated from James Madison University in 2012, receiving her Bachelor of Arts degree in Political Science with a minor in History. During her studies, she held a year-long internship with Virginia House of Delegates member Tony Wilt (R). There, she communicated with constituents, businesses, and government officials alike, facilitating meaningful conversations. Michelle was also a member of a pre-law fraternity where she planned events and hosted social functions that sought to encourage long-lasting professional and personal relationships with members. A native Virginian, Michelle currently resides in the Washington, D.C. neighborhood of Capitol Hill.
Andrew Kline
Director of Public Policy, National Cannabis Industry Association
Andrew Kline is NCIA’s Director of Public Policy. In this new role established in early 2019 at NCIA, Andrew leads NCIA’s substantive public policy efforts, striving to prepare and protect the state-legal cannabis industry. He will also lead NCIA’s Policy Council, a group of NCIA members focused on influencing federal and state public policy. Kline most recently served as President of the National Association of Cannabis Businesses (NACB), the first self-regulatory organization for the high-growth cannabis industry. At the NACB, Andrew led the creation of national standards for the state-legal cannabis industry, oversaw its standards governance board, and led day to day operations and strategic planning. Kline has a deep and celebrated background in public policy, law enforcement, and coalition creation/management. He is renowned for his ability to create solutions to complex domestic and global public policy issues that appeal to both private and public constituencies.
Member Blog: Pathogens And Public Health – The Dire Need To Detect Microbes
As a new industry, cannabis has the opportunity to do business the right way. From day one. Many industries have come before ours, making missteps as well as setting best practices. In fact, we have the Harvard Business Review articles to prove it.
That’s why it frustrates me to no end to see industry players short-cut the right path forward. One of those areas is testing. In every consumer product area, testing is vital to ensuring consumer health and safety, but it is even more dire for products that are consumed or inhaled.
The Dire Need to Detect Microbes
Microbial contaminant testing is a critical step in the supply chain for all food and agricultural products, but it becomes ever more important to ensure cannabis products are verified as free of hazardous contaminants as cannabis-derived products become accepted treatments for various medical conditions.
Currently, the regulatory framework for evaluating the safety of cannabis products differs from state to state, with an abundance of clinical cases to back up the reason for testing, and the availability of technology to meet the safety standards to protect immuno-compromised patients and consumers. Conventional methods such as Petri-dish culturing and qPCR methods are not nearly as accurate or sensitive as commercially available, next-generation technology such as DNA microarray testing. Yet, the continued use of these outdated methods opens up the possibility that dangerous and deadly contaminants can enter the supply chain, and get consumed by millions of consumers.
In a recent study released to regulators and labs across the country, it was presented that plate culturing and qPCR testing was unable to detect the presence of a deadly fungal species, Aspergillus, that is presently common in both recreational and medical marijuana. A different technology, the DNA-Microarray tests not only detected Aspergillus, it also identified the exact species of the fungus, a nuance that requires longer testing times and additional testing steps when using petri dishes or qPCR methods.
Technologies such as sequencing and DNA microarrays can test for dozens of different deadly pathogens multiple times simultaneously from the same sample, whereas plate and qPCR methods test for a single or limited number of microbes. What this means is definitive confirmation when using the Microarray technology. This is where the technology is different and better, and also saves on costs, streamlines the entire testing process and reduces any opportunity for operator error.
In addition to being more accurate, DNA microarray testing is also faster. Plate methods require microbials to be cultured before being tested, which takes a minimum of 24 hours and often closer to a week for slower-growing organisms, such as many fungi including Aspergillus. In contrast, DNA Microarray testing yields results in six hours, and reduces harm to lab technicians by not subjecting them to large amounts of live cultures.
The point here is when technology is available that protects consumers and patients to an even greater level, is faster and more economical to process, and better in terms of performance, then why should the cannabis industry walk down the same path other industries have traversed, and one which they have tripped over multiple times? Why not learn from the lessons of these other industries and set a path that ensures greater safety and quality to the product?
History Not Worth Repeating
We’ve seen what happens when industries and governments turn a blind eye to deadly matters. In the pharmaceutical industry, the FDA came under scrutiny after a study found that excess dosages of the Merck drug Vioxx tripled a patient’s risk of cardiac arrest. In front of a Senate Finance Committee, the FDA was asked why danger signals of Vioxx went ignored. Questioning specifically focused on its relationship with the drugmaker, its expedited review process and the timeliness in conducting and stopping clinical trials when potentially adverse information was found that put the public at risk.
And yet, a similarly concerning matter remains ongoing with asbestos makers. The U.S. began regulating asbestos in the 1970s but has yet to ban the mineral, despite it being the number one cause of work-related deaths in the world. In fact, evidence suggests there is no safe level of asbestos exposure.
Similarly, science shows that there are no safe levels of Aspergillus. All it takes is one spore to kill. Sub-par and outdated testing methods not only risk the health of immunocompromised patients, it also puts consumers exposed over a period of time into the line of fire – as well as the credibility of the industry as a whole. Regulators need to demand cannabis is 100 percent contaminant-free by using testing methods that deliver absolutely proven and reliable results.
A number of stakeholders in the industry and beyond have reason to take up the call. In the recent e-vape crisis over 2,000 people have been hospitalized and 50 people have died due to lung infections. The pathogenic strains of the Aspergillus family would exacerbate this crisis further, and so gives the industry reason to ‘tighten’ the regulatory framework even more so not only with trusted testing methods, but ones that definitively protect public health. Even today in certain states that have not mandated testing of Aspergillus, but only mandating testing of Yeast & Mold, those states are allowing their consumers and patients to inhale Aspergillus ultimately fueling a national pandemic in lung infections. Just reference a peer-reviewed scientific paper by Kagan MD et al in the Journal of Allergy Clinical Immunology published in 1983, where the authors concluded that “[t]he use of MJ thus assumes the risks of both fungal exposure and infection, as well as the possible induction of a variety of immune and infectious lung disorders. Given the extraordinary number of individuals estimated to be MJ smokers, the occurrence of these illnesses may well become more commonplace”.
Sometimes the way things have always been done just isn’t good enough anymore. Technology has changed the way we take pictures, listen to music and even hail a ride. Can you do those things the old way? Sure, but they won’t have as much definition or clarity. It won’t be as convenient or cheap. When there is truly a better way, why wouldn’t you change?
And that’s what we ask when it comes to protecting the supply chain, a place where quality and accuracy cannot be compromised. When it comes to which testing method is the best, there is a clear choice – a choice that literally comes down to life and death. In order to safeguard both consumers and the legitimacy of the industry, cannabis stakeholders should demand labs use rigorous testing methods that pinpoint pathogens and protect public health.
Photos by Michael Chansley Photography, www.michaelchansley.com
Mr. Patel leads the strategic vision, financial health and global growth of PathogenDx, a Scottsdale, AZ based company which provides disruptive DNA-based pathogen testing technology and solutions for the cannabis, botanical, food and agricultural industries.
Previously, Mr. Patel spent over 25 years working with large public, small private and entrepreneurial companies in numerous fields from the life sciences, to biotechnology, to government services and the automotive industry. Milan served as COO/CFO of GMSbiotech. He also was CFO of 2020 Company, LLC, a leading premier professional services firm that delivered business and technology solutions to the government, in the areas of health, education and science.
Mr. Patel also worked at Intel Corporation in Sales & Marketing, Finance and Manufacturing. He has extensive experience in corporate finance, mergers and acquisitions, business strategy and planning, infrastructure and organizational development, and controls, compliance and audit and has led several company exits.
Milan earned his BS in Electrical and Electronics Engineering from the University of Detroit Mercy; a MS in Biomedical/Medical Engineering, University of Michigan; and a MBA in Finance and Marketing, University of Detroit Mercy.
NCIA Committees: Quarterly Update And A Look Ahead
NCIA committees are an opportunity for members to get directly involved in specific industry issues and sectors. These volunteer-driven efforts engage members’ expertise and passion to drill down in areas of expertise and passion to effect change, provide professional development opportunities, and develop best practices and guidelines that will shape the future of our industry.
We recently checked in with these various committees to learn more about what they’re up to and what projects they’re working on this term. Get updated on their activities below.
Scientific Advisory Committee (SAC)
SAC is comprised of practicing scientists, physicians, and other scientific field professionals. SAC’s vision is to disseminate educational materials to NCIA members on scientific topics in the cannabis industry and to advise other NCIA committees as they work to develop standards and guidelines, ensuring that any formal recommendations produced are scientifically sound, sustainable, and legitimate.
SAC is currently working on five projects, all of which are in the outline or first draft phase:
1) Blog on the science behind why ‘sativa’ and ‘indica’ are no longer the best way to classify cultivars.
2) White paper on how cannabis may help the opioid crisis with a review of scientific studies that show how cannabis can be an alternative for pain management.
3) Blog calling doctors to action in the cannabis industry and why it is important for doctors to get involved.
4) Blog on the vaping crisis from a physician’s point of view. 5) General audience and technical white papers on the Endocannabinoid System.
Marketing & Advertising Committee (MAC)
The MAC coalesces the talents of 20 of the industry’s top-tier marketing and communications professionals around three focus areas: Education, Advertising Access and 2020 political goals. We use our personal, professional and business skills and networks to help build a responsible, legal cannabis industry. The committee is producing best practices, webinars, workshops and social media campaigns to aggregate and generate support from NCIA members, the public, media, government and business leaders.
In our first quarter, our Education Sub-Committee began creating a Speakers Bureau to provide qualified experts for conference organizers and media who will address topics of interest and concern in the industry.
Our Advertising Access Sub-Committee is completing best practices for advertising, making presentations to media groups and expanding Advertising/Labeling Do’s and Don’ts from five states to all legalized states.
Our 2020 Sub-Committee is driving awareness around policy change through panel presentations, preparing a campaign supporting pro-cannabis candidates and is encouraging professionals from the cannabis industry to run for office.
Cannabis Cultivation Committee (CCC)
We are working on producing our first podcast episode, which will feature top-notch farmers who are doing great work employing sustainable practices in indoor facilities.
There will be more podcast episodes to come on other hot cultivation topics.
State Regulations Committee (SRC)
The State Regulations Committee has been hard at work on a number of exciting pieces of work-product that should be available soon. For example, we hosted a webinar on December 3, 2019, in which the expert members of the Committee break down what operators need to know about Michigan’s adult-use market’s rules before it launches in 2020.
The State Regulations Committee has work-product in the pipeline on a number of topics of great importance to members. That includes a recurring guidance series on social consumption in markets across the nation, posts analyzing challenges in local/municipal regulation, a focus on the crucial questions of promoting social equity, and much more.
Cannabis Manufacturing Committee (CMC)
The Cannabis Manufacturing Committee is focusing on reviewing existing business practices and state regulations of concentrates, topicals, vaporizers and, edibles ensuring the manufacturing sector is helping shape its destiny. In this approach, we have published our first blog using lessons learned from the e-cig sector. We are also engaging with NCIA’s Safe Vaping Task Force.
CMC has created three sub-committees; GMP (Good Manufacturing Practices), Testing (from the operator’s view), and Nomenclature (providing clarity to industry language). GMP has its first draft complete and will be ready for publication in November. Nomenclature has a concrete draft to review for publishing its first part of a multi-piece series.
Packaging & Labeling Committee (PLC)
The PLC has 4 subcommittees: Honesty & Labeling, Sustainability, Security, Next Generation Packaging. Each subcommittee has set a goal of producing 3 or more blogs and 1 webinar. We have a very motivated and strong group this year. Our biggest vision for the year is to use our data, blogs, white papers, webinars, and PLC members’ knowledge to create a document reflecting the industry views on what federal policy should be around packaging and labeling.
The Retail Committee is working on a compilation of SOPs for retail compliance to turn into a white paper and webinar series, combining efforts from various retailers in several states/markets in order to be most useful to the national audience.
Facilities Design Committee (FDC)
As a new committee, we have established a mission statement: To provide access to resources for the NCIA community and regulators that will inform the design and use of GMP-driven, sustainable and operationally efficient facilities to position our industry to compete in the global marketplace.
We have established two sub-committees: Standards and Sustainability. The Standards Sub-Committee is linked through membership to ASTM’s D37 committee on cannabis.
Banking & Financial Services Committee (BFSC)
Our vision is to provide reliable, actionable and current information to NCIA’s members via committee member videos and a monthly newsletter. The committee will also be coordinating “NCIA Panels” at Bank and Credit Union conferences throughout the country to spread awareness to the issue and bring these institutions closer to the industry.
Lastly, the committee will be contributing language to the Policy Council for revision of the current version of the SAFE Act.
We will keep the NCIA updated as the Bank and Credit Union panels are confirmed. The committee will continue to pair any operator with the best banking option based on a myriad of factors, free of charge.
NCIA’s Safe Vaping Task Force Submits Testimony
Last week, the Center for Disease Control (CDC) identified a probable proximate cause of recent vaping injuries and deaths. Simultaneously, the United States Senate (HELP Committee) noticed a hearing for tomorrow (Wednesday) on the vaping crisis, where CDC officials will testify.
NCIA Policy Council’s Safe Vaping Task Force has submitted testimony for the record, which can be found here.
For weeks, NCIA’s Policy Council has been calling for de-scheduling and regulation at the federal level to displace the illegal, untested, unregulated illicit market. It’s time for Congress to act. We can no longer sit by and watch as people are sickened by unregulated, untested, and dangerous products from the illicit market.
Former FDA Commissioner Calls For Descheduling And Federal Regulation
by Andrew Kline, NCIA’s Director of Public Policy
With uncertainty about the proximate cause of the vaping crisis continuing to roil state regulators, and state governors trying to determine the right short-term solution to protect the public health, the former Commissioner of the FDA has a longer-term plan. Former Commissioner Scott Gottlieb is rightly calling for descheduling and federal regulation in an op-ed in the Wall Street Journal. NCIA made the same argument in our Policy Council’s recent white paperon regulating cannabis post-legalization and in our public responses to the vaping crisis.
While no one yet knows for certain what has been causing these injuries and deaths, it is readily apparent that unregulated and untested products are extremely dangerous and continue to infiltrate the market. Just last week, a mother and her two sons were arrested for allegedly illegally filling over 30,000 vape cartridges in Wisconsin from their home. That burgeoning illicit and untested market poses real risks to American consumers. And the best way to eliminate the illicit market is to create opportunities for consumers to purchase products from legal dispensaries and market awareness of the benefits of purchasing from those regulated markets.
For example, if consumers know that legal dispensaries are selling regulated products that have been tested to improve consumer safety, then they will be more inclined to stop purchasing from the illicit market. People already know that when they step foot into a grocery store, the foods they eat and the drugs and dietary supplements they take are part of a supply chain designed to improve safety. That is because they have placed trust in the USDA and FDA. And no better way to build consumer confidence, than to make sure that trusted federal agencies are in charge of promoting public health in the cannabis industry.
We can’t continue to leave the cannabis industry in a state of uncertainty. It’s time to deschedule, regulate at the federal level, and require mandatory lab testing. We must displace the illegal, unregulated and untested illicit market. There is no plan B.
Andrew Kline is Director of Public Policy for NCIA and Chair of NCIA’s Safe Vaping Task Force
Member Blog: Cannabis Seed To Sale Transparency Provides Solution To Vaping Illnesses
by Jessica Billingsley, CEO of Akerna NCIA Board Member
The day I sat beside the MRI while my daughter’s mystery neurologic symptoms were investigated, I began my crusade for product transparency. I didn’t know then that transparency in products would become life’s work. On that day, I only knew my daughter risked potential long term physical and mental disability due to unknown causes. I then spent months, which turned into years, hunting for a solution to her neurologic events, which started with an unexplained fever that would sometimes develop into lesions in her brain causing varying symptoms depending on the location of the lesions. Often the symptom manifested as trouble walking; however, one heartbreaking time, she slurred her words and couldn’t remember many basic components of speech.
She was diagnosed with recurrent ADEM, an autoimmune demyelinating illness that doctors didn’t understand and were at a loss to cure. The western medicine approach didn’t have an answer, and I wasn’t really surprised. Western medicine’s approach of diagnose and drug (or diagnose, surgery, and drug) rarely takes into account what we put in and on our bodies. And my gut told me I needed to take a closer look at foods and products to find the source of her illness. This is a lot easier than it sounds. We actually know very little about what’s in our products. There’s an assumption that harmful ingredients or additives have to be disclosed in products, but they don’t. My journey into product transparency — looking at ingredients, additives, and the chemicals used to make our products — led me to find a solution for my daughter that has resulted in her being 7 years in remission and counting.
My passion for saving my daughter and my tenacity in peeling back the layers in our consumer product goods supply chain left me with a sobering conclusion: Consumer transparency and public safety is not at the forefront of our current consumer goods regulations. We don’t have any requirements to give consumers transparency regarding what’s fully in the products we eat or absorb. That perspective is what inspired me to launch the first seed-to-sale tracking technology in 2010. I believed then that cannabis patients needed to know how their medicine was grown and the public needed assurances that we can identify the regulated, tested medicine from the illicit alternatives.
The number of vaping-related illnesses keeps climbing. The crisis has claimed at least six deaths and there are over 450 cases in 36 states and the U.S. Virgin Islands. And best, early thinking is additives – cutting agents, potentially Vitamin E – may be the culprit. I am reminded clearly of my daughter’s early years and my hunt for product transparency. We’ve done a lot of good with seed-to-sale tracking in cannabis. The regulated cannabis industry has the most transparent and accountable supply chain of any consumer packaged good.
For nearly ten years, my team has refined a technology that pinpoints most every aspect of every gram of cannabis tracked in our system — the plot of land it was grown on, soil nutrients, water and light intake, additional ingredients for edibles, when it shipped out and in what batch, and finally where and when the product was sold and to what patient. The exactness and granularity of this data enables prompt reactions in times of crisis that narrows down areas/people of impact, points investigators to probable causes, and importantly allows consumers and patients to make informed decisions.
As much as we do track in regulated cannabis, we need to track more. Most governmental compliance frameworks don’t require additives to be tracked and thus communicated to consumers and patients. We need to make this mandatory in our regulations.*
Consumers and the industry should rally around three things. First, the majority of the cartridges in this crisis were purchased on the illicit market with completely unknown ingredient sources, which gives more reason to legalize cannabis in every state for adult use. Second, legal markets should continue to implement seed to sale tracking compliance as table stakes. And third, we need to make additives information a requirement for cannabis oil manufactured products.
I knew the industry needed a means of monitoring products through its lifecycle and generating transparency and accountability to support the 3P’s — patient, product, and public safety. I know the data in our system has the power to do great good — for science and medicine, for food and agriculture, for communities and tax revenues, for governments’ ability to respond to issues and effectively direct investigations and enforcements. I contend that while the industry is part of the health crisis story today — we are part of the response tomorrow. I am as committed today as CEO of Akerna as I was when I started MJ Freeway; we can give consumers the full product transparency they deserve to make the best choices for their health. It’s what I want for my daughter, and it’s the solution I commit to deliver every day.
Jessica Billingsley is a technology pioneer, solutions creator and industry leader, providing proven compliance software solutions to the cannabis market. She is the Chief Executive Officer of Akerna—the first cannabis compliance technology company to be traded on Nasdaq—making her the first CEO from this market space to bring a company to a major U.S. exchange. Jessica is also the CEO of Akerna’s flagship subsidiary—MJ Freeway. She established MJ Freeway in 2010 and it is the leading seed-to-sale regulatory compliance technology provider and developer of the cannabis industry’s first enterprise resource planning (ERP) platform. Akerna also offers Leaf Data Systems as a government resource for public sector compliance. Combined entities tracked more than $16 billion in world-wide, client cannabis sales to date. She is the first woman ever from the cannabis industry to receive the prestigious Fortune’s “Most Promising Women Entrepreneur Award” and is also recognized as one of Inc.’s “Female Founders 100.” Jessica received a degree in Communications and Computer Science from the University of Georgia and lives with her daughter in Denver.
Akerna’s MJ Platform includes “additives” as ingredients clients can use to communicate to patients any additives in a finished gram of oil. We believe additive ingredients should now be a required data field captured and communicated to patients, and we’re committed to training our existing client base on how to do so.
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Andrew Kaye has been involved in all aspects of the financial services industry, as a fund portfolio investment manager, investment banker, family office investor and attorney. He has worked with start-ups on their first raise through global enterprises undertaking billion-dollar stock offerings, and has significant investment experience in the cannabis industry. Currently, Andrew works as Sweet Leaf Madison Capital’s Chief Commercial Officer. Lending his expertise toward the creation of middle market financing solutions for real estate and equipment financing needs in the cannabis space.”
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