Nearly 40% of the nation’s top 100 CBD brands focus on need states. Chief among them is sleep, something the American Academy of Sleep Medicine (AASM) reports that 85% of Americans are falling far short of.
The 7.2 million sleep-related Google searches logged this past year provide ample evidence of interest. according to NBC News, which reports that 9 million Americans take prescription drugs to help them fall asleep.
Others prefer more natural solutions.
Nearly 11 million rely upon CBD and/or cannabis-based products to manage insomnia or sleeplessness, according to a 2021 report issued by High Yields Insights. Among them, almost 70% are women considered statistically more likely to suffer from insomnia.
YOUNG AND RESTLESS
Millennials are driving the bulk of market growth. Together, with a smaller percentage of Gen Z consumers, these severely stressed consumers represented 48% of the U.S. CBD market in the fourth quarter last year, according to High Yields Insights President Mike Luce.
Regardless of age or gender, brands like CBDfx are discovering that an ever-increasing number of their customers are using CBD to treat sleep-related issues. The Brightfield Group reports more than 58% of CBDfx customers purchased sleep products in the fourth quarter.
Collectively, 40% (4 in 10) of consumers, rely upon CBD to manage insomnia or sleeplessness, according to a recently issued High Yield Insights and InnovateMR 2021 sleep trend report.
FIGHTING FOR SLEEP
Growing pandemic-related uncertainty, anxiety, and associated sleep deprivation issues have kept sleep specialists like Colorado-based Pulmonologist Dr. Julie Whitaker, struggling to manage ever-increasing patient loads.
“We’re not seeing everyone we should,” says Dr. Whitaker, who sees the need to elevate the understanding of the importance of sleep, particularly among Americans.
The pandemic helped to elevate awareness of the importance of good sleep and has softened the momentum of the “sleep is for suckers” mantra, according to the pulmonologist.
CBD and cannabis brands are seeing significant growth, most notably among 25 to 35 year-olds. Although millennials dominate the growth trends, one brand reported moms 40 – 50 years of age are among its fastest-growing demographic.
Veterans, known to experience higher levels of insomnia (57% veterans) than the general population (30%), face elevated pandemic-related risks. Among veterans with Post-traumatic stress disorder (PTSD) or a traumatic brain injury (TBI), the rates are even higher — 93%, according to the Department of Veteran Affairs in San Diego.
Sleep specialists, like Whitaker, are particularly concerned about the stress levels in at-risk populations, particularly women- and veteran-headed households, whose support needs are more imminent.
When it comes to sleep, routines are important, according to the specialist who recommends patients develop healthy and consistent sleep routines, avoid consuming alcohol and OTC products known to disrupt sleep cycles, particularly antihistamines known to disrupt healthy sleep patterns.
CBD AND CANNABIS EFFICACY GROWING
In regard to other solutions, Dr. Whitaker says there’s “reasonable scientific evidence,” that CBD, particularly when combined with a small amount of THC, can help promote sleep.
Two in five working moms use cannabis, according to a newly minted survey released by San-Francisco analytics firm Lucky Analytics.
Women are helping cannabis brands like Ganja Goddess achieve record-breaking triple-digit sales growth. The cannabis company reports a 635% increase in its sleep lines last year, according to its SVP of Marketing Heidi Genrich.
Gummies provide a popular entry point, according to Incredible Edibles Brand Director Jessica Benchetrit, whose company helps make cannabis more accessible via entertaining and informative educational sessions.
“Consumers are looking for an enhanced sleep experience, says Benchetrit. “The majority (78%) are actively seeking out ‘indica-like’ edibles.
Incredibles’ Snoozzzeberry gummies climbed to the number one infused gummy product in the markets it sold in, during the fourth quarter of last year, according to BDS analytics reports.
A 2019 study published in the Journal of Alternative and Complementary Medicine, found cannabidiol (CBD) improved the sleep quality and reduced nightmares of 38% of the participants, all of whom had PTSD.
Joseph Maroon, M.D., a clinical professor and neurosurgeon at the University of Pittsburgh Medical Center who has researched the effect of cannabis on the brain, says that CBD has properties that could help some people sleep better. Most notably, he says, it appears to ease anxiety and pain, both of which can make it harder to fall asleep or stay asleep, according to a published statement in Consumer Reports.
“CBD is safe,” says Dr. Daniel Clauw, an internationally known pain expert and head of the University of Michigan Director of Chronic Pain and Fatigue Center, who frequently collaborates with the Arthritis Foundation on education efforts.
Among sleep associations, the American Sleep Association has indicated that cannabis may help induce sleep in people with insomnia, anxiety or post-traumatic stress.
A MEANINGFUL IMPACT
“People are interested in better ways to relax at the end of the day,” says Ginrich. “And they are increasingly concerned about safeguarding their well-being over the long term.
“Stress and anxiety are not going away, so products and rituals that help people sustainably manage these pressures are in high demand,” adds the Ganja Goddess Marketing Director.
We all have a role to play in helping put America’s sleep issues to bed.
Author Jackie Berg is the publisher of the Health Hub, a publication division of CBD Marketing Hub, as well as the publisher of TheHUB Detroit, TheHUB Flint and recipient of the Association of Women in Communications 2018 Vanguard award. To learn more CBD Marketing Hub, a cultivator of CBD and cannabis clients, visit its website or reach out at email@example.com.
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.
…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.
Member Blog: GMPs – A Way Ahead for Hemp and CBD Firms
The hemp industry is the marijuana industry’s half-sister. Both are variations of the plant cannabis sativa and both were made illegal in 1937 with the passing of The Marijuana Tax Act. Flash forward to the Agriculture Improvement Act of 2018 (known as the 2018 Farm Bill) that was signed into law by Congress on December 20, 2018. One year later, The USDA issued interim regulations that entitled Establishment of a Domestic Hemp Production Program for the cultivation of hemp on October 31, 2019. Both were huge steps forward for public access to hemp and hemp products. FDA legalized the growing of hemp in states with a state-mandated hemp program and removed hemp and its derivatives from Drug Enforcement Administration (DEA) Schedule I status and the U.S. Domestic Hemp Program aims to approve cultivation plans issued by states and Indian Tribes.
Even so, then FDA Commissioner Scott Gottlieb issued a statement hours after the signing of the Farm Bill reiterating that “Congress explicitly preserved the agency’s current authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and section 351 of the Public Health Service Act.”
Still today, two years later and counting, FDA only permits CBD products submitted as an Investigational New Drug (IND) Application as a pharmaceutical and there remains only one such accepted CBD product, Epidiolex, manufactured by G.W. Pharma. All other CBD products are illegal for interstate shipment.
In-state production and sales may be a different story, provided that state has a mandated hemp program. In those cases, provided state law is followed, production and sales are legal and protected, but the minute products cross state lines, they become the jurisdiction of the federal government and, more specifically, the FDA. At least 47 states have enacted legislation to establish hemp production programs or allow for hemp cultivation research.
Section 10113 of The 2018 Farm Bill states that (c) Nothing in this subtitle shall affect or modify:
(1) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.);
(2) section 351 of the Public Health Service Act (42 U.S.C. 262); or
(3) the authority of the Commissioner of Food and Drugs and the Secretary of Health and Human Services- ‘‘(A) under- ‘‘(i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.); or ‘‘(ii) section 351 of the Public Health Service Act (42 U.S.C. 262); or ‘‘(B) to promulgate Federal regulations and guidelines that relate to the production of hemp under the Act described in subparagraph (A)(i) or the section described in subparagraph (A)(ii).”
The mission of the FDA is “to ensure the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.” As such, FDA categorizes every product for sale in the U.S. which is either ingested or applied to a human or animals into categories. That means hemp-derived CBD products will have to lawfully fit into one of those categories, however, while there has been positive movement towards the legal sale of hemp products on the USDA cultivation side, the FDA has authority over foods and dietary supplements, and the FDA’s position is that the addition of hemp/CBD to a food or dietary supplement is “violative.” In a Consumer Update statement revised on November 25, 2019, the FDA clearly stated that “it cannot conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food.”
That being said, FDA has indicated it would be open to review of safety data for submission of a cannabinoid as Generally Recognized as Safe (GRAS) for Food or as a New Dietary Ingredient (NDI) in a supplement as the lack of any federal regulation runs the potential of putting people at risk. That has sent the industry scurrying to design and initiate studies in the hopes of demonstrating levels of safety that meet FDA’s satisfaction.
In the meantime, those currently operating in states where hemp manufacturing is legal, must ensure Good Manufacturing Practices (GMPs) are adhered to closely. Should the FDA ever allow hemp products with CBD to be sold in the future, a manufacturer’s ability to demonstrate understanding and compliance with GMPs will be critical. Each FDA regulated industry has its own set of GMPs for the development and implementation of quality systems.
21 CFR 117, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food
21 CFR 507, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Food for Animals
21 CFR 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
21 CFR 210, Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General
21 CFR 211, Current Good Manufacturing Practice for Finished Pharmaceuticals
FDA Draft Guidance for Industry, Cosmetic Good Manufacturing Practice, June 2013
As the industry waits in the hopes that FDA will come on board with those states that have already legalized CBD’s use in products, it important to take the necessary steps to develop GMP protocols and quality systems as part of documented Standard Operating Procedures and record-keeping that those procedures are being followed, products are being tested and those tests are being validated.
Ensure as you begin to develop or strengthen your GMP programs that you do so with a full understanding of the requirements set forth in 21 CFR 111. Whether these programs are designed in-house or with the assistance of an outside consulting firm, ensure your GMPs are specific to your manufacturing procedures as opposed to a stock one-size-fits-all program. A reputable consulting firm with demonstrable expertise in FDA regulations and in helping to develop these GMPs is a good place to start, one that listens to your questions and concerns before providing you their stock answer. A good consulting firm can walk you through your unique processes.
Ensure your quality systems are robust and documented, including your demonstrations that your cGMPs are being followed.
Charlotte Peyton supports EAS Consulting Group CBD and hemp clients as well as that of dietary supplements and pharmaceuticals. As an independent consultant, she assists with projects ranging from startup through manufacturing and support. Her expertise includes quality, regulatory and management, method development, and method validation for FDA regulated drug, dietary supplement, and bioanalytical samples. She has extensive experience in writing validation protocols, reports, and SOPs and assists with implementation of stability programs and report writing for finished products.
EAS Consulting Group, a member of the Certified family of companies, is a global leader in regulatory solutions for industries regulated by FDA, USDA, and other federal and state agencies. Our network of over 150 independent advisors and consultants enables EAS to provide comprehensive consulting, training, and auditing services, ensuring proactive regulatory compliance for food, dietary supplements, pharmaceuticals, medical devices, cosmetics, tobacco, hemp, and CBD.
Meet The Team: Madeline Grant – NCIA’s Government Relations Manager
by Madeline Grant, NCIA’s Government Relations Manager
It’s funny how things just happen… one day, like any normal day, I was working the lunch shift at a restaurant called Carolina Ale House in Columbia, South Carolina. At first, I was worried about how much I would make in tips that day, as anyone with experience in the service industry can relate to, but then I started chatting with one of my tables… small talk, really. I told them how I was a sophomore at the University of South Carolina studying journalism and mass communications with a focus in public relations and a minor in women and gender studies. One man asked, “Well what do you want to do after college?” A question I thought about often but never had an answer to. He handed me his business card and asked if I was interested in politics. A few days later, I reached out, interviewed with the firm partners, and successfully scored the internship.
As I entered the political realm, I knew close to nothing but had a desire to learn as much as possible. Growing up, I was never really introduced into the world of politics as my parents didn’t say much about it – it was a whole new world to me! I attended caucus meetings, sat in the Senate and listened, followed legislation pertaining to their clients, researched, etc. My boss walked in one day and said he had an interesting project for me: to research and find everything I can about medical cannabis. I discovered so many fascinating miracle stories such as the effectiveness of medical cannabis for children with epilepsy. Seeing the great benefits and possibility, I kept thinking: why is this classified a Schedule 1 substance?
Fast forward to the classic “college graduate in search of a job” situation. I moved back home to Frederick, Maryland and started as an intern on Capitol Hill. After two months of interning, I landed a job on Capitol Hill and fell passionately in love with health issues (every staffer that went the legislative route had their assigned issues to become experts on). I began to learn more about cannabis and the detrimental effects of its Schedule 1 status.
Cannabis being classified as a Schedule 1 substance deems it to have a high potential for abuse, no currently accepted medical treatment use, and lack of accepted safety for use under medical supervision. Because of this classification, we can’t fully explore the medicinal benefit that it can in fact offer.
As I started taking more meetings with cannabis advocates, lobbyists, and patients, there was one significant group that stuck with me: a group of mothers and children with debilitating chronic diseases. The mothers were there to advocate on behalf of their children who significantly benefited from CBD oil. They told me a story about a family that uprooted their entire lives for their epileptic child because CBD was the only medicine that was working to reduce the seizures. On that day, I realized how important cannabis is for patients and how it truly can make an unlivable life livable. And that was JUST CBD. Can you imagine what we could gain from the whole plant? If we had the ability to research every single component of the plant, we could begin to know the full, true potential of medical cannabis.
The Schedule 1 status of marijuana hinders research and that needs to change, but thankfully, I can help.
As the Government Relations Manager at NCIA, I passionately lobby for those patients and businesses. I’ve been at NCIA for nearly three years and slowly but surely I’ve seen a significant change in the stigma associated with cannabis on Capitol Hill. It is my job to educate members of Congress, Hill staffers, and the public on all issues the cannabis community faces. This can include anything from cannabis business getting access to banking to educating members on the injustice the war on drugs had on Americans. My job is to educate and tell your stories which I do with great honor. I’m proud to represent you and what you do in the cannabis community.
As we are at home, I would love to meet with you virtually!
As I am unable to be on Capitol Hill right now, I want to use my time to compile your stories to forward to Hill offices, so please reach out if you are able and willing to tell your story. Stay safe and healthy.
Committee Blog: Cannabis Banking – Regulatory Outlook and Effective Compliance
During a recent webinar, we polled the audience on their current positions on offering financial services – traditional financial services – to direct marijuana-related businesses (MRBs). The results, as you might imagine, were mixed but we identified one common theme: The vast majority have taken action to address cannabis banking issues. This has been the theme we’ve been championing for years. The dichotomy between state and federal cannabis laws has placed our financial institutions in a precarious position: Bank the cannabis industry, be first to the market in doing so, create a non-traditional revenue stream and help to solve public safety and other logistical issues by solving the all-cash conundrum OR continue to watch from the periphery as others take the leap?
We see the number of financial institutions – banks and credit unions – that offer financial services to cannabis businesses expanding, but not to the level suggested by FinCEN SAR data. There remains a critical need for financial services within the cannabis industry.
Why the hesitancy in tackling this issue?
The current regulatory environment is a critical factor. As it stands, our industry is relying primarily upon the FinCEN guidelines to offer financial services to cannabis-related businesses. These guidelines, coupled with a surge of proposed legislation and a regulatory perspective on risk-based risk-taking, have allowed financial institutions across the country to effectively provide financial services to cannabis-related businesses. There is a key term we’ve been using: cannabis-related businesses. Within this term, we encompass direct and indirect marijuana-related businesses, hemp, and CBD entities. The majority of those polled feel more comfortable with hemp and CBD entities primarily due to the passage of the 2018 Farm Bill. Getting into the intricacies of how the Farm Bill and the USDA’s resulting interim final rule have added a layer of complexity to banking hemp and CBD businesses is more than we can cover in this blog post. Let’s focus instead on those providing financial services to direct MRBs, those that are state-legal, licensed cultivators, extractors, and dispensaries.
It IS possible to actively bank direct MRBs, to offer stable banking services that bring the cash off the street and provide a means for these businesses to operate more effectively and efficiently, and surely in a less costly manner than an all-cash business. The regulators are not criticizing financial institutions for providing financial services to MRBs; they review these services as they would any higher-risk, complex activity. When an institution takes on too much too fast or does not have sufficient controls to know whether it actually has a higher risk or complex business concentration within its customer base, the regulators will be critical… as they should be.
So, what are they looking for?
This goes back to the theme we mentioned: Financial institutions actively addressing cannabis banking issues.
Every financial institution, whether it intends to bank direct or indirect MRBs, hemp or CBD should have a Cannabis Banking Program that assesses the inherent risks of doing so, speaks to the controls necessary to effectively manage those risks, and determine whether they are well-positioned, or have a risk-appetite for, providing financial services to the cannabis industry. Conversely, if a financial institution that has no appetite for, or does not reflect sufficient regulatory health to bank cannabis, it must establish effective controls to ensure that position can be maintained.
But, this post is about empowerment. It is about speaking to the regulatory environment in which we find ourselves. It is about providing the perspective that banking marijuana, hemp and CBD CAN be done effectively, safely and soundly. Yes, there is a significant level of infrastructure needed to do so. Yes, it does come with the need for ongoing, strong risk management and control enforcement. Yes, it can be a bit scary. By establishing a Cannabis Banking Program, comprised of a comprehensive risk assessment that drives an equally comprehensive policy, a financial institution can provide financial services across the spectrum of marijuana, hemp and CBD, and undergo regulatory scrutiny with confidence. Moreover, such a program has become a regulatory expectation to support a financial institution’s cannabis position. This is also not a program where a financial institution will set it and forget it. The risk assessment and policy must remain dynamic as legislation evolves, as regulatory perspective changes, and as a financial institution’s position or outlook may shift.
This is an industry that has already proven prolific. This is a time that will be ingrained within our nation’s history. Let’s be remembered as those who championed the issues, established the country’s infrastructure, and set the standard for those who follow.
As a former Federal bank regulator and seasoned consultant, Angela’s knowledge of regulatory compliance, risk management and investment advisory services has established her reputation as a leading resource within the financial consulting industry, spanning consumer protection and anti-money laundering statutes, fraud and cannabis banking issues.
Angela is the Managing Partner and Co-Founder of Sterling Compliance, LLC, a consumer compliance consulting firm based out of Pittsburgh, Pennsylvania. Sterling specializes in consumer protection and anti-money laundering compliance within the community banking industry and enjoys a significant online presence with a client base spanning the coasts.
In December 2019, Angela joined Integrated Compliance Solutions, LLC (ICS) upon the ICS acquisition of Sterling Compliance as an independent operating subsidiary. Angela oversees the firm’s Compliance Strategies division, of which cannabis banking is a significant component. ICS is a financial technology, banking compliance and innovative payments solution provider helping financial institutions with complex solutions. In joining the ICS team, Angela has continued the firm’s mission of bringing its complete SEED-TO-BANK™ solution to financial institutions and cannabis-related businesses throughout the United States, and has expanded the firm’s industry engagement as a well-respected authority on the regulatory and compliance issues surrounding cannabis banking.
Member Blog: Hemp and Marijuana Genetics – A Closer Look At The Differences
There are many ways to classify cannabis variants, but the most popular distinction is between hemp and marijuana. Although most of us take these classifications for granted, perhaps you’ve wondered if they are really legit? Put another way: are there real genetic and anatomical differences between marijuana and hemp? And, if so, what are they?
The hemp/marijuana classification is still a major debate within the cannabis community. Although up-to-date research suggests there are genetic differences, critics contend these distinctions have much more to do with legality than botany.
To better understand the complexity of the hemp v. marijuana classification, let’s quickly go through a primer on the cannabis genus. Afterward, we’ll take a closer look at the differences often associated with hemp v. marijuana and why these terms have gained such prominence.
The Basics Of Cannabis Distinctions
The first thing we should clear up is that the word “cannabis” is reserved for the plant genus. This means that both hemp and marijuana technically fall under the cannabis label. For many years, botanists have categorized the cannabis genus into the following three groups:
Of these three, sativa and indica are probably the most familiar to you. Usually, cannabis connoisseurs draw the sativa v. indica distinction to help differentiate the physiological effects of each strain. Sativa-heavy strains are said to be more energizing while indicas are supposedly more sedating.
It’s important to remember, however, that sativas and indicas were first split up due to their flowering patterns and features. Here are just a few of the key distinctions often ascribed to these two cannabis variants:
Enjoys mild climate
Enjoys a humid climate
Ruderalis is a shrub-like variety of cannabis that evolved in harsh northern environments. Due to its history in regions with little light or warmth, ruderalis strains evolved unique genetics that allows them to flower automatically rather than relying on specific amounts of light.
Cultivators nowadays cross-breed ruderalis strains with indicas, sativas, or hybrids to create what are known as “autoflowering seeds.” These auto varieties are convenient due to their predictable flowering period, but they tend to have fewer cannabinoids than standard sativas or indicas. Most often new cannabis cultivators use auto seeds to gain valuable growing experience.
Hemp v. Marijuana: The Legal Distinction
So, why do we need a hemp v. marijuana distinction on top of all these cannabis varieties? A short answer is that drawing the line between hemp and marijuana helps a lot in the legal department.
You see, hemp is legally defined as a substance containing less than 0.3 percent of the high-inducing compound tetrahydrocannabinol (THC). Marijuana, on the other hand, could have 0.3 percent THC content or above.
Obviously, this makes it a lot easier for legal authorities to categorize what is and what is not legal. As of today, the U.S. legalized hemp at a federal level, but marijuana laws vary by state.
Beyond THC: The Different Uses Of Hemp V. Marijuana
This all doesn’t mean that the hemp v. marijuana distinction was arbitrarily drawn up to help legislators. OK, the 0.3 percent benchmark was pretty arbitrary, however, it’s true that hemp naturally produces less THC than marijuana strains. But there’s more to this story than just THC.
Now that the CBD market has skyrocketed, it’s often hard for us to imagine non-edible uses of hemp. However, for most of human history, hemp has been cultivated strictly for industrial purposes. Indeed, people have used the hemp plant’s fibrous stalks to make clothing and rope for thousands of years. Amazingly, hemp is now showing great potential in a variety of fields including papers, plastics, cosmetics, and even fuel.
Marijuana, on the other hand, has always been associated with recreational and medical use. Growers who cultivated marijuana were always interested in maximizing certain terpene and cannabinoid profiles for their chosen strain.
So, the distinction between industrial hemp and marijuana is still valid and useful as the cannabis industry expands. Growing hemp for industrial purposes is far more interested in quantity rather than quality. Marijuana cultivation, on the other hand, requires a greater degree of care and attention to detail.
Industrial hemp cultivators could often get away with planting their male and female seeds in rather tough environments. Professional marijuana cultivators, on the other hand, need to focus a lot of attention on making their environment hospitable for female seeds.
Of course, there are now many high-CBD hemp cultivators out there using similar marijuana grow methods. With that in mind, it’s still quite useful for cultivators to distinguish between industrial hemp and marijuana to better plan their growth cycle.
Does Hemp Look Different Than Marijuana?
Now we know how hemp and marijuana differ in THC content, growth features, and traditional uses… but do they look different?
To the untrained eye, mature hemp and marijuana might appear to be the same. Indeed, there are many cases of police accidentally arresting truck drivers for “marijuana possession” when they were actually transporting hemp. There are, however, a few key anatomical differences to look out for.
For instance, hemp plants are generally taller than most varieties of marijuana. Remember that many cultivators are interested in hemp’s fibrous stalks, which is why they’ve bred them to grow as tall as possible.
In addition to their height, hemp plants also tend to have thinner fan leaves compared with most strains of marijuana. These hemp leaves also tend to be concentrated at the top of the hemp flower with few leaves further down the stem. Marijuana plants, on the other hand, tend to have more leaves evenly spread throughout their branches.
Looking Into The Genes: Novel Research On Hemp v. Marijuana
After reading the above description, you might understandably conclude that hemp strains might lean more towards the sativa side. After all, sativas are typically associated with tall height and thin leaves.
While this makes logical sense, recent genetic research is changing how we think about the sativa v. indica theory. A team of Canadian researchers recently published a study examining the genetic makeup of over 80 marijuana and about 40 hemp strains. Shockingly, they found that hemp plants have a closer genetic tie to indicas rather than sativas. Most marijuana strains, however, showed a mix of sativa and indica influences.
The scientists concluded that there was enough of a genetic difference between hemp and marijuana strains to warrant the classification. Of course, more research will be necessary to understand these complex hereditary differences.
So, Is The Hemp v. Marijuana Distinction Valid?
While there will likely still be a debate about the hemp v. marijuana distinction, this classification system is popular for good reason. Also, there appears to be a scientific basis for grouping hemp and marijuana into separate genetic categories.
Distinguishing between hemp and marijuana can help consumers make a more informed decision when purchasing hemp flowers, hemp trim, oils, or other products. Plus, with the growing interest in hemp’s industrial uses, it’s important for farmers to separate out strains for industry and those for human consumption.
While it might not be a perfect classification system, “hemp v. marijuana” is still around because it continues to help cultivators and consumers make informed choices.
George Mouratidis is a cannabis writer and freelance contributor to Industrial Hemp Farms, Cannabis Tech, and Highlife Media.
IHF LLC is a Colorado-based, fully licensed & certified hemp farming and wholesale company. IHF wholesales CBD hemp biomass and many different cultivars of clones and seeds. The Company also wholesales CBD distillate, T-Free, Decarboxylated Crude, Isolate and other cannabinoids produced at our extraction facility. One of our primary goals is to make mutually beneficial deals, connections and contacts in the hemp industry.
Member Blog: There’s No Place Like CBD For The Holidays
While April 20th, or “420” is the “high” holiday of cannabis, did you know there are a variety of lesser-known CBD-related holidays throughout the year that can be great grist for the promotional mill? To achieve notoriety and engagement, CBD purveyors may want to include lesser-known celebrations into their annual marketing calendar.
For example, there’s National CBD Month in January, National Hemp Day February 4, National Hemp Month in July, Oils and Concentrates Day July 10 (sometimes referred to as 710 because OIL upside down resembles the number), National CBD Day August 8 and National Pet CBD Month in October.
And let’s not forget Jack Herer’s (The Hemperor’s) birthday celebrated June 18. According to Wikipedia, the devoted cannabis rights activist and author promoted cannabis and hemp for decades. His book, “The Emperor Wears No Clothes” has been in print for three-plus decades. Herer was “frequently cited in efforts to decriminalize and legalize cannabis… Herer also founded and served as the director of the organization Help End Marijuana Prohibition (HEMP).”
CBD purveyors wanting to get even more innovative can use their branding — including labels — to tie to lesser-known holiday promotions. Here are some ways to use labels as powerful promotional tools in conjunction with “holiday” celebrations:
Extend their reach for a whole year via extended content labels (ECLs). For CBD purveyors committing to promotions tied to a calendar of holidays, ECLs can be a fun and impactful way to present information, offers and calls to action.
Create a major promotion around one celebration (e.g., January’s National CBD Month), and use ECLs to explain/inform. This could be a contest with details, one or more discount offers, or even a history of the CBD “movement.”
Print specific labels for each holiday. For example, create fun and informative labels around “The Hemperor’s” birthday month in June. A series of labels could detail various hemp-related accomplishments by Herer, even possibly going so far as to be small pieces of art depicting him and his life’s work.
Use them to link to digital media. There’s always a case to be made for labels containing QR codes, URLs and other links to more information. This can be especially appropriate for surveys, reviews and other interactive platforms where consumer feedback is desired. Any of these efforts can be themed around holiday celebrations (e.g., an upcoming anniversary of hemp or CBD adoption/legalization). In the CBD world particularly, companies need to understand how their consumers view them, assess the quality of products and express any concerns that may emerge.
Present labels as a quality control and consumer safety tool. At a time when buyers worry about the safety and authenticity of the products they consume, labels can help come to the rescue. And what better holiday than one which celebrates both the healthy effects of products and a concerted effort to protect those consuming them?
For example, new label technologies enable consumers to verify the authenticity of their products through a smartphone app that scans a small digital ID on the label. These track-and-trace digital IDs offer a powerful deterrent to counterfeiting, protecting consumers from harmful or ineffective fake products. In turn, CBD product manufacturers can demonstrate to customers that they are working actively to ensure their safety. That creates favorable word-of-mouth, goodwill and loyalty among buyers who will criticize or even pursue regulatory and legal remedies if they feel there’s a problem.
Gary Paulin is Director of Sales and Client Services for Lightning Labels, a Denver-based label printer that has been offering state-of-the-art affordable, full-color custom labels and custom stickers of all shapes and sizes to cannabis purveyors for more than a decade. They offer many options for materials and laminates and special effects to achieve digital short-run requirements (50 minimum) on up to 15 million labels, plus Lightning fast delivery. For more information and to place orders online, visit LightningLabels.com. For the latest in packaging news and labeling promotional offers, find Lightning Labels on, Facebook, Instagram, Twitter (@LightningLabels), Pinterest, and LinkedIn.
Member Blog: Hemp And CBD Consumer Insights – Who, Why, And How
Hemp CBD became the fastest growing CPG product in 2019, following its legalization in the Farm Bill of December 2018. Consumers show great interest in its use for wellness, health & beauty applications and for pets. Its many distribution channels require integrating convenience store and shipment data not required for most dispensary products.
In U.S. Convenience Stores, total sales of CBD have increased 168% in the first half of 2019 while average weekly dollar sales increased by 235%.
The higher revenue growth accompanied CBD content per package increasing from 100mg on January 5, 2019 steadily to over 350mg on July 20, 2019, after having peaked briefly in June 2019 near 450mg per unit. See graph below.
Mg CBD per SKU at Retail
Medical Conditions Treated with Cannabis
Pain relief is the major reason cited as a medical condition for cannabis use, followed by nausea, PTSD, muscle spasms, IBD and opioid addiction as seen in the following table:
Cannabis and Opioid Use Disorder
Of particular note is the growing number of consumers using Cannabis to treat Opioid Use Disorder (OUD). As of August 2019, seven states have approved medical cannabis for treating OUD: PA, NY, NJ, NM, MO, IL & CO. Twenty-one studies (2009-19) show the effect of cannabis on helping opioid users to reduce or eliminate the use of opioids to treat pain. NFL professional athletes have withdrawn from using opioids after they retire, with the aid of CBD and/or adult cannabis.
Consumer Purchase Drivers of OTC Hemp CBD
The top consumer drivers of OTC Hemp CBD are pain relief, reducing anxiety and helping sleep, as shown in the following graph.
Cannabis Product Composition and Patient Outcomes
Over the past several years, advances in technology have greatly enhanced the prospects for cannabis growers, processors, and dispensaries to provide medical cannabis products to patients that efficaciously treat the medical conditions and alleviate the incapacitating symptoms that they suffer.
Pre-clinical scientific research is determining the physiological effects of individual cannabinoids and terpenes on specific medical conditions and symptoms. Mobile apps are enabling the systematic querying of patients about the efficacy of specific cannabis strains and products in alleviating symptoms and conditions.
Collectively, these advances and other medical research are creating volumes of evidence to which human and artificial intelligence will be applied to develop insights for use by patients and medical researchers, growers, and processors in formulating products creating newer therapeutic options. Patients are already making informed decisions that improve individualized treatment of medical conditions progressively over time due to CBD being an approved over-the-counter consumer product.
Advanced Consumer and Patient Targeting to Improve Marketing and Medical Outcomes
Consumer attitudes, perceptions, and usage in local markets create richer, more actionable insights from customer segments, creating advanced quality scores and indices for scoring first-party internal data.
Cannabis consumer data is used for strategic and tactical product development, applications including:
Market Architecture: differentiating dimensions of product form and brand choice
Key Reasons for Use and Purchase
Affinity with Media, Channel, and other Product Categories
Multiple correspondence analysis of hundreds of consumer survey category questions is used to understand dimensional distinctions and differences between clusters. These key spatial dimensions for segmentation illuminate key differentiators, for use in innovation/new products, brand strategy, marketing execution, and digital media tactics.
Create Target Profiles
Merging cannabis consumer data with general consumer data such as Financial, Healthcare, Restaurants, Grocery/Drug Stores, and Media usage & exposure for each respondent facilitates creation of new consumer segments.
Using zip code identified respondent level data, the above Target Profile clusters can be integrated with other market and first–party data to prioritize personalization, enhance brand positioning, inform messaging, new customer marketing & acquisition efforts, and multi-touch attribution databases.
Mr. Stephen J. Gongaware is Sr. Vice President of Business Development at MSA (Management Science Associates, Inc.), a privately held diverse information technology development and service firm that for over 50 years has provided innovative solutions within its three core competencies of analysis, technology and data management. He has played a major role in developing and managing several MSA businesses in addition to his focus since 2014 on the medical value of cannabis for prospective patients, beginning with CBD and 20 other nonpsychedelic cannabinoids then measured by leading edge test labs. Other businesses he’s created and managed at MSA in the last 20 years includes services to develop/market pharma “rare disease” solutions, and MSA Casino Gaming solutions improving operation of slot floors, player satisfaction and also lead smart phone and sports book innovative projects with 6 of the Top 10 global casino operators and with several major gaming equipment manufacturers.
Prior to joining MSA, Mr. Gongaware was CEO of NetworkNext, an innovative national advertising firm; R&D Director at Cellomics, Inc. where he was awarded US Patent #US6365367; and an Electrical Engineer at Westinghouse Electric Corp. He received his BSEE degree from University of Pittsburgh in 1992 and his MBA from its Katz School of Business in 1995.
MSA is an Analytics firm with Big Data integration capability incorporated in 1963 to focus on improving government and management decisions. MSA has 800+ professionals with expertise in data science & AI, software development, test marketing, data management and management consulting and many of its innovations have become industry-standard solutions. MSA has served over 70 Fortune 500 Customers/Clients in the CPG, Media, Metals, Life Sciences & Pharma, and Casino Gaming & Sports Betting industries. It has been engaged in cannabis research since 2013 with the goal of providing the cannabis industry similar services to what has been now provided to the CPG, Steel, Tobacco, Casino Gaming, and Pharma industries for more than 50 years.
Member Blog: The Differences Between Strain Specific Terpenes, Terpene Enhanced Flavors, and E-Juice Flavoring
As the nation’s largest wholesale terpene provider, we spend a lot of time getting to know the needs and wants of our customers. One of the biggest questions our new clients have refers to the flavor profiles of our terpenes. More specifically, people are wondering why our strain-specific terpenes (like Banana Sherbet, Cherry Pie, and Cookies & Cream) don’t taste like the real sugary sweet confections that go by the same name.
There is a slight misconception when it comes to terpenes. Many people expect terpenes to work like e-juice in a vaporizer to make whatever you’re smoking taste like something else. While it isn’t uncommon for vape juice to taste like Skittles, cinnamon rolls, mojitos, and orange juice, terpenes don’t. There are no additional additives like sugar or artificial flavors in the terpenes that’ll make a hash pen or oil taste just like fruit, candy, and cake. It’s best to only use what nature gives us!
Here’s the difference between isolated terpenes and wholesale versus e-juice for vaporizers, as well as a quick rundown on flavor enhanced terpenes to help you or your customer make a more educated purchase:
What are terpenes?
Terpenes are organic compounds found in all plants that are responsible for giving the plant – from blueberry bushes to pine trees – its distinct smell. The unique smell helps plants existing in the wild to attract pollinators and ward off predators. Terpenes are the primary source of the resin and trichome production in cannabis, and they are created in the same glands that produce CBD and THC. That being said, marijuana can create its own combinations of terpenes. No two plants smell exactly the same.
Terpenes are also responsible for several medical benefits and adult uses. When they’re combined with some of the different cannabinoids found in cannabis, they can create what is known as the entourage effect. The entourage effect is what gives strains of cannabis a variety of different effects since the flavor profiles can come about from an almost infinite number of terpene combinations.
In layman’s terms, terpenes are so useful because they can be blended seamlessly with each other. This gives enthusiasts more control over what they taste and feel when they vape. Cannabis contains over 100 different terpenes that offer unique effects.
Liquid terpene products and extracts typically contain a combination of terpenes found in cannabis. Some products will have more of an indica profile (like Blackberry Kush) while others will have more of a Sativa (Clementine) or Hybrid (Banana Kush) profile. This helps to encourage the specific physical effects you’ve come to expect from cannabis.
What is e-juice?
The e-juice, vape juice, and e-liquids can be used in vapes and electronic cigarettes to create actual vapor. Most of the time, e-juice contains nicotine though many flavored e-juices don’t contain any. E-juices come in a ton of different flavors that cater to just about everyone, from people with intense tobacco cravings to people with a sweet tooth. E-juice is made with propylene glycol or vegetable glycerin, flavoring (often with terpenes, but usually artificial) and water. Vape juices that are made with propylene glycol are more likely to irritate your throat while you smoke it. On the other hand, e-juices made with vegetable glycerin are more likely to add a thick layer of sweetness to the vapor.
This is where a lot of the misconception kicks in. Since some vape juices made with vegetable glycerin are sugary sweet and taste like candy, many people assume that terpenes by themselves are responsible for the flavoring. By adding terpenes to e-juice, you can achieve a variety of different and new flavors. However, the terpenes won’t add anything artificial.
Natural terpenes vs. artificial flavors
E-juice, hash oil and CBD isolate can all benefit from adding terpenes and flavonoids to the mix. While marijuana has one of the most extensive ranges of flavor profiles in the plant kingdom, it will never naturally taste like cake, blue raspberry, or piña colada. Those are artificial flavors that have no natural terpene representation in the plant kingdom. Essentially, that just means that if you want blue raspberry vape cartridges, you’ll need to get artificial flavoring and avoid terpenes. Terpenes won’t be able to come close in taste and umami to that artificial flavor that doesn’t exist anywhere naturally.
Natural terpenes are becoming increasingly popular to add to cartridges, oils, and vaporizers. These are natural flavors that mimic the natural terpene profiles of cannabis strains. Natural terpenes are an excellent option if you’re trying to give your products an extra burst of flavor. For example, a processor wants to make the perfect Blue Dream cartridge, though the cannabis used for the extraction didn’t taste as vibrantly blueberry as the processor hoped. To achieve that ideal Blue Dream flavor profile, they could add a close match of terpenes found in the Blue Dream strain profile. The terpenes can add the sweet, summer-berry flavor the cannabis extract may be missing to the mix. That will allow the processor to create a tastier product with no side effects.
Overall, you should choose terpenes if you want to mimic natural flavors found in cannabis. You should select artificial flavors if you want something to taste like something unnatural or extra sweet.
What are flavor-enhanced terpenes?
Flavor-enhanced terpenes are the best of both worlds. While e-juice is more often artificially flavored, it often tastes better than terpenes alone. Flavor enhanced terpenes are terpenes extracted from cannabis with extra flavoring added in. Flavor enhanced terpenes offer the natural health benefits of natural terpenes but with the added benefit of tasting delicious. Our line of flavor enhanced terpenes includes fruit flavors like Ripe Strawberry and Berries and Cream as well as non-fruit flavors like breakfast cereals and pastries.
Do strain-specific terpene flavors really taste like the strain they’re based on?
Flavor is subjective and depends on things like classic tastes, aromatic chemicals, and the taster’s mood and physiology. Strain-specific terpenes are scientifically formulated to mimic the real strain’s natural terpene ratios.
To create strain specific terpene extracts, we primarily identify the terpene ratios commonly found in the strains and reverse engineer the process while removing the cannabinoids from the mix. It’s best to start by testing real cannabis at a certified lab. Then recreate that flower’s terpene profile in the lab and test the formula against real cannabis flowers. If the terpene profile doesn’t make the cut, it doesn’t get sold.
Our strain-specific terpenes are designed to match the terpene profiles of the flowers we extract these essential oils from. Just because they’re named Birthday Cake and Biscottidoesn’t mean they’ll taste like the real thing. However, they do taste like the real cannabis strain since their terpene profiles match.
Terpenes Vs. E-Juice: TL;DR
If you’re just here for a quick answer, here’s the difference between natural terpenes and vape juice.
All plants naturally produce terpenes.
E-juice or vape juice is often artificially flavored
Artificial flavors are not terpenes. They don’t exist anywhere naturally and are created synthetically.
Strain-specific terpenes are reverse engineered to mimic natural terpene profiles of cannabis strains
Strain-specific terpenes contain no artificial flavorings
Strain-specific terpenes will taste like the cannabis strain, not the food or fruit it’s named after. For example, Chocolate Cookies tastes like hash, spice, and coffee, just like the cannabis strain. It doesn’t taste sugary sweet and chocolatey.
If you want the best of both worlds, try flavor enhanced terpenes to get the benefit of terpenes and the flavor of e-juice.
Everyone has different taste and smell preferences, but now you should be able to find the best fit when looking for that perfect terpene blend.
Nicole Flanigan is one of the newest additions to the Peak Supply Co family. Her knowledge base on terpenes and cannabinoids has helped throughout the educational process. Nicole is a Colorado-based content marketing professional who has dedicated her life to cannabis awareness, advocation, and education. When she’s not writing or developing something groundbreaking for her clients, she enjoys growing cannabis organically and hiking all over Colorado with her two huskies. 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.
FDA Rulemaking on Hemp/CBD – Hurry Up And Wait?
by Andrew Kline, NCIA’s Director of Public Policy
In April of 2019, the National Cannabis Industry Association (NCIA) formed a coalition of more than 100 CBD/Hemp entrepreneurs, scientists, medical doctors, and FDA lawyers to inform and influence FDA rulemaking on cannabis and cannabis-derived compounds. Over the past two months, coalition members worked tirelessly to draft public comments. Our goal was to answer all of the questions posed by FDA (including scientific questions), to be helpful to FDA by informing their rule-making process, and to influence the direction of their rule-making.
NCIA Files Public Comment And Testimony
On May 30, 2019, we filed 60 pages of formal comments which can be found here. I’m really grateful for the coalition’s collaborative work and quite proud of our final product. I’m also extremely grateful to the authors, including Alena Rodriguez of RM3 Labs, Dr. Paul Murchowski of Dr. Pauls, Khurshid Khoja of Greenbridge Corporate Counsel, Vanessa Marquez and Chris Elawar of CBD Care Garden, Jonathan Havens from Saul Ewing, Andrew Livingston from VS Strategies, and many others who devoted time to produce a great submission.
On May 31, I testified before the FDA and listened intently as dozens of others spoke. My takeaways were that most of the industry echoed our sentiment – that CBD is generally safe, but that safety issues do arise with adulterated products and with irresponsible manufacturing and marketing practices. I spoke about the need for consensus-driven industry standards, to include marketing and labeling practices, and for mandated lab testing. These practices will go a long way toward making certain that the industry is safe for consumers.
Concerns And Misinformation
I am genuinely concerned that there is currently great confusion in the market. People seem to think that CBD is federally legal as a result of passage of the Farm Bill of 2019. But, that is only partially true. While CBD was de-scheduled, the FDA still retains the authority to regulate the industry as a result of their prior approval of a prescription drug for epilepsy, Epidiolex. In the absence of clear regulatory guidance, people are making health claims that violate federal law. And banks and payment processors are shutting off accounts for CBD businesses because they are having difficulty assessing whether a particular business is operating lawfully.
We hope that FDA will act with deliberate speed in drafting regulations for the industry. If FDA takes its time in crafting regulations, there is danger that many CBD companies will shudder because of a lack of banking and payment processing. And we will inevitably lose market share to Canada and other international players. As always, NCIA stands ready to help.
Learning objectives for the panel include, (1) what the FDA was interested in learning about and why, (2) understanding how our industry coalition responded to the FDA’s scientific questions, (3) predictions for how the FDA will regulate CBD/Hemp and what it might mean for cannabis regulation in the future. Panelists will include members of the coalition who drafted our public comments to FDA.
In the coming weeks, NCIA will be releasing some new policy papers via NCIA’s Policy Council – the think tank for the state-legal cannabis industry. As always, if you’re interested in joining the Policy Council or have any thoughts about how we can propel this industry, please reach out me at firstname.lastname@example.org.
CBD (cannabidiol) is everywhere right now. Front page articles proclaim its virtues and ubiquity. New retailers announce their intentions to sell CBD products almost every day. But a lot of the media coverage of CBD is inaccurate or misleading. Below are five common misconceptions about the legal status of CBD.
CBD is legal in all 50 states
Unscrupulous promoters like to claim that the 2018 farm bill has fully legalized hemp as well as any and all derivatives of hemp. That’s not true. The 2018 farm bill exempted hemp and its derivatives from the definition of marijuana under the federal Controlled Substances Act (CSA), but it does not require states to do the same. Furthermore, under the 2018 farm bill, states are permitted to prohibit hemp production and several states continue to do so. While some states explicitly authorize and regulate the production and sale of CBD, or otherwise provide legal protection for authorized individuals to engage in commercial hemp activities, other states maintain outdated drug laws that do not distinguish between marijuana, hemp and/or hemp-derived CBD, resulting in hemp being classified as a controlled substance under state law. In these states, sale of CBD, notwithstanding origin, is either restricted to state medical or adult-use marijuana program licensees or remains unlawful under state criminal laws. Additionally, a number of states prohibit the sale of certain consumable CBD products, such as CBD-infused foods or dietary supplements. So, before you start selling CBD or invest into a CBD company, do your research on the states where you will be producing and selling product; you could be violating state criminal laws.
The FDA doesn’t regulate CBD products
Although the 2018 farm bill removed hemp and the cannabinoids derived from hemp from the purview of the CSA, the 2018 farm bill expressly preserves the U.S. Food and Drug Administration’s (FDA) authority to regulate food, dietary supplements, cosmetics, and drugs, including those that contain hemp ingredients. The FDA’s position is that THC and/or CBD cannot lawfully be added to food or marketed as dietary supplements. To date the FDA has sent warning letters to several CBD companies expressing this position and requesting corrective action. Therefore, although the FDA is accepting public comment and is holding a hearing to evaluate alternative approaches for regulating CBD products, the agency currently has jurisdiction over food, supplements, cosmetics and drugs containing CBD and continues to disseminate warning letters to CBD manufacturers for violating federal laws and regulations.
CBD is non-psychoactive
CBD is often marketed as the non-psychoactive cousin of THC. This is misleading. Research has indicated CBD has antipsychotic, anxiolytic (anxiety-reducing), and antidepressant effects – clearly demonstrating that it is a mood-altering substance (i.e., psychoactive or affecting the mind or behavior). It would be more accurate to say that CBD lacks the intoxicating effects of THC. From a legal perspective this matters because making deceptive claims in advertising is illegal and can result in serious consequences. Section 5(a) of the Federal Trade Commission Act prohibits “unfair or deceptive acts or practices in or affecting commerce.” We have seen the FTC jointly send warning letters with the FDA to a number of CBD companies and ongoing litigation surrounding the marketing of CBD products demonstrates there is meaningful risk that false or misleading label claims can create a cause of action for fraudulent inducement.
CBD has no side effects
There is increasing evidence that CBD has side effects and may interact with other medications, such as the anticoagulant warfarin, especially at high doses. The FDA has identified several safety concerns associated with the consumption of certain CBD drug products, including potential for liver injury, somnolence, lethargy hypersensitivity, decreased appetite, diarrhea and sleep disorders. FDA further noted that the potentially serious risk of liver injury can be managed through medical supervision, but questioned how effectively this particular risk can be managed in the absence of medical supervision and FDA-approved labeling. While more research is necessary to better understand the impacts of long-term CBD use at various levels, blanket claims that CBD has no side effects may provide false and misleading information to consumers.
CBD can be freely included in pet products
Although CBD products are widely marketed for pets, there are currently no hemp (or CBD) ingredients that have received express FDA approval for use in animal products. The FDA cooperates with the Association of American Feed Control Officials (AAFCO) for the implementation of uniform policies regarding the regulation of animal feed products, and although the FDA does not recognize animal supplements as its own regulatory category (it either classifies such products as food or drugs), the FDA’s policy has generally been to exercise enforcement discretion, allowing animal supplements where stakeholder groups such as the National Animal Supplement Council (NASC) permit them. At present, neither AAFCO nor NASC permits the use of CBD in animal products. While NASC’s position on the use of hemp ingredients in “dosage-form products” as of January 30, 2019, is that hemp is allowed in dosage form products (i.e. supplements) provided it doesn’t contain CBD concentrates, isolates, or synthetics, and the THC content is 0.3% or less, AAFCO has not approved any hemp ingredients for use in animal feed. As with human products, risk of enforcement and regulatory scrutiny is increased where products make any disease claims, where products are marketed as containing “CBD,” and where products are advertised widely in interstate channels. In addition, a product may be considered misbranded if its labeling is false or misleading in any way or fails to include required information.
Due to the highly nuanced nature of cannabis regulation, the infancy of the domestic legal industry, and the constantly changing regulatory landscape at both the state and federal level, businesses must be sure to stay informed, educated, and vigilant.
2 – Grayson, L., Vines, B., Nichol, K., Szaflarski, J. P., & UAB CBD Program (2017). An interaction between warfarin and cannabidiol, a case report. Epilepsy & behavior case reports, 9, 10–11. doi:10.1016/j.ebcr.2017.10.001
3 – Scientific Data and Information About Products Containing Cannabis or Cannabis-Derived Compounds; Public Hearing; Request for Comments 84 Fed. Reg. 90, 12969 (April 3, 2019) (to be codified at 21 C.F.R. pt.15).
4 – Id.
5 – Hemp and CBD in Pet Supplements Weaves Same Tangled Web as in Products for Humans (Jan. 31, 2019), NUTRA ingredients-usa.com
Charles Alovisetti is a partner and chair of the corporate practice group at Vicente Sederberg LLP based in Denver. He assists licensed and ancillary cannabis businesses with corporate legal matters, and he has experience working with clients on a broad range of transactions.
Courtney Barnes and Corey Cox are associate attorneys in Vicente Sederberg LLP’s Denver office. They both aremembers of the firm’s hemp and cannabinoid practice group, where they focus on policy, regulatory compliance, and risk management in the hemp space.
Committee Blog: Cannabinoid Analogues Offer a Promising Future for Medical Cannabis
As outside industries fuse with the cannabis market, we will begin to see innovations that will flesh out our understanding of cannabinoids and how they interact with the human body. I had the opportunity to sit down with chemist Dr. Mark Scialdone and Chris Barone, founder and lead chemist at The Clear™ to discuss the introduction of semi-synthetic cannabis compounds to the market. We focused on hydrogenated cannabinoids; cannabis with a slight twist that could change everything about why and how we consume cannabis.
Hydrogenation is simply treating a compound with hydrogen, which causes a chemical reaction between hydrogen (H2) and another compound or element, usually in the presence of a catalyst such as nickel, palladium, or platinum. This is done in order to reduce or saturate organic compounds, imbuing them with properties the original compounds did not have. These cannabinoid analogues (or semi-synthetic compounds) have a number of applications in manufacturing and medicine.
Hydrogenation is a minor modification to the natural framework of the compounds the cannabis plant produces biologically. Barone describes the process as, “adding hydrogens across the double bonds, thus changing the molecular weight, the molecules geometry, and also its effects on the body.”
Benefits of Hydrogenated Cannabinoids
A major benefit to hydrogenation is that it offers stability at the molecular level, assisting with both shelf life, and resistance to heat. Scialdone explained, “hydrogenation is a chemical transformation on unsaturated compounds to improve their stability and resistance to thermo-oxidative breakdown,” – which occurs when these compounds are in the presence of air. This is the reason you cannot leave cooking oils on the counter exposed to sunlight, as eventually this reaction will cause them to go rancid. Hydrogenation improves the oxidative stability by removing the unsaturation.
Based on a study referenced in Scialdone’s patents (US10071127B2 & US9694040B2), the effects of cannabinoids and hydrogenated cannabinoids were examined, in reference to tumor growth in mice. In these cases, the hydrogenated cannabinoids showed significant improvement in the reduction of tumor sizes; with Hexahydrocannabinolic Acid (HHCA) at a 39.70% reduction, and HCBDA at 55.83% reduction (compared to the non-hydrogenated compounds THCA at 37.67% and CBDA at 47.02%) (source). It’s possible that hexahydrocannabinoid (HHC), being more stable than tetrahydrocannabinoid (THC), and less prone to dehydrogenation (converting to DHC and CBN), may have an impact on resistance towards oxidative metabolic breakdown in the liver, though there is no critical examination at this time. It has been observed in metabolic studies that hydrogenated compounds are resistant to this kind of breakdown, suggesting that hydrogenated cannabinoids may exhibit this trait as well.
Difference Between Natural and Semi-Synthetic Cannabinoids
There is still much research to be done to define the exact pharmacological differences between hydrogenated and their plant-derived cannabinoids, but the chemical differences are quite distinct. “Tetrahydrocannabinoids like THC are metabolized into the 11-Hydroxy-THC-metabolite and ultimately the nor-carboxy-THC-metabolite; because we’ve converted the THC to HHC, metabolites will differ from the ones derived from THC,” explained Scialdone. Thus, they will have a different pharmacokinetic profile because the metabolites are going to be different in hydrogenated compounds. Meaning, the hydrogenated compounds could have a longer half life and bind to different receptors within the ECS.
A study published in the Journal of Medicinal Chemistry evaluates the ability of various cannabinoid analogues to modulate the production of reactive oxygen intermediates (ROI) various metabolic functions as well as their binding capabilities to the cannabinoid receptor (CB1). It was found that hydrogenated CBD and Cannabidiol-dimethylheptyl (CBD-DMH) demonstrated bioactivities different from their original compounds (source). The study focused on the anti-inflammatory and immune responses that have been previously observed in the non-analogue compounds. To compare the hydrogenated cannabinoids, they observed the derivative compounds for their ability to suppress the production of ROI, nitric oxide (NO), and tumor necrosis factor (TNF-⍺) by activated macrophages in vitro. Some of the compounds (7 and 4) exhibited an increase in their suppressive effects of NO, TNF-⍺, and ROI. Compounds 7 and 8 are strongly bound to the central cannabinoid receptor (CB1), but with an opposite effect on their ability to modulate the release of inflammatory mediators. When compared to the effects of natural cannabinoids, it is noted that isolated cannabidiol (CBD) also has tumor growth suppressive qualities, with similar functions of hydrogenated CBD (source). The distinction between the two is the bioavailability and slow breakdown of the hydrogenated compounds, however more research is required.
The JMC study concluded, hydrogenated cannabinoids exhibited good binding to CB1, but have varying effects on inflammation – which could spring opportunities for anti-inflammatory and immunosuppressive properties in murine collagen-induced arthritis, as suggested by the Ben-Gurion University. This is because the hydrogenated cannabinoids seem to have a strong effect on hyper-inflammation, which would reduce pain and swelling of the joints.
Public Health and Safety
When dealing with new compounds, it is crucial that health and safety are considered. “We will want to look at what impacts the hydrogenation has on the metabolic profile, and whether or not the hydrogenation is having a beneficial impact on biological actions with the cannabinoids,” explained Scialdone.
It will still take a few years for a product like this to be available to the public. Although the market may see hydrogenated cannabinoids present in medical and recreational states sooner, extensive research on these compounds will remain difficult under current federal laws. The Federal Analog Act states any substance derived from a schedule I or II substance will be treated as the same schedule substance when its purpose is for human consumption. “Pseudo-synthetic cannabinoids should be allowed in my opinion,” Barone adds, “but only through close analysis of the SOPs and quality control conditions. In states where they do not have the resources, I believe manufacturers should be mandated to hire third-party chemical manufacturers to audit and approve the techniques being used.”
Research in this arena will provide greater understanding as researchers gain further understanding about hydrogenated cannabinoids and their impact on the human body. Barone pointed out, “I’d like to emphasize that the human interaction with this molecule is the driving force of the progression. Without the idea and the human, the molecules sit untouched and unexplored.” Utilizing the unbound creativity of science, the cannabis plant has more to offer than we once knew.
Courtney Maltais is co-founder and lead biologist at The Clear; a California-based extract company that brought the first Cannabis distillate to market in 2013. Maltais works with industry leaders in cultivation, manufacturing, and product development to create efficient, safe, and standardized lab practices. Her passion for science and education has led her to expand into educational outreach for both business owners, employees, and consumers alike.
NCIA’s 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.
Committee Blog: Accurate Pasteur Pipette or Grandma’s Turkey Baster – Cannabis Dosing
by NCIA’s Infused Products Committee; contributors Todd Winter, Ashley Hansen, Danielle Maybach, Lee Hilbert, Trevor Morones, and Greg Scher
Where is cannabis in the journey of dosing edibles?
Edibles are growing as a market share only behind concentrates. It is essential to have accuracy across the industry to protect human health and stabilize the consumer market. Potency, homogeneity, absorption rate, interpretation of dose (by State, County, International), percentage error/variance, labeling, and source of raw materials are just some of the items always questioned.
While we are discussing this issue, there will be no right answer for everybody. What is the dose? What is a serving? A check of an operator’s shelves will show chocolate bars with 800 mg of THC and a similar sized bar with 80 mg of THC. If you walked off the street and bought the 800 mg bar with only experiencing the 80 mg bar; you are in for a trip, and not a good one.
BDS Analytics’ GreenEdge Retail Tracking Platform as presented by Tamar Maritz in February had shown that when California consumers purchased cannabinoid products in 2018, they often want to know the CBD and THC content.
Label requirements vary state by state on the THC side and are often inaccurate both in the reporting of potency and the way they are displayed on CBD products. Extracts used as raw ingredients in product formulation come in various forms, it is important for the manufacturers to know the percent of actual CBD or THC when making purchase decisions. CBD extracts can be in the form of isolates with low bioavailability, or full spectrum which means the cannabinoid retains more of the plant’s original components.
Additionally, there are infused products, where the flower is extracted by an infusion into an oil, retaining even more of the original cannabinoid profile. All these extracts have specific formulation and labeling nuances that need standardization. The medical community wants even more specific terpene profile information as individual levels of Limonene, Myrcene, and other terpenes gain recognition for properties that have some additional benefit.
Do the terpenes solely earn the credit for their benefits or is it in combination with the other chemical compositions?
There are many ways to add cannabinoids into edibles; for example, when developing cannabis-infused products, are the manufactures using the “sprinkle” method to add the raw material/additive by literally sprinkling isolate? Are they using a pipette for exact measurement from a reputable supplier that is approved for food contact having been third-party audited, or a turkey baster from grandma’s kitchen utensil drawer which has seen some years? Methods abound!
Perhaps the most accurate method to create a homogenous product is to incorporate the raw material during the mixing step; before cooking, gassing (CO2), or pasteurization. Not everybody that starts an edible factory comes from the food or pharmaceutical industry. A standard serving size or dosage, whichever you prefer, could make life easier for all stakeholders with a few exceptions. As yield models mature for extraction, markets will adjust, and prices can stabilize based on real data.
In Iowa, they have just legalized for medical use, but the flower is not legal. It is 100% treated as a drug. Any product needs to have no more than 3% THC to be permitted. We can’t forget our colleagues dealing with burdensome regulation. I doubt they can measure with turkey baster there, and if we saw a manufacturer in Iowa, we would probably see a pipette. Consensus on a dose can help elected officials know more and lift heavy restrictions.
Caffeine, like cannabis, is a naturally occurring alkaloid in 60+ plants. Cannabis produces THC and CBD, which are cannabinoids. The next step for the industry in supporting cannabinoid dosing of THC and CBD or any other cannabinoid is to increase general public recognition, routine toxicology studies, and develop appropriate data and work methods to obtain public recognition or certification for food safety, public safety, and documentation.
In the United States caffeine, when in soda, is limited to 65 mg per 12 liquid ounces of beverage. In pill form, the FDA allows 200 mg of caffeine. While this is about THC/CBD, the parallels are plain. While the Cannabis industry addresses dosing challenges are many. Stakeholders composed of consumers, operators, manufacturers, laboratories, distributors, and regulators would like to see the order in the industry.
The Federal Government does not yet consider cannabis as a food additive that is “Generally Recognized as Safe (GRAS).” Caffeine, a GRAS substance under current regulation, attained status under industry practices over 60 years ago. Within our industry, GRAS is not a deeply-rooted measurement for quality or safety standards. Cannabis has no history of being hazardous when infused in products and defining a serving, or a dose should not impact the operations of notable brands that provide excellent food safety and quality.
Each consumer (patient or recreational user) has their personal approach to cannabis dosing based upon their due diligence. Manufacturers are producing THC and CBD products that range from “micro-dose” to “mega-dose” because they understand that no one standard dose is the right for every individual.
Consumers look at labels to determine which product to buy. Manufacturers rely on testing to confirm THC and CBD content. CBD and micro-dose product categories are trending; unfortunately, many laboratories are not equipped to test CBD products accurately and consistently. THC Micro-dose products have similar problems. Not all laboratories have equipment that can report trace amounts accurately. Homogeneity, labeling, and raw ingredient sourcing are opportunities for manufacturers to set themselves apart to the retail operators in a wide-open market. Let us collectively work together towards clarifying the issue and work with all the stakeholders to define for the public some language that can be understood by all, encourage federalization, and develop a standard of excellence.
NCIA’s Infused Products Committee (IPC) focuses on edible and topical products, reviewing existing business practices and state regulations. Regulation of these products is the IPC’s initial key focus, but the committee’s purpose is to ensure the infused product sector is helping shape its destiny, rather than being driven by differing jurisdictional regulations. The IPC is also working with the Policy Council and Council on Responsible Cannabis Regulation (CRCR) to develop standardized regulations for legislators and regulators to adopt as their states legalize the industry.
Member Blog: Hiring New Budtenders – Keep Your Eyes Out For These Red Flags
The success of your dispensary relies on many things – your location, the quality of the products you sell, and the people who work for you. While it might seem as if you can put just about anyone behind the counter and have them ring up transactions, the art of being a budtender is a completely different animal. Managers and owners who are in the position of needing to replace or expand their current staffing may not fully realize how their employees can make or break their business, so let’s go through a few important considerations.
It goes without saying that anyone can end up unintentionally hiring someone they shouldn’t have, so if any of the following scenarios have happened to you, don’t feel bad. This information can help in many types of businesses and will specifically save you a headache if you work in the cannabis industry.
On-the-job training is certainly something that every dispensary manager should provide, as it’s impossible for someone to walk right in and run the show on their very first day. However, it’s another situation entirely if your new hire doesn’t know the first thing about cannabis. Not only is a basic understanding required pertaining to strains, methods of consumption, and weed culture in general, but if they bring knowledge to the table that impresses you, they’re a keeper.
Anyone who can’t answer simple questions about cannabis or CBD may not be the best choice for your operation unless you have the time and patience to teach someone from the ground up. Ultimately you want your customers to feel as if they’re consulting with experts, not the other way around.
Don’t Neglect Background Checks
This tip can take a two-fold approach, as the person you end up hiring is going to be trusted with access to tons of product, money, and maybe even the store keys someday. Reference checks are a must in today’s day and age, so if they don’t readily have people available for you to chat with, you may want to dig a little deeper.
Aside from simply calling previous employers, it doesn’t hurt to run a full background check on your potential new employee. You never know if people are representing themselves truthfully and it’s always better to be safe than sorry. Again, if your prospect is uncomfortable with this idea, you don’t simply want to brush it off and continue hiring them anyway. That’s not to say that you should instantly dismiss them either as some people have a criminal record they are embarrassed by but have changed.
Common Sense And Intuition
When it comes down to it, working as a budtender does require a specific set of skills but in general isn’t that much different than many other professional retail occupations. Take some time to consider everything a person brings to the table, listen to your gut, and above all else, let common sense guide you. If something doesn’t feel right about your new hire, pay attention to that notion or else it could cost you your business.
Courtney Elder is a cannabis and CBD expert. She’s a mother of 2 from Portland, Oregon and has done countless hours of research around both cannabis and CBD benefits. She’s written for some of the industries top authority sites and is the lead content creator at CBD Nerds.
The 2018 Farm Bill and the Return of Hemp to American Farms
by Michelle Rutter, NCIA Government Relations Manager
Farming and agriculture has long been a part of North American history. When the Great Depression hit in the 1930’s, both President Franklin Delano Roosevelt and Congress knew that the United States would struggle until the agriculture industry became prosperous again. As a result, many New Deal programs dealt with farming, but arguably the most notable agriculture related legislation was the Agricultural Adjustment Act of 1938, which was the first version of what we know today as simply the “Farm Bill” that is updated roughly every five years.
Now, for the first time since the end of World War II, states are slated to soon be able to create federally legal hemp programs under the 2018 Farm Bill, which President Trump is expected to sign into law any day. The bipartisan legislation, which passed overwhelmingly in the Senate and House last week, would allow states to submit plans created by their respective Secretaries of Agriculture in coordination with their governors and chief law enforcement officers to the Department of Agriculture to grow and process hemp and hemp-derived products.
SEED TO SALE
As the law is written, state applications would need to include methods for tracking land used for hemp production and audit producers to make sure that the hemp they are growing contains less than 0.3% THC. Programs would also need to be approved by the Secretary of Agriculture, Sonny Perdue, in consultation with the Attorney General within 60 days of being submitted. Additionally, states would not be permitted to ban the transportation of hemp and hemp products through their jurisdictions, but production and sales would only be permitted in states with approved programs. The bill also contains a number of directives for research on hemp and hemp cultivation.
Hemp-derived cannabidiol (CBD) would be exempted from the Controlled Substances Act (CSA) in states with approved programs, but CBD will remain a Schedule 1 substance under the CSA and illegal at the federal level. The Farm Bill also does not impact the current Food & Drug Administration ban on CBD products or its ability to regulate the substance in the future.
The law prevents anyone with a drug-related felony from working in legal state hemp industries, preventing many people who have been impacted by the unequal enforcement of cannabis prohibition from participating in the economic opportunities created by new programs. However, a late compromise led to the inclusion of a ten-year sunset period from either the date of conviction or the start of the state program, whichever is more recent.
Marijuana’s “cousin,” hemp, is generally barred because it is part of the cannabis plant, despite the fact that it contains very little of that drug’s key psychoactive ingredient, THC. In 2014, Majority Leader McConnell (R-KY) secured a hemp pilot program in that year’s farm bill. Since then, at least 35 states have taken up the offer and developed industrial hemp programs, and those states will be eligible to pursue a legal, regulated market when the bill is signed into law. The passage of this provision will surely bring about a new era for the agricultural industry, and the cannabis industry — when hemp returns to American farmlands.
Member Blog: 2018 Farm Bill – What Does This Mean For Hemp-Derived CBD?
For marijuana businesses, the 2018 Farm Bill is landmark legislation. Congress passed the Bill yesterday awaiting the President’s signature into law.
Transportation Of Hemp Across State Lines Allowed
Federal legalization of Hemp will be astounding for the cannabis industry nationwide. Drafted into 807 pages of law is Sec. 10113 [Hemp Production] and Sec. 10114 [Interstate Commerce] of Title X. Sec. 10113 adds “Hemp” to the list of “agriculture commodities” among other things. Sec. 10114(a) allows for “the interstate commerce of hemp or hemp products” and “the transportation or shipment of hemp or hemp products produced in accordance with [section 10113] . . . through the State or the territory of the Indian Tribe, as applicable.” [Sec. 10114(b)]
Hemp Means CBD
Federal Legislators defined “Hemp” as:
“[T]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.”
States May Regulate Hemp Production, But Not Interstate Commerce
The bill allows States and Indian Tribes to regulate Hemp and expressly provides for “No Preemption” of any law of a State or Indian tribe that “regulates the production of hemp” and is “more stringent” than federal law [Sec. 10113.]
However, Federal lawmakers went on to expressly provide for interstate commerce of Hemp and Hemp products [Sec. 10114] – the express language of the bill further states that “No State or Indian Tribe shall prohibit the transportation or shipment of hemp or hemp products produced in accordance with [Sec. 10113.]”
While the Federal government occupies the field of interstate commerce under any circumstances, it will be interesting to see what happens in light of existing state cannabis regulations which make illegal the transport of marijuana across state lines.
Either way, when the President signs this landmark legislation into law, the entire cannabis industry, and commerce alike, will finally have breathing room. For marijuana businesses, hemp would be fully legal according to the Federal Government. Every barrier to entry in banking, commercial real estate, intellectual property and everything in between will lift – advancing the industry one monumental step further to social acceptance of marijuana as simply a commodity just like any other commodity – like cabbage perhaps.
If you would like a highlighted copy of the legislative text for the hemp sections under the 2018 Farm Bill, contact Eskaton Law.
An experienced corporate litigator having worked in both the private and government sectors, Attorney Robyn Ranke has taken a modern business approach to the cannabis industry and in working with cannabis business startups. Throughout her legal career, Robyn has represented a diverse base of business clientele in a variety of industries involving both complex and novel legal matters. Her diverse experience as a business litigator provides a valuable legal platform from which she is uniquely postured to address the regulatory hurdles, costly pitfalls, unique business transactions, and business litigation risks that confront California cannabis business owners today and into the future as state regulations continue to evolve.
Member Blog: Hemp & CBD Legalization, Regulation & Compliance – Key Language in the Farm Bill
Few developments in the world of cannabis — whether marijuana or hemp — could match the impact of the 2014 Farm Bill. But the 2018 Farm Bill, approved by the House and the Senate this week, promises to do just that.
As a quick reminder, the 2014 Farm Bill created an exception to the federal laws that prohibit the cultivation and sale of cannabis. To simplify, to the extent that a state created a pilot program to study hemp cultivation and the plants were of a sufficiently low level of THC, the resulting plant would be considered “Farm Bill hemp” and not subject to the prevailing federal prohibitions. To state the obvious, this was a very significant change. In fact, as a result of a combination of the magnitude of the change and the narrowness of the exception, apparent confusion led to periodic enforcement actions and court challenges.
As 2018 draws to a close, Congress must once again reauthorize the Farm Bill. It’s worth noting that the periodic reauthorization has nothing to do with hemp policy, and everything to do with the federal legislative process.
And the relatively narrow “exception” for hemp in the 2014 Farm Bill is on the cusp of significant expansion. Hemp, defined as cannabis plants and all their parts, extracts, “cannabinoids,” and derivatives with a THC concentration of less than 0.3%, will be subject to a regulatory scheme devised by the federal Department of Agriculture and will be removed from the federal Controlled Substances Act. States that wish to regulate hemp may propose regulations that the state “shall submit to the Secretary” of Agriculture. Notably, no state “shall prohibit the transportation or shipment of hemp or hemp products” produced in compliance with these new rules.
So, inquiring minds might wonder, what happens if 2018 Farm Bill hemp turns out to have a THC concentration of 0.31% instead of the permissible 0.3%? To the extent that higher THC concentration is the result of an honest mistake, Section 297B(e)(2) provides the answer: if the state has developed hemp regulations, and the state concludes the violation was the result of “negligence” (e.g., an unintentional oversight), the producer will be required to take corrective action. If that happens 3 times in a 5-year period, the producer will be ineligible to produce. If the state has not developed hemp regulations, the same standard will be applied by the federal Secretary of Agriculture pursuant to Section 297C(c)(2).
That is, a “negligent” mistake should not place the cultivator at risk of being placed outside of the protections of the Farm Bill (discussion of the reach of those federal laws is fascinating, but beyond the scope of this post). As a result, it will remain advisable for hemp cultivators to implement sufficient compliance efforts to avoid any potential inference that they are intentionally seeking a higher THC concentration.
Barring the unexpected, the 2018 Farm Bill will have a seismic impact on the hemp and hemp-derived CBD industry. With the nation watching, a smooth, well-regulated transition can only help to bolster calls for broader cannabis reform. As a result, once the 2018 Farm Bill becomes law, the industry will undoubtedly be paying close attention to the regulations promulgated by federal and state hemp regulators. And they will be working hard to demonstrate that they are staying within those guidelines.
Michael Cooper is the co-founder and managing member of MadisonJay Solutions LLC, a leading regulatory advisor to the adult-use cannabis industry that helps businesses understand the latest rules and build effective compliance infrastructure to address risk. He is the Vice Chair of the NCIA’s State Regulations Committee, and publishes and speaks frequently on cannabis regulation.
He is a graduate of Harvard College and Harvard Law School, and previously served as General Counsel of MHW, Ltd. and in the litigation department of Cravath, Swaine & Moore LLP. He began his legal career as a law clerk on the U.S. Court of Appeals for the Fifth Circuit. He can be reached at email@example.com.
New Study Proves CBD Helps with Addiction, Anxiety, Impulsivity
by NCIA Editorial Staff
A new study reveals CBD (cannabidiol) can be used as a treatment in curbing cocaine and alcohol relapse in lab animals. The Neuropsychopharmacology study from Nature Journal serves as further proof that cannabinoids do, in fact, have therapeutic value.
Much of the cannabis-focused scientific community and business owners are well aware of these benefits. However, this study is a welcomed addition to the mounting evidence in favor of treating patients with CBD- as well as calling cannabis medicine.
Mary’s Medicinals is a trusted leader in the therapeutic CBD industry. Their Chief Scientific Officer, Jeremy Riggle Ph.D. isn’t surprised with the study’s outcome but hopeful it may result in human clinical testing in the future. “While the outcome of this study is exciting, there are literally hundreds of other animal/preclinical studies that have demonstrated the potential of CBD for human health,” he said to NCIA in an exclusive interview. He added, “Until the federal government allows comprehensive double blind randomized placebo-controlled studies on human populations these studies will continue to pile up without any action or validation.”
The Executive Director of California marijuana dispensary, A Therapeutic Alternative, agrees its a step in the right direction. “When a study like this comes out it corroborates the decade of anecdotal evidence that I have been seeing first hand,” said Kimberly Cargile. One of the top reasons members come to her shop is to reduce their use of pharmaceuticals, street drugs, alcohol and cigarettes. Her go-to recommendations for new members: CBD products.
CBD attenuated context-induced and stress-induced drug seeking without tolerance, sedative effects, or interference with normal motivated behavior
Following treatment termination, reinstatement remained attenuated up to ≈5 months
CBD also reduced experimental anxiety and prevented the development of high impulsivity in rats with an alcohol dependence history
Mary’s customers and patients can shop online for vaping oil, topical muscle freeze, and their CBD-releasing transdermal CBD gel pen – the same method of delivery used by researchers for the new study.
Unlike products with THC, CBD can be shipped across America because CBD is found in industrial hemp. As Dr. Riggle explained, “Industrial hemp is legal across the United States and most of the world so that gives hemp-infused product manufacturers more freedom than cannabis product manufacturers. Being able to sell products online and ship them nationwide is a game changer, and it allows for plant-based remedies to quickly and easily reach those who need it most.”
The team at Mary’s is also breaking new ground in the scientific community as they were the first to release products with lesser known compounds of the plant including; THCa, CBN, and CBC. “We dedicate a significant amount of resources to R&D so that we’re able to stay ahead of the curve and pave the way in releasing products that target different human indications,” said Dr. Riggle.
This new era of cannabis research is great for patients and for business. Savvy small business owners like Cargile know that by providing consumers with the option of CBD products, their business can increase sales. In addition to providing a higher level of customer satisfaction, “CBD products hold a higher sales value and will give a larger return as opposed to high-THC products,” she explained.
In the past decade, the medical community has seen more cannabinoid-related studies than any other time in history. As the industry and medical communities continue to establish cannabis as medicine, it’s only a matter of time until the U.S. Government removes cannabis from it’s list of banned substances without medical benefits.
The political implications of the study aren’t lost on the authors. They wrote, “the findings also inform the ongoing medical marijuana debate concerning medical benefits of non-psychoactive cannabinoids and their promise for development and use as therapeutics.” For Dr. Riggle, the issue of marijuana legalization and the medical application of CBD are completely separate. “I’d like to think that the vast number of studies being conducted, and the mounting amount of evidence can help move the needle,” he told NCIA.
Member Blog: How CBD Helps Patients With Debilitating Conditions
As a dispensary budtender or owner, you always want to do everything you can to better serve your patients. Oftentimes, that means suggesting different strains and types of medical cannabis based on specific conditions and symptoms. To do that, you and the rest of the staff must understand the chemical makeup of marijuana, including the intricacies of cannabidiol and other cannabinoids.
Cannabidiol and Patients With Chronic Illness
Cannabidiol (CBD) is one of the two primary chemical compounds, or cannabinoids, found in the cannabis plant. The other is tetrahydrocannabinol, more commonly known as THC. However, unlike THC, CBD does not have the psychoactive properties that cause the user to feel high.
Instead, CBD alone can provide patients with many of the pain-relieving benefits of traditional marijuana products without creating that euphoric, but often debilitating, “stoned” feeling. This allows patients who prefer to avoid that effect — like children, the elderly, and recovering addicts — to still benefit from healing powers of medical cannabis.
So, CBD can be used to treat the pain that results from many conditions and symptoms, including cancer, epilepsy, lupus, Parkinson’s disease and related diseases. You can also use CBD to treat mental health conditions, such as anxiety, depression, obsessive-compulsive disorder, insomnia, and schizophrenia.
How Can Budtenders and Dispensary Owners Talk to Patients About CBD?
As budtenders, part of your job is helping patients understand how using CBD to treat chronic conditions can help them. Remember, most people probably have not heard of CBD, and patients may be hesitant to learn about it. Start by explaining the benefits of using only this cannabinoid, such as being able to avoid the high while still finding pain relief. If they seem interested, encourage them to ask questions and tell them more about the specific products that would best treat their symptoms.
A general rule of thumb when discussing marijuana strains is that indica strains — as well as indica-dominant hybrids — have higher CBD content, while sativa strains and sativa-dominant hybrids have a higher THC content. Of course, every strain has a different ratio of CBD-to-THC, but there are many that have little to no THC at all.
While the CBD strains a budtender should recommend will depend heavily on the patient’s specific symptoms, here are a few examples you can choose from:
Frequently Asked Questions About Cannabidiol
The best way to prepare for patients’ questions is to think about what they may be. Here are three common concerns patients will likely have about CBD:
Is It Safe for Children?
Yes — in fact, it’s incredibly beneficial for children suffering from epilepsy, specifically. One study found that epileptic children experienced an 80 percent reduction in seizures when they used cannabis with a high CBD content.
Will It Still Work?
While everyone reacts to marijuana differently, countless studies have shown CBD is effective in treating all sorts of health conditions and symptoms, like the ones discussed above.
How Can I Ingest CBD?
You can ingest or administer CBD the same ways you would take any other form of marijuana, including by smoking or vaping the herb or oil, eating or drinking an edible product, applying it as a topical lotion or taking a tincture or capsule. However, be sure to check your state’s laws on how you can take your medicine, as each has different guidelines.
Learn More About CBD and Patients With Chronic Illness From MarijuanaDoctors.com
Interested in learning more about how your dispensary can better serve its patients? MarijuanaDoctors.com provides patients with the resources needed to find a trusted doctor in their area and to find reputable dispensaries so that obtaining medication is simple. Check out our other resources at MarijuanaDoctors.com for more information. For even more benefits, register your dispensary with our site today.
Member Blog: The Most Important Things to Consider When Purchasing Bulk or Wholesale Hemp Derived Phytocannabinoids
Hemp, more than any other plant on Earth, is unique in its ability to literally suck the heavy metals and toxic waste out of the environment. Hemp is even being used in phytoremediation at Chernobyl in Russia. What does this mean to consumers of hemp products? Knowing as much information as possible about your hemp is crucial to understanding its legality, limitations, and effectiveness.
Hemp from China, for example, contains some of the most dangerous heavy metals in the world. According to a 2011 study of Chinese hemp strains, the plant was able to absorb dangerously high levels of the heavy metal cadmium without detriment to the plant itself. Cadmium (Cd) is an extremely toxic industrial and environmental pollutant classified as a human carcinogen.
What is the heavy metals and residual solvent content of the hemp oil? Residual solvents and heavy metals can negatively influence the health benefits of the oil.
Besides CBD, what other cannabinoids and terpenoids are present in the extract? A full spectrum profile of synergistic compounds has been shown to be more effective than an extract with only cannabidiol.
Was the hemp grown using clones or seeds? Clones provide a much more consistent end product. With seeds, you never truly know what is going to grow.
Can your supplier provide you with a consistent and reliable product? What good is the product if you cannot get it the exact same way every time and when you need it?
Considering the fact that many people are relying on CBD for their health and wellness, ensuring that your hemp oil is the highest quality is vital to its effectiveness. Prior to purchasing bulk or wholesale CBD oil, make sure you know where your hemp was grown and processed. Ask yourself this question before purchasing imported Chinese or European hemp oil: Would you feed your child milk imported from cows located in China or Eastern Europe? Didn’t think so.
***EDITOR’S NOTE: Federal policy toward hemp-derived CBD products with respect to Section 7606 is currently subject to substantial debate. The USDA’s website states, “[S]ection 7606 did not alter the approval process for new drug applications or any other authorities of the FDA, nor does it alter the requirements of the Controlled Substances Act that apply to the manufacture, distribution, and dispensing of drug products containing controlled substances.”
Ryan Lewis is the VP and Head of Global Sales for Folium Biosciences of Colorado Springs, CO. Folium Biosciences is the largest vertically integrated producer, manufacturer, and distributor of hemp derived phytocannabinoids in the U.S. Folium, along with their exclusive distributor, Entourage Nutritional Distributors, supplies section 7606 US Farm bill compliant hemp derived phytocannabinoids to some of the leading brands and companies in the world. Ryan graduated with high honors from Brown University and attended Pepperdine University Law School and Business School.
CBD Oil, the DEA, and the Law
New action from the DEA today caused a stir among hemp and CBD producers. The action – the insertion of a new rule in the Federal Register regarding cannabinoids – could have serious consequences for CBD product makers.
Is your CBD derived from hemp? Doesn’t matter to the DEA. The new extracts classification applies to all “extracts that have been derived from any plant of the genus Cannabis and which contain cannabinols and cannabidiols.” Hemp is not a separate genus. (Although it may be a separate species; lot of debate on that point.) Legally speaking, hemp is simply cannabis with no more than 0.3 percent THC content.
NCIA member Hoban Law Group produced a detailed memo responding to the DEA’s action and exploring ways that it might be challenged in court.
The fact that the DEA, an unelected government body with no legislative authority, is attempting to outlaw all cannabinoids is concerning and problematic as it pertains to portions of the plant not legally defined as “marihuana,” and as it pertains to lawfully cultivated and processed Farm Bill-compliant industrial hemp.
We’ll continue to monitor the activity around the DEA’s new rule and keep you updated with additional information.
Member Spotlight: Naturally Mystic Organics
For NCIA’s March member spotlight, we cruise into Santa Cruz, California, to chat with the owners of Naturally Mystic Organics. Owners D’Angelo “Cricket” and Jozee Roberto offer the knowledge and traditions of ancient herbal medicine paired with their dedicated advocacy work in Santa Cruz on behalf of cannabis patients and environmental sustainability.
Cannabis Industry Sector:
Cannabis Infused Medical Products
NCIA Member Since:
Tell us a bit about you and why you started Naturally Mystic Organics?
As we’ve raised our seven children over the past 23 years using plant medicines (non-cannabis), we’ve witnessed first-hand the amazing power herbs have to offer. We both have had the pleasure of growing up in California and being raised within the cannabis movement. Along the way we came to develop a personal relationship with cannabis as we’ve witnessed and experienced its numerous benefits. Quite compelled, we decided to share our high standards of what we consider to be real medicinal healing as an offering to the world.
Why should patients seeking medical cannabis look for products made by Naturally Mystic Organics?
We specialize in high-CBD products and provide the finest tinctures and topicals on Earth. We approach cannabis like an herb. As herbalists we take special care to craft with ancient methods, avoiding the use of metal to extract or infuse. We use glass, ceramic, and bamboo equipment and instruments.
In herbalism, as in any area of life, we learn that your final product is only as good as what you start with. For example, we pick only the best (top shelf) cannabis flowers for our tinctures, never trim, that has been grown with loving care and without the use of harmful pesticides or chemicals. Our topicals are made from the trim of these beautiful flowers. The spiritual connection between the plant energy and the herbalist is maintained throughout our process by setting the intention of health and well-being during production through prayer, silence, or chanting. If someone is having a bad day then that person does not make the medicine until a well-balanced attitude is in place. All other materials put into our products are certified organic and GMO-free. And to put the icing on the cake, we use violet glass bottles for our tinctures. Eliminating light is a supreme way to eliminate contamination after opening.
Tinctures provide a great alternative to consuming cannabis, as opposed to smoking it. Our tinctures, formulated for consistency and reliability of potency, are a great way to monitor dosage. Providing patients an opportunity to connect with other plant medicine that they otherwise might never have, we pair cannabis with other amazing herbs to help guide an endocannabinoid system to the desired outcome. Our Pure 1000 line of tinctures is designed for patients with extreme situations. Oh, and by the way, our tinctures taste great. Perfectly preserved terpenes make it taste like you are drinking a bud.
We are proud to present our humble offering to the world: supreme traditional cannabis herbal medicine in the form of tinctures and topicals – products fit for royalty.
You’re based in Santa Cruz, California, where regulations are constantly changing. Several pieces of legislation have been proposed to further regulate and legalize cannabis throughout the state. How have you been involved in this process?
We, Cricket and Jozee, are founding members and representatives of RCSC (Responsible Cultivation Santa Cruz). Santa Cruz County has a wide acceptance for the medicinal value of cannabis. Care for the environment and the safety of our communities are also shared values. Our county had a somewhat advanced policy about cannabis prior to 2015 that led to reports of environmental degradation and an assault to the quality of life in some communities because of an influx of production. This became a real issue that forced the County Board of Supervisors to respond. Their response came in the spring of 2015 as a vote to ban all commercial cultivation. The cannabis community responded. RCSC hatched out of community meetings hosted by the CAA (Cannabis Advocates Alliance) and petitioned to referendum before the ban became law. Our referendum was a success. The county had a couple of choices at this point to repeal the law or to put it before the county for a vote. They decided to repeal it and then a couple of Supervisors proposed the creation of the Cannabis Cultivation Choices Committee, aka C4. C4 was created as a conversation between community stake holders to propose recommendations to the Board of Supervisors for cannabis policy. Naturally Mystic Organics cofounder D’Angelo “Cricket” Roberto represents RCSC on this committee.
Santa Cruz County is on the leading edge of cannabis policy in California. C4 began holding meetings at the beginning of September 2015 and at this point the cannabis community wanted a clear pathway to legitimacy. Sometime after that our state legislature passed a bundle of bills that our governor signed into law, aka MMSRA (Medical Marijuana Safety & Regulation Act). This legislation helped to shape C4’s discussion from ‘what could be possible’ to ‘what is possible.’ The shared values of Santa Cruz are the core to the framework that C4 is building on. The recommendations that come forth will be to protect our environment, to protect the health and safety of our communities, and to assure an adequate supply of medicinal cannabis. It is important to note that these recommended regulations are being designed to nurture our current cannabis community and will restrict expansion so that we do so responsibly.
Santa Cruz County is the second smallest county in the state. We have a great portion of the population in the rural areas and much of our terrain is on slopes greater than 30%. We have a lot to consider here. In regards to any aspect of the emerging cannabis industry the question always is: How much and where? There are a lot of details. This is an industry that has struggled illegitimately for way too long and the side effects have finally forced society to realize the sensibility of a regulated system. We’re proud to be a part of history and helping to shape the future of cannabis in California.
Why did you join NCIA?
Naturally Mystic Organics joined NCIA to become a part of the foundation that helps to solidify the future of national cannabis policy. We’ve been very effective on the local level and are in entrenched on the state level. It’s been said that as California goes, so goes the nation. As we help to advance the conversation we hope to lend our voice to the choir at NCIA. To understand that we’re ushering in a new era is to preserve what the cannabis movement has taught us – empathy. Empathy leads to compassion, and as the cannabis industry unfolds we need to pass the values our history has taught us. This can be done through sustainable business models that encourage innovation and provide a real living wage. Society is in the middle of an overhaul and cannabis is in the center of it all. A healthy society shapes policies rather than policy shaping society. The cannabis policy landscape across the United States is transforming right before our eyes. The industry will revitalize the economy and create jobs. It will provide opportunities consistant with the promise of America. NCIA has positioned itself in the center of the conversation – right where we want to be.