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Committee Insights | 7.13.23 | Know Your Hazards – Occupational Health and Safety Considerations in Cannabinoid Ingredient Manufacturing

NCIA’s #IndustryEssentials webinar series is our premier digital educational platform featuring a variety of interactive programs allowing us to provide you timely, engaging and essential education when you need it most.

In this edition of our NCIA Committee Insights series, originally aired on July 13, we were joined by members of NCIA’s Cannabis Manufacturing, Scientific Advisory and Hemp Committees for an in-depth discussion highlighting the occupational health and safety considerations to make during the manufacture of cannabinoids and provide recommendations for mitigating risk.

There is no mistaking that manufacturing cannabinoids is here to stay. It is more and more prevalent to see historically plant/naturally derived bulk ingredients being manufactured in a controlled environment in the lab or through innovative processes like precision fermentation. It is likely that bulk ingredient manufacturing of cannabinoids will go this route too.

For cannabinoids like HHC, that do not exist naturally in the plant or in high enough quantities to be commercially viable for extraction, it is most certainly the case that manufacture of these compounds will occur in the lab. To produce these compounds safely, we can luckily look toward existing regulations and occupational health and safety guidelines for producing novel ingredients for use in foods and non-foods.

Learning Objectives:

• Recognizing common occupational safety hazards associated with manufacturing cannabinoids and recommendation to mitigate these hazards

• Learning the different occupational safety considerations between isolation and purification of naturally occurring cannabinoids and the manufacture (synthesis) of cannabinoids in the lab

• Understanding the special safety considerations that processes like hydrogenation and others have and why these are critical to mitigating liability for your business

Panelists:

Jacob Enslein
Consultant
AJ Cannabis Consulting

Rhiannon Woo
Co-Founder & CSO
TraceTrust

Tenay Woodard
Director of Safety & Security
KIVA Brands, Inc.

Tucker Holland
Co-founder, CFO and Processing Director
Entourage Cannabis

Keith Butler
CEO
OP Innovates / Naturia+™

This is the fourth of five in a multi-part series of #IndustryEssentials webinars. You can watch Parts I-V at the links below.

Defining the Conversation: Minor, Novel & Synthetic Cannabinoids (Part I): https://bit.ly/3D2LReB

Meet the Minors (Part II): https://bit.ly/3qUD8Ip

Safeguarding Consumers in the Cannabinoid Product Landscape (Part III):

Know Your Hazards – Occupational Health and Safety Considerations in Cannabinoid Ingredient Manufacturing (Part IV)https://bit.ly/3rEUeKP

Concepts for Regulatory Consideration – Shifting the Conversation from “Cannabis vs. Hemp” to “The Cannabinoids” (Part V): https://bit.ly/3P3r5AW

Member Blog: Quality Over Quantity – Why Stronger is Not Always Better

by Andrew Kaye, Sweet Leaf Madison Capital

Over the last 15 years, cannabis has seemingly catapulted away from the days of schwag and dirt weed. Today, we are seeing THC levels well beyond percentages that were displayed in dispensaries 10 years ago when cannabis first became legal in certain states. Advancements in technology, a better understanding of growing cannabis, and strain cloning has allowed for growers and chemists alike to fine-tune the plant to offer more bang for our buck – but not everyone needs to blast off every time they light up, right? 

Right. 

Recently, there has been a shift in the way we approach cannabis use, especially for medicinal purposes – proper dosing is everything. These stronger strains that have been Frankensteined together to ensure a potent one-hit high making it nearly impossible to provide a controlled dose for someone just looking for a chill evening or relief from their chronic pain. Granted, these strains have their place among seasoned tokers, but for others who are novice cannabis enthusiasts or patients looking for a treatment, stronger does not necessarily mean better. More intention should be put toward partaking, and it is as simple as asking yourself a few questions: How do I want to feel? What do I want to do? Where am I going? What hurts? Who is part of the experience?

Realistically, when was the last time you went to the bar to enjoy a casual night out with friends and started throwing back tequila shots until your knees buckled? 

Hopefully, you are not recounting a night where that happened, but if so, you can probably guarantee that you would not put yourself in that situation again, at least not right away. Be honest with yourself, answer the questions above and chat with budtenders to find the best solution for you. 

Knowledge is Your Best Friend

For a lot of people entering dispensaries for the first time, they see these high THC numbers and equate it to a better high, but the reality is that cannabis potency can be attributed to more than the THC percentage. Terpenes, differing cannabinoids and other compounds found within the plant also play a major role in how strong the strain is and what effect it has on your body and mind. Think of the subtlety of wine versus the kick of jello shots.

This is why it is important to talk with budtenders to better understand which strain is going to work best for what you are seeking. The problem today is that dispensaries are experiencing high turnover rates, as 55% of budtenders who held jobs over the last year left within 12 months of starting, according to a Headset market report. Losing seasoned employees not only impacts the store itself, but customer service tends to take a hit (no, not that type of hit). Inexperienced budtenders might be rushed to the counter without proper training, leading to misguided direction and customers walking away with flower or edibles that will send them to space, or to a space that they did not intend to go. Again, there is nothing wrong with having highly potent strains, but making and distributing them comes with a responsibility toward customer and patient care. As more states migrate to adult use cannabis, many are abandoning the medical dispensary model and focusing on high-profit strains, not curative or palliative care.  Dispensaries need to ensure they are properly onboarding and training new employees to provide the best service possible. 

The Future of Cannabis

As science improves and technology becomes more refined, cannabis potency is going to continue to go up, but it also means that mid- and low-potency strains will get better. If you look at the craft beer industry, the days of high abv IPAs and stouts are slowly fading and more focus is being put on taste and balance. 

Since 2014, there has been an almost “gold rush” mentality where growers were fine-tuning their product at a high rate to offer a better punch than their competitors, but in 2023, after nearly 10 years of legal cannabis, customers are looking to refine their tastes and highs. 

For most, the quality of the strain is going to be far more beneficial than the quantity of THC, but at the end of the day it is all preference. So do yourself a favor the next time your supply is low and chat with budtenders – lean on their expertise and compare with your own research. Try different strains along the potency spectrum and really consider taste. No one consumer is the same; make your experience yours. The higher the price is not always the nicer the nice.


Andrew Kaye has been involved in all aspects of the financial services industry, as a fund portfolio investment manager, investment banker, family office investor and attorney.  He has worked with start-ups on their first raise through global enterprises undertaking billion-dollar stock offerings, and has significant investment experience in the cannabis industry. Currently, Andrew works as Sweet Leaf Madison Capital’s Chief Commercial Officer. Lending his expertise toward the creation of middle market financing solutions for real estate and equipment financing needs in the cannabis space.”

“Sweet Leaf Madison Capital provides non-dilutive, asset-based lending solutions to the underserved middle market of the cannabis industry by originating real estate loans, equipment financing, securitized term loans, and more for entrepreneurs and businesses. The company is based in Denver, Colorado and has offices in New York City and West Palm Beach, Florida. To learn more or complete a loan application, visit Sweet Leaf Madison Capital online, or continue the conversation on LinkedInTwitter and Facebook.”

Andrew J. Kaye is Chief Commercial Officer of Sweet Leaf Madison Capital. He can be reached at akaye@sweetleafmadison.com.

Video: NCIA Today – Thursday, January 26, 2023

NCIA Director of Communications Bethany Moore checks in with what’s going on across the country with the National Cannabis Industry Association’s membership, board, allies, and staff. Join us every other Thursday on Facebook and LinkedIN for NCIA Today Live.

Member Blog: Reaching The Highest Common Denominator

by Raina Jackson, Founder & CEO of PURPLE RAINA Self Care
Member of NCIA’s Diversity, Equity, & Inclusion Committee (DEIC)

This past September I had the pleasure of lobbying in D.C. for the first time as part of NCIA’s 10th Annual Lobby Days. The lobbying process was demystified for me, and I found that lobbying isn’t easy, but it isn’t that hard when you share your talking points from your heart, representing your own and others’ experiences. I learned that the NCIA delegation shares more common ground than we realized with Congressmembers, especially through their younger and more hip staffers and family members. One senator has a daughter who used to be a budtender and now podcasts about the industry, Senator Gary Peters (D-MI).

I was encouraged by how receptive legislative aides and advisors were to the factual talking points and statistics NCIA provided us to appeal to their sense of reason and fairness. They recognized the public health and economic benefits cannabis has delivered and its potential, without being distracted by useless moral arguments against it. Our team gave an overview of the cannabis landscape and advocated while offering solutions to our varied struggles as cannabis entrepreneurs.  

  • We highlighted that 47 states have adopted some form of cannabis commerce and decriminalization, representing 97.7% of the U.S. population! The majority of the American public demands safe access to cannabis. Why not ride the wave? 
  • Cannabis has been found to be a “gateway” medicine for a more safe withdrawal from opioid addiction, especially crucial to states experiencing high overdose death rates. 
  • We discussed the DEA recently approved funds for even more substantial clinical research on the myriad of proven and potential health benefits delivered by the cannabis plant in a wide range of forms. Yet existing cannabis research is often more robust and held to higher standards than over the counter aspirin. Many pharmaceutical drugs are advertised on TV as the best thing since sliced bread one day (albeit with alarming potential side effects), then next named in TV ads for class action lawsuits for their harmful effects. 

A case for an enhanced SAFE Banking Act 

The legal U.S. cannabis market is valued at $17.7 billion, with a substantial amount unbanked, causing a public safety crisis. Our discussions illuminated our common ground regarding the public safety improvements and economic benefits that the bipartisan supported SAFE Banking Act will bring to each state choosing to introduce its own customized hemp CBD/low THC, medical, or adult recreational cannabis program.

  • When compliantly banked these funds will offer financial institutions of all sizes more capital for lending to spur economic recovery and a safer industry. While no financial institution will be required to participate, the risk mitigation and sizable financial benefits can’t be ignored. 
  • SAFE will remove the risk of federal prosecution for compliant financial institutions already offering banking to cannabis businesses, while encouraging more banks and credit unions to join them. Too many existing entities providing cannabis banking services tend to mitigate risk by charging exorbitant monthly fees, financially hobbling startup cannabis businesses or excluding them altogether. 
  • SAFE would also support hemp CBD businesses like mine, still navigated the grey area regarding access to banking, loans, leases/mortgages, and payment processing.

In my follow-up email to the Congressional aides and advisors we met with, I attached a white paper authored by the Cannabis Regulators of Color Coalition (CCRC) offering best practices for increasing financial access to cannabis businesses, prioritizing groups that have been historically underserved by traditional financial institutions and disproportionately harmed by prohibition.

What’s next?

This regulated cannabis industry is so new that we must allow each other some grace as stakeholders. As cannabis advocates, we have learned that “calling people in” for discussions on the benefits of the SAFE Banking Act and comprehensive cannabis reform is more effective than “calling them out.” 

Elected officials and their staff don’t understand first-hand what we experience as cannabis entrepreneurs, and many care more than I expected. Lobbying and sending them emails on new and modified policy recommendations helps them to be well-informed enough to support us. My highlight was meeting with a CA legislative aide who is a fellow CA native and sincerely wanted to be updated on my progress and pain points. We all had a laugh about him agreeing to let me go into “the weeds” concerning the licensing process, pun intended. 

Since Lobby Days, President Biden announced the upcoming FDA and DEA review of cannabis as a Schedule 1 drug. It could potentially be de-scheduling within the next 12 to18 months! However, to date, only seven states provide licensing priority, exclusivity, or set aside a percentage of licenses for qualified social equity applicants. The same way the SAFE Banking act should be passed with amendments fostering equity, state, and future federally legalized cannabis programs must include targeted equity programs to help level the playing field. I look forward to returning to D.C. in May for 2023 NCIA Lobby Days!


Raina Jackson is a multifaceted cannabis brand strategist, product developer, and advocate, and is the founder & CEO of PURPLE RAINA Self Care, the culmination of her love for beauty wellness products, the color purple, and the musical and cultural phenomenon Prince. For the past 7 years she has worked in the San Francisco Bay Area cannabis industry in sales management, field marketing, distribution, and product development, and a verified SF Cannabis Equity applicant in Oakland and San Francisco. For the past year she has served on the NCIA Diversity, Equity, & Inclusion Committee and the Regulatory Compliance subcommittee.

Raina has over 15 years of experience in beauty/wellness care product development, sales/ marketing management, and product education at Maybelline, L’Oréal Professional, and Design Essentials Salon System and has taught cosmetology at The Aveda Institute in SoHo NYC. A San Francisco native, Raina earned a B.A. degree in cultural anthropology and linguistics from Stanford University and an MBA in marketing and management from NYU.

 

Member Blog: Payment Processing In The Cannabis Space

by Todd Glider, MobiusPay, Inc

There is a lot of confusion about payment processing in the cannabis space because payment processing is somewhat confusing to begin with, and because, in the cannabis space, ambiguity is a way of life. 

The title of this very blog post could, realistically, seem misleading to some. 

So, to be clear, when I say, “Cannabis Space,” I mean the entire industry — from plant-touchers (CBD included) to the ancillary businesses built up around it.

The passage of the 2018 Farm Bill marked an exciting new chapter for the industry. Suddenly, CBD, or, more specifically, any ingestible cannabis product containing .3% THC or less by volume, was classified as hemp. And since it is marijuana, and not hemp, that is defined as a Schedule I substance under the United States Controlled Substance Act, the Farm Bill, technically, made products like CBD as legal as cow milk — federally, anyway.

The upshot of this new classification is that now, at least some players in the cannabis space can market their products to a national base of consumers and clients, and they can do so by accepting credit cards as payment. 

However, the myriad Acquiring Banks across the United States have not exactly jumped for joy at the prospect of providing credit card processing in the form of merchant accounts to CBD retailers. Reticence rules. CBD is considered high risk, and four years on, only a handful of them have thrown their hat in the ring. 

Jargon Alert I: Acquiring Banks and Issuing Banks

In merchant processing parlance, banks fall into two categories: Acquiring Banks and Issuing Banks. Acquiring Banks, or, Acquirers, provide merchant processing accounts to businesses wishing to accept credit card transactions. Issuing Banks, short for Card Issuing Banks, are banks that offer branded payment cards directly to consumers. For example, if your bank has ever offered you a Visa card, it is an Issuing Bank (not that it couldn’t also be an Acquiring Bank, too).

Jargon Alert II: CBD is ‘High Risk’

CBD is deemed high risk by the card associations (i.e., Visa, MasterCard, American Express), and when the card associations deem a product or industry high risk, most Acquiring Banks tap out. This is because financial institutions are, by nature, risk averse (subprime mortgage crisis notwithstanding). 

So let’s talk for a minute about risk. High risk, that compound term, is a truncation of a longer phrase: ‘Higher risk of fraud or chargebacks.’

Why are CBD products at higher risk of fraud? It’s impossible to say for sure since the Visas and MasterCards of the world are publicly traded companies with their own trade secrets and IP, but there are several characteristics unique to CBD, or any cannabis product now federally legal, that likely figured into that decision.

Those FDA disclaimers that CBD retailers must print or paste on all product packaging and webpages are as good a place as any to start. They are mandatory because none of the benefits assigned to CBD have been clinically proven. There just isn’t enough data or testing at this point, and no big story there. That’s what happens when you demonize a plant for 100 years.

Consequently, from the perspective of the FDA, and the card associations, by extension, consumers are making CBD purchases with baked-in expectations based, exclusively, on word-of-mouth advice and anecdotal data. That’s a recipe for dissatisfied customers. And dissatisfied customers tend to charge back transactions.

The card associations, and the banks who provide merchant accounts, worry incessantly about fraud and chargebacks. 

Too Close for Comfort

Dissatisfied customers aside, there are onerous legal nuances that make the prospect of boarding cannabis merchants, even those selling products that are federally legal, daunting for banks. 

Selling a product with .31% THC across state lines is felonious. It is a federal offense. Violating a law like that could get a bank’s charter revoked, or, at a minimum, result in massive fines. 

On the other hand, selling a product with .30% THC across state lines is 100% federally legal. As stated above, safe as milk, federally.

That is a heck of a distinction. If any product contains more than .3% THC by volume, it is ‘marijuana’ in the eyes of the federal government. From the perspective of the banks, that’s a little close for comfort. Furthermore, banks don’t operate laboratories. They must rely on testing data presented to them in the form of third-party lab reports — Certificates of Analysis or COAs for short — to verify that the products being sold are federally legal.

The last thing an Acquiring Bank wants to do is violate a federal law EVER. It could result in a loss of their charter, lawsuits, and massive fines. And it’s important to keep in mind that the Acquiring Banks out there offering merchant accounts to CBD retailers are not giant, publicly traded institutions like Bank of America or Wells Fargo. They tend to be much smaller, and therefore, have infinitely smaller war chests for court cases.

Still, separating the federally legal Tier I cannabis product from the federally illegal Tier I cannabis product should be pretty cut-and-dry. If the product you’re selling is .3% THC by volume or less, it is exempt from the Controlled Substance Act (CSA). If that threshold is documented in the product’s Certificates of Analysis (COA), you ought to be able to sell it.

Unfortunately, it’s not that simple. When bank underwriters look at percentages of Delta 8, Delta 9, and Delta 10 on the COAs that cross their desks, they’re frequently at sixes and sevens trying to figure the whole thing out. 

From the perspective of the 2018 Farm Bill, a cannabis product is hemp if it contains .3% Delta-9 THC or less by volume, but what everybody says is “.3% THC or less by volume.” Consequently, when the compliance officer at the bank is performing her due diligence by inspecting the COAs corresponding to each product, she may encounter a lot of crooked numbers, and she may blanch at the results.

Those results, often, look something like the following: 

00.195% D9-THC

52.475% d8-THC. 

Federally, the Delta-9 threshold is the only threshold that matters. The 2018 Farm Bill says as much, and the 9th Circuit Court of Appeals in California affirmed it in a ruling this past May. Therefore, in the example above, the Delta-9 threshold has not been crossed. It’s not even close. It is textbook HEMP, even if the Delta-8 threshold is off the charts.

However, if the compliance officer was provided the remit, “.3% or lower,” he’s likely to look at this and say, “Fail,” without realizing that the Delta-8 THC information is irrelevant as far as federal law goes. 

Complicating the underwriting further is the fact that there is, to date, no standard template for COA reports. Every lab presents them differently. Bank compliance officers rarely moonlight as scientists. Like most of us, these CBD COAs are probably the first lab reports they’ve looked at since high school chemistry.

Furthermore, the banks can set their own rules. They don’t have to board CBD merchants. Few do, and those few that do have their own standards and practices. 


Todd Glider has been an e-Commerce leader since the start of the Internet age. He has an MFA in Creative Writing from the University of Miami, and has served as CEO for small and medium-sized technology companies in Spain, Austria and the United States. As our Chief Business Development Officer, Todd introduces MobiusPay’s suite of award-winning financial services to new industries, and implements the development strategies and key partnerships needed to bring value to new customers.

MobiusPay, Inc. is a U.S.-based global financial services organization that is committed to empowering individuals and businesses. For more than a dozen years, MobiusPay has leveraged state-of-the-art secure billing technology, long-standing relationships with financial institutions and award-winning customer support to provide merchant processing and payment solutions to brick and mortar and digital businesses around the world.

 

Member Blog: Report Shows Inflation Will Reduce Dispensary Profits – Here’s What You Should Do

by Lee Johnson, CBD Oracle

A new survey from CBD Oracle found that if inflation drives cannabis prices up, most customers will start to buy less cannabis. Unfortunately, inflation isn’t going anywhere anytime soon, currently standing at 8.3%, and things are very competitive for both dispensaries and growers. Plus, the survey shows that the fear that customers will go to a competitor if you raise prices is actually very justified. So what can companies do? We’ve put together some suggestions that play on consumer psychology to help you stay profitable.

The Survey: Why It Looks Bad for the Industry

The survey from CBD Oracle asked 1,450 Americans in adult-use states about their buying habits and how they may change with inflation. While there were many results, the most interesting ones concerned how people would respond to more inflation and the price of cannabis increasing.

They found that 54% of respondents would buy less cannabis if prices increased as a result of inflation. Although over a third (37%) would buy around the same amount, it’s clear that there will be some impact on companies’ bottom lines. The survey also asked about the maximum amount people would be willing to pay for an eighth (around 3.5 g) and found that while 83% would pay $30, only 57% would still buy at $40.

But with increased prices for everyone from growers to dispensaries, it’s difficult to make ends meet at current prices. Mature markets like Colorado have an even bigger issue, with more than enough stock and tons of competition, so increasing prices may really feel like a gamble. The situation is totally unsustainable, and around 30% of dispensaries will be raising prices in the near future, if they haven’t already.

Andrew Livingston, Director of Economics & Research at Vicente Sederberg commented to us, “Cannabis is clearly not ‘inflation proof.’ Companies struggle to operate profitably as their cost of labor, distribution, and input ingredients climb along with prices across the rest of the economy.”

Raising Prices While Retaining Customers: A Guide for Dispensaries

The survey shows that the problem is on the horizon, but what’s the solution? Here are some suggestions.

Use Price Anchoring

Anchoring is a very useful psychological concept for dispensaries, and there are many ways you can benefit from it. The way it works is really simple. Imagine you have a “regular” price on the tag crossed out, and a sale price below it. Even if the sale price is still higher than customers might want to pay, customers note the crossed-out price and then look at the other relative to the original amount. So if your eighth is labeled “$35 $25,” customers “anchor” onto the $35 and the $25 seems like a bargain. This specific type is called strike-through price anchoring.

Anchoring Through Product Grouping

Price anchoring can be very powerful when used intelligently. For example, you could have your biggest-selling product on the shelf, but with a much more expensive strain beside it, ideally marked and labeled such that it’s hard to ignore. While very few customers will pay for that $50 eighth, that will make the $30 one sat beside it look much better.

Costco-Style Anchoring

In this approach, you arrange your store so that higher-price items greet customers – again, made hard to ignore through ads and positioning – and they anchor onto higher prices. Then as they make their way into the store and see your regular prices, they seem cheaper, even if they haven’t changed or have even increased.

Raise Prices Elsewhere to Keep Cannabis Cheap 

You can also try to balance less profitable products out with other items. As McKinsey & Company suggests, raising prices on secondary and tertiary items (think grinders, bongs, vape pens, and other accessories) can help you recoup losses on key-value items (cannabis products). Combined with other approaches, this can be a clever way to boost profits while minimizing the risk customers will simply go elsewhere for weed.

Focus on Your Brand

With over half of dispensary customers sticking to the same seller, one way to minimize the impact of inflation is to make your brand their brand. Shopify’s report on the Future of Retail recommends focusing on your brand story (why are you in business? What sets you apart from the competition?), showing that your values align with customers’ and treating your employees as a “brand audience.” If you educate your employees about your brand, you will make them brand evangelists, improving customer loyalty as a knock-on effect.

Cut Costs Wherever Else You Can

Simply reducing costs on packaging – child-proof plastic packets rather than glass, for instance – can help you stay in profit without pushing costs to customers. Freezing hiring or even laying off staff is another alternative. This isn’t ideal, but if there are ways you can streamline, automate or digitalize processes, you may be able to cut back until the economy gets back on its feet.

Collect Data and Adapt

Arguably the most important thing you can do alongside any of these changes is to improve your data collection and response process. This is simply so you know the impact of the interventions as quickly as possible. You need to combine this with an enhanced decision-making process so you can make company-wide changes quickly and efficiently. It’s unlikely you’ll be able to make one set of changes and leave it that way, so set up systems to streamline the process for the future.

Conclusion: Remember, We’re All in This Together

With the report showing tough times are likely ahead for the cannabis industry, the most important thing to remember is that basically every dispensary in your state is in the same boat. If you’re friends with any other businesses in your area, talk to them about it and how they’re planning on responding. If prices must rise, it’s much better if you can present a united front to consumers. One dispensary raising prices might be a death sentence; all dispensaries raising prices is just inflation, plain and simple. Be up-front with each other and customers, and you’ll be surprised at how well you can pull through.  


Lee Johnson is a writer at CBD Oracle who has been covering science, vaping, and cannabis for over a decade. He focuses on research-driven deep dives into topics ranging from medical uses for CBD to industry and user statistics, as well as general guides and explainers for consumers. He is a passionate advocate of both CBD and cannabis, and a strong believer in informed choice for consumers.

CBD Oracle is a cannabis consumer research company working to improve the safety and transparency of cannabis products, producing in-depth research pieces, along with long-form analysis of social and legal issues.

Member Blog: Stellar Customer Service, Transparency, & Education Drive Cannabis Success

by Gary Paulin, VP of Sales and Client Services at Lightning Labels

With expansive product choices, it’s no longer enough to rely solely on product quality and availability. Today’s maturing cannabis marketplace requires differentiation to resonate and succeed.

Three pillars of that differentiation are stellar customer service, total transparency, and excellent education. At the core of each, sincerity and truth must predominate. In this age of “fake news,” anything that doesn’t seem trustworthy and true likely will backfire on the company sooner or later.

It only takes one unsubstantiated quality control or product claim to hit the social media lie detector, then potentially go viral. At the very least, one consumer badmouthing your company via word-of-mouth and/or digital messaging will harm your reviews and ratings. In most cases, the damage will be undetectable until it reaches a level where revenues and reputation are noticeably impacted.

Following are four basics of stellar customer service, transparency, and education:

  1. Interact authentically. Scripts and canned phrases instinctively don’t resonate with most consumers. One obvious example is the “I’m so sorry you’re having a problem” response. How likely is it that the person is really sorry and not just parroting something they’ve been told to repeat time and time again? Instead, communicate in a real way by tuning into what the existing or prospective customer is trying to address.

For example, when someone complains about lengthy waits to receive live phone support (including disconnects while waiting), it’s okay to say something like, “I get it. We’ve been having challenges. Now that we’re on the phone together, let’s address your needs right away. And, please give me your phone number, just in case this call drops. I’ll call you right back.”

  1. Offer multichannel communications preferences. Some people want live phone support, not a digital option. Chat bots can be extraordinarily frustrating unless the programming and ability is advanced. Ditto for “live chat.” As much as possible, make it easy and meet everyone’s preferences. Email, live phone support, texting, website knowledge center, and digital chat should all be offered to meet the customer in a way that works best.

     

  2. Offer total and transparent education. Knowledge centers (and associated forums) and FAQs can be excellent tools to help provide priority information, but they’re only one piece of the puzzle. Consumer questions and concerns can cover anything. There should be an easy way to find more information through the above-referenced channels as needed. Product labels can provide easy access to a variety of information, starting with label content and extending to either Augmented Reality or QR digital gateways for more in-depth education. Those digital gateways should contain valuable information, along with easily found follow-up calling, emailing, live chat, and additional educational options (including possibly Knowledge Center, FAQs, and keyword-search forums/articles, et al).

“Full disclosure” should be at the core of all things educational, both in information repositories and customer service support. For example, CBD can make some people cranky and anxious. Full disclosure must override the desire to sell. By fully informing a consumer of risks as well as rewards, the experience is much more likely to result in high marks for the company.

Conversely, incomplete or inaccurate information provided by salespeople motivated only by making sales will backfire when less than optimum outcomes occur. In contrast, a salesperson willing and able to fully educate will help build long-term customer relationships with the company. 

  1. Hire motivated, attentive, smart people. No matter what policies and training are in place, ultimately companies need to focus on hiring the best candidates — those dedicated to top-notch customer service, truthtelling, and education. Workforce shortages are not a valid reason to abandon these core values in the name of expedient hiring. Be committed to employee wants and needs, and be prepared to follow through. Offer generous wages, but beware of those who seem overly money motivated and demanding. They likely will be gone as soon as the next “shiny toy” opportunity comes along.

There are companies that have weathered supply chain and workforce shortage issues — and even inflationary pressures — well. One that comes to mind is Costco. Unlike many retailers during the pandemic, their quality of service has remained high. Product availability and selection have been maintained. Prices, although subject to some upward movement, don’t seem to have risen as much as most retailers.

Clearly, Costco found solutions instead of blaming challenging conditions and using those as an excuse for failure. Follow this example. Find ways to do more with less, get creative about becoming more efficient, and plan ahead so that emergent problems don’t become overly taxing. 

Cannabis companies that excel in being trusted, liked, and respected will outperform their competitors willing to live with mediocrity.


Gary Paulin is VP of Sales and Client Services at Lightning Labels, a Denver-based custom label printer that uses state-of-the-art printing technology to provide affordable, full-color custom labels and custom stickers of all shapes and sizes. Contact: sales@lightninglabels.com; 800.544.6323 or 303.481.2304.

 

 

Committee Blog: Cannabis and Cancer – Cannabinoids as Cancer Cell Disablers (Part 2)

by Ann Allworth, Ph.D. and Cynthia Shelby-Lane, M.D.
Members of NCIA’s Scientific Advisory Committee

There is abundant anecdotal evidence showing that people can live with cancer for decades after diagnosis. Several books and films describe various alternative approaches to traditional medicines that patients have used to help them heal, many citing the use of cannabis. For example “Weed the People” is an excellent film documenting the cannabis experiences of children with cancer and advocating for the sorely needed research on the healing potential of this powerful plant.  

This blog will explain how cannabis can help our cells and the endocannabinoid system (ECS) components work together to weaken the ability of cancerous cells to survive. Let’s begin with a quick overview of cells and how they work. Cells are the smallest living unit in the body. There are about 200 different types of cells that come in different shapes and sizes, depending on their job. All cells are enclosed by a cell membrane which holds the cell’s contents and houses receptors, structures that allow cells to communicate with each other via ligands. Ligands carry specific messages and include, but are not limited to, neurotransmitters, hormones, growth factors, endocannabinoids, and phytocannabinoids.  They circulate throughout the body in our bodily fluids and bind to specific receptors. Receptors have a binding site with a distinct shape that matches the shape of specific ligands. In other words, each ligand is like a key that fits a lock to “open” the receptor so that the message the ligand carries can be received and transmitted to the cell. 

Receptors and ligands are two of the main components of the ECS. Even though it is called a system itself, the receptors and ligands of the ECS are found in other systems of the human body, such as the neurological, gastrointestinal, and immune systems. This means most cells in the body contain cannabinoid receptors, known as the first cannabinoid receptor, CB1, and the second cannabinoid receptor, CB2. These receptors are activated by cannabinoids our body makes itself, known as endocannabinoids [anandamide (AEA) and 2-arachidonoylglycerol (2-AG)], cannabinoids made by plants, known as phytocannabinoids, and some enzymes [e.g., fatty acid amide hydrolase (FAAH) and monoacylglycerol lipase (MAGL)]. 

This is an excellent basic understanding, but the ECS is much more complex. It is incredibly important to human health as its function is to maintain balance throughout the body and it helps to regulate many facets of physiological, behavioral, immunological, and metabolic functions in humans. The vast medicinal value of cannabis comes from the mixture of cannabinoids, terpenoids, and flavonoids that interact in some way with the ECS. Although research is still being performed to better explain how the ECS is involved with cancer, it has been demonstrated in animal and cell experiments that cannabis stops a number of vital functions in cancer cells, including proliferation, angiogenesis, and metastasis, and also causes apoptosis of malignant cancerous cells.  

Proliferation is the scientific term for how quickly a cell can divide into two cells. Cancer cells can quickly proliferate because the molecules that regulate how often a cell can divide and create new cells have been disabled. This process allows cancer cells to grow in an uncontrolled fashion and to compete with healthy cells for space and nutrients. Animal and cell studies have shown that the compounds in cannabis can stop cancer cell proliferation in a wide variety of cancer types including breast, lung, prostate, liver, pancreatic, and many others. 

Angiogenesis means the formation of new blood vessels. As cancer cells multiply and form large clumps, they secrete chemicals, many of which are ligands, that bind to receptors on cells in the tumor microenvironment. These cells receive the messages and begin building blood vessels. The newly formed blood vessels guarantee the growing clump of cancer cells will be fed all the nutrients and oxygen it needs to survive and flourish. A growing number of studies demonstrate that cannabis can inhibit angiogenesis in experimental cancer models. 

Metastasis occurs when cancer cells spread to another part of the body other than where the cancer began. Cancer cells physically extend into the normal cells in their microenvironment, or they can pass through the walls of nearby blood or lymph vessels to get to distant locations. When they stop moving, they secrete messages that direct angiogenesis. Metastasis is a feature of more advanced cancer stages, such as stage 4 cancer. Experimental data shows that cannabis can hinder metastasis. 

Apoptosis is a form of programmed cell death. Apoptosis is a process that cells perform if specific genes are turned on. The cell then goes through a series of steps that end in its death. Cannabis has been shown to induce apoptosis, which is an excellent fate for a cancer cell. Although the experimental data here is predominantly from animal and cell cancer models, it is likely that these critical cellular processes are happening when cancer patients improve using cannabis. 

Hopefully soon, more research will help scientists elucidate the exact mechanisms by which patients experience relief using cannabis!  


Ann Allworth Ph.D. is founder and CEO of Cannabis Education Solutions. In her first year of undergrad, Ann Allworth Ph.D. developed a great interest in embryology while taking Anatomy & Physiology. After graduating, she enrolled in a Ph.D. program in cell biology and studied mammalian eggs and embryos. For several years after completing the program, she continued this research at Tufts University Health Sciences Center while working as a Gross Anatomy instructor. Next, Ann worked as an assistant professor at Howard University College of Medicine, continued teaching Gross Anatomy and began studying breast and ovarian cancer cells.   

After 19 years in medical academia, Ann did a 180 and moved on to the natural product industry, where she learned there were many alternatives to pharmaceuticals to achieving health. And among other topics,  taught the immense value phytonutrient rich foods and herbs have to optimal health and well-being for almost 15 years. Upon learning of the existence of the endocannabinoid system (ECS) in March 2019 she was shocked she had never heard of it, but she is far from alone. The general public is for the most part clueless about the ECS and the medical establishment by and large ignores its existence. So, she decided to create a company dedicated to illuminating minds to the expansive nature of the ECS and its unparalleled importance to human health. 

Cynthia Shelby-Lane, MD, is an emergency physician, board-certified in anti-aging and functional medicine, and a certified Marijuana Doctor practicing medicine in Detroit, Michigan. Dr. Shelby-Lane has certified more than 10,000 medical cannabis patients in the State of Michigan. She coaches patients on their use of cannabis in conjunction with their current medications and medical conditions. She has been a member of NCIA and the Scientific Advisory Committee for the past five years, in addition to membership in multiple cannabis associations and organizations. She speaks at conferences/webinars and in the community on the use and benefits of cannabis and the evolving landscape of cannabis research. Dr. Shelby-lane has worked closely with the Last Prisoner Project.

Equity Member Spotlight: Ontogen Botanicals – Dr. Adrian Adams

NCIA’s editorial department continues the Member Spotlight series by highlighting our Social Equity Scholarship Recipients as part of our Diversity, Equity, and Inclusion Program. Participants are gaining first-hand access to regulators in key markets to get insight on the industry, tips for raising capital, and advice on how to access and utilize data to ensure success in their businesses, along with all the other benefits available to NCIA members. 


Tell us a bit about you, your background, and why you launched your company.

Hello, I’m Adrian Adams, EdD. I spent a decade teaching Biology and Chemistry as well as coaching football. I chose to spend several years as a stay-at-home dad (the hardest job by far) and then worked in the pharmaceutical industry. I know many of the physicians in my area. While at dinner one night with a couple of doctors, the conversation revolved around having to combat the misinformation that patients come in with from “Dr. Google.” Minutes later, one doctor asked the others what they were saying to the increasing number of patients who come in asking about cannabis therapy. There was a prolonged silence until another doctor said “I just tell them I don’t know anything about that and to look online.”

Another doctor said, “me too.” The irony within the few-minute span was worthy of a fork drop. The FDA has approved CBD as a medicine. To me, not educating a patient about a legal, safe, and effective treatment option meant they just didn’t have the cannabis knowledge. That also meant more legal, safe, and effective products needed to be made for doctors and their patients. In that moment, Ontogen Botanicals CBD was born.

What unique value does your company offer to the cannabis industry?

We offer reduced costs, which can be a barrier to entry for consumers. And a deep knowledge of the intersection between cannabis and medicine. Physicians are a choke point for the industry that is overlooked. Simply put, doctors are good people. Most of them have simply had zero training on the endocannabinoid system as it was only identified in the 1990s. Ontogen Botanicals believes if they knew better, they’d do better. We offer doctors the information to make an informed decision on the utility of cannabis for their patients. We also offer the ability for doctors to provide legal cannabis products for their patients right in their office as part of a sound treatment plan.

Ontogen provides effective CBD products that are truly full-panel lab tested for safety. We strongly believe in starting at a low dose, which also lowers cost. Using the least medication necessary is part of medical training. Low-dose products work for many people and reduce the cost barrier of entry to try CBD and other cannabis products.

What is your goal for the greater good of cannabis?

We want to increase the healthcare provider and patient knowledge of what this plant can do, as well as provide quality of life-improving products. Now we’re expanding to help the population at large. Medically speaking, cannabis is as good as advertised. The more people use it, the more legitimate the industry becomes.

Cannabis gets a bad rap for being a gateway drug to the opioid crisis. In fact, doctors are beginning to address the pain that often starts and underlies chronic opioid use. You cannot pull opioids and not address the pain that drives many folks back to opioids. Regulated cannabis can reduce pain without the many harmful side effects of opioids – especially unregulated heroin.

With industry growth, and Ontogen Botanicals‘ growth, will come the capital for Ontogen to address the challenges that poverty creates for people who may have much less access to healthcare and prescription drugs to get the medicine they prefer. There is enough money in cannabusiness to use it for social good.

What kind of challenges do you face in the industry and what solutions would you like to see?

A big problem for any small business is finding the right people to do business with. Minority business owners face discrimination and mistrust when trying to do business in general. Now add cannabis to the equation. I’ve been asked for $5K just for the right to open a business checking account.

Groups like NCIA, MCBA, and Minorities for Medical Marijuana help us find each other to do business with as well as bridge the gap between us and traditional business communities like banking for access to capital.

This industry has shown the ability to help remediate the cannabis criminalization harms done to minorities during the war on drugs. Big tobacco and many other industries are already investing and awaiting federal law changes. I fear that once the flood gates open to large companies investing billions of dollars, the feeding frenzy will create an extinction-level event for smaller minority-owned companies. We need federal and state-level legislative dams in place before then to protect minority-owned smaller businesses.

Why did you join NCIA? What’s the best or most important part about being a member through the Social Equity Scholarship Program?

I joined to try to help advocate for social equity and social justice for minorities to have a once-in-a-lifetime chance to start an industry. The best part about the NCIA Social Equity program is that it brings minority entrepreneurs together weekly to support each other. We’ve locked elbows, pick each other up in hard times, and celebrated the good.

 

U.S. Federal Appeals Court Legalizes Delta-8 THC, Setting Precedent for the Cannabis Industry

By Sadaf Naushad, NCIA Intern 

Thanks to the Agricultural Improvement Act of 2018 (2018 Farm Bill), hemp is now federally legal, permitting U.S. farmers to cultivate, process, and sell hemp. Since its passing, however, businesses in the hemp industry have found themselves in a legal gray area. 

With the 2018 Farm Bill eliminating restrictions on the psychoactive cannabinoid delta-8 THC, the companies deemed their delta-8 THC products within legal guidelines. Several jurisdictions disagreed, calling for clarification on the status of delta-8 THC. 

Last week, the U.S. Court of Appeals for the Ninth Circuit addressed the dilemma, claiming delta-8 THC products as federally legal. 

Let’s consider what delta-8 THC legalization means for the future of the cannabis industry. 

Because recreational cannabis use remains federally illegal, delta-8 THC products continue to gain popularity nationwide. Manufacturing developments have led to enhanced consumer products, in which cultivators safely extract delta-8 THC cannabinoids from hemp plants. 

While delta-9 THC constitutes a major psychoactive cannabinoid in the marijuana plant, delta-8 THC appears in trace amounts of the plant. Its psychoactive properties grant consumers gentler side effects compared to delta-9 THC. 

On Thursday, a three-panel judge of the U.S. Court of Appeals published their opinion regarding delta-8 THC, ruling products containing the psychoactive ingredient as federally legal. According to the panel, delta-8 THC qualifies as a legal substance under the present federal definition of hemp. Federal law outlines hemp as “any part of” the cannabis plant, in which “all derivatives, extracts and cannabinoids” with less than 0.3% delta-9 THC by weight are allowed.

Had U.S. Congress unintentionally created a loophole leading to the legalization of delta-8 THC, the U.S. Federal Appeals Court stated that Congress should be responsible for resolving the issue. The panel specified that they would not replace its own judgment with Congress’ policy rulings. In the meantime, the Court defines the federal hemp law as “silent with regard to delta-8 THC.” 

According to a Politico article, “Members of Congress have proposed fixes to federal hemp laws that would close this loophole. Rep. Chellie Pingree (D-Maine) introduced a bill in February to limit hemp and hemp products by calculating the total THC rather than focusing on Delta-9 THC. At the same time, state hemp regulators are voicing for a similar change advocating for the 1 percent total THC definition of hemp. Meanwhile, some states have moved to ban the sale of Delta-8 THC products or to regulate them similar to recreational marijuana.” 

NCIA takes a strong position that Delta-8 products and any other psychoactive cannabinoids must be restricted to adults over 21 and regulated by the states so that these products are subject to the same testing requirements, track-and-trace rules, and excise taxes as other adult-use cannabis products.

Furthermore, if you are interested in learning more or getting involved with NCIA’s Government Relations work please contact Madeline Grant at madeline@thecannabisindustry.org to schedule a call. As the oldest and largest trade association, our Government Relations team has been hard at work for over a decade educating and working with congressional offices. NCIA held its Virtual VIP Lobby Days last week, May 16-19 on Capitol Hill. NCIA’s Evergreen members participated in congressional meetings all week long to advocate and educate members of Congress(s) and staff on the importance of cannabis policy reform. We discussed the importance of keeping the Secure and Fair Enforcement (SAFE) Banking in the America COMPETES Act and descheduling cannabis at the federal level. You can read more about cannabis and banking from last week’s blog HERE.

NCIA members were able to share their personal stories about being in the cannabis space and relay their expertise to further understanding of the struggles and hurdles cannabis businesses face every day. There is never a time more important than now to support NCIA’s efforts for cannabis policy reform. 

 

 

Committee Blog: Protect Against Corporate Identity Theft with Trademark Rights

By NCIA’s Cannabis Manufacturing Committee

A company’s brand is its identity. Branding elements – names, logos, colors, graphics, slogans – are how customers recognize a product or service as coming from a particular source. Done properly, brands can be as recognizable to consumers as a person’s face, name, and voice. In some cases, brands may be some of the most valuable assets a company may own. Protecting physical assets is common in the cannabis industry, but how do companies protect intangible assets, like their identity? Fortunately, there are bodies of intellectual property law designed to provide legal protections against others from using brand elements that are too close to your own. To take advantage of these protections, however, cannabis companies must understand how each one works and develop a branding strategy that leverages intellectual property laws.

This is the second article in a 3-part series about cannabis IP. The first article focused on patent law and can be found here. The series will culminate with a Q&A-based webinar on April 19th at 1:00 Eastern. Advance questions can be sent to paul@thalo.io.

Mechanisms of Brand Protection

Brands are protected most prominently by legal domains known as trademark and trade dress.  Trademarks include a company’s name, logos, and slogans, as well as those of any individual products. In some instances, trademarks may also include recognizable elements like colors (UPS’s brown) and sounds (NBC’s chimes). Trade dress is a similar concept to trademarks, but applies to the distinct appearance of a product or its packaging. Trade dress can even be used to protect the unique look and feel of a retail establishment, such as a restaurant or dispensary.

Both trademark and trade dress is intended to reduce confusion in the marketplace as to the origin of a product or service. The idea is that the public is best served when they can reliably determine which company to associate with each product. Reliable product-company association increases quality accountability, facilitates safety controls, allows consumers to form powerful brand loyalty.

Companies that avail themselves of trademark and trade dress laws gain access to a set of tools to legally fence off others from using branding that is likely to confuse customers about the source of a product. And, unlike other forms of intellectual property, trademark rights can last indefinitely and even strengthen over time. Some of these rights arise automatically just by using a mark, others must be sought out through registration.  

Principles to Consider When Selecting a Brand

Every company should consider trademark principles from day zero, when first selecting a name. U.S. trademark rights only apply to marks that are “distinctive,” meaning they are capable of distinguishing things bearing the mark from goods and services offered by others. The more distinctive a mark is, the stronger protections provided by trademark law. Names that merely describe the goods or services are non-distinctive and are typically not eligible for trademark protection.

There are five general categories along the spectrum of distinctiveness – fanciful, arbitrary, suggestive, descriptive, and generic – arranged from strongest to weakest.

Fanciful marks words that were invented specifically to serve as a trademark, such as Xerox or Nvidia. Because these words have no other meaning than to identify the source of goods or services, they are the most distinctive category of trademark and receive the greatest protections.  

Arbitrary marks are the second most distinctive category of mark and include words that have alternative meanings, but only meanings in contexts unrelated to the goods or services being sold. These include Apple computers, Lotus cars, and Bicycle playing cards.

Suggestive marks are less distinctive than Fanciful and Arbitrary marks, but still considered sufficiently distinctive to receive trademark protection, though registration may be more difficult.  Suggestive marks imply a quality or characteristic of the good or service the mark is used in connection with. Some examples of suggestive marks would include: Microsoft, a portmanteau of microprocessors and software; ChapStick, for a stick-shaped balm used on chapped lips; and Netflix, which is suggestive of an internet-based video service. 

Descriptive marks simply describe the goods or services being offered and are, therefore, not distinctive. In some cases, however, descriptive marks can acquire distinctiveness and achieve a “secondary meaning” as a source-identifier through long-term use (usually +5 years), heavy advertising, or pervasive adoption. Examples of Descriptive Marks would include: International Business Machines (IBM Computers); Best Buy retail stores; and Sports Illustrated magazine. 

Generic marks are terms that broadly identify the product or service being offered. Generic marks are so non-distinctive that they are not eligible for trademark registration, even if secondary meaning can be shown. The idea is that these marks are so fundamental to the product that it would be detrimental to consumers and the marketplace to allow a brand to have exclusive use of the term in connection with the goods. “Escalator” and “Dumpster” were once brand names but, because they were used widely to refer to all mechanized stairways and trash receptacles regardless of manufacturer, they lost all trademark distinctiveness.

Parody Does Not Apply – Avoid Famous Brands

A surprising number of cannabis companies have used trademarks that reference or parody famous brands. Gorilla Glue, Girl Scout Cookies, and many others have been used as names for cannabis products.  Companies have used packaging that resembles well-known products such as Life Savers and Sour Patch Kids. This is a bad idea. While this practice seems to be increasingly limited to unregulated markets, a recently published (and ill-advised) application for the mark and logo MCWEED for apparel shows that not everyone has received the message:

Registration and Scope of Protection

Some trademark rights are established as soon as a trademark is used in commerce. But to obtain the full scope of legal protections available, trademark owners must register their marks, preferably federally. Federal registration stakes a claim to a nationwide priority date, increases protections available, increases potential damages, and embodies a definities property that can accrue value.

All trademark registrations begin as applications. Trademark applications must, among other things, identify the mark, the applicable dates of use. Applicants must also describe the goods and/or services the mark is (or will be) used with and select one or more classes from an international menu of product classifications. The classes selected and the description of the products can greatly affect the scope and validity of a registration, so it is important to consult with an experienced trademark attorney.

These applications are examined by the U.S. Patent & Trademark Office to ensure they meet the statutory requirements. Typically, the USPTO completes examination within about 6 months, but currently the office is experiencing some delays and it is commonly taking 7-10 months for an application to be evaluated. If the examining attorney identifies any problems, they may issue rejections, to which the applicant will have an opportunity to respond.

If the USPTO approves the application, it will be published for 30 days (expandable to 180 days) to allow other trademark owners to oppose registration of the mark. Sophisticated trademark owners can set up alerts to be notified when any similar applications are published that may be concerning. At the close of that period the mark is recorded in the federal register and the trademark registration is complete. 

A qualified trademark attorney can help guide you through the process and provide counseling concerning how to maximize your chances of registering your trademark without prejudicing your rights. Trademark application fees run $250-$350 per class of goods or services and a trademark attorney will typically charge a few hundred to a few thousand dollars, depending on their experience and the level of pre-application clearance. While trademark mills and self-guided applications are available, there are many pitfalls to avoid while preparing and prosecuting a trademark application, and applicants should be wary of attempting to navigate the process without legal guidance.

Applicants should also be aware that many companies mine the USPTO database to send unsolicited offers to trademark applicants. While these offers can look official and typically include some deadline to respond, they are usually scams. Nevertheless, it can be helpful to have an attorney review any correspondence relating to the trademark application to ensure that no important correspondence from the USPTO is missed.

Embrace the Zone of Expansion

There are a lot of benefits to registering trademarks, but registration is not available in all instances. Under federal law, registrations cannot be issued that cover goods or services that are federally illegal. But the same mark can be registered for other, legal products, and the trademark rights will extend to a reasonable “zone of expansion,” covering products that the trademark owner could reasonably branch out to in the future. This allows a brand owner to obtain the benefits of federal trademark registration and use it to provide some umbrella protection for their cannabis brands.

One option is to sell branded accessory products, such as apparel or smoking accessories, for which a trademark registration will pass muster. It is debatable, however, whether cannabis products are within the zone of expansion of t-shirts.  

Another option is to develop one or more low-THC hemp products under the same brand as high-THC cannabis products. At least one case is already working its way through the courts where a trademark owner is claiming that cannabis edibles are within the zone of expansion of a line of hemp-infused, low-THC edibles. Edible IP, LLC and Edible Arrangements, LLC v. MC Brands, LLC and Green Thumb Industries, Inc., (Case No. 20-cv-05840). Though that approach is also not without its pitfalls, as discussed below.

A final option that every cannabis company should consider is state trademark registration. State registration requirements are typically governed by state law and, therefore, state trademark registrations can often be obtained for cannabis products. State registrations are more limited than federal registrations, but can be a powerful tool in the current landscape of cannabis IP.

Products with CBD Can Be Trademarked, But You Can’t Trademark “CBD” Products

Companies that produce hemp products do not have the same problem with federal illegality as companies with high-THC products. Federal registration is available for trademarks that are used on hemp and hemp products. However, as most hemp companies should know, the advertising of cannabidiol or “CBD” is regulated by the Federal Drug and Cosmetic Act (“FDCA”), 21 U.S.C. §§ 321(g)(1), 331(d) and 355(a). Because CBD is the active ingredient in an FDA-approved drug (Epidiolex®), the FDCA prohibits marketing CBD products (absent a New Drug Application or Abbreviated New Drug Application). Though that may change. As of now, however, the USPTO will refuse to register marks that identify the goods as “CBD.” In re AgrotecHemp Corp., Serial No. 88979905 (issued Feb. 10, 2022) (finding that PUREXXXCBD for plant extracts should be refused registration).  

Notably, the AgrotechHemp decision went further than previous USPTO decisions in that it also criticized the issuance of registrations for marks used on products “derived from hemp.” This may signal a crackdown on all hemp-related registrations, or it may be limited to registrations that explicitly identify the goods as containing “CBD.”

Where’s the Value in Trademarks?

It may come as no surprise that brands can be incredibly valuable assets. In some cases, a company’s brand can make up a significant portion of its balance sheet and brand-centric companies can fetch a premium when they are acquired, known as “goodwill.” Increasingly, specialized lenders are even willing to use secured IP as financing collateral. Nonetheless, the real value for many trademark owners is non-monetary.

When many people think about intellectual property, they recall headlines of jury verdicts with huge damages that can reach into the billions of dollars. The reality is that, absent intentional copying, trademark cases rarely result in large-dollar awards. More often, successful trademark suits result in an injunction preventing further infringement and some relatively minimal damages. The primary value of trademark rights is the ability to control your brand and how consumers perceive your brand in the marketplace. Trademark rights give you the tools to define your brand as a unique identity and preserve that identity in an increasingly crowded industry.

 

Video: NCIA Today – Thursday, March 24, 2022

NCIA Deputy Director of Communications Bethany Moore checks in with what’s going on across the country with the National Cannabis Industry Association’s membership, board, allies, and staff.  Join us every other Thursday on Facebook for NCIA Today Live.

Member Blog: FDA Cites Multiple Violations for Selling CBD as Supplement, Food, Cosmetic, or Animal Food Ingredient

by Gisela Leon, MS, MBA, Independent Consultant, EAS Consulting Group

The FDA’s position on the use of CBD in dietary supplements and foods is steadfast. In 2021, five warning letters about CBD-containing dietary supplements and foods went out – three based on website reviews and two based on facility inspections. All cited violations relate to pain relief claims. The products are therefore unapproved new drugs. Two warning letters emphasize the FDA’s position that CBD does not meet the definition of a dietary supplement, from which it is excluded due to the authorization for investigation as a new drug. 

In November 2019, the FDA published 15 warning letters in a “catch-all” effort regarding cannabidiol products. The products range from articles sold as dietary supplements, conventional foods, cosmetics, and animal food. The FDA sent out the 15 warning letters to companies in a number of states, including California, Texas, Oklahoma, Colorado, Oregon, New York, Florida, North Carolina, Arizona, and Kentucky based on the content of websites and social media sites. This was not the first time the FDA had sent warning letters regarding cannabidiol [CBD]. The first seven CBD warning letters were issued in March 2019, so attentive manufacturers could have been aware of t the FDA’s position and that enforcement actions might be taken.

In the 2019 warning letters, the FDA states that CBD in products sold as dietary supplements does not meet the definition of dietary ingredients in the Federal Food, Drug, and Cosmetic Act (321(ff)(B)(i)(ii)). This provision clarifies that a dietary ingredient cannot be a substance that has been approved as an active ingredient in a drug. The FDA has confirmed that CBD is an active ingredient in the approved drug Epidiolex. 

Products containing CBD and sold as conventional food often worry the FDA even more, because they are often advertised for toddlers and infants. FDA clarified that CBD does not have an authorization as a food additive. Food additives need to be pre-approved by the FDA and there is no such regulation for CBD. CBD also is not a GRAS substance. This is based on the FDA’s review of publicly available data, which shows that CBD is potentially harmful and may cause liver injuries and interact with other drugs. Furthermore, studies in animals have shown that it might impair sexual behavior in males.

Similarly, the FDA states in relevant warning letters that CBD is an unapproved new animal drug because of the disease claims. The products are also adulterated animal foods because there is no animal food additive regulation that authorizes the use of CBD and there is no basis to conclude that CBD is GRAS for use in animal foods.

Besides the illegal status of CBD as a dietary ingredient, the warning letters regard the products as unapproved new drugs, because they claim that CBD cures, mitigates, treats, or even prevents diseases. Most warning letters are very long because the manufacturers cite numerous diseases for which CBD might be helpful. CBD is often depicted as a “cure-all.” Some of the popular disease claims involve pain relief, anti-inflammatory, diabetes, acne, anxiety, depression, and cancer. For example, one warning letter cites 45 diseases. Simultaneous to being unapproved new drugs, all products are regarded as misbranded drugs. 

Most 2019 warning letters were signed by three FDA compliance directors from Center for Drug Evaluation and Research, Center for Veterinary Medicine, and Center for Food Safety and Applied Nutrition. In some of the earlier warning letters, the FDA also involved FTC – Federal Trade Commission – because of unsubstantiated claims. Both agencies are concerned that some of the efficacy claims may not be substantiated by competent and reliable scientific evidence.

There are clearly more than 27 companies in the market selling CBD. My thought is that the FDA has picked some of the worst offenders with respect to claims to establish impressive examples. Throughout the years in articles and press notifications, the FDA has always stated the regulatory position that CBD does not meet the definition of a dietary ingredient. This position has been challenged by industry and is a controversial topic. Some plaintiffs’ lawyers have initiated class-action lawsuits on the basis that clients were harmed by buying an illegal product and paying too much for it. It appears that the FDA is currently only enforcing against CBD products with disease claims. So far, the FDA has not written warning letters solely because a dietary supplement uses CBD. All of the mentioned warning letters could have been written to any dietary supplement making obvious disease claims.

So, what can be learned from the FDA’s actions? The first and most important step for manufacturers would be to “clear” all web pages, social media pages, and third-party referrals of disease statements. A second approach should be to not use CBD as a food ingredient or as an animal food ingredient. As a regulatory strategy, this may buy some time until the controversy about the legality of use in dietary supplements is clarified. For dietary supplements – in a conservative regulatory approach – a next step could be not using CBD as a dietary ingredient, because it is an approved drug. 

A possible alternative legal ingredient is a full spectrum hemp extract which contains all hemp components – not just isolated CBD. Hemp-derived ingredients are eligible for use as dietary ingredients by virtue of being “botanicals.” However, hemp-derived substances must submit a New Dietary Ingredient notification 75 days prior to first marketing the hemp supplement. A less conservative regulatory approach for dietary supplements could be to wait and see what the FDA decides under the pressure from industry and consumers. Hopefully soon, the FDA will clarify the legality of use in dietary supplements.


Gisela Leon brings in over 33 years of experience in international labeling. She is well-experienced in USA labeling requirements of food, dietary supplements and cosmetics, in European food laws and multi-language labeling. As a regulatory consultant, she focuses on a concise review process, having reviewed hundreds of labels for U.S. compliance and helped international products to come into compliance with U.S. regulations. Her international labeling background allows her to point out differences or similarities with other countries.

After receiving her Master’s degree in Food Technology Engineering, Ms. Leon received her DGQ Audit-Specialist Certification from the German Institute for Quality, and her Master’s in Business Administration from George Mason University. For over 20 years she worked at Schöller Lebensmittel GmbH & Co KG as Director of Quality Management and Labeling Compliance. Ms. Leon speaks English, German, and French.

EAS Consulting Group, as part of the Certified Group of companies, merged with Food Safety Net Services, (FSNS), to become the global leader in testing and regulatory solutions for the FDA and USDA regulated industries. 

EAS’ network of 200 independent advisors and consultants enables us to provide comprehensive consulting, training and auditing services, ensuring proactive regulatory and quality compliance for food, dietary supplements, pharmaceuticals, medical devices, cosmetics, tobacco, hemp and CBD.

The merger of FSNS (FSNS.com) with the Certified Laboratories group of companies, (certified-laboratories.com), has created a leading, national testing  and regulatory consulting  platform. EAS can assist with your regulatory and quality requirements and challenges, while offering access to a robust scope of testing services to meet your organization’s sophisticated needs. 

From regulatory strategy, auditing, training, FDA inspection preparation, 483 & Warning letter remediation, quality system implementation, labeling compliance, preparation of technical submissions such as GRAS, Food Additive Petitions, DMFs, NDIs, 510(k)s and more; to FSMA compliance, expert witness services and due diligence assessments, EAS offers the expert knowledge and experience your company requires to ensure compliance through accurate and timely assistance. With our vast expertise in FDA’s and USDA’s policies and enforcement, EAS is the proven choice for assistance with product testing and other regulatory and quality consulting solutions. easconsultinggroup.com 

 

Video: NCIA TODAY – Thursday, March 10, 2022

NCIA Deputy Director of Communications Bethany Moore checks in with what’s going on across the country with the National Cannabis Industry Association’s membership, board, allies, and staff. Join us every other Thursday on Facebook for NCIA Today Live.

Equity Member Spotlight: Raina Jackson – Purple Raina Infused Self Care

NCIA’s editorial department continues the Member Spotlight series by highlighting our Social Equity Scholarship Recipients as part of our Diversity, Equity, and Inclusion Program. Participants are gaining first-hand access to regulators in key markets to get insight on the industry, tips for raising capital, and advice on how to access and utilize data to ensure success in their businesses, along with all the other benefits available to NCIA members. 


Tell us a bit about you, your background, and why you launched your company.

I am an Oakland-based hemp CBD & cannabis brand strategist, product developer/educator, and cannabis industry advocate who recently became a member of the NCIA DEI Committee. 

I am a Black “urban hippie” born and raised in San Francisco’s Haight Ashbury neighborhood who earned a B.A. with honors from Stanford University in cultural anthropology and sociolinguistics as a first-generation graduate and an MBA from the NYU Stern School of Business.

A product junkie with over 15 years of experience in sales/marketing management, personal care product development, and education. I have worked in the cannabis industry in sales management, distribution, and field marketing since 2015 and have been a Verified San Francisco Cannabis Equity Applicant seeking a cannabis business permit and license since 2018. 

PURPLE RAINA Self Care is the culmination of my personal and professional passion for self-care products, the color Purple, and the artist Prince. Prior to entering the cannabis industry, I worked for top NYC beauty/personal care companies Maybelline and L’Oréal Professional, trained at the Vidal Sassoon school in London, and taught cosmetology at The Aveda Institute in SOHO NYC. 

Upon returning to the San Francisco Bay Area in 2013, I became enamored with cannabis dispensaries and the local cannabis culture. While waiting for my permit, I decided to offer a hemp CBD version of PURPLE RAINA to show proof of concept, gain market feedback, and to promote the benefits of hemp CBD to a broader audience. The THC:CBD version will be launched in mid 2022. 

What unique value does your company offer to the cannabis industry?

PURPLE RAINA Self Care offers topical infusions that soothe sore muscles and joints, nourish the skin from head to toe, and pamper the senses with aromatherapy. PURPLE RAINA Self Care promotes “mindful self-care and grooming” and seeks to appeal to our collective humanity focusing on our common need for daily grooming and self-care on a physical, mental, and spiritual level.  

PURPLE RAINA offers a fresh approach to the category through multi-purpose infused topicals that will serve a range of self-care and grooming needs from head to toe, regardless of gender. Most topical products addressing pain relief overlook daily skin/hair care, personal grooming, and aromatherapy. Many have unpleasant odors and can be irritating to sensitive skin. I created PURPLE RAINA for people like me seeking to moisturize dry/sensitive skin and to soothe sore muscles with aromatherapeutic plant-powered products free of allergens and artificial ingredients.

PURPLE RAINA will eventually employ people from the community. I plan to recruit a “Purple Posse” of brand ambassadors who will conduct impactful in-store product demonstrations for consumers and retail staff. The “Purple Posse” will earn income and gain valuable sales presentation skills training. 

What are some lessons learned from the beauty industry that you brought into your cannabis business?

My career has more recently reached the intersection of beauty/personal care and cannabis products. I recently learned that some of the largest cosmetic/personal care companies in the world are now incubating emerging brands instead of regarding them as competition to be squashed or absorbed. Some are being groomed for future acquisition but not always anymore. It’s a more mutually beneficial business relationship.

These beauty behemoths realize the importance of an ecosystem of high-end products, mid-priced and value brands, mature institutional brands, and young indie/niche brands readily available online and in stores. It best serves the customer when they have multiple quality choices at a range of price points. These companies are also assuming their corporate responsibility to the industry and society. They are abstaining from unfair competitive tactics aimed at eliminating competition from emerging brands. 

What is your goal for the greater good of cannabis?

The cannabis plant, as a metaphysical healing force, deserves to be represented by an equitable accountable industry under a new breed of conscious compassionate capitalism valuing Profit & People / People & Profit like Yin & Yang. 

During the 2021 Meadowlands conference/retreat at Camp Navarro, CA, surrounded by majestic redwood trees, I imagined the notion of a relationship between big trees and little trees as an analogy for cultivating an equitable cannabis ecosystem where little trees can still thrive to grow among the big trees, some eventually becoming big trees themselves. Imagine if big trees could share the nutrients in their roots with neighboring little trees, as a metaphor for how corporate financial, technical, and educational resources could be redirected to help benefit emerging equity and legacy businesses. This doesn’t exist in nature but imagine the social and financial impact it would have on so many who have been systematically excluded and discriminated against, as well as on those who contribute these resources. 

What kind of challenges do you face in the industry and what solutions would you like to see?

Challenges: I face financial challenges like so many other cannabis entrepreneurs. Yet this is compounded as a Black woman, a member of an underestimated undervalued group that is underrepresented as cannabis business executives and owners. We receive the lowest amount of investment funds across industries due to racism and sexism, though we are the fastest-growing group of business owners in the U.S. and tend to be successfully bootstrapped and financially savvy. 

Additionally, there is a big disconnect in current equity programs between the criteria to qualify and the financial resources and business acumen necessary to succeed if you don’t have access to investors and sound cannabis business and legal advisors. Late in the game, I was even told that I didn’t need a cannabis license to make my products and can just hire a manufacturer to produce them under their license. This is a viable option initially to go to market but not long-term. I would have wasted significant time and money and missed the whole point if I abandoned the pursuit of my own license. Also, as a brand of customized topical formulations manufactured by contract manufacturers, my rare business model tends to be overlooked by local and state cannabis regulations. For example, it took a few years and forfeited application fees for the type 13 transport only/self-distribution license I now seek to be introduced, representing the only feasible path to licensure and the only way I could go to market, other than the type-S shared license which doesn’t work for me.  

Solutions: As part of a corporate responsibility mandate, successful profitable cannabis businesses along the supply chain, MSOs, and future alcohol and tobacco corporations entering the industry should make contributions into a Cannabis Equity/Legacy Fund collected by state licensing agencies and administered by an industry non-profit like the NCIA or a group of B-corps operating in the highest integrity. These big trees would contribute financial resources and access to key technical services as part of their platinum “industry membership fees,” a standard cost of doing business. In the same way their license fees are proportionate to projected revenue, their contributions into the fund would be proportionate to recent and projected revenue. 

Our allies are instrumental in helping those who are resistant or just don’t know what to do to recognize their responsibility to use their privilege for the greater good, ultimately benefiting all parties’ bottom lines and corporate morale. There’s no need for guilt or blame, just empathy, goodwill, good works, and collaboration to help undo historic wrongs over time.

I want to see U.S. cannabis legalization soon with equity and anti-monopoly policies already in place. The cannabis industry should under no circumstances become fully dominated by oligarchies/monopolies like the early telephone and utility companies that had to be split up or even the current social media and tech giants under scrutiny. This policy should demonstrate recognition of the value DEI and BIPOC partners bring to the cannabis industry along the entire supply chain. Government solutions would include SBA grants and forgivable PPP-like loans like any other industry receives. 

Why did you join NCIA? What’s the best or most important part about being a member through the Social Equity Scholarship Program?

I always wanted to join the NCIA since I attended an annual conference years ago but couldn’t afford it. The best part of being a member through the Social Equity Scholarship Program is the weekly Zoom call held by Mike Lomuto for equity cannabis entrepreneurs and allies nationwide. We check in to discuss our triumphs and challenges and share valuable business insights and ideas for building a more equitable cannabis industry. These calls inspired me to apply for the DEIC and to intensify my cannabis equity advocacy and thought leadership.

 

Member Blog: How Can Hemp Businesses Better Self-Regulate?

by Lee Johnson, CBD Oracle

The hemp industry is still in its early stages, especially when it comes to emerging products like delta-8 THC. While there is some regulation for hemp products, it’s much less than for legal cannabis, and this gives companies some freedom in terms of how they operate and what they do. For the most part, this is a good thing, but there is a downside too. Our report into the industry found that 76% of delta-8 THC products contained illegal quantities of delta-9 THC. This is terrible for consumers, but it also poses a risk to the industry: if you keep raising red flags, the government will eventually swoop in and take action. This is why self-regulation is a crucial concept for hemp businesses going forward.

Why Self-Regulate?

Self-regulation is crucial for hemp businesses because of the scrutiny the industry faces and to improve consumer confidence. Although CBD is generally accepted, this is especially important for companies selling something like delta-8 THC, which attracts more scrutiny because of its psychoactive nature. With states like Texas attempting bans on the substance and the findings of our report showing that the vast majority of products break legal limits for delta-9, the industry is in serious danger of attracting the attention of more lawmakers who may opt for an outright ban. In fact, there are already 18 states with some form of ban or restriction on the substance.

Jayneil Kamdar, PhD from InfiniteCAL Labs commented to us that: “The current delta-8 THC products on the market are very concerning because there is no regulatory body monitoring the safety of these products.”

In our report, we also found that companies tend to undercut customers on delta-8, that only 14% of companies perform substantial age verification checks and that two-thirds of companies don’t test their products for impurities.

It isn’t that self-regulation would be a cure-all, but if companies opt to act responsibly, it is much less likely that they will attract attention from lawmakers. In addition to this, though, self-regulation sends a strong message to consumers that you care about them and that they will get what they wanted when they buy your products. When this doesn’t happen, people will tell others about it.

The more the industry can mirror the regulations of regulated cannabis companies, the better things will go in the long run.

How Can Companies Better Self-Regulate?

However, “self-regulation” can’t just become a vague, catch-all term for generally responsible business practices: clear recommendations are essential in making this goal a reality. Luckily, our in-depth investigation of the delta-8 industry and other similar investigations into the CBD industry have revealed some key areas companies can focus on.

Provide Transparent Lab Reports with QR Codes

Lab reports are a vital part of building consumer trust, and you should ensure there is a QR code on the report so it’s easy for consumers to verify the report on the lab’s website. 90% of CBD companies already do this, based on our industry analysis.

Offer a Lab Report for Every SKU

Many companies, however, only offer a COA for the base distillate, rather than every specific type of product it produces. If you sell vape cartridges, for instance, you should have a report available for each variation in flavor, strain, and potency.

Choose Credible Labs for Your Report 

Not all labs are equal. If you get a report from a questionable or unknown lab, savvy consumers will still be wary of your product, and in some cases, the results may be unreliable. It’s best to choose a lab with a strong reputation, such as ProVerde, Anresco, SC Labs, InfiniteCAL, and CannaSafe.

Test for Impurities 

With two-thirds of delta-8 companies not lab testing their products for impurities, this is a good way to stand out in the marketplace as well as good practice in general.

Verify Customer’s Ages

With most CBD companies not performing robust age verification checks, using a credible age verification system such as AgeChecker is a great step towards self-regulation. They stay up to date with FDA requirements, state laws, and merchant account policies, so you can set it up and then continue basically as normal. This is especially important for delta-8, but it’s also crucial for higher-strength CBD products too.

Label Your Products Accurately 

What you claim on the label should be what’s in the product. Lab reports help you verify that this is the case.

Warning and Caution Labels  

Only about 55% of hemp delta-8 companies use a warning label, but this is another key part of self-regulation. Suggested verbiage includes:

  • This product should be used with caution when driving motor vehicles or operating heavy machinery.
  • Use this product under the guidance of a physician if you have a medical condition, are pregnant or lactating.
  • Keep out of the reach of children.
  • This product was manufactured from hemp material that meets federal requirements for hemp products; however, consumption may be flagged by some drug tests.
  • Use with caution if subject to urinalysis.

Use Child-Proof Packaging

The CDC recently raised an alert about children accidentally consuming delta-8 products. Using child-proof packaging is an easy way to prevent this from happening.

Avoid Child-Attractive Packaging

This goes hand-in-hand with the above, but also, having your products that look like a bag of Cheetos or anything along these lines is not a good look.

Avoid Medical Claims 

Although many people opt to use delta-8 and CBD for medical purposes, if you’re selling the products, making medical claims that might not meet official organizations’ standards of proof is simply a terrible idea. Leave it to your consumers to determine.

Get Industry Certifications

Getting certified by an organization like the U.S. Hemp Authority is a great way to show your customers that you’re one of the responsible companies.

Conclusion

Self-regulation really just means taking a few basic steps to establish to both customers and politicians that you’re running a legitimate business which does what it claims to and is socially responsible. It might increase costs in the short-term, but over time and especially as consumer knowledge increases, it will pay off many times over. And the next time there’s a situation like what happened recently in Texas, the industry will have a much easier time defending its practices.


Lee Johnson is a writer at CBD Oracle who has been covering science, vaping, and cannabis for over a decade. He focuses on research-driven deep dives into topics ranging from medical uses for CBD to industry and user statistics, as well as general guides and explainers for consumers. He is a passionate advocate of both CBD and cannabis, and a strong believer in informed choice for consumers.

CBD Oracle is a consumer research company working to improve the safety and transparency of cannabis products, producing in-depth statistics on CBD and cannabis, detailed research pieces and analysis of social and legal issues.

 

Member Blog: Cannabis as a Performance Tool 

By Dr. Dominick Monaco, CLS Holdings

As we make our way closer to 2022, the world is also entering a new paradigm for the cannabis industry. Due to advancing global legalization efforts, cannabis use is gaining mainstream acceptance for the first time in history. With these shifting perspectives also comes the rapid deterioration of traditional stereotypes. 

Today, cannabis is not only widely regarded as a legitimate medicine, but many people also look to it as a performance tool. To this end, the endorsement of the herb by pro athletes, media icons, and high-powered executives has again turned our conceptions of cannabis on its head. 

With such rapidly shifting perspectives, we are witnessing a monumental moment in time where propaganda is being replaced with factual evidence. As things evolve, active people are not only endorsing legalization, but many swear by cannabis as a performance tool. 

Indica and Sativa

The more places that legalize cannabis around the world, the more opportunities we have to study cannabis in controlled settings. As our knowledge expands, so does our ability to use specific compounds in cannabis to aid particular activities. 

In the early days of legalization, broad terms such as “Indica” and “Sativa” were used to describe just about every attribute of cannabis – including both product descriptions and psychoactive effects. To this end, Indicas are widely accepted as calming, while Sativas are known to be energetic. 

Terpenes & Strains 

While the effects of Sativas and Indicas are still widely accepted across the industry, we are also beginning to see a much more nuanced approach to cannabis consumption. Especially when it comes to performance, a more granular perspective of cannabis is necessary. 

To maximize the performance benefits of cannabis, it’s critical to understand the constituent parts of the cannabis flower. By understanding the effects of different strains and cannabinoids, and terpenes, people can better choose the right products for their performance needs. 

Notable cannabinoids and terpenes and their effects:

  • Tetrahydrocannabinol (THC): Cannabinoid that provides energy and focus during activities helps boost creativity. Pain reliever after physical activity. 
  • Cannabidiol (CBD): Cannabinoid that relieves anxiety before and during performances. Pain reliever and anti-inflammatory agent after physical activity. 
  • Cannabigerol (CBG): Cannabinoid, which promotes motivation and stimulates pleasure. Pain reliever and anti-inflammatory agent after physical activity. 
  • Beta-pinene: Terpene believed to act as an anti-depressant
  • Caryophyllene: Terpene with anti-inflammatory properties. 
  • Humulene: Terpene thought to provide energy

CLS Holdings’ own City Trees developed several popular products based on the effects of certain cannabinoids and terpenes. Their Calm, Relief, Rest, and Energy distillate vape cartridges offer simplified shopping experiences for new cannabis consumers. By building product messaging around the effects of the products, they help people understand exactly what they are purchasing. 

Physical & Mental Performance 

While a detailed assessment of the compounds found in cannabis can go a long way, you must also account for your specific performance needs when finding the right cannabis product. Depending on how your body and mind react with cannabis, you can utilize it to help with physical activities and cerebral pursuits. 

Whether you are interested in feeling more energized for your workout routine or getting the creative juices flowing for a writing assignment, there is likely a cannabinoid and terpene combination to suit your needs. 

Olympic gold medalist snowboarder Ross Regalati swears by cannabis during both training and competition. The famous Canadian snowboarder feels cannabis “improves concentration” and is great for training because flowers are both “fat-free and calorie-free.” While no longer a professional snowboarder, Regaliti is still a world-class athlete. Today, his choice cannabis strain for exercise is the Sativa-dominant hybrid Bruce Banner. 

The famous female vocalist Alanis Morisette swears by cannabis as part of the creative process. In an interview with High Times, she states, “As an artist, there’s a sweet jump-starting quality to [marijuana] for me… So if I ever need some clarity… or a quantum leap in terms of writing something, it’s a quick way for me to get to it.” Morisette can utilize the right cannabis product for her needs and push through creative boundaries and explore new territories. 

Tips for Finding the Perfect Fit 

While studying different terpene profiles and cannabinoids is a great way to learn about the effects of cannabis, you also need to consider your physiology. Notably, a cannabis product that works well for one person won’t necessarily do the same with another. 

For example, if you are an introverted, anxiety-prone person, using an energetic strain like Diesel for a social situation might not be a good idea. In this case, a mellow Indica CBD hybrid like Cannatonic might be just what you need to feel relaxed and engaged. Yet, a naturally extroverted person would likely enjoy an energetic strain for social situations and need the CBD hybrid to wind down at the end of the day. 

If you aren’t sure what cannabis products will work for you, we recommend visiting a credible dispensary with well-trained budtenders. Once you have sound recommendations, always start small when experimenting with new cannabis products. With a bit of careful trial and error, you will likely discover cannabis products that can help you with anything from enhancing your workout to stimulating your sex life. 

Summary 

Having been on pain management therapies since the age of 17 for my Kyphosis, I now rely solely on concentrated cannabis extracts to manage my pain and keep my Activities of Daily Living at peak performance. Being diagnosed at 17, I was prescribed 1x Hydrocodone per day to manage my pain. By the time I graduated from Pharmacy School, I was taking 18 pills a day (540/month) to manage my pain and the side effects of other medications. It’s been 8 years since I’ve taken a prescribed medication and cannabis and cannabis products have replaced every medication that I was on prior. I’m grateful and humbled to be a key member of a team that produces the very own products I use to manage my health and wellness.

Looking back just a few short years to the genesis of legal cannabis, it’s remarkable to see how far we have come. In the industry’s early days, people didn’t have the luxury to match a specific cannabis product to a particular performance need. Not only was our knowledge of cannabis not sophisticated enough to accomplish this task, but Good Manufacturing Practices (GMPs) were still lacking in the early days. 

As our knowledge of cannabis continues to expand, so does our ability to make informed decisions on the products we use. Whether you are a trail runner who enjoys a Sativa before you head to the mountains, or a musician who likes to settle into practice with hybrid flowers, some careful study will lead you to the right products for your performance needs. 

During this period of rapid change, it’s exhilarating to see negative stereotypes of lazy cannabis users finally being upended. Even more, it’s incredible to witness pro athletes, high-powered executives, and famous artists not only advocate for legalization but openly promote cannabis as a performance tool. 


Dr. Monaco is the Director of Laboratory Operations for CLS Holdings’ newly opened approximately $4 million laboratory, and is responsible for all day-to-day operations inside the North Las Vegas facility. Dr. Monaco brings over 8 years of licensed & regulated cannabis experience, starting back in 2012 when medical marijuana first opened in Arizona, he has held numerous positions, with escalating responsibilities year over year. He graduated from the University of Arizona College of Pharmacy, in Tucson, Arizona, with a Doctor of Pharmacy in 2010.

How Sweet It Is… Contemplating Cannabis Confections

by Rachel Kurtz-McAlaine, NCIA’s Deputy Director of Public Policy

Have you ever had a bad experience eating edibles? Someone gave you a homemade brownie, you ate it, and they were like, “You weren’t supposed to eat the whole thing!” There are many people who won’t eat edibles at all because of past negative experiences. Maureen Dowd’s now infamous column about her harrowing experience eating too much of an edible was from an infused chocolate bar she bought from a licensed retail facility in Colorado. That didn’t do much to help the scary reputation of edibles.

Dowd’s article quoted Andrew Freeman, Colorado’s Director of Marijuana Coordination at the time: “There are way too many stories of people not understanding how much they’re eating. With liquor, people understand what they’re getting themselves into. But that doesn’t exist right now for edibles for new users in the market.” To imply that liquor is somehow safer was disingenuous and dangerous. In the seven years since this article was written, it’s clear that the alarmist predictions about cannabis edibles aren’t coming true, but I just read an article about another fraternity pledge that died recently from alcohol poisoning.

However, Dowd and Freeman were both correct that as the responsible cannabis industry that we are, we should be educating our consumers on the potential harm from overconsumption (e.g. extreme discomfort) and how to properly titrate. While we know it’s not as dangerous as it’s made out to be, happy customers make for repeat customers. We have gotten more sophisticated as an industry in the last seven years with things like labeling, dosage, and consistency, but there is so much potential for more innovation and refinement.

I consider edibles to be one of the best things to come out of the legal, regulated cannabis marketplace, and they’re gaining in popularity. According to BDSA, the edibles market grew 39% over the past year, and with good reason: people prefer the healthier aspect of eating to smoking, it’s more discreet, and it’s consistent. For some people it’s like eating a gummy vitamin or dietary supplement. There is also a trend toward micro-dosing, especially if the edible is so tasty it should be enjoyed in larger quantities, and playing with ratios between THC, CBD, and other cannabinoids. People can pay attention to their bodies and discover what amount works best for what they’re trying to achieve.

I was honored to speak recently at the American Association of Candy Technologists’ 2021 Technical Seminar. They were incredibly friendly people, and I’m not just saying that because they gave me enough candy it reminded me of trick or treating in that good neighborhood where there are a ton of kids and all the houses are decked out and you come home with a huge bag full of candy. They were genuinely nice! We played trivia and roasted s’mores in the evening. It felt like the summer camp every kid dreamed of going to.

They were also extremely interested in learning more about the cannabis industry. NCIA was invited to speak through one of our common members, Clara Food Technology, who provides expertise in making better cannabis edibles through science. In fact, most of the people I met who were interested in the industry weren’t planning on starting their own edible company, but providing the industry with some pretty incredible food science expertise that can only make the industry better as a whole. Cool things like making sure candy doesn’t get too hard or stick together, the ingredients are properly mixed so they’re consistent throughout, ramping up production with new systems and machines, and staying shelf-stable. 

People who are entering the edibles market should absolutely find one of these food science consulting companies from the start to help avoid costly errors. Edible companies should have a food science consultant on hand, or even on staff, to elevate the quality and consistency of the products, and bring fresh ideas.

If you’ve been hesitant, take another look at edibles and the value they bring to the cannabis industry. We’ve come so far since the Dowd article, but the potential is limitless.

 

Video: NCIA Today – September 3, 2021

NCIA Deputy Director of Communications Bethany Moore checks in with what’s going on across the country with the National Cannabis Industry Association’s membership, board, allies, and staff. Join us every Friday here on Facebook for NCIA Today Live.

 

 

Member Blog: Cannabis Commoditization

by Claudia Della Mora, Black Legend Capital

What would it take for cannabis to become a commodity? To answer this question, we must first understand what a commodity is. Commodities are often raw materials, such as mineral ores, petroleum, sugar, rice, corn, wheat, etc., traded in large quantities, with little restriction, with prices fluctuating based on supply and demand. These commodities are often traded on exchanges to facilitate transactions, as price and availability are the main factors, not product differentiation or branding. Thus, standardization of the commodity and minimum quality standards are essential to commoditization. Currently in the EU and UK, hemp raw materials and finished goods must be compliant with the Novel Food Regime to be sold. To be compliant, manufacturers must apply for Novel Food status which will then be approved by the Food Standards Agency. This is a perfect example of standardization beginning to take place. However, globally, there are ~800 recognized strains of cannabis, although realistically, that number is likely in the thousands. This is in comparison to most commodity markets which usually have less than a dozen different variations. We can break this down into three main sub-sectors: industrial hemp, medical cannabis, and adult-use cannabis, and the challenges to commoditization for each.

Industrial hemp is cultivated primarily for its seeds or fibers to make clothing, paper, biodegradable plastic, building materials, etc. Most CBD extracts also come from industrial hemp, so the hemp farmers can potentially be seen as commodity producers while the buyers, who then use the CBD extracts to produce their differentiated products, are not. However, one major issue is the lack of price stability and transparency for differentiation seen in other commodities. In the United States, prices for high-CBD cannabis biomass declined up to two-thirds in value in 2020 compared to the previous year.

Medical cannabis, which can be over the counter or pharma-grade, has various medical applications, some still yet to be discovered. On the pharma side, GW Pharma has the only cannabis drug that has been approved by the FDA, which treats different types of epilepsy. Cannabis is also being researched for its effectiveness in treating Alzheimer’s, cancer, eating disorders, mental health disorders, seizures, and many more. However, firms focused on medical cannabis often attempt to produce products with specific ratios of THC and CBD through crossbreeding and generating unique terpene profiles. However, for a company to develop pharma-grade products, the product must meet the minimum standards required by its prospective country. These are usually for a particular type of treatment, making commoditization difficult.

Adult-use cannabis has seen tremendous growth and legalization in the past years; however, products differ between producers. While there are thousands of strains of cannabis, even the same strain can vary widely between producers depending on cultivation methods and conditions. Naturally occurring terpenes also allow for differentiation. It can come in a wide range of different potencies, even due to farming techniques, thus making it challenging to produce premium quality cannabis at scale consistently. At the same time, countries are beginning to implement minimum requirements for its products, like the EU and UK’s Novel Food Regime explained above. As countries continue implementing these requirements, the ability to differentiate products will decrease.

As you can see, the most likely to be commoditized would be industrial hemp, as standardization would be a massive obstacle for both recreational and medical cannabis. However, other factors need to be resolved before cannabis can reach commodity status, including price transparency and legalization. There are benchmark prices for commodity products that are easily accessible, and currently, a platform to publish these benchmark prices has not been fully developed yet. Regarding legalization, in the US, cannabis with a THC content over 0.3% remains federally illegal, despite individual states allowing growth, processing, and sale. Multi-state operators cannot transport THC products across state lines, preventing the national distribution of branded products. The problem with interstate commerce would disappear when cannabis becomes federally legal, but it is currently a challenge and simply put, for now, a surplus in California stays in California.

While there are still many hurdles for cannabis to become a commodity, many tailwinds could lead to its successful commoditization. Federal legalization in the U.S. would likely remove restrictions in transactions, allowing for the free trade of cannabis within the country. On a global scale, the real barrier to global trade centers around the United Nations Drug Treaty. In December 2020, the U.N. Commission on Narcotic Drugs transferred cannabis from a Schedule 4 to a Schedule 1 drug. Schedule 1 drugs are still prohibited substances but are seen as having medicinal value. For cannabis to trade freely, the United Nations must move cannabis to a U.N. Schedule II or III drug. This is because countries must be compliant with the 1961 U.N. Convention to import and export cannabis, which requires a narcotic license. Additionally, once regulators such as the FDA come out with specific rules, CBD will begin to act more like a commodity with significant supply and demand. One World Pharma, The Cannabis Mercantile Trading Exchange (CMTREX), Panexchange, and Canxchange have begun developing exchanges for cannabis to trade on, with One World Pharma even beginning to offer limited futures contracts. On the positive side, cannabis has a head start in testing to meet minimum quality standards. Most jurisdictions already require it, although the threshold levels needed to sell the product still vary between locations. The regulations between different countries vary greatly, as countries in South America and places like Canada and Israel are very open to cannabis. However, in others, such as most EU and Asian nations, there is still a lot of stigma surrounding cannabis, which will likely take much longer to gain widespread acceptance. While there are still many hurdles to cross until commoditization, the current Biden administration has shown a willingness to legalize cannabis federally, the first and most crucial step towards cannabis becoming a commodity.

Reference: Grower Talks


Ms. Della Mora is the Co-founder of BLC, a financial advisory and investment firm based in Los Angeles with satellite offices in Houston, New York, London, Hong Kong, and Melbourne. During her tenure at BLC, she successfully invested, assisted in the capitalization, and helped business develop small cap oil companies in Kentucky, Texas, Louisiana, Illinois, Colorado, California, Wyoming, North Dakota, and Alaska. She has also structured oil & gas partnerships in several U.S. states, and in Ecuador, Central America. Ms. Della Mora has been involved in many LNG (Liquid to Natural Gas) projects in the U.S., as well as many commodity trades worldwide. She has personally advised also Chinese conglomerates in their U.S. oil & gas investments.

Black Legend Capital is a leading Merger & Acquisition boutique advisory firm based in California with offices worldwide. Black Legend Capital was founded in 2011 by former senior investment bankers from Merrill Lynch and Duff & Phelps. We provide M&A advisory services, structured financing, and valuation services primarily in the cannabis, technology, healthcare, and consumer products industries. Black Legend Capital’s partners have extensive advisory experience in structuring deals across Asia-Pacific, Europe, and North America.

 

Video: NCIA Today – August 20, 2021

FDA Punts on Regulating CBD Again

by Morgan Fox, NCIA’s Director of Media Relations

Last week, the hemp and CBD industries took another blow from the Food and Drug Administration when the agency refused to grant a request from prominent CBD producer Charlotte’s Web to regulate the substance as a dietary supplement. This is the latest in a series of delays and setbacks on the part of the FDA when it comes to regulating hemp-derived cannabinoids and products since they became technically legal at the federal level under the 2018 Farm Bill.

Bloomberg reports: “The company’s bid to sell its full-spectrum hemp extract with CBD as a dietary supplement won’t be considered because of the FDA’s own prior decision to treat CBD as a drug, according to a letter posted on the agency’s website Wednesday. This shouldn’t disrupt the business of Charlotte’s Web or prevent other companies from continuing to sell such products, which already exist in a gray area without the agency’s oversight. The decision shows the agency’s ongoing hesitancy to regulate cannabidiol, the non-psychoactive ingredient in cannabis plants better known as CBD… The FDA’s objection rested in part on its prior approval of Epidiolex, a CBD drug to reduce seizures, which the agency said precludes it from authorizing CBD for dietary purposes. Even if the drug hadn’t been approved, though, the FDA said in the letter to Charlotte’s Web dated July 23 that it “has concerns about the adequacy of safety evidence” that the company submitted.”

You can read the full FDA letter here.

This position is likely to create serious problems for the CBD industry. Without allowing CBD products to be regulated as dietary supplements or food additives, the FDA will be forcing producers to get federal approval for their products under the Investigational New Drug program. This process can often take years and cost applicants millions of dollars.

This casts even more doubt on what the future of the CBD market will look like as producers continue to operate in an uncertain landscape. The legality of CBD combined with the lack of federal regulations has created a lot of opportunities for responsible producers to bring products to market without dealing with the often overly strict state cannabis programs, but it has also opened the door to irresponsible operators who have been accused of actions from making misleading or unsubstantiated health claims to selling mislabeled or adulterated products.

Furthermore, the lack of federal regulations has discouraged many larger retailers from selling CBD or hemp-derived products altogether, drastically limiting the market options for producers. Some industry insiders have theorized that lack of access to those retailers has directly led to some producers desperately searching for ways to unload their excess CBD, including processing it into unregulated Delta 8 THC and flooding the markets in both legal and prohibition states, creating concerns among regulators, lawmakers, licensed cannabis operators, and consumers.

This troubling news follows on the heels of another memo issued by the Farm Credit that suggests that financial institutions that provide financing to hemp businesses should only do so if the company is operating under the auspices of a USDA-approved state hemp program.

“While many states and federally recognized tribes have since submitted those plans, 20 states are still operating under an earlier provision: a hemp pilot program created by the 2014 Farm Bill. That program, which is still valid and would be further extended under pending legislation that has passed the House and is pending in the Senate, requires less federal oversight than the new USDA-approved programs,” Marijuana Moment reports.

Some in the industry are concerned that the memo will lead to lenders dropping their hemp clients operating under the pilot programs, but others have suggested that it will not have a significant impact on the lenders who are already working with hemp businesses given the amount of reporting that they must already complete for the federal government and the lack of federal prosecutions for doing so historically.

It seems pretty clear by this point that the FDA will not move forward with regulating CBD in a timely and reasonable manner without outside pressure. You can add your voice to the chorus calling for sensible CBD regulations by visiting RegulateCBDNow and urging Congress to take action.

Committee Blog: Safety – Terpene Limits in Cannabis Manufacturing

by NCIA’s Cannabis Manufacturing Committee

From the taste of your fruits and vegetables to the aroma that travels from trees and flowers in bloom, terpenes are the organic compounds that play a vital role in the flavors and smells we experience daily. Terpenes are common ingredients that are used in many industries such as food, cosmetics, tobacco, and pharmaceuticals. Therefore, the information on the safety of terpenes in these industries can be used for determining the safe use of terpenes in a wide range of product applications. 

Terpenes are currently being introduced into a variety of adult-use and medical cannabis preparations across the U.S. and hemp-CBD markets around the world for both flavor and functional purposes. Much research has been and still is being conducted on the therapeutic effects of terpenes and their synergistic effects when used in conjunction with cannabinoids. The strong research background supports the benefits of infusing terpenes into cannabis extracts, both in reference to endogenous terpenes found naturally in the plant and those terpenes that have been added back into preparations from other botanical sources. Therefore, almost every manufactured cannabis product contains a percentage of terpenes. However, the clear lack of understanding of the full potential of the terpene profiles, and misuse of these volatile, fragile compounds bring up various misconceptions regarding terpene safety versus their efficacy in creating an elevated user experience.

As terpenes make a significant contribution to the quality of cannabis products, which varies from one consumption method to the other, it is highly important to utilize the most advanced knowledge regarding terpenes in order to maximize their potential while maintaining product safety.

Inhalation

Bioavailability 

Terpenes are a naturally occurring constituent in resin cannabis extracts. Terpenes have been incorporated into vaporizable formulations in the form of pre-filled cartridges. These terpene formulations are designed to produce specific effects based on the creator’s intentions, or the terpenes are simply reintroduced to mimic the source material since the extracts are often refined to the point that they have little or no taste (i.e., lost their original essence).

Inhalation of these volatile molecules leads to quick absorption of the compounds via the lungs and directly into the bloodstream. The high solubility of monoterpenes in the blood and hydrophobic medium suggests a high respiratory uptake and accumulation in fat tissues ( Falk 1990a). This was confirmed by recent studies of uptake and elimination of a-pinene and 3-carene in humans (Falk 1990b, Falk 1991b). The bioavailability range via inhalation of alpha pinene, camphor and menthol has been studied and reported to be 54-76% (Kohlert 2000) which is relatively high compared to oral bioavailability. Therefore, terpenes via inhalation are an efficient route of administration which allows low dosage of terpenes.

General Guidelines

When examining terpene infusion, the points below should be taken into consideration:

  • From accumulated knowledge within the cannabis industry and considering terpenes’ natural ratios in cannabis (1 – 5%) and data on safety, it is suggested not to exceed a concentration of 10% in the final product.
  • As terpenes are volatile molecules, the final terpene-infused product is recommended to be used only with adjustable temperature vaporizers such that the oil will not be heated to high temperatures to prevent unnecessary heat-derived toxin production.
  • Aerosol testing for the final product is recommended to test for heavy metals leaching into the vaporizable product.
  • Terpenes are recommended to be used within their defined expiration date labeled on the suppliers’ bottle. The final vaporizable product must be tested in a certified lab under the requirements of the authority having jurisdiction to make sure it meets all quality and regulatory requirements.

Terpene Limits 

By using position papers such as the ANEC Position Paper on E-cigarettes and e-liquids, suggestions regarding terpene limits can be made for cannabis inhalable products. It is important to mention that the final decision on added terpene amounts and determination of product safety is the sole responsibility of the manufacturer based on their assessments, internal procedures, and local regulations.

The following numbers are the suggested infusion percentage of specific terpenes in E-liquid. This suggestion was calculated by using DNEL (Derived No Effect Level) levels in inhalation as well as frequency of puffs a day.

On average, E-liquid users take 500 puffs a day (ANEC position paper), whereas cannabis users take around 9 puffs a day. Therefore, the suggested terpene limit percentage in cannabis inhalables may be higher than E-liquid due to the lower daily usage.

Substance  Suggested Terpene Limit in E-liquid According to ANEC
Linalool  0.34%
Menthol  7.8%
Beta Pinene  0.7%
Alpha-Terpineol  1.1%
Geranyl Acetate  7.4%
Carvone  0.14%

Ingestion

Bioavailability 

Terpene presence in foods of plant origin and in herbs with functional properties has led to further exploration of their bioavailability following oral consumption. The research on terpenes’ bioavailability is commonly done through medicinal plants since they are subjected to digestion within the mouth and stomach before accessing the small intestine. Bioavailability through oral ingestion is affected by mechanical actions, enzymatic actions, and different pH conditions, Transformations into usually more water-soluble and more readily excreted in the urine compounds affect this process as well. These transformations appear mainly in the liver, but also in the gastrointestinal tissue, lungs, kidneys, brain, and blood ( Furtado 2017) Several studies have shown that terpenes consumed orally are absorbed through the gastrointestinal tract and are bioavailable as soon as 0.5 h after intake, reaching their peaks between 2 and 4 h (Furtado 2017, Papada 2018).

General guidelines 

Terpenes are commonly used as flavor ingredients and their usage guidelines are clear when used in foods, such as the FEMA values table below. However, when terpenes are used for therapeutic purposes, the suggested dose in food is not fully researched, and the balance between flavor and functionality is still yet to be determined. Basing the dosing according to flavor guidelines is a good place to start. Upper limits should be defined by safety limits such as the DNEL values table found below.  It is important to use natural, Food Grade terpenes that are backed up with certificates of analysis and are safe to ingest.

Terpene Limits

The Flavor and Extract Manufacturers Association of the United States (FEMA) has developed an innovative program utilizing the GRAS concept to evaluate the safety of flavoring substances. The FEMA GRAS program began in 1959 with a survey of the flavor industry to identify flavor ingredients then in use and to provide estimates of the amounts of these substances used to manufacture flavors. This database provides information on all ingredients that have been determined to be “generally recognized as safe” under conditions of intended use as flavor ingredients. According to The FEMA GRAS assessment – aromatic terpenes used as flavor ingredients are ubiquitous throughout the food chain; and therefore, not surprising that they serve as effective flavoring ingredients. 

The below table presents the average maximum usage levels of terpenes used as flavors in several product types as provided by FEMA. 

Product Lime Terpenes

Average Max (ppm)

Orange Terpenes 

Average Max (ppm)

Grapefruit Terpenes

Average Max (ppm)

Limonene Average Max (ppm) Myrcene Average Max (ppm) Linalool Average Max (ppm)
Beverages, Nonalcoholic 750 1,550 500 31 4.4 7
Beverages, Alcoholic 1,000 1,000 1,000 NA NA 50
Chewing Gum 20,000 20,000 20,000 2300 NA 200
Hard Candy 5,000 5,000 5,000 49 13 400
Soft Candy 5,000 5,000 5,000 NA NA 10

 

ppm is an abbreviation for “parts per million” and it also can be expressed as milligrams per liter (mg/L) or in a percentage where 10,000 ppm is 1%. For example, the maximum suggested infusion for orange terpenes in chewing gum is 2%, where the suggested infusion in hard candy is 0.5%.

*Point of thought*: Since terpenes in the cannabis industry are mostly infused in cannabis-based products, the frequency of usage of such products is lower than regular food products. 

Additional safety data can be gathered from reviewing reports from governmental agencies such as European Chemicals Agency (ECHA). The following data about the DNEL (Derived No Effect Level) in the category of General Population was collected from ECHA website. These numbers may be used as a guideline for maximum daily intake via oral administration:

Substance  DNEL (Derived No Effect Level) Calculated Daily DNEL for 70kg subject (mg/day) 
Linalool  0.2 mg/kg bw/day  14
Menthol  4.7 mg/kg bw/day 329
Beta Pinene  0.3 mg/kg bw/day 21
Alpha-Terpineol  no hazard identified no hazard identified 
Geranyl Acetate  8.9 mg/kg bw/day 623
Carvone  69.4 µg/kg bw/day 4,858

 

For example, a 70 kg person consumes a 1g cookie that is infused with 1% Pineapple Express terpene formulation and Linalool constitutes 10% of the formulation, then there will be overall 10mg of terpene formulation in the cookie, out of the 10mg there is 0.1mg of Linalool which doesn’t exceed the DNEL level.

Topical

Bioavailability 

Terpenes are lipophilic, small, and nonpolar molecules that are considered to be the largest group of natural fragrances. Terpenes can easily penetrate the skin and enhance transdermal delivery (Aqil 2007) and can potentially aid cannabinoid transdermal delivery. Terpenes are also known to have several dermal benefits including anti-inflammatory (Maurya 2014), wound healing (d’Alessio 2014) and anti-acne (Yuangang 2010). Terpene bioavailability via transdermal delivery ranges between 3-12% depending on the type of terpene, medium and application (Brain 2007, Gilpin 2010). Following topical application, maximum plasma levels of terpenes are reached within 10 minutes (Kohlert 2000).

General guidelines  

While some terpenes are known as dermal irritants, the severity of the irritation may depend on their concentration. These should not be used on any inflammatory or allergic skin condition and should always be appropriately diluted. The oxidation of terpenes can increase risk of causing skin reactions because the oxides and peroxides formed are more reactive. This can be seen with (+)-limonene, δ-3-carene and α-pinene and arise due to the formation of oxidation products, some of which are more sensitizing than the parent compound. For this reason, proper storage of terpenes is required to preserve their effectiveness and decrease the risk of adverse reactions.

The table below lists commonly known allergenic terpenes, and for this reason, should be declared on the packaging or in the information leaflet if the concentration of these allergenic fragrances is higher than the permissible concentration of 0.01% in shower gels and baths (rinse-off products) and higher than 0.001% in body oils, massage oils and creams (leave-on products)

Allergenic Terpenes 
Citral 
Citronellol
Eugenol
Farnesol
Geraniol
Isoeugenol
D-Limonene
Linalool

Terpene Limits 

The International Fragrance Association (IFRA) defines which compounds represent a potential allergy risk and determines their maximum concentration to produce safe cosmetic products. IFRA also issues recommendations for the safe use of fragrance ingredients, which are published in the IFRA Code of Practice and its guidelines. In the below table, there can be found specific infusion recommendations for specific terpenes. 

Substance Name Restriction Limits in the Finished Product (%) according to IFRA:
Lip Products Body Lotion, Cream & Oils Hand Sanitizer & Hand Cream Body Wash
Citronellol 2.20% 12.00% 3.20% 24.00%
Citral 0.11% 0.60% 0.15% 1.20%
Farnesol 0.21% 1.20% 0.29% 2.30%
Eugenol 0.45% 2.50% 0.64% 4.90%
Geraniol 0.85% 4.70% 1.20% 9.20%
Alpha Bisabolol 0.42% 2.40% 0.60% 4.60%

Testing of terpenes in dermal products can be achieved safely by making a sample product with terpene formulation infused at 0.5% to 5% concentrations in petrolatum. Patch testing can be a useful technique to detect and avoid skin reactions.

 

House Rules Committee Weighs In On Cannabis Appropriations Amendments

By Morgan Fox, NCIA’s Director of Media Relations

The process of approving the federal budget is moving full steam ahead, with the House Rules Committee considering several amendments related to cannabis to a series of funding bills this week. Amendments that pass this committee move on to a full vote on the House floor.

In terms of overall cannabis policy reform, the most prominent amendment is one that would prevent the Department of Justice from using funds to interfere with state adult-use and medical cannabis programs or target people and businesses that are in compliance with state cannabis laws. This amendment was offered by bipartisan congressional cannabis champions Reps. Earl Blumenauer (D-OR), Tom McClintock (R-CA), Eleanor Holmes Norton (D-DC) and Barbara Lee (D-CA). The amendment was ruled in order Wednesday and will proceed to a vote, possibly as soon as this week.

Even though the DOJ has generally been respecting state cannabis laws in recent years, passage of this amendment in the final federal budget would add the force of law to that policy for the next fiscal year, providing peace of mind for tens of thousands of regulated cannabis businesses and millions of consumers across the country. This would also add significant momentum to congressional efforts to remove cannabis from the schedule of controlled substances and regulate it at the federal level in separate stand-alone legislation.

Provisions to prevent the DOJ solely from targeting state-legal medical cannabis programs and providers have been approved by Congress every year since 2014. With public support for medical cannabis at roughly 90%, these protections have become mostly a non-issue in Congress and have been included in the original base language of the relevant House appropriations bills since 2019.

The amendment extending those protections to state adult-use programs was approved by the House in the budget votes in 2019 and 2020. Unfortunately, it did not receive the same support in the Senate and was not included in the final funding packages approved by the previous Congress.

An amendment that would remove the renewal of medical cannabis program protections from this legislation, flying in the face of long-supported policy and unnecessarily taking up lawmakers’ time, was also introduced by Rep. Doug LaMalfa (R-CA) and ruled in order.

Rep. LaMalfa, a staunch prohibitionist, has also introduced several amendments to appropriations bills to increase DEA funding for eradication efforts. He made headlines recently when his office released videos of him joining law enforcement in bulldozing outdoor cultivation sites in Siskiyou County, California while grandstanding for the camera and ripping off quotes from the film Apocalypse Now. These sites were located in primarily Hmong communities, a Southeast Asian ethnic diaspora that alleges that the county has prevented its members from obtaining cannabis licenses and prevented water shipments to their communities with serious harm to the quality of life there. LaMalfa’s behavior in these videos is particularly offensive given that many Hmong fled their homes to settle in the United States during and following the Vietnam War after facing persecution for supporting America in that conflict.

Unfortunately, some positive cannabis amendments were ruled out of order by the committee this week and will not be voted upon in this legislation. Delegate Norton offered a pair of provisions that would have prevented the Dept. of Housing and Urban Development from using funds to punish residents of federally assisted housing for state-legal cannabis use in adult-use and medical states, respectively. These reforms are incredibly important, as people living in federal housing can be and are frequently evicted from their homes if they or anyone in their household exercises their legal rights or uses the medicine that works best for them. This leaves many people with no place to legally use cannabis, leading to increased public consumption in low-income communities and continued racial disparities in arrests and citations.

On the positive side, an amendment from Rep. Kurt Schrader (D-OR) to highlight the need for the Food and Drug Administration to establish regulations for CBD products was also ruled in order and approved.

Last week, another bad amendment, introduced by Rep. Debbie Lesko (R-AZ), to remove language from the original legislation that would allow federal funding for universities that are conducting cannabis research was ruled in order but voted down in the House.

The House appropriations bills have a broad range of other cannabis provisions related to topics like banking reform, research, law enforcement funding and grant programs, federal employment guidelines, and allowing the District of Columbia to finally regulate cannabis after it was legalized by voters in 2014. We’ll get into these in more detail in the coming weeks as we get closer to a full vote in the House. Stay tuned!

Crazy for Cannabis Administration and Opportunity Act (CAOA)

Photo By CannabisCamera.com

By Michelle Rutter Friberg, NCIA’s Deputy Director of Government Relations

Last week was undoubtedly one of the most exciting weeks in federal cannabis policy ever! On July 14, Senate Majority Leader Chuck Schumer (D-NY), along with Sen. Cory Booker (D-NJ) and Senate Finance Committee Chair Ron Wyden (D-OR), unveiled long-awaited draft legislation that would remove cannabis from the schedule of controlled substances while allowing states to determine their own cannabis policies. Let’s take a look at what we know:

What is it?

You’ll recall that back in February, the trio of Senators announced that they were working on a comprehensive cannabis bill. Since then, NCIA and other advocates have (im)patiently been waiting to see what shape that would take – I was calling it the best-kept secret in Washington! However, at long last, the discussion draft of the Cannabis Administration and Opportunity Act (CAOA) was released. 

A discussion draft is exactly what it sounds like – prior to introducing this language as formal legislation, the Senators have shared it in this form, allowing stakeholders, the public, and others the opportunity to weigh in and provide their expertise and feedback.

What’s in it?

As I mentioned above, the CAOA removes cannabis from the list of controlled substances, effectively legalizing it at the federal level while still allowing states to set their own policies. According to the bill’s detailed summary, it has a few goals:

“… [it will] Ensure that Americans – especially Black and Brown Americans – no longer have to fear arrest or be barred from public housing or federal financial aid for higher education for using cannabis in states where it’s legal. State-compliant cannabis businesses will finally be treated like other businesses and allowed access to essential financial services, like bank accounts and loans. Medical research will no longer be stifled.”

The bill also includes:

  • Restorative measures for people and communities who were unfairly targeted in the war on drugs. 
  • Automatic expungements for federal non-violent marijuana crimes and allows an individual currently serving time in federal prison for nonviolent marijuana crimes to petition a court for resentencing. 
  • An “Opportunity Trust Fund” funded by federal cannabis tax revenue to reinvest in the communities most impacted by the failed war on drugs, as well as helping to level the playing field for entrepreneurs of color who continue to face barriers of access to the industry. 
  • An end to discrimination in federal public benefits for medical marijuana patients and adult-use consumers. 
  • Respect for state cannabis laws and a path for responsible federal regulation of the cannabis industry. Like with federal regulations on alcohol, under CAOA, states can determine their own cannabis laws, but federal prohibition will no longer be an obstacle. Regulatory responsibility will be moved from the U.S. Drug Enforcement Agency (DEA) to the Alcohol and Tobacco Tax and Trade Bureau (TTB), the Bureau of Alcohol Tobacco Firearms and Explosives (ATF), as well as the Food and Drug Administration (FDA) to protect public health. 
  • A federal tax structure – CAOA would impose an excise tax on cannabis products in a manner similar to the tax imposed on alcohol and tobacco. The general rate of tax would be 10 percent for the year of enactment and the first full calendar year after enactment. The tax rate would increase annually to 15 percent, 20 percent, and 25 percent in the following years. 

What’s next?

The discussion draft comment and feedback process will be ongoing until September 1. Until then, NCIA will be working with our board, Policy Council, committees, and our members (particularly our Evergreen members!) to solicit their expert input on some of the areas the Senators have expressed interest in. After that deadline, the Senators will take their time to review submissions and subsequently formally introduce the revised language later this year. Stay tuned via our newsletter, blog, and upcoming events to learn the latest on this and how you can actually submit your thoughts to us! 

Member Blog: Why Cannabis Accessories are the Future of Corporate Gifting

Dan Broudy, CEO of rushIMPRINT

Cannabis, CBD, and hemp companies are giving out cannabis-themed promotional gifts – but they’re not the only companies to follow this trend. 

The stigma against cannabis is slowly disintegrating. And the more mainstream cannabis gets, the more companies are establishing themselves as open-minded and unique by using cannabis as a part of their marketing and business strategy. 

A decade ago, cannabis and hemp were still niche topics. Few people outside the industry could’ve predicted that we’d now be living in a world where cannabis was so widely accepted. CBD can now be found in most health stores, there’s bipartisan support for cannabis legalization, and the world’s biggest celebrities have their own CBD and cannabis lines. 

While we still have a long way to go in terms of breaking down stigma and advocating for reasonable cannabis laws, it’s clear that we’re getting somewhere. One thing that demonstrates this is the fact that many companies are aligning their brands with cannabis – even those that aren’t in the industry.

CBD, in particular, is gaining more mainstream interest. This popularity is partly because CBD is non-intoxicating and doesn’t carry the same level of stigma. As a result, health stores and pharmacies -– including chains like Walgreens and CVS – are selling CBD. Even Sephora, one of the U.S.’s most popular beauty stores, now stocks CBD-infused skincare products. 

It’s not just huge corporate businesses that are embracing cannabis: smaller businesses are, too. At-home beauty spas use CBD-enriched serums. Local health stores stock CBD oil. Little bakeries are offering edibles. Small clothing companies are creating sustainable garments using hemp. While this proximity to cannabis might’ve been shunned years ago, these businesses are now simply keeping up with demands, staying on-trend, and experimenting with the now well-known benefits of cannabinoids. 

It’s clear that, as our society moves away from cannabis stigma, cannabis is becoming a signifier for open-mindedness. Brands that embrace cannabis, CBD, and hemp products show that they’re in touch with the latest trends and informed about the science-backed benefits of these products. This establishes those companies as modern, progressive, and youthful.

As a branded merchandise company, we know that corporate gifts, promotional items, and branded apparel say a lot about a company. When someone orders branded goods for their business, they choose items that align with their business’s values, brand, and target market. 

Just as with regular gifting, corporate gifting says a great deal about the giver. When you give someone a gift, they’ll think of you whenever they see or use it. The same goes with corporate gifting and branded items: companies give out items that they want us to associate with their brand. If you want to know how a company sees itself, take a look at what they’re willing to put their name on. 

As such, branding merchandise companies, like our own, have access to interesting insights. We can tell what’s trending based on what the most innovative and exciting brands are gifting their clients, staff, and partners. Gift-giving is something of a litmus test when it comes to industry trends.

And what’s trending now is cannabis. More and more companies – including those outside of the industry – are excited to put their names on cannabis-related items, such as grinders, storage products, and rolling papers. 

When we decided to establish a category for our cannabis-specific merchandise, we expected cannabis companies to be our main clients. We didn’t expect companies outside the industry to be interested in those same items, but we were wrong. 

It seems to be that more and more brands want to align themselves with the cannabis industry, even when they don’t directly offer cannabis-related goods or services. Edgy new clothing companies and innovative start-ups alike might use cannabis-specific promotional items to show that they’re forward-thinking companies that rebel against outdated, traditional concepts.

The other side of gifting is that you expect the recipient to actually use their gift. This is why time-tested promotional items, such as branded pens and tote bags, continue to be brand favorites. The more often someone uses your gift, the more likely they are to think positively of you, so it makes sense to choose functional items instead of white elephants.

In the same way, the popularity of branded cannabis accessories is a reflection of how widespread and accepted cannabis use is. Nowadays, cannabis use is tolerated more than ever before, and CBD is a household name. Companies that use cannabis-related promotional items are saying something about their target market: their intended audience is cool with cannabis. 

Two decades ago, young starlets who were “caught” using cannabis were the subject of scandal. This year, Academy Awards nominees were given a compensatory gift bag that included luxury cannabis vaporizers. Part of the assumption of giving gifts here is that people will be excited to use what they receive, and the exact same principle applies to promotional items. 

Up until recently, you’d never have seen CBD-infused items on a Mother’s Day gift guide. But in 2021, the world’s approach to cannabis and hemp is far more permissive, especially since more people are now informed about the potential health benefits of cannabinoids. We’re at the point where cannabis and CBD items aren’t just something you’d buy yourself: you can gift it to others because you think they’ll like it, too. 

In many ways, corporate gifting and promotional merchandise can tell us a lot about branding trends. The growing popularity of cannabis-specific branded items is a reflection of how society is becoming more and more tolerant of – and excited about – using cannabis, hemp, and CBD. 

The fact that this once-disparaged plant is slowly being embraced by individuals and businesses alike is encouraging. It shows us that the stigma is slowly fading away – a sign that the industry is slowly gaining more and more support. 


Dan Broudy is the CEO of rushIMPRINT, a marketing supply chain firm providing products and programs that stimulate sales, motivate employees, and strengthen corporate identity. rushIMPRINT serves companies and organizations throughout the USA and Canada.

As a finance and marketing expert with over 20 years of experience in the industry, Dan realizes the importance of having a recognizable brand. That is why he takes great pride in providing cost-efficient branded solutions using state-of-the-art technology. rushIMPRINT creates branded merchandise for the cannabis industry, such as grinders, storage solutions, rolling papers, personalized lighters and more – a unique offering for a growing industry. In addition, rushIMPRINT offers apparel, promotional products, signage, business cards and brochures to help you grow your business. 

His current goal is to partner with dispensaries, distributors, labs, growers, cultivators, and vape shops to help them scale their businesses. Dan is excited to get involved in this revolutionary industry by assisting innovative cannabis and hemp brands.

Dan has an undergraduate degree in Psychology from Washington University in St, Louis. He also holds an MBA in Finance and Marketing obtained from the University of Miami Herbert Business School and is a Certified Franchise Executive (CFE).

Dan’s visionary perspective, enthusiasm, and exceptional organizational skills have earned him opportunities to work with brands such as European Wax Center, Blaze Pizza, TCBY, and Amazing Lash.

 

Hurry Up And Wait: Descheduling, DEA Licenses, And Other Reform Legislation to Watch

By Morgan Fox, NCIA’s Director of Media Relations

The cannabis world is still eagerly awaiting the introduction of Senate Majority Leader Chuck Schumer’s comprehensive descheduling legislation, but that doesn’t mean things haven’t been moving on the policy front in recent weeks!

First up, the DEA announced that it was finally moving forward with approving applications to cultivate cannabis for research purposes, which would effectively end the federal government’s stranglehold on research production. The agency spent years fending off lawsuits from applicants, who correctly asserted that not only was the monopoly limiting research, but the cannabis being grown at the single licensed facility at the University of Mississippi was basically unusable for research purposes anyway. This announcement comes several years after the DEA publicly stated that it would begin the licensing process. Better late than never.

Of course, we don’t think the DEA should be involved in cannabis research whatsoever, seeing as how they are a law enforcement organization and not, you know, scientists.

Next, Sen. Ron Wyden, who is also working closely with Majority Leader Schumer on descheduling along with Sen. Cory Booker, introduced S. 1698 last week. While text of this bill is currently not publicly available, the name suggests that this legislation would direct the FDA to allow hemp-derived CBD, made legal under the 2018 Farm Bill, to be used as a dietary supplement or in food. Some perceive this bill as necessary to get some regulatory clarity from the FDA, which has been dragging its feet and missed several deadlines for CBD regulations. Many in the industry blame this lack of regulation for larger retailers staying out of the CBD market, which has led to massive supply gluts of the substance and has been hypothesized to be a leading cause for the recent boom in Delta 8 THC production.

And earlier this month, Rep. David Joyce, an Ohio Republican who co-chairs the Congressional Cannabis Caucus, introduced a narrowly tailored bill to remove cannabis from the schedule of controlled substances. The bill assigns regulatory responsibilities to the FDA and the Alcohol and Tobacco Tax and Trade Bureau and gives them a one-year deadline to come up with a regulatory structure similar to alcohol. It also contains provisions similar to the protections that exist in the House-approved SAFE Banking Act, calls for studies on how cannabis impacts pain and driving, and improves access for veterans. Notably, this bill does not contain any social equity or restorative justice language.

While the chances of such legislation passing in the Democrat-controlled House are slim, it could serve as a doorway to get fence-sitting Republicans into the debate. It could also be a tool to identify those members of the GOP who are steadfastly opposed to any legalization bill and out of touch with their constituents, many of whom would directly benefit from cannabis policy reforms and who are increasingly in support of ending federal prohibition.

We’re also getting word that the Marijuana Opportunity, Reinvestment, and Expungement (MORE) Act is getting reintroduced in the House this week (and may have already been at the time of this publication). This legislation made history last December when it became the first descheduling bill to receive a floor vote – and pass – in either chamber of Congress. We are hopeful that there will be some revisions from the previous bill, including the removal of a provision that would allow federal licensors to deny applications for cannabis business licenses based on prior state or federal felony convictions, and the inclusion of a more sensible and robust regulatory framework.

We are less than halfway through the calendar year, and it is shaping up to be a momentous one for cannabis advocacy! Stay tuned for more updates from Capitol Hill.

P.S. On the state side, Alabama became the latest state to approve an effective medical cannabis law. Yes, Alabama. That brings the count of medical states to 36, after unfortunately losing Mississippi to a shameful court decision. So far in 2021, four states have approved adult-use or medical cannabis legislation, and more are expected to do so in the coming weeks and months.

Member Blog: GRAS Cannabinoids

Brad Douglass, Ph.D., EAS Consulting Group Independent Consultant

The Agricultural Improvement Act of 2018 (the “2018 Farm Bill”) helped to further define the pathway by which “hemp-derived” ingredients can be legally incorporated into food. Since then, hemp-ingredient companies have materialized selling purified cannabinoids that are found naturally-occurring in hemp. Despite the young market, these companies are facing difficult times as the buyers for these ingredients are few and manufacturers mostly compete on price. The GRAS path offers a route out of this conundrum.

What is GRAS?

The Generally Recognized as Safe (GRAS) for food-use pathway was established by the 1958 Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act (FD&C Act). It delineated how substances that are GRAS for their defined conditions of use in food are different from food additives.  

Others have previously delved into why firms might consider pursuing GRAS notifications and/or New Dietary Ingredient Notifications (NDIN) independent of hemp and hemp-derived ingredients so I will refrain from wholesale repetition. Two key points on specificity are nonetheless worth repeating: 1) a substance is deemed GRAS for a specific use under specific conditions and 2) a GRAS notification is specific to the company filing the notification.

Why GRAS?

There are a number of practical reasons why firms that produce cannabinoids would seek to pursue the GRAS pathway. Here are five:

Market Expansion

Currently, firms that produce purified hemp cannabinoids are mostly selling their wares to businesses operating in state-regulated delta-9 tetrahydrocannabinol (THC) markets or to operations that may not be in full-compliance with dietary supplement regulations.  Almost all firms that produce food products, including beverages, and most dietary supplement manufacturers, will not use ingredients that do not have a history of use in food or that cannot be legally marketed.  

For ingredients such as purified hemp cannabinoids that do not have a history of use as articles used for food, the only way to open-up the food, beverage, and dietary supplement markets is via the GRAS/NDIN pathways.

Safety Demonstration

An integral part of any GRAS dossier is the basic demonstration of acceptable risk (cf. safety) for the named substance and impurities.  This includes any byproducts that may be introduced by the manufacturing process. Whether one is interested in pursuing a GRAS Notification for submission to FDA or for a self-affirmed GRAS conclusion, the process involves an evaluation of safety for the conditions of use (e.g. serving size, no-observed adverse event level, etc.).

Beyond the ethical necessity of understanding the hazards of a product meant for human consumption, pursuing GRAS helps protect a firm from product liability in the event that harm is created. But more importantly, GRAS helps guard against product liability by seeking to prevent the potential hazard in the first place. That is always good for business.

Avoiding Drug Preemption

FDA has described in numerous forums, including the Administration’s own website, why it has concluded that cannabidiol (CBD) cannot be used as an ingredient in food or dietary supplements. The key is section 201(ff)(3)(B) of the FD&C Act. This section disqualifies an ingredient from use in food or dietary supplement products if the ingredient is 1) an active ingredient in an approved drug or 2) if substantial clinical investigation of the substance as a drug has been conducted AND made public.  

While the situation remains unclear for CBD, the only way to avoid a similar murky situation for other cannabinoids (e.g. cannabigerol, CBG) is for those ingredients to be marketed as a food or dietary supplement prior to the public disclosure of clinical trials directed at the development of that substance as a drug.  

It is FDA’s position that “legal” marketing entails more than simple inclusion of the substance in marketed products — the substance must have been the subject of GRAS, food-additive, or NDIN pathways, if required, to be legally marketed. To that point, FDA is highly unlikely to conclude that legal marketing includes the marketing of products in state-regulated cannabis systems while THC remains federally illegal.

Side-Stepping Price Wars

The nascent hemp-derived ingredients market is experiencing significant downward price pressure. The reasons are simple. There is currently more supply than demand (see #1 above) and all commercial offerings are essentially generic.

The GRAS pathway is a mechanism out of this me-too trap. A GRAS cannabinoid would be a premium ingredient by virtue of GRAS status alone. Premium ingredients command premium prices. And the types of sophisticated customers that firms like to do business with do not mind paying premium prices for compliance.

Regulatory Intelligence

While we wait on FDA to draft regulations for manufactured hemp-derived products, it is difficult for businesses to make decisions about what products to pursue. Some firms may not care about internal FDA thinking for hemp-related issues like delta-8 THC or proposed New York State in-process hemp material THC limits of 3%, because they are going to seek to exploit the here-and-now.

For forward-looking firms, engaging with FDA through GRAS or other regulated ingredient pathways can help illuminate what lay around the bend. Effectively navigating bends in a fast-paced, regulated marketplace can be the difference between knowing when to brake… and going broke.  

How GRAS?

There are a few ways to go about this, but simply asking the question within your company and with your legal and regulatory counsel will help generate more of a groundswell. There are a few hemp- and cannabinoid-specific intricacies that must be navigated in practice, including FDA’s own policies on hemp. But there is no reason why this cannot be done. 


EAS Independent Consultant, Brad Douglass, Ph.D., evaluates FDA and FTC compliance of dietary supplement materials including review and audit of dietary supplement labels and labeling. He is experienced in multiple technical, quality, and formulation roles in the dietary supplement and cannabis industries which lends perspective not only regulatory requirements but also the realities of real-world business. Brad’s previous positions include VP of Regulatory Affairs and Director of Advanced Botanical Strategy at the Werc Shop in Los Angeles. He has a doctorate in Organic/Medicinal Chemistry from USC. EAS Consulting Group, a member of the Certified Group 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. easconsultinggroup.com 

If you represent a firm that creates hemp-derived cannabinoids, are a regulator that has responsibility over products that incorporate non-THC cannabinoids, or are just an interested reader that has been intrigued by this blog post, do not hesitate to reach out to me at bdouglass@easconsultinggroup.com.

 

Committee Blog: Why Insurance Companies Should Cover Medical Cannabis Now

by Carol Welch & Jim Gerencser
NCIA’s Risk Management & Insurance Committee

Cannabis was legalized for medical use in California in 1996. Since then, 47 states, the District of Columbia, and three territories (Puerto Rico, Guam, and CNMI) have legalized some form of cannabis, leaving only three states with no legal use. Thirty-six states have an effective medical use law in place. The main reason insurance companies haven’t had to consider providing coverage for patients is because federally cannabis is still listed as a Schedule 1 drug. Even though the likelihood of cannabis being legalized nationally seems bound to happen within the next few years, insurance companies should start planning to incorporate new cannabis policies into their plans now.

Here are five great reasons to cover medical cannabis:

SAVES MONEY

Science has proven that cannabis helps over 60% of epilepsy patients decrease the frequency and severity of seizures. Cannabis products should cost less than traditional epilepsy medications, especially when taking into account the added prescriptions often needed to combat the side effects of currently available prescription drugs.

Compared to the traditional cost of cancer treatment, patients opting to skip conventional treatments for cannabis could save their insurance companies thousands in initial cancer treatment, and potentially will have less recurrence and costly maintenance prescriptions.

Insurance companies are paying billions in healthcare costs to include doctor visits, lab tests, hospital admissions and prescriptions for conditions that cannabis has shown to improve dramatically. Chronic pain, depression and PTSD are all treatable with cannabis, and cannabis is much less dangerous than the opioids that are commonly prescribed in chronic pain cases.

SAVES LIVES

There are no known deaths reported from cannabis consumption alone. According to the CDC, there were 70,630 deaths due to drug overdose in 2019. In addition, there are estimates of over 1.5 million hospitalizations per year from adverse drug reactions that don’t cause death but are still costly to many people. Insurance companies can avoid some of the negative PR, potential litigation and upset related to deaths caused by pharmaceuticals, while providing patients with a solution that works for many conditions.

Research is increasingly showing that certain strains and compounds within the cannabis plant can have a significant positive effect on several conditions. For instance, breast cancer responds very well to FECO (full extract cannabis oil), with lab tests showing how cannabis causes cancer cell death. More study is still needed, and that is currently being conducted in Israel where there are fewer legal barriers to research.

REDUCES MEDICARE SPENDING

Data from all prescriptions filled by Medicare Part D enrollees from 2010-2013 showed a significant decrease in prescriptions being filled for symptoms for which cannabis could serve as an alternative treatment. Overall reduction in Medicare spending in states that implemented medical marijuana laws were estimated to be $165.2 million per year (2013).  This one difference alone could mean billions in savings for insurance companies in the coming years.

IMPROVES SATISFACTION RATINGS

Let’s face it, insurance is a competitive business. Several large health insurers cover most of the country and will likely be the last to jump on board to cover medical cannabis. But for the smaller, regional or state-specific insurers out there, adding cannabis to the coverage lineup in legal states can provide a competitive advantage with employers and group plans.

Medical cannabis is listed as an eligible expense in many Canadian companies’ HSAs and is listed as an eligible medical expense by the Canada Revenue Agency. Since our northern neighbors are starting to cover it, hopefully that will encourage U.S. insurers to do the same.

IT’S THE RIGHT THING TO DO

Cancer is the #2 leading cause of death in the United States and can cost several thousand dollars for treatment. Using cannabis as a complementary treatment to traditional cancer therapies could decrease the cost of treating cancer to the patient, to the insurance companies and in the end to all of the people across the United States that contribute to Medicare and Medicaid.    

If you would like to take action, contact your legislators to push for the federal legalization of cannabis or sign this petition calling on all U.S. insurers to step up and cover medical marijuana for their patients. Here’s a link to the Care2 petition: Health Insurance Companies Should Cover Medical Marijuana Now.

 

 

 

 

Member Blog: Sleep-Focused Brands Are Seeing Bottom Line Dividends

By Jackie Berg, HealthHub

Nearly 40% of the nation’s top 100 CBD brands focus on need states. Chief among them is sleep, something the American Academy of Sleep Medicine (AASM) reports that 85% of Americans are falling far short of.

The 7.2 million sleep-related Google searches logged this past year provide ample evidence of interest. according to NBC News, which reports that 9 million Americans take prescription drugs to help them fall asleep. 

Others prefer more natural solutions.

Nearly 11 million rely upon CBD and/or cannabis-based products to manage insomnia or sleeplessness, according to a 2021 report issued by High Yields Insights. Among them, almost 70% are women considered statistically more likely to suffer from insomnia.

YOUNG AND RESTLESS

Millennials are driving the bulk of market growth. Together, with a smaller percentage of Gen Z consumers, these severely stressed consumers represented 48% of the U.S. CBD market in the fourth quarter last year, according to High Yields Insights President Mike Luce. 

Regardless of age or gender, brands like CBDfx are discovering that an ever-increasing number of their customers are using CBD to treat sleep-related issues. The Brightfield Group reports more than 58% of CBDfx customers purchased sleep products in the fourth quarter.

Collectively, 40% (4 in 10) of consumers, rely upon CBD to manage insomnia or sleeplessness, according to a recently issued High Yield Insights and InnovateMR 2021 sleep trend report.

FIGHTING FOR SLEEP

Growing pandemic-related uncertainty, anxiety, and associated sleep deprivation issues have kept sleep specialists like Colorado-based Pulmonologist Dr. Julie Whitaker, struggling to manage ever-increasing patient loads.

“We’re not seeing everyone we should,” says Dr. Whitaker, who sees the need to elevate the understanding of the importance of sleep, particularly among Americans.

The pandemic helped to elevate awareness of the importance of good sleep and has softened the momentum of the “sleep is for suckers” mantra, according to the pulmonologist.

CBD and cannabis brands are seeing significant growth, most notably among 25 to 35 year-olds. Although millennials dominate the growth trends, one brand reported moms 40 – 50 years of age are among its fastest-growing demographic. 

Veterans, known to experience higher levels of insomnia (57% veterans) than the general population (30%), face elevated pandemic-related risks. Among veterans with Post-traumatic stress disorder (PTSD) or a traumatic brain injury (TBI), the rates are even higher — 93%, according to the Department of Veteran Affairs in San Diego.

Sleep specialists, like Whitaker, are particularly concerned about the stress levels in at-risk populations, particularly women- and veteran-headed households, whose support needs are more imminent.

When it comes to sleep, routines are important, according to the specialist who recommends patients develop healthy and consistent sleep routines, avoid consuming alcohol and OTC products known to disrupt sleep cycles, particularly antihistamines known to disrupt healthy sleep patterns.

CBD AND CANNABIS EFFICACY GROWING

In regard to other solutions, Dr. Whitaker says there’s “reasonable scientific evidence,” that CBD, particularly when combined with a small amount of THC, can help promote sleep.

Two in five working moms use cannabis, according to a newly minted survey released by San-Francisco analytics firm Lucky Analytics. 

Women are helping cannabis brands like Ganja Goddess achieve record-breaking triple-digit sales growth. The cannabis company reports a 635% increase in its sleep lines last year, according to its SVP of Marketing Heidi Genrich.

Gummies provide a popular entry point, according to Incredible Edibles Brand Director Jessica Benchetrit, whose company helps make cannabis more accessible via entertaining and informative educational sessions.

“Consumers are looking for an enhanced sleep experience, says Benchetrit. “The majority (78%) are actively seeking out ‘indica-like’ edibles.

Incredibles’ Snoozzzeberry gummies climbed to the number one infused gummy product in the markets it sold in, during the fourth quarter of last year, according to BDS analytics reports.  

REVEALING RESEARCH

A 2019 study published in the Journal of Alternative and Complementary Medicine, found cannabidiol (CBD) improved the sleep quality and reduced nightmares of 38% of the participants, all of whom had PTSD.

Joseph Maroon, M.D., a clinical professor and neurosurgeon at the University of Pittsburgh Medical Center who has researched the effect of cannabis on the brain, says that CBD has properties that could help some people sleep better. Most notably, he says, it appears to ease anxiety and pain, both of which can make it harder to fall asleep or stay asleep, according to a published statement in Consumer Reports. 

“CBD is safe,” says Dr. Daniel Clauw, an internationally known pain expert and head of the University of Michigan Director of Chronic Pain and Fatigue Center, who frequently collaborates with the Arthritis Foundation on education efforts.

Among sleep associations, the American Sleep Association has indicated that cannabis may help induce sleep in people with insomnia, anxiety or post-traumatic stress.

A MEANINGFUL IMPACT

“People are interested in better ways to relax at the end of the day,” says Ginrich. “And they are increasingly concerned about safeguarding their well-being over the long term.

“Stress and anxiety are not going away, so products and rituals that help people sustainably manage these pressures are in high demand,” adds the Ganja Goddess Marketing Director. 

We all have a role to play in helping put America’s sleep issues to bed.


Author Jackie Berg is the publisher of the Health Hub, a publication division of CBD Marketing Hub, as well as the publisher of TheHUB Detroit, TheHUB Flint and recipient of the Association of Women in Communications 2018 Vanguard award. To learn more CBD Marketing Hub, a cultivator of CBD and cannabis clients, visit its website or reach out at hello@cbdmarketinghub.com.

 

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