Member Blog: Think Your Disposable Gloves are Clean? Think Again.

by Justine Charneau, Eagle Protect

For those working in the cannabis industry, disposable gloves provide a protective barrier when working with products during the cultivation, harvesting, and processing stages. The benefit to wearers is essentially twofold. While “food-safe” rated gloves can greatly reduce the threat of cross-contamination between the wearer and products, they also help keep employees safe from dermal threats such as THC exposure, chemicals, fertilizers, and a wide variety of pesticides, especially if utilized during the growing season. In one well-documented incident, the culprit for a costly product recall turned out to be cross-contamination from single-use gloves, when O-Phenylphenol (OPP) – a cancer-causing chemical compound – was discovered in a seemingly pesticide-free cannabis operation.

If cannabis employees are under the impression that all disposable gloves are clean, intact, and contaminant-free right out of the box, you may want to reevaluate your perception.

Recent Study Identifies Glove Contaminants

The recent findings from a multi-year study on the potential for glove contamination revealed some alarming results about new and unused gloves. 2,800 gloves from 26 brands were subjected to four separate metagenomic testing sequences to determine the presence of contamination on both interior and exterior surfaces. Of all the samples analyzed and tested, 50% of the gloves contained traces of human fecal matter. In addition, the testing also detected other harmful pathogens which can lead to cross-contamination in cannabis supply chains. These included various yeast species, and a wide range of distinct genera of fungi – including Penicillium, Cladosporium, and Aspergillus.

How Can This Happen?

You may be wondering how it’s possible for unused disposable gloves to be contaminated right out of the box. Because the contamination occurs during manufacturing, before they are packaged in their box – and there are two root causes that contribute to the potential threat. First, not every glove supplier manufactures their products in a clean and hygienic environment. Putrid water sources, unsafe raw materials, and inadequate processes for quality control plague many of the factories where single-use gloves are produced. Compounding this problem is the lax oversight and enforcement of the FDA’s current regulatory policies, which actually don’t require imported food-compliant gloves to be pathogen-free or tested for performance such as rips, tears, and holes.

All Glove Suppliers are Not Equal

Before you adopt a defeated mindset about the safety and quality of gloves you wear, there are suppliers and distributors that go the extra mile to make sure their product lines are free from harmful contaminants. Glove suppliers that adhere to the highest industry standards for performance, quality, and safety are known for self-policing their manufacturing processes, ensuring that products are produced with proper raw materials, absent of unsafe chemicals, toxins, or microbial contaminants. They also conduct routine audits to test the effectiveness of their manufacturing process, and some have even adopted product traceability to ensure a contamination-free supply chain from initial production to final shipping and delivery.

Buying the cheapest gloves may save you a little on the front end, but also come with elevated contamination risk. In the long-run, premium quality gloves are much more cost-competitive than you think. And you’ll have peace of mind in knowing that your required PPE will probably never be the cause of a costly product recall that can be damaging to your organization’s profitability and reputation.


Justine Charneau is the head of cannabis industry sales at Eagle Protect, a disposable glove supplier dedicated to the responsible sourcing of quality products that ensure customer safety and impact reduction, ultimately mitigating customers’ risk. Eagle Protect is the only global PPE supplier that is a Certified B Corporation, a designation that a business has met the highest standards of verified glove safety and performance, accountability, and transparency. She can be reached at justine@eagleprotect.com

Committee Insights | Meet the Minors (Novel, Minor, Synthetic Cannabinoids – Part II)

In this edition of our NCIA Committee Insights series, originally aired on May 11, 2023, we were joined by members of NCIA’s Cannabis Manufacturing, Scientific Advisory and Hemp Committees for an in-depth discussion of the most talked about minor, novel, and synthetic cannabinoids.

What scientific publications exist for each compound? What do we know about each molecule’s physiological, psychoactive, and therapeutic effects?

You’ll find out during this informative session featuring leading chemical experts, manufacturers and product development specialists. Along with audience members they explored these compounds from various perspectives to examine their implications for consumers, medical practitioners, patients, producers and regulators.

Learning Objectives:

• Molecular Structures and Identification of novel, minor, and synthetic compounds
• Published Physiological and Psychoactive effects of these compounds
• Perceived therapeutic effects
• Opportunity to ask about other new compounds not in presentation.

Panelists:

Cassin Coleman
Founder
Cassin Consulting

James Granger
Chief Political Officer
Clintel Capital Group

John Murray
President
Sustainable Innovations

Scott Seeley
Patent Attorney & Intellectual Property Lawyer
Eastgate IP

This is the second 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

From Lab to Label: Safeguarding Consumers in the Cannabinoid Product Landscape (Part III)https://bit.ly/3Xc9Lx6

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: What Ever Happened with the New York Minute in the Cannabis Industry?

by Andrew Kaye, Sweet Leaf Madison Capital 

2023 is New York’s year for cannabis – at least that is what we are being told. It has nearly been two years since the state voted in legalized recreational use and sale, but the state has been very slow in getting processing facilities and dispensaries up and running, with only three of the 66 licensed establishments in operation as of the end of February. It is no secret that New York has the potential to be one of the largest cannabis markets in the world. This year alone, New York City is expecting over 50 million visitors – many of them looking to buy legal weed. 

Everyone can see the value that New York will bring to the industry, but why does it feel like they are dragging their feet to bring something to the table? 

It appears that the state may have bit off more than it can chew. 

A lack of understanding of the complexities of securing commercial cannabis real estate combined with the fact that raising necessary capital has been slow-moving, has made it so that cultivators now have too much supply with no means of distribution to meet the demand. 

Good intentions, slow follow-through 

The guiding social equity program behind New York’s retail licensing system is a giant leap forward within the cannabis industry to bring up those directly affected by the failed war on drugs. The Cannabis Adult-Use Retail Dispensary (CAURD) licenses are aimed at prioritizing these underserved communities and awarding licenses to those who have been convicted of marijuana-related crimes, or have a direct family member that has been charged, with the opportunity to open retail locations. Nonprofits that work directly with these communities have a chance at obtaining licenses as well. 

One of the most enticing things about these licenses is that the Dormitory Authority of the State of New York (DASNY) has been tasked with finding storefronts for entrepreneurs who have been granted licenses and even build them out for them. To do so, the state has contracted 10 firms to design and construct each dispensary. But again, the state has been very slow in getting dispensaries up and running. It seems that DASNY has discovered the reality that finding landlords willing to lease to a cannabis business may be more daunting than expected. 

This only adds to the sense of urgency that has lingered in the air for the last two years. Businesses are ready to get up and running just to play catch up to the underground market that is thriving across New York City’s boroughs. Currently, New York has estimated that there are roughly 1,400 unlicensed retailers operating in the city. Unregulated sales mean that weed has the potential of going to underage kids, being tainted and it is all ultimately going untaxed. New Yorkers and the state are hurting due to the delayed rollout, but there is still time to change things around.

Since spaces are limited for license holders waiting on DASNY to figure out the real estate landscape, the state has started to give licensees the option to go out on their own to secure a location for the sake of being one of the first to the legal market. 

The problem is that this good news comes with a caveat. If a licensee decides to break out on their own, they will be forgoing their share of the $200 million public-private fund that DASNY has budgeted to help with operating costs. This fund is essentially a state loan that each retailer will have to pay back, including interest. But the problem is that DASNY has not yet raised the necessary funds to dole out to retailers – the only amount that the public is aware of is the $50 million that the state provided. 

So, the million dollar questions are, do these entrepreneurs take a chance to be first to the scene? Or do they trust that the money and real estate issues will work themselves out? 

It is hard to say. But what we do know is that there are new cultivating and processing licenses being secured this year as well, and a huge backlog of weed in storage, so there will be no lack of product once the doors to the public open up – right now, it is just a matter of time. 

So maybe NYC should get out of its own way, put a bit more “market” in the cannabis market, and let 1,000 blossoms bloom! 


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

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

 

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

Member Blog: Breaking the Bad – Easy Steps to Better Secure Your Cannabis Facility – Part 1

by Kevin Hill, Spara Group

First things first, when I selected this article photo I wanted to show someone prying a back door to a business. While this illustrates the message that I’m trying to get across, cannabis burglaries do not often occur during daylight hours. In fact, it seems much more likely that this is a pic of a distressed GM who lost their badge and is frantically trying to get in the building so that they can open before their Retail Director finds out!

All joking aside, rear-door breaches account for the majority of cannabis burglaries throughout the United States. Burglars prefer this entry technique mainly due to the fact that they are much more concealed at the rear of the building than the front (streetside) portion of the structure. Having this in mind, we can literally focus on bolstering this ONE door in order to mitigate much of our overnight vulnerabilities.

Rear commercial doorways almost always come with two built-in theft deterrents, one by design, and one from just plain luck. The first being that they are mostly solid and constructed of metal, and the second being that they swing outward rather than swinging into the location due to fire egress mandates. From a breaching standpoint, it is much easier for a bad guy to force a door open by inward force (kicking, shouldering, etc.) than by prying the doorway outward. Having established this, burglars are forced to pry these doorways open in order to achieve entry.

So good news, now we have deduced not only where our bad guy is likely to come in from, we now know how they are going to do it! All we need to do now is find a product that will make a pry-fashioned entry nearly impossible. I’ll list three options with each of their respective price points and considerations.

Common Latch Guard:

A latch guard is a strip of metal that basically covers the empty space between the door and frame. This makes it much more difficult to “get a bite” with a pry tool by placing the tool in the aforementioned space. Most of these guards are 6 to 8 inches long and are placed on the area covering the area where the door latches to the frame, however, I would recommend a full-length latch guard that will cover the full length of the door. While the shorter piece may keep a villain from getting in, their attempts could damage the doorway to a point where it would need to be replaced, which leads to compliance issues and subsequently unwanted store closures. Local locksmiths will have these in stock and should be able to install them for around $500.

“Panic bar” styled exit system:

These systems are basically a panic bar on steroids. The system bolts to the interior of the door with retracting bolts that insert into each side of the door’s jamb/frame while deployed. Once the handle is depressed, both bolts retract and allow the doorway to open. These systems often come with an alarm that can be programmed to sound when opened and can also be ordered with an electrical kit that will work with your access control system. This option will cost around $1000.

“Three Point” bolting systems:

On the higher end of the spectrum are “Three Point” bolting systems. These systems incorporate a heavy latch with two additional bolts to the top and bottom of the doorway. These systems can also be incorporated into your access control system, making it possible for authorized users to badge-in from outside. These systems carry a price tag around $2,200, although they come with all the hardware needed for the door, so you are at least saving additional hardware expenses.

So there you have it, three options to GREATLY diminish the likelihood of a break-in.


Over the span of a 22-year career with the City of Tulsa Police Department, Kevin served much of his tenure as a Disaster Response Team member, violent crimes task force investigator, and homicide detective.

In 2018 Kevin retired from the Tulsa Police Department and joined Harvest Health and Recreation, a top ten vertically integrated, multi-state operated cannabis company. Kevin served as Harvest’s National Security Director until Harvest was acquired by the cannabis industry giant Trulieve in 2021. Once at Trulieve, Kevin assumed the role of National Security Director, overseeing all facets of physical security for 200 retail locations, 15 production facilities, and 11,000 employees throughout the United States.

In November of 2022, Kevin launched Spara Group, a niche cannabis consulting firm focused on offerings related to Physical Security, Compliance, and Learning+Development throughout the cannabis canopy.

Kevin maintains his residency in Tulsa, Oklahoma, where he lives with his wife Sonya.

Please give me a call at 918-809-8850 or email kevin@sparagroup.com if you have any questions.

Take care and thanks everyone!

The NCIA DEI Delegation Reports Back from Lobby Days in D.C.!

by Mike Lomuto, NCIA’s DEI Manager

On September 13-14, Social Equity applicants and operators from around the country traveled to Washington D.C. as part of NCIA’s Lobby Days. Lobby Days provides the opportunity for NCIA members to speak directly with national lawmakers about the issues most important to small cannabis businesses – from SAFE banking to federal de-scheduling. This first-ever DEI delegation was supported by our members’ contributions to the Social Equity Scholarship Fund, and was the first of its kind – intentionally bringing diverse voices from our membership to Lobby Days. 

Due to the pandemic, this was our first in-person Lobby Days since the launch of our DEI Program in 2019, and the launch of our Social Equity Scholarship Program in Spring of 2020. Since then, we have been coalescing our members’ diverse voices into clear perspectives and opinions on the direction of our industry. Something that our DEI Program is very proud of is that at this year’s Lobby Days we supplied talking points with the purpose of creating a proper impact. 

Some of these talking points were sourced from the excellent white paper on SAFE Banking by the Cannabis Regulators of Color Coalition, which provides very thorough recommendations including: Requiring federal banking regulators to identify best practices to achieve racial equity in financial services; and Clarifying that cannabis criminal records are not an automatic red flag. Notably, this group which has some of its roots from NCIA’s very first Catalyst Conversation over two years ago, and its Treasurer, Rafi Crockett, now serves on NCIA’s DEI Committee. 

The Social Equity applicants and operators comprising the delegation spoke directly to lawmakers on the kind of real changes we need for DEI and social equity to become a reality in our industry, in particular regarding SAFE banking. From their experience as professionals and advocates in the industry they were able to provide much-needed insight into how legislation impacts owners, operators, budtenders, and the social equity community in particular at the ground level. These conversations proved to be the missing link for a lot of these elected officials on Capitol Hill who stated their support for making a more equitable industry and righting the wrongs of the war on drugs, but lack real-life experience on the matter. 

Here are some of the highlights from the delegation: 

“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.” 

  • Raina Jackson, Founder & CEO PURPLE RAINA Self Care

NCIA Diversity, Equity, & Inclusion Committee (DEIC) 

 

“As I moved from meeting to meeting, one thing became crystal clear; there’s a knowledge gap that surrounds this plant, a gap fueled by learned behaviors, stigmas, pain, gain, and loss. This message rang clear to me from members and staff of both the senate and house…” 

  • Toni MSN, RN, CYT, Toni

NCIA Education Committee and Health Equity Working Group

 

“From my experience, I learned that people make a difference. The people who make the laws don’t know everything and us providing information and answers can and may make that difference” 

  • LaVonne Turner, Puff Couture, LLC

NCIA DEI Committee

 

“NCIA Lobby Days was an interesting peek behind the curtain of how the sausage is made in D.C. It became easier to see why some politicians seem so ill-informed about cannabis. Elected officials may themselves come from a state with draconian laws and politics about cannabis. Mix that with their staffers/advisors being recent college grads from other parts of the country with those same conditions, and you have a recipe for horrific policy. What was refreshing however was the amazing amount of knowledge that some of those staffers did possess both about cannabis policy and the plant itself. Not surprisingly they without fail worked for pro-cannabis congresspersons.” 

  • Dr. Adrian Adams, CEO Ontogen Botanicals 

NCIA DEI Committee – Subcommittee Regulation

“In each session, as I spoke about equity in underserved communities, the representative(s) appeared as it was the first time hearing the phrase Safe Equitable banking. Through their perplexed faces, I saw them registering that safe, equitable banking is needed.” – Toni

“I’ve never done something like this before sounds so cliche but it’s the best way to describe this eye-opening experience of speaking directly to Congressional staff about what it means to be a small business owner in the cannabis space.  The challenges and hurdles that we have to deal with because of 280e and cannabis being a “controlled substance” are real and huge burdens to us as small businesses and owners of color. The lack of banking and financing is exponentially more damaging and difficult to black and brown communities because of our historic lack of fair and equitable access to this vital resource.  This lobby days opportunity strengthened my resolve to be a loud voice for the Latino and black communities to ensure we have our seat at the table from this day forward!”

  • Osbert Orduña, The Cannabis Place

“Everyone we met with was compelled by the financial and public safety benefits that SAFE would offer under any form of cannabis decriminalization, from CBD with low-THC to adult consumption” – Raina Jackson

 

All in all, the consensus was that it was a valuable experience and folks would take the time to lobby again and encourage others to do the same. Lobbying in DC is one part of many strategies that have the potential to spark policy change at the federal level and without a doubt, getting a chance to speak personally to experienced industry professionals with a social equity lens was invaluable for the policymakers. 

Next year we are pledging to double or even triple our DEI delegation. If you’d like to be a part of making this happen, we are already accepting sponsorships as we plan for 2023’s event, NCIA’s 11th Annual Cannabis Industry Lobby Days on May 16-18, 2022.

If you did not get a chance to read our blog post before the delegation left for Washington, D.C. to participate in NCIA Lobby Days as part of the first-ever Lobby Days Social Equity Scholarship delegation, you can read more here

 

Member Blog: Top 6 Pathogens Seen in Cannabis Plants

By Angel Fernandez and Felipe Cisternas, MyFloraDNA

Pathogens cause diseases when looking for a host body to infect. They come in diverse forms: bacteria, fungi, worms, viruses, and also prions. Pathogens are one of the significant threats to cannabis fields. These silent visitors may cause your plants to produce fewer trichomes, small buds, or even death. 

Identifying each pathogen will help to understand how each of them propagates, its symptoms, and its consequences. In this blog, you’ll find everything you need to know about:

  • Hop Latent Viroid
  • Botrytis (gray mold)
  • Cannabis Cryptic Virus
  • Lettuce Chlorosis Virus
  • Alfalfa Mosaic Virus
  • Beet Curly Top Virus

Hop Latent Viroid

Hop Latent Viroid (HLV) is a single-stranded infectious RNA that interferes with cannabis plant growth. Once the Hop Latent Viroid has infected the plant, the obvious sign of infection is dudding, which is when the plant grows smaller, shorter leaves in the process. HLV can also cause other symptoms, such as yellowing, and necrotic and malformed leaves

These plants will have fewer traces of trichomes in their structure. Detecting HLV on time is crucial to avoid an existential threat to the entire garden.

Botrytis Cinerea

Botrytis Cinerea, or bud rot, is a fungus that damages the tender parts of plants in areas of high humidity. This necrotrophic fungus will invade damaged tissue. The symptoms include smaller buds, the development of gray mass spores, and brown, water-soaked spots found on leaves. A major consequence of this fungus is that it can kill cannabis plants within a week. 

Lettuce Chlorosis Virus

Much like Botrytis Cinerea, Lettuce Chlorosis Virus can potentially destroy an entire garden. Likewise, Lettuce Chlorosis Virus occurs in lettuce grown in southern California. The plants change into a frail yellow color. They will become very brittle and stunted. One way to prevent the virus from spreading is to take a sample of tissue from a cannabis plant and perform qPCR tests to make sure the plant is virus free. 

Cannabis Cryptic Virus

Cannabis Cryptic Virus is a double-stranded RNA virus causing subtle symptoms to plants. Some of these symptoms include smaller flower quality and stunted growth. Thus, this virus can affect plants by producing fewer terpenes, cannabinoids, and trichomes, which are three essential components that serve different purposes for cannabis plants.

Alfalfa Mosaic Virus

Another pathogen is Alfalfa Mosaic Virus, the virus starts by killing cells within a plant and this can be a potential problem for groups of plants. Aphids, small insects, will begin to infect one plant after another as they move and transmit the virus instantly. Seed transmission is also a possibility. There’s no known cure so it is best to care for plants to avoid infection from this type of virus. The symptoms are the same as many of the previous viruses and diseases; stunted growth, slower yield, and calico or yellow color is typically seen on leaves. The good thing is that this can be detected on time by performing serological tests, or antigen and antibody tests to help prove immune status.

Beet Curly Top Virus

Lastly, Beet Curly Top Virus is a dangerous plant virus containing a single-stranded DNA that can affect all kinds of plants, especially cannabis plants, giving them a serious infection. Symptoms include showing a yellow color with purple veins, leaves beginning to curl, seedlings dying out, and deformation beginning at the buds. Since this virus contains a protein carrying a unique code that allows for host cell replication if the virus is not detected on time the cannabis plants will die.

Recognizing the danger these pathogens pose to cannabis plants, and acknowledging their potential to prevent cultivation is very important for growth and success. 

If you would like to know more about cannabis pathogens and how to prevent infections in your garden, download our free guides about How to treat Infected Material and The Ultimate Hop Latent Viroid Guide

Keep growing safe and healthy cannabis!


Author: Angel Fernandez, CEO & Co-Founder at MyFloraDNA. “It is time to fill in the gap between DNA Sciences and Agriculture. MyFloraDNA is willing to show the huge opportunities that exist for modern genetics in agriculture. Now, it is time for another agricultural revolution”

Co-author: Felipe Cisternas, Intern at MyFloraDNA

Editor: Ashlyn East, Intern at MyFloraDNA

About MyFloraDNA: We are a genomic laboratory based in Woodland California, delivering modern genomics for the cannabis industry. MyFloraDNA provides data-driven decisions to help breeders increase their plant yields. 

Our services include Trait detection (cannabinoid profile and sex/gender ID), Pathogen Detection, and Genetic Validation Services. We offer breakthrough solutions using the inner power of your plants.

Who asks if you think you have an infection in your garden?

We highly recommend you consult with DNA Laboratories. They will guide you through the process, test your plants, and let you know if they are infected with HLV or not. 

 

Member Blog: The Delicate Issue of Dermal Considerations

by Justin Charneau, Eagle Protect

Skin-related (dermal) issues from the constant wearing of disposable gloves were among the top complaints revealed in various cannabis workplace surveys. Many employees required to don single-use gloves to conduct a variety of job-related tasks – in the cannabis cultivation process and several other industries – remain unaware of the distinct types and qualities on the market, and how they differ. The quality, fit, durability, and functionality of disposable gloves are determined by several factors, including the type, application, raw materials, and manufacturing processes used to produce them.

Gloves by Type and Dermal Risk

Among disposable gloves, there are three primary types – latex, vinyl, and nitrile, each with differing qualities and risks. Here is a snapshot of each variety, along with their associated dermal risks:

Latex – these gloves are constructed of rubber, a snug fit like second skin that is both highly elastic and resilient. They are mostly worn in the medical industry, where a high level of dexterity and tactility is warranted. However, latex gloves can trigger a Type I hypersensitivity reaction to latex and Type IV hypersensitivity reaction to rubber chemicals. Latex-free nitrile gloves have generally superseded this option in the market. 

Vinyl – these cheap gloves are manufactured from brittle polyvinyl chloride (PVC) material, prone to a high rate of defects (rips and holes) in the glove barrier, an immediate cross-contamination risk.

Vinyl gloves are manufactured with plasticizers to soften the PVC, which often contain toxic phthalates and chemicals. Many of these ortho-phthalates have been shown to harm reproductive health and brain development. These threats can be absorbed into the glove wearer’s skin, and leach into the food handled which, in turn, can later be ingested by customers. Phthalates in vinyl gloves are highly restricted in Europe and Japan for food handling and were recently banned by the state of Maine.

Vitrilea blend of vinyl and nitrile. These gloves should be stronger than plain vinyl gloves and less expensive than nitrile. Due to pandemic-related price increases in gloves, the vitrile option has recently grown in popularity. Buyers should beware of cheap nitrile gloves, blended with cheaper vinyl, yet still marketed as nitrile. Vitrile gloves carry the same risks to the wearer, and the products they handle, as vinyl gloves.

Nitrile – these gloves are among the best choice for the cannabis industry, as they protect against harmful chemical substances, and their puncture and tear-resistant qualities are ideal for complex cultivation and processing tasks. They also provide the highest level of protection and durability as a barrier to harmful chemicals and pesticide exposure.

However, nitrile glove allergies can also occur, posing potential problems for the glove wearer. Cheap and toxic raw material ingredients, which reduce glove manufacturing costs, can also cause occupational skin disease (OSD), such as contact dermatitis and Type IV hypersensitivity to rubber chemicals. Accelerators, added to speed up rubber vulcanization during the manufacturing process, are the typical cause of glove contact allergies.

For glove wearers prone to skin allergies and irritation, higher quality gloves and accelerator-free options are a necessity.

Keeping Your Workforce Safe

There are ways and means of reducing the risk of dermal disorders caused by single-use, disposable gloves. The more frequently gloves are worn, the higher the risk. Below are several ways to mitigate the risk of dermal disorders:

  1. Choose quality nitrile gloves, marketed by reputable suppliers with an extensive history of glove sourcing and experience. Look for well-established company websites, including industry-related blogs, published articles, and resources that demonstrate the supplier’s commitment to quality
  2. Request proof of factory and third-party audits, as well as HACCP compliance certifications
  3. Plan to undergo a commercial trial of glove products prior to committing to bulk purchasing. Any established and reputable supplier should be more than happy to ship glove samples for trial usage
  4. If possible, choose accelerator-free nitrile gloves
  5. Consider your options for glove types. Be wary of vinyl / nitrile-mixed gloves passed off as nitrile – always sample first before you buy
  6. If alternatives are available, avoid vinyl gloves

For more information on how disposable gloves can affect your business and productivity due to skin disorders and repetitive hand movement injuries, please read our recent NCIA blog post, “PPE and Staff Efficiencies – How Much Do the Quality of Your Disposable Gloves Matter?


Justine Charneau is the head of cannabis industry sales at Eagle Protect, a disposable glove supplier dedicated to the responsible sourcing of quality products that ensure customer safety and impact reduction, ultimately mitigating customers’ risk. Eagle Protect is the only global PPE supplier that is a Certified B Corporation, a designation that a business has met the highest standards of verified performance, accountability, and transparency. She can be reached at justine@eagleprotect.com.

 

Member Blog: What Growers Should Know About Hop Latent Viroid

by Angel Fernandez, María Zuccarelli, and María de Catarina, MyFloraDNA

For many years, growers and breeders have speculated why “dud plants” are seen across different cannabis crops.

It is a fact that cannabis has faced many viral infections. Due to viruses and viroids, some varieties mutated into genetic changes over time, altering the evolution of the plant.

But… how can we detect Hop Latent Viroid (HLV)?

Hop Latent Viroid (commonly known as Dudding Disease) is a single-stranded, circular infectious RNA. It is not a virus. Let us explain the difference:

Viroids only replicate in plants. Also, viruses are more complex than viroids. Viroids are compounded by only RNA, while viruses are composed of a protein capsule enveloping their genetic material.

Viruses infect new hosts only once they enter a host and replicate on it. Viroids are transmitted through direct contact of a healthy plant with an infected one. Also, can be transmitted by contaminated tools and instruments (gloves, scissors, tweezers, even human hands).

Talking about HLV, we must remember that this viroid is latent, so there are many asymptomatic transmissions. It can spread without symptoms, and you will only realize it when it is too late.

HLV Symptoms:

HLV is a silent viroid, meaning that this viroid may or may not show early visual clues from its presence. Some physical symptoms in cannabis plants are:

What about transmission?

This issue is important, so please take note. If you have any doubts about an infection of Hop Latent Viroid in your garden, TREAT EVERYTHING AS IF IT IS INFECTED. Download here our guide on how to treat infected material.

HLV and other viroids in your garden or greenhouse can spread quickly from infected to healthy plants. The main transmission causes are:

  • Infected equipment: sterilize the equipment before working on new plants to reduce the possibility of contamination.
  • Clones: before cutting, we recommend doing a complete pathogen test, to avoid infected clones.
  • Seeds: this is currently under research, but HLV has an 8% chance of being present in the seeds of an infected mother plant.
  • Human touch: cultivation managers and staff have to sterilize their hands and gloves before jumping from one plant to another. A simple touch is enough to transmit HLV.
  • Bugs and pests: bugs and pests are always present, and their bites may transmit HLV, spreading the pathogen through your entire garden in a blink of an eye.

How can you prevent HLV?

Here are some essential tips:

  • Keep your equipment clean. You can read more about how to sterilize your tools on our Instagram profile.
  • Make sure you have pests under control
  • Tissue culture: HLV can travel through the plant’s vascular system and may be left behind in older tissues as plants develop. It can outgrow the problem by producing clones from the infected plant. The more cuttings a grower roots, the higher the chances of selecting a clean one.
  • Pay special attention when visits come by: HLV may come in a visitor’s hand, glove, or even shoes! 
  • When a plant or leaf enters, please do not accept it unless it has a negative DNA HLV test. It is the only way you can be sure it is not a threat to your garden.

Who asks if you think HLV may be in your garden?

Thank you for reading! We hope you find this information useful. In case of any doubts, do not hesitate to ask us regarding any related topic and download our Complete HLV Guide here. We highly recommend you consult with DNA Laboratory. They will guide you through the process, test your plants, and let you know if they are infected with HLV or not. 

Angel Fernandez, CEO & Co-Founder at MyFloraDNA. “It is time to fill in the gap between DNA Sciences and Agriculture. MyFloraDNA is willing to show the huge opportunities that exist for modern genetics in agriculture. Now, it is time for another agricultural revolution”

Co-author: María Zuccarelli, CMO at MyFloraDNA.
Editor: María de Catarina, PR Intern at MyFloraDNA.

About MyFloraDNA: We are a genomic laboratory based in Woodland California, delivering modern genomics for the Cannabis Industry

Our services include Trait detection (cannabinoid profile and sex/gender ID), Pathogen Detection, and Genetic Validation Services. We offer breakthrough solutions using the inner power of your plants.

 

Committee Blog: Is American Cannabis Still the Wild West? 

by NCIA’s Risk Management and Insurance Committee
Matthew Johnson, Quadscore Insurance Services

Cannabis is America’s riskiest business. 

Cannabis itself is a highly valuable commodity, but cannabis businesses also deal largely in cash – making them a prime target for thieves across the country. Recent headlines have reported a rash of unsolved robberies in the Bay Area and Washington State, not to mention the seizure of cash from Empyreal’s fleet of armored transport vehicles (fortunately, that cash has now been returned by the police). 

This is a national problem, which begs the question… What should cannabis businesses do to stay safe during these trying times?

There are many different means of minimizing the risk faced by your modern cannabis business, but we’re going to focus on the big three today – security, technology, and compliance. Through careful consideration of these three tenets, cannabis businesses can take significant steps to mitigate risk and protect their employees. Appropriate investments can yield tenfold savings in the form of fewer stolen assets, lower insurance premiums, peace of mind, and safer employees. 

SECURITY

Let’s start with the topic that gets the most attention during a crime spree – security. In cannabis, security means a number of things… video cameras, man traps, motion sensors, hardened glass, ID checks, and more. When building or retrofitting a facility for cannabis operations, it is crucially important to consult with security experts like Sapphire Risk Advisory Group or Cannabis Compliant Security Solutions. 

“In many areas, it’s not a question of ‘if’ a cannabis business will be robbed – it’s ‘when,’” cautions Chris Eggers, CEO of Cannabis Compliant Security Solutions. With 13 years of experience as a law enforcement officer in the Bay Area – including several years working as an undercover narcotics officer – Chris is uniquely qualified to address the ongoing issues in Oakland and other areas along the West Coast. “There’s a question of how you navigate and survive an incident, but beyond that, how you ensure that your business will survive too.”

There’s an important distinction between security consultants like CCSS, security integrators, and vendors. To achieve best results, cannabis businesses should work with a security consultant who can identify ways to protect the business – without being tied to commission-based sales contracts or a specific ‘brand’ of security solutions. 

TECHNOLOGY

Physical security aside, there are a number of high-tech security tools that can help cannabis business owners protect their operations. For example, let’s take a look at the biggest security company you’ve never heard of – an organization called 3SI Security.

3SI Security began their journey over 50 years ago as the original producer of dye and smoke packs intended to deter bank robbers in the 1970s. Technology has evolved over the years, and so has 3SI’s product offering – now, their GPS tracking tech is ubiquitous throughout banking, pharmaceuticals, luxury retail, and telecommunications.

As VP of Business Development for 3SI, Carlos Casas works to connect cannabis businesses with this tech to protect their assets and employees. “According to a Forbes report from July 2020, an estimated 70% of cannabis businesses are cash-based. This is a staggering statistic which shows the real risk to the industry is on an upward climb.” With the SAFE Banking Act still in the works, savvy business owners have to explore alternative solutions like 3SI’s technology to ensure their business stays safe.

Apart from 3SI, there are a number of technology companies that provide technology to make the cannabis industry a safer place. ADT Security has recently launched a cannabis-focused divison of ADT Commercial to provide critical security technology to cannabis businesses around the country. After spending three years keeping HERBL’s fleet secure on the west coast, Andy Fleet now leads ADT’s efforts to provide security solutions to the cannabis industry. 

According to Andy, “Security planning is critical for any cannabis organization. Take the time to evaluate all the risks within your establishment and build a robust plan that ensures all areas of physical safety and security are considered and protected.” Underscoring the points above, Andy continues, “Working with a licensed, experienced consultant will ensure adherence with all relevant regulations and help keep your employees safe while having technology do the heavy lifting for you.”

COMPLIANCE & COVERAGE

Next up, everyone’s favorite topic: compliance. In this sense, we’re not talking about adhering to the myriad regulations imposed on cannabis businesses wherever they operate – but rather, making sure that your operation complies with the protective safeguard requirements in your insurance policy. Non-compliance with or material misrepresentation of your active protective safeguards could result in an uncovered or denied claim – and could even cause problems with your investors. If you’re buying insurance, you want to make sure that your policy will pay out when stuff hits the fan!

Theft Sublimit – Most cannabis insurance policies will only cover theft losses up to a certain ‘sublimit’ depending on the quantity of cash/cannabis being stored, the physical location of the cannabis business, and any relevant losses that the insured business may have sustained due to theft. Make sure that you are comfortable with the sublimit provided and, if you aren’t satisfied, work with your insurance broker to see if you can secure higher limits.

Protective Safeguards – Virtually all cannabis insurance policies carry some warranties around protective safeguards that can impact your coverage in the event of a claim. Make sure to read the Protective Safeguards endorsement and check that all of your security systems are functioning in compliance with these requirements.

Motor Truck Cargo – Similar to the protective safeguards warranty, make sure that you study your policy to ensure that any requisite safeguards are in place. For transportation operations, these safeguards are likely to include vehicular telematics, buddy systems for drivers, GPS tracking, and possibly even an escort vehicle to accompany the transport unit. 

Security guards – When hiring security guards, it is recommended to employ a third-party guard service that carries appropriate limits of insurance. Make sure that your business is listed as an additional insured on their insurance policy to ensure coverage in the event of an altercation at your business!

Financing – Lenders and VC firms will often stipulate that the companies accepting their funds will need to adhere to certain requirements, like securing Directors & Officers insurance for the officers and executive board. Beyond insurance, it’s important to make sure you are actually doing what you promised to do in terms of safeguarding the property and not just so that you may be eligible for coverage, but also so that you are not held liable for losses suffered by third parties, such as lenders and investors. 

Joseph Cioffi, chair of the Insolvency+Finance practice at the Davis+Gilbert law firm in New York advises, “Operators typically make certain representations to investors, lenders, and other capital providers, and undertake certain activities intended to preserve asset and collateral values. The operator is looking at default if it’s in breach of contract, but worse, the operator and its principals could be sued for misrepresentations made in obtaining funding – and be held liable for losses that flow from those misrepresentations.” 

CONCLUSION

Like an onion, there are many layers to a risk management program for cannabis businesses. Through careful implementation of security measures and protective technology, many businesses will be able to prevent damage to their business with proper planning. In case all security measures fail, a comprehensive insurance policy should be able to help make a business whole again after a claim. Make sure to work with the proper insurance, security, and legal experts when building or restructuring a cannabis operation!

 

Committee Blog: Everything You Wanted to Know About Cannabis Facilities But Were Afraid to Ask Field Guide – Part 3 – Extraction

by members of NCIA’s Facilities Design Committee
Jacques Santucci, Brian Anderson, David Vaillencourt, and David Dixon

Continuing our five-part series on the behind-the-scenes workings of the legal cannabis industry. This series focuses on all of the inner dealings and industry advice from established professionals to craft this unlimited How-to-Guide to assist you in setting up your own facility. These articles cover cultivation, extraction, infused products, and retail facilities as well as support activities. In general, remember to be compliant with all local rules and regulations and contact a licensed contractor and industry expert. 

Part Three, Food: 10 Things to Consider When Planning Your Manufacturing of Infused Products (MIPs) Operations

Food safety and handling practices are an issue for any industry working with or processing products for human consumption and often come with strict guidelines that need to be followed. In the cannabis industry, edibles and other processed or infused products Manufactured Infused Products (MIPs) are ready-to-eat foods, so many states are regulating them as foods under the cGMP requirements of 21CFR117. We feel this is likely the approach that will be appropriate when cannabis becomes federally legal. These 10 things should be considered as you begin to plan your facility.  Always remember to be compliant with all local rules and regulations. 

Sanitary Design and Operation

A production room is straightforward, conceptually: design the space so walls, floors, and ceilings can be washed and sanitized, then verified (ATP swabs) to confirm the cleaning process is effective. To facilitate cleaning, everything needs to be pulled away from the walls, the ceiling needs to be solid and the walls need to be sealed. Insulated metal panels (IMP) are a cavity-free construction that is seeing wide acceptance in the industry. To keep the space clean during operation, slope the floors to spot drains, install coves along with the floor/wall interface and avoid ledges and traps for water or dust.

Employee Hand Washing

A stringent internal process for sanitation and washing of hands is crucial. Make sure that lavatories are available throughout your facility for proper sanitation. Confer with the municipal board of health for locations and quantity. Generally locate any place where employees are handling consumable products or encounter the potential for microbiological. 

Boot Washing

Sanitation includes making sure all boots/shoes are free of contaminants. Employee captive corporate footwear programs prevent contamination potential from non-business-related employee activities.

Cart Washing

For carts that transport ingredients and materials, it is important to prevent floor debris getting transferred from one area to another. Two areas of concern; are wheels and cart shelves. Either wheel or shelf area can be addressed from multiple washing devices specific to each type of cart used.

Product Storage

Food safety temperature and humidity separation of products are an important factor. The purpose is to store food products at such a temperature and humidity level to prevent the growth of undesirable bacteria.

Allergen cross-contamination

Make sure to arrange products to avoid cross-contamination of open and unopened products. Keep the first pallet off the floor at a height of 6” AFF to avoid picking up contaminants. OHSA SHARP may apply how to organize products. 

You can design barriers to keep contamination from entering a room.

Limit contamination by having and always renewing Personal Protective Equipment (PPE), since the adjacent hallways may transport raw biomass. Test all ingredients, including THC, to ensure that everything is microbiologically safe. Wipe down, or unpackage ingredients, materials, and supplies before bringing them into the ‘clean environment’ room. Wear specific scrub, clean boots, and wash off any carts entering the room.

Employees entering the food production space

Contaminants can enter via the employees.  It is essential to have all employees and agents clean up before entering the food production space. You must provide facilities to wash and sanitize hands as well as boots. Continuous training of employees and monitoring adherence to the procedures is important. Your procedure will include how sanitation is necessary, where are smocks hung, how are shoes cleaned, etc. Typical controls are in the FDA Food Code for jewelry, open sores, illness, etc.

Food Safety Inherent in the Recipes

Complete a Food Safety Hazard Analysis to know if you need to implement an upstream preventative control, such as for chocolate, or if you need to manage a thermal kill-step such as cooking the gummies mass. Low water activity, high acid, or a natural biocide additive, can all be considered. 

Control for Allergens

MIPS often contain soy, flour, eggs, dairy, peanuts, tree nuts, coconut, and perhaps others. Each has special considerations for allergen separations and allergen cleaning.

Ware Washing and Clean Parts Storage Room

Don’t Underestimate the Ware Washing and Clean Parts Storage Room. Adjacent to your MIPs production room, consider building a washroom with a commercial dishwasher for utensils, kettles, wetted parts, trays, molds, etc. You might install a three-compartment sink. And make sure to safely store clean items, so they dry and do not get recontaminated prior to use. This room is maintained at negative pressure to the MIPs production room.

Plan for the Pantry

Store ingredients, materials, and supplies in a pantry off the MIPs room can be considered. It is much easier to clean the MIPs room if such items are stored outside production. If you pre-weight, or decant in the pantry, cardboard and plastic are kept out of production. It is a great idea to provide a door also to the adjacent hallway to drop off ingredients, then your staff can enter from the MIPs room. Special care is taken when storing opened products.

Keeping Final Products Food-Safe

The best practice might be to put products such as chocolate bars into primary film envelopes or fin-seal gummies while still in the MIPs room. Often, subsequent packaging is done where there are other possible contaminants such as open bud, pre-rolls, chipboard or corrugated, etc. If the food products are already protected by primary packaging, you will greatly reduce the risk of recontamination. 

HVAC, Humidity Control, and Filtration

HVAC, Humidity Control, and Filtration are critical. The MIP production room should be air-conditioned and filtered to at least MERV 14. Cook kettles may be a source of humidity that could be placed under a commercial hood. Cooling and tempering of chocolates and cooling and drying of gummies/jellies have their own special considerations. And consider provide enough HVAC capacity to dry out the production room after a heavy cleaning. 

Airlocks and Room Pressurization

Airlocks and room pressurization should be planned properly based on your goals, budget and facility. The MIPs room pressure should be positive to all other adjacent rooms: washroom, pantry, extraction, corridors, lab. There are a wide variety of approaches to airlocks, from a pharma approach with air showers down, to just a door with sufficient air supply to the production room to ensure that it is always positive to the adjacent hallway.


Check Out These Related Articles for More Top Things to Consider When Planning:

Part 1 – Cannabis Cultivation Facilities
Part 2 – Cannabis Extraction Facilities
Part 3 – Cannabis Food Production Facilities
Part 4 –Cannabis Retail & Dispensary Facilities
Part 5 – Cannabis Facility Support Areas

Member Blog: Hard to Get – Why Disposable Gloves are Scarce and Pricey

by Steve Ardagh, founder and CEO of Eagle Protect

Disposable gloves are standard issue for the medical, food, and yes – cannabis industry. But thanks to COVID and subsequent disruptions in the supply chain, the market for procuring disposable gloves has gone from routine to challenging. In fact, the demand for quality disposable gloves has skyrocketed, more than doubling since the global pandemic’s arrival, thereby creating an unpredictable cycle of availability. Demand for single-use gloves is expected to continue increasing in the coming years, as the health and safety of workforces across multiple industries – including medical, food, and cannabis-related operations – are required and dependent upon their usage.   

Let’s examine the factors that have made disposable gloves both scarce… and pricey, as of late.

Global Glove Origination

Approximately 99% of all disposable gloves are manufactured in southeast Asia, most notably Malaysia and Thailand. But for these regions, compared to the U.S., lockdown to prevent the spread of COVID infections has a much more literal meaning. The restricted movement, as well as outbreaks, led to output at 60% of its normal capacity. In addition, most experts agree that there’s clearly a shortage of workers – many of whom were immigrants affected by travel restrictions. It’s estimated that an additional 25,000 workers are needed to restore full production capacity.

Supply and Demand

As the demand for disposable gloves increased globally, it put added stress on manufacturers and the supply of raw materials, driving up prices tenfold compared to pre-COVID levels. Though glove costs have recently dropped, prices have not reached pre-COVID levels.

Cost of Gas

The raw materials of nitrile gloves are primarily petrochemical based, subject to the volatile price swings in the oil and gas industry. Combined with the tenfold increase in shipping costs, disposable glove prices are not likely to continue dropping.

Labor Violations

In the midst of this price spike, one of the top importers, Malaysia’s Top Glove, the world’s largest glove producer, was banned from importing gloves to the U.S. from July 2020 to September 2021, due to conclusive evidence of forced labor. However, this ban did not extend to other countries.

Knockoffs

When the pandemic nearly doubled the demand for disposable gloves and other PPE components, several new manufacturers with little to no industry experience, assisted by dealers with nothing more than a financial incentive, flooded the market with cheap, counterfeit, and reject-quality gloves. Spotting these unscrupulous suppliers can be done by looking for a few common signs, as they’re often given away by their offering of discount or wholesale pricing, especially in bulk. It’s estimated that the market has already absorbed an influx of gloves of a defective and dangerous quality.

Safeguarding Your Operation

Currently, poor quality gloves continue to flood the disposable-use market. In business, it’s human nature to seek the lowest price for inventory, but saving a little now may cost you dearly on the backend. Cost is obviously important, but consistent quality will keep you from having to replace gloves that rip and tear too easily. When sourcing disposable gloves, seek reputable suppliers – those who have a clear ownership origin, quality web presence and active social media accounts. Taking it a step further, you can inquire about factory audits and HACCP compliance certifications. The cannabis industry has already dealt with at least one recall due to glove contamination. And recalls can have negative financial and brand ramifications. Lastly, always remember when dealing with a new vendor – you can conduct your own product trial before ordering.


Steve Ardagh, “The Glove Guy,” is the founder and CEO of Eagle Protect, a disposable glove supplier dedicated to the responsible sourcing of quality products that ensure customer safety and impact reduction, ultimately mitigating customers’ risk. Eagle Protect is the only global PPE supplier that is a Certified B Corporation, a designation that a business has met the highest standards of verified performance, accountability, and transparency. He can be reached at steve@eagleprotect.com

 

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 

 

Equity Member Spotlight: YS Cannabis Delivery Services

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.

Originally from Ecuador, Yadira Elizabeth Silva Leon, I came to the United States when I was only 16 years of age. I graduated with honors from Sheridan High School and Arapahoe Community College in Colorado. Then I graduated from the American Intercontinental University online, with a BA in Business Administration. I own my construction clean-up company, officially named YS Construction Clean Up Services.

As a single mother of two and minority business owner, I started to become more involved in the world of cannabis after two separate accidents, leaving me with a damaged spine. Doctors prescribed medications and pills that began to damage my nervous system and I started to lose sensation in my legs, inhibiting me from taking care of my children. It was around this time that Colorado legalized cannabis, and after becoming legally accessible, I decided to take advantage of the medicinal benefits of cannabis to calm my pain. Cannabis inspired me to begin a new career in the cannabis industry. Serving people who are in pain by bringing their medicine in the comfort of their home in a timely fashion became an interest and passion of mine. 

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

The health and safety of our patients, customers, and employees is our top priority. We see the future where our company impacts the wellbeing of our drivers and the life of our planet. That is why YS Cannabis Delivery Services was created. 

We specialize in transporting cannabis products business to business and business to customer. We also collect empty containers from customers to recycle properly, and return clean, disinfect, and sterile containers for businesses.

What is your goal for the greater good of cannabis?

Securing the life of carriers, and our environment. We are working on a new security system where we use AI (Artificial Intelligence) and VR (Virtual Reality) to deliver cannabis from business to business with efficiency and security. While we are expanding security to protect cannabis shippers and vehicles against prohibited intrusions, we are also making sure plastic containers get to the right place and be recycled properly. 

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

COVID-19 created many challenges for most industries, but the cannabis industry faced more threatening challenges such as violence and robbery. What we would like to see is the safety of cannabis employees become a priority. That is why we are looking into virtual reality as a security measure. 

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 the National Cannabis Industry Association to collaborate in the development of my company at a national and international level. Because of NCIA, I was able to receive access to the resources my business needed to grow and thrive. I was able to speak with leaders, consultants, and other like-minded professionals. 

 

Member Blog: Stickier Products Need Thicker Gloves, Right?

by Steve Ardagh, Eagle Protect CEO

“My gloves keep ripping” is a common frustration we hear from cannabis businesses, especially growers and processors. If your gloves are ripping just buy thicker gloves, right? Maybe. It is a common misperception that thicker gloves are stronger, but this is not always the case. Here are four factors about glove thickness to understand that will help solve this chronic glove problem.

4 Things to consider before buying a thicker glove

  1. Thicker does not mean stronger – A glove’s strength is directly related to the quality of materials used to make it. Period. A glove’s raw material ingredients account for 45% of the production cost. Gloves can have fillers, like carbon black, silica and chalk, added to manufacture them cheaper. Chalk doesn’t stretch. When fillers are added to reduce production costs, the glove’s durability and elasticity will reduce as well.

In one minute, this video shows how to estimate the quality of your nitrile gloves. When buying disposable gloves, always remember, a gloves’ strength is directly proportional to the quality of ingredients used to make it.

  1. Musculoskeletal issues – Low-quality, thicker gloves have less elasticity which in turn makes workers’ hands use stronger muscle force, increasing the chance of injury. For example, a worker’s hand could have unnecessary force put on it with every hand movement they make while bucking or trimming the plant. A disposable glove needs to be of a high enough quality to perform the task and protect the product and the wearer, but excessive thickness can create additional issues. A better-made glove can be thinner while outperforming cheaper, thicker gloves.

  2. Worker efficiency – Despite its thickness, a glove made with lower quality ingredients will rip more frequently. When your staff is constantly having to stop working to change failed gloves, productivity decreases. When workers are busy changing failed gloves they are no longer planting, growing, harvesting, trimming, or curing. Gloves that perform will increase overall productivity and efficiency, not to mention worker satisfaction.

  3. Increased waste – Another possibly less considered consequence of buying thicker gloves is the environmental impact. Glove thickness directly correlates with the amount of waste, disposal costs, and environmental impact generated. A thicker glove equates to more material per glove being disposed of. A glove made of cheap ingredients that fails more frequently will also negatively affect a businesses’ sustainability efforts by increasing the overall quantity of gloves used. Generating more waste will in turn increase disposal costs and the amount of waste that ultimately is put into landfills.

Cannabis plants can be prickly, sticky, and sometimes relatively tough on disposable gloves. A better glove is needed. A better glove, not necessarily a thicker glove. Additionally, different stages in producing cannabis products, from growing to harvesting to processing to tinctures to edibles, can require different gloves. A single glove most likely will not live up to the performance and safety requirements at the various stages. The best way to know you’re buying a quality glove is to purchase from reputable suppliers with specific and ongoing quality control procedures in place. This ensures glove quality, performance and protection, all of which directly mitigate risk to your product and business.

Trustworthy and knowledgeable glove suppliers will be able to help arrange glove trials through which you will be able to determine the best glove to use for every task. Purchasing too heavy of a glove for a task increases costs unnecessarily. Investing the time into ensuring you are sourcing the correct gloves will protect your product, workers and budget.

Disposable gloves are not indestructible. Some tasks, like harvesting and trimming, do require a thicker glove even when they are made of the highest quality. But simply put, a thicker glove spec is not always the answer to a sticky situation.


Eagle Protect, the world’s only glove and PPE supplier to be a Certified B Corporation®. Eagle Protect supplies disposable gloves and protective clothing to the food processing, food service, cannabis, medical and dentistry sectors in both the U.S. and New Zealand.

Eagle is implementing Delta Zero, a proprietary third-party glove analysis program to ensure a range of their gloves are of consistent high-quality, and free from harmful contaminants, toxins and pathogens. The Delta Zero program mitigates the risk of product contamination and recall due to the unknown use of dirty gloves. 

After establishing Eagle Protect as an industry leader in New Zealand, where the company supplies approximately 80% of the primary food processing industry, Steve Ardagh relocated with his family to the U.S. in January 2016 and launched Eagle Protect PBC. Steve brought with him Eagle’s values of providing products that are certified food safe, ethically sourced and environmentally better. Steve is driven to keep consumers safe, one high-quality disposable glove at a time, and has been instrumental in developing Eagle’s proprietary third-party Delta Zero program glove testing program.

 

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: What Every Cannabis Company Needs to Know About Compliance Now

By Nicole Cosby, Chief Data & Compliance Officer at Fyllo

Two Thirds of Companies in Highly Regulated Industries Such as Cannabis Say Compliance Is Key Barrier to Growth

Not long ago, the role of the General Counsel with regard to compliance in highly-regulated industries was largely about setting up sensible guardrails. The job was to ensure a solid approach focused on good reporting, defensible “best-effort” internal practices, and a rock-solid audit trail. The words “compliance” and “growth” wouldn’t be used in the same sentence.

However, according to a study Fyllo recently completed in partnership with The Harris Poll of more than 300 compliance leaders, nearly two-thirds of heavily regulated companies agreed compliance was the critical factor blocking growth. In fact, compliance issues ranked as a bigger barrier than having the right strategy or even capital to fuel growth. This belief was shared by companies as small as local cannabis start-ups managing rapid growth and global banks with deeply-experienced compliance leaders.

One of the biggest factors cited by compliance professionals is the inability to adapt quickly. Nearly two-thirds (61%) did not believe their organizations could adapt quickly to sudden changes in regulations, with 28% pointing to outdated technology as the cause.

Patchwork Legislation is a Significant Pain Point

When taking a look even closer, managing regulations across jurisdictions is a significant pain point for compliance professionals, with 76% citing that decentralization of regulatory information is a challenge. The majority of professionals discussed how complicated it is to decipher between local and state laws. More than half of respondents (51%) even went as far as to say that the number of regulations their organization needs to keep on top of is unmanageable. Moreover, the dynamic nature of regulations even has these leaders questioning their own compliance. 

For cannabis operators, even basic functions of marketing and advertising are so restricted by location that it would take a literal army of compliance officers to humanly tackle the problem on a day-to-day basis.

Among companies in highly regulated industries, data for privacy regulations (59%), product-related regulations (45%), and marketing or advertising-related regulations (44%) are the three most common areas where regulatory or compliance issues are the most difficult to balance with business processes.

What risks must General Counsel (GCs) guard against?

Growth risks Market expansion and innovation may be constrained
Opportunity risks A lack of awareness of pending regulatory shifts that may open new opportunities may leave your company unable to respond quickly enough
Reputation risks Companies with a poor track record may face harsher scrutiny from the government. In cannabis, this might make obtaining new licenses in new geographies slower and more difficult
Revenue risks Every compliance misstep risks delays in products getting to shelves, or worse, requiring product to be destroyed. Every delay and loss of product results in lost revenue.
Cost risks Keeping up to date with ever-changing regulations is costly and difficult, particularly for understaffed compliance departments

Compliance Missteps Go Beyond Financial to Reputational

While compliance citations have become the norm, with companies being cited on average 12.6 times for noncompliance over the past five years, the ramifications of those missteps reach far beyond fines.

Nearly two-thirds (73%) say that key stakeholders like consumers, employees, and regulators have lost trust in a company due to compliance issues, and almost half (49%) say it results in higher costs to attract new customers and investors.

Use Technology to Turn Compliance Into a Competitive Advantage

The emphasis on growth demands a different approach that encompasses both defense and offense. Fast-growing companies need to access new markets, develop innovative new products, and challenge the status quo — all while managing the challenges of dealing with an ever-changing patchwork of state, local, and federal legislation.

Compliance professionals need to redefine their compliance roadmap based on real-time intelligence which should take into account federal, state, and local laws and ordinances. In fast-paced, highly-regulated industries, the winners are the companies who know more and know it sooner. Leveraging technology can help.

Once GCs recognize that a compliance suite does much more than just protect a company from citations, they can begin to understand the true cost of non-compliance from a financial, operational, and reputational perspective, giving them a leg up in today’s most challenging regulatory environments.


Nicole Cosby, an attorney and ad tech executive, has an impressive background in digital advertising/data policy, brand strategy/licensing, and business alliance development across the advertising, media, fashion, and entertainment industries. After earning her bachelor’s degree at Tufts University and her JD law degree from Howard University, Nicole entered the fashion field in New York, working in licensing and business affairs for Donna Karan, Phat Farm, Anne Klein, and the Jones Apparel Group. 

Prior to joining Fyllo, Nicole was senior vice president, standards, and partnerships for Publicis Media. She has also held director-level posts in product management, ad product marketing, and partnership development for AOL, Kai Communications, and BET Networks. Previously named one of Cynopsis Media’s Top Women in Digital, Nicole received the Facebook/PMX Marisa Marolf Strength Award and earned a place in Campaign Magazine’s Digital “40 Over 40” for 2019.

The Fyllo Compliance Cloud is a suite of software and services that enable organizations to navigate today’s ever-changing regulatory landscape, streamline compliance and scale with speed. Mainstream brands also use the Fyllo Data Marketplace to target previously inaccessible cannabis and CBD consumers.

Video: NCIA Today – Friday, October 8, 2021

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

Committee Blog: Don’t Wipe Out – Riding the Wave of Cannabis Standardization

by NCIA’s Facilities Design Committee

Staying ahead of the quick rollout of state, national, and international cannabis regulations is a huge and complex challenge. The patchwork of more than three dozen (and counting) different state regulatory regimes remains disconnected as cannabis remains federally illegal as a Schedule I drug. The framework of regulations and standards that guides allied sectors such as Foods, Dietary Supplements, Pharmaceuticals, or Tobacco is just beginning to take shape. Where do you look for guidance? How do you choose how to invest, how to design your operation, and how to produce?

There are a number of considerations and industry-relevant organizations to become familiar with when looking to conduct business in the cannabis space. In doing so, businesses can operate more successfully and mitigate risk. Risk should not be underestimated – many cultivation and manufacturing facilities will fall seriously short of the expectations of agencies such as the Federal Food and Drug Administration (FDA), Occupational Safety and Health Administration(OSHA), the Environmental Protection Agency (EPA), if risk, both business and consumer health and safety, is not considered upfront. Market pressures will build quickly as brand-savvy companies with significant capital and operational expertise enter the field. One way to avoid wiping out – is looking to national and international standards, guidelines and regulations already in place. For a comprehensive list of relevant standards regulatory bodies, refer to our recent blog post here.

As standards continue to be developed by industry experts for adoption by regulators, businesses can be empowered to run their operations with more predictability and reliability knowing that they demonstrate compliance with approved industry guidelines. Laboratories will have access to valid test methods and reference materials. Equipment specifications will require globally accepted certification marks or labels (such as CE or UL) which ensures safety and longevity of operations.

What is the cost of not adhering to established standards?

A simple batch loss can easily exceed tens of thousands of dollars of lost product, let alone the damage to your brand, labor costs surrounding rework, and relationships with your clients. Crop and batch losses due to subpar equipment sourcing, processes that are not validated, and worse – risk of fines or losing your license are all symptoms of a business lacking standardization.

Credible standards – they are data-driven, go through a rigorous and transparent process. In most cases, these standards were developed with input and guidance from federal and international regulatory agencies.

Here is the snapshot today. Read it fast, because it may be out of date next month: 

The NCIA has several relevant committees sharing best practices and developing guidance for our industry.

ASTM International, one of the oldest and most recognized Standards Development Organizations (SDO) formed Committee D37 on Cannabis in 2017, and has already approved over 25 standards that provide guidance on key areas such as: 

AOAC International, another 100+ year old SDO has a Cannabis Analytical Science Program (CASP) where cannabis standards and methods have also been developed – principally in the area of product standard method performance requirements (SMPRs) and methods of analysis such as:

You don’t have to put your business at risk of wiping out! The resources that NCIA Committees continue to create have your best interest in mind. Stay tuned to ensure you have the latest resources and guidance!

Video: NCIA Today – September 10, 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 on Facebook for NCIA Today Live.

 

Committee Blog: Successful Retail Outcomes of SAFE Banking

By NCIA’s Retail Committee

Have you ever wondered where or how a cannabis retail business banks? You should know that it’s complicated because of federal prohibition. So what do you do? Some are finding workarounds and loopholes, others are able to obtain services with smaller financial institutions for exorbitant costs, while many others struggle to maintain an expensive, risky, and dangerous cash-only ecosystem.

The 2020 elections set the creation of four new regulated state cannabis markets in motion, and four more state legislatures followed suit in the first half of 2021, making the last year arguably one of the most consequential and momentous periods for the cannabis industry and policy reform.

However, cannabis is still illegal at the federal level, classified as a Schedule I substance under the Controlled Substances Act, despite state-level regulated cannabis markets in more than half the country. This prevents banks from doing business with cannabis companies because of fear of prosecution or reputational risk, as these businesses aren’t viewed as legal under outdated federal laws.

The cannabis industry is optimistic about the future, though, thanks to an increasing interest in cannabis, public safety, and economic development in Congress. Lawmakers in both chambers are actively debating comprehensive legislation to remove cannabis from the schedule of controlled substances and regulate it federally while repairing some of the harms caused by prohibition, but there are also incremental reforms in play that have a track record of success in the House as well as bipartisan support. Chief among them is the Secure and Fair Enforcement (SAFE) Banking Act, which would provide safe harbor for financial institutions that wish to work with state-legal cannabis businesses and allow them to provide services to the industry without fear of prosecution. This legislation originally passed the House in 2019 and was the first piece of standalone cannabis policy reform legislation ever to receive a vote or be approved by a full chamber vote.

Since then, cannabis banking has been approved in the House three more times in various forms, mostly recently when it passed the SAFE Banking Act again – and with record bipartisan support – earlier this year. The bill is now awaiting consideration in the Senate, but has yet to be taken up by the Senate Banking Committee. 

So, what does the SAFE Banking Act mean for retail cannabis businesses?

Loans, capital markets, and credit card processing are common interests for cannabis companies. Access to traditional lending is particularly important for small businesses that usually lack connections to angel investors and venture capital. However, some of the benefits of this legislation are of special interest to cannabis retailers. Check out what some of the Retail Committee members are considering to be important aspects of broadened access to banking and financial services:

Safety 

“As a retail cannabis business operator, safety is of our top priorities as it directly affects our staff, our patrons, and our bottom line,” said Larina Scofield, director of retail operations at Lucy Sky Cannabis Boutique dispensary chain in Colorado and vice-chair of NCIA’s Retail Committee. “We are required to operate as a predominantly cash business in a high-risk industry that can sometimes lead to criminal targeting; this can put not only our business at risk but also the potential individuals on-site if a targeted crime were to take place. 

“There is also no doubt that operating a cannabis business is costly, due in part to the fact that we do not receive the same benefits and protections that other businesses have; cannabis companies are also subject to higher fees in order to get similar services, if those services are available at all. Lucy Sky is fortunate enough to have banking and armored services, as well as a cashless ATM service to allow for safer money handling, but this does not come without a price… a high price. Our company pays top dollar every year in order to have banking and secured payment delivery (something that is not seen in traditional businesses), in order to provide safety for our business and to the individuals who frequent our facilities.

“SAFE Banking would mitigate that and allow for retail cannabis companies to operate without having to “constantly look over their shoulders” so to speak. It would provide an enormous sense of security in an already high-risk business, it would allow for small business owners to receive proper funding to allow for safer operations, and it is truly crucial in the progression of the industry as a whole.”

Less Cash on Premise 

“Less cash during COVID-19 is always a plus. The goal is to limit contact, and we all know cash is constantly being passed from person to person. There are plenty of studies highlighting how many germs really are on physical cash. Researchers found plenty of questionable microbes on $1 bills in a more recent study. In a world where we are all concerned about our physical health, the time is now to reduce physical cash in cannabis businesses. Or at least, give people the choice to go cashless if they want to. Let’s also not forget the security benefits of carrying less cash on the premises”, said Byron Bogaard, CEO of Highway 33, a cannabis dispensary in Crows Landing, California, and chairperson of NCIA’s Retail Committee.

Contactless Delivery for Retail

“Golden State Greens had a spike in deliveries during the COVID pandemic but were still forced to collect cash and signatures from customers. When online orders can process card transactions we can make a true contactless delivery where both payment and signature are managed from the customer’s device. This will increase the safety of our drivers by maintaining safe distancing practices and allow new types of deliveries to drop boxes or to customers’ homes similar to Amazon,” said Gary Strahle, chief growth officer for California dispensary Golden State Greens.

Beyond these major issues, there are a number of potential outcomes that could impact retailers as well.

Revamping the relationship between cannabis businesses and banks will likely trigger higher competition for banking services, resulting in lower fees. This would clearly benefit small businesses but could also have an impact on the frequency and nature of mergers and acquisitions in the cannabis space.

Regulatory frameworks will certainly change, and outstanding litigations will most definitely become more complex. Chargebacks from credit transactions will be a constant problem, due to the level of surveillance and data collection they will more easily be disputed.

Better access to banking also positions technology companies for success, as there will be a high demand for mobile wallets, online ordering, and automatic recurring memberships. We can’t predict everything, and there might be more hurdles to cross than we realize, but the technologically-agile retailer may benefit most. Studies show that most of the Top Fortune 500 Companies use software platforms such as Salesforce to manage their enterprise, however many of the canna-specific solutions are missing much of the integration and scalability needed to immediately handle broadly increased access to the banking system.

Speak your voice.

The SAFE Banking Act is critical to the cannabis industry’s success, and your voice will tip the scales. Reach out to your members of Congress, especially your Senators, and tell them what safe banking means to you as a cannabis retailer. Remember, policy needs to support logic over emotion. Emotions are important, but remind Senators of the logic behind implementing safe banking solutions for cannabis businesses: 

  • Reducing the risk of robbery & theft with less cash on the premises 
  • Supporting the demand cannabis businesses receive, which in turn supports the local and national economy and helps minimize the unregulated market
  • Reduce pathogen transmission by limiting physical cash transaction

If your senator already supports the SAFE Banking Act, please politely ask them to prioritize this legislation in the current session.

Member Blog: “Food Safe” Gloves Cause Cannabis Recall

by Steve Ardagh, CEO of Eagle Protect

A pesticide-free cannabis producer and processor from Washington was recently forced to issue a recall after the chemical o-Phenylphenol (OPP), traced back to their “food safe” gloves, was found on its products. OPP, listed under California Proposition 65 as a chemical known to cause cancer, was found in the food-safe gloves they were using to handle their crop.

In a statement announcing the recall, the company said, “Nothing ruins your day like testing your product, confident it will be clean, only to find it contaminated with some crazy, toxic chemical. The gloves were the last thing we tested, we just never imagined something sold as food safe could transfer such nastiness. The discovery was just the beginning… recalls are costly in more ways than one.”

Why “food safe” gloves can cause a recall

After initial approval, non-sterile FDA compliant food grade gloves are not subject to ongoing controls to ensure the reliability and consistency of raw material ingredients or quality processes during manufacturing. Opportunity exists for glove manufacturers to use cheap raw materials which lower glove durability and can introduce toxic compounds, which can transfer not only to products handled but also to glove users. 

Demand for lower costs from the end-user pressures glove manufacturers to sacrifice quality, and substitute other compounds to meet these demands. This can include increased levels of cyanide, fungicides, inexpensive phthalate plasticizers, or others on the Prop. 65 list of chemicals known to cause cancer.

Steve Ardagh, CEO of Eagle Protect, a specialist glove supplier explains, “People assume ‘food grade’ gloves are clean and toxin free, but that’s not necessarily the case. The actual FDA Compliance does not even require gloves to be tested clean or sanitary which surprises most people. Having tested 25 different brands of gloves, we’ve found everything from feces, fungicides, Staphylococcus, yeast, and mold,” says Ardagh, “due to putrid water sources and unhygienic manufacturing conditions.” 

Recalls & brand reputational damage

Single-use gloves, even those FDA compliant, can be a risk to product recalls and brand reputation. Peer-reviewed scientific studies have identified harmful toxins and contaminants in and on single-use gloves. These “food handling” gloves pose risks for companies producing consumer products, especially in industries such as organics and cannabis whose products must be clean if tested. 

Staff & consumer risks

In addition, staff wearing contaminated gloves are at risk of absorbing toxins, as are the consumers of products contaminated by gloves. The contaminants have often been identified as causing cancer, and reproductive and hormonal damage.

Mitigating glove contamination risks

Gloves are often purchased with little thought or foresight into their risks. Cost is commonly the determining factor in their procurement decision-making. However, sourcing gloves from established companies who partner directly with glove manufacturers to ensure consistent quality is essential for all cannabis companies. Gloves may seem trivial, but can cause fines up to $200,000, put consumers and staff at risk, and damage brand reputation. 

This is especially important currently in the post-COVID world as the glove market is being flooded with counterfeit and reject quality gloves. The new glove suppliers, traders, and brokers who came into the COVID PPE space with little or no experience, with an intention to simply trade and make quick money, are now bailing out of their poor quality junk gloves and dumping them into the U.S. market. Consider the following before purchasing gloves:

Is your glove supplier reputable, with a long history of glove sourcing direct from the manufacturer and proven quality control processes in place?

Can your glove supplier ensure your glove quality is consistently high through documented factory audits, HACCP compliance certifications and quality processes?

Have you undergone a commercial trial of products prior to committing to purchasing to ensure glove quality is consistently high?


After establishing Eagle Protect as an industry leader in New Zealand, where the company supplies approximately 80% of the primary food processing industry, Steve Ardagh relocated with his family to the U.S. in January 2016 and launched Eagle Protect PBC. Steve brought with him Eagle’s values of providing products that are certified food safe, ethically sourced and environmentally better. Steve is driven to keep consumers safe, one high-quality disposable glove at a time, and has been instrumental in developing Eagle’s proprietary third-party Fingerprint Glove Analysis glove testing program.

Eagle Protect, the world’s only glove and PPE supplier to be a Certified B Corporation®. Eagle Protect supplies disposable gloves and protective clothing to the food processing, food service, cannabis, medical and dentistry sectors in both the U.S. and New Zealand.

Eagle is implementing a proprietary third-party glove analysis to ensure a range of their gloves are of consistent high-quality, and free from harmful contaminants, toxins, and pathogens.

Committee Blog: Safety – Terpene Limits in Cannabis Manufacturing

by NCIA’s Cannabis Manufacturing Committee

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

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

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

Inhalation

Bioavailability 

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

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

General Guidelines

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

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

Terpene Limits 

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

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

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

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

Ingestion

Bioavailability 

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

General guidelines 

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

Terpene Limits

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

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

Product Lime Terpenes

Average Max (ppm)

Orange Terpenes 

Average Max (ppm)

Grapefruit Terpenes

Average Max (ppm)

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

 

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

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

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

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

 

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

Topical

Bioavailability 

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

General guidelines  

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

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

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

Terpene Limits 

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

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

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

 

New Risk Management and Insurance Committee Manual: Introduction to Cannabis Insurance

The cannabis industry is one of the fastest-growing industries in the U.S., maturing at more than 25% annually. As the cannabis industry continues to emerge and flourish from state to state, there remains uncertainty as to the immediate future of federal legislation to remove cannabis from the schedule of controlled substances.

The cannabis industry will continue to experience the convergence between state and federal government regulations until a uniform regulatory and compliance framework can be established. Fundamental services such as banking, financing, and insurance, along with IRS 280E tax regulations, will continue to burden state-regulated cannabis businesses. And, with the industry still in its relative infancy, emerging and shifting regulatory backdrops create risks to these businesses. 

Cannabis businesses can manage these risks in a variety of ways. Perhaps the foremost among them are the procurement of appropriate insurance coverage. While just a few years ago, insurance coverage options for cannabis operators were incredibly limited, today there are dozens of insurance carriers serving the industry .

Cannabis operators have to be proactive in developing a risk management program that conforms to local and state compliance and security requirements. As the industry continues to evolve, we will need to be more diligent in controlling and managing risk.

To assist with this process, NCIA’s Risk Management & Insurance Committee (RMIC) is pleased to provide the first in a series of Insurance Manuals that will help guide you through the various coverages and definitions used in the cannabis insurance industry. This first edition of the RMIC Insurance Manual will outline the basic and entry level knowledge base for the cannabis insurance industry, and explore the various insurable risks attributed to the cannabis supply chain. Future additions will dive deeper into more specific insurance topics.

NCIA’s Risk Management & Insurance Committee is a multidisciplinary group of risk management professionals convened to draw on expertise and experiences of professionals dedicated to the cannabis community. Primary contributors for the first installment of the Insurance Manual include:

DOWNLOAD THE MANUAL

Eric Rahn, S2s Insurance Specialist

Shay Gilmore, Shay Gilmore Law

Adam Patt, iCann Insure, LLC               

Mathew Grimes, Grimes Law Group LLC 

Sandra Sheils, Safety Equation

Jason Horst, Horst Legal Counsel 

Summer Jenkins, Cannasure Insurance 

Doug Esposito, Owen Dunn 

Christopher Payne, CLIC Risk Retention Group, Inc 

Cimone Casson, Cimone Casson, LLC 

Jim Gerencser, Nationwide Auto Services 

Merril Gilbert, TraceTrust 

 

Committee Blog: Cannabis Auto Insurance – Best Practices, Claims Processes, and More!

by Jesse Parenti, Programs Director of Nine Points Strategies, Stephanie Bozzuto of Cannabis Connect Insurance Services, Matthew Johnson, Vice President of QuadScore Risk Services, and Helkin Berg, CEO of Strimo
Members of NCIA’s Risk Management and Insurance Committee

If your company has an “auto exposure” such as delivery, distribution, or employees simply running company errands, your company needs a robust risk management program.

Managing a fleet is essential to ensure drivers are given the necessary tools to be safe and responsible while on the open road. Implementing a vehicle maintenance program is also a necessary component of fleet management.

Proper automotive risk management starts with driver guidelines on how you hire your drivers and what is required to qualify to be employed by your organization. Best practices on age, driving experience, motor vehicle reports, and training make for a great start. Even though your employees may think they are only delivering or transporting cannabis, they are commercial drivers, and they need to take that duty very seriously. Morbid as it may sound, death is not the worst thing that can happen…

Here are some best practices:

  1. Drivers should ideally be at least 25 years old with five years of driving experience. For the best insurance pricing and experience, you should hire drivers that are between 35-55 years old. Note that commercial drivers over a certain age will face increased pricing from insurance companies much like their youthful counterparts. Keep that 22-year-old with four speeding tickets off your policy, even if they are the business owner’s relative!

  2. Only hire drivers with squeaky clean driving records. Experienced drivers with a clean record are more likely to continue to drive this way when working for your organization. If you hire drivers with violations or points on their records, expect this level of driving to continue when working for you. Drivers don’t often change driving habits just because of their employment status. Note that age and driving records directly affect commercial auto rates.

  3. Set up an Employee Pull Notice Program or Motor Vehicle Report pull program through the DMV. A “pull program” ensures that you are aware of your drivers’ violations in real-time, whether the violations happen during or outside of work. Suppose a driver is out of compliance based on your insurance carrier guidelines. In that case, your insurer can deny a claim based on your driver’s record or violations that happened while employed by your organization, even if the violation occurred outside of work. If you are not monitoring your drivers, you would never be aware of these concerns or problems. Secured motor vehicle records (MVR) storage is also crucial to protect your employee’s personal information. Make sure you backup all your records in the cloud or a protected server network. Identity theft can happen quickly, and unprotected data will create cyber liability exposures if not protected correctly.

  4. Take cell phone, texting, or distracted driving violations very seriously. Distracted driving is the #1 cause of death and accidents since 2012 and is increasing yearly as time goes on. The NHTSA reports that an estimated 1.6 million accidents in 2020 were caused by distracted drivers too busy eating, texting, smoking, etc., to keep their eyes on the road. Suppose one of your drivers has a distracted driving violation. In that case, you can rectify it by having them take a distracted driver class to understand the gravity of such infractions. Then put that driver on probation with consistent monitoring of their MVR for 18-24 months to ensure they don’t continue to have these violations.

  5. Onboarding driver training must include how to drive defensively, what to do if you are held up for a robbery, and what to do if you are pulled over by the police. This training makes a world of difference when or if any of these take place. In addition to robust onboarding training, training needs to continue over time as safety never stops, and good practices always need to be reinforced.

Here are some examples of claims to give you an idea of what could happen to you:

  1. A large distribution company hires a driver and has them complete some training in a large, empty box truck. This training helps the driver understand how to drive and brake with a(n empty) truck. The next day the driver goes out with a full load of cannabis flower and concentrates in their truck. The driver notices that the truck is handling differently than when it was empty. A wind picks up just as the truck is taking a turn. The truck rolls onto its side and totals the box on the truck, damaging the product inside. The company could have avoided this accident had they trained their driver in real-life experiences, with actual loads.

  2. A driver is delivering cannabis to a customer’s home. While en route, the driver accidentally hits a pedestrian crossing a sidewalk on a poorly lit street. The driver did nothing wrong, but the accident still caused permanent disability to the man who was the head of the household, and the insurance company paid out over $7M. If the insured didn’t have the $10M in auto liability, they would have had to close their doors. 

You and your employees can do everything right, but accidents can and will still happen. That is why culture, safety, and accountability are essential when working in the transportation and delivery space. If you don’t take this seriously, your company will pay the price. To avoid these costly mistakes, work with your legal team, insurance providers, and software vendors to ensure ideal policies, training requirements, and data storage.

——————————————————————————————–

Nine Point Strategies is a national risk management firm specializing in all forms of commercial auto for the cannabis industry. We can help you with anything you need concerning hiring, training and maintaining all your required driver compliance you need to be a safe and profitable organization. Contact us to discuss how we can better protect your cannabis auto exposures.

QuadScore Insurance Services is the nation’s leading insurance provider for marijuana businesses. QuadScore offers comprehensive property & casualty solutions as well as a full  suite of risk management services for large cannabis companies around the United States.

The Strimo™ team is comprised of industry veterans. We are both practitioners in cannabis and long-time experts in software. We have supported companies in rapid growth and deeply understand that your software needs to grow with you. Strimo is the leading enterprise cannabis SaaS platform.

Cannabis Connect Insurance is a specialty division of Bozzuto Insurance, an insurance firm serving businesses since 1978 and part of Acrisure, LLC the 4th largest insurance brokerage in the United States. We specialize in connecting cannabis business owners with custom built insurance programs.Cannabis Connect was founded on basic principles of honesty, integrity, and trust. We are actively involved in the cannabis industry on both a local and state level. We are involved in multiple cannabis associations and continue to remain informed on policy forms and legislative changes to ensure our clients best interests come first. 

 

 

Committee Blog: The Asset We Wish We Knew Before 2020 – HACCP

by Trevor Morones, Darwin Mallard, Liz Geisleman
NCIA’s Cannabis Manufacturing Committee

Read on for insight and guidance for the vitally important topic of preventing, eliminating, or reducing microbial growth in cannabis edibles and packaging. 

It all starts with the HACCP (Hazard Analysis Critical Control Point) Principles. Gather your team to share the five preliminary steps of HACCP and develop a plan (figure 1). This management system was launched by Pillsbury along with NASA and the U.S. Army for food safety in space exploration in the 1960’s. Quality, safety and efficacy is obtainable and sustainable with the HACCP discipline. 

The objective is to PREVENT packaging from being a failure point and inhibit microbial growth in edible products. We know moisture (water activity), temperature, pH, and oxygen levels are primary microbial growth drivers. 

HACCP is an asset, not an expense. Food is medicine for some, and cannabis products are medicine for many. Resin cannabis products (RCP) must be safe, consistent, and reliable products continuously. To generate those results, learn the HACCP mindset. Practice being an advocate with HACCP discipline displaying the actions written in the programs. It’s a system for cannabis safety that encourages operations to have Emergency and Business Continuity plans before disruptive events occur, e.g., natural disasters, pandemics, etc.

  • Resin cannabis product – Any product, whether finished or a work in progress, containing or comprised of cannabis flowers or resins or both and includes, but is not limited to, the cannabis flowers and resins themselves, extracts/concentrates/derivatives thereof, and preparations therefrom.
    • And can be further classified as Adult-Use or Medicinal-Use and subclassified as Topical-Use.

Creating such a plan is important because exposure to microbes may result in allergic symptoms such as sneezing, coughing, wheezing, nasal congestion, and watery or itchy eyes. Consumers using cannabis products as medicine, such as cancer patients on chemotherapy, are even more susceptible to harm caused by microbes. Thus, it is critical to ensure your products do not have microbial growth. 

This is not only a health concern, but the financial impacts can be detrimental. How much did the February 2021 Canadian infused gummy recall cost? More than 330,000 packages of THC infused gummies, worth approximately 8.2 million Canadian dollars, were lost. Overhead costs go above and beyond. The global cannabis industry must learn from industry events such as this.

Effective HACCP management system ensures control. Empower your team through education and training on discipline of HACCP. Take the infused gummy recall from February 2021 as an example where cross-contamination, improper employee hygiene, and package permeability were failure points that led to loss of control. Lack of control during transport of the initially sterile packaging also contributes to contamination. Personal clothing worn by team members or visitors are also known sources of pathogenic fungus. 

Best practice is to address preventive controls and reducing/mitigating risks. For example, consider installing two-way humidistatic control devices in packaging, such as desiccant packs, to maintain water activity (Aw) in acceptable ranges to mitigate microbial growth. Reducing moisture prevents powdery mildew caused by Golovinomyces Cichoracearum (figure 2)

A great resource to mitigate risks can be found in the ASTM D37; Standard Guide for Cleaning and Disinfection at a Cannabis Cultivation Center; Aw ASTM Standards for Cannabis Flower: D8196 – Standard Practice for Determining Water Activity in Cannabis Flower; and D8197 – Standard Specification for Maintaining Acceptable Water Activity Range for Dry Cannabis Flower.

 Sanitary environments are critical from seed to sale.

Figure 2, Right. Powdery mildew development on leaves, stems, and flower buds of Cannabis sativa, caused by Golovinomyces cichoracearum. 2

Use the principles of HACCP to guide and maintain the integrity of your work. Each principle builds on the next to create a solid foundation to build and operate a safe and consistent management system. Establish storage conditions in your control and transport; determine the temperature and humidity for each product type (gummies do not tolerate heat, and certain ingredients are sensitive to humidity which could change the potency). This includes evaluating the stability of each of the ingredients when in final product form (how long do they remain potent). 

Depending on the ingredients used, i.e., the formulation, gummies can take on or reject water. Most typically let out the water, then that water has nowhere to go (trapped in the packaging), and the product molds. This is why commercially produced gummies are coated in wax, literally to trap the water inside the product. Inadequate gummy formulations lead to water permeability; change in cannabinoid content is the least of the concerns.

General chapter 659 on Packaging and Storage requirements published by the USP (United States Pharmacopeia and the National Formulary, USP–NF) is a great resource. Though not all cannabis products may be for the medical market, using the standards of excellence from the USP is the best way to minimize product failure and help ensure consumer safety. Packaging 659 states that packaging materials must not interact physically or chemically with a packaged article in a manner that causes its safety, identity, strength, quality, or purity to fail to conform to established requirements.

Empower your cross-functional team to apply and implement HACCP through your organization. In doing so, you will have the discipline and tools to mitigate risks and prevent costly downtime. Your consumers benefit by having safer, consistent, and quality products. Finally, collect the data and share the story. We all need to drive improvement and produce safe consistent products for our consumers. HACCP systems are a tried-and-true tool to achieve this.

Please note that prerequisite programs such as current Good Manufacturing Practices (cGMPs) are an essential foundation for the development and implementation of successful HACCP plans. This article is intended to level up your current manufacturing processes and mitigate your exposure to potential recall or unsafe products in the marketplace.

For resources on how to establish an effective HACCP system and other quality management related tools, consider adopting the best practices defined in ASTM D8250 – Standard Practice for Applying a Hazard Analysis Critical Control Points (HACCP) System for Cannabis Consumable Products and/or following the guidelines provided in ASTM D8222 – Standard Guide for Establishing a Quality Management System (QMS) for Consumer Use Cannabis/Hemp Products and ASTM D8229 Standard Guide for Corrective Action and Preventive Action (CAPA) for the Cannabis Industry.

 

Cannabis Advertising, Marketing, and Branding Restrictions are Aimed at Preventing Youth Use, So Why Are We Driving Them to Drink?

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

A Seattle Hempfest lawsuit against the Washington State Liquor and Cannabis Board asks this question.

The title for this piece was inspired by the late Steve Fox, one of the founders of the National Cannabis Industry Association and co-author of the book, “Marijuana Is Safer: So Why Are We Driving People to Drink?” Written in 2009, it questioned why we were punishing adults for choosing a safer alternative to alcohol by criminalizing cannabis use while alcohol was legal. But it remains relevant when considering the laws and regulations under which each respective industry operates.

Last week I wrote about SMS text messaging and the challenges the cannabis industry is currently facing. The industry turns to SMS (text messaging) to a large extent for marketing purposes, often connected with loyalty programs. SMS is a great way to reach someone who specifically asked to receive the marketing and has already been vetted at the store to be over 21, which is huge in an industry with so many restrictions around marketing,  advertising, and branding.

But a lawsuit currently under appeal at the Washington State Court of Appeals (having been passed down by the Wash. Supreme Court) is questioning some of these restrictions, especially when compared to the dearth of alcohol marketing restrictions. Seattle Events, who produces Seattle Hempfest, and a couple of legally licensed Washington cannabis companies brought the lawsuit against the Washington State Liquor and Cannabis Board (WSLCB) challenging some statutes and regulations that unfairly harm the industry and Hempfest by imposing restrictions around marketing, advertising, and branding that are not based on any meaningful data and are far more severe than restrictions around alcohol marketing. The differences are pretty stark when comparing the marketing rules and regulations on alcohol RCW 66.08.060 and WAC 314-52-070 with those on cannabis RCW 69.50.369 and WAC 314-55-155.

In Appellant’s Opening Brief, Hempfest and the other appellants offer convincing arguments on First Amendment grounds and broader free speech protections under the Washington state constitution for why some regulations are over-restrictive, but they also make very clear they agree that the prevention of use by youth is a valid state interest. In general, the cannabis industry is interested in keeping cannabis away from minors except for medical purposes – it’s one of the reasons we promote a safe, legal, regulated market. (To fully understand the legal arguments in this appeal, read the WSLCB, et. al/Respondents’ Brief here, and Hempfest, et al./Appellants’ Reply to the Response here.)

As more and more states legalize cannabis for medical and adult-use, and descheduling is contemplated at the federal level, lawmakers and regulators are working with the cannabis industry to craft rules and regulations around such things as marketing. State policymakers are connecting with each other to see where they can make their regulations more uniform, and federal policymakers are considering to what extent they’ll regulate marketing at the federal level on top of what the states do individually.

While these conversations are happening, it’s important to keep in mind the real-world effects these regulations have on the cannabis industry and if they’re unnecessarily more restrictive than the alcohol industry. That’s not to say the cannabis industry wants to look like the alcohol industry, being sold next to toys at Target, or mixing intoxication with driving by sponsoring NASCAR, but sometimes the industry is accused of purposely marketing towards kids for things like infused gummy candies when adults regularly use gummies to take vitamins. 

The industry needs to take control of the narrative around youth prevention, working with agencies around rational messaging and regulations. The alcohol industry has a close relationship with the state and federal agencies that regulate it. In fact, a large part of marketing restrictions are self-regulatory standards, aimed to discourage underage drinking, that are entirely voluntary. The more we as an industry can voluntarily create marketing standards, the less likely harsher regulations will need to be implemented. Cronos, an NCIA Evergreen member and a leader in the international cannabis market, recently released its own standards limiting marketing to youth, and NCIA committees frequently release standards that are best practices for the industry. 

The cannabis industry is incredibly creative, and thinking outside the box toward what appeals to adults without marketing to kids can be rewarding. The NCIA Marketing and Advertising Committee recently held a contest for best marketing around the 4/20 holiday. You can check out the webinar showcasing the best of that contest for examples on how creative we can be.

The cannabis industry wants to be a shining example of what a responsible industry can look like, that includes how advertising, marketing, and branding might interact with youth. But it is important to use real data for what actually works, come up with voluntary standards, and not put unnecessary restraints on an industry that is under enough restraint.

 

(If you’re interested in contributing to an Amicus Brief in support of Seattle Hempfest’s lawsuit, please contact Rachel.)

Member Blog: Eradicating Pesticide Use in the Cannabis Industry – Without Sacrificing Crop Quality 

By Carlos Perea, Co-founder and CEO of Terra Vera

One of the direst, yet infrequently discussed, issues in the cannabis industry is the lack of federal guidelines regulating pesticide use. Despite the adult-use cannabis market consistently expanding on a state-by-state basis, as long as the crop remains illegal on the federal level, much-needed national oversight will continue to be limited. 

The more states that legalize under a national prohibition, the more varying and convoluted state-by-state crop management regulations may become. Meanwhile, without standards firmly set in stone across the country, some cultivators have turned to hazardous chemicals to control pathogens and preserve their crop yields. Such cultivation solutions can compromise the safety of staff, the environment and, of course, the consumers. 

Health Hazards of Pesticides in Cannabis

Even when shopping at a licensed adult-use or medical dispensary, consumers today still cannot be 100 percent confident that the cannabis they are purchasing is completely safe and free of contaminants and unwanted components, such as pesticides, harmful microbials, heavy metals, and solvents. Emerging research from Colorado State University shows that contaminants in cannabis, including pesticides, “are imminent threats that directly impact public health and wellness, particularly to the immunocompromised and pediatric patients who take cannabis products as a treatment for numerous human disorders including cancer patients and those suffering from epileptic seizures.” With many consumers turning to cannabis for its health benefits, and because it’s a natural alternative to heavily processed pharmaceuticals, the cultivation process should honor cannabis’ medical use by being as safe and accountable as possible.

The pesticide issue is compounded when we think about how cannabis is often consumed: through inhalation. Additional research has shown that nearly 70 percent of the pesticides used in cultivation remain in the cannabis flower that consumers smoke. 

Even when these same pesticides are permitted in other types of American agricultural industries, this is a global anomaly. More than 25 percent of pesticides used in the U.S. are banned in other countries.

Moving Towards a Pesticide-Free Flower  

So how do we work towards a pesticide-free cannabis industry? Licensed businesses, regulators, and consumers need to band together to set standards and guidelines for pesticide use across each legal state, and eventually on a federal level. 

In 2020, Arizona took a page out of Oregon’s playbook by establishing a regulatory agency and adopting Oregon’s standards for limiting pesticide use in cannabis, setting a prime example for inter-state collaboration and accountability. Measures also need to be taken to lower the cost of testing cannabis products for pesticides and contaminants. And, of course, we need to embrace more sustainability and environmentally-minded education, and emerging technologies.

While testing does not necessarily prevent contaminants during the grow process, frequent, reliable, and standardized testing can help ensure contaminated products don’t make it to market. Unfortunately, testing requirements continue to differ by state, with some being more lenient than others. For instance, certain states only test for certain types of microbials, while others allow companies and cultivators to cherry-pick samples. This makes it easier for companies’ products to meet compliance, however, doesn’t ensure that the final products available for purchase will be safe for the consumer. Looking ahead towards inevitable federal legalization, testing requirements need to be uniform across all legal markets.

However, cultivators shouldn’t wait for federal oversight to hold themselves to the highest possible standards. There are inexpensive testing procedures currently available that cultivators can adopt before sending their cannabis products to the lab, which can help to better ensure what they are doing is working and catch a problem before it starts. 

There are also non-toxic crop management technologies available now, and in addition to seeking out vendors offering innovation-driven solutions to replace conventional pesticides, cannabis companies and their cultivators can embrace simple, preventative measures to minimize outbreaks of bio-contaminants. This includes controlling humidity at the grow site, plant spacing, adequate air circulation, and implementing a strict chain of custody throughout the supply chain. Successful prevention mitigates the temptation to turn to potentially toxic pesticides to eradicate contaminants. 

While federal legalization looms, it likely won’t happen this year. Therefore, state regulatory agencies should continue to be prepared with comprehensive outreach plans to communicate their pesticide and testing regulations to cultivators and their companies, ensuring that industry participants are fully informed. Planning and communication also sets the stage for the industry to have tried and true standards already in place by the time federal legalization does come to fruition. 

The good news is the cannabis industry has the potential to lead a paradigm shift towards a safer agricultural sector as a whole. In years past, the amount of information shared between cannabis and other agricultural industries was limited, cutting cannabis cultivators off from reliable best practices for cultivation and crop management. However, this is changing quickly. Cannabis is also pushing the envelope towards more sustainable practices, with more cultivation sites moving indoors and into greenhouses, complete with LED lighting and additional sustainable practices. Cannabis cultivators are becoming more cutting-edge and setting an example for the broader agricultural community. The industry should continue these forward-thinking approaches by embracing pesticide-free solutions on a broad, scalable level.


Carlos Perea is the CEO and Co-founder of Terra Vera, an agricultural technology company offering innovative solutions to replace conventional pesticides and increase product safety and consumer confidence within the agriculture industry. Carlos is a serial entrepreneur with a focus on the intersection of technology and social impact. Prior to founding Terra Vera, he formed MIOX Corporation, a technology company that treats water in a variety of applications and is distributed in over 30 countries. He is active as an advisor and board member with several early stage companies and social enterprises including YPO, where is he an active board member. Carlos has an MBA from the Stanford Graduate School of Business, and an BS in Mechanical Engineering from the University of New Mexico.

 

Video: NCIA Today – May 7, 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.

Committee Blog: Future-Proofing Cannabis Manufacturing Processes – Part 2

by NCIA’s Cannabis Manufacturing Committee

Despite prohibition, the cannabis industry is not behind the curve of sustainability progress. While other industries were inventing modern Cloud-based quality control/distribution systems and making stuff out of plastic, cannabis producers were maximizing yields per watt and creating stronger concentrates in attempts to get the most out of their value streams while staying under the radar. Now all industries are racing towards a more sustainable future and the cannabis industry has the opportunity to show that it can be a good example, even a leader in sustainability. Regardless if it is in preparation for competition or regulation, now is the time to start building more sustainable, energy-efficient, and overall lower footprint businesses.

As the manufacturing branch of the cannabis industry paves its way into the future, the processes involved need to be made environmentally sustainable and best practices need to be shared and standardized to ensure product safety and industry longevity. Collecting and sharing data from manufacturing facilities is the ideal way to achieve these sector goals.

Environmental sustainability is a multi-discipline effort. Experts in engineering, emissions, air quality, worker health and legal matters should be relied on for educating and guiding businesses into a more sustainable future.

The Data Vacuum Is Holding Back Environmental Sustainability Advancements

While cultivation is one of the main focuses of the cannabis sustainability effort, manufacturing procedures are also prime targets for sustainable advancements. Due to the nature of the organic chemical processes used to produce consumables, some of the materials and practices could have a negative impact on both worker and environmental health if not addressed and handled properly. As a best management practice, regulated cannabis manufacturers typically operate closed-loop systems, which greatly reduce certain dangers, but this can require other more energy-intensive systems. As these relatively new processing techniques are being pioneered, we need more data to understand how they can be made more efficient and sustainable. For various reasons — such as intellectual property concerns — advancements in sustainable practices are often not shared and therefore not visible to potentially become a standard process that ensures product and consumer safety.

Cannabis Science Outpacing Regulations

The scientific improvements for manufacturing cannabis into consumer products in high demand have outpaced regulations. From process design and equipment to processing material sourcing, the manufacturing branch of the cannabis industry has much to offer the future of sustainable cannabis products. In many jurisdictions today, regulators have hastily opted for vertical, prescriptive regulations which have left many manufacturing operations without the leeway required to innovate more sustainable process strategies. Even more businesses with the legal leeway simply do not want to push the envelope in today’s regulatory climate. More forward-thinking, regulation-savvy equipment manufacturers have begun focusing on lower energy-use in their newer products as a selling point. The industry as a whole could be making progress much faster if regulators focused on performance standards for manufacturing facilities.

Strategies inspired by building and process heat recovery offer dozens of basic possibilities when it comes to implementation in a cannabis manufacturing facility. Using the energy released during solvent condensation for solvent evaporation is a prime example. Connecting liquid-cooled equipment with the building’s central plant system is another. These are big ideas that could be implemented in different ways with different efficiencies. Intelligent use of insulation, exhaust recirculation, odor mitigation, ventilation minimization, demand-control ventilation for providing makeup air, etc. could also make significant differences. Data collected from actual operating facilities experimenting with different strategies will be the best guide going forward in determining what the best energy saving strategies are.

Cannabis Extraction Processes and Air Quality

In an effort to prevent unnecessary Volatile Organic Compounds (VOC) emissions it is important to maintain proper solvent transfer and storage, perform extraction equipment inspections, and ensure a maintained inventory and handling of solvents on site are a part of a facility’s standard operating procedures. Best practice for extraction and post-processing dictates the use of butane, propane, CO2, ethanol, isopropanol, acetone, heptane, and pentane as solvents to encourage safe consumer products.

Carbon filtration is also the best management practice for controlling cannabis terpenes (VOCs) and odor emissions. It is important to install properly engineered molecular filtration systems (aka carbon scrubbers) that are sized appropriately for a facility’s ‘emission load’ and don’t exceed the maximum cfm rating for air circulation through the filter. To prevent VOC and odor breakthrough, it is imperative to inspect and conduct regular maintenance of HVAC systems and carbon filters. A standardized method for measuring the lifespan of carbon is by using a Butane Life Test, which equips manufacturers with the data to know how to manage their carbon replacement schedule effectively, minimizing unnecessary carbon waste. Additionally, processors can conduct air sampling to detect and measure VOC and odor levels in their facilities and the data can be used to validate the impact of control technologies further protecting worker and environmental health.

Proper VOC and cannabis odor control from manufacturing processes helps reduce community odor complaints and improve neighborhood relations. It also improves public and environmental health by reducing local ozone concentrations. Proper emissions control when running cannabis manufacturing processes and handling chemicals helps to shift the industry at large toward sustainable and environmentally conscious business practices.

Preparing Your Business for the Next Stage

Cannabis manufacturers are seeing big changes on the horizon. Increased legalization brings increased competition and inevitable M&A activity. Whether a business aspires to compete on the world stage or to be acquired in one of the coming green waves, there are actions that can be taken today to help cannabis manufacturers maximize their value to both customers and potential acquirers.

One of the most important assets a company can have — both to compete effectively and to attract purchasers — is intellectual property. Intellectual property, or IP for short, is the term for an intangible asset that has been afforded certain legal protections to solidify the asset into a commodity that can be bought, sold, and licensed. IP can have a negative connotation in some circles, mostly resulting from misconceptions in the law but also rooted in IP abuses by unscrupulous “trolls.” In reality, IP is an important tool to help companies protect their hard work and, when properly deployed, intellectual property can increase transparency into cannabis manufacturing processes and open new avenues of scientific advancement.

Intellectual property broadly covers a number of different types of rights. Patents protect new inventions like processes, machines, compositions of matter, ornamental designs, and plant genetics. Patents can grant relatively broad rights to these ideas, but with substantial additional costs and scrutiny.

Similarly, copyright can protect creative works, like writings, drawings, and sculptures. But many do not recognize that copyright can also protect compilations of data that have been creatively selected or arranged. Data and algorithm copyrights are relatively nascent, but they promise to play a large role in the intellectual property landscape of the future cannabis industry.

Another sect of intellectual property, trademarks, is all about protecting a brand: the names, logos, slogans, and overall look that tells customers that a good or service is from a particular company. Federal trademark registration is unavailable for federally illegal goods and services, but that does not mean that federal trademark protection is unavailable to cannabis brands. Many companies are using the zone-of-expansion doctrine baked into federal trademark law to set up registrations on related legal products (smoking/vaping devices, clothing, and even CBD edibles) that can be expanded to cover THC products when federally legal.

The nuances and requirements of these property rights — along with other IP rights like trade secrets and trade dress — are highly fact-specific, so involve a good IP attorney to guide your strategy from the start.

Towards A More Sustainable Future

Now is the time to start building more sustainable, energy-efficient, and overall lower carbon footprint businesses and the emerging legal cannabis industry is well-positioned to be the leader. If manufacturers are incentivized to safely share processing data directly or through emerging data collection and tracking platforms, the industry will make major advancements towards more environmentally sustainable practices. Environmental impact areas, such as air quality, energy, water, soil waste, and community all need to be considered by the manufacturing arm of the cannabis industry. Regulators can help push the industry forward by reducing negative impacts in these areas though focusing on performance standards for manufacturing facilities and their processes. Lastly, understanding that IP, including trademarks, can in fact increase transparency into cannabis manufacturing processes and open new avenues of scientific advancement will help position operators for M&A activity coupled with proper legal representation. These factors work together to protect the environment and communities, as well as future-proof manufacturing operations setting up the rest of the cannabis industry for longevity and federal legalization.

 

Member Blog: 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.

 

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