Tag Archives: regulations

National Ag Day: An Interview with Industry Leaders Disrupting Agriculture in Positive Ways

By Aaron Green
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National Agriculture Day (March 23, 2021), is an annual event held by the Agriculture Council of America (ACA), a not-for-profit 501-c (6) organization, to increase the public awareness of agriculture’s vital role in our society.

The ACA believes that every American should:

  • Understand how food and fiber products are produced.
  • Appreciate the role agriculture plays in providing safe, abundant and affordable products.
  • Value the essential role of agriculture in maintaining a strong economy.
  • Acknowledge and consider career opportunities in the agriculture, food and fiber industry.

We investigated how the hemp and cannabis industry is disrupting agriculture in positive ways, from automated trimming, to controlled environment agriculture, to water conservation and beyond. We interviewed Aaron McKellar, CEO and President of Eteros Technologies, parent company of Mobius Trimmer and Triminator, Mark Doherty, Executive Vice President of Operations, urban-gro, Inc. and Derek Smith, Executive Director at Resource Innovation Institute (RII) to get their perspective on agricultural innovation.

Aaron McKellar, CEO and President of Eteros Technologies

Aaron Green: Why is hand-trimming inefficient at scale?

Aaron McKellar: Hand-trimming is inefficient at scale because it is so labor-intensive and time-consuming, not to mention repetitive and frankly boring. It’s hard to stay fully engaged as a worker trimming by hand, so the consistency of your finished product isn’t reliable with a crew of hand-trimmers.

Aaron McKellar, CEO and President of Eteros Technologies

A hand-trimmer can produce good quality trim on about 2 or 3 pounds per day. A scaled-up facility running just one Mobius M108S Trimmer can realize up to 120 pounds per hour, replacing many dozens, or even into the hundreds of hand-trimmers. The HR nightmare this presents, and all the associated costs of paying and facilitating dozens of employees (parking, washrooms, lunchrooms, PPE and gowning, etc) is simply unworkable. And that’s before COVID.

Green: How does automated trimming benefit large producers and how does the quality compare to hand-trimming?

McKellar: Not all automated trimmers are created equal. Any of the machines out there will help to reduce the need for hand-trimmers by taking off the bulk of the leaf, leaving a small team of “hand-polishers” to finish it up. The Mobius Trimmer is the only automated trimmer on the market today that leaves the technology of the original machines in the past and employs next-gen technology to truly mimic hand-trimmed quality with stunning through-put rates.

We have high-end producers using Mobius Trimmers whose own QC department cannot discern Mobius-trimmed flower from hand-trimmed flower. Hand polishing crews tend to be far smaller when using a Mobius vs first-gen machinery, and many Mobius users don’t touch up at all, instead going straight to market right out of the trimmer. For a look at how our technology differs from the rest of the field, check out this look under the hood.

Mark Doherty, Executive Vice President of Operations, urban-gro, Inc.

Aaron Green: What is controlled environment agriculture?

Mark Doherty: Cannabis cultivators understand growing indoors because, prior to legalization, they had been doing it for years in the gray market. It is by way of that experience that cultivators learned how to manipulate a highly-valuable, complex plant in an indoor setting. As cannabis legalization spread across the United States, many government regulators required that it be cultivated indoors according to strict regulatory protocols. Fast forward 10 years, and we have an industry that is keenly aware of the indoor environmental conditions required to be successful. Critical factors like heating, cooling, ventilation, dehumidification, and how to best mimic Mother Nature’s energy through lighting are all deliberately optimized.

Mark Doherty, Executive Vice President of Operations, urban-gro, Inc.

With cannabis cultivation driving the advancements of controlled environment agriculture, market and regulatory forces demanded higher efficiency, reduced energy and resource consumption, and clean crops. In most states, cannabis crops have more stringent testing than food crops. For instance, the lettuce in Massachusetts will not pass the standards for cannabis in Massachusetts. It’s through rapid innovation and technology adoptions that the cannabis industry has paved the way for lettuce to be profitably grown indoors.

Green: How can controlled environment agriculture help alleviate supply chain stresses?

Doherty: By growing food closer to the consumer, you reduce food miles; meaning, that link in the food supply chain gets a lot shorter and is less prone to disruption. Whether you have hyper small cultivation facilities on every street corner, or a larger cultivation facility geographically close to consumers, you can grow 24/7/365. Furthermore, growing locally allows for better prediction of facility output—10 boxes of greens on Monday, 50 boxes of greens on Tuesday, and five boxes of greens on Thursday. This eliminates harvesting a large crop before it is ripe and likely requiring cold storage. The controllability of controlled environment ag is that consistent, reliable contribution to the food supply chain and shortening that path to the consumer.

Derek Smith, Executive Director at Resource Innovation Institute (RII)

Aaron Green: What motivated you to publish the Cannabis H2O: Water Use and Sustainability in Cultivation report?

Derek Smith, Executive Director at Resource Innovation Institute (RII)

Derek Smith: Until this report, if you searched for cannabis water usage, you’d basically find one cited statistic. It was “six gallons per plant per day.” We knew this was from a model based on one extreme illicit market scenario. Based on the data we were seeing and the conversations we were having, this number seemed way off. So, we pulled together a multidisciplinary Water Working Group as part of our Technical Advisory Council. The objective of the Water Working Group was to establish a scientific understanding of how, and how much, water is used for cannabis cultivation so that cultivators have confidence in taking steps to be more efficient, and so that industry leaders, governments and media can be accurately informed about the range of water practices of today’s regulated market.

Green: What key points should cannabis cultivators take away from the report? What key points should regulators and policymakers take away from the report?

Smith: As the cannabis industry matures, water use efficiency will become more important, as it has for other agricultural crops. Pressures to use water efficiently will mount from multiple channels including – reducing input and energy cost, protecting the environment, meeting regulatory standards and simply being good stewards. We recommend that industry and regulators focus efforts on the following areas:

  1. When grown outdoors, water for cannabis production should be assessed like any other agricultural crop and be subject to state and local regulations that apply to other crops. Our research indicates that cannabis neither uses a massive share of water nor uses more water than other agricultural crops. Applying the same standards to cannabis as to other agricultural crops will correctly categorize outdoor grown cannabis as an agricultural crop.
  2. In areas where there may be conflict between water use for cannabis and environmental concerns, regulators and the industry should focus (1) on the timing of water use and (2) the potential of storage to mitigate environmental conflict. Our results show that in many parts of the country legal cannabis farmers have ample water storage to satisfy their needs. In areas where storage is insufficient, increasing storage should be a priority for farmers and regulators.
  3. Our research shows there are still massive differences between cannabis production techniques. As farmers continue to experiment and improve, we expect to see water use be a more important part of cannabis farming decisions and expect new plant varieties and growing techniques to be developed that increase water use efficiency. Yet more data from actual farms and facilities are needed to point the way toward the technologies and techniques that drive optimal efficiency and productivity. It is recommended that producers benchmark their performance and governments consider requiring energy and water reporting by producers. The Cannabis PowerScore can assist in these efforts.
  4. As indoor production continues to grow, especially in areas that have unfavorable climatic conditions for outdoor growing, we expect more cannabis users to rely on municipal water sources. Yet, it is unclear if municipal water suppliers are equipped to work with the cannabis industry. We suggest outreach efforts between the cannabis industry and municipal water suppliers to incentivize efficiency where possible.

Flower-Side Chats Part 3: A Q&A with Harvey Craig, CEO Harvey’s All Naturals and Co-Founder of Boot Ranch Farms

By Aaron Green
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In this “Flower-Side Chats” series of articles, Green interviews integrated cannabis companies and flower brands that are bringing unique business models to the industry. Particular attention is focused on how these businesses integrate innovative practices in order to navigate a rapidly changing landscape of regulatory, supply chain and consumer demand.

Large-scale agricultural practices can take a toll on soil health leading to inefficiencies over the long term. Harvey’s All Naturals is a Colorado-based company specializing in premium farm-to-table full spectrum CBD products. Harvey’s gets all of its hemp from Boot Ranch Farms, an off-grid sustainable hemp farm in Southern Colorado supplied by an artesian well.

We spoke with Harvey Craig, CEO Harvey’s All Naturals and co-founder of Boot Ranch Farms, to learn more about the benefits of regenerative agriculture, how he thinks about soil health, and how they produce their CBD products. Harvey started Boot Ranch Farms in 2014 after the passing of the Farm Bill and Harvey’s All Naturals followed shortly thereafter.

Aaron Green: How did you get involved in the cannabis and hemp industry?

Harvey Craig: I got involved at a very young age, as the youngest of eight kids, seven of which are boys, I was introduced to cannabis on the marijuana side first. As an engineer through the years, I’ve always been involved in creating very efficient growing systems for cannabis.

Harvey Craig, CEO Harvey’s All Naturals and co-founder of Boot Ranch Farms

In the early 2000s, I learned about CBD a little bit through experimenting with marijuana strains to help a friend who had Parkinson’s and also through the research performed by Raphael Mechoulem, an organic chemist and professor at the Hebrew University of Jerusalem in Israel. In 2014, when the Farm Bill made hemp legal, I dropped everything and went into it because I felt “this is what I need to be doing.”

Green: What is sustainable farming mean to you?

Craig: Sustainable farming to me means putting soil health and responsible natural growing practices at the forefront of all agriculture – regenerative processes for soil, in a nutshell. To me, soil health is one of the biggest problems in the United States right now. By regenerating and making our soils living, healthy and with a rich nutrient base we create an ecosystem that is good for human health and health all around.

Green: What do you mean specifically when you say, “soil health?”

Craig: Soil is living. A good natural soil has a living microbiotic structure inside it. There’s a living habitat that forms inside our soil over the years. Large scale agriculture in many cases has depleted or killed this living structure through readily accessible fertilizers and tilling practices.

Farmers understand the soil. There are practices we can undertake that are helping our living soils and helping the microbiotic habitat to thrive. Practices such as no-till technologies, rotating crops, using cover crops, not being a monocrop, responsible water use, healthy fertilizer and pesticide technologies, minimal processing, the list goes on and on…

When we talk about this thing called sustainability, I think it’s very important that we understand there are two sides of cannabis. There’s the marijuana and then there’s the hemp. We can’t put those two together – they’re governed very differently. Hemp became legal through the Farm Bill and is governed by the Department of Agriculture. Hemp is just like any other crop out there really. That means we can mix hemp in with other crops. It’s very much like corn and other crops in how it’s grown on a large scale, industrial basis.

Marijuana on the other hand is governed by each state’s regulatory commission. Those regulations make it very hard to mix in with general agriculture. So, when it comes to the marijuana side, unfortunately, it must be a monocrop. Most marijuana is grown in pots and pots are fine. However, if you are just growing in a pot and then throwing your soil away, that is not very sustainable. As it sits right now, in the marijuana industry there is really no sustainability, unfortunately. The energy use for the lights in indoor grows, for example, creates a huge carbon footprint and load on the electrical grid. I’m not trying to put indoor growing down, but that’s the way it is. The only way I foresee sustainability in the marijuana side of cannabis is to let loose a little bit on regulation and allow it to become a part of normal agricultural processes.

Green: What is it about tilling that degrades the soil quality?

Craig: When we till our soil, we’re turning the organisms in the soil up and we’re allowing the sun to dry them out. If it’s not done properly, you kill that soil structure.

Now, these little microorganisms in our soil create a healthy soil, but it doesn’t happen instantly, this takes years to create. Nobody has the time anymore, everybody’s “go go go” and “make it happen instantly”. So that gets destroyed. Now we have all these dead soils that everybody’s growing in and growers turn to factory-produced fertilizers with readily available nutrients.

When we are talking about cannabis, we can’t just look at monocropping. If you grow one crop in the same soil over and over, the soil is going to get depleted. One of the main things that we deplete is nitrogen and growing other crops, such as clover, can replenish that nitrogen. Growing cover crops protects the soil from the sun, creates nitrogen for the soil, and holds the water within the soil.

Instead of tilling, you can rotate with crops like root vegetables, radishes and other things that have deep root structures. Instead of tearing them up, just let them degrade organically and go back into the soil. Those deep root structures will also help aerate the soil.

Green: What is a farmer’s first approach?

Craig: Farmers want their land to be healthy. True farmers have a oneness with the earth and understand the earth. The farmer’s first approach keeps the farmer involved in creating new technologies for agriculture.

Green: Let’s say you’re a farmer that has land or recently acquired land that’s been industrially grown upon. How would you take that land and start fresh with a regenerative process?

Craig: The first thing you have to do is take soil samples and send them to a lab. That’ll tell you what you’re working with. Also, knowing a little history about the land helps as well. Was it used for grazing? Was it used for growing corn? What was it used for? Were organic practices used?

Then, there are many things you can do to start to regenerate your soil, but it takes time. In many situations, people don’t want to take that time. But what we’re learning is, the people and the farmers that do take that time often take a hit monetarily for the first two or three years. After that, once that structure is maintained, the natural health of the soil can be replenished. Crops will grow better, and they won’t spend as much money on fertilizers and pesticides in the long run because the microbiotic structure in the soil is creating a healthy ecosystem. When we destroy that ecosystem, it doesn’t come back easily or quickly. If there’s a little bit there, it can be regenerated with the right practices.

Green: I understand that the Boot Ranch is an off-the-grid farm. What was your motivation for either going off-grid or remaining off-grid?

Craig: I have a background in alternative energies and engineering, and when creating Boot Ranch Farms there was a lot that went into the sustainability side of it. The farm is extremely far away from the power grid for starters. So, an investment in solar for electricity was money well spent. My thought process was, why would I invest in bringing the wires in when I could actually save money and resources by creating a very efficient solar system and not be tied to the grid? Our farm is self-sustaining without being connected to any grid, which is one of the main reasons for remaining off-grid.

Green: I understand the farm is supplied by an artesian well. How do you monitor your water quality?

Craig: Well, we’re very fortunate. Existing natural water quality is one of the main reasons we decided to grow in the San Luis Valley. When you’re starting something new, you have to look at your financial side of things. Investing in a hemp farm is very different than the marijuana side because you won’t make as much money per pound of product sold. So, you have to watch your budget and not spend too much, or you’re never going to make a profit.

The self-sustaining artisanal well and water rights were existing on the property. There’s no pumping required for it and the water goes into a 10,000-gallon holding tank, where we can monitor and test for water quality. In order to water our plants, we use a pump/drip water system that supplies water to each individual plant. It’s very efficient compared to most watering systems out there, such as flood irrigation or pivots, and really doesn’t use a heck of a lot of water.

Green: Are you growing in open air or greenhouses?

Craig: We grow in two 3,000 square feet industrial-grade greenhouses at Boot Ranch Farms. Greenhouse One has all the bells and whistles including heating, cooling, light deprivation, supplemental lighting, automated controls and more. That greenhouse allows us to mimic Mother Nature a little bit. We can get up to six harvests throughout the course of the year in that greenhouse. However, in reality, we get about four.

In addition, we have a second greenhouse that is set about 100 feet away and set up to keep plants growing on mother nature’s cycle. We can move groups of mature plants to Greenhouse One after each harvest for multiple flowering cycles. Lastly, between greenhouses, we have a 10,000 square foot courtyard that’s protected with shade cloth and other things to help protect those plants from the elements. In late October, all remaining plants in both greenhouses and the courtyard become mature and ready to harvest due to shorter days created by mother nature.

Green: Do you insure your crops?

Craig: We have not. Hemp is a new industry and we have not found good crop insurance.

Green: Do you cultivate your own genetics?

Craig: We work with some other companies here in Colorado to provide genetics. Consistent genetics are extremely important on the hemp side because we need to trust that they are going to keep the THC levels down. On the marijuana side, that part doesn’t matter so much

There are different strains that have been created that I absolutely love, and I’ve tried to stick with them and stay with that seed stock. One of them is called The Wife and the other Cherry Wine. Most of the best hemp I have found is based upon the Cherry strain. People are always looking for high CBD. I’d rather have a lower CBD level in the 8% to 12% range. Something higher in the 14% to 20% range has a higher chance of producing a product with more than the legal amount of THC.

Green: Is Harvey’s All Naturals fully supplied by Boot Ranch Farms?

Craig: Yes, it is. There are a lot of things that go into a quality product and we focus on that at Boot Ranch. We’re small, not trying to compete with the large-scale market. Unfortunately, a high percentage of the products out on the market come from large-scale industrial hemp grows. We focus on long-term medicinal value and grow very high-quality hemp and we try not to degrade it in any way, shape or form throughout processing.

Green: How many square feet or acres is the Boot Ranch Farm?

Craig: Boot Ranch farm is about 260 acres. We only grow on less than three of it.

Green: What’s your extraction process?

Craig: We use cold alcohol extraction. We do not distill to separate our alcohol from the hemp oil. We use what’s called a roto vape. That cold processing preserves our terpenes, it preserves our full-spectrum cannabis oil profile and doesn’t fully decarboxylate our CBDa. We want a large CBDa percentage because there are many things that CBDa is good for when it comes to long term medicinal reasons.

Green: Are you processing your own hemp?

Craig: No, we sub that part of it out. What I’ve learned in this industry is three main parts: 1- the farming; 2- the extraction, and; 3- the product line. Those are three very separate processes and require specialized expertise within themselves. Each is a large investment and it’s very hard to do it all. I decided to work with other people on the extraction part of it. They have the expertise, and we pay them well to do what they do.

Green: Okay, great. And then any final words for Ag Day?

Craig: Support your small farmer in nutrient-rich agricultural products.

Green: Great. That concludes the interview, Harvey!

Craig: Thank you very much!

Cannabis Revival and Year of the SPAC’s: What’s To Be Expected the Rest of 2021?

By Michael Sassano
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The unusual nature of 2020 gave rise to a reciprocally roller-coaster-like cannabis market. Cannabis was cemented officially as an essential industry with the rise of COVID-19, and November elections resulted in even more United States markets welcoming medical and adult-use sales.

The stagnant cannabis stock market of 2019 became a thing of the past by the end of 2020. Throughout the course of last year, bag holders anxiously watched cannabis options creep back up. Now, nearly two years since market decline in 2019, the cannabis stock market is exploding with blank checks and buyout fever. Much of this expectant purchasing is due to Canadian companies considering U.S. market entrance. Combined with the recent surge in the use of special purpose acquisition companies (SPACs) to invest, this has led to an increase in asset prices.

A SPAC is defined as “a company with no commercial operations that is formed strictly to raise capital through an initial public offering (IPO) for the purpose of acquiring an existing company.” Though they have existed for decades, SPACs have become popular on Wall Street the last few years because they are a way for a company to go public without the associated headaches of preparing for a traditional IPO.

In a SPAC, investors interested in a specific industry pool their money together without knowledge of the company they’re starting. The SPAC then goes public as a shell company and begins acquiring other companies in the associated industry. Selling to a SPAC is usually an attractive option for owners of smaller companies built from private equity funds.

The U.S.-Canadian market questions that this rising practice asks are: Can Canadian companies enter a bigger market and be more successful? Is it advisable for U.S. companies to sell their assets to Canadian corporations whose records may be marred by a history of losses and a lack of proper corporate governance? Regardless — if both SPAC’s and Canadian bailout money is here, what comes next?

What is Driving this Bull Market?

Underpinning these movements are record cannabis sales internationally, making last year’s $15 billion dollars’ worth of sales in the U.S. look small in comparison. New markets have opened up in various states and countries throughout 2020, and that trend is only expected to continue. New demographics are opening up, especially among older age groups. This makes sense, as most cannabis sales — even in a recreational setting — are people treating something that ails them like insomnia or aches and pains.

Cannabis is set to take off, and we are entering only the second phase of its market expansion. The world is becoming competitive. Well-run companies that are profitable in key markets are prime targets for bigger, growing companies. At the same time, the world of SPACs will continue to drive valuations. Irrespective of buying assets, growing infrastructure is and will continue to be greatly needed.

The Elusive Profitability Factor

When Canada blew up, one of the biggest changes was companies began focusing the year on cost cutting and — most importantly — profitability. Profitability became the buzzword. But bigger companies are on the search for already-profitable enterprises, not just those that have the potential to be. However, profitability is currently still unobtainable in Canada. Reasonable forecasters should expect this year will show a few companies getting bailed out while many others will be forced to either merge for survival or declare bankruptcy.

An ideal company’s finances should highlight not only revenue growth, but also profitability. Attention should be focused on how well businesses are run, and not on how much money they have the potential to raise or spend. Over the years, there have been many prospective companies that spent hundreds of millions only to barely operate, and are now shells in litigation. Throwing money at any deal should have been a lesson learned in the past, but SPACs are tempting because they are trendily associated with new, interesting management styles and charismatic businesspeople.

Companies should be able to present perfect and clear financials along with maintenance logs for all equipment. In today’s day and age, books must be stellar and clean. As money pours into SPACs, asset valuations for all qualities of companies will rise. The focus instead becomes about asset plays, which will cause assets to continue rising as money is poured into SPACs.

Once upon a time, if number counters presented a negative review or had to dig too much, executives would turn a cold shoulder on investment. But in the age of SPACs, these standards of evaluation will be greatly undervalued. Aging equipment and reportability of every piece of equipment may or may not be properly serviced and recorded in a fast-moving market. Costs of repair or replacing equipment that isn’t properly maintained may be a problem of the past. Because when money comes fast, none care for the gritty details.

Issues for SPACs

Shortage of talent and training has become a big concern already in the era of SPACs. How many quality assets are out there? Big operators in the U.S. are content and don’t see Canada as an enticing market to enter. So, asset buys are likely to primarily be in the U.S. Large companies like Aphria may buy out some of the major American players, but most Canadian companies will use new funding rounds to pay down debts. Accordingly, they will then be forced to piece together smaller operators as a strategy.

A cannabis company’s personnel and office culture are very important when looking to integrate into a larger corporate culture. Remember, it’s not just the brick and mortar that is being invested into, it is also the people that run a facility. Maintaining employee retention when a deal occurs is always critical. Your personnel should be highly trained and professional if you want to exit. Easy to plug-in corporate structures make all the difference in immediately gaining from the sale or having to retool the shed and bring in all new people.

The rise of the SPAC-era and Canadian entry into the U.S. market will cause asset increases, but it is only the second chapter in the market expansion of cannabis. Proper buys will nail profitability, impeccable books, proper maintenance records and will have created an efficient corporate structure with talented personnel. The rest will be overpriced land buys that will require massive infrastructure spending. The basics of a well-run organization don’t change. The cannabis market is going to ROAR, but don’t worry if the SPACs pass you by- they are buying at the start of cannabis only.

How to Develop Quality Cannabis Products with Advanced Analytical Testing

By Vanessa Clarke, Melody Lin
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A thorough cannabis product development process goes far beyond extracting and packaging. Performing advanced analytical testing at each and every stage allows producers to know the quantity, quality and behaviour of compounds in samples. Here are the four key stages from flower to consumption.

Stage 1: Flower

Developing a quality cannabis product begins with knowing the composition of compounds in your starting material. The best analytical tests utilize a metabolomics approach. Metabolomics is a suite of techniques that include a variety of instruments to run samples through in order to receive compositional data. In this stage, LC-qTOF and GC-MS are the best instruments to track all the compounds in the starting plant material. Essentially, metabolomics establishes a fingerprint of the compounds in a plant sample. This is beneficial because producers have to understand how their chosen cannabis plant differs from other cultivars and how it would potentially behave in their desired end product formulations.

Stage 2: Concentrate

After the plant material has gone through an extraction process, producers want to know precisely what is in the extract. Are there compounds that should not be there and are all the desired compounds present? The best way to test the quality of cannabis oils is again to use metabolomics (e.g. via LC-qTOF). This test reveals all the compounds in the sample in order to help the producer determine the purity and consistency of molecules beyond just THC and CBD.

When testing cannabis isolates, it is best to use NMR spectroscopy and X-ray diffraction. NMR characterizes and assesses the purity of single compounds or mixtures in solution or solid state. X-ray diffraction provides information about the crystal structure, chemical composition and the physical properties of the cannabis sample to help the producer prove the identification of desired compounds. Establishing that the concentrates are pure and aligned with what the producer intended to extract is key in this stage of product development.

Stage 3: Formulation

Designing an appropriate drug delivery formula is a universal challenge producers face at this stage of product development. Where nanoemulsion or other carrier approaches are being used, formulation characterization allows producers to understand how their active compounds behave in simulated physiological environments as well as how stable their products are over time. Specifically, nanoparticle sizing and assessing size changes over time can help a formulation scientist ensure the highest quality product is being mixed, and that the desired effect will be imparted on the consumer/patient.

Stage 4: Smoke/Vapor

Many producers might not consider this final stage, but it is critical for all inhalable cannabis products and devices. Using a smoke analyzer and metabolomics testing can identify and quantify compounds present within the formed smoke or vapor from pre-roll joints to vape devices. This is not only important for preventing the production of toxic by-products, but it can help producers create an optimal smoking experience for consumers.

One area that is often an afterthought is quality compliance testing. Despite a number of groups using the required tests well during development, many forget to continue the same robust testing on end products. In the current cannabis product development landscape, there is little guidance on how compliance testing should be conducted on every product “batch.” With these advanced analytical tests, producers can confidently develop compliant, stable and quality cannabis products.

 

The Ten Biggest Mistakes When Building a Cultivation Facility

By Michael Burnstein
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As cannabis legalization becomes more prolific across the United States, entrepreneurs are entering the cultivation business in droves. With so many new companies entering the market and growing cannabis, there are a lot of common errors made when getting started. Here are ten of the biggest mistakes you can make when building a cannabis grow facility:

  • Failure to consult with experts in the cannabis business – poor planning in floorplan and layout could create deficient workflow causing extra time and costing profits. Bad gardening procedures may result in crop failure and noncompliance could mean a loss of license. Way too often, people will draft a design and begin construction without taking the time to talk to an expert first. Some important questions to ask yourself and your consultant are: What materials should be used in the building of the grow? Is my bed-to-flower ratio correct? How long will it take before I can see my first harvest? 
  • Contractor selection – DO NOT build your own facility; leave it to the experts. Sure, you have experience building things and you have a friend who has worked in construction. Do not make this mistake – Our experience can save you from the mistake’s others have made. To stay lucrative in this competitive industry and to maximize your products’ quality and yields, have the facility built right the first time. Paying an experienced, qualified cannabis professional to build you a facility will produce better yields and will save you time, stress and money in getting you from start of construction to your first crop.
  • Not maximizing your square footage potential – With today’s fast changing environment, multi-tiered stationary racks, rolling benches and archive style rolling racks help maximize square footage. Without the proper garden layout, you will find yourself pounds short of your potential each harvest.
  • Inadequate power – Not planning or finding out if there is sufficient power available at the site for your current and future needs. This will stop you from building the overall square footage you want. When finding a building make sure you first know how much power you will need for the size grow you want. With proper engineering you will find out what load requirements will be so you can plan accordingly.
  • Material selection – The construction material that goes into a cultivation and extraction facility should consist of nonabsorbent anti-microbial finishes. The days of wood grow benches are long gone. Epoxy flooring, metal studs and other materials are mandatory for a quality-built, long-lasting facility.
  • Hand watering – Once your facility is up and running, many people feel they have spent enough money and they can save by hiring people to water by hand, rather than going with an automated system to handle the watering and nutrients. The problem with this is your employees are not on your plants timetable. What if an employee calls off and can’t come into water at the right time or they mix the wrong amount of nutrients from the formula you have selected? These are issues we see a lot. It is critical to perform precise, scheduled watering and nutrient delivery to increase your yields.
  • Failure to monitor and automate – Automating your grow is important for controlling the light and fertigation schedules as well as data collection and is crucial to maximizing yields. Being able to do this remotely gives you peace of mind in that you can monitor your grow room temperature and humidity at all times and be notified when something is not right.
  • MedicineManTechGrowPoor climate – This can cause stunted growth, smaller harvests and test failures. Our experience has taken us to facilities that have had mold and mildew issue due to poor climate. Proper air balancing, additional dehumidification along with a proper cleaning procedure can get a facility back in working order. Installing proper climate control systems could save millions of dollars.
  • Choosing the wrong site or building – Not knowing the history of the building you are choosing to rent or buy can create logistical and monetary nightmares. The wrong site can be a distribution and marketing disaster. In the wrong building, exponentially more money is spent to bring that building up to the standards needed for successful production and yields. For example, bringing in the ceiling and the cleaning of an existing facility can be a great expense. If you do not know what you are looking at when you purchase, you may be in for months of unaccounted expenses and inaccurate timelines. This can be detrimental for companies and individuals that are on restricted timelines and have to start producing successful and continuous yields from a space that has to be converted into a prime grow facility.
  • Failure to maintain your facility – A dirty site creates an invitation for pests, workplace injuries, unhealthy working environment and equipment failure. Keeping the facility and equipment properly maintained with routine service will ensure efficiency, longevity of equipment life span and reduce mold and bacteria risk. Clean facilities = clean plants and better flower.

Mark Your Calendars: The Cannabis Cultivation Virtual Conference Returns

By Cannabis Industry Journal Staff
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On March 23, 2021, Cannabis Industry Journal is hosting our annual Cannabis Cultivation Virtual Conference. From Noon to 5 pm EST, you’ll get access to nine veterans of the cultivation market discussing a variety of topics related to the ins and outs of growing cannabis and hemp.

Hear from subject matter experts who will share their perspectives on growing organically, facility design and planning, hemp farming and integrated pest management.

Back in December during the Cannabis Quality Virtual Conference, the Cultivation Technology episode featured a session titled A Panel Discussion: Integrated Lifecycle of Designing a Cultivation Operation. Due to a large amount of interest and attendee questions that the panel did not have time to address, we are reprising this panel discussion and bringing it back on March 23.

Speakers for that panel discussion include: Gretchen Schimelpfenig, PE, Technical Director of Resource Innovation; Brandy Keen, Co-Founder & Sr. Technical Advisor at Surna, Inc; Adam Chalasinski, Applications Engineer at Rough Brothers/Nexus Greenhouse Systems/Tetra; David Vaillencourt, Founder & CEO of The GMP Collective, and Kyle Lisabeth, Vice President of Horticulture at Silver Bullet Water.

Other talks from the Cannabis Cultivation Virtual Conference on March 23 include:

  • Why CBD Companies Should Go Organic
    • Brad Kelley, COO of Socati
  • The Beginner’s Guide to Integrated Pest Management
    • David Perkins, Founder of Floresco Consulting
  • Starting from Scratch: Launching a Hemp Farm in Georgia
    • Reginald “Reggie” Reese, Founder & CEO of The Green Toad Hemp Farm
    • Dwayne Hirsch, President & Chief of Business Development at The Green Toad Hemp Farm

You can check out the agenda in its entirety and register here. Attendees will have the opportunity to ask speakers questions during the live Q&A session that follows each session. Registration is complimentary. For sponsorship opportunities, contact RJ Palermo at Rj@innovativepublishing.net

Wyoming Lawmakers Introduce Bill to Legalize Cannabis

By Cannabis Industry Journal Staff
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Update: The House Judiciary Committee has passed the legalization bill, HB0209, by a 6-3 vote. After moving out of the Judiciary Committee, the bill now awaits a floor hearing, which is expected to come within the next week or two during the legislative session that ends on April 2. 

A bipartisan group of lawmakers in Wyoming have introduced a bill to legalize cannabis in the state’s legislature. First reported by Buckrail.com, HB0209 was assigned on March 2. The bill would legalize possession, home grow and sales for adults, as well as establish a regulatory framework for licensing, tracking and taxation.

In November 2020, voters in Montana and South Dakota passed ballot measures that legalize adult use and sales of cannabis. About a month after Election Day, the University of Wyoming conducted a poll that found roughly 54% of Wyoming residents now support legal adult use cannabis. In 2018, UW found that 85% of Wyoming residents support medical cannabis legalization.

In March of 2019, Wyoming Governor Mark Gordon signed a bill into law that essentially legalized hemp in the state. That bill was a boon for the state’s agricultural economy, giving many farmers a much-needed boost in their crop diversity.

Wyoming Governor Mark Gordon

You can find the current version of HB0209 here. Sponsors of the bill include: Representatives Jared Olsen (R-Laramie), Mark Baker (R-Sweetwater) Eric Barlow (R-Campbell/Converse), Landon Brown (R-Laramie), Marshall Burt (L-Sweetwater), Cathy Connolly (D-Albany), Karlee Provenza (D-Albany), John Romero-Martinez (R-Laramie), Pat Sweeney (R-Natrona), Cyrus Western (R-Sheridan), Mike Yin (R-Teton) and Dan Zwonitzer (R-Laramie) and Senators Cale Case (R-Fremont) and Chris Rothfuss (D-Albany).

According to Buckrail, if the bill becomes law, Wyoming could get roughly $49.15 million in tax and license fee revenue in 2022. That number would mean a sizable windfall for the state that saw an 8.5% decline in tax revenue in 2020. Governor Gordon proposed budget cuts as high as 15% for agencies across the state last year. Most of the revenue generated from cannabis taxes would be earmarked for education.

Wyoming’s tax revenue is notoriously limited when it comes to diversity: the state makes its money on oil and gas, and that’s about it. Earlier this year, the Biden administration halted oil and gas leasing on federal land, hitting pause on a nearly half-million-acre deal. If the pause on oil and gas leasing on federal lands continues or were to become permanent, Wyoming stands to lose tens, if not hundreds, of millions of dollars every year.

So, what does the least populous state in the country do when they can no longer generate revenue from oil and gas? Simple. Legalize cannabis.

Navigating Compliance: Practical Application of Fit-For-Purpose

By Darwin Millard
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What is “fit-for-purpose?” Fit-for-purpose is an established best practice used in several major industries, like information technology, pharmaceuticals, agriculture and inventory management. It is a concept that aligns infrastructure and systems specifications with desired outputs – be that product, service or bottom line. When applied to a cannabis plant, its parts, products and associated processes, it can streamline regulatory framework development, implementation and compliance.

Fit-for-purpose is simply a series of logic questions you ask yourself to determine what business practices you should implement and the regulatory framework in which you must comply. What are you making? Who is it for? Where will it be sold? All this impacts how you would cultivate, process, handle and store a cannabis plant, its parts and products regardless of the type of cannabis plant. The fit-for-purpose concept is a tool that can be applied to any scenario within the cannabis/hemp marketplace. Take for instance, sustainability: a practical example would be to design cultivation standards that are “fit-for-purpose” to the climatic region in which the plants are grown – allowing any type of cannabis plant grown anywhere in the world to meet specifications regardless of the method of production.

There is no “special sauce” here. All fit-for-purpose does is get you to ask yourself: “Are the protocols I am considering implementing ‘fit/appropriate’ to my situation, and if not, which protocols are more ‘fit/appropriate’ based on the products I am making, the target consumer and marketplace in which the products are to be sold?”“Fit-for-purpose is a powerful concept that can be used for simplifying regulatory framework development, implementation and compliance”

A non-cannabis/hemp example of fit-for-purpose could be a scenario where a banana producer wants to implement a data management system into their cultivation practices to better track production and yields. There are many data management systems this banana producer could implement. They could implement a data management system like that of big pharma with multiple levels of redundancy and access control related to intellectual property and other sensitive data. They could also implement a data management system used for tracking warehouse inventory; it cannot exactly capture everything they need but it is better than nothing. Neither example is really “fit/appropriate” to the banana producer’s needs. They need something in between, something that allows them to track the type of products they produce and the data they want to see in a way that is right for them. This idea is at the core of the fit-for-purpose concept.

Applying Fit-for-Purpose

So how do we apply fit-for-purpose to the cannabis/hemp marketplace? Fit-for-purpose reduces the conversation down to two questions: What products are you planning to make and how do those products affect your business practices, whether that be cultivation, processing, manufacturing or compliance. The point being the products you plan to produce determine the regulations you need to follow and the standards you need to implement.

Growers can use it to guide cultivation, harvesting, handling and storage practices. Processors and product manufacturers can use it to guide their production, handling, packing and holding practices. Lawmakers can use it to guide the development, implementation and enforcement of commonsense regulations. This is the beauty and simplicity of fit-for-purpose, it can be applied to any situation and related to any type of product.

Growers can use fit-for-purpose to guide most aspects of their operation

Let us look at some practical examples of fit-for-purpose for cultivators and processors. Cultivators have three main areas of focus, growing, harvesting and storage, whereas processors and product manufacturers have it a little more complicated.

Cultivation of a Cannabis Plant

Growing

Requirements for growing a cannabis plant, including those that can be classified as “hemp”, should be dictated by the product with the strictest quality and safety specifications. For example, growing for smokable fruiting tops (i.e. the flowers) may require different cultivation techniques than other products. You may not want to apply the same pesticides or growth additives to a cannabis plant grown for smokable fruiting tops as you would to a cannabis plant grown for seed and fiber.

Harvesting

The next point is important – harvesting and handling requirements should be agricultural, period. Except for those products intended to be combusted or vaporized and then inhaled. Following our previous example, smokable fruiting tops may require different harvesting techniques than other products, especially if you are trying to maintain the aesthetic quality of these goods. You may choose a different harvesting technique to collect these fruiting tops than you would if primarily harvesting the seed and fiber and thinking of the leftover biomass as secondary.

Storage

When considering the products and their storage, you need to consider each one’s quality and safety specifications. One product may have a temperature specification, whereas another may have a humidity specification. You need to make sure that you store each product according to their individual quality and safety specifications. Then consider the products with the highest risks of diversion and potentially if you need to implement any extra protocols. Continuing our example – smokable fruiting tops, whether classifiable as “hemp” or not, pose a higher risk of theft than seeds or fiber and may require additional security measures depending on the authority having jurisdiction.

Processing and Manufacturing Operations

When applying fit-for-purpose to processing and manufacturing operations, first you must choose the products you want to make and specify the intended use for each product. This allows you to identify the quality and safety requirements and the potential for diversion for each good. Which in turn allows you to specify your manufacturing, processing and handling protocols for each product related to their quality and safety requirements. Then those specific products with higher risks of diversion requiring extra protocols to be put into place depending on local regulations and/or internal risk assessments, should be considered and your practices modified, as necessary.

Commonsense Regulations

Image if regulations governing a cannabis plant, its parts, products and associated processes were based on the intended use rather than a set of attributes that vary from jurisdiction to jurisdiction. It is complicated enough for regulators to think about a cannabis plant or cannabis product without having to worry about if that cannabis plant or cannabis product can be classified as “marijuana” or “hemp.” Fit-for-purpose removes this complication and simplifies the debate.

Using a fit-for-purpose approach eliminates the need to think about the molecular constituents and focuses the conversation on the intended use rather than one or two specific molecules – in this case, d9-THC, the boogie-man cannabinoid. Considering the intended use promotes consumer and environmental health and safety by allowing operators and regulators to focus on what is most important – quality and safety instead of whether something is “marijuana” or “hemp.”

This idea is what drives the real impact of fit-for-purpose. It creates a path forward to a one plant solution. We have where we are now – with “marijuana” and “hemp” – and where we want to get to – cannabis. It is all one plant with many different applications that can be used to create different commercial products. Fit-for-purpose helps bridge the gap between where we are now and where we want to get to and allows us to start thinking about “marijuana” and “hemp” in the same manner – the intended use.

Fit-for-purpose is a powerful concept that can be used for simplifying regulatory framework development, implementation and compliance. Regulations imposed on a cannabis plant, its parts and products should be appropriate to their intended use, i.e. “fit-for-purpose.” This approach challenges the confines of the current draconian bifurcation of the cannabis plant while working within this system to push the boundaries. It creates a path forward to a one plant solution and begs the question: Is the world ready for this novel concept?

Jane & Leafly Join Forces: An Interview with Socrates Rosenfeld, CEO of Jane

By Aaron Green
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As retailers accept the end of in-store shopping as we know it and start adjusting to e-commerce, an improved and more involved customer experience will be imperative for an e-retailer to grow, let alone stay afloat.

Jane recently announced a strategic partnership that combines Jane’s best-in-class product catalog and business tools with Leafly’s consumer marketplace and reach. Together, the companies will build solutions that empower cannabis retailers with fast and simple online shopping experiences that increase consumer purchase behavior. The partnership will seek to help instill consumer trust in the online shopping experience, build stronger customer acquisition tools for retailers, and help dispensaries grow their ecommerce capabilities with consistency and automation.

This strategic partnership comes after a massive year of growth for both Jane and Leafly. In the past year, Jane powered over 17 million orders and $2 billion in cannabis sales, while Leafly has seen more than 4,500 cannabis retailers in North America leverage their platform to bring new customers through the door.

Socrates Rosenfeld, CEO of Jane

We spoke with Socrates Rosenfeld, CEO of Jane to learn more about e-commerce and online marketplaces and how Jane and Leafly came together as partners, rather than competitors. Prior to Jane, Socrates was an Apache helicopter pilot for the US Army later transitioning to consulting with McKinsey.

Aaron Green: Socrates, thanks for taking the time today. What trends are you seeing and following in the industry?

Socrates Rosenfeld: Always happy to chat about the industry. Thanks for having me.

If you were to ask me that question a year ago, I’d say having a digital footprint was something that would give a dispensary or a brand a nice advantage. Today, it’s a must-have for survival. Where it used to be one or the other; online or offline, now we are able to merge the two by replicating a physical store into a digitized form to extend its reach far beyond its walls.

As things become more digitized, information becomes more necessary to run operations. With that we are able to meet the expectations of the consumers who are accustomed to convenience and curation. The omnichannel experience provides the best of both worlds. Access and ease of search with the ability to pick up or have the product delivered the same day from a locally owned and run business.

Reviews are one of the most important aspects of this unification of online and offline. It is something that is lost in solely offline purchases, that we’re now able to collect and organize. This product information allows us to provide customers the purchasing power to make a well-informed decision.

At Jane, we believe it is possible to create wins for the dispensaries, brands and customers – and digitization creates the opportunity for that to happen. I think there’s no better incubator in the world than the cannabis industry to prove that online and offline retail can work in harmony.

Aaron: Jane is the largest e-commerce platform in North American cannabis and Leafly is the largest marketplace in North American cannabis. What’s the difference between an e-commerce platform and a marketplace?

Socrates: Great question. There is definitely some overlap between the two, which is why it makes so much sense for us to collaborate. Ultimately though, our focus and expertise are different. Jane’s ecommerce platform serves as the industry’s digital infrastructure that pushes digital products across various order origination points like a dispensary’s own website, a brand’s own website and now, Leafly’s marketplace. Paired with Leafly’s industry-leading content and market information, together we can complete the entire online cannabis shopping experience – from product discovery through order fulfillment.

Aaron: At first glance, one might think that Jane and Leafly are competitors. How did you see it differently? And how did this partnership come about?

Socrates: Not only is our tech complementary, but we are aligned on mission – to empower consumers, dispensaries and brands with the integrity of the plant in mind.

We want to make it simple for consumers to reach the products that will be most helpful for them. We want to make it possible for dispensaries and brands, regardless of their size, to be able to compete on an even playing field.

It all comes back to being good stewards of the industry. Education and access create a healthy demand for a diverse range of products. That means that the plant stays in the hands of many – safeguarding it from homogenization.

Aaron: How do consumers benefit from the partnership?

Socrates: It really is all about bringing this industry in line with any other retail vertical and meeting the customer where they are. It unlocks more avenues for customers to discover products and access a vast catalog of information and verified customer reviews. Bottom line, this partnership makes shopping for cannabis as simple as shopping online for everything else in the world, while also ensuring the success of the sellers.

Aaron: When you say the sellers, are you talking about the dispensary or the brands?

Socrates: Both, we want to provide value for the entire ecosystem. We can do that directly for dispensaries and brands by enabling an automated ecommerce platform that they can use to power their own website. At Jane, we know that technology can unlock value for everyone, where it is not a zero-sum game and success for one means success for the other. With Jane, both the dispensaries and the brands win.

Aaron: What kind of regulatory challenges do you face through the partnership?

Socrates: There are no real regulatory challenges for the partnership itself. The entire industry operates under regulatory challenges, but it is those regulations that have been the catalyst for innovation. I see the opportunity for legal online payments and national product distribution to play a large role in shaping the industry soon, and a partnership like this will ensure a seamless transition for the industry as things continue to evolve.

Aaron: Final question. What are you personally interested in learning more about?

Socrates: I’ve always been curious about disruptive models. The companies, not just in tech, but any company that has set out to do things differently and has been able to hold true to a vision. That’s what interests me, and I think I will always have something to learn and draw inspiration from. 

Aaron: Excellent, that’s the end of the interview, Socrates!

Socrates: Thanks, Aaron.

GMPs & Cannabis Manufacturing

By Kathleen May
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Editor’s Note: While CIJ typically omits the word “marijuana” where possible due to antiquated nomenclature and prejudicial connotations, we understand the legal distinction between cannabis containing THC and hemp requires the use of the word when referencing federal government policies and legislative language.

Despite the rapid evolution of the cannabis industry, the assurance of safe manufacturing practices remains unclear.Both the Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA) have imposed significant hurdles for cannabis operators to remain on the “right side of the law.” Therefore, manufacturers of both hemp and marijuana products have been left to figure things out on their own, or choose to ignore existing guidance because the lack of federal oversight allows them to do so. Inconsistent regulation on manufacturing, packaging, labeling and testing of cannabis products offers the potential for unsubstantiated, non-scientific and often times blatantly false claims on product safety and efficacy.

Science vs. Law

Hemp and marijuana are both species of the Cannabis family, Cannabaceae. Genetically they are identical but are arbitrarily defined by the presence of delta-9 tetrahydrocannabinol (THC). While science does not differentiate between hemp and marijuana, the law does.

The hemp industry declared a small victory with the passing of the Agricultural Act of 2014 (2014 Farm Bill). Under this bill universities and state agriculture departments were allowed to grow hemp under state law. Additionally, “industrial hemp” was officially defined by establishing the legal limit of THC at 0.3% on a dry weight basis. The Agricultural Improvement Act of 2018 (2018 Farm Bill), under the guidance of the United States Department of Agriculture (USDA), took things a few steps further by authorizing the cultivation of hemp and removed hemp and hemp seeds from the CSA. The bill however provides no language that mandates the safe manufacture of hemp-derived consumer goods. The 2018 version also preserved the FDA’s authority to regulate products containing cannabis and cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FD&C Act). To the surprise of most, listing cannabidiol (CBD), even hemp-derived, as an ingredient on consumer product labels remains illegal under the bill. Furthermore, CBD product manufacturers are not protected under the current regulations. Since 2015 the FDA has issued warning letters to firms marketing CBD products as dietary supplements and/or foods, and in December 2018, FDA declared it illegal to introduce food containing CBD (or THC) into interstate commerce, regardless if it is derived from hemp. To date, the only FDA approved CBD product is GW Pharmaceutical’s Epidiolex.

Marijuana remains classified as a Schedule I controlled substance under the CSA. Thirty-six (36) states have approved comprehensive, publicly available medical marijuana programs, and now 14 states have approved adult use programs, with New Jersey passing legislation on February 22, 2021. However, the industry has seen minimal movement toward mandating GMP requirements in the marijuana market. Only a handful of medical programs require manufacturers to follow GMP. Furthermore, the requirements are inconsistent between states and the language in the regulations on how to approach GMP implementation is vague and disjointed. This fragmented guidance supports the complexity and difficulty of enforcing a coherent, standardized and reliable approach to safe manufacturing practices.

What is GMP and Why Should You Care?

Good Manufacturing Practices (GMPs) are a system for ensuring that products are consistently manufactured and controlled according to quality standards and regulatory guidelines. The implementation of a GMP compliant program ensures consumer health and safety, allows manufacturers to understand the intended use of their products, allows manufacturers to defend product specifications as being appropriate, considers the risks to vulnerable populations and minimizes overall business risk. In a nutshell, GMP equals product safety and quality, and defines the responsibilities of the manufacturer to ensure consumers are protected from the distribution of unsafe and ineffective products. Currently, the GMP “landscape” in the cannabis space is complicated. The various “flavors” (food, dietary supplements, cosmetics and drugs/devices) of GMP leave many confused and frustrated when making the decision to implement GMP. Confusion is a result of unclear regulatory requirements as well as operators not fully understanding how to classify or designate the end use of their product(s). Implementing an effective GMP program requires proper planning (both short and long term), financial commitment and qualified resources.

Where Should You Start?

As the regulatory landscape continues to evolve and mature in the cannabis space, your business model must consider GMP implementation if you wish to remain successful and sustainable.

Intended Use

Before you can implement GMP you must first understand what GMP regulations apply to the intended use of your product(s). Are you manufacturing food, beverages or dietary supplements? Get acquainted with the FDA Code of Federal Regulations (CFRs) on GMP. 

Conduct a Gap Assessment

A gap assessment allows you to determine your deficiencies in relation to GMP compliance. The assessment should include, but is not limited to facility design, equipment design, supply chain, risk management and employee training.

Develop an Action Plan

Once the gap assessment is complete a comprehensive action plan will be developed to map out the steps required to achieve GMP compliance. The action plan should follow the SMART Goal principles:

  • Specific (simple, well-defined)
  • Measurable (meaningful)
  • Attainable (achievable, agreed upon)
  • Relevant (resource-based, reasonable and realistic)
  • Timely (time-based, defined due dates)

The plan will include prioritized deliverables, due dates and allocated resources in order to strategically plan and execute and complete the required tasks.

Schedule a Mock GMP Inspection

A mock inspection verifies that the action plan was adequately executed. Hire an experienced resource familiar with related GMPs and QMS to conduct the inspection. A successful mock inspection is a perfect litmus test if the end goal is to achieve GMP certification.

Cannabis manufacturers that ignore the obvious progression toward an FDA-like industry will not survive the long game. Those that embrace the momentum and properly plan to mitigate product and business risk – those who demonstrate integrity and are truly in this space to ensure safe, effective and quality products to consumers will come out on top, gain credibility and secure brand recognition.

References:

  • 21 CFR Part 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements.
  • 21 CFR Part 117, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and the Food Safety Modernization Act (FSMA).
  • 21 CFR Part 210, Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General.
  • 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals.
  • 21 CFR Part 700, Subchapter G-Cosmetics.
  • 21 CFR Part 820, Subchapter H-Medical Devices; Quality System Regulation
  • Congressional Research Service, FDA Regulation of Cannabidiol (CBD) Products, June 12, 2019.
  • United States Food and Drug Administration-Warning Letters, Current Content as of 02/19/2021.

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