Tag Archives: medical

Meet Looming Federal Cannabis Regulatory Compliance Management with Automation & Confidence

By Steven Burton
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Federal regulation of the cannabis and hemp sectors is coming sooner rather than later — and this is mostly good news for cannabis businesses and consumers. But cannabis producers already struggling to meet complex and ever-changing local regulations (where they exist) will be facing a new set of challenges with another level of regulatory oversight and compliance.

Navigating multi-jurisdictional regulatory compliance management requirements is near-impossible with legacy manual systems. That’s why it’s time to leverage the right enterprise resource planning (ERP) system, so that you and your team can meet these compliance management complexities with confidence and ease. Whether you manufacture flower, edibles, beverages, supplements or other dispensary products, here’s what you need to know to stay agile and profitable as more changes loom.

Federal Legalization is Coming

To date, there are 18 states with adult use cannabis markets, 37 with medical cannabis programs, and an additional 13 that have some level of decriminalization. At the federal level, there have already been several attempts at cannabis law reform, with even more on the table in the coming year.

One of the most promising is the Republican-led States Reform Act, filed in November 2021. The central tenant of this proposed legislation is to remove cannabis and cannabinoids from listing as a Schedule 1 Drug under the Controlled Substances Act.

Importantly, if this law passes, it would allow individual states to pursue their own cannabis policies and remove the current risks companies face when going against current federal anti-cannabis scheduling.

The States Reform Act also proposes a three percent federal tax on all cannabis sales and that all cannabis sales fall under the ​​Alcohol and Tobacco Tax and Trade Bureau’s (TTB’s) control. The States Reform Act would — finally — guide the regulation of hemp-derived products through the Food and Drug Administration (FDA).

US Senate Majority Leader Chuck Schumer has also been working on another reform bill, specifically the Cannabis Administration and Opportunity Act (CAOA), which he plans to introduce in April 2022 to further emphasize the criminal justice aspects of legal reform in the context of the War on Drugs.

While the government’s track record on cannabis regulatory reform hasn’t been as progressive as many would like, at this point there is widespread public support and proposed bills from both sides of the aisle. As a result, the US may finally see some movement on cannabis law reform in the very near future.

How to Prepare for Federal Regulatory Compliance Management

With federal regulation looming, it’s time for licensed producers to elevate their internal systems. Whether you work with tetrahydrocannabinol (THC) or cannabidiol (CBD), the regulatory protocols in an already complex marketplace are going to change.

This is especially paramount for those producing cannabis or hemp beverages, edibles and supplements. You will need comprehensive and efficient systems to facilitate this transition. An ERP should reduce compliance headaches and ensure your business is ready to scale when a national marketplace launches.

Automate Data Gathering

It is no longer cost effective to manage seed-to-sale traceability with manual data capture. With the thousands, if not tens of thousands, of data points required at most commercial facilities on a routine basis, data logging is by far the best way to start compliance automation.

Automated ERP systems, which capture essential information across your entire operation, ensure access to real-time data for forecasting, accounting, regulatory compliance reporting and traceability. That means using software that captures and logs intel from across your organization about quality control, inventory and traceability, all without arduous manual input.

The best and most successful ERP systems should be used by all employees to collect data, from sorters/pickers to fork lift drivers to supervisors to senior management. For this to happen easily, the solution must be accessible and user friendly for all employees. ERP systems that can be easily integrated with tablets and smartphones (as well as IoT devices) reduce the need for expensive terminals on the production floor and make data collection a straightforward part of daily operations.

Build Systems to Facilitate Growth from the Start

A rigid ERP system that can’t grow with you is not a smart long-term investment. An adaptable multi-platform system evolves with your company and constantly changing regulatory compliance requirements. A solution that provides access to the entire facility, instead of being limited to individual users, ensures that growing teams can easily contribute to data quality from the plant floor all the way up to the executive office for actionable insights.

Markets are opening up across the country and quite soon, many companies will be looking to expand their operations nationally. As a result, you’ll need systems that can scale, cover additional facilities, keep up with increased production, and even work across different jurisdictions.

Having instant access to detailed operational information delivers greater business oversight at the micro and macro levels – insight that is crucial for expansion, profitability, and cost-cutting measures. Companies with the right systems in place will effectively manage the resulting federal complexities to deliver on regulatory expectations and capture a competitive market share.

Leverage Regulatory Frameworks and Technology from the Food Industry

The Canadian example demonstrates clearly that the regulatory frameworks from the food and beverage industry are the most applicable to the cannabis sector – more so than for pharmaceuticals, nutraceuticals or alcohol. This is most obvious in lucrative value-added markets like edibles and extracts, which are actually also food products.

Issues like dosage standardization, controlling common hazards, managing traceability chains and inventory, and introducing quality standards (including third party certifications like organic and SQF) are all crossovers from the food industry.

Just as the compliance automation wave has hit the food industry in recent years, manufacturers of infused products and extracts can then use the same technology to reduce safety and quality control costs as well as documentation and administrative costs. The lesson? Cannabis industry leaders don’t need to totally reinvent the wheel.

Cannabis Producers Need an ERP System Tailored to Their Needs

In Canada, cannabis manufacturers have learned all too well what a few little mistakes can do to reputation and profitability. MJBiz Daily reported in 2021 that the Canadian government had issued more than CDN $1.3 million (USD $1 million) in fines since legalization. That’s a lot of regulatory compliance issues. Considering there are nearly 500 compliance fields to fill out for monthly reporting, mistakes are difficult to avoid, especially if you rely on a manual system.

FDAlogoThe story is similar in the United States. State regulatory compliance management requirements are complex and arduous for individual companies and employees. When federal regulation does come, US-based producers will very likely face even more strenuous reporting requirements to multiple jurisdictions.

Cannabis companies will need a data-driven system in place to align with the FDA’s Cannabis-Derived Products Data Acceleration Plan. Finding food safety and traceability software that makes reporting easier, automatic, and less prone to human error is paramount to success. As you prepare for the looming federal legislation, look for an ERP system that covers all the bases, including one that:

  • Improves Market Agility: Expedites opening new facilities in new markets as they come online
  • Evolves with Regulatory Changes: Facilitates the transition from unregulated markets into federally regulated ones
  • Automates Reporting: Protects you from regulatory compliance management bumbles stemming from manual input and human error
  • Reduces Workload: Optimizes workflow and reduces labor costs associated with manual input
  • Is Comprehensive: Covers all bases, including food safety, quality control, traceability, production management, and even occupational health and safety

If you aren’t automating the capture of essential information across the entire operation, you won’t be prepared for the regulatory burdens likely to come with federal cannabis legislation. To stay compliant and on top of what will likely be an incredibly competitive marketplace, you are going to need real-time data — data that will provide precise seed-to-sale traceability, product recall capability, and reporting.

Digitizing safety, traceability and complex production management through one state-of-the-art ERP system allows cannabis companies to reap the rewards of data-driven, automation technology almost immediately without the significant capital expenditure on large-scale equipment or robotics. From there, navigating regulatory complexity becomes not only streamlined and operationalized, but an actual market advantage for future growth.

Petri dish containing the fungus Aspergillus flavus

Salmonella & Aspergillus: Controlling Risk in Your Supply Chain

By Cameron Prince
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Petri dish containing the fungus Aspergillus flavus

Risk management is the process of identifying potential hazards, assessing the associated risk, then implementing controls to mitigate those risks. With Salmonella and Aspergillus being two of the leading causes of cannabis contamination that can occur throughout the supply chain, applying upstream risk management strategies can keep supplier contamination issues from impacting your products.

Salmonella enteritidis

In recent months cannabis products have been recalled for Salmonella and/or Aspergillus contamination in several states, including California, Arizona, Michigan, Florida, as well as Canada. While the recalls impacted retail products, in most cases, the contamination occurred farther back in the supply chain, as evidenced by recalls that impacted several dispensaries or other sales locations.

For example, the November 2021 Arizona recall caused multiple establishments and dispensaries to recall product due to possible contamination with Salmonella or Aspergillus; the Michigan recall of an estimated $229 million in cannabis products due to “inaccurate and/or unreliable results of products tested.” While a lab lawsuit against the recall released some of the product to market, the companies faced significant impact – in both removing and returning the product.

While microbial contamination can occur throughout the supply chain, Aspergillus is ubiquitous in soil and the flower, leaves, roots of the cannabis plant are all susceptible to such contamination. The mold also can colonize the bud both during growing and harvesting. Salmonella can be introduced during growing through, untreated manures, direct contact with animal feces, or contamination of surface water used for irrigation. However, the plant matter also can be compromised during drying, storage and processing from environmental contamination.

Petri dish containing the fungus Aspergillus flavus
Aspergillus flavus

Supply chain risk management. To prevent a supplier’s contamination issues from becoming your problem to deal with, each facility at each step of the chain should develop a supply chain risk management program to assess and approve each of its upstream providers. Following are 5 key steps to assessing and managing risk in your supply chain:

  1. Conduct a hazard analysis. A complete supply chain assessment should begin with a hazard assessment of all the ingredients, products or primary packaging you receive. There are two essential steps involved in conducting a hazard analysis: that is the identification of potential hazards – considering those related to the item itself, as well as the supplier environment and process as well as item – and an evaluation to determine if each hazard requires control based on its severity and likely occurrence.
  2. Evaluate the risks. Based on the hazard analysis, the next step is to determine the associated risk. As defined by the European Food Information Council (EUFIC), “a hazard is something that has the potential to cause harm while risk is the likelihood of harm taking place, based on exposure to that hazard.” For example, the higher the exposure, the higher the risk.
  3. Ensure risk control. Once risk is determined, it is critical to ensure that it is being controlled, who is controlling it and how it is being done. Depending on the risk, that control may need to be conducted by the supplier, by you or even by a downstream customer.
  4. Require documentation. No matter which step in the chain is controlling the risk, it is essential that all be documented with records easily accessible – including the controls, any out-of-compliance events and corrective actions. The adage, “If it’s not documented, it didn’t happen,” is very applicable here, particularly should a problem arise and an inspector appear at your door.
  5. Use only approved suppliers. Implementation of the above steps enable the development of a supplier approval program focused on quality, safety and regulatory compliance. Use of only suppliers who have been assessed and found to meet all your standards will help to protect your product and your brand.

Salmonella and Aspergillus contamination can occur throughout the supply chain, but implementing a supply chain risk assessment and management program will enable you to determine where the greatest risks lie among your ingredients and suppliers, allowing you to allocate resources based on that risk.

Busting the THC Myth: When it Comes to the Best User Experience, Terpenes Reign Supreme

By Mark Lange, PhD
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The scent of pine from your Christmas tree. The fragrance of a ripe summer peach at the farmer’s market. The whiff of eucalyptus and lavender that greets you when you enter a spa.

Aroma is a keystone in how we experience the world. In any given environment, aroma can help shape your mood, solidify memories and instantly transport you to another place or time.

I have focused my career on studying the fascinating compounds that are often behind these powerful aromas: terpenes. They form the largest class of natural products (compounds produced by living organisms), found in nearly all living beings. There are around 50,000 currently known terpenes in nature — with potentially thousands yet to be discovered.

Terpene-rich plants you might be most familiar with are lavender, mint, oranges (in the peel), and yes, cannabis. In recent years, terpenes have rightfully become a central discussion in the recreational cannabis world. This is because terpenes — not THC level, not “Indica-Sativa” classification — are a key determinant of cannabis’s effect, both psychoactive and non-psychoactive. But the current lack of prioritization and understanding of the crucial role terpenes play may put the collective quality of U.S. cannabis at risk.

At this crucial inflection point for legal cannabis, on its path to becoming a $70 billion dollar global industry by 2028, we need to ensure that everyone across the cannabis space, from breeders to testers, growers and consumers, understands which traits to prioritize for a cannabis world brimming with diversity and predictable effects.

What the cannabis industry has to lose 

What do we lose if the cannabis industry continues to scale without a clear understanding of the compounds that define the uniqueness of each variety?

There is a ripple effect across the ecosystem. For cannabis testing labs, focusing on only twenty of the most dominant terpenes means we are missing out on tapping into potentially over a hundred of less common terpenes in cannabis. For the cannabis consumer, lack of understanding on the breeding and testing side may make it difficult to find cannabis that delivers on its promised effect time and time again. And, most detrimentally for breeders, not understanding the direct correlation between genetics and the formation of terpenes means we will have increasingly fewer terpene profiles and combinations to work with, especially when the industry-dominant focus has been on cannabinoid potency.

Let’s explore some misconceptions related to potency. In recent years, many breeders have prioritized high THC levels over genetic diversity. Consumers often associate high THC levels and that telltale strong “skunky” aroma with a strain’s quality and effect, when in reality, these are poor indicators of potency. (In fact, recent research indicates that this specific cannabis aroma is caused by a family of sulfur compounds.) Terpene profiling is a much more accurate way to determine a variety’s given effect. In focusing too much on increasing THC, breeders miss out on the true potency powerhouse: tapping into the terpene diversity that’s out there.

Terpenes are responsible for giving flowers (including cannabis), fruits and spices their distinctive flavors and aromas. Common terpenes include limonene, linalool, pinene and myrcene.

To illustrate the impact of breeding practices that prioritize crop yield over product quality, I first have a question for you: When was the last time you enjoyed a really good tomato?

If you’re lucky enough to have a great farmer’s market nearby, maybe you purchased an heirloom tomato at peak freshness last August. It was likely fragrant, flavorful and didn’t need much preparation to be enjoyable.

Or maybe you can’t remember the last time you’ve eaten a good tomato, as the last standard grocery store tomato you purchased was watery, tasteless and essentially scentless.

Tomatoes are a prime example of what is unfortunately true for a whole host of traditional crop plants in the U.S. When yield is the goal, flavor and aroma profiles often suffer. The culprit: lack of genetic diversity in the breeding process. The tragedy of the tomato serves as a harbinger for the cannabis industry — and we can draw parallels to what we’ve seen happen to cannabis.

What the cannabis industry should do: Tap into the diversity that’s out there

An important aspect of preventing cannabis from going the way of the tomato is to better understand the genes that generate these different terpene profiles. Different cultivars with varying aromas will hold different collections of genes. We as an industry must learn more about which terpenes correlate with desirable aromas, and then access already existing genetic diversity.

We have just begun to scratch the surface of the potential of terpenes in cannabis. With the right alignment across the industry and a stronger focus on genetics in breeding, we will see the rise of completely unique cannabis varieties. They will smell like lavender, lilac, orange peel or even brand-new aromas that have yet to be discovered. To ensure this future, we need to prioritize the right traits and the right genetics.

Cannabis Quality Conference & Expo logo

Cannabis Quality Conference Dates, Location Announced

By Cannabis Industry Journal Staff
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Cannabis Quality Conference & Expo logo

EDGARTOWN, MA, Feb. 21, 2022 – Innovative Publishing Company, Inc., the publisher of Cannabis Industry Journal, has announced the return to in-person events with the Cannabis Quality Conference & Expo (CQC), taking place October 17-19, 2022 at the Hilton in Parsippany, New Jersey. Presented by Cannabis Industry Journal, the CQC is a business-to-business conference and expo where cannabis industry leaders and stakeholders meet to build the future of the cannabis marketplace.

“Cannabis markets in New Jersey, New York, Connecticut, Pennsylvania and Massachusetts are all beginning to get off the ground,” says Aaron Biros, editor of Cannabis Industry Journal and director of the Cannabis Quality Conference. “Taking place in a pivotal year for the cannabis industry and in a location surrounded by new market opportunities, the CQC will deliver hands-on education, networking and business discussions. The venue setting, just a short train ride from New York City and Newark International Airport, coupled with highly focused content, creates a unique business meeting environment.”

The 2022 program will have three separate tracks of educational presentations and panel discussions, focused on Regulations & Policy, Safety & Quality and Business & Operations.

Due to safety protocols and venue restrictions, limited space is available for sponsors and attendees. The CQC is a hybrid event, meaning attendees will have the option to either attend in-person in New Jersey, or attend remotely via the virtual platform. Registration is now open. Click here to stay up to date on lodging, early bird pricing, keynote announcements and more.

The CQC is co-located with the Food Safety Consortium, which will take place immediately following the CQC, October 19-21, 2022. For sponsorship and exhibit inquiries, contact RJ Palermo, Director of Sales, and Chelsea Patterson, Account Executive.

About Cannabis Industry Journal

Cannabis Industry Journal is a digital media community for cannabis industry professionals. We inform, educate and connect cannabis growers, extractors, processors, infused products manufacturers, dispensaries, laboratories, suppliers, vendors and regulators with original, in-depth features and reports, curated industry news and user-contributed content, and live and virtual events that offer knowledge, perspectives, strategies and resources to facilitate an informed, legalized and safe cannabis marketplace.

About the Cannabis Quality Conference & Expo

The Cannabis Quality Conference & Expo is an educational and networking event for the cannabis industry that has cannabis safety, quality and regulatory compliance as the foundation of the educational content of the program. With a unique focus on science, technology, safety and compliance, the “CQC” enables attendees to engage in conversations that are critical for advancing careers and organizations alike. Delegates visit with exhibitors to learn about cutting-edge solutions, explore three high-level educational tracks for learning valuable industry trends, and network with industry executives to find solutions to improve quality, efficiency and cost effectiveness in the evolving cannabis industry.

Curaleaf Expands in Pennsylvania

By Cannabis Industry Journal Staff
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According to a press release published last week, Curaleaf Holdings, Inc. announced the opening of two new dispensaries in Pennsylvania. Their newest location in State College opened its doors to patients this week and the company is expecting to open an new dispensary in Erie next month, pending regulatory approval.

With those two additions to the Curaleaf portfolio, the company will have 127 retail dispensary locations across the United States, with sixteen of them being in Pennsylvania. In addition to their new locations in State College and Erie, Curaleaf also has dispensaries in Altoona, Bradford, Brookville, City Avenue, DuBois, Gettysburg, Greensburg, Harrisburg, Horsham, King of Prussia, Lebanon, Morton, Philadelphia and Wayne

Just last month, they acquired Bloom Dispensaries, adding four dispensaries in Arizona, in addition to the 44 locations they already had in Florida.

“Curaleaf is excited to begin serving our newest patient communities in State College and Erie through our premium medical products and inclusive retail experiences,” says Joe Bayern, CEO of Curaleaf. “Expanding our presence within Pennsylvania enables us to further support our patients by providing them with quality products and service to make confident and informed decisions about their medical marijuana journeys.”

Going Vertical: How Vertical Farming Is Revolutionizing the Cannabis Industry

By Jeffrey L Garber
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In the cannabis industry, it’s crucial to be able to predict the future, to adapt and survive in a competitive industry that is arguably regulated more closely than any other.

From licensing to buildout, there are a growing number of barriers to entering the cannabis industry as a cultivator. Those who are lucky to successfully establish a grow operation are well aware that one of the crucial hurdles is managing space to maximize facility efficiency and capacity.

To stay profitable, the more plants you can grow and harvest at a time in a continuous cycle, the better. From an economic and environmental perspective, managing cost, space and time comes down to automation and efficiencies. One of the most efficient ways we optimize is through the practice of vertical farming.

Vertical farming maximizes canopy square footage while minimizing Cost of Goods Sold (COGs) to produce high-quality cannabis at scale year-round, and the industry is slowly finding that this method is an incredibly efficient and profitable way to maximize cannabis output.

Yellow Dream Farm is our family-owned cannabis cultivation, manufacturing and distribution company based in San Bernardino County, California, often known as the Silicon Valley of cannabis. Our craft, boutique-style cannabis is grown from floor to ceiling in the 30,000-square-foot facility. We’re using cutting-edge technology that’s only come to market in the last five years and using a variety of sustainable practices. With environmental and feeding efficiencies, we’re able to harvest 300 pounds per week when compared to 150 pounds per week from a facility of the same size.

Vertical Farming for Space Optimization

Like any medical field, cannabis has seen large numbers of outside investments into the space, bringing ideologies and efficiencies from other time-tested industries. One such efficiency is vertical farming – a practice already seen in large-scale agriculture.

The Yellow Dream Farm vertical cultivation facility

We choose vertical farming to maximize our canopy square footage and minimize COGs to produce high-quality cannabis at scale. The barrier to entry into the cannabis industry is expensive, and you must utilize every square inch to stay profitable. We believe vertical farming is the most efficient and most profitable way to maximize output and our numbers can back that up; for example, we can produce double the amount of flower than the average single-tier room with the same square footage, without doubling the cost.

Our rooms contain double stacks to double room capacity by using ceiling heights instead of square footage. Even though vertical farming has larger start-up costs, we can maximize square footage and output, allowing us to get a better and faster ROI. Vertical farming can be done in many different ways but the way we built our facility was always with a sustainable outlook. We also look to improve and remove human error; with full irrigation control and crop steering technologies, we can recalibrate sensors, irrigation media and environmental sensors when needed based on successes, challenges or environmental constraints. Additionally, we have a few other sustainable practices that make a difference.

Water Conservation, Lighting and Automation

Being a California-based grower, water conservation is a key part of our operations. With San Bernardino County being located in the heart of the high desert, conserving water is not only a requirement but a competitive advantage. Our practices provide cost savings which we then pass along to our customers. Each cannabis plant on average requires between a half gallon and one gallon of water per day, which we then recirculate through condensate water from our A/C and dehumidifiers. All runoff nutrient water is re-filtered and reused to get the most out of our nutrients before discarding waste. Our freezer panel walls hold temperatures at consistent rates, and we have a fully automated system to dial in specific needs at any given time.

LED lights above a crop at Yellow Dream Farm

Lighting is another major environmental and capital cost. Our primary lighting system is LED technology, and we use LED spectrums to find which spectrum benefits the plant most. With LEDs, our energy consumption is 30 percent less.

Vertical Farming Is the Future of Cannabis and Agriculture

Vertical farming has been hailed as the future of many agricultural industries and cannabis is no different. We already see large vertical farms in most legal states, but surprisingly it’s still not a common style of growing. As the price per pound steadily declines in California, being able to keep COGs down will allow vertical farmers to sustain and thrive in this volatile industry.

In order to adapt, grow and leave a positive mark on the industry, we must pave the way for new styles of growing and utilizing new technology and science that was not available to growers in the past. We can use these advanced new technologies to make real-time changes to each sector of our facility and optimize both people power, and energy efficiency. And most importantly, we’ll be able to produce top-quality cannabis for adults to enjoy at affordable prices.

For more information, visit Yellow Dream Farm.

Innovations in Dosing Technologies: Getting an Accurate Hit, Every Time

By Michael Sassano
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Cannabis products and medicines are progressing rapidly, eating away at the market share of smokable flower. Currently, the general adult use cannabis market is split in three, in order of popularity: cannabis flower, vaporizers and ingestible products like edibles or capsules. In the medical market, flower is increasingly being replaced by alternative methods of delivery – and the same trend is now starting to be seen in the adult use market.

This is to be expected to some extent. Initially, only flower was available to medical cannabis users. On top of not everyone feeling comfortable with smoking, inhaling a combustible substance into the lungs is not the healthiest consumption method for those already suffering from a serious illness.

In the present day, there are new alternatives to smoking that come without the risk and actually have additional benefits. For example, there are now much more precise ways to measure your cannabinoid intake than weighing out the flower you’re about to burn. As technology develops, there is an expectation that – despite flower sales being fairly stable last year – we will see continued incremental growth in the non-flower category, especially on the medical side.

Oral Cannabinoid Delivery

Thankfully for those who want to use non-smokable products, there are a growing number of alternative oral products that are currently available in the market or are under development.

Some of the many infused products on the market today.

Cannabis edibles might be the first products to come to mind when you think about non-smokable products – but for many medicinal users, these are actually a fairly unpopular option. While having a cannabis-infused brownie or gummy might be quite discreet compared to smoking a joint, the need for patients to take in extra sugar or extra calories every time they need to take their medicine can be off-putting. Additionally, tradionally infused edibles can take between one to three hours to feel as the body needs time to digest.

Cannabinoid capsules or pills have recently emerged as an equally discreet alternative to edibles. These pills come in many forms, including hard capsules containing ground cannabis flower, softgel capsules containing measured doses of cannabis extract, and gelatin-free alternatives. Though these pills, like edibles themselves, do come with a relatively long onset time.

Cannabinoid capsules

Pills and edibles are also both affected by first-pass metabolism. This means that the active cannabinoids will be processed through the digestive system and the liver before passing onto the brain or the other organs. During this process, some amount of CBD or THC will likely be broken down by the body before it can make its effect felt, leading to inaccuracies between the labelled dose of a product and the active dose that reaches the brain or target area in the body.

To avoid these problems with first-pass metabolism, some have turned to use sublingual cannabis oils and tinctures. By placing a measured dose of oil under the tongue using a dropper, this theoretically allows for the fast absorption of THC or CBD into the bloodstream without the product being processed by the digestive system. However, in practice, these sublingual tinctures need to be held under the tongue for around ten minutes before they are fully absorbed. This is fairly difficult to do without accidentally swallowing some amount of the tincture, and so this still introduces some amount of uncertainty with dosing.

Fast-Acting Absorption

Fast-acting absorption techniques and nano emulsions are also gaining in popularity. Nanotechnologies and techniques have been developed by many firms, and boast claims of increasing absorption through the digestive system in order to effectively double the volume of cannabinoids absorbed into the body. Nano emulsions are also promising, which come with claims of up to four to five times more improved absorption. Such technologies rely on cannabis oils being immiscible with water-based substances, and process these cannabis oils in such a way that they become nanoscale droplets suspended in a larger mixture. Because of their size, these small pockets of cannabis oil are able to be absorbed rapidly through the gastrointestinal tract and into the bloodstream.

A drink additive, made by Splash Nano, that uses nano emulsion technology

Older liposomal and newer nano-liposomal combinations have also boasted similar claims. Liposomes are commonly used as a novel drug delivery system for pharmaceutical products to facilitate the absorption of drugs into the body, and the adaption of such techniques for the cannabis sector is also intended to dramatically improve the absorption of cannabinoids into the bloodstream. Given the marketing of these products, it can become confusing to know which is the best. The only way to know for sure is to have either a breath or blood analysis to see which style works and is best for the individual consumer.

As manufacturers progress from flower and basic products, the largest brands and more advanced medical companies are all producing ingestible products with fast absorption methods and additives. The difference is pronounced and significant enough that consumers and patients are starting to demand fast absorption products. As the market becomes more educated, you can expect that the market for fast absorption ingestible products will greatly outpace the older, more basic formulations. Of course, some emulsion additives will increase the operating costs for businesses, but over time, this difference will likely be fairly minimal.

Microencapsulation to boost cannabinoid absorption

Microencapsulation is another new method for producing drugs with high bioavailabilities, and the technique has recently made headlines in the cannabis industry.

Using a technique known as ionic gelation, or ionotropic gelation, scientists are able to trap drugs inside nano- or microscale capsules. These tiny capsules are robust enough to be able to protect the active drug ingredient–which in this case would be CBD or another cannabinoid–against the harsh environment of the gastrointestinal tract without necessarily limiting bioavailability.

The structure of cannabidiol (CBD), one of 400 active compounds found in cannabis.

Unlike the other oral dosing methods, cannabinoid microcapsules are not yet a commercially available product. However, there is early research indicating that this drug delivery technology could be a significant step forward in terms of improving cannabinoid bioavailability and absorption.

Published in the journal PLOS One, a new study from a team of Australian scientists reports that CBD microcapsules used in combination with a permeation-modifying bile acid can boost the peak concentration of CBD reaching the brain by 300 percent. These peak concentrations of CBD in the body also happened much earlier with the CBD microcapsules than with regular CBD oil, reflecting a faster absorption by the body.

This improved absorption and bioavailability addresses many of the limitations seen with traditional oral cannabinoid delivery. However, there is still potentially a very long road before these microcapsules are approved for general use in humans, making them an unrealistic option at present.

Metered Dose Inhalers

So far as innovative cannabis dosing technology that is currently available on the market goes, metered dose inhalers lead the way. Making up one-third of the market share, these devices are easy to use, discreet and are far less invasive than burning cannabis flower.

A metered dose inhaler by MÜV

Heating and vaporizing a purified cannabinoid also exposes the user to fewer potentially harmful combustion products than smoking flower. Using vapes, manufacturers are also able to adjust the formulation of vape oils in order to deliver a truly consistent product. This can help the consumer to truly measure their intake of beneficial cannabinoids.

Vaporizers for general adult use are very common now and come in many forms and flavors. Until recently though, there were very few vaporizers that met the specific needs of the medical market, like being able to deliver very controlled doses of cannabinoids. Now, innovation in the sector has led to a number of companies developing special metered dose inhalers for this purpose. These devices use smart technology to only heat and vaporize a pre-set controlled dose of cannabis oil from their compatible cartridges, allowing for intake to be tracked more precisely. This is different from regular vapes, where the amount inhaled can vary depending on how deeply a person inhales, or other environmental factors.

Recently, Syqe Medical received approval from Health Canada for their metered dose cannabis vaporizer. There is already a similar registration for approval in the US and Europe that looks promising for similar devices.

Recreational acceptance of products, like these high-tech vaporizers, drives up spending on innovations that would otherwise just be novel ideas. The cannabis industry has a wealth of creative talent, and with the market beginning to tear away from flower and towards novel and innovative products, like vaporizers and fast acting ingestible products, now is the time for the medical market to invest in this talent and follow the demand and the money.

New York Expands Medical Access, Prepares for Adult Use

By Cannabis Industry Journal Staff
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Now entering its sixth year of medical cannabis legalization, the Empire State is well on its way to expanding the market considerably. When New York first legalized medical cannabis, it had some of the strictest rules in the country. Dispensaries needed to have pharmacists and doctors with special training on staff, they couldn’t sell flower and there was a very small list of qualifying conditions for getting a cannabis prescription.

While New York legalized adult use cannabis back in March of 2021, the actual market is still probably about a year away from launching. The bill immediately decriminalized possession up to certain amounts and set up the Office of Cannabis Management (OCM), New York’s regulatory body now overseeing the medical, adult use and hemp markets.

Over the past six years since the state legalized medical cannabis, the rules have eased incrementally, with more licenses awarded, more doctors participating, more qualifying conditions approved and a larger variety of products on dispensary shelves. Back in 2017, they added chronic pain to the list of qualifying conditions, which was seen as a big effort at the time for expanding patient access.

Just a few weeks ago on January 24, 2022, the Office of Cannabis Management, dropped all qualifying conditions. That means patients with more common ailments and really any type of condition, like anxiety or sleep disorders, can get a prescription for cannabis.

“Launching the new patient certification and registration system and expanding eligibility for the Medical Cannabis Program are significant steps forward for our program,” says Chris Alexander, executive director of the OCM. “We will continue to implement the MRTA and ensure that all New Yorkers who can benefit from medical cannabis have the access they need to do so. It’s important for New Yorkers to know that even as we shift the medical program to the OCM, your access will not be disrupted and the program will continue to expand.”

New York City
Image: Rodrigo Paredes, Flickr

In addition to dropping qualifying conditions, the state took a number of other measures to increase access and allow the market to expand further. For example, dispensaries can now sell flower, more physicians like dentists, podiatrists and midwives can participate, the OCM removed the patient registration fee and they increased the amount of cannabis patients can purchase at a time.

Beyond the medical market, New York is making strides in launching their hemp program as well as preparing for the eventual launch of the adult use market. Back in November, the state’s Cannabis Control Board approved new regulations for the hemp program, establishing standards for manufacturing, lab testing, packaging and labeling.

On the adult use front, delays are the name of the game. According to a publication called The City, delays to launch the new market have been made worse by former Governor Andrew Cuomo’s resignation following sexual harassment allegations. They say the state might not see the launch of the adult use market until early 2023 at best. Decisions on licensing, standards and rules are to be made by the Cannabis Control Board, a five-member commission tasked with overseeing the OCM. So far, the Board has not addressed a timeframe for when they will begin adult use sales.

2022 Infused Products Virtual Conference: February Program

By Cannabis Industry Journal Staff
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2022 Infused Products Virtual Conference: February Program

Sponsored by Columbia Laboratories

Click here to watch the recording

Agenda

cGMP Certification: What it is, Can you get it, and What does it take

  • Kim Stuck, Founder & CEO, Allay Consulting

Kim Stuck, a former cannabis regulator for Denver Department of Public Health and Environment now turned compliance consultant for the cannabis industry will be sharing her experiences and discussing quality assurance in cannabis when it comes to cGMP Certification. She will be explaining what cGMP is and:

  • How it fits in the cannabis industry
  • What the steps are to gaining cGMP Certification
  • Tips on how to be successful in the certification process.

TechTalk: Columbia Laboratories

  • Jessa Youngblood, Food & Beverage Market Coordinator II, Hardy Diagnostics

From Idea to Product: How to Launch an Edible 

  • Katherine Knowlton, Founder, Happy Chance
  • Kalon Baird, Founder & COO, Splash Nano

Learn everything you need to know about launching an edible product from two experts currently doing just that. Attendees learn about finding a niche, quality, the supply chain and the retail ecosystem.

Food Safety for Infused Edibles

  • Steven Gendel, Ph.D., Gendel Food Safety

This presentation takes a deep dive into current regulatory programs, why standardization is crucial, the importance of food safety in edibles, the importance of the ingredient supply chain and some shortcomings in current regulations.

Why Are Infuser Licenses Tricky?

  • Sumer Thomas, Director of Regulatory Operations, Canna Advisors
  • Brian Harris, Project Manager, Canna Advisors

Attendees of this session will learn:

  • Learn how being in the middle of the supply chain complicates everything
  • What is different about capital requirements
  • How team member requirements are make-or-break for your success

Click here to watch the recording

Pennsylvania Recalls Vape Products

By Cannabis Industry Journal Staff
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The Pennsylvania Department of Health sent emails back in December to registered medical cannabis patients, notifying them of a safety review being conducted on ingredients found in cannabis vape products. According to the Pittsburgh City Paper, the emails the state agency sent out were kind of cryptic; They did not include any information on why they were conducting this review or what exactly patients should be worried about in their vape products.

Then on February 4, the state’s health agency sent a third email. This one notified patients they were recalling more than 650 products and ingredients. “As you know, the Department recently conducted a statewide review of all vaporized medical marijuana products containing added ingredients,” reads the email to patients. “After finishing this review, the Department has determined that certain vaporized medical marijuana products containing some added ingredients have not been approved for inhalation by the United States Food and Drug Administration (FDA).”

While the FDA does approve added ingredients in other products, they don’t really deal with vaping, let alone cannabis. In October of 2021, the FDA did start regulating the space, making their first-ever approval for vaping products with nicotine e-cigarettes. Still though, the FDA has not conducted broad studies on specific vaping ingredients and their effects, so it’s not exactly an authority on what makes a safe cannabis vape product.

Pittsburgh City Paper says they have not received a response from the Pennsylvania Department of Health for requests to comment. The recalls and the state agency’s seemingly impulsive decision and subsequent radio silence leave more questions than answers.