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FDA Issues Update on CBD: Still Working, Still Waiting

By Aaron G. Biros
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On March 5, 2020, the U.S. Food and Drug Administration (FDA) issued a press release to the public about their work on devising a regulatory framework for cannabidiol (CBD) products. The FDA also submitted a report to Congress on their rulemaking progress.

The main theme of the report is the same story we’ve been hearing from the FDA for a while now: They are still working on figuring out how to regulate CBD products and wants to do more research before they tackle the rulemaking.

The most intriguing new development from this report is the FDA’s newfound interest in regulating CBD products like dietary supplements:

“FDA is actively considering potential pathways for certain CBD products to be marketed as dietary supplements. Under current law, CBD products cannot lawfully be marketed as dietary supplements, but FDA has the authority to create an exemption through notice-and-comment rulemaking that would allow products containing CBD to be sold legally as dietary supplements.”

If you’ve been living under a rock for the past couple years, here’s a recap: In June of 2018, the FDA approved GW Pharma’s drug, Epidiolex, for the treatment of rare forms of epilepsy. This allowed a drug containing CBD to go to market, but only through the agency’s drug approval process. When the 2018 Farm Bill (Agricultural Improvement Act of 2018) was signed into law in December later that year, the federal government removed cannabis (hemp) with less than 0.3% THC from the Controlled Substances Act, essentially legalizing it on a federal level. Congress tasked the FDA with figuring out how to regulate the market. Without any FDA guidance in the early days, the subsequent market growth created mass confusion for the industry and consumers alike, with no one really knowing if selling CBD products is legal or not. In May of 2019, the agency held a comment period and public hearing on CBD, which included a lot of discussion around the benefits, the risks and further research on CBD. Throughout 2019, the FDA sent a large number of warning letters to companies marketing CBD products with unsubstantiated health claims. Towards the end of 2019, Congress passed a bill mandating that the FDA update them on their progress to regulate the market within 60 days. That deadline came and went, and then the FDA issued the public update and submitted the report mentioned above to Congress last week. FDAlogo

The FDA says they intend to take a number of steps towards providing some market clarity, while still protecting the public from unknown risks. Firstly, they want to educate the public more about potential risks associated with CBD. “We remain focused on educating the public about the number of questions that remain regarding CBD’s safety,” reads the update. “There may be risks that need to be considered before using CBD products outside of the monitored setting of a prescription from your health care provider.” Those concerns mentioned above include potential liver injury, drug interactions, reproductive toxicity and more benign side effects like drowsiness.

The agency also wants to try and close knowledge gaps in the areas of safety and potential benefits. In this section of the update, the agency asks industry stakeholders for help. “We’re seeking reliable and high-quality data.” The agency is requesting data on sedative effects, impacts of long-term use, pharmacokinetics, safety of various drug delivery mechanisms, safety for animals, different processes for full or broad spectrum or isolate derivation, among other areas of interest. They plan to re-open the public docket from the public hearing back in May 2019, extending the comment period indefinitely as a tool for stakeholders to share information with the FDA.

As far as enforcement actions go, the agency wants to take a risk-based approach to it. While there is still no official enforcement policy, the FDA is working on it. Their biggest concern is with companies marketing CBD products using drug and health claims, which could “deter consumers from seeking proven, safe medical therapies for serious illnesses – potentially endangering their health or life.” The agency is also worried about potential contamination risk and consumer exposure to things like residual solvents and heavy metals. Their last concern in this area involves truth in labeling, like making false label claims, not listing every ingredient or incorrectly stating the amount of cannabinoids in the product.

“Our ongoing efforts related to CBD, including the steps we’re announcing today, are in line with our mission to protect the public, foster innovation and promote consumer confidence. We recognize the significant public interest in CBD and we must work together with stakeholders and industry to develop high-quality data to close the substantial knowledge gaps about the science, safety and quality of many of these products. We are committed to working efficiently to further clarify our regulatory approach to these products – as always, using science as our guide and upholding our rigorous public health standards.”

Overall, the public update and the report don’t disclose anything groundbreaking. They do, however, provide some much-needed guidance for the CBD market on how stakeholders can help the FDA’s efforts. The fact that they are investigating dietary supplements as a path toward a regulatory framework is the by far the biggest take away from all this.

Cannabis Labs / Food Labs 2020 Agenda Announced

By Cannabis Industry Journal Staff
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EDGARTOWN, MA, March 11, 2020 – Innovative Publishing Co., the publisher of Cannabis Industry Journal and organizer of the Cannabis Quality Conference & Expo is announcing the agenda release for the Cannabis Labs Conference. The event will address science, technology, regulatory compliance and quality management as they relate to the cannabis testing market. It will take place on June 3–4 at U.S. Pharmacopeia in Rockville, MD.

Two keynotes for the Cannabis Labs Conference are listed in the agenda: Rowing in the Same Direction: The Biggest Safety Issues Facing the Cannabis Industry & How We Intend to Tackle Them – this talk will be delivered by Andrew Kline, Director of Public Policy at the National Cannabis Industry Association (NCIA). The second keynote is titled Cannabis Testing in Maryland: Protecting Patient Safety – this talk will be delivered by Lori Dodson, Deputy Director of the Maryland Medical Cannabis Control Commission.

The event will begin on June 3 with an opening general session with Charles Deibel speaking to both the cannabis and food lab testing industries: The Evolution of the Lab Testing Market: A History of Food and Cannabis Testing & How Far We’ve Come

Other notable presentations include: Building a Comprehensive Analytical Testing Program for Hemp by Grace Bandong, Global Scientific Strategy Leader at Eurofins; FDA Compliance for Cannabis- Stories from a Cannabis Public Health Investigator by Kim Stuck, Founder of Allay Consulting; Evaluation of Cannabinoids Reference Standards by Shiow-Jyi Wey, Reference Standard Scientist at the US Pharmacopeia; and more.

The event is co-located with the Food Labs Conference, which will focus on regulatory, compliance and risk management issues that companies face in the area of testing and food laboratory management. More information about this event is available on Food Safety Tech. Some of the critical topics include a discussion of FDA’s proposed FSMA rule, Laboratory Accreditation Program for Food Testing; considerations in laboratory design; pathogen testing and detection; food fraud; advances in testing and lab technology; allergen testing, control and management; validation and proficiency testing; and much more.

“By presenting two industry conferences under one roof, we can provide attendees with technology, regulatory compliance and best practices that cannabis and food might share but also focused topics that are unique to cannabis or food laboratory industry needs,” said Rick Biros, president of Innovative Publishing Co., Inc. and director of the Cannabis Labs Conference.

To learn more about the agenda, speakers and registration pricing, click here. The early bird discount of $395 expires on March 31.

Innovative Publishing Company, Inc., the organizer of the conference, is fully taking into considerations the travel concerns related to the coronavirus. Should any disruption occur that may prevent the production of this live event at its physical location in Rockville, MD due to COVID-19, all sessions will be converted to a virtual conference on the already planned dates. More information is available on the event website.

India’s Cannabis Market: Examining Regulatory Frameworks Then & Now

By Shantanu Sinha, Rohit Fogla
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A Sacred Plant

In India’s ancient Vedas texts, religious scholars described cannabis as “one of the five most sacred plants.” Cannabis has been a part of India’s religious rituals and festivities for millennia. Ancient Indian Ayurvedic practices used cannabis as an active ingredient in medicines, ranging from digestion problems to blood pressure. Nearly 191 formulations and more than 15 dosage forms have included cannabis as a key ingredient in the Ayurvedic texts. The plant grows wild throughout India’s Himalayan foothills and the adjoining plains, from Kashmir in the west to Assam in the east. This accessibility and abundance of cannabis presents India with the unique opportunity to harness the plant for economic growth.

Despite the country’s long history of cannabis use, the plant remains illegal except for in government-authorised premises that produce and sell bhang (which can be either ground cannabis balls or a drink made by mixing cannabis in milk), or for research and medicinal purposes.

Regulation of Cannabis in India Today

Cannabis is misunderstood legally and industrially in India. Under the Narcotic Drugs and Psychotropic Substances (NDPS) Act of 1985, trade and consumption of both cannabis resin (charas) and the bud (ganja), are illegal and anyone found with them could face up to 20 years imprisonment. There is also a strict ban on cannabis (including hemp) production in India. Although some powers are given to the state government to grant licenses to cultivate cannabis under certain circumstances (such as for research and medicinal use), relatively few research organisations have obtained them. In fact, only the Uttar Pradesh and Uttarakhand regions, which are both in northern India, have received hemp cultivation licenses.

Kashmir region of India, the Northern-most part of the country
Image: Tanvir Kohli, Flickr

The Indian cannabis market has gathered significant attention recently, with various activists/NGOs filing court petitions demanding legalization of cannabis. They argue that the medicinal benefits of cannabis are hard to ignore, and the ideal climatic conditions for cannabis cultivation have the potential to boost the Indian economy and create millions of jobs. One of these NGOs is the Great legalization Movement, which is working to legalize the use of cannabis for medical and industrial purposes in India. In the summer of 2019, the Delhi High Court admitted a writ petition filed by GLM seeking decriminalisation of cannabis under the NDPS. The public interest litigation argues that the grouping of cannabis with other chemical drugs under the NDPS Act is “arbitrary, unscientific and unreasonable.” Although originally planned to be heard in February 2020, the hearing has been pushed back to May 1, 2020.

There is also traction among some government officials for the legalization of cannabis. Officials including Maneka Gandhi and Tathagata Satpathy have spoken in favour of cannabis decriminalisation. In November 2019, Madhya Pradesh, the second largest state in India, decided to legalize the cultivation of cannabis for medicinal and industrial purposes. As one of the poorest states in the country, it is hoped that the legalization will attract new businesses to the fore. Even more recently, it was announced in February 2020 that the BJP government in Manipur is also considering the legalization of cannabis for medical and industrial purposes.

The Market for Cannabis in India

According to a report by Grand View Research Inc., the global legal marijuana market is predicted to reach USD $146.4 billion by the end of 2025. For India, with a population of approximately 1.4 billion and a growing middle class, the potential market for cannabis products is substantial.

A number of promising Indian cannabis start-ups have arisen in recent years, some of whom are collaborating in order to grow in the domestic market. These start-ups are generally focusing on medicines, cosmetics, textiles, accessories and foods. One of the most promising is Boheco (the Bombay Hemp Company), which is backed by high-profile investors including Google India’s Managing Director Rajan Anandan, and Ratan Tata of Tata Sons. The company is agro-based and intends to reimagine the future of Indian agriculture and sustainable living with hemp. It is also a major supplier of raw material to fellow start-ups, Hempster and B.E. Hemp.

In February 2020, the India-based healthcare start-up HempStreet (who concentrate on the use of cannabis in Ayurvedic medicine) raised USD $1 million in pre-series A funding. The company will use the funding to support its technology growth, research development and to launch a new set of cannabis-based products. Abhishek Mohan, HempStreet’s co-founder said they intend to set new milestones for the medicinal cannabis sector in the country. They are also building blockchain technology to track the cannabis from seed to sale, eliminating the risk that the cannabis they grow will add to the substance abuse problem.

According to HempStreet’s founder Mohan, globally about one in five, or 1.5 billion people suffer from chronic pain. India is predicted to be ranked highest in terms of chronic pain cases by 2025, presenting a huge market for those companies who intend to create treatments for chronic pain with cannabis.

Medical Research

In government authorised research premises, India has begun its medical research of cannabis. In order for cannabis to be used for medicinal purposes, it must have both CBD and THC components in the required proportion. Research is needed on Indian cannabis to study the chemistry and breeding of the plant to ensure it is appropriate for use in medicine.

The Indian Institute of Integrative Medicine (IIIM) have taken legal license to cultivate cannabis for scientific and medical research purposes to develop products for epilepsy and cancer treatment. Under a tripartite agreement, the Council of Scientific & Industrial Research (CSIR), the India Council of Medical Research (ICMR) and the Department of Biotechnology have agreed to develop the epilepsy and cancer treatment products. The CSIR will cultivate the cannabis product and then carry out clinical work. The ICMR will then administer the clinical trials at the Tata Memorial Centre in Mumbai and AIIMS in Delhi. In February 2020, the IIIM and CSIR entered into a cross-border agreement with the Canada-based cannabis research company IndusCann. This research & development collaboration aims to create ample opportunities for developing varied medicines from cannabis. Union minister Jitendra Singh described the agreement as a “historic” achievement, and that Jammu and Kashmir will be the first in the country to develop medicines from the cannabis plant. Singh noted that, incidentally, this is happening at a time when the government is making efforts to encourage foreign investment.

Medical Cannabis Clinics

Bangalore’s Vedi Wellness Center.
Image credit: Bangalore Mirror

The doors of Bangalore’s Vedi Wellness Center opened for the first time on February 1, 2020, establishing itself as India’s first medical cannabis clinic. After five years of extensive research, HempCann Solutions will sell tablets and oils made from cannabis at the center. Since opening, the center has received over 100 calls and 25 drop-ins. The company regards Bangalore as a place that is open to new ideas and treatment methods. It was also where The Great legalization Movement began. The establishment of this center mirrors a trend in Europe, Canada and Australia in the opening of medicinal cannabis clinics. One year after the UK’s first cannabis clinic opened, it was announced in January 2020 that the UK’s Medical Cannabis Network plans to open more sites in the coming months.

Looking Forward

Despite being a trusted ingredient in the treatment of various ailments for thousands of years, the use of cannabis in modern medicine is restricted by India’s outdated cannabis laws. Although legalization is still some way off, the rising number of cannabis and hemp start-up companies, and the growing popular support for the plant’s legalization , is encouraging. Considering the medical and economic reasons in favor of legalizing cannabis, it may not be long before the Indian Government unlock the full potential that legalization would bring. For now, it will be interesting to track the success of India’s first medical cannabis clinic, and whether it will pave the way for others clinics to open across the country.


References

BBC – ‘Cannabis-based medicines: Two drugs approved for NHS’ 

Benzinga – ‘India-Based Health Care Startup HempStreet raises $1m’

Daily Pioneer – ‘India has the best cannabis hence more research is required’

Economic Times – ‘Is India losing out on a ready-to-boom cannabis market by not legalising its use?’ 

Great Legalization Movement

Grizzle – ‘Indian State Legalizes Cannabis’

Labiotech – ‘Here’s the latest new on medical cannabis from Europe and Germany’

Live Mint – ‘These Indian startups are betting on Cannabis without the high’ 

Marijuana Business Daily – ‘How India can be come a global cannabis leader: Q&A with Bombat Hemp’s Avnish Pandya’

Marijuana Doctors – ‘Medical Marijuana in India’ 

Nutra Ingredients – ‘Marijuana cultivation in India permitted for research and medicine, but nutraceuticals remain left out’

Opindia – ‘Manipur Considering Legalising Cannabis Plantation’

Quartz India – ‘Legalizing cannabis could be one solution to India’s agrarian distress’ 

The Asian Cannabis Report – May 2019

The Hindu – ‘The risks of legalizing cannabis’

The Kashmir Images – ‘CSIR-IIIM signs Agreement with IndusCann for research on cultivation of cannabis’

Times of India – ‘Delhi HC to examine plea to legalize cannabis use’

Your Story – ‘Cannabis startup HempStreet offers Ayurvedic prescription products for pain relief’

Youth Kiawaaz – ‘The Cannabis Industry: India’s Untouched Gold Mine’

Youth Kiawaaz – ‘The Complicated Relationship of India and Cannabis’

Thinking of Hiring a Cultivation Consultant? Here’s What You Can Expect

By David Perkins
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Hiring an experienced cultivation consultant is yet another cost, amongst the laundry list of never-ending expenses in the setup of a regulated, recreational grow. However, in the big picture it can actually save you a significant amount of time and money by providing you with the information you need to formulate a realistic budget, profitable cultivation site and a well-trained workforce. This article will explore just some of the many benefits a cultivation consultant can provide to your company.

An experienced consultant will have a vast array of knowledge to ensure the success of your company. One important area they can advise you on is budgeting. With years of experience cultivating, in both medical and recreational markets, an experienced consultant will have knowledge of not only start-up costs, but also hidden costs you must prepare for in advance. They will also be able to advise you on strategies to avoid future costs and problems. There may also be expenses in the build-out of your cultivation site you have not considered. For example, you may need a waste water treatment plan if you have any fertilizer run off that will flow to a sewage drain. It is important to know all possible costs when securing your investment or planning out your budget for the year.

Setting up a large-scale cultivation site in a regulated market can be extremely costly. Gone are the days of putting up a few lights in a closet; growing in a regulated market requires a larger scale, and therefore, larger costs and more complications. A consultant experienced in design and implementation of such large-scale, intricate cultivation plans will provide you with the knowledge you need to properly set-up and maintain your facility in order to ensure your company’s success. They will also know the tips and tricks to save you money along the way.

Something as simple as a centralized irrigation distribution zone can save you a lot of time and money.

A good consultant will be able to advise you on the design of your facility to ensure that the layout supports productivity, and that there is a proper workflow. It is important to hire a consultant before you get started with the build out of your facility, as it will be much more costly to have to correct mistakes in your design later on down the road. An experienced consultant will implement superior facilities layout and design to avoid future problems at the outset. Something as simple as a centralized irrigation distribution zone can save you a lot of time and money.

Once you have created the proper space, cultivation planning is important to avoid unnecessary problems from arising, which will ultimately delay profit. A well thought out cultivation plan will help you plan for success. A consultant will know what does and doesn’t work. For example, some equipment will run off an app on your phone; while convenient, there are some that don’t perform well which could end up costing the entire crop. These are things you want to know and work around, before you spend money unnecessarily.

An experienced consultant will have previously worked in various types and scales of cultivation sites, and from that experience will be able to teach you which processes and techniques work, and which ones don’t. Someone with less experience may believe that watering plants by hand would be an easy method to keep your garden irrigated, but it is actually the most time-consuming labor task (and therefore extremely costly), while an automated watering system can be very simple and cost-effective to install.

Some equipment will run off an app on your phone; while convenient, there are some that don’t perform well which could end up costing the entire crop

A skilled consultant can provide necessary training for your employees. Let’s face it, this is an entirely new industry, and therefore, most people applying for entry-level jobs at a cultivation site are unskilled. However, the best path to success when dealing with large-scale cannabis cultivation is to have skilled, happy employees. Educating and properly training your employees is essential. It helps to teach employees not only how to complete a task, but to help them understand why they are doing a given task. This will give your staff the skills and confidence they need to complete the task properly. Unskilled hands in your garden can jeopardize the success of your cultivation.

Don’t make the same mistakes others have made. Hiring a cultivation consultant can help you to avoiding problems before they occur. A professional consultant has the knowledge required to predict issues and problems before they occur, or implement a solution when corrective measures are necessary. Oftentimes issues can be avoided just by knowing the cause and effect of decisions and the potential outcomes they will have.

A cultivation consultant should also have a wide network of professional contacts to help you address any issues or problems that arise. Having a network of professionals to employ when necessary is critical for ensuring the success of every project. For example, wholesale contacts for cultivation equipment can help you not only to get the best price, but also ensure you are using the best equipment possible for your situation.

If you are still unsure about whether or not you need a cultivation consultant to help plan out your grow, or fix your grow if you’ve encountered problems, feel free to contact me to discuss your needs. I assure you there are ways I can save you money, improve your yields, and help your company be more successful in this ever-changing market.

Illinois Raises Over $10 Million of Tax Revenue in January

By Cannabis Industry Journal Staff
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After just one month of legalized recreational cannabis, Illinois is already seeing a massive return on their investment. According to the Chicago Sun Times, Illinois has raised roughly $10.4 million in tax revenue from their newly legal market ($7.3 million in cannabis tax revenue and $3.1 million in retails sales tax revenue).

When Illinois Governor J.B. Pritzker first announced their estimated budget before the market was legalized, he predicted that Illinois would generate about $28 million in tax revenue in the first six months. The totals from January more than doubling the predicted per month revenue indicates that his office’s estimates were significantly lower than reality.

Illinois Governor J.B. Pritzker

In total, dispensaries in the state did just under $40 million in sales in January, which makes it the second-largest first month rollout in the country. For reference, Illinois did $39.2 million total sales in their first month which, whereas Nevada took the #1 spot with $39.8 million.

About 35% of the tax revenue that Illinois generates will be used in the state’s general revenue fund, 10% will be spent on previous expenses, 25% goes to the Restore, Reinvest and Renew Program, an initiative for unemployment and preventing violence and recidivism, and the last 30% of that revenue goes towards mental health services, substance abuse services, public education and awareness campaigns as well as a police grant program.

Toi Hutchinson, senior adviser on cannabis control to Governor J.B. Pritzker, told the Chicago Sun Times that the tax revenue from legalization is to be spent on social equity and helping communities adversely impacted by the war on drugs. “Revenue raised in this first month will soon begin flowing back into those communities to begin repairing the damage done by the failed policies of the past and creating new opportunities for those who have been left behind for far too long,” says Hutchinson.

Product Safety Hazards: Looking Beyond Food Safety in Cannabis

By Radojka Barycki
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I think that we need to start changing the terminology around the hazards associated with cannabis from food safety hazards to product safety hazards. These hazards have not only been associated with harmful effects for those that ingest cannabis infused products, but also for those that consume the cannabis products in other ways such as inhalation (vaping or smoking). So, when we refer to these hazards as food safety hazards, the immediate thought is edibles, which misleads cultivators, manufacturers and consumers to have a false sense of security around the safety of products that are consumed in other ways.

Food processing and sanitation
By standardizing and documenting safety procedures, manufacturers mitigate the risk of cannabis-specific concerns

There are several product safety hazards that have been associated with cannabis. These hazards can become a public health problem if not controlled as they could harm the consumer, regardless of the method of consumption.

Let’s take a look at the different types of hazards associated cannabis:

Biological Hazards refer to those microorganisms that can cause illness to the consumer of a product that contain them. They are not visible to the naked eye and are very dangerous when their metabolic by-products (toxins) are ingested or their spores are inhaled. The symptoms for illnesses caused by these microorganisms will vary. Consumers may experience gastrointestinal discomfort (vomiting, diarrhea), headaches, fever and other symptoms. The ingestion of these pathogens, allergens or their by-products may lead to death, if the illness is not treated on time or if the consumer of the product is immunocompromised. In addition, the inhalation of mold spores when smoking cannabis products, can lead to lung disease and death. Some of the biological hazards associated with cannabis are: Salmonella sp., E. coli, Clostridium botulinum, Aspergillus sp. and Penicillium sp.

Chemical Hazards refer to those chemicals that can be present in the plant or finished product due to human applications (pesticides), operational processes (extraction solvents and cleaning chemicals), soil properties (heavy metals), environmental contamination (radiological chemicals) or as a result of occurring naturally (mycotoxins and allergens). Consuming high concentrations of cleaning chemicals in a product can lead to a wide range of symptoms from mild rash, burning sensation in the oral-respiratory system, gastrointestinal discomfort or death. In addition, long term exposure to chemicals such as pesticides, heavy metals, radiological contaminants and mycotoxins may lead to the development of cancers.

Physical Hazards refer to those foreign materials that may be present in the plant or finished product. Foreign materials such as rocks, plastics or metals can cause harm to the consumer by chipping teeth or laceration of the mouth membranes (lips, inner cheeks, tong, esophagus, etc.) In the worst-case scenario, physical hazards may lead to choking, which can cause death due to asphyxiation.

These hazards can be prevented, eliminated or reduced to an acceptable level when foundational programs (Good Agricultural/Cultivation Practices, Good Manufacturing Practices, Allergen Management Program, Pest Control, etc.) are combined with a Food [Product] Safety Plan. These lead to a Food [Product] Safety Management System that is designed to keep consumers safe, regardless of the method of consumption.

Comparable to Organic: How This California Company Aims to Certify Cannabis

By Aaron G. Biros
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Cannabis that contains more than 0.3% THC is not eligible for USDA organic certification, due to the crop’s Schedule I status. While some hemp farmers are currently on the path to obtain a USDA organic certification, the rest of the cannabis industry is left without that ability.

Growers, producers, manufacturers and dispensaries that utilize the same practices as the national organic program should be able to use that to their advantage in their marketing. Ian Rice, CEO of Envirocann, wants to help cannabis companies tap into that potential with what he likes to call, “comparable to organic.”

Ian Rice, CEO of Envirocann & co-founder of SC Labs

Rice co-founded SC Laboratories in 2010, one of the first cannabis testing labs in the world, and helped develop the cannabis industry’s first testing standards. In 2016, Rice and his partners at SC Labs launched Envirocann, a third-party certification organization, focused on the quality assurance and quality control of cannabis products. Through on-site inspections and lab testing, Envirocann verifies and subsequently certifies that best practices are used to grow and process cannabis, while confirming environmental sustainability and regulatory compliance.

“Our backyard in Santa Cruz and the central coast is the birthplace of the organic movement,” says Rice. California Certified Organic Farms (CCOF), founded in Santa Cruz more than 40 years ago, was one of the first organizations in the early 1990s that helped write the national organic program.

“What we came to realize in the lab testing space and as the cannabis market grew, was that a lot of cannabis companies were making the organic claims on their products,” says Rice. “At the time, only one or two organizations in the cannabis space were making an attempt to qualify best practices or create an organic-type feel of confidence among consumers.” What Rice saw in their lab was not cannabis that could be considered organic: “We saw products being labeled as organic, or with certain claims of best practices, that were regularly failing tests and testing positive for banned chemicals. That really didn’t sit well with us.”

Coastal Sun Farms, Enviroganic-certified

At the time, there was no real pathway to certify cannabis products and qualify best practices. “We met with a few people at the CCOF that were very encouraging for us to adopt the national organic program’s standards for cannabis. We followed their lead in how to adopt the standards and apply a certification, building a vehicle intended to certify cannabis producers.”

Because of their background in lab testing they added the requirement for every crop that gets certified to undergo a site inspection, sampling, as well as a pesticide residue test to confirm no pesticides were used at all during the production cycle. One of their clients is Coastal Sun Farms, a greenhouse and outdoor cannabis producer. “They grow incredible products at a high-level, commercial scale at the Enviroganic standard,” says Rice. “They have been able to prove that organic cannabis is economically viable.”

The Envirocann certification goes a bit beyond the USDA’s organic program in helping their clients with downstream supply chain risk management tools (SCRM). “Because of the rigorous testing of products to get certified and go to market, we are getting way ahead of supply chain or production issues,” says Rice. “That includes greater oversight and transparency, not just for marketing the final product.”

A good example of using SCRM to a client’s advantage is in the extraction business. A common scenario recently in the cannabis market involves flower or trim passing the pesticide tests at the lab. But when that flower makes it down the supply chain to a manufacturer, the extraction process concentrates chemical levels along with cannabinoid levels that might have previously been acceptable for flower. “I’ve witnessed millions and millions of dollars evaporate because flower passed, but the concentrated final product did not,” says Rice. “We’ve introduced a tool to get ahead of that decision-making process, looking beyond just a pass/fail. With our partner labs, we look at the chromatograms in greater detail beyond regulatory requirements, which gives us information on trace levels of chemicals we may be looking for. It’s a really rigorous audit on these sites and it’s all for the benefit of our clients.”

Envirocann has also recently added a processing certification for the manufacturing sector and a retail certification for dispensaries. That retail certification is intended to provide consumers with transparency, truth in labeling and legitimate education. The retail certification includes an assessment and audit of their management plan, which goes into details like procurement and budtender education, as well as basic considerations like energy usage and waste management.

Fog City Farms, Envirocann-certified

While Envirocann has essentially adopted the USDA’s organic program’s set of standards for what qualifies organic producers, which they call “Enviroganic,” they also certify more conventional producers with their “Envirocann” certification. “While these producers might not be considered organic farmers, they use conventional methods of production that are responsible and deserve recognition,” says Rice. “A great example for that tier would be Fog City Farms: They are growing indoor with LED lighting and have multiple levels in their indoor environment to optimize efficiency and minimize their impact with waste and energy usage, including overall considerations for sustainability in their business.”

Looking to the future, Ian Rice is using the term “comparable to organic” very intentionally, preparing for California’s roll out of their own organic cannabis program. The California Department of Food and Agriculture (CDFA) is launching the “OCal Comparable-to-Organic Cannabis Program.” Envirocann is obviously using the same language as the CDFA. That’s because Envirocann aims to be one of the verifying agents under the CDFA’s new program. That program will begin on January 1, 2021.

Large Scale Cultivation Planning: 4 Important Factors to Consider

By David Perkins
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Before you begin any large-scale cultivation project, you must necessarily consider the four factors highlighted below, among many others, to ensure your cultivation is successful. Failure to do so will cost you greatly in both time and money, and ultimately could lead to failure. While the four areas highlighted below may be the most important considerations to address, you should hire a cultivation advisor to determine the numerous other considerations you must deal with before you begin.

1. Genetics

Genetics will play a huge role in your cultivation plan, as they can ultimately make or break the success of your business. Access to quality, verified genetics will greatly affect your profits. All cannabis genetics grow differently and may require different conditions and nutrients. Further, consumers in today’s regulated market have greater awareness; they are much more knowledgeable about genetics and able to discern between quality cannabis versus commercially produced cannabis.

Market trends will dictate whether or not you’ll ultimately be able to sell your harvest at market rate. You need to project out at least one year in advance the genetics you will be growing. But often it is impossible to predict what consumers will be purchasing a year in advance so this part of your cultivation plan should be well thought out. Further compounding this difficulty is the fact that it may take six months to ramp up production of any given variety.

Genetics that are popular now may still be popular next year, but that also means there will be more competition for shelf space, as more competitors will also likely be growing these same genetics. Therefore, don’t rely on only one trendy variety as the bulk of your selection for the year, no matter how popular it is at the moment. Producing a single variety as the bulk of your crop is always risky, unless you have a contract with a sales outlet, in advance, for a set quantity of that one particular variety. Diversity in your genetics is beneficial, when chosen correctly.

Making proprietary genetics from your own seed collection can give you a big advantage in today’s competitive market. Having a variety with a distinct, unique and desirable smell, taste, effect or cannabinoid profile will allow you to distinguish your brand amongst others. Entire brands have been built off of a single variety: Cookies and Lemontree are two examples of companies that have done this. All it takes is one really good variety to attract a lot of attention to your brand. Having your own breeding project on site will allow you to look for and identify varieties that work for you and your business model, and ultimately will help to distinguish your brand apart from others.

Only buy seeds from reputable breeders! Any new varieties that you are going to be cultivating should be tested out at least three times, on a small scale, before being moved into a full production model. If you are growing from seed there is always the potential for your crop to get pollinated by male plants or hermaphrodites that went unnoticed, and therefore, they could be a potential risk to your entire harvest. Treat them accordingly, i.e. by cultivating them on a small scale in a separate, enclosed area.

Buying clones from a commercial nursery can be risky. Genetics are passed from one grower to another haphazardly, and names are changed far too easily. This can create a lot of confusion as to what variety you are actually purchasing and whether you are getting the best version of the genetics. Just because a clone is called “sour diesel” doesn’t mean you’re actually getting the real, authentic sour diesel. And to further complicate things, the same clone grown in different environments can produce a noticeable difference in flavor, smell and effect depending on your cultivation method. Always try your best to verify the authenticity of the genetics you purchase. Ask about the history and origin of the particular genetics you are purchasing. Better yet, ask for pictures, physical samples, and most importantly, certificates of analysis from a laboratory, indicating the potency. In many states anything under 20% THC is going to be hard to sell, while anything over 30% will easily sell and command the highest price. It’s a good idea to have a laboratory test the terpene profile in order to verify a variety is actually what the seller purports it to be.

Knowing the source of your genetics is imperative. It will help ensure that you actually have the variety that you were intending to grow, and therefore, allow you to achieve your intended results. Knowing what varieties you are going to cultivate, before you grow them, will also give you a better idea of the ideal growing conditions for that specific variety, as well as what nutrients will be required to achieve optimum output.

2. Automated Watering Systems

Installing an automated watering system, during build out, will by far be the most cost-effective use of your money, and will save you the most amount of time in labor. An automated watering system, commonly referred to as a “drip system” or “drip irrigation,” is necessary regardless of whether you are cultivating indoors or outdoors; it will allow you to water multiple different areas at once, or only water a few specific areas of the garden at one time. Hand watering a 22,000 square-foot cultivation site will take one person eight hours every single day, on average, to maintain. However, a properly designed drip system can water an entire large-scale garden in a couple of hours, without any employees, record all the relevant data and notify you if there is a problem. This enables you more time to spend closely inspecting the plants to ensure there are no bugs or other problems present, and that your plants are healthy and thriving. This attention to detail is necessary if you want to have consistent success.

Larger scale cultivation requires bigger and more expensive equipment.

Automated watering systems not only save a great deal of time but also eliminate the possibility of human error, like over watering, which can kill an entire crop quickly. There aresoil moisture sensors  that can be placed in the soil to regulate the supply of water to the plants in a precise manner. Without an extremely skilled, experienced work force, damage to plants due to over watering is very common. A drip system will reduce the threat of human error by ensuring delivery of precisely the correct amount of water and nutrients to each plant every single time they are watered.

Not all drip systems are created equally. There are different types of automated watering systems. Designing the right drip system for your cultivation site(s) can be complicated. Make sure you do your research, or better yet, work with a cultivation advisor who has experience with automated irrigation systems in conjunction with a licensed plumber, to ensure you are installing the best system for your particular set up.

Adding a fertilizer injector to your drip system can further increase the efficiency of your operation and save you money on nutrients by using only what you need and ensuring correct application. Again, automating this process will save you time and money, and reduce the threat of human error.

3. Nutrients

The types of nutrients you use and the amount of nutrients you use, are going to directly affect the quality of your cannabis flower. Conventional agriculture and Dutch hydroponic cannabis cultivation have always used salt-based fertilizers. However, they can be toxic for the plant in high amounts. While cheap and easy to use, salt- based nutrients are made in big factories using chemical processes to manufacture. They are not good for the environment, and overall, they produce an inferior product. The highest quality cannabis, is grown with organic living soil. Although seemingly contrary to popular knowledge, when done properly, cultivating in organic living soil is more cost effective than using powdered or liquid salt-based fertilizers.

Yield and quality depend on the skills of the cultivator, more than the method they are using. Having healthy plants from the start, will always yield better results, no matter what way they were grown. In my 20 years of experience I have seen plants grown in balanced living soil yield just as much as plants grown with synthetic nutrients. Further, the quality is not comparable.

Controlling your clone supply can ensure they are healthy

Always remember, it is the quality of your flower that will determine the price it is sold for, not the yield. Even if you produce more overall weight of chemically grown cannabis, if nobody wants to purchase that product, then you are going to yield far less profit than another company growing in the same amount of space using organic practices that yield a higher quality product.

The difference in quality between plants grown in balanced living soil versus any other method of cultivation is undeniable. It is really easy to post a pretty picture of a flower on Instagram but that picture doesn’t tell you anything about what went into producing it. When flower is produced using chemical nutrients, it is likely going to be harsh and not enjoyable to smoke. Lesson learned: don’t judge a bud by an Instagram photo! There is a stark difference between cannabis grown using synthetic nutrients versus cannabis grown in living soil. Once you’ve experienced the difference you will never want to consume cannabis that is grown any other way.

4. Plant Propagation

Having the ability to propagate your own clones, from mother plants that you have cultivated, can save you a staggering amount of money. In some states, having a cultivation license allows you to produce your own clones for your cultivation, while having a nursery permit will allow you to sell clones for commercial sales to other companies. The average price of a wholesale clone is around eight dollars. If you require 5000 plants for every harvest, that’s a $40,000 expense you must bear, every grow cycle. This can obviously add up quickly. And as previously mentioned there’s the risk of purchasing inferior genetics or unhealthy plants, both of which greatly affect your profit margins.

On the other hand, the cost of materials and labor to produce a healthy clone can be as low as one dollar when using advanced cloning techniques. Controlling your clone supply can ensure they are healthy and allow you to know exactly what you are growing each time. Further, it doesn’t take a lot of space to propagate your own cuttings. In a 400 square-foot space one could produce between 5,000 to 10,000 clones per month, all of which could be maintained by one person depending on your situation.

And last but definitely not least, the most important thing you can do to ensure the success of your cultivation, is hire an experienced knowledgeable grower who is passionate about cannabis. The success of your company depends on it. You need someone with the knowledge, experience, and skills to make your cultivation dreams a reality. You need someone who can plan your build-out and cultivation to ensure success from the start. And you need someone with the skills to handle the multitude of inevitable problems that will arise in a cost effective and efficient way.

These are just some of the many considerations you must account for when planning a large scale grow in the regulated market. An experienced cultivation advisor can help you with these, and many other considerations you will need to contend with before you begin your grow. Creating a well thought out plan at the outset can end up saving you thousands, if not hundreds of thousands of dollars down the road.

The Impact of Brexit on the Global Cannabis Industry

By Marguerite Arnold
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HMS Great Britain has now set forth from its European home port for another intriguing and very British escapade on the high seas.

So far the jury is out.

It could be the beginning of the next British Golden Age, Spanish Armada and all that. Or could it could end up (more likely) somewhere up the Khyber Pass (a sordid misadventure of British Imperialism that did not go well in the 19th century with global implications still reverberating to this day). For Netflix fans of The Crown, think “Suez Crisis” as a more recent and apt analogy. Starting with as much as a 6.7% reduction in domestic GDP already on the horizon.

Snarky historical analogies and nostalgia aside, how will Brexit influence and shape a global cannabis industry, starting at home?

The UK Is Not Actually in Regulatory Free Fall

The first thing to realize is that most of the puffery around Brexit was that with the exception of labor conditions, there is little free choice in the world of trade anymore. The players who get export and import licenses, for anything, have to conform to basic equivalency rules, no matter what they are called.

This applies to cannabis in a big way. No matter how the UK market develops domestically in other words, and that is a separate discussion.

Currently, shamefully, the domestic medical guidelines for prescription of cannabis exclude chronic pain patients and a few other obvious groups. The NHS medical market in other words, is a monopoly, set up by the current and previous governments, mainly serving GW Pharmaceutical patients who qualify for Sativex and Epidiolex. Not to mention company shareholders.

Everyone else, including those for whom these drugs do not work well, or work less well than other alternatives, are left in an international trade negotiation in their living rooms as they and or their children suffer.

The import barriers for cannabis – both from Europe and from Canada are absolutely in the room and in a very personal way for the British right now.

How they actually define cannabis, will also clarify. This will be driven now by the UK’s biggest import partners – namely Europe, the United States and Canada (although South Africa and Australia of course, will always be in the picture).

Which regulatory scheme the UK adapts, including for cannabis and of both the THC and CBD variety (not to mention other cannabinoids), in other words, will at minimum have to be broadly equivalent with all of the above. Not the other way around. No matter how much the Food Standards Agency (FSA) wants to fuss and fiddle with “Novel Food.” That alone is a canard.

Cannabis is a plant. It is time to start acting like that. And it is no more “novel” than tomatoes in many, easy-to-understand environments, including commercial ones. Not to mention will increasingly be regulated like commercial food crops – even if those crops are then also bound for dual purpose medical use.

The regulators will eventually get there – but not without a lot of tortuous twists and turns.

A “New” Market? Not So Much…

There is a lot of consultant palaver and baloney in the room right now. There is no more a new market in the UK as there was in Germany (or Canada or Colorado). Local producers are already organizing, and on the hemp front. The big ones are hip to regulations and are getting certified to enter it. Everyone else is being left on the dangerous sharp end of police raids, even with prior local approvals.

GW logoThat said, foreign producers are of course looking at the UK right now, and in a big way. The lock GW Pharmaceuticals has on the domestic market will not hold long. European producers are absolutely in the room (starting with Tilray in Portugal and Alcaliber in Spain). Not to mention what is going on in other places right now, even if of less well-known corporate branding.

Every big Canadian company is already in the room in the UK, and many Americans are now beginning to show up in the market.

However, for the most part, such ventures are doomed outside of conference sponsorships until the regulatory questions are answered if not met.

And that includes federal certifications that are easy to find – there is no one single authority that handles cannabis internationally. And there never will be. Supply chains are already global.

A Perfect Export Market

One of the biggest, so far widely discussed questions is who in Europe will start exporting to the UK (forget Holland for the moment). Not to mention producers in Spain, Greece, Poland if not Macedonia. That conversation is also on the table now. For the first time, so is Germany, and on the medical side.

Pharmaceutical producers in particular who meet international pharma standards may be the best hope yet – although right now policy makers are still looking at cars rather than cannabis to help keep Germany’s trade export quota where it feels “comfortable” domestically.

Image credit: Flickr

That too will change. And fairly quickly. See Greece, if not South Africa.

The political roil of branding and politics afoot in Germany right now makes this new kind of export market idea as a part of economic development, an inevitability.

Not to mention, at least for the present, a reverse trade in regulated British CBD products – if producers are smart about regulations – throughout the continent right now.

Of all countries, outside Switzerland, the UK has the ability to develop a broad and intriguing market in the EU – but only if they are compliant with regulations in Europe.

And this is where the policy makers in Parliament and 10 Downing Street have already misjudged if not broadly misled, not in a regulatory environment of their own, but in fact in a diplomatic “room” where the rules are already set via international standards and certifications, not to mention treaties.

Soapbox

Destination Cannabis Europe: Employment in the Industry

By Marguerite Arnold
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It is obviously not just at conferences but now on the ground in Germany and across Europe that Americans are heading to the industry here. And it is not just the “new” cultivation guys at Demecan in Berlin (currently hiring), or in Guernsey, but in truth, throughout the industry.

Wish you were here? Here is the broad skinny to actually getting (and keeping) a job in the industry in Europe.

Get A Job Before You Come

By far, the easiest and safest way to come to a new country, like Germany (or the UK for that matter) is to have pre-arranged employment. That is also beginning to happen, as large companies set up grow and manufacturing facilities throughout Europe. That said, these are hard to come by (there are many Germans and other natives vying for the same jobs). However so far, certain kinds of experience in the U.S. (or Canada) beats anything that has gotten going here so far from the cultivation side and many other aspects of the biz.

But – and this is a big one – you have to have the kind of experience that counts. Regulated industry participation is a must on your CV if this is your preferred route of travel. Pharmacists in particular, could have a fascinating career path here not open in the United States at all yet. So will doctors – but that certification has to be earned here to practice.

It is also far easier to deal with the paperwork that is required than it used to be ironically – in that there are new qualifications being set out for the same in both the UK and Germany at the moment. Understanding them, however is another matter, and interpretation at the immigration office is not something you want to sign yourself up for. In any language.

european union states
Member states of the EU, pre-Brexit

However, immigration law is just the beginning on the regulation front. Regulations across the cannabis industry are also changing fast – and not just under the heading “cannabis.”

Nothing, really is “easy” about being an expat. You have to want to do this.

There are now starting to be numerous European job postings in the industry on Linked In. It is a great place to start. Having B1 Deutsch (third level, very hard to pass, intensive German language certification) is usually a must for employment (not to mention getting around in the country).

Disclosure: This journalist failed A1 German in Germany (introductory level) twice. Starting from scratch is not recommended, because the rest of your class (usually with previous German training) will kick your butt in numbers bingo by the end of the first week. Learning – including punctuation and spelling 50 new vocabulary words a week is pretty standard. And that is before the grammar. All taught in German too! Four hours a day, five days a week.

Yes, your class will laugh at you, even if they think you are otherwise cool as a North American.

It also helps if you have taken at least one German language course (as in college semester level) before you come. Otherwise you will hit unbelievably intimidating compound words that take up a great deal of space on a page and four different tenses that even native Germans do not really understand by the end of the second week (and it is mind-blowing). You learn to appreciate Mark Twain’s humour about the dratted language very quickly, not to mention that the umlaut is really the only thing you have any freedom of expression with.

Be prepared to sign up for language courses when you land with the local VHS (Volkshochschule) – which is sort of like German community college for anything you want to take classes in. It is also the cheapest deal on language courses around. The private ones are pricey.

That said, master the lingo, even passably, and Germans are super pleased about the same. No matter how badly you mangle the language, they are just happy to hear you try.

Student Visas and the Educational Path

By far, the easiest path to starting your journey overseas, is luck. The second one however, is actually one way to go if you are prepared to work yourself to the bone, and do it while learning German intensively. Plus get a university level or graduate degree along the way.

If Cannabis Europe is your dream job and vocation, you will make it happen. Just don’t expect it to be easy, or just like anywhere else.Go first as a language student. That gets you two years, fairly easily, as long as you have €8k in your bank account at all times, and do not work at a German job. That is verboten. However, as an American, particularly in Germany, you still have the right to come here and learn.

There is also about to be a fairly ground-breaking immigration law that comes into effect as of March in Germany that allows highly skilled foreigners to earn their way to citizenship. There is a list of requirements that go along with this, of course. The path to being able to stay includes getting a higher German degree or special German training. Expect pretty much the same thing from post-Brexit Britain too – just in the same language.

You also have to have health insurance and a lot of other things taken care of. It is not a sudden move or jump. For all the amazing things that come with this, also be prepared to think about looking in the mirror at least a few times and thinking “am I stupid, what on earth have I done?”

Then there is location. A Kreuzburg address may impress the folks back home, but those are not cheap these days, and extremely hard to come by. Rent, in general, and not just in Berlin, is beginning to be a real issue in every German city. Finding an accommodation that you can afford in “starting out” circumstances – is not easy right now anywhere.

But it’s not just about rent or the buzz you might have heard. Don’t just put Berlin on the map (or even Munich, also a growing professional scene). Both cities are far from the center of the cannabis scene in Europe, much less Germany although there is a lot going on all the time there. Dortmund, and the Ruhrgebeit in the former “Rust Belt” of Germany are much cheaper, full of students, and popping with cannabis reform all over. Cologne is also a very interesting city right now. So are Bremen and Stuttgart.

The Differences Are Large Besides the Language

No matter what you think you can expect, the only thing you can rely on is that just about everything will not be the same. Yes, German beer fests and bratwurst are comfortingly familiar to be accepted easily. But when it comes to really immersing yourself in a country well enough to think of it as “home”, let alone understanding the vagaries of this business in particular? Just about everything is different. This ain’t Kansas, (or Colorado, for that matter) Dorothy.

Bottom line? If Cannabis Europe is your dream job and vocation, you will make it happen. Just don’t expect it to be easy, or just like anywhere else.