Tag Archives: regulations

January 23, 2020

Israel Imports Cannabis: What Happened to Exports?

By Marguerite Arnold

Canndoc, an Israeli medical cannabis producer, just received a shipment of 250kg of dried whole flower cannabis. The company, a subsidiary of InterCure, just signed a strategic cooperation agreement with Canada’s Tilray.

Interestingly the agreement is both for the import and export of flower. So don’t count out a stream coming the other way. Or, more likely, the export of seed and cannatech related to the same.

Everything goes both ways – yin and yang. Even in this industry.

However what this also does is set up Tilray to have an excellent shot at being partnered at least with the first Israeli exporters when local demand is satisfied. And that, given their strategic footprint globally, but particularly in Europe, is a very unique advantage in a cannabis map that is shifting, literally, as the year becomes the new decade.

What Gives With The Ex-Im Discussion Anyway?

Israeli producers have longed for the day when they can bring their considerable tech and research advantage if not plant genomes and medicines to a global market. The medical program in Israel was originally funded largely by American federal money while domestic reform was fought, tooth and nail until the middle of the last decade. And of course so far, at least, despite Illinois clocking over into the 11th recreational state as of January 1 of this year, has remained stalled on a federal level in the U.S.

However, no matter the shifting politics of Israel (where lets not forget, the government is also mired in scandals and it appears the Israeli president, Benjamin Netanyahu delayed the export of cannabis in a deal with the U.S. to move the capital to Jerusalem), one thing was made clear last year by government officials: Israelis come first.

It is likely to be an attitude that spreads – particularly in places like Europe and even more so Germany. So far, the entire market here has been met with imports. This is the first year that there is regular medical production hitting pharmacy shelves thanks to Demecan and the former Wayland (now ICC).

Indeed, Wayland basically did the same thing in Germany as Tilray is doing now in Israel, although the firm had to sink a huge capital expenditure into setting up its cultivation sites. And at far greater cost.

Tilray appears to be hitching a ride on an existing industry to expand its reach, markets and of course, IP. Israeli cannatech, for sure, is going global.

How Could This Impact Other Discussions?

There are two places this development is likely to impact policy discussions outside of Europe where home grow has, let’s not forget, also hit Italy in the last months. But similar ripples are afoot everywhere right now – from Portugal and Spain to Greece. While exporting can be a lucrative game, should it come at the expense of domestic citizens?

The first place this issue has already been a theme is obviously Canada, where this spectre was much in the room last year as the country transitioned to recreational while its top companies also established themselves abroad. In Europe this was mostly done without cultivation domestically except in a few rare instances. See Tilray in Portugal, Demecan in Germany, ICC in Italy and all of the partnerships between the top Canadian cultivators and Danish, Greek and Maltese producers.

The second place this will undoubtedly have an impact, however, is very much likely to be the United States. While most pundits agree that federal reform is at least a year or so off (roughly equivalent with European change of a recreational kind), this discussion is already in the room.

These days, six years after Colorado and Washington State upped the ante, companies may operate separate operations in multiple states, but of course, cannot ship across the border of any of them.

As soon as federal reform hits however, also expect to see these discussions going on at a state level across the United States. With healthcare devolving very much to the states, locally grown cannabis is going to play a major role in all of these discussions (starting with the opioid epidemic). If not, as many expect, an influx of cannabis from south of the border.

Those days, however at least in the U.S. are still several years away. In Israel, however, as Tilray lines up a unique profile across all of said jurisdictions, look for intriguing cannabis developments coming soon, in multiple jurisdictions.

January 20, 2020

Preventing Mold & Fungus in Cannabis with Data Analytics

By Leighton Wolffe

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Cannabis legalization has taken the United States by storm, with 33 states approved for medicinal cannabis use — 11 of which are also approved for recreational use for adults aged 21 and over. With new patients and consumers entering the market every day, it’s more important than ever for cannabis cultivators to establish more effective methods for mold and fungal prevention in their crops and to ensure consumer confidence in their brands.

Today, many cultivators address the risk of mold and fungus growth by testing crops for contaminants at the end stage of production. While this helps to catch some infected product before it reaches the market, this method is largely ineffective for mold and fungal prevention during the cultivation process. In fact, recent studies have shown an 80% failure rate in mold and fungal testing in Denver cannabis dispensaries. By relying on late-stage, pass/fail testing, cannabis entrepreneurs also expose themselves to increased risk of lost crops and profits.

Photo credit: Steep Hill- a petri dish of mold growth from tested cannabis

However, emerging sensor technologies exist that can test plants during the grow process, significantly reducing the risks associated with cannabis cultivation while increasing the bottom line for commercial grow operations. By leveraging data from these monitoring sensors along with environmental automation systems that are integrated with data analytics platforms, cannabis professionals can take a proactive approach to achieve the ideal environmental conditions for their crops and prevent against mold and fungal infestation.

Common Causes for Bud Rot in Indoor Growing Systems

Botrytis cinerea — commonly known as “bud rot” — is a pathogenic fungi species that creates a gray mold infection in cannabis plants. An air-borne contaminant, it is among the most prevalent diseases affecting marijuana crops today and can lead to significant damages, particularly when left untreated during post-harvest storage. Bud rot is one of the most difficult challenges cannabis entrepreneurs face: Once plants have been affected, only 2% can be expected to recover. This is because Botrytis cinerea can use multiple methods for attacking host plants, including using the plant’s natural defenses against it to continue infestation.

While difficult to contain, bud rot is very easy to spot. Plants affected with the fungus will begin yellowing, experience impaired growth, and develop gray fungus around its buds. Overall crop yield will be significantly reduced, leading to decreased profit for cannabis cultivators. The biggest contributing factors to a Botrytis cinerea infestation are as follows:

Humidity: Indoor grow facilities that maintain humidity levels in excess of 45% are breeding grounds for mold and fungus. These environments can become perfect conditions for mold and fungal growth.
Temperature: Bud rot typically thrives in environments where temperatures fall between 65- and 75-degrees Fahrenheit, which is why greenhouses and grow rooms are often the victim of such infestations.
Ventilation: Poor airflow is another contributing factor to Botrytis cinerea Without proper ventilation, excess moisture buildup will eventually result in mold and mildew growth.
Strain: Some marijuana strains are better equipped to fend off bud rot infection. In particular, sativa plants have a higher resistance to mold development than their C. indica and C. ruderalis cousins.

Controlling mold and fungal growth in commercial grow facilities is a top priority for cannabis cultivators. Not only detrimental to their profitability and crop yield, infected plants can pose serious health risks to consumers, especially for immunocompromised patients. Consuming cannabis products that have been compromised by bud rot or other mold and fungal infections can cause a wide range of medical concerns, including pneumonitis, bronchitis, and other pulmonary diseases. As a result, growers are required to dispose of all infected plants without the possibility to sell.

Bud rot isn’t the only culprit responsible for cannabis plant destruction. Powdery mildew, Fusarium, sooty molds, and Pythium all contribute to the challenges faced by cannabis professionals. In fact, a recent study conducted by Steep Hill Labs and University of California, Davis – Medical Center found that in 20 randomly-selected samples submitted for testing, all samples showed detectable levels of microbial contamination⁷. Many of these samples also contained significant pathogenic microorganism contamination. Without proper detection and prevention methods in place, these pesky plant-killers will only continue to terrorize the cannabis cultivation industry.

The Current Cannabis Cultivation Landscape

The data is clear: Current practices for cannabis cultivation are insufficient for preventing against mold and fungal growth. Sterilization and pass/fail testing do not identify the root cause of harmful infestations in plants, therefore leaving cannabis professionals in the dark about how to better optimize their grow conditions for improved crop reliability and safety. In order to prevent against damages incurred from mold and fungal infestation, marijuana growers must be more diligent in their grow condition monitoring practices.

Many cannabis professionals rely on manual monitoring to identify environmental changes within their indoor grow facilities. While it’s important to collect data on your operation’s essential systems, doing so without the right tools can be time-consuming and ineffective. Manual monitoring often relies on past data and does not illustrate the relationship between different systems and their impact on environmental changes. The goal is to assemble data from all the grow systems and create correlations on actual bio-environmental conditions during the grow process to compare to yield results. This is only available when an information management platform is synthesizing data from all the systems within the grow facility and presenting meaningful information to the growers, facility operators and owners.

Especially as the cannabis industry is expected to grow exponentially in coming years, growers need more robust tools for tracking and manipulating environmental changes within their indoor growing systems.

Leveraging Building Automation Systems & Data Analytics in Cannabis Cultivation

A powerful approach to prevent environmental conditions that are known to lead to mold and fungus growth exists in leveraging the data produced from your grow facility’s various automation systems. Most commercial cultivation facilities have multiple stand-alone and proprietary systems to control their indoor environment, making it difficult to not only collect all of this valuable data, but also to achieve the level of grow condition monitoring necessary for mold and fungal prevention.

With some data analytics platforms, such as GrowFit Analytics, data is collected across disparate systems that don’t normally communicate with one another, providing access to the key insights necessary for achieving environmental perfection with your cannabis crops. A viable solution collects vital grow facility system data and relevant bio-environmental monitoring data, and delivers this information in one, centralized software interface. The software then will apply analytic algorithms to develop key performance indicators (KPIs) while working to detect system anomalies, faults, and environmental fluctuations. The right analytics solution should also be customizable, allowing you to track the KPIs that are most important to your unique facility, and to achieve the vision of your chief grower. Ultimately, the software should serve up actionable insights that empower facility management and growers.

Sample data visualization dashboard from GrowFit Analytics showing real-time Temperature and Relative Humidity readings and indicating potential Mold Risk as defined by the Grower.

Collecting reliable data from different grow facility systems and environmental sensors can be a complex process and the information collected illustrates more than just what’s working right and what isn’t. By implementing an advanced data analytics solution, cannabis cultivation professionals can now be empowered to track minute details about their indoor grow facility, providing a safer, healthier environment for their crops and avoiding those environmental conditions that lead to mold and fungus altogether.

An ideal data analytics platform won’t simply collect data to be analyzed at a later date, and simple trending of sensor data is not enough. Information — especially in a commercial grow facility — is time-sensitive, which is why growers should select a system that offers real-time analytics capabilities. Some platforms offering real-time analytics utilize cloud computing, allowing for easy access from anywhere while also providing enhanced security to protect sensitive facility data. The most robust data analytics platforms provide detailed historical data for your entire crop’s lifecycle that provide a “digital recipe” to replicate successful crops, and fine-tune the process for continuous improvement.

Data analytics tools can also impact the bottom line by lowering operational costs. GrowFit Analytics, for example, was born out of a software solution designed to lower energy costs for large complex buildings like commercial grow facilities.

The data and insights provided can help identify opportunities for greater energy efficiency, which can lead to significant utility savings. Grow facilities operate 24 hours/day, with energy expenses representing one of the largest operational costs. With data analytics tools at their disposal, facility managers are armed with the information they need to improve system efficiency, increase energy savings, and improve profitability.

Eliminating Mold & Fungus from the Future of Cannabis Cultivation

By focusing on grow condition monitoring using data analytics tools, cannabis professionals can effectively eliminate the risk of mold and fungus growth in their crops. Leading data analytics tools make tracking environmental changes simple and easy to manage, allowing cannabis professionals to take a proactive approach to mold and fungus prevention. As we look to the future of the cannabis cultivation industry, it’s paramount for professionals to explore the technological advancements available that can help them address their business’ most pressing challenges.

January 20, 2020

How Cannabis Businesses Can Prepare for Tax Season

By Melissa Diaz

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A Little About 280E

The 280E statute bans businesses from deducting business expenses for gross income associated with the trafficking of Schedule I or II substances. While other businesses can deduct any number of expenses when filing their taxes — employee salaries, rent, equipment, electricity, etc. — 280E limits cannabis companies to only expensing deductions directly related to earning a profit, or the cost of goods sold (COGs).

For example, a dispensary whose square footage is split between 60% sales floor and 40% lobby may only deduct 60% of rent expenses because that’s the portion dedicated to COGs. Transactions do not occur in the lobby, so that portion of the rent is not deductible.

So long as cannabis remains a Schedule I substance, companies that produce, sell and otherwise touch the plant in their operations must comply with 280E.

Tips for Tax Success

While taxes can be complex and stressful for cannabis businesses, it is possible to limit the headaches. With tax season right around the corner, here are a handful of tips to ensure a successful filing.

Close Out Your Books. Before tax preparation can even start, cannabis businesses want to make sure to close out their financials for the previous year. It may sound like a no-brainer, but with the extra scrutiny facing companies in the industry and the nuances of 280E, it’s extremely important to have fully reconciled and closed-out books to work from when preparing taxes. Incomplete books can cause delays and add unnecessary extra stressors to the process that could result in penalties or additional liabilities.
Consult a Cannabis Tax Professional. Once books are ready to go, it’s time to consult a tax professional who has experience in the cannabis industry. A cannabis-focused tax pro will be familiar with the intricacies of 280E and and will be able to identify relevant business expenses to ensure compliance and limit liabilities. In addition to 280E issues, a competent accountant will also be able to highlight any other tax code changes that may impact a business. Every business is different — even in the cannabis industry — and since the tax code is large, complex and prone to new rules and interpretations, it’s important to have a strong accountant guiding the way.
Justify Your Numbers. After consulting with a tax professional and identifying relevant business expenses, it’s time to back up the numbers. This is where strong record-keeping comes into play. Ongoing regulatory hurdles limit cannabis firms’ ability to participate in the financial system where, generally, record creation is inherent with each transaction. But in a cash-heavy industry like cannabis, record creation and retention fall on the businesses themselves. This is because cash transactions don’t come with any built-in records. That inherent lack of documentation is yet another potential pitfall for cannabis businesses and taxes since large amounts of cash often raise eyebrows at the IRS. It is up to businesses to provide adequate proof of their tax numbers. Since the IRS will put zero effort into investigating the accuracy of your numbers, it will likely assume the worst when reviewing your filing.

Preparation is King

Taxes can be stressful. But they don’t have to be. Navigating tax season as a cannabis business is all about preparation. By putting in the work and partnering with an experienced tax professional, cannabis operators will be able to avoid penalties, limit their audit risk and stay on track with their business goals.

January 17, 2020

Food Safety: What it Means and How ERP Helps Edibles Manufacturers

By Daniel Erickson

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The diverse cannabis industry has experienced tremendous growth, especially in the popular edibles market whether consumed recreationally or medicinally. Since these cannabis-infused food and beverage products come in a variety of forms, including candies, baked goods, energy drinks, chips, chocolates and teas, food safety questions and concerns for companies manufacturing these products can seem daunting. ERP software solutions designed for the cannabis industry play an imperative and necessary role in addressing key food safety issues for edibles producers, helping to fill in the gaps where new and established businesses struggle. By mitigating the potential for damaging effects of a food safety event, companies can prevent, or greatly lessen the impact, to both their reputation and public perception, as well as limit the financial liability and legal penalties.

What is safety?

On a fundamental level, safety is the state of being protected from undergoing or causing hurt, injury or loss. As a manufacturer of cannabis edibles, it is critical that products are consistent, labeled appropriately and safe for consumers. Forward-thinking companies are employing ERP solutions to help ensure their products are not harmful to their current and future customers.

A lack of safety in the cannabis edibles market stems from the unregulated nature of the industry on a federal level, despite consumers’ expectations otherwise. Similar to products in the food and beverage industry, safety issues with inaccurate labeling, food-borne pathogens and disease outbreaks are all concerns within the manufacturing environment. Particularly to cannabis businesses, extraction methods, bacteria and mold growth, pest and pesticide contamination, chemical exposure, improper employee handling and the unintentional consumption or overconsumption of edibles are all potential safety concerns. In states where edible products are legal, local municipalities and state governments each have their own unique regulations – requiring manufacturers to comply to different guidelines. With the absence of federal regulations, many cannabis companies have adopted a more conservative approach to food safety. Following U.S. Food and Drug Administration (FDA) guidelines and Food Safety Modernization Act (FSMA) best practices allows manufacturers to address key current food safety issues and prepare for future regulation.

Utilize Best Practices and ERP

Introducing current Good Manufacturing Practices (cGMP’s) traditionally implemented in the food and beverage industry help to form a foundation for cannabis edibles safety in 9 key areas:

Personnel – As an often-overlooked aspect of cannabis edibles manufacturing, adequate training on procedures to ensure disease control and proper cleanliness is required to maintain a company culture of safety. Advocating for quality standards with proper safety procedures should be a priority for every employee.
Manufacturing Environment – Effective management of the manufacturing environment ensures that facilities are controlled to prevent the contamination of finished goods – restricting extraneous materials such as glass, metal, rubber, etc. from the production floor. Warehouse and office lighting should be adequately maintained so that employees are able to inspect equipment, by-products and finished goods and conduct their jobs effectively.
Sanitary Operations – Physical facilities and all equipment must be maintained in clean and sanitary conditions and kept in good repair to prevent food and beverages from becoming contaminated. Cleaning processes should protect ingredients, work in progress, finished goods and workspaces from potential contamination.
Sanitary Facilities and Controls – Effective control of water, plumbing, sewage disposal and drainage are essential. Staff must have access to adequate handwashing and restroom facilities and employee changing rooms. Restrooms and break rooms should be clean and stocked at all times, while garbage is handled properly and disposed of in a timely manner.
Equipment and Utensils – Properly cleaning and maintaining vats, conveyor belts, shrink wrap machines, blenders, etc. to avoid contamination and allergen cross-contact ensures safe procedures are being followed. A robust sanitation program with defined cleaning schedules should be followed for the sanitizing of utensils and equipment.
Processes and Controls – The manufacturing of edible products should be done in accordance with best practices established in the food and beverage industry, taking account of sanitation, quality control and protection from allergens and contamination. Ongoing testing is conducted to identify sanitation failures and contamination occurrences and ensure items are discarded properly.
Personal Protective Equipment (PPE) can reduce the risks of contamination
Warehousing and Distribution – Establishing proper storage and transportation processes protects the products from contamination, allergen cross-contact and container deterioration – ensuring proper handling procedures throughout the growing, manufacturing and distribution steps.
Defect Action Levels – Quality control is used to minimize defects by requiring an action response when a problem is discovered. An established response plan demonstrates the proper procedures to follow when defects occur during production.
Holding and Distribution of By-products for use as Animal Food (if applicable) – This applies to food and beverage facilities that either donate or sell a by-product for use as animal food. By-products used for animal consumption that are managed properly remain free from contamination. Accurate labeling should identify by-product by the common or usual name and denote not for human consumption when distributed.

Cannabis-specific ERP solutions efficiently provide the structure, integration and processes to follow cGMP’s to address food safety concerns in all phases of growing, manufacturing and distribution. By automating the documentation of audit trails, edibles companies are equipped with the same tools that food and beverage manufacturers have utilized for decades. Validated procedures and best practices incorporate safety initiatives from cannabis cultivation to the sale of edible products and beyond, offering greater efficiency than manual methods. Since cGMP’s provide a foundation for Hazard Analysis Critical Control Points (HACCP) planning, edibles manufacturers are able to take advantage of incorporating control points into the ERP solution to prevent and control hazards before they affect food safety. Having a HACCP Plan, along with proper implementation and adherence to cGMP’s, helps to minimize food safety hazards for edibles manufacturers in the cannabis industry.

Quality and safety in the cannabis edibles market is an area that cannot be ignored, as the consequences for failing to handle hazards are potentially devastating. Savvy cannabis companies are employing best practices of food and beverage manufacturers, including the 9 addressed above, in tandem with an ERP software solution, to effectively navigating this highly competitive market. Paving the way with their commitment to quality and in delivering safe and consistent products to the market demonstrates to customers and investors alike their preparedness for growth.

January 15, 2020

Practical Advice on How to Avoid a TCPA Suit

By Paul Gipson

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Texting consumers is a very effective means to drive engagement and ultimately sales. Text messages have outpaced emails when looking at conversion and click-thru rates. In fact, 95% of texts are read in ninety seconds or less! While text messages can be a great way to engage with prospects and customers, the FCC’s Telephone Consumer Protection Act (TCPA) is a regulation you need to be mindful of. In fact, the average cost of a TCPA settlement is over $6m dollars, which doesn’t include legal fees or reputational damage.

Over the past few years, there have been about 4,000 TCPA cases filed annually. Take a look at the growth:

Companies are being targeted for various reasons, but there are a few that I’ll cover below along with some advice on how to avoid TCPA suits.

See if you can spot the trend in these cases:

Papa Johns: $16.5m settlement due to texting pizza specials to consumers without their consent.
Abercrombie & Fitch: $10m settlement due to texting store promotions to consumers without their consent.
Rack Room Shoes: $26m settlement for texting their reward program members with various sales without their consent.

Do any of these campaigns sound like something your company is engaged in?

So, you’ve got someone who has signed up for a rewards program, wants to receive deals, or has provided their number to your company for other purposes, but you are concerned about the TCPA (hopefully). Based on my experience working with hundreds of clients at CompliancePoint, here’s where I think you should start. But first…

Quick assumption: Your company is using an automated system to send both informational and promotional texts. Examples include “blast campaigns” (upcoming sale) or “triggered campaigns” (signed up for rewards).

Quick point: Just because the text message says your store is having a sale but doesn’t ask the consumer to buy anything on the message, you may think it’s not considered “telemarketing”. This is wrong. Any plan to sell now or in the future through direct marketing is telemarketing and subject to the TCPA.

Here are my top 5 things to consider:

Obtain consent. This is not achieved by simply having a number provided by the consumer. Instead, the consumer must affirmatively agree to receive promotional calls/texts by automated means. This is done through a clear disclosure and often accompanied by an unchecked checkbox.
Honor opt-outs. This seems obvious right? Provide instructions on how to opt-out and look for other phrases like “stop/quit/cancel”. Opt-outs should occur immediately with most common texting platforms.
Keep records. If you receive a complaint, you want to be able to respond confidently and records help you do that. The key records to maintain are your texting records (the phone numbers you texted, the date/time of the text, and the content of the text), your consent opt-in forms, and opt-out requests from consumers with dates. Ask yourself: what records do you need to prove you had consent, and what records prove you didn’t text a consumer after they opted out.
Only text consumers between the hours of 8AM and 9PM according to their time zone. I always recommend going off address and not phone number due to cellphone mobility. If you text a California number at 8PM, but the phone owner lives in New York, you might get a few complaints.
Monitor compliance with these items. Another one that seems obvious, yet most companies fail to do so, and you see above what happens. I guarantee you’ll find issues with most audits.

Bonus – here is a more comprehensive checklist on how to achieve a Safe-Harbor defense.

This article is not intended to be a scare tactic. The TCPA legal landscape is rampant and consumers are more aware now than ever of their rights. A quick Google search of “Cannabis TCPA” helps to illustrate the fact that this industry, like most, is not immune. However, with proper compliance parameters in place, your company can enjoy the benefits of texting with consumers with peace of mind.

January 14, 2020

PharmLabs Accredited to ISO 17025

By Cannabis Industry Journal Staff

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According to a press release emailed today, Perry Johnson Laboratory Accreditation Inc. (PJLA) announced the accreditation of PharmLabs LLC to ISO/IEC 17025. Based in San Diego, California, PharmLabs has four locations, with three in the Southern California region and one in Maui.

PharmLabs offers a very wide variety of services including: California Compliance testing, a specialized Hemp Testing Program, Hemp Biomass Verification testing, and THC-free testing for the state of California. In addition, they offer the testing of cannabinoids, pesticides, residual solvents, microbiological contaminants, mycotoxins, heavy metals, terpenes, water activity, moisture content, and filth/foreign material testing.

“Our experience with [Perry Johnson Laboratory Accreditation] has been incredible over the years. Since we have multiple locations, we have had many visits with PJLA and their knowledge and quick response time has helped us get where we need to be,” says Greg Magdoff, founder of PharmLabs.

According to the press release, PharmLabs has plans to expand throughout the state of California and the rest of the United States in both hemp and cannabis testing in legal states.

January 14, 2020

PJRFSI Introduces Cannabis Safety Standard for Manufacturing

By Amy Wayne

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With the rapid expansion of the cannabis industry in North America, there are more questions than ever about the safety and integrity of the new products constantly flooding the market. It seems as if there’s something new hitting store shelves every day, and as legalization spreads across the United States, the market is widening to an increasing range of consumers. But just how safe are all these new products? With regulations and requirements varying state to state, how can new medical and recreational users be certain of a product’s potency, safety, or other qualities?

Certification of products is a likely answer. Much like how requirement of food safety standards has helped ensure produce and manufactured foods are safe to eat, a cannabis safety standard can help guarantee a safe, thriving industry. Perry Johnson Registrars Food Safety, Inc. (PJRFSI) now offers specialty certifications to cover all facets of the cannabis industry, based on successful food, agricultural and pharmaceutical safety certifications. From growing and harvesting to production or extraction, there are streamlined and effective resources available for everyone.

Since requirements vary so widely from coast to coast based on state mandates, PJRFSI cannabis certifications are custom-tailored state by state, and based on Good Manufacturing Practice (GMP) guidelines. In addition to this fully-customizable approach, PJRFSI is part of a family of companies that have worked with cannabis testing lab accreditation for years; numerous producers have already partnered with PJRFSI to develop their own custom cannabis quality audits. Not only have our specialists worked with producers and industry players, but with state regulators and lawmakers as well in providing input for cannabis program implementation. Download the PJRFSI standard for free today!

To learn more about designing your own customized cannabis quality and safety certification audit, or to hear more about just why PJRFSI certification may be the best option for your operation, give us a call at (248) 519-2523, or visit www.PJRFSI.com.

January 9, 2020

The Power of Prevention: Pathogen Monitoring in Cannabis Cultivation and Processing Facilities

By Nathan Libbey

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As the cannabis market matures and the value chain becomes modernized, it’s important to address product safety in a comprehensive way. In other areas of manufacturing, Hazard Analysis & Critical Control Points (HACCP) has been the standard for reducing hazards both for employees and for the products themselves. A Critical Control Point (CCP) is any spot from conception to consumption where a loss of control can potentially result in risk (Unnevehr, 1996). In the food realm, HACCP has been used to drive quality enhancements since the 1980s (Cichy, 1982).

In a nutshell, HACCP seeks to help identify where a problem may enter a product or environment and how that problem may be addressed before it escalates. In cannabis, these hazards include many of the same problems that food products have: specifically molds, yeasts, and pathogenic bacteria (Listeria, E. coli, etc.). While the current industry standard is to test products at the end stage for these contaminants, this late-stage pass/fail regimen leads to huge lots of destroyed product and a risk for consumer distrust (Yamashiro, 2019). HACCP, therefore, should be applied at every stage of the production process.

Pathogen Environmental Monitoring (PEM) is a tool that can be used to identify CCPs in a cannabis cultivation or processing facility. The main goal of a PEM program is to find a contaminant before it reaches a surface that touches the product or the product itself. PEM is conducted using a pre-moistened swab or a sponge to collect a sample from the cannabis environment. The swab can then be sent to a lab for microbial testing. Keys to an effective PEM are:

1. Start with a broad stroke – When the FDA comes to a facility suspected of producing pathogen-laced food products, they conduct what is known as a Swab-a-thon. A Swab-a-thon is a top to bottom collection of samples, usually totaling 100 or more. Similarly, preemptively swabbing should be the first step in any PEM—swab everything to see what exists as a baseline.

2. Map your scene – identify on a map of your facility the following:

Cannabis contact surfaces (CCS) (belts, clippers, tables, etc)
Non-cannabis contact surfaces (Non-CCS) (floors, lighting, drains, etc)
Flow of air and people (where do air and people enter and where do they go?

Identifying the above zones will help deepen your understanding of where contaminants may come into contact with cannabis and how they may migrate from a Non-CCS to a CCS.

3. Plan and execute:

Based on the results of mapping, and Swab-a-thon, identify where and when you will be collecting samples on a consistent and repeatable basis. Emphasis should be placed on areas that are deemed a risk based on 1) and 2). Samples should be collected at random in all zones to ensure comprehensive screening.

4. Remediate and modify:

If you get a positive result during PEM, don’t panic—pathogens are ubiquitous.
Remediate any trouble spots with deep cleaning, remediation devices or other protocols.
Re-test areas that were positive for pathogens to ensure remediation is successful.
Revisit and modify the plan at least once a year and each time a new piece of equipment is added or production flow is otherwise changed.

The steps above are a good starting point for a grower or processor to begin a PEM. Remember that this is not a one-size-fits-all approach to safety; each facility has its own unique set of hazards and control points.

Comprehensive guides for PEM can be found at the links below, many of the concepts can be applied to cannabis production.

https://affifoodsafety.org/lcp/advanced-search/

http://www.centerforproducesafety.org/amass/documents/document/263/Listeria%20Guidance%20UFPA%202013.pdf

Cichy, R. (1982). HACCP as a quality assurance tool in a commissary food-service system. International Journal of Hospitality Management, 1(2), 103-106.

Unnevehr, L., & Jensen, H. (1996). HACCP as a Regulatory Innovation to Improve Food Safety in the Meat Industry. American Journal of Agricultural Economics, 78(3), 764-769.

Yamashiro, C, & Baca, Y. (2019). Prevent high-value cannabis crop loss with innovative environmental monitoring tool.

January 9, 2020

The Ultimate Guide to Intellectual Property Protection for Cannabis Businesses

By Roger Bora

4 Comments

As of this writing, one cannot register trademarks with the U.S. Patent and Trademark Office (USPTO) for cannabis products and services that “touch” the cannabis plant (i.e., cultivate, manufacture or dispense cannabis products), with the recent exception for certain hemp-based products and services, because use of trademarks must be lawful under federal law for federal trademark registration eligibility. Brand owners may, however, secure federal trademark registration protection for their brand names for certain cannabis-related products and services that are currently legal under federal law in advance of what could be the full legalization of cannabis at the state and federal levels.

Federal trademark registration provides brand owners with valuable benefits beyond common law (unregistered) and state registered trademark rights, including the preservation of national expansion rights and presumption of trademark ownership and validity. For those reasons, securing federal trademark registration protection for trademarks is a prudent business strategy.

This article summarizes certain laws and regulations for securing federal trademark registration protection for cannabis products (including cannabidiol (CBD) products) and services. It also identifies other forms of intellectual property protection for cannabis businesses.

What Are Cannabis, Marijuana, Hemp and CBD?

Cannabis is a plant of the Cannabaceae family and contains many biologically active chemical compounds, including the well-known delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) compounds.
Parts of the Cannabis sativa plant are controlled under the Controlled Substances Act (CSA) under the drug class “marijuana.” The CSA is a federal law that regulates drug policy for the manufacture, importation, possession, use and distribution of certain substances. Marijuana is currently listed as an illegal Schedule I drug under the CSA, along with cocaine and heroin, due to its high potential for abuse, which is attributable mainly to the psychoactive effects of THC and the absence of a currently accepted medical use in the United States.
Marijuana, a term the CSA uses, is the dried leaves of the cannabis plant. It is derived from the cannabis sativa and cannabis indica species and is used primarily as a psychoactive drug.
Hemp is derived only from the cannabis sativa species and has historically been grown primarily for its strong fibers used for industrial purposes, including for making fabrics, clothing and rope.
There is a significant difference between marijuana and hemp with respect to their concentration of THC, which gives the plant its psychoactive effect. While marijuana can reach THC levels of 30%, THC levels in hemp are typically 0.3% or less.
The low level of THC in hemp is a reason why federal authorities recently removed it from the legal definition of marijuana, which means that cannabis plants and derivatives such as CBD derived from hemp that contain 0.3% or less of THC on a dry-weight basis are no longer considered controlled substances under the CSA.
Cannabidiol (CBD) is an active ingredient in the cannabis plant and is derived primarily from the hemp plant. CBD has been touted for its many health benefits, including for the treatment of insomnia, pain and anxiety, and it has become a widely used ingredient in many types of products, including foods, cosmetics, building materials, industrial oils, plastics and textiles.

Relevant Laws and Regulations

Controlled Substances Act (CSA)

Under the CSA, the drug class marijuana is defined as “all parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin” (subject to certain exceptions). 21 U.S.C. §802(16).

The CSA prohibits, among other things, manufacturing, distributing, dispensing or possessing cannabis that meets the definition of marijuana, including CBD derived from marijuana.

2018 Farm Bill Removes Hemp from the Definition of Marijuana

The 2018 Farm Bill signed into law on December 20, 2018, amended the Agricultural Marketing Act of 1946 and changed certain federal laws and regulations concerning the production and marketing of “hemp,” defined as “the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol [THC] concentration of not more than 0.3 percent on a dry weight basis.”

Those changes included removing hemp from the CSA’s definition of marijuana, which means that hemp and its derivatives, such as CBD derived from hemp, that contain no more than 0.3% THC on a dry-weight basis, are no longer controlled substances under the CSA.
The recent change in the classification of hemp allows brand owners that legally manufacture and sell certain hemp-based products, including certain hemp-derived CBD products, to federally register their associated trademarks.
However, the 2018 Farm Bill explicitly preserved FDA’s authority to regulate certain products containing cannabis or cannabis-derived compounds, even if derived from hemp, including CBD derived from hemp. Thus, federal laws, including FDA regulations, must still be considered for product legality before introducing products into commerce.

Food and Drug Administration (FDA)

Even with the removal of hemp from the CSA’s definition of marijuana, not all hemp-derived products are lawful following passage of the 2018 Farm Bill because certain products may still violate the Federal Food, Drug, and Cosmetic Act. For example, certain hemp-derived CBD products, including human foods, beverages, dietary supplements and animal foods, still violate FDA laws absent FDA approval.

The FDA monitors and investigates the sale of products that violate FDA laws, including CBD products promoted for therapeutic uses and treating diseases. When the FDA detects such violations, it may send warning letters to the violating parties as a first step in the enforcement process.

On December 20, 2018, the then FDA Commissioner Scott Gottlieb, M.D. made the following statement on that point:

“We’ll take enforcement action needed to protect public health against companies illegally selling cannabis and cannabis-derived products that can put consumers at risk and are being marketed in violation of the FDA’s authorities. The FDA has sent warning letters in the past to companies illegally selling CBD products that claimed to prevent, diagnose, treat, or cure serious diseases, such as cancer. Some of these products were in further violation of the FD&C Act because they were marketed as dietary supplements or because they involved the addition of CBD to food.”

Furthermore, in a recent letter to a company selling CBD products, the FTC sent a joint letter with the FDA, and that letter included the following statements and warnings:

“The FTC strongly urges you to review all claims for your products and ensure that those claims are supported by competent and reliable scientific evidence. Violations of the FTC Act may result in legal action seeking a Federal District Court injunction or Administrative Cease and Desist Order. An order also may require that you pay back money to consumers.

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct violations may result in legal action without further notice, including, without limitation, seizure and/or injunction.”

What about using hulled hemp seed, hemp seed protein powder and hemp seed oil in human food?

In December 2018, the FDA generally recognized as safe (GRAS) hulled hemp seed, hemp seed protein powder and hemp seed oil. Accordingly, the FDA’s current position suggests that those products may legally be marketed in human foods for the uses described in the notices, provided they comply with all other requirements. To date, the FDA has not received any GRAS notices for the use of hemp-derived ingredients in animal food.
Hemp seeds are the seeds of the Cannabis sativa plant. They do not naturally contain THC or CBD. The hemp seed-derived ingredients that are the subjects of the GRAS notices contain only trace amounts of CBD and THC. The FDA has reported that “[c]onsumption of these hemp seed-derived ingredients is not capable of making consumers ‘high.’”
Those GRAS conclusions do not affect the FDA’s position on the addition of CBD and THC to food.

U.S. Trademark Registration Eligibility

Trademarks Must Be Used for Lawful Activities

A trademark’s use must be lawful under federal law for federal trademark registration eligibility. Whether activities associated with cannabis and/or cannabis-related goods or services are lawful under federal law requires review of various federal laws, including the Federal Food, Drug, and Cosmetic Act.

Federal law controls federal trademark registration eligibility, period.

If a trademark application is filed for goods or services that violate federal laws, including for marijuana products and/or services or certain products that feature CBD, such as foods and nutritional supplements, the USPTO Examiner should refuse the application. Furthermore, filing an “intent-to-use” trademark application cannot obviate that refusal.

What does that mean? It means that filing a trademark application based on an “intent to use” the trademark “in the future” in anticipation of federal law legalizing cannabis still violates current law (the law as of the application filing date), and thus the application should be rejected because the applicant does not and cannot have a “bona fide intent” to use the applied-for mark for a legal purpose.

The USPTO Examination Guide 1-19 for examining cannabis marks states that:

“[r]egistration of marks for foods, beverages, dietary supplements, or pet treats containing CBD will still be refused as unlawful under the FDCA, even if derived from hemp, as such goods may not be introduced lawfully into interstate commerce.”

The following is an excerpt from an issued Trademark Office action refusing registration of a mark on the basis the listed cannabis goods are unlawful:

“Registration is refused because applicant does not have a bona fide intent to lawfully use the applied-for mark in commerce.

To qualify for federal trademark/service mark registration, the use of a mark in commerce must be lawful. Gray v. Daffy Dan’s Bargaintown, 823 F.2d 522, 526, 3 USPQ2d 1306, 1308 (Fed. Cir. 1987) (stating that “[a] valid application cannot be filed at all for registration of a mark without ‘lawful use in commerce’”); TMEP §907; see In re Stellar Int’l, Inc., 159 USPQ 48, 50-51 (TTAB 1968); Coahoma Chemical Co., Inc. v. Smith, 113 USPQ 413 (Com’r Pat. & Trademarks 1957) (concluding that “use of a mark in connection with unlawful shipments in interstate commerce is not use of a mark in commerce which the [Office] may recognize.”). Thus, the goods and/or services to which the mark is applied must comply with all applicable federal laws. See In re Brown, 119 USPQ2d 1350, 1351 (TTAB 2016) (citing In re Midwest Tennis & Track Co., 29 USPQ2d 1386, 1386 n.2 (TTAB 1993) (noting that “[i]t is settled that the Trademark Act’s requirement of ‘use in commerce,’ means a ‘lawful use in commerce’”)); In re Pepcom Indus., Inc., 192 USPQ 400, 401 (TTAB 1976); TMEP §907.

Here, the items or activities to which the proposed mark will be applied are unlawful under the federal Controlled Substances Act (CSA), 21 U.S.C. §§801-971.”

USPTO Guidelines for Marijuana and Hemp Products: Key Takeaways

Trademark registrations for marijuana and marijuana by-products, including CBD derived from marijuana, are still unavailable.
Trademark registrations for certain hemp products are available. If an applicant’s goods are derived from hemp, as defined in the 2018 Farm Bill, the identification of goods must specify that they are derived from hemp and that the products contain less than 0.3% THC. Thus, the scope of the resulting registration will be limited to goods compliant with federal law.
Trademark applications covering certain CBD infused products, including foods, beverages, dietary supplements and pet foods, are still refused, even if derived from hemp, because such goods may not be introduced lawfully into commerce without FDA approval.
The USPTO is currently approving trademarks for skin care preparations and cosmetics that feature hemp ingredients, including CBD derived from hemp, as long as the application complies with the 2018 Farm Bill and USPTO filing requirements.
If a pending application’s filing date is prior to December 20, 2018 (the effective date of the 2018 Farm Bill), the applicant must amend the filing date to a date later than December 20, 2018 before the application may proceed. Once the date has been amended, a new search is conducted for any prior pending confusingly similar marks.
Trademark applications for hemp cultivation and production, if allowed, will require proof of authorization and licensure in accordance with a plan approved by the U.S. Department of Agriculture.

Federal Trademark Registration Considerations and Options

Although marijuana products and services (i.e., products and services that “touch the plant”) and certain hemp-based products are currently illegal under federal law, making their associated marks ineligible for federal trademark registration protection, there are still certain cannabis-related activities that are legal and thus eligible for federal trademark registration.

Examples of legal activities include:

Providing informational services related to cannabis or marijuana-related goods and services.
Clothing, including t-shirts and hats, featuring a cannabis-related trademark.
Educational programs in the fields of cannabis and CBD, including for health benefits and therapeutic uses of medical cannabis and CBD.
Providing an internet news portal featuring links to current events, information, commentary, non-downloadable publications in the nature of brochures, articles, and non-downloadable multimedia files containing video, audio or text in the fields of cannabis or cannabis news.
Online journals, namely blogs featuring information about cannabis.
Entertainment services, namely, providing podcasts featuring medical and industry experts in the field of cannabis and medical marijuana.

If a brand owner secures federal trademark registration protection for marks for legal activities, including those listed above, those trademark registrations and rights may arguably preserve future product and service expansion under the same registered mark for “related” goods and/or services that are unlawful as of the trademark application filing date, but later become lawful, including CBD infused foods and nutritional supplements and marijuana itself.

Why? Because trademark law protects consumers from “source confusion.”

For example, if a brand owner adopts the trademark N-DuraRun for running shoes, another party may not adopt the same or confusingly similar mark for running pants because consumers would likely be confused as to the source of running shoes and running pants if offered under the same trademark by different parties.
- It is not confusion as to what a consumer is buying (“I thought I was buying running shoes… instead I mistakenly purchased running pants…”). Rather, it is confusion as to the source of the products (“I purchased EnDuraRun brand running pants because I thought they were made by the same company that makes N-DuraRun brand running shoes!”).
- A question to ask is “Would the average consumer reasonably believe that the parties’ respective goods are of the type that would originate from the same source?”
  - If the answer is “yes” and if the parties’ respective marks are confusingly similar, there may be a likelihood of consumer confusion as to the source of the parties’ respective goods.

For example, if a company provides informational services in the field of cannabis and cannabis derivatives, including CBD infused foods, and/or provides foods and nutritional supplements featuring hemp seed protein powder and hemp seed oil, and it secures federal trademark registration protection for its trademark for those goods and/or services, that existing federal trademark registration and rights may arguably preserve the brand owner’s right to use and register the same mark for “related” goods and services, which could include CBD-infused foods and nutritional supplements if/when those goods become legal. That is so because the average consumer would arguably believe that informational services about CBD infused foods and CBD infused foods themselves would originate from the same source and also believe that foods and nutritional supplements featuring hemp seed protein powder and hemp seed oil and foods and nutritional supplements featuring hemp-derived CBD would originate from the same source.

Source confusion is the crux of trademark law.

Therefore, securing federal trademark registration protection now for goods and services that are lawful can preserve future trademark rights for cannabis-related products and services that are currently unlawful and may avoid losing valuable trademark rights to third parties.

As companies prepare for the potential federal legalization of all forms of cannabis, securing federal trademark registration now for brand names for goods and services that are currently legal is vital for protecting valuable company assets, current and future business opportunities, and future growth, and it is possible as long as brand owners understand the current status of the regulatory landscape and the intricacies of trademark law.

Other Forms of Intellectual Property Protection

In addition to trademark and federal trademark registration protection, there are other intellectual property protections available for marijuana, hemp and cannabis businesses, including:

State trademark filings. In states that have legalized cannabis, state trademark registrations may be available.
Common law trademark rights. In states that have legalized cannabis, common law trademark rights may be available.
Patent protection. Patent protection may be secured for various inventions, including plants, such as new strains of the cannabis plant, and methods of cannabis hydration and lighting.
Trade secrets. Trade secrets can protect certain aspects of a business, including formulas, processes or methods, that are not generally known or reasonably ascertainable by others and that can help a business obtain an economic advantage over competitors or customers. To be eligible as trade secrets, however, a business owner must take the necessary steps to legally protect them or they will be lost.
Copyrights. Copyright protection may be secured for certain company creative works, including trademark logos (artwork), written materials, photographs and software.

As the laws governing the cannabis industry continue to evolve, including trademark, FDA and banking laws and regulations, all interested parties, including cannabis business owners, law firms and investors, must stay abreast of the rapidly changing legal landscape to maximize business growth opportunities, ensure proper legal and regulatory compliance, and avoid having their businesses go up in smoke.

Notice: This article is for educational purposes only, is not legal advice and should not be substituted for retaining an attorney.

January 9, 2020

The Launch of Cannabis-Related ETFs In Europe

By Marguerite Arnold

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Here is the headliner: As of the second week in January, there will be a cannabis related exchange-traded fund (ETF), trading on the Frankfurt Stock Exchange (or Deutsche Börse), the third largest stock exchange in the world and the meeting point between equities and the vast majority of institutional investment globally.

The Medical Cannabis and Wellness UCITS ETF (CBSX G) will trade on Deutsche Börse’s Xetra.

London-based ETF provider HANetf is the creator of the fund.

The idea is to create a fund with targeted exposure to the European market. And as a result, it is bound to be interesting. Especially as the companies included must go through a due diligence process that will only include equities traded on stock exchanges like the NYSE, Nasdaq and TSX.

This of course is no guarantee, particularly given the scandals of the major Canadians last year (who are listed on all or an assortment of the above).

Indeed, in the eyes of German authorities, this is not necessarily all that significant. And that in and of itself is a watchword of caution here. Namely the Deutsche Börse put the entire North American cannabis equity market under special watch two years ago and that has not changed since then. That said, with legalization now clearly in Europe, things in general look a lot different on the ground.

What will be really intriguing is when the fund (or the ones inevitably to follow) that look at the discussion from a European market perspective.

Purpose Investments, the Canadian partner involved, has over CA $8 billion in assets under management as of last month and across a range of ETFs.

Solactive, the German company which independently calculates the index, may also be unknown to North Americans in particular. In Germany, particularly Frankfurt, they have developed, since their founding in 2007, a reputation for being not only quirky, but not risk averse. In other words, decidedly “non-German,” at least by stereotype. And cannabis right now, particularly with this approach, is an inevitable development. This could, in fact, do very well. The problem, however, that is still in the room is the vastly different levels of compliance – but that too is a risk calculation that is to the people at the table, no different than certain kinds of commodities.

That alone makes this ETF intriguing simply because it will indeed be evaluated by German eyes – if not processes.

Significance

Things are clearly normalizing on both the accounting and reform front. The growth of the regulated Canadian market and the increasing focus on regulation of all kinds is only going to make things less risky for investors.

Bottom line: Good development, but won’t be the last. By far.Further, there are not many public European companies, yet. That may also change. However, for the moment, they are still a trickle (and all over the map).

What is intriguing is the timing of the fund. If not what it potentially spells for the public markets. And further the obvious research the Auslander team have done in finding the right European-based partner. Look for interesting things indeed.

This is the first real foray into Europe by anything outside a single stock offering on a European equity market.

For Germans, in particular, who are extremely risk averse, and tend to invest in other kinds of securities if not insurance to build up their pensions, the equity markets sniff a bit too much for most of “North American scam.” Far from cannabis. Yet some Germans do invest in the markets. As do other Europeans.

Bottom line: Good development, but won’t be the last. By far.