Tag Archives: cannabis

Wildfires Devastating Californian Cannabis Farms

By Aaron G. Biros
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Earlier this week, a series of wildfires began ripping through Napa, Sonoma and Mendocino Counties, causing mandatory evacuations, rampant property damage and taking the lives of at least 17 people. Extraordinarily high wind gusts up to 50 mph have swept through communities in Northern California, leaving complete destruction in its wake.

According to The Washington Post, flames have reached more than 170,000 acres since Sunday when the fires began. The cause is still unknown. The President declared a state of emergency, allowing emergency funds to go to clearing debris and supplies for shelters. Nearly 25,000 have fled their homes to shelters in seven counties.

NASA’s Aqua satellite took this picture of the smoke over California on Tuesday
Photo: NASA, Flickr

The area is well known for its wine production, an industry that is taking a very hard hit from the wildfires. It is also known as a productive cannabis growing area as part of the Emerald Triangle, synonymous with high quality, outdoor cannabis farms. A number of cannabis farms have been severely impacted by the flames.

We’ve received numerous reports of growers fleeing their homes and farms to get to safety. The LA Times reported that at least seven cannabis farms have been engulfed in flames. According to Amanda Reiman, vice president of community relations at Flow Kana, a distribution company working with cannabis farmers in the Emerald Triangle, they are in active evacuations and the fire is only about 5% contained. “It will be a while before we know the extent of the damage to our farmers and our community,” says Reiman. “The Emerald Triangle is a large region and central Mendocino county contributes a lot. Our farmers are resilient, but right now we are all focused on safety and vigilance.”

Kristin Nevedal, founder and chair of International Cannabis Farmers Association (ICFA), says she’s received information about cannabis farms being destroyed. “The true extent of damage to farms, lives and communities won’t unfortunately be known for sometime,” says Nevedal. “There is no rain in the immediate forecast, conditions are dry and we have had high winds.” Nevedal says the damage goes way beyond just a business setback. “Traditional sun grown cannabis farmers often live on the property they farm, so for many, a forest fire can mean not only loosing the crop but also their homes,” says Nevedal. “While there are fire insurance policies available for houses and outbuildings, the operational infrastructure components and the crop itself can be challenging or impossible to insure.” She says things like water storage tanks, water supply systems, irrigation systems, fences, water pumps and solar systems might not be insured at all. “Law enforcement in Mendocino is coordinating, to the best of their ability, with evacuees who have fire damage or have been evacuated, to insure public safety while assisting folks with repopulating their property and/or assessing the status of fire damage,” says Nevedal.

Because California is expected to implement their full adult use legalization in early 2018, the wildfires are particularly devastating to businesses that have been gearing up for the new market. To make matters worse, the fires came during peak harvest time, while growers are cutting plants and preparing their entire crops for distribution and sale.

Over 5,000 residents have evacuated in Sonoma County

Devika Maskey, founder of TSO Sonoma, a cannabis farm in Sonoma County, could only speak briefly because her farm is under evacuation orders. “We are getting all personnel off the hill to safety,” says Maskey. “The wind will be picking up to 40-50mph again later today.” Those high winds have the potential to spread the flames quicker, destroying more property and putting more lives at risk.

Maskey says the wildfires are having an enormous impact on their crops this year. “We do not have enough time to harvest the outdoor crop,” says Maskey. “So far there has been clear skies, but if the fire gets closer it can taint the buds with a smoky smell and flavor.”

Maskey says she has a number of friends in the cannabis space that have been severely affected already. “We do have a few friends that have lost their farms already,” says Maskey. “About a dozen other friends and family members who have lost their homes.” In Sonoma County alone, 5,000 people have been evacuated to shelters as of Wednesday morning, reports The Washington Post. “This has been a devastating week for many people and businesses,” says Maskey. “Our priority is getting everyone off the hill and to safety.” If you want to help the cannabis growers impacted by the fires, Maskey recommends donating to this growers relief fund or donate to the North Bay Fire Relief fund here. 

This list of charities, including GoFundMe pages, food banks and shelters in need of supplies and donations, is also a helpful resource to figure out how you can help those impacted by the fires.

Colorado To Begin Requiring Potency Testing For Medical Infused Products

By Aaron G. Biros
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After a delay due to their proficiency testing program roll out, the Colorado Marijuana Enforcement Division (MED) will now require all medical infused products and concentrates be tested for potency and homogeneity, starting November 1st, 2017.

After November 1st, all production batches of concentrates from medical product manufacturers will need to have a potency test before being sold, transferred or processed. The same goes for medical infused products, such as edibles and topicals. The homogeneity test refers to making sure THC or other active ingredients are distributed evenly throughout the product.

According to Alex Valvassori, author of a regulatory compliance-focused blog post on Complia’s website, these new testing requirements could lead to a surge in pricing, passed on to patients. He also recommends dispensaries take a close look at labels coming in from suppliers. They need to make sure potency data is listed clearly on the label to stay compliant.

Production batches created before November 1st are not required to meet the new testing regulations, but any and all batches after that date will be required to perform those tests.

On The Cusp of Revolution: 9th IACM Conference on Cannabinoids in Medicine

By Marguerite Arnold
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As cannabis conference backdrops go, Cologne (or Köln as it looks to the locals) has some major plusses. Cologne is a German city that has all sorts of both historical and cutting edge things to explore. Plus of course there is the timing. This part of the world just pre-Oktoberfest is a refreshing splash of multi-hued natural colors populated by people who wear lederhosen and dirndls in public (and with great enthusiasm).

Beyond its postcard settings, Cologne is a German center of medical research, as well as public policy making. The intricacies of pre and post war, not to mention post reunification politics, have made this whole region (which includes both Düsseldorf and Bonn) a major powerhouse in both deciding how things get done and then making sure they do. Including on all things scientific and medically focussed.

Overview of the Conference

Where German geographical proximity intersects with the global cannabis research and medical community is the work of the people who have made the International Association for Cannabis Medicines (IACM) one of the leading international scientific and medical cannabis conferences in the world. One look at the speakers list confirms that the top people in the cannabis research world came, spoke and even discussed unpublished research. Yes, that is the mark of a real academic conference. But in a world where medical efficacy is still being challenged, it is worth saying.

Even if you were not old enough to know about cannabis or well read, and had just showed up for the day, the subject matter and presentations were clear, easy to understand and stunning both individually and altogether.

Doctors Janice, Jessica and Rachel Knox, founders of the American Cannabinoid Clincs

Topics and abstracts ranged from trial data to changing legislation. Peppered between those were visions of where cannabis as medicine is clearly going as well as a far greater understanding of the role of the endocannabinoid system.

As a medical doctor, researcher, public policy expert or medical cannabis distributor, in other words, it is already a must-attend event. It is also packed with investors, not only from Europe but far from its shores.

If there was a message beyond the fact that the cannabis industry is now jumping the shark and going global, it was that the industry has now arrived in Europe and there is no turning back. On any front.

Most Interesting Highlights

It is very hard to pick which was the most ground-breaking research. It all is at this point and it is all fascinating. One of the most heartening abstracts was submitted from Montana. It was just a single patient study. However it showed visual evidence of a stage 1A malignant melanoma completely resolving after 60 days of treatment both topically and orally. Research out of Tel Aviv (of course) was presented showing that low doses of THC might even reverse age-associated cognitive impairments.

All of the genetic research into the plant not to mention new knowledge about terpenes was, literally, spell-binding to those who follow the science. Some of the presentations about ingestion technology in particular, were a clear indication of how much this world will be impacted by tech, where it is not already.

It was stunning just to sit and listen to ground-breaking science that is being produced by globally-known scholars at internationally renowned universities, but still ignored in every place where medical cannabis is not only still illegal, but out of reach of patients.

The current dire situation facing German medical users, of course, was frequently mentioned throughout the conference, and even from the presenting stage, as a human rights crisis.

The Ambassador Program

The conference was, by definition, not only an exchange of information and research, but also a gathering of the scientific cannabinoid community with a global reach. It was also clearly a gathering of academics and scientists on a mission. The dire need to educate both doctors and patients as the details and kinks get worked out on the ground is well recognized here. The IACM at least is also trying to do something about it.

On Friday night, the first full day of the conference, IACM organizers invited conference participants to a side meeting they at first wanted to limit to 30. The idea was to discuss the launch of an ongoing “Ambassador” program as well as a pilot project to help doctors and researchers communicate with each other. More than 60 people showed up and stayed, even if it meant standing against the wall for several hours.

The mood was helpful and light. Dr. Franjo Grotenherman, the best known and leading cannabis advocacy doctor in Germany, kicked off the gathering by serving food to guests before opening the floor to attendees to introduce themselves.

The idea clearly here, is to spread the word, no matter how, as quickly as possible.

An Intimate, Science-Based Networking Event

The event has a different vibe from purely “industry” events. While the industry was clearly in attendance, in other words, it was clearly there in a supportive role. The star of the show was the unbelievable wealth of scientific knowledge that spilled from the stage.

That is not to say that there was not a lot of business conducted here. On all levels. The networking is terrific. And this being the cannabis industry, most people are friendly, open and willing to give a polite stranger a few minutes of their time.

This is an absolutely intriguing event to consider, particularly for Americans who do not have much insight into the European medical or scientific worlds when it comes to cannabis. That includes cannabis clinics in legalizing states to prescribing doctors looking for medical evidence of using CBD in treating their patients. Canadians, Israelis and Swiss were here in force, beyond the locals with representatives from most countries in Europe. If looking to network with an international crowd of doctors, scientists and companies on the cutting edge of cannabis globally, this is absolutely one of the best places on the planet to be.

Enforcement of Intellectual Property Rights for Cannabis Put to Test in Federal Court

By Dr. Travis Bliss
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A number of cannabis businesses have pursued federal intellectual property protection for their cannabis-related innovations, such as U.S. patents that protect novel cannabis plant varieties, growing methods, extraction methods, etc. Enforcement of such federal IP rights requires that the IP owner file suit in federal court asserting those rights against another cannabis company. However, given that cannabis is still illegal under federal law, the industry is uncertain about whether a federal court will actually enforce cannabis-related IP rights. This question might be answered soon.

The potential impact of this case goes way beyond the two parties involvedOrochem Technologies, Inc. filed a lawsuit in federal court in the Northern District of Illinois on September 27, 2017, seeking to assert and enforce trade secret rights against Whole Hemp Company, LLC. According to the complaint, Orochem is a biotechnology company that uses proprietary separation methods to extract and purify cannabidiol (CBD) from industrial hemp in a way that produces a solvent-free and THC-free CBD product in commercially viable quantities.

The complaint goes on to say that Whole Hemp Company, which does business as Folium Biosciences, is a producer of CBD from industrial hemp and that Folium engaged Orochem to produce a THC-free CBD product for it. According to the allegations in the complaint, Folium used that engagement to gain access to and discover the details of Orochem’s trade secret method of extracting CBD so that it could take the process and use it at their facility.

The complaint provides a detailed story of the events that allegedly transpired, which eventually led to an Orochem employee with knowledge of the Orochem process leaving and secretly starting to work for Folium, where he allegedly helped Folium establish a CBD production line that uses Orochem’s trade secret process. When Orochem learned of these alleged transgressions, it filed the lawsuit, claiming that Folium (and the specific employee) had misappropriated its trade secret processes for extracting and purifying CBD.

While the particular facts of this case are both interesting and instructive for companies operating in the cannabis industry, the potential impact of this case goes way beyond the two parties involved.

If it moves forward, this case will likely provide a first glimpse into the willingness of federal courts to enforce IP rights that relate to cannabis. Orochem is asserting a violation of federal IP rights established under the federal Defend Trade Secrets Act (DTSA) and is asserting those rights in federal district court. As a result, the federal district court judge will first need to decide whether a federal court can enforce federal IP rights when the underlying intellectual property relates to cannabis.

If the court ultimately enforces these federal trade secret rights, it could be a strong indication that other federal IP rights, such as patent rights, would also be enforceable in federal court. Since the outcome of this case will likely have a far reaching and long lasting impact on how the cannabis industry approaches and deals with intellectual property, it’s a case worth watching.

Ask The Expert: Exploring Cannabis Laboratory Accreditation Part 1

By Aaron G. Biros
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Laboratories throughout the world and in a variety of industries get accredited to demonstrate their competency. In the cannabis industry, some states are beginning to require it and many labs get accredited even if their state doesn’t require it. So what does accreditation mean and why is it so important?

The International Organization for Standardization (ISO) is a standard-setting organization that works to promote industrial and commercial standards. The standards set by ISO are designed to help prove a product’s safety and quality to a certain minimum level.

The ISO/IEC 17025:2005 standard sets specific requirements to demonstrate the competence of a lab for carrying out tests. It essentially shows customers or regulators that a lab has the skills and scientific know-how to perform testing, certifying the lab is capable. Accreditation means certifying a lab to that standard and is synonymous with both quality and competence of an organization.

Michelle Bradac, senior accreditation officer at A2LA

The American Association for Laboratory Accreditation (A2LA), founded in 1978, is a non-profit, internationally recognized accreditation body in the United States that offers laboratory and laboratory-related accreditation services and training. They have worked in the cannabis industry to accredit a number of cannabis laboratories to the ISO/IEC 17025:2005 standard. In this series of articles, we sit down with experts from A2LA to learn more about cannabis lab accreditation, why it’s so important and some of the challenges labs face when seeking accreditation.

In the first part of this series, we sit down with Michelle Bradac, senior accreditation officer at A2LA, to learn the basics. Michelle earned a bachelor’s degree in Biology at Towson State University and then attended Hood College, earning a master’s certificate in Regulatory Compliance in Biomedical Science. She has worked at A2LA for eight years, assisting in the accreditation of food testing, environmental testing and cannabis testing laboratories to ISO/IEC 17025, as well as performing quality system assessments. She also facilitates a number of accreditation programs including Field Sampling Measurement Organizations, STAC (Air Emissions) and Cannabis Testing. Bradac is also a member of the ASTM Cannabis Working Group and the ACIL Cannabis Working Group.

In the next part of this series, we will hear about specific requirements in states, some of the benefits of using ISO/IEC 17025 and the influx of start-up or novice testing laboratories.

CannabisIndustryJournal: What is Laboratory Accreditation? 

Michelle Bradac: Laboratory accreditation is a formal means of determining and recognizing the technical competence of laboratories to perform specific types of testing, via the use of an independent third party accreditation body. It provides laboratory users a mechanism to identify and select reliable testing organizations. Use of ISO/IEC 17025 as a basis for laboratory accreditation is internationally recognized as THE conformity assessment standard to which laboratories are accredited; it is used in the USA by both Public (State, local, federal (FDA, USDA, CDC, DoD and EPA) and private laboratories for testing of foods & feeds, drugs, cosmetics, tobacco, natural products and cannabis (among other materials and products).

CIJ: How does laboratory accreditation benefit the cannabis testing laboratory? 

Michelle: It provides a framework for continuous improvement and self-correction where the cannabis testing laboratory data management system is independently reviewed and blinded sample Proficiency Testing is encouraged.

CIJ: How does laboratory accreditation benefit the medical cannabis prescribing physician?

Michelle: The physician gains assurance that the dosage and concentrations of material being prescribed is what the label says it is and that the product is safe for use. This is especially important in working with patients that are immunocompromised.

CIJ: How does the testing of medical cannabis by an accredited laboratory benefit the patient?

Michelle: The patient gains increased confidence that the medication is going to be both safe and effective.

CIJ: What specific challenges does A2LA face in accrediting cannabis testing laboratories?

Michelle: Much of the typical infrastructure is lacking or only now being developed. This ranges from proficiency testing programs, Reference Material Producers, method development and sampling procedures. There is also difficulty in ensuring that laboratories are appropriately validating methods in states where cannabis product is not yet available.

CIJ: Why is A2LA the optimal choice for ensuring the quality and reliability of the results produced by medical marijuana testing laboratories?

Michelle: A2LA has by far the most experience as an accreditor of laboratories that perform testing of natural plant products. We have been performing assessments of and granting accreditation to these types of laboratories for over twenty years. This results in our staff and our assessor corps who are then able to provide valuable insight and technical sophistication that other accreditation bodies do not have. Specific to the cannabis industry, A2LA is also represented in all the major standards development organizations, tradeshows and industry groups; which strengthens our understanding of the industry and ability to assist our customers towards meeting their goal of obtaining accreditation.

PA Approves First Two Cannabis Labs

By Aaron G. Biros
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According to a PennLive article, Pennsylvania’s Department of Health approved the first two cannabis laboratories for their medical cannabis program. ACT Laboratories of Pennsylvania LLC and Keystone State Testing LLC are the companies that were approved to perform analytical testing for safety and quality in cannabis products.

Both laboratories expect to be operational before the end of 2017, according to the PennLive article. Those labs are required to test for CBD and THC content, pesticides, moisture content, residual solvents and microbiological contaminants.

The temporary lab testing regulations are somewhat comprehensive, detailing lab reporting, licensing, sampling protocols and ownership stipulations, among other rules. ACT and Keystone, the labs that were approved by the Department of Health, have their approval for two years and can renew their license after.

While the state still expects the program to be fully implemented by 2018, Health Secretary and Physician General Dr. Rachel Levine said last week they are hoping to launch the program sometime next year, according to a press release. December 2017 will mark a full year since the state opened applications for licensing businesses.

January 2018 has long been the goal for the full implementation of the program. “We have made significant progress in getting this program off the ground since Governor Wolf signed the Medical Marijuana Act into law last year,” says Dr. Levine. “These proposed regulations for patients and caregivers to participate are one of the final pieces we need to have in place to launch the program sometime next year.”

Digipath Expands To California

By Aaron G. Biros
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In July, we sat down with the folks at Digipath, Inc. when they received their testing license in Nevada for the adult use market. In that conversation, they mentioned they were looking to expand into California.

According to a press release published September 25th, DigiPath, Inc. has entered a joint venture to establish their first cannabis-testing lab in California. They will be working with Don Ashley, an experienced real estate developer and cannabis entrepreneur, to launch Humboldt Botanical, LLC, conducting business under the name “Digipath Botanical Testing”.

Ashley says they expect to be fully operational by Q1 of 2018. “We expect to break ground on this project in the next few weeks and hope to be operational in early Q1 2018 just after the state-wide adult-use market is expected to launch, as we have already obtained approval from the local planning authorities for the entire complex,” says Ashley.

Todd Denkin, founder and president of Digipath

Todd Denkin, president of Digipath, is optimistic for California’s market and the coming regulations. “The state of California is estimated to be the single largest cannabis market in the U.S. Adult-use cannabis legislation was approved by California residents last November, and we expect these new regulations to be implemented in 2018,” says Denkin. “The good news for the industry is that the requirements for cannabis testing will be significant, and we are excited to partner with Don and his team to pursue this opportunity in Humboldt County.”

Ashley is contributing roughly $2 million to build and equip the lab with instrumentation, while Digipath Labs will manage and supervise operations at the lab. According to the press release, Digipath will provide a non-exclusive license to use its intellectual property for the operation of the lab. Digipath Labs will retain rights over all the scientific data generated in the lab.

Cindy Orser, PhD., chief science officer at Digipath

According to Cindy Orser, PhD., chief science officer at Digipath, that data will be put to good use. “Digipath Labs has developed an algorithm for use in strain authentication based largely on terpene profiling from our testing lab in Nevada and we are eager to further test our hypothesis with an expanded dataset from cannabis grown in Northern California,” says Orser.

While testing labs are primarily seen as safeguards for public health and safety, using data to correctly identify strains is a relatively new concept. “Digipath Labs is all about public health and safety through testing for adulterants,” says Orser. “Another component to quality is having confidence in product authenticity at the dispensary level. Not only is the consumer buying quality assured products but truth in advertising when it comes to strain nomenclature.”

Denkin says they were proactive in working toward getting the license early on. “Our partners have been dealing with the local regulators while we have been providing the proper SOP’s for the local government in order to receive the proper licensure in the area,” says Denkin. Taking their experience from Nevada to California, Orser says they have been asked to present to the California Toxicology Association on their experience with cannabis testing in the highly regulated marketplace of Nevada.

The laboratory in Humboldt is going to be part of a “cannabis industrial park,” alongside an R&D facility, oils/concentrate manufacturing center, health and wellness center, distribution and processing facility, tissue culture nursery, hemp clothing outlet, and coffee bistro, according to the press release.

Looking forward to growing their business, Denkin says they hope to launch a lab in Southern California. “We do expect to have a larger footprint in California because of the size of the market and are looking for locations in Southern California as well,” says Denkin. When asked about any new plans to expand elsewhere, Denkin says they’ll let us know. “We are continuing with our business plan and actively seeking the right mergers and acquisitions. Stay tuned.”

Nevada Cannabis Lab License Suspended

By Aaron G. Biros
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Last month, G3 Labs LLC, a Las Vegas-based cannabis-testing lab, had their license suspended for an unknown regulatory compliance issue. According to Stephanie Klapstein, spokeswoman for the Nevada Department of Taxation, the reason why their license was suspended is confidential. “We can’t disclose the details of the suspension, including anything about penalties,” says Klapstein.

When asked about the license suspension, Klapstein told us it was a compliance issue, but could not go into detail. “I can confirm that we did suspend G3’s license for compliance issues,” says Klapstein. “We are working with them to bring them back into compliance. In the meantime, they cannot operate.” Klapstein told the Las Vegas Review-Journal that the Nevada Department of Agriculture tested cannabis samples from the lab to determine if there was a need for a recall. She also confirmed with us that the compliance issue does not necessitate any product recalls.

According to the Las Vegas Review-Journal, this is the first time a cannabis business license is suspended in the state since the beginning of adult-use sales back in July of this year. Nevada’s cannabis regulations require independent lab testing of products before they reach shelves. That required testing includes checking for potency, microbials, pesticides, residual solvents, moisture content, growth regulators, Mycotoxins and foreign matter.

When we reached out to G3 Labs, they did not immediately respond to a request for comment.

Dr. Chao-Hsiung Tung, lab director at G3 Labs, told the Las Vegas Review-Journal that they couldn’t comment, based on advice from their legal counsel. “G3 Labs is actively sorting out the issues with the Department,” Dr. Tung told the Review-Journal in an email.

Colorado Issues Safety Advisory; More Pesticides Found In Cannabis

By Aaron G. Biros
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According to a press release issued on Friday, September 22nd, the Colorado Department of Public Health and Environment (CDPHE), along with the Colorado Department of Revenue (DOR) and the Colorado Department of Agriculture (CDA), issued a public health and safety advisory for cannabis products tainted with pesticide residue.

The advisory was issued after the detection of pesticide residues on retail cannabis plant material and products with cannabis grown by RK Enterprises LTD, doing business as Rocky Mountain Remedies. The CDA confirmed that they detected the pesticide, Avermectin, an insecticide with a relatively high acute toxicity.

When pesticides like this are not on the list approved for use in cannabis cultivation, it is considered an off-label use. According to the press release, some of the products affected include flower, trim, concentrates and infused-products.

Consumers are advised to look at the label of their products and check to see if it matches the license number 403R-00180 and harvest batch numbers r206goldenkush9.11.17 and m206larryog9.11.17. Consumers are told to either dispose of the product properly or bring it back to the retail store where they purchased it.