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Test Rick Simpson Oil?
In 2003, Rick Simpson used a self-made unrefined cannabis oil to treat his basal cell carcinoma, a type of skin cancer. Simpson had used medical cannabis in the past and believed in the medical powers of the cannabis plant. He claims to have applied his oil topically to his tumors, and within days, they had vanished. Simpson took it upon himself to spread the word of this miraculous cure, later called Rick Simpson Oil (or RSO) in his name.
If you do choose to try this treatment, there are a few things you should know.
Does It Really Work?
Although Simpson’s physician and other medical professionals have refused to acknowledge the oil as a treatment, plenty of anecdotal evidence can be found online which paints RSO as a miracle cure. Studies do exist that show the safety of using cannabinoids in cancer patients, although these studies don’t demonstrate the effectiveness of cannabis as a cancer treatment.
Too few scientific studies have been done and as far as science and medicine are concerned, the results remain inconclusive. Larger and longer-term studies are needed to get a fuller understanding of how different cannabinoids and cannabis strains affect cancer cells.
The biggest risk associated with RSO (arguably) is if someone stops their doctor’s recommended cancer treatment in favour of RSO. If you are interested in using RSO or other cannabis extracts to treat cancer or the side effects of conventional treatments, talk to your doctor. If you are supplying patients with RSO, ensure that they are aware of the risks and have spoken to their physician.
Testing RSO
As a concentrate, RSO is extremely potent with a THC range of 60-90%. To guarantee careful and gradual dosing to avoid unpleasant side effects, testing prior to use is crucial. An additional point is to keep in mind the differences in each person’s body chemistry and tolerance levels. While finding the right dose can involve a lot of trial and error, knowing the potency of the RSO being used minimizes the uncertainty.
Another point to be made in favor of testing is the quality. While quality of a product is always a concern to the person using it, this becomes magnified when the product is consumed for medical purposes. THC is a psychoactive substance, meaning it can produce psychological effects such as paranoia, disorientation, anxiety, hallucinations, depression, and irritability.
Additionally, THC can cause physical side effects which include low blood pressure, bloodshot eyes, dizziness, slow digestion, sleeping issues, impaired motor control and reaction time, and impaired memory. These effects do not generally last longer than a few hours and pose no major health risks.
GemmaCert has developed a solution for cannabis potency analysis which is customized to also estimate the THC potency in RSO. GemmaCert devices are being used by patient groups and caregivers precisely for this reason. To use the device for this purpose, it is necessary to use the Extract Accessory. GemmaCert’s simplicity and efficiency provides real-time results for informed and safe dosing.
How Do You Know if Your Cannabis or Hemp Is Safe to Store?
Water activity (aw) is particularly critical to food and pharmaceutical safety for predicting the growth of bacteria, yeasts, molds, and more. Products are generally safer to transport and store at lower water activity levels. This also applies to cannabis which is why water activity already features as part of cannabis regulations in legalized markets.
Lower water activity means water in the system behaves less like pure water. The risk in this is having the plant become either:
- too dry, which will make the trichomes brittle, delicate, and less potent or destroy them completely, and your profits along with them
- or too wet, which can damage your company’s reputation by causing mold or contamination and exposing customers to health risks.
Water Activity and Storage
To store and transport it, harvested cannabis (marijuana and hemp) must be dry to avoid the development of molds, yeasts, or bacteria which grow during storage if the water activity is too high. Dried biomass generally has water activity ranging from 0.60 to 0.70. Molds (besides a few rare xerophilic species) stop growth at water activity under 0.65.
Water activity is temperature dependent; generally, higher temperatures lead to increased levels of water activity. Cannabis buds with water activity levels above 0.65 can grow mold during storage and transport, putting users at risk of inhaling mold spores or mycotoxins. Meanwhile, a clear correlation between moisture content causing microbial growth, chemical or physical stability has not been found.
To minimize this risk, we aim for water activity levels below 0.65. Above this level there are also other risks besides mold and bacteria, such as undesired oxidation and possible THC decarboxylation. Therefore, water activity should be monitored across the supply chain, starting with growers.
Shelf Stability
While products with a level higher than 0.70 aw but less than 0.86 aw are considered shelf-stable, pathogenic bacteria cannot grow on the product, but mold and yeast can. These products are not dangerous as molds and yeast do not lead to foodborne illnesses, but even nonpathogenic organisms can cause the production of mycotoxins and aflatoxins, which are potentially harmful to eat and more so to inhale.
To prevent this, water activity should be kept below 0.65 aw or other precautions such as vacuum packing or a preservative system must be implemented.
Many legal cannabis markets have set the water activity limit at 0.65 and new markets opening are likely to do the same.
GemmaCert Tests for Water Activity
GemmaCert’s November over-the-air software update empowers users worldwide to test for water activity so that they can determine if their product is safe for transport and storage. Unlike other solutions on the market, GemmaCert not only enables real-time water activity analysis but also does so for whole flower buds. To determine the water activity for a batch of flowers, the analysis must be conducted on whole flowers rather than ground material; grinding leads to water loss and misrepresentation of the actual water activity level, and wrong decision-making based on such results can have adverse commercial and health ramifications.
Is a Blockbuster Medical Cannabis Pharmaceutical Drug Coming Anytime Soon?
Introducing a new drug to the market is harder than it seems. The reality is that very few companies, excluding big pharma, simply do not have the resources needed to bring a new pharmaceutical drug into the market.
This may be because:
Financial investment required - the average cost of introducing a new drug to the market is around $1.3 Billion
Time - the average time needed for a drug to go from experimental to the pharmacy shelf is about 12 years
Any new drug being developed now has very low chances of succeeding, as the likelihood of a new drug getting approved by industry initiative is a tiny 9.6%
What This Means for the Cannabis Industry
This reality means that the cannabis companies of today most probably will not bring to market tomorrow’s pharmaceutical products based on medical cannabis; there is a higher likelihood that they will supply Big Pharma with the necessary raw materials or active ingredients, if they are able to ensure safety, quality and consistency.
One of the exceptions to this hypothesis is a British company dedicated to developing and marketing medical cannabis drugs, GW Pharmaceuticals. Currently they have two drugs on the market, Sativex which was approved in 2010, and Epidolex which was approved in 2018. The company, established in 1999, generated just over $310 million dollars in revenue just last year, a far cry from the revenues of Big Pharma.
What About Synthetic Drugs?
Synthetic THC has existed as a pharmaceutical drug since the late 1970s with drugs such as Marinol (dronabinol), Syndros (dronabinol), and Cesamet (nabilone). Companies have less profit incentive to sell actual cannabis or whole plant extracts, than to isolate and synthesize its components. Yet none of these synthetic alternatives are blockbuster drugs making over US$ 1 billion in annual sales. If the therapeutic potential of medical cannabis were simply down to THC or CBD on its own, or the ratio between the two, synthetic THC drugs would be blockbusters and GW’s revenue would be much greater. Additionally, most patients stop using them after one round because of side effects, which do not exist in the botanical version.
The reality is more complex, as the cannabis flower has hundreds of active compounds which can influence its efficacy and are more than just THC or CBD. Some call this the entourage effect in which the active compounds in cannabis act together to adjust its affect.
To determine the function and potential of each compound will take years at the very least. This progress depends on dedicated researchers devoting their professional careers to this important research.
For the industry (and investors), this means that the chances of a significant medical cannabis breakthrough resulting in a blockbuster pharmaceutical drug generating annual revenues of at least $1 billion happening in the coming years is unlikely. There are simply too many challenges and obstacles along the way. For the time being, however, there are other directions and opportunities for the medical cannabis industry to pursue and grow for the benefit of individuals and communities worldwide.
The Synthetic TCH Risk: GemmaCert has a Solution
The Synthetic TCH Risk: GemmaCert has a Solution
There are ever more reports of cannabis supplied to coffeeshops across The Netherlands with synthetic THC. This poses a serious business and health risk. The Meetpoint coffeeshop recently raised awareness about this risk by social media.
Fortunately, there is a solution available to detect synthetic THC. The answer is the GemmaCert smart cannabis analyser, used by professionals in over thirty countries, and by many coffeeshops in Amsterdam and other Dutch cities, including The Bulldog, Prix d’Ami, Green House Seed Company coffeeshops, Boerenjoengens, and Meetpoint.
GemmaCert devices have already detected synthetic THC in cannabis, recently in Switzerland. Synthetic cannabinoids are human-made mind-altering chemicals that are either sprayed on dried, shredded plant material so they can be smoked or sold as liquids to be vaporized and inhaled in e-cigarettes and other devices. They are not safe and may affect the brain much more powerfully than natural cannabis; their actual effects can be unpredictable and, in some cases, more dangerous or even life-threatening.
GemmaCert is the only company specializing in diagnostic solutions for cannabis with its own in-house ISO 17085 certified analytical laboratory. The GemmaCert patented solution, combines Near Infrared (NIR) spectroscopy, image analysis and machine learning. NIR spectroscopy is used across multiple industries, most critically in the pharmaceutical industry. GemmaCert’s solution is CE compliant, TÜV Rheinland certified and conforming with German Pharmacopeia.
GemmaCert owns the world’s largest NIR reference database for cannabis. Thousands of flowers have been sourced from around the world and tested by the GemmaCert team since 2015. The database is growing on a continuous basis. Customers have accumulated over 1 million spectral datapoints on their GemmaCert devices.
Two of the most important assets a coffeeshop has are its brand and the trust of its customers. Synthetic THC is a threat to both. Smart coffeeshops will adopt NIR-based solutions, such as those provided by GemmaCert for quality management and to make sure that they are not tricked into buying CBD treated with synthetic THC.
The Advantages of NIR Spectroscopy
NIR or near-infrared spectroscopy is a technology which can be used to determine both physical and chemical parameters in both solids and liquids. The technique has a rich and well-known history of use in the medical field, but few people know of its uses in other industries.
It is widely used to analyze a variety of things across multiple industries, including the chemical industry, petrochemical, personal care, agriculture, and most critically in the pharmaceutical industry. While crop monitoring and regulation is important in general agricultural, it becomes even more critical when you apply it to the pharmaceutical field.
NIR Technology in the Pharmaceutical Field
NIR technology is already in use by pharmaceutical companies as a way to achieve full product inspection. NIR instruments are being moved from laboratories to warehouses and dispensaries and even near tablet presses to non-destructively assess the product’s quality at the point of manufacture.
Maintaining a standard of quality and meeting government testing regulations can cost up to 25% of the total annual operating budget, and that’s excluding the costs of raw materials. This may seem expensive but avoiding testing and risking non-compliance with regulations can end up costing even more due to product recalls and brand reputation damage.
The FDA and EMA (European Medicines Agency) have even provided formal protocols and guidelines for companies using NIR in the pharmaceutical field. Additionally, the technology can be used to perform quality checks which are required by the cGMP.
Advantages of Using NIR Technology
Besides the non-destructive nature of the test which allows you to reuse samples after analysis, the list of advantages to using NIR technology is extensive and includes:Results in minutes; the test is quick and provides immediate results.
Samples do not require preparation; liquids and solids can be used in their pure form.
Sample cost is low; you won’t need any expensive chemicals or solvents.
The technique generates no waste and is environmentally friendly.
Even inexperienced users find the technology easy to operate.
Bottom Line
While NIR is an alternative technique for testing the parameters of a product, it is well established and recognized, and is well regarded in a large range of industries. Its ability to be used without the necessity of a lab or especially trained staff as well as the quick results it provides, makes it an excellent resource for companies looking to maintain a high standard of product quality while complying with industry requirements.
In-House Testing or Contract Laboratory: What’s Best for Your Cannabis Business?
The cannabis industry shares much in common with others such as agriculture, retail, and pharmaceuticals. In all of these industries, customers rely on the product to meet certain expectations of safety and quality, and match the package description. When customers’ expectations aren’t met, the first place they turn to in order to air their grievances is various social media platforms. This can have an immediate catastrophic impact on your brand’s reputation.
Regularly testing your cannabis not only satisfies federal regulations but can also protect your brand from customer frustration, and maintain your brand’s reputation. Providing a product with consistent high quality and uniformity will give customers a reliable and homogenous experience - earning their trust. From cultivation to retail, licensed entities know that doing regular testing offers better brand-building opportunities.
In-House vs. Lab Testing
As a cannabis business owner, you’re required to send samples of your product to a third-party contract laboratory for federally-mandated testing. So is in-house testing still worth the investment? The general consensus is yes. In fact, the brands that combine in-house with laboratory testing are proving to be the leaders and smart players of the industry.
At some points in the production process, you will often face an issue in which real-time decisions need to be made and you can’t afford the wait offsite laboratories require before getting results. Using in-house testing allows you to make these snap decisions in areas such as:
- Identifying the ideal time to harvest a crop
- Validating income products to ensure they match supplier specifications
- Support pricing negotiations
- Guaranteeing the efficiency of the extraction line
In such situations, urgency is a crucial factor, and the need for access to data in a timely manner is vital. In-house testing with GemmaCert gives you the information you need when you need it, and is usually ideal for simple but important tests such as potency analysis.
GemmaCert’s solution for cannabis potency and composition analysis was specifically designed by industry professionals for use outside of a laboratory setting, and is easy and affordable to use. It supplies you with the information you need to quickly make the best decisions for your business. The perfect in-house testing solution should be simple to operate, allowing any member of your team to conduct the test, while being affordable to purchase, maintain, and calibrate.
To Summarize
So, which is best for your business? The short answer is both. As cannabis is a relatively young industry and is constantly under intense government supervision and scrutiny, a company looking to establish itself with customers is best advised to combine in-house testing with regular government-mandated testing.
This is a win-win situation, as no regulator is likely to complain that you as a cannabis business manager are testing too much, and by using in-house testing you are more likely to supply customers with a consistently high-quality product, leading to customer satisfaction and avoiding unnecessary damage.
GemmaCert is now TÜV Rheinland certified.
Start Low, Go Slow: Is That the Future of Medical Cannabis?
For hundreds of years, cannabis has been used both medically and recreationally, but the recent acceptance and legalization of medical cannabis propelled the movement to use it as both a treatment for disease and to manage symptoms. Currently cannabis is used to treat anorexia, nausea, glaucoma, seizures, and most commonly to alleviate chronic pain.
A recent report from the American Center for Disease Control and Prevention indicates that chronic pain is one of the most common causes for adults to seek medical care, as well as being linked to a slew of issues including limited mobility, anxiety, depression, opioid dependence, and poor overall health or quality of life. Researchers estimate that 20.4% of adults (50.0 million) in the USA experience chronic pain and for 8% of adults (19.6 million) the pain is both chronic and high impact.
The Issues with Using Cannabis Medically
Public policy is progressing faster than the science of medical cannabis. The plant contains many cannabinoid and non-cannabinoid components which may work together in the flower as what’s known as the “entourage effect” vs. as separate compounds. Unfortunately, the correlation between the cannabinoid and non-cannabinoid composition when using the plant medicinally remains largely unknown.
Researchers have found it difficult to acquire and study the whole plant due to the plant’s illegal status. So far, most of the research done has focused on the social detriments and physiological risks linked to recreational use of the drug, and research into the efficiency of treating or alleviating symptoms with particular strains of the drug remains incomplete.
This challenges medical professionals, who are dealing with a sore lack of evidence-based guidelines on cannabis dosage and/or composition. Currently, doctors will give a recommendation to begin the patient at a low dose and record the results to observe the symptom relief given. If necessary, the dosage will increase slowly - a method known as the “start low - go slow” protocol.
Unfortunately, due to this process relying heavily on trial and error, it can lead to frustration in patients, failure to treat symptoms in a timely manner, and doctors to being wary of using cannabis as a treatment for pain relief.
https://www.youtube.com/watch?v=XxnnircaNVY
What Can Be Done to Manage This Issue
Discussions with doctors who specialize in pain management have shown that it takes six months on average to reach the ideal THC:CBD dose to manage a patient’s pain successfully. This period of adjustment can cause both doctor and patient frustration, and lead to patient reliance on addictive opiates and government financial support.
Clearly, there is a great need for more evidence-based research to support the prescription of cannabis as a treatment for various health conditions, particularly chronic pain. To allow doctors to provide efficient treatment, further clinical research must focus on finding the ideal dosing and/or composition for pain relief. Scientific evidence is critical to lead the way for medical cannabis into the mainstream.
Technologies can assist in the search for scientific evidence. GemmaCert’s new technology uses fundamentals of spectroscopy, image analysis, and machine learning to depict the cannabis flower’s unique spectral fingerprint. This does not just include major cannabinoids like THC and CBD, but all the active compounds. GemmaCert essentially allows the entourage effect to become visualized.
Using machine learning and complex algorithms, GemmaCert’s patented technology can look for the associations between the cannabis treatment’s spectral fingerprints and its efficiency as a treatment for specific health conditions.
Once the technology has identified the connections, only the products with a similar fingerprint need be used to treat that specific health condition. Companies can be instructed to breed cultivars with similar fingerprints. Ultimately, there will be enough scientific evidence to back specific claims, which can be published on product labels. Once there is enough scientific evidence, medical cannabis can become an accepted therapeutic product like any other medication.
How Do Regulations Benefit Businesses?
Although the strict federal regulations may seem like an added hassle for business owners, regulations also clear the market of questionable businesses, and builds consumers’ confidence and trust in the products and businesses. Overall, regulations raise a business’ value in the long run, and mutually benefit both the business and the consumer.
What Does the FDA Have Against CBD?
The hemp-growing industry is a young and complex one. Although the market can be difficult to predict, Hemp Industry Daily project that hemp-derived CBD sales will grow from $1.2BN in 2019 to up to $10.3BN by 2024. Despite this, the FDA is wary of approving products containing CBD, and a prescription drug used to treat two rare and severe forms of epilepsy is currently the only approved product.
What Are the FDA’s Concerns?
The concerns around CBD safety revolve around the limited data available to support its safe use. Marketing CBD by adding it to food, or labelling it as a dietary supplement is still illegal in the U.S. Among health concerns associated with CBD use are: interactions with other drugs, liver injury, and drowsiness. CBD may also prove risky to animals and products marketed for pets containing CBD are not FDA approved.
Despite the FDA’s concerns, they are actively working towards studying a wider range of CBD product samples to better understand the risks and benefits involved in using these products. Particularly concerning to the FDA is the common issue of misleading labelling on cannabinoid products.
The FDA is consistently working on updating and evolving its regulations on cannabinoid use, creating a more quality-controlled market. The FDA’s goal is to regulate CBD as a dietary supplement and food additive, in addition to clearing the market of products with misleading labels and unsafe additives.
What Can You Do About It?
While the FDA regulates the industry, you as a CBD business owner have an opportunity to take the initiative and regulate your products for safety and consistency. One aspect of regulation is to adopt in-house testing as a core part of your best practices. As the market grows rigorous inspections will increase and more in the industry will begin adopting in-house testing solutions to support decisions around quality and regulation compliance.
While external labs are crucial for regulatory compliance testing, businesses should conduct in-house tests before sending out a sample. Throughout North America, there is an average of one lab for every 10 growers. Additionally, the market is growing fast, and businesses can’t afford to wait up to three weeks for results from 3rd party testing labs. In-house testing with GemmaCert saves growers time and money and provides timely information, making business management easier.
How Do Regulations Benefit Businesses?
Although the strict federal regulations may seem like an added hassle for business owners, regulations also clear the market of questionable businesses, and builds consumers’ confidence and trust in the products and businesses. Overall, regulations raise a business’ value in the long run, and mutually benefit both the business and the consumer.