The National Institute of Standards and Technology (NIST) has announced that a new program launched to standardize Cannabis testing methods and to aid commercial and forensic laboratories to accurately measure chemical compounds in marijuana, hemp, and other cannabis products.
The aim of the Cannabis Quality Assurance Program (CannaQAP) is to achieve accuracy in product labeling and help laboratories to distinguish between hemp and marijuana.
While the labels on most cannabis products illustrate the concentration of tetrahydrocannabinol (THC) and cannabidiol (CBD), without official testing methodology, laboratories can often differ in their testing techniques, in turn, providing ’unreliable’ results.
It is therefore primarily the inconsistencies in testing results that the researchers at NIST are looking to address in the course of the program.
“When you walk into a store or dispensary and see a label that says 10% CBD, you want to know that you can trust that number.” —NIST research chemist Brent Wilson
To achieve the program’s objective, NIST is looking to partner up with a range of hemp testing laboratories. The first point of the CannaQAP effort will consist of NIST sending out hemp oil samples to the participating laboratories and asking them to measure the total of CBD and THC using their routine testing methods. Each lab will then test the oils and relay its results and techniques back to the NIST researchers. It is expected that further exercises will include the testing of plant material samples.
The data collected from the participating laboratories will then be evaluated. NIST is looking to publish the data anonymously so that the participating laboratories’ names are not revealed. Research chemist Melissa Phillips has stated: “Anonymity means that labs don’t have to worry about how their performance will be viewed. Our goal is to help labs improve, not to call them out.”
While the laboratories will not be named, the results will show how much variability there is between them. Furthermore, NIST is looking to publish the correct measurements, so that each laboratory can see how accurate its measurements were and how it performed compared to its peers.
Once NIST researchers can review the results, and evaluate the scope of the inconsistencies, they will be in a much better position to issue guidance on best practices for cannabis testing.
NIST has said it will be developing a standard hemp reference material, which will provide accurate measurement values that labs can use to validate their testing methods. One reason these measurements vary so much is that there are currently no reference materials for cannabis.
Finally, it is understood that the new federal CannaQAP endeavour might go beyond legal hemp products. “NIST is also planning to conduct future exercises with ground hemp and possibly marijuana,” the agency has indicated. “Those exercises will involve measuring a larger number of compounds, including terpenes—the chemicals that give different strains of marijuana their distinct aromas—and compounds that people don’t want in their cannabis such as fungal toxins, pesticides, and heavy metals. Future exercises may also include extracts, concentrates, distillates, and edibles.”
We will continue following the program and will provide updates as soon as new data comes to light. Be sure to subscribe to our newsletter to stay in the know. Laboratories that are interested in participating in the program can find more information and register online.
FDA Issues Draft Guidance on CBD Clinical Research and Submits CBD Enforcement Policy to OMB for Review
July 2020 has been a busy month in the CBD world whereby FDA issues draft guidance on CBD clinical research and submits CBD enforcement policy to OMB for review.
After much anticipation, the FDA has begun to address its policies on CBD. On July 21, 2020, FDA issued draft guidance on clinical research involving CBD-containing investigational drugs and other cannabis-derived compounds. Further, on July 22, 2020, the long-awaited draft guidance on CBD enforcement policy was sent to the Office of Management and Budget (OMB) for a review.
To date, FDA’s movement has not officially changed the existing position on the legal and regulatory status of various CBD-containing consumer products, but more is expected. Still, the recent reports to Congress and draft guidance on investigations involving CBD and other cannabis-derived compounds do provide us with a glimpse of FDA’s current reasoning surrounding CBD.
Clinical Research Draft Guidance
On July 21, 2020, FDA issued draft guidance on quality considerations for clinical research where cannabis-derived compounds are concerned. The guidance titled “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research” builds off previous guidance FDA had issued regarding the quality and regulatory considerations that govern the development and FDA approval of cannabis products. The draft guidance highlights the following key points :
1. Sourcing of Cannabis
For many years, the only domestic source of cannabis for legal clinical research was the National Institute on Drug Abuse (NIDA) Drug Supply Program (DSP), but with the changes made by the 2018 Farm Bill, hemp can serve as a source for cannabis cannabis-derived compounds for drug development. This change gives the investigational drug sponsors of clinical studies new options that do not involve the NIDA DSP.
2. Quality Considerations
Sponsors of cannabis-derived compounds will be expected to provide sufficient information to ensure the identity, quality, purity, and potency or strength of the investigational product. Furthermore, there will be a requirement to provide quantitative data regarding phytochemicals present in their proposed product, such as cannabinoids, terpenes, and flavonoids. The guidance goes on to list several helpful resources from which sponsors may obtain more information about specific methodologies and other related insights. The guidance clarifies that cannabis is held to the same regulatory standards as any other botanical raw material, botanical drug substance, or botanical drug product; therefore, any FDA guidance that pertains to such items will also be helpful.
3. THC Calculation
The guidance acknowledges some of the challenges of calculating THC and notes the importance of consulting the DEA before commencing drug-development activities. Amongst other things, the FDA recommends that sponsors calculate the THC level in their product candidates early in the development process to gain insight into its potential control status.
Cannabidiol Enforcement Policy Draft Guidance
On July 22, 2020, the FDA sent its draft Cannabidiol Enforcement Policy to OMB for review. The scope and the contents of the document titled “Cannabidiol Enforcement Policy; Draft guidance for Industry” are not yet publicly available, but the industry is eagerly anticipating the long-awaited guidance on CBD enforcement.
While the full extent of the FDA’s intended enforcement consideration will be clear only when guidance is finally released, we expect, like many others, that FDA will focus its efforts on consumer products that carry the most significant risk to public health. Therefore, we anticipate that the enforcement guidance will focus on lawful marketing and transparency.
We will continue to monitor the FDA’s issuance of the enforcement guidance and update as soon as it passes the OMB review. Make sure to sign up to our newsletter for further updates.
The Pandemic has taken its toll not only on our outer world but most certainly on our inner. Even the World Health Organization has published the dim prospect of an imminent, pandemic-related mental health crisis. It is well known that psychological stress from any origin is likely to raise the risk of depression and anxiety. The stress originating from coronavirus implications may likely come with its own mental health challenges. Chronic stress is known to weaken the endocannabinoid system (ECS), therefore making us more exposed to illness.
With the cannabis plant’s ability to support the endocannabinoid system and research demonstrating that CBD has helped relieve various mental health symptoms, we have dug a little deeper into CBD’s effect on anxiety and depression.
CBD and Anxiety
The link between cannabinoids and anxiety and fear has been of special interest in clinical research.
Anxiety disorders are the most well-known mental illness in the U.S., affecting 40 million adults, or 18.1% of the population and are routinely defined by excessive worrying about things and events that manifest in physiological responses in the body.
In laboratory settings, CBD has been shown to decrease experimentally induced anxiety and lessen fear memories in healthy adult participants. Clinical trials in patients suffering from post-traumatic stress disorder (PTSD) have demonstrated that dronabinol and nabilone can reduce their symptoms.
Although CBD trials have shown limited impact on baseline levels of anxiety, it is evident that CBD reduces experimentally induced anxiety and fear. For example, one study in healthy participants and those suffering from social anxiety disorder found that CBD decreased task-related anxiety. Whereas another study implies that CBD reduces amygdala activation in case of a threat and alters functional link between prefrontal regions and the amygdala, which could explain its inherent anxiolytic effects.
While more is to be learned about CBD’s anxiolytic effect, and with clinical research moving at a slow pace, we might be a while from an official approval of CBD as an anti-anxiety solution. In the meantime, to minimize any damage to our endocannabinoid system caused by current coronavirus stress (which may make us more exposed to anxiety disorders), we could do far worse than incorporate high-grade CBD oil into our self-care regimen.
CBD and Depression
Depression is characterized by having a persistently low mood or loss of pleasure in regular activities for at least two weeks. Approximately 17.3 million adults in the U.S. have had at least one major depressive episode.
Studies in animals have shown that CBD certainly improves the symptoms of depression. This is to be thought most likely due to the activation of 5-HT1A receptors in the brain.
In one study, animals were given a 5-HT1A receptor antagonist beside CBD, limiting the cannabinoid from bonding with the serotonin receptor. This seemed to prevent the mood-enhancing impact of CBD. Another study found that aside serotonin, CBD increased glutamate production, and neurotransmission resulting in immediate antidepressant-like effects.
The current research unquestionably indicates that CBD can improve symptoms related to depression. It is hoped that more clinical data will be available soon, however, it is unmistakable that CBD for depression continues to be one of the most common reasons people turn to CBD oil.
CBD is inevitably a multifaceted supplement that’s becoming well established by research with more evidence emerging that shows real therapeutic benefits.
For more information and to try out our range of CBD oproducts or to see how CBD can help you cope during stressful times, head over to our store.