A Few Major Cannabis Developments to Start the Year

We take a moment to review two recent developments that set the stage for major advancements in the new year

The past two years have shown that the cannabis industry is both incredibly resilient and amazingly unpredictable. As we enter the third year of the pandemic, many indicators point towards getting back on track – with further growth of the testing, standardization, and research sides of the industry.

Expansion of Cannabis Research

There has been a growing number of basic and clinical research efforts centered on cannabis over the past few years. We previously mentioned the increasing number of clinical trials involving cannabis, a number that currently sits at 566 for THC and 366 for CBD, according to ClinicalTrials.gov. In 2021 alone, it is reported there were over 3,800 research papers published on cannabis.

The growth of research is the result of increasing interest in the medicinal qualities of cannabis and cannabis-derived compounds at both the basic and clinical research levels. A major obstacle that has challenged government sponsored research to this point has been the restriction to only a single approved cannabis supplier from which researchers could obtain material.  Not only did this limit the amount available for use, but it restricted the range of chemotypes produced. This presented a major problem when considering the wide range of cannabis chemotypes and products out in the legal medicinal market. In short, researchers were largely unable to obtain and test the types of cannabis most relevant to therapeutic use and consumption in the field.

This has now changed dramatically. The tail end of 2011 saw the approved production of research-grade cannabis by several companies, with the full support of the drug enforcement agency (DEA). This follows the steps indicated earlier by the DEA, which proposed a new authorization process to allow additional manufacturers of research-grade cannabis.

What does having multiple cannabis suppliers for research mean going forward?

First, basic research can better uncover the effects of exogenous cannabinoids such as THC, CBD, and others on biological processes. Such efforts could help clarify the role of endogenous cannabinoids and the physiological effects of altering the balance of the compounds in the body.

Clinical research may be bolstered by a better understanding of the effects of cannabinoids and other compounds on processes such as inflammation and impacts on disorders such as chronic pain, insomnia, PTSD, and the range of diseases found to be at least anecdotally affected by cannabis.  Moreover, such research may solidify the association between cannabis as a therapeutic and certain types of cancer and other complex diseases.

This expansion of research comes at critical time.

A recent study, published online as a pre-print, discovered that cannabis compounds, cannabigerolic acid or CBGA and cannabidiolic acid or CBDA – the acid precursors to CBG and CBD, bind to the spike protein of SARS-CoV-2 and limit the ability of the virus to infect cells in the lab. A further pre-print study found that synthetic CBD “appears to prime the innate immune system of cells, potentially offering protection against pathogens such as SARS-CoV-2.” Most recently, researchers published a report in the journal Science titled, "Cannabidiol inhibits SARS-CoV-2 replication through induction of the host ER stress and innate immune responses."

Expansion of the quality and breadth of new research will help identify and validate the potential roles of cannabis in the therapeutic world, which in turn would benefit us all.

Technology Development and Testing Standardization

The tail end of 2011 also saw the AOAC approval for a novel Method of Metals Analysis in Cannabis. The approved method was developed by Agilent and CEM, and represents a big step forward in validation of ICP-MS technology to quantitate metals (arsenic, cadmium, mercury, lead, and other elements) in cannabis. Previous ICP-MS methods were based on standards adopted from the food and agriculture testing industries administered by the FDA, and were not specifically developed and validated for cannabis testing.

Until this point, states and provinces have instituted their own guidance regarding metals testing regulations. This has made it difficult to ensure quality and safety across the industry.  Validation of the novel ICP-MS method for cannabis and subsequent approval by the AOAC cannabis analytical science panel (CASP) panel of experts supports industry-wide standardization, which may lead to federally adopted guidelines in the future. Such progress may quicken the enactment of federal oversight and standardization, which would benefit quality and safety for consumers and all those involved.

This development follows the recent approval of several other testing methods as well. In mid-2021, AOAC approved six different test kits for enumeration of yeasts and mold in dried cannabis flower. Although several of the kits had previously been approved for food testing, the kits can now be recognized by accreditation bodies as validated methods for dried cannabis flower. The approvals were part of the Emergency Response Validation Process (ERV) administered by AOAC, to provide AOAC-approved methods for cannabis testing labs in accordance with certain state guidelines. These cannabis-specific approvals will increase quality and safety of cannabis products, as well as support the needs of cannabis producers in controlling microbes in crops and downstream production lots.

What does test validation and approval mean for the industry? An increase in safety and quality control in the short term for sure. But similar to approval of the metals analysis test described above, these approvals may eventually lead to federally adopted guidelines and standards.

Outlook

Beyond this, increased approval of testing platforms by standardization bodies such as AOAC may motivate the development of new technologies to address ongoing needs. 2022 may well see new products designed with the performance capabilities to addresses these challenges.