As the European cannabis industry grows, so too does the need for laboratories to verify that what exists on the market is safe and legal, with labelling accurately reflecting whatever is indicated.
The U.S. has largely led the way about medical and adult-use cannabis. As a result, they were among the first to take testing seriously. However, cannabis testing was (and remains) a new field. Early market leaders such as Steep Hill Labs in California had to define their methodologies. When they began in 2008, there were only four certified reference materials available for calibrating their equipment. Thus, they had to identify their own in order to provide richer information to their clientele. The subsequent processes afforded Steep Hill and other labs scrutinizing and developing their own techniques with some first-mover advantages as competitors were left to figure out their own techniques and services. Now there are 18 certified reference materials, so laboratories know better how to home in on their targets.
In a fast-moving sector of a rapidly growing industry, the testing methodologies of laboratory companies are still often viewed as their individual IP, never to be shared. While some may argue that it is a sensible business approach for the short term, it does little to help the testing industry at large find common ground toward the development of collective standards and aims toward industry-led regulation.
What may have been a necessity early on may have worked well, but as the industry grows there comes a point where standards for methodologies need to be shared, lest samples from different labs will offer different results, leading to “lab shopping” in cutting corners for getting to market.
There exists a relationship between a laboratory’s popularity and its revenues. To manufacturers of cannabis products, it makes sense to get one’s products tested at a laboratory that finds minimal issues. If such a lab charges less to do so, all the better in the immediate term.
“The real issue in the industry is that there is not enough focus by the testing labs on generating accurate results for cannabis products. Shortcuts are taken to cut costs and reduce turnaround,” explains Wendi Young of Colorado-based Mile High Labs.
Another factor at play is the fail rate: While more convenient for some that there is no federal oversight in checking fail rates, the void can lead to a de facto popularity contest where a laboratory’s incentive is to produce inexpensive (if more loosely favorable) test results for those customers. At some point regulations, common standards, accreditation, and auditing become essential to ensure that the standards sector of the industry remains impartial and credible.
“There is a lot of distrust put on laboratories by the industry due to the fact there is no standardization,” explains Reggie Gaudino, formerly of Steep Hill (and New Frontier Data’s Chief Science Advisor). “If regulations have no teeth, they don’t deter anyone, and people can cheat left, right, and centre to avoid the rules.”
But how to regulate? While being too draconian and dictating the methodologies which laboratories need to use can stifle innovation, being too hands-off could warp results as companies profit by exploiting loopholes. An example of regulations set in place by regulators and not scientists (and the pitfalls so created) is the differing approach to banned pesticides in different U.S. states. The number of pesticides to test for can range from as few as 25 in one state, to over 70 in another, with some states listing broad categories and classification to potentially drive the number far higher. Federal harmonization of such regulations will be a complicated process once cannabis is legalized nationally.
Meanwhile, in Europe there is a risk that laboratories (and regulators) may be heading toward similar traps. There exists no harmonization across the EU for cannabis legislation, so member states are making their own rules. Simultaneously, the rapidly growing market is rich pickings for the first laboratories to market. Just as with their U.S. peers, they too are keenly protective about the methodologies they use.
Aside from having the necessary accreditation to run a laboratory in the first place (which is desirable but not obligatory), there are no specific regulations in place to define standards for a laboratory’s required methodologies when it comes to the testing of cannabis. It is not a surprising circumstance given the immaturity of the cannabis industry in Europe, but it is becoming a more acute issue as the success of the CBD market turns cannabis-based products mainstream.
Ultimately, the onus is not just on the laboratories or regulators, explains Sophie Thomas of UK-based PhytoVista Laboratories. “There needs to be better education for manufacturers and resellers on what they need to be testing their CBD products for,” she said. “To that end, [labs]have a set of guidelines that can help companies submitting samples throughout the process. We see an inconsistency in conformity, and understand it should be addressed through customer education.”
In many European states the legal requirements are unclear or clouded in misinformation. Rumours of the UK allowing 0.2% THC in CBD products is an example of such a misinterpretation. In actuality, the laws are very clear: THC is a controlled drug in the UK, so there must be no detectable amount. The rule makes things more complicated for producers. As Gaudino points out, “genetically it’s possible to get THC without CBD, but so far the data hasn’t show that high levels of CBD can be obtained without THC. So, specially developed cultivars and processes to remove THC will need to be developed.”
Standards for methodologies in cannabis testing are available. U.S.-based AOAC International is emerging as one of the leaders for common standards in cannabinoid testing. Its open platform for methodology development — the Cannabis Analytical Science Program (CASP) — brings together government, industry, and academic stakeholders and experts to establish standard methods of analysis which are then submitted for accreditation from organizations such as the United Kingdom Accreditation Service (UKAS), government’s sole and globally recognised accreditation body responsible for determining the technical competence and integrity of organisations offering testing, calibration, and certification services.
Europe has an opportunity to get things right. U.S. laboratories and regulators have laid the groundwork and standards for methodologies which had not existed when U.S. state markets first established their processes. European regulators need to work with organizations such as AOAC to coordinate an industry- and academia-informed led collaboration for standards. As Gaudino concludes, “the industry must eventually get to a point where we need a oneness.”