Can SB-544 Change California’s Legal Cannabis Industry for Good
For any laboratory, creating and maintaining a reputation of integrity is paramount to success. If a lab’s test results cannot be trusted, the impact can be catastrophic.
Picture this for a moment: what if you heard that a clinical laboratory notoriously inflated the results on a lipids panel? Wouldn’t you question your doctor for using this lab and prescribing cholesterol medication on these results? Especially if you are in great physical health and have no history of high cholesterol?! I certainly would. OR what if you do have high cholesterol and are supposed to take a 100mg of a medication. Would you be okay knowing that the testing laboratory that certified this batch of medication faces publicly accusations of producing highly variable and inaccurate results? While I would worry about my personal safety taking this medication, the Food and Drug Administration ensures this does not happen.
Now, what about for cannabis? It’s the year 2021; cannabis has been legal in California since 1996; the first testing labs have been in existence for over 10 years; and now all legally sold cannabis and cannabis products require mandatory quality and safety testing. But with legalization first based on the premise of cannabis as medicine, can we trust lab results just like we do in other industries?
The Integrity Problem Facing Legal Cannabis
The fight for legal cannabis in the US has been an uphill battle. Because we work in an industry that has been criminalized for far too long (think Reefer Madness), the burden of proof that cannabis should be treated as any other agricultural commodity rest squarely on all of us. Which is why laboratory quality testing is so important.
However, when you hear about “Lab shopping” for the “right” results, “THC potency inflation,” and “Faked test results,” the industry reeks of grift and falsification, giving opponents of legal cannabis another argument for why marijuana should remain illegal.
Hearing of potency results at over 50% total cannabinoids is absurd for cannabis flower; and concentrates with over 95% total cannabinoids and ~10% terpenes is theoretically impossible. Yet, labs have issued compliance Certificates of Analysis (COAs) for these products and regulators accept them. But why??
In California, Proposition 64 created a unique system where distributors must have final-form products analyzed by a State-licensed, ISO 17025 accredited testing laboratory before a batch of product is released to the consumer. And since most consumers decide “quality” based on THC (for flower and concentrates), wholesale costs are directly proportional to Total THC and/or Total Cannabinoids. Effectively, the higher the percentage THC flower or concentrate, the more the product can ultimately sell.
On top of hunting for the highest THC percentage, cultivators and manufacturers can lose entire batches (and potentially millions of dollars) to failed safety tests like microbial contaminants, heavy metals, and residual pesticides. Obtaining a passing Compliance Certificate of Analysis can make or break a small business.
Let me be clear – it is NOT just unscrupulous labs; threat(s) of cultivators, manufacturers, and distributors pulling testing business from a reputable laboratory is always a fear for lab operators – losing business to another lab promising “better” results or possibly guaranteeing a “passing” result. Either way, this is a dilemma for the entire industry and undoes what we as a collective whole have been championing.
SB-544 and how standardized methods aim to reduce lab shopping, potency inflation, and fake results?
On October 5, Governor Gavin Newsome signed SB-544. This bill requires the Department of Cannabis Control (DCC) to establish one or more standardized cannabinoids test methods for use by all licensed testing laboratories by January 1, 2023. This bill aims to address and hopefully eliminate lab shopping due to potency inflation by forcing all labs to use the same methodology for determining cannabinoid potency.
Standardized methods are nothing new for reference laboratories outside of cannabis. Alcohol/beverage, food safety, clinical, and environmental labs all follow standard methods. However, because cannabis has only been studied in the US through the lens of Drug Abuse, few standard methods exist, requiring cannabis testing labs to develop and validate in-house methods. Critics typically point to in-house test development as a place for alleged cannabinoid potency variation.
However, a method alone cannot fix potency inflation without looking at all the factors that go into cannabinoid potency testing.
A word of caution for those waiting for a standard method
The implementation of a standard method by the DCC, while not a panacea to eliminate all issues, is a step in the right direction, though it has the potential to stifle innovation.
Not all cannabis and cannabis derived products are analyzed the same manner. Yes, the method on the analytical instrument can be similar (or the same), but the preparation can and will vary product-to-product. For the DCC to best implement standard methods in cannabinoid potency, they must also prescribe a full Standard Operating Procedure (SOP) that outlines homogenization, preparation of various matrices, and instrument analysis.
Moreover, and something those in the industry do not want to hear, standard methods may slow down final Compliance turn-around-times. In 2020, AOAC INTERNATIONAL’s Cannabis Analytical Science Program (CASP) released the first standard method for cannabinoid analysis and have since released other cannabis and cannabis product specific methodologies. While this step of standardization is great for the industry, cannabis laboratory professionals agree that these methods are not always “production friendly” SOPs, requiring long run times and extensive preparation.
Conclusion
To bring consistency to cannabis testing in California, bills like SB-544 are a step in the right direction. Requiring standardized cannabinoid potency analysis could help bring parity to what is referred to as the wild west of cannabis. However, directing the DCC and the Department’s new reference lab to develop a standard method before setting up other priorities is short-sighted. Instead, the Department could develop inspection and enforcement guidelines as well as addressing the taxes that are crippling the industry and only promote the illicit market.
