Fragmented Regulatory Environment Leads to THC Inflation in Cannabinoids
In 2020, Keagan Skeate, a data analyst and now whistleblower, reported Praxis lab for data tampering and inflating THC levels in marijuana products tested there. In July 2022, Steep Hill, Inc. was presented with a class action lawsuit by 3 patients alleging the state-run lab intentionally overstated the amount of THC in the marijuana it sells to its medical patients in Arkansas. Other states are noticing similar scenarios playing out with THC results being altered before or after analysis, intentionally or not. The cannabinoid industry is relatively young but has grown at a rapid pace with states unable to keep up with regulating the industry and ensuring proper reporting. Contrarily, cannabis companies have thrived under this environment to achieve record profits. Testing has heavily focused on potency in order to woo customers and justify higher prices.
As of 2022, only three states have no cannabis access law on the books, with 38 states (and the District of Columbia) legalizing medical marijuana and 19 states legalizing it for recreational use. Medical and recreational marijuana both possess THC as an active compound, but the desired effect differs by end user with medicinal users seeking various therapeutic benefits, while recreational users mainly prize the psychoactive effects – namely, a ‘high’. Tetrahydrocannabinol (THC), a chemical compound, acts by binding to the receptors in the brain that control pain and mood, among others. Medical users seek relief from symptoms such as nerve pain and nausea, or from degenerative conditions like Parkinson’s disease. In addition, cannabidiol (CBD), another active compound produced by cannabis, is often taken to treat anxiety, arthritis, diabetes, insomnia, etc.
Even with its widespread use, both medically and recreationally, it wasn’t until 2013, 17 years after medical marijuana was first legalized, that Massachusetts became the first state to mandate analytical testing of medical marijuana. Any companies wanting to sell medicinal cannabis in the state would have to hire an independent lab to test their products for contaminants and for potency, the latter of which would ensure the accuracy of the product label claims. Other states were quick to follow and as of 2022, 26 states have introduced mandatory testing for medical and/or recreational products containing cannabinoids. In the absence of federal regulation – federal law still generally prohibits all usage – or a unified independent body to issue guidance on THC and CBD testing, state labs and private companies are tasked with developing and validating their own methods and issuing their own requirements and standards. This stands in stark contrast to the pharmaceutical industry, where pharmaceutical analytical methods must meet set criteria led by USP, EP and harmonized by the ICH to ensure accurate and precise results. This approach has led THC methods and results to vary lab to lab, and fostered an environment that has enabled some labs to tamper with results.
THC and CBD have molecular similarities to other cannabis compounds, presenting a challenge for measuring concentrations. The potency of cannabis products varies by strain and further contaminants may be introduced to the plant materials during growing, manufacturing and storage processing, presenting an additional challenge in properly quantifying THC potency, or in setting limits for THC potency amid concerns when high values are observed. High performance liquid chromatography (HPLC) has emerged as the gold standard for THC and CBD testing, as well as for their acidic precursors, tetrahydrocannabinolic acid and cannabidoiolic acid, which degrade to THC and CBD upon being heated through smoking or preparation for oil and edible products. A sample for analysis is first obtained by grinding the dried plant material and then dousing it with solvent to extract cannabinoids. The residual fluid is then collected and fed into an HPLC system. A successful HPLC method allows chemists to separate the THC or CBD from terpenes, flavonoids, and other cannabinoids to accurately detect each component’s concentration.
Unfortunately, there are many accounts of labs producing drastically different potency measurements for the same products, with variation of up to 40%. This has led cannabis producers to shop around when it comes to contracting labs for their potency tests and has reinforced the profit motive for labs to participate in THC potency manipulation. Cannabis producers tend to prefer labs reporting higher THC potencies as the price is driven by the amount of THC found in the product. The issue is generally not with the underlying instrumentation being used to conduct the tests, but rather a variety of different variables in the testing. The Michigan State Police Forensic Science Division lab in August of this year recently determined that specific reagents used in their analysis caused inaccurate THC readings. Also, the variability and lack of properly validated methods for THC potency has further exacerbated the problem. And with the increasing catalog of cannabinoid products, lack of knowledge can lead to improper sample preparation affecting final potency values. Other labs may intentionally resort to document manipulation, as was the case at Praxis lab, where it was found that the weights of the marijuana samples reported were reduced, therefore increasing the THC concentrations calculated.
As more states adopt marijuana usage and the cannabis market grows, the regulatory situation is likely to improve, so that labs will be placed under greater scrutiny and required to ensure proper reporting of potency on product labels. Demand for HPLC will increase in order to meet these strict regulations, which will contribute to the overall HPLC market in 2022. In addition, the need to enforce data integrity in the industry will drive demand for chromatography software and data systems to hold labs accountable during and after testing. The market for HPLC (for all applications) is assessed in the SDi Global Assessment Report 2022. The report examines the HPLC market as well as the market for over 80 other types of analytical lab instrumentation in order to provide information on the market size, vendor share, and forecasts by product type, region, end market and application. In September 2022, SDi will also publish a more in-depth review of the HPLC market which will cover traditional HPLC, UHPLC, SEC/GPC, AAA, Prep HPLC, SFC, and Clinical HPLC, providing a thorough market analysis for each HPLC technology, as well as in-depth end-user perspectives relating to HPLC gained through a quantitative survey of laboratory personnel across the major end markets and regions.