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The Best Offense is a Good Defense: Quality Assurance, Consumer Protection, and the Role of Regulators

March 1, 2023

Cannabis quality and cannabis safety are not mutually exclusive  

To achieve product parity in the cannabis space, legal-market producers must synthesize what is desired, a positive consumer consumption event, with what is compulsory, consumer protection. Few direct measures exist that ground consumer product preference for high-quality, terpene-rich cannabis with risk management strategies for herbal medicinal products like water activity. 

Water activity (aW) is a cannabis quality specification that informs the consumer-quality paradigm. Cited in both food and pharmaceutical industries as a critical control point, this fundamental criterion facilitates both cannabis product safety and freshness. Measured on a scale from 0-1, water activity indicates the amount of “free” water in a sample and, therefore, the potential for microbial proliferation within a product or product package. From a cannabis consumer quality standpoint, failure to control water activity results in over-dry cannabis that leaves consumers with a harsh, dry smoke- bereft of terpenes, flavor, and medicinal value.  

There are numerous operational advantages to implementing a water activity control program

Terpenes and the quality of flower are maintained from cure to consumption; plant material is less susceptible to contamination from mold, yeast, bacteria, and other harmful microorganisms; and retained water weight results in greater financial gains. However, regulatory agencies have been slow to impose water activity (aW) standards on cannabis operators. Instead, operators are largely left to their own internal processes and anecdotal market feedback when establishing aW control programs. This self-regulated approach leads to inconsistent enforcement of cannabis quality across many, if not all, of the United States’ cannabis-friendly jurisdictions.  

Regulators are not without guidance, and it is time for the cannabis industry to adopt stricter aW standards to improve consumer protection, business and government revenues, and the quality of cannabis available.  

Quality controls exist in the cannabis industry  

Regulators in the cannabis industry are no strangers to enforcing quality standards. Currently, all cannabis-friendly jurisdictions in the United States require potency and contaminant testing of consumer-facing cannabis products and treat the “testing” phase as a critical control step for product quality. Test metrics generally focus on the cannabis product’s total cannabinoid content and the presence of contaminants – microbes, heavy metals, and other substances not safe for humans – to dictate whether a cannabis product is “safe” for consumers. Unfortunately, the actual quantitative standards that determine if a cannabis product is “safe” vary significantly from jurisdiction to jurisdiction.  

The American Society for Testing and Materials (“ASTM”) is an organization that develops and publishes voluntary consensus technical standards for a number of industries, materials, products, systems, and services. ASTM has released various standards for the cannabis industry, including ASTM D8197, which specifies an acceptable aW range for dry cannabis flower that is intended for human use. The suggested range for dried cannabis flower is 0.55 to 0.65.  

Current control metrics promote bad faith testing  

The current test control point is focused on identifying a cannabis product’s total cannabinoid content and detecting the presence of contaminants. However, certain relevant standards – like a defined aW range for dry cannabis flower – are generally not imposed on cannabis operators.  

The current regulatory focus on cannabinoid content and detecting the presence of harmful substances creates an environment that promotes bad faith approaches to gaming test results. Marketing strategies in the cannabis space focus on cannabis product potency and consumers have come to expect high-potency flower. Operators know they can manipulate potency results by submitting bone dry test samples to labs that result in abnormally high tetrahydrocannabinol (“THC”) percentages by weight. Whereas a typical 2016 cannabis consumer expected dry flower potency ranges from 15% to 20% THC, a typical 2023 cannabis consumer is used to seeing dry flower potency ranges from 25% to 30% THC.  

Conversely, operators know well that the more their flower weighs, the more revenue they can expect. Common practice is to submit a specially dried test sample for potency testing while the buds that are packaged for consumer purchase have higher water content and thus a lower THC percentage by weight. The result is that consumers purchase products that they believe have a higher THC percentage by weight. Further, if water activity is not controlled for the duration of time that it takes for a flower package to transfer from a source facility to a retailer and eventually into a consumer’s hands, the quality of cannabis may degrade.  

Water activity is a relevant control point

aW is a simple metric, but the regulation of aW in cultivation processes would lead to a reduction of contaminated flower available to consumers while simultaneously ensuring a higher quality of flower enters the market. ASTM D8917 provides a great foundation for regulators to generate policy from and suggests that dry cannabis flower intended for human consumption should have an aW maintained between 0.55 and 0.65. Related ASTM standard D8196 provides comment as to the significance of controlling water activity:  

5.3 Analysis of water activity should be considered an important quality control step in ensuring a cannabis flower sample is being stored under optimal storage conditions to prevent mold and/or other microbiological growth and/or breakage.  

5.4 Maintaining the requisite [aW] throughout the supply chain from completion of drying through merchandising ensures safety and quality for the consumer.  

Regulatory agencies would thus hit two birds with one stone by implementing standards for water activity in cannabis flower: consumers would enjoy a higher quality product that has a cannabinoid content aligned with what they are being told, and there would be a reduced risk of contaminated products reaching retail shelves.  

Some regulators are taking the lead

While there is a general lack of standardization of appropriate water activity levels in dry flower available to consumers, some jurisdictions, like Colorado, have implemented policies that could guide other jurisdictions in developing their water content policies. Colorado’s Department of Revenue’s Marijuana Enforcement Division (“MED”) issued a Rule, effective July 1st, 2021, that establishes an upper limit of acceptable water content detected in flower, shake, kief, and trim of 0.65 aW. CCR 4-115(D)(1). The water content test is a required part of Colorado’s overall microbial contaminant test. CCR 4-120(C)(1). The upper limit approach adopted by the MED reduces the risk of microbial contamination in packaged cannabis as it moves through the supply chain before being available for purchase to consumers.  

Regulators would be prudent to consider a floor to acceptable water content as well. Overly dry cannabis leads to inferior quality product being made available to consumers and allows operators to manipulate cannabinoid potency test results. However, the upper limit is a key control in consumer safety and represents a logical place for rulemaking efforts to start. Other jurisdictions in the United States may look to cannabis policy leaders, like Colorado, to define how water activity should be regulated in cannabis. Fortunately, regulators can rely on the ASTM D8916 and D8917 standards described above as guidance. In the humble opinion of this long-time cannabis attorney, they should.  

The views and opinions expressed in the article represent the view of the authors and not necessarily the official view of Clark Hill PLC. Nothing in this article constitutes professional legal advice nor is it intended to be a substitute for professional legal advice. 

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