Cannabis manufacturing: Nexus between quality control and safety
In the cannabis manufacturing space, companies that have a strong, well-defined quality assurance (QA) process will produce safe products and be more sustainable in the long run. This is because QA is the set of principles, protocols, and procedures defined by a company that ensures the quality of its products is high and compliant with organizational and regulatory standards.
The regulatory standards in place for cannabis products are aimed at keeping consumers safe and healthy. Although, without federal oversight, states have been left to create regulations for consumer safety all by themselves. States and consumers alike have had to learn the hard way through emerging quality and safety issues.
A recent health crisis stemming from the illicit market was the use of vitamin E acetate as a thickening additive in cannabis vape cartridges that is linked to vaping-related lung disease (EVALI). Vitamin E acetate is a common thickening ingredient, however, the effects of inhaling it were unknown prior to these incidents that caused severe lung damage and death.
A strong understanding of how cannabis products are created along with a foundational knowledge of regulatory compliance that is supported by structured QA and safety processes can help prevent emerging health and safety problems.
Without the QA process or a blatant disregard for safety, there is no data to back up a product’s safety. QA and safety are tightly connected by fluidly structuring a process that maintains a level of quality by preventing mistakes and defects throughout the process.
This is obtained through a four-step management method, Plan-Do-Check-Adjust (PDCA), where objectives are established, the plan is executed, and the collection and analysis of data are then used to improve the parts of the process that aren’t working. The QA process relies upon documentation and data.
Cannabis manufacturers will need to identify the potential safety risks and problems that may occur during the manufacturing process in order to plan to prevent them. If there is not a comprehensive QA process in place, the consumer’s safety is at risk.
Quality and safety problems observed with cannabis Products
Contamination: Contaminants can range from microbial to chemical to physical debris. Microbial contamination is broader concern for unprocessed cannabis while chemical contamination is a concern for processed cannabis products. In August 2019 in Michigan, the Marijuana Regulatory Agency (MRA) issued a health and safety bulletin recalling four products that failed heavy metal testing (arsenic, cadmium, and chromium) and contained chemical residue of bifenazate.
The bulletin indicated the contaminants could cause coughing, wheezing, vomiting, decreased pulmonary function, abnormal heart rhythm, and damage to blood vessels. In January 2021, the Oregon Liquor Control Commission (OLCC) issued recalls for two products that were made from cannabis that had failed to pass a test for pesticides. The health effects of inhaling pesticides are unknown.
Potency and Dosing: There have been issues with potency testing which presents a problem for medicinal cannabis consumers that need to know how strong a product is. A recent study indicated that patients using medical cannabis products had different levels of cannabinoids than what was expected. These findings were consistent with a previous study that showed discrepancies in concentrations presented on product labels of edible cannabis products in California and Washington.
Potency testing problems that lead to inaccurate dosing may be occurring due to not having a globally accepted standard method to accurately measure the concentration of cannabinoids. Cannabis test results from one lab may say one thing and the results from the second lab may say something different even though both labs used the same analytical method. The marketing of a product that is labeled to have a certain amount of cannabinoids when it does not is bad quality.
So how do manufacturers rectify and/or prevent these problems from reaching the consumer? By having a comprehensive QA program in place aimed at accurate testing to identify problems so those products not in compliance do not pass the QA process.
National QA standards
The inconsistency in cannabis testing results and the lack of standard reference materials have held back the QA process for the budding industry. Currently, the National Institute of Standards and Technology (NIST) is in the process of developing standard reference material so that quality assurance can be developed.
The Cannabis Quality Assurance Program (CannaQAP) was launched in May 2019 to support the testing of hemp products and the related THC concentrations but has broadened in scope to include testing for toxic elements.
This step towards standardization means there is a path towards the development of concise methods and protocols for testing cannabis, not only concentrations of cannabinoids but for unwanted compounds such as fungal toxins, pesticides, heavy metals, etc. Once a standardized method with standard reference material has been developed, we can begin to feel more confident about the quality and safety of cannabis products.
Hazard assessment and critical control points (HACCP)
If we consider cannabis-infused product safety, the Hazard Assessment and Critical Control Points (HACCP) safety system should be a priority. The HACCP considers three hazard categories:
- Biological Hazards – These can be microbes, like pathogens that cause foodborne illness, or fungal toxins, like mold.
- Chemical Hazards – Presence of residual solvents, heavy metals, pesticides, and other chemical residues.
- Physical Hazards – Debris that is big enough to cause harm, like metal or glass fragments.
Sometime in the future when the federal government becomes involved and federal regulations are developed, cannabis manufacturers may be asked to implement a HACCP system or similar practices. The HACCP structure allows manufacturers to consider the steps in the process to identify and eliminate the risk of hazards. This system is one piece of a larger structure of safety programs like standard operating procedures and good manufacturing processes (GMP).
In order to run a compliant and sustainable cannabis manufacturing company, it is important to use these practices and procedures. The future of the cannabis manufacturing industry is reliant upon company executive teams to take the initiative to push quality assurance and safety to the forefront of the company. The health of consumers and the success of the company rely upon it.