By: David Skinner
As we move towards legalizing cannabis for recreational purposes the public will need to be assured that the product they are consuming meets robust standards for safety, quality, and that these products are rigorously tested.
Developing such standards will take time; however, there are several regulatory tools and best practices that the cannabis industry can use to guide its operations in advance of future regulatory controls.
Much can be learned from the existing federal regulations for medical marijuana, including the allowed dosage forms for cannabis and its derivatives. Quality assurance and processing standards are critical to ensuring that the medicinal product is appropriate for prescribing and safe for consumption. These measures help to ensure that levels of specified components are consistent and measurable within any established thresholds.
For many botanical products, there are existing testing requirements that ensure the finished goods are well characterized with respect to contents, both for the raw plant material and any extracts produced. Methodologies need to consider all possible identity tests, (e.g. macroscopic, microscopic, chemical analysis and other assays) to ensure the ingredients entering the supply chain are only those specified in the quality documentation. The purity of raw plant material with respect to controlling for the presence of undesirable components is a well-known concern for industry (e.g. pesticide residue, mycotoxins, cyanobacterial toxins, elemental impurities and microbial contamination). As such, there is a need to have controls to ensure compliance to any established limits.
While contaminants in the raw materials is one aspect of quality control, the further processing to produce finished goods also requires vigilance to ensure that only a high-quality product is released into the distribution system. Companies will need to ensure that what is packaged and released for consumer use are tested for residues such as solvents and radioactivity (if irradiation is used to control for microbial load).
Are there practices already in play that could influence Canada’s system? Yes. Standard-setting organizations like the United States’ Pharmacopeia are setting their sights on writing the monographs and other documents that may well be incorporated into the Canadian regulatory system. These technical papers may either be incorporated directly into the regulations (incorporation by reference) or they may be used administratively to support compliance and enforcement activities of government inspectors.
Much of the burden to provide good quality cannabis falls into the spectrum of Good Manufacturing Practices (GMP) and Good Agricultural Practices (GAP) (including collection practices) and the myriad of testing requirements needed to ensure compliance. Medical-grade product would likely attract a heavier quality burden than the recreational type because of the need to provide confidence in its use for specified therapeutic purposes.
Tools are available and Canada’s emerging cannabis industry should take a leadership role in working with the government to implement solutions.
David Skinner, Senior Associate at Global Public Affairs. He brings his experience in standard development with the Canadian Standards Association, Health Canada and the United States Pharmacopeia to the team at cannabisCONNECT.