Cannabis production has been one of the most-discussed emerging domains in both social and economic forums. The race toward the optimal production of cannabis goods marks an incredible opportunity for prospective manufacturers as it presents an entirely new market with rapidly expanding demand. A healthy cannabis industry with rigorously implemented standards provides local job creation and federal revenue in the form of taxes while also supporting a host of ancillary businesses that parallel the industry (i.e. logistics, marketing, and new technological development).
However, despite being legal in Canada and Mexico, cannabis manufacturers and marketplaces must contend with the fact that cannabis remains a Schedule I substance in the United States, making it federally illegal to produce or consume, despite several states already having permitted both.
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The current state of the industry
This legality issue has resulted in numerous challenges for the production, manufacture, and regulation of cannabis products. For example, as a Schedule I substance, the FDA is not permitted to create any standardization or Good Manufacturing Practices (GMP) in the production of cannabis products. Importantly, a lack of FDA oversight also means inconsistent testing and batch verification methods. Each company might use an in-house battery of tests and protocols, which can result in overlooking contaminants or discrepancies in potency thereby increasing the quality variance of their cannabis products.
Such protocol inconsistencies are a direct result of lacking Certified Reference Materials (CRMs) for manufacturers, which are industry standards typically used to ensure product uniformity and comparability. Cannabis production can be quite complex given the variety of desirable and important molecules produced by the plant. Aside from cannabinoids, it can be important for production to have high-quality data regarding terpene and antioxidant content, as well as the abundance of volatile organic compounds (VOCs). The low-availability plus high cost of many CRMs to measure these qualities might lock many smaller labs completely out of the market, barring innovation and competition. Additionally, there may be legal complications inhibiting the acquisition of CRMs that may be classified under the same level of restriction as cannabis itself (e.g. cannabinoid standards).
These legal restrictions will limit the number of available CRM suppliers, who, in turn, face their own legal challenges with supplying cannabis-related CRMs. Because of the limited number of suppliers, issues with one might slow down the whole industry. These bottlenecks can disrupt the supply chain, exacerbating the problems listed above, and create gaps in testing that can have wide-reaching impacts on the industry.
The current solutions
Though the current industrial challenges are quite significant, cannabis manufacturing and quality assurance practices progress regularly as manufacturers and suppliers develop solutions that improve production and efficiency. The current testing methodology tends to center around lab testing being performed at the end-product stage. However, this method is unreliable because it can lead to the loss of entire batches if end-point testing turns out poorly. Instead, the focus is shifting toward the development of proactive quality control measures implemented throughout the production process that can be used predictively, making results more consistent while reducing waste.
The development of ad hoc GMP can include methods like continuous monitoring of the production process at all stages, such ascultivation, extraction, and manufacturing. This strategy ensures that issues in the supply chain can be addressed early and more effectively, which maintains quality from raw material to final product. For example, some manufacturers have integrated the Foundation of Cannabis Unified Standard (FOCUS), created by Lezli Engelking, who recognized the need for standardized practice in an emerging cannabis market. These guidelines focus on voluntary adoption of a standardized manufacturing practice prioritizing quality and safety protocols at every point of the production process. These solutions can be combined to create internal protocols and Standard Operating Procedures (SOPs) that bolster the safety and quality of any manufactured cannabis good.
It will also be important to form strategic partnerships with specialized vendors and service providers that can help bridge gaps in issues like reliable testing, quality control, equipment, and expertise. However, quality partners can be difficult to find, and evaluating them even more so. Key criteria of evaluation to help determine quality partnerships can include a review of their standards—for example, if they adhere to FOCUS as their production standard. It can also encompass an examination of their equipment, the quality, type, and suitability for your purposes. Ask about their track record with other business partners and collaborations. Finally, ensure their employees are well-trained and properly certified where appropriate.
The final product
The challenges facing the cannabis industry are complex but not unapproachable. The US federal legality issue creates uncertainty in the industry, leading to a lack of consistent regulation and products between states, vendors, and manufacturers. Operating without unified GMP can lead to methods that are inefficient or inadequate. However, the establishment of proper GMP is made more complex when the distribution of CRMs is significantly impeded.
Overcoming these challenges will require strong partnerships and innovation. Improving the quality of product testing with tools like chromatography to determine cannabinoid composition, as well as techniques to identify and manage product impurities, will be an important part of the development of the cannabis industry under any regulatory paradigm.
