© 2024 MJH Life Sciences™ , Cannabis Science and Technology . All rights reserved.
Inconsistent testing is a significant issue in the cannabis industry, contributing to fears about potency inflation and product safety. However, adopting cGMP compliance offers a clear solution by implementing standardized testing protocols, comprehensive batch testing, and rigorous third-party verification.
As federal legalization of cannabis looms on the horizon, the industry is grappling with significant concerns about inconsistent testing practices. Issues like lab shopping, cherry-picking samples, and a lack of standardized testing protocols have led to fears of potency inflation and unsafe products. For those opposed to cannabis legalization, these inconsistencies raise red flags about the reliability of the industry and the safety of its products.
Incorporating current Good Manufacturing Practices (cGMPs) into the cannabis industry offers a solution to these concerns. By adopting standardized, consistent testing protocols as part of cGMP compliance, the industry can ensure the safety, quality, and transparency of its products. This proactive step not only addresses the issue of inconsistent testing but also helps reassure skeptical voters and regulatory bodies ahead of potential federal legalization.
While there is no cGMP certification specifically for labs—since cGMP standards apply to manufacturing facilities—requiring cGMP compliance could expose many of the current testing inconsistencies. This may prompt the Food and Drug Administration (FDA) to push for standardized testing protocols, ensuring that labs operate under clear, uniform guidelines. Such standards would significantly reduce risks across the industry. With federal rescheduling on the horizon, the requirement for cGMP compliance is likely just around the corner.
Testing is one of the most significant issues facing the cannabis industry today. There are many issues with testing, but these are some of the most well-known and prominent at this time. With different labs using varied protocols, equipment, and testing standards, there is a lack of consistency in how cannabis products are tested for potency, contaminants, and overall safety. This leads to several problems:
These issues undermine consumer trust and fuel the concerns of those who are opposed to cannabis legalization. Without standardized, reliable testing, how can the public be sure that cannabis products are safe, consistent, and accurately labeled?
cGMP certification offers a pathway to resolving the problem of inconsistent testing. These FDA-enforced standards require strict, uniform testing protocols across the entire manufacturing process, ensuring that products are safe, effective, and consistently meet quality standards.
Here’s how cGMP compliance can specifically address inconsistent testing:
1. Uniform Testing Protocols Across the Industry
If brought to light, the FDA could require all cannabis companies to follow the same testing protocols, eliminating the issue of lab shopping. Whether it's testing for potency, pesticides, heavy metals, or microbial contaminants, every product would be held to the same standards, using the same methods and equipment.
This uniformity ensures that products meet consistent quality and safety standards, regardless of where they are tested. It also reduces the likelihood of potency inflation, giving consumers confidence that the product they purchase matches the labeling.
The goal would be to set a standard limit of detection (LOD) or limit of quantification (LOQ). These limits define the sensitivity and precision of the testing method in detecting and quantifying certain compounds, such as cannabinoids, pesticides, or residual solvents, in cannabis products.
Different labs may use various testing equipment, methods, and set different LODs and LOQs, which can lead to inconsistent results. If one lab’s LOD is lower than another’s, it might detect contaminants or cannabinoids at smaller concentrations, while the other may not pick them up at all. This contributes to the discrepancies in testing results across labs, alongside other factors like lab shopping or lack of standardized protocols.
2. Comprehensive Batch Testing
Under FDA/United States Department of Agriculture (USDA) regulations, testing would not be limited to a handpicked sample of a product. Instead, cannabis companies would need to conduct comprehensive testing on entire batches, ensuring that all products sold to consumers meet safety and potency standards. The way they would do this has not been worked out yet, but it is likely that sampling may need to be done with oversite, or by a government agency or third-party lab/sampling company.
This eliminates the possibility of cherry-picking the best samples for testing while ignoring subpar products in the same batch. By making testing more rigorous and representative, cGMP compliance ensures a higher standard of accountability and transparency.
3. Third-Party Testing
cGMP-compliant businesses must work with accredited, third-party labs that follow FDA standardized testing procedures. This reduces the incentive for lab shopping and ensures that test results are reliable and consistent across the board.
These accredited labs would also be subject to regular audits, ensuring that they meet the necessary standards for accuracy and reliability. By establishing a system of checks and balances, cGMP compliance would significantly reduce the risks associated with inconsistent testing.
If you are looking for a standard that has already been written, check out the ASTM testing standard that has been written by hundreds of industry volunteers since 2017. It is possible that these standards will be adopted by the FDA if cannabis is rescheduled since they have adopted these kinds of standards in the past in other industries. Why reinvent the wheel, when the work has already been done for you?
4. Real-Time Documentation and Traceability
One of the core elements of cGMP compliance is meticulous record-keeping. This means that every step of the testing and manufacturing process would be documented and traceable. Should an issue arise, such as a product recall or a batch that tests positive for contaminants, businesses can quickly identify the source of the problem and take corrective action.
This traceability not only improves accountability within the industry but also builds trust with consumers and regulators who are concerned about product safety.
For those opposed to cannabis legalization, the current inconsistencies in testing raise valid concerns. They worry about potency inflation, safety risks, and the lack of reliable oversight. By adopting cGMP standards and addressing these issues head-on, the cannabis industry can demonstrate its commitment to producing safe, trustworthy products.
As we approach a crucial election that could see cannabis reclassified as a Schedule III drug, showing a proactive effort to resolve testing inconsistencies can help sway skeptical voters and win over regulators. cGMP compliance represents a gold standard for safety and quality, positioning the industry as responsible, transparent, and prepared for federal oversight. Preparing for cGMP compliance now will not only address the problem of inconsistent testing but also help reduce the fears of those opposed to legalization. By prioritizing safety, transparency, and accountability, the cannabis industry can pave the way for a safer, more accepted, and federally legalized future.
Kim Stuck is the CEO and founder of Allay Consulting. Direct correspondence to: kim.stuck@allayconsulting.com.