The cannabis industry works hard to convince regulators, politicians and the public that their business is a responsible and legitimate part of the economy. But outlaw testing labs are producing sloppy, inconsistent results and even fake reports – unfairly affecting the reputations of the vast majority of honest and professional labs. These bad tests lead to false potency claims and financially ruinous product recalls. Doctors, patients and recreational users must trust the safety and efficacy of cannabis-based products. If they can’t, then politicians and regulators will make life even more difficult for the industry.
Outlaw Laboratories Undermine The Cannabis Industry
The state-level patchwork of cannabis legalization — and ongoing federal prohibition — places the cannabis industry in a unique regulatory environment that no other industry experiences. The lack of federal standards for cannabis testing, for example, results in best practices that vary from state to state — and even from lab to lab. This regulatory grey zone lets outlaw testing labs thrive by playing fast and loose with the rules to everyone’s detriment.
Standards compliance is one way to defeat the outlaws. When cultivators and manufacturers refuse to deal with un-accredited laboratories, bad actors will face a simple choice: go legit or go out of business. Yet nationwide, industry-specific standards won’t be available until Washington deschedules cannabis. So what can the industry do in the meantime?
ISO/IEC 17025 Accreditation for Cannabis Labs
One solution is to adopt standards like ISO/IEC 17025 that are practice-specific rather than industry-specific. Developed by the 165 nations in the International Organization for Standardization (ISO), ISO/IEC 17025 provides a process for laboratories engaged in testing and calibration to prove their trustworthiness.
“ISO/IEC 17025 enables laboratories to demonstrate that they operate competently and generate valid results, thereby promoting confidence in their work both nationally and around the world.”
Within the context of the cannabis industry, ISO/IEC 17025 accreditation demonstrates that a laboratory has the systems, processes, training and organization needed to produce consistent and accurate test results. Cultivators can have more confidence in reports that their crops are contaminant-free. Manufacturers and sellers of cannabis-based products can have more confidence in safety and potency reports. And consumers are put at less risk. Other potentially applicable standards include validation to International Council for Harmonisation (ICH) guidelines and the European Pharmacopeia, which comply with Health Canada, and FDA regulations.
Accreditation also prepares cannabis testing laboratories for the end of federal cannabis prohibition. Labs that test edibles, for example, should be aware of the growing role of ISO/IEC 17025 in federal and state food safety programs. In 2020, the Food and Drug Administration published a proposed rule as part of the FDA Food Safety Modernization Act. The rule limits certain food safety tests to laboratories that, among other requirements, have ISO/IEC 17025 accreditation. In addition, most states have cooperative agreements with the FDA’s National Integrated Food Safety System to send third-party food testing through labs with ISO/IEC 17025 accreditation.
CannaQA Helps Labs Meet Industry Standards
The most recent version of ISO/IEC 17025 recognizes the role of laboratory information management systems (LIMS) in testing accuracy and consistency. Traditional paper-and-spreadsheet data handling inevitably leads to transcription, reporting and other errors that impact a laboratory’s reputation.
LabLynx tailored its LIMS solution, CannaQA LIMS, specifically for the needs of laboratories serving the cannabis industry, and fully supports both state and local standards, track-and-trace requirements, ICH, FDA and ISO/IEC 17025. Labs can automate their data management from the point of collection, through testing and reporting. For example, instruments can pull sample data directly from, and write results directly to, the CannaQA LIMS cloud database without any manual intervention. This level of integration lets laboratories reliably document the consistency and accuracy of their testing processes, streamlining validation and/or accreditation. LabLynx also provides validation services to help laboratories document compliance with the standards.
“The Wild West of Cannabis Testing” The Scientist
“Lack of standards, dubious business practices threaten to upend cannabis testing industry” Marijuana Business Daily