How cGMP Compliance Can Tackle Inconsistent Testing

Kim Stuck, CEO and founder of Allay Consulting | Image Credit: © Kim Stuck

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.

The Problem: Inconsistent Testing in the Cannabis Industry

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:

• Lab Shopping: Some cannabis companies seek out labs that will give them the most favorable results, inflating potency numbers or overlooking potential contaminants. This is an issue especially with an uneducated customer base. Potency is the main thing that consumers look at when buying cannabis, and this is causing potency inflation within testing labs. Some companies will send testing to several labs and use the results that come back as the highest potency in order to have the highest tetrahydrocannabinol (THC) percentage possible. Another example of this is if there is contaminated product they will use a lab that has a non-detect because they aren’t testing down to a level that would show contamination.
• Cherry-Picking Samples: Businesses may send in "perfect" samples for testing, which do not accurately represent the quality or consistency of the entire batch of products. In some states a lab will do on-site sampling to prevent this form happening, but in most states this happens regularly.
• Lack of Standardization: This is a problem in every state so far. Without a uniform set of testing protocols and equipment standards, labs can vary significantly in their results, leading to concerns about product safety and the reliability of cannabinoid concentrations. In many states labs are required to be certified to an ISO 17025 standard, but this standard doesn’t address the testing limits or parameters and equipment standards so that every lab is testing in the same way. This standard only covers internal documentation and tracking within the facility.

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?

The cGMP Solution: Standardized Testing and Increased Accountability

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.

Looking to the Future

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.

About the Author

Kim Stuck is the CEO and founder of Allay Consulting. Direct correspondence to: kim.stuck@allayconsulting.com.