SC Laboratories, a third-party testing lab, has received ISO (International Organization for Standardization) accreditation for a hemp/CBD testing panel that combines the published regulatory requirements of all U.S. states which have their own unique hemp testing rules.
 
Since the U.S. Food and Drug Administration (FDA) does not consider CBD a dietary ingredient, there are no federally-required testing regulations, leaving each state to develop its own set of requirements. Beyond individual state standards, consumers may have difficulty in determining the quality and safety of products as a result, despite the fact that CBD has been available on the market since the passage of the 2018 Farm Bill. Consequently, the onus has been on state governments to put quality requirements into place, making the process of testing more complex.
 
“The Farm Bill created a path forward, but left too many questions unanswered,” said Josh Wurzer, president of SC Labs. “States began to set up their own hemp regulatory models but that process was slow and lacked harmonization across different regulations. A pesticide that could disqualify a product in Colorado may not even be required to be tested for in Florida. In certain states, there are no regulations at all. The problem is clear but the FDA and other federal agencies have been reticent to act. The motivation and framework for a solution does not seem to be there. In the interim, the industry is coming up with its own solutions. As a laboratory, we had to cobble together regulations from every state to offer the industry the only test panel applicable on a national scale.”
 
SC Labs now offers a suite of tests that target specific requirements for multiple states, and a test panel that targets a complete list of contaminants and active constituents at the lowest action limits as required by each state.
 
“As an industry, we’ve been advocating for a national, standardized, and transparent testing regulations for years now,” said Jeff Gray, CEO of SC Labs. “The test we’ve created meets or exceeds the requirements of most states and that will give consumers greater peace of mind. No one else can say that right now.”
 
Currently, SC Labs is licensed in California, Oregon, and Texas, and has a pending license in Colorado. Its testing platform can be utilized for other states in order to assure that a product will meet state requirements ahead of testing at a state-licensed laboratory. For companies, getting ahead of the curve by the time a product reaches a specific state-licensed laboratory is crucial to tackling potential surprise costs.
 
“By the time a product reaches the final batch testing at a licensed distributor, it has been fully packaged and labeled,” Wurzer said. “A failure on any of the contaminant testing at this point in the process is very costly. Furthermore, if the cannabinoid content listed on the label of the product turns out to be incorrect, the distributor will have to re-label all of the packages, which is also a potentially expensive process. Beyond that, a lot of the testing we do is to help manufacturers improve the quality of their products, help them develop new products, and assess the effectiveness of various performance targets for their products. Basically, we often end up being an extension of our customers’ R&D department.”
 
A forward-looking test that aims to go beyond verifying compliance could help prevent future contamination issues, Wurzer said. “With such stringent contaminant requirements for cannabis products, it is very important for cannabis manufacturers to continuously monitor contamination levels on all of their inputs,” he said. “With some of our specialty testing options, we can help our customers identify potential contamination in inputs at levels many orders of magnitude lower than the action limits so that even if they concentrate on those contaminants in their processes, they can be assured that the final products will still pass state requirements.”
 
Although these expanded offerings are targeted for hemp, “they are also relevant to our cannabis clients who want to go beyond compliance regulations,” Gray said. “As more companies aim to expand products nationally, we saw a need for testing at a universal level so we poured our efforts into the development of a test that would meet those needs. It’s paid off because we have several national brands that are implementing the test panel as the quality assurance standard for their line of hemp-derived CBD products.”
 
The new testing panel covers a range of cannabinoids, pesticides, microbiological contaminants, mycotoxins, heavy metals, and residual solvents, combined to harmonize each state’s requirements in order to meet the most far-reaching regulatory bar, with options to include the test methods or quality standards published by organizations such as the United States Pharmacopoeia (USP), American Herbal Products Association (AHPA), or the American Herbal Pharmacopoeia (AHP).
 
Testing Challenges
In today’s market, a lack of federal guidance presents many challenges and pitfalls that could be reduced or eliminated with national standards, Wurzer said. “Each state is in a different stage in establishing their regulations. Oftentimes, states have completely changed the requirements of their testing panels without notice. Other states have established the testing requirements but have given no guidance for the labs. Other states have requirements that products be tested but have provided no or not enough detail on what actually needs to be tested.”
 
Wurzer said the most difficult tests to perform in cannabis products today are pesticide analysis. Due to the unique properties of the cannabis plant, most pesticide test methods were developed with a bias for other, more water-based, plant materials, requiring special diligence for safety assurance.
 
“Cannabis is a very resinous, oily plant which causes a ton of interference in our analysis and is almost impossible to ‘clean up’ using traditional sample prep techniques. Most of the pesticide testing methods on the market were developed for water-based plant material rather than dried resinous material like cannabis. To further complicate matters, the action limits for pesticides in cannabis are generally much more strict for food products. As such, our tests have to be much more sensitive. So, we have a more difficult product to test, we have to test it to lower levels, and we can’t build upon the work done in the food testing industry because our product is so much different in composition.”
 
On top of that, he continued, “we have to use two different pieces of analytical equipment to perform the whole panel. We have to split the sample in two and run it on both an LCMS [liquid chromatography mass spectrometry] and a GCMS [gas chromatography mass spectrometry] to be able to measure all of the analytes on a California pesticide panel.”
 
In the absence of federal regulations, or guidance in the midst of today’s challenges, Wurzer said that aligning with USP, an organization for which he serves on the expert committee for Cannabis and Hemp, has been highly beneficial. “Ideally the FDA will weigh in soon,” he said. “But, in their absence, I am really excited about the work the United States Pharmacopoeia is doing to establish federal standards for hemp-based products. The USP sets standards for food ingredients and dietary supplements. The USP plays a role in federal law and could include hemp and hemp products in their National Formulary which would be a really big step toward getting the FDA to weigh in.”