Total THC testing paves way for Texas hemp production
05 Aug 2020 --- US-based Santé Laboratories has become the first laboratory to test Texas-grown hemp for total tetrahydrocannabinol (THC), according to the company. Addressing the needs of the hemp industry, which is just taking root, Santé Laboratories expresses an urgent need for testing harmonization. Accordingly, the company specializes in increased accuracy, reliability and transparency. Importantly, the company reports it has developed analytical methods to give confidence to farmers and brands that they don’t exceed the legal level of THC in their products.
“Currently, testing laboratories in the recreational hemp and cannabis industry have high levels of uncertainty and unharmonized analytical methods. This means that products existing on retail shelves and distributed inter-state to consumers may not have accurate levels of THC stated on the product, including products that exceed total THC limits. Multiple peer-reviewed and US Food and Drug Administration (FDA) studies substantiated this assertion, which poses great risk to consumers requiring a ‘THC free’ product,” Mike Sandoval, President at Santé Laboratories tells NutritionInsight.
Hemp is a relatively recent addition to Texan agriculture. House Bill 1325, which was signed into law on June 10, 2019, authorized the Texas Department of State Health Services and Texas Department of Agriculture, to propose plans to regulate the production, retail sale and inspection of industrial hemp crops and finished products in the state.
More than a year later, a milestone was reached when hemp grown in Texas soil was collected and processed for legal compliance testing for less than 0.3 percent total THC.
Santé Laboratories aims to revolutionize the testing industry by providing customers access to scientifically validated and legally defensible test methods.“Santé Laboratories’ analytical methods meet and exceed standards set by the Association of Official Analytical Collaboration (AOAC) International and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). [These help us to] provide the most reproducible, accurate and precise method producing the lowest measurement of uncertainty in the industry,” says Sandoval.
“Our test methods minimize the opportunity for false positives and false negatives, which is creating significant uproar in the industry,” he adds.
Revolutionizing testing
Santé Laboratories focuses on providing scientifically valid testing services such as assay testing for total THC and other cannabinoids, pesticide residues, terpenes heavy metals and microbial examinations to agricultural, processing, retail and biopharma hemp communities in Texas and beyond.
This level of comprehensive testing is not well-known in this budding industry, according to Sandoval.
“High quality and transparent testing is uncommon in the current hemp and CBD industry. As a result, recreational laboratories are struggling to meet industry expectations and regulatory requirements to keep every member of the value chain compliant,” he explains.
Sandoval warns that as federal regulation in the US becomes established, manufacturers should be prepared to meet a number of regulations, including current good manufacturing practices (cGMPs) for dietary supplements and foods and with a high level of accuracy.
“[Preparing ahead] assists manufacturers in ensuring that when those regulations are put in place, they are ready to continue doing business as normal with their easy-to-read, detailed certificate of analysis,” he says.
Furthermore, the company has developed a delivery platform that is a water-based formulation with a validated shelf life over 14 months and increased absorption of up to 80 percent.
“We’ve also established a number of methods to ensure high level testing for every product type,” he adds.
CBD and THC in foods
CBD is beverages is becoming more commonplace in the US market.
US legislation regarding the legal status of hemp and its products is currently a patchwork. In November, the US FDA denied CBD generally recognized as safe (GRAS) status for its use in human or animal food, based on the lack of scientific information.
He explains that CBD in foods has gained traction at the state level, although the FDA regulates interstate commerce.
“While the uptick in CBD foods may not be happening quite yet, CBD beverages seem to be appearing everywhere and we expect this trend to continue,” says Sandoval.
“Unfortunately, we don’t see a lot of products that will be ready for increasing regulations, especially from the FDA. Foods will certainly be a challenge for the industry with increased regulation,” he adds.
A similar mosaic of legislation exists for the use of THC, which has made the industry an uncertain place and with no clear standards for testing.
“Considering there are differing regulations in place from state to state, country to country, it will be a slow hurdle to have a unified regulation for both THC and CBD. Standardization in the testing laboratories will be crucial in ensuring that regulations are followed,” he concludes.
CBD seeks standardization
In January, US-based Origin Labs launched a four-part CBD product line, PearlCBD, which harnesses the power of Near Field Communication (NFC) technology to bring transparency and accountability to an industry lacking standardization. With a tap of a mobile phone to the PearlCBD product, consumers can easily access its educational content, authenticity verification and batch-specific lab test results.
Meanwhile, in June, the Council for Responsible Nutrition (CRN) filed a Citizen’s Petition to the FDA, requesting it to establish a regulatory pathway to legally market dietary supplements containing hemp-derived CBD.
Hemp on the horizon
Texas, in particular, is looking toward the hemp industry. With its vast acreage, farms and ranches covering 127 million acres, Texas could also become the desirable farming land for hemp.
“Making Texas the leader in hemp will require unprecedented collaboration across the hemp ecosystem, with laboratories, farmers and processors coming together like never before,” says Lisa Pittman, Co-Chair of Coats Rose P.C.’s Cannabis Business Law Group.
By Missy Green
