Obstacles for Testing Cannabis Edibles
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When it comes to testing cannabis-based products, consumers want them all tested. That desire gets even more intense for an edible. For most people, if something is prepared for consumption, they want to know that it’s safe. Unfortunately, inadequate quality control of edibles continues to be one of the biggest problems in the cannabis industry.
“The key challenge in the testing of cannabis-based edibles is the absence of a scientifically based regulatory framework that all stakeholders have agreed upon, a situation that is complicated by the need to encompass recreational and medicinal markets,” says Brian Thomas, Principal Scientist for Discovery Sciences at RTI International and author of the book The Analytical Chemistry of Cannabis: Quality Assessment, Assurance, and Regulation of Medicinal Marijuana and Cannabinoid Preparations. “In the U.S., the Drug Enforcement Agency (DEA) and the Food and Drug Administration (FDA) dictate material handling and standards of production, manufacture, analytical characterization, product packaging, qualification, labeling and storage of medications to ensure that pharmaceutical products are suitable for their intended use.” In the U.S., though, cannabis-based edibles at not regulated by the FDA. “So, product standardization and labeling requirements have been slow to evolve, and products have been found to vary widely from their label claims in both the recreational and medicinal cannabis markets,” Thomas explains.
There’s a large gap between FDA requirements and the analysis of cannabis-based edibles. For something destined to be a pharmaceutical, the FDA demands documentation of the source and quality of the raw materials, how the product will be manufactured, packaged, delivered and stored. And that’s all on top of the rigorous clinical testing required to get approval for marketing. Those clinical trials include crucial testing for how the body processes a drug and sophisticated safety and toxicity testing.
“The FDA laboratory procedures for an orally administered drug model the consumption, chewing and disintegration of edibles and the dissolution of the drug substance prior to absorption into tissues and fluids,” Thomas notes. “Thus, the analytical testing of orally administered drugs, such as cannabis-derived edibles, can be quite difficult, time consuming and expensive, depending upon the complexity of the formulation and the variability between batches.”
Instead of testing so many variables, most companies that make cannabis-based edibles test for the obvious, like tetrahydrocannabinol (THC), cannabidiol (CBD) and some phytocannabinoids, like CBDA, CBN and THCA. With only that, as Thomas points out, “the ability to translate existing laboratory information into estimates for human dosing can be problematic.”
Job one here is identifying the problem, but the bigger task might be addressing it. Nonetheless, Thomas says, “Reference standards, standardized analytical methods and specifications for all raw materials and finished drug products, and further guidance from the FDA for the development and approval of botanically derived tinctures, edibles and other formulations of cannabinoids would be useful for both the medicinal and recreational markets.”
Like many other challenges in the U.S. cannabis market, the edibles segment faces the need for some oversight and standardization. For an industry that—in many respects—still hangs onto its rebel roots and a country that cannot find a way to establish Federal cannabis guidelines, edible products could remain inadequately tested for some time.