There is an expanding patchwork of cannabis policies across the United States, and this applies to testing standards from state to state. Researchers with the U.S. Food and Drug Administration published a study in March in the peer-reviewed journal Cannabis and Cannabinoid Research that highlights just how disparate medical cannabis testing rules are.
Today, cannabis is legal for medical use in dozens of states. And while these state programs have plenty of overlap, no one state is completely like another. This is largely the product of a lack of top-down guidance from the federal government, which prohibits cannabis for any use, and of the passage of these state laws over the course of more than 25 years.
In order to “better understand the quality of cannabis found in these programs,” the study noted, researchers “collected laws, regulations, and guidance documents available on public state-run websites and compared them with current good manufacturing practices (CGMPs) applicable to finished drug products.”
“We are aware that there does seem to be an increased public interest in using cannabis and cannabis-derived compounds from the state-regulated dispensaries in human clinical trials, so we really want to better understand the types of quality-related tests that these products undergo at each level,” Cassandra Taylor, a chemist at the U.S. Food and Drug Administration within the Center for Drug Evaluation and Research (CDER) in the Office of Pharmaceutical Quality, told Cannabis Wire.
Understanding the products sold at the state level is a rising priority among federal officials and lawmakers. The National Institute on Drug Abuse (NIDA) is “starting to look at” products sold by state-licensed operators in state-legal shops, as Cannabis Wire reported. And, a bill that passed out of the House last month would allow researchers to access these products for research, as Cannabis Wire reported.
“We are also interested in understanding how the various state regulations on testing for cannabis and cannabis-derived products that are accessible in these state medical programs and how they compare to our regulations for human drug products,” Taylor added.
More specifically, researchers drilled down on the various state requirements for the methods, facilities, and range of controls used in business owners’ manufacturing, processing, and packaging of a “drug product to assure it is safe for use,” according to the research.
“Such a comparison will aid the development of consistent quality standards that could, in turn, improve the quality of a wide range of cannabis medical products in development that may be sold in the United States,” researchers wrote. “States may likewise choose to have the cannabis and cannabis-derived products that fall within their [medical cannabis program] to follow quality-focused guidelines, such as those listed in [current good manufacturing practices], to ensure the quality of these products and promote public health.”
Researchers kicked off this study before the launch of the FDA’s Cannabis-Derived Products Data Acceleration Plan, which was announced last October and prompted because the country’s cannabis product market “continues to outpace the growth in the science and our understanding of the public health implications of these products,” the plan notes. One of the FDA’s many goals with the plan is to identify whether cannabis consumers are replacing prescribed medications with cannabis products, and the “role of human and animal healthcare providers” in “promoting or preventing [cannabis-derived product] consumption.”
The FDA’s moves – however small – loom large as far as the cannabis industry is concerned. The Administration has been on a mission to collect information about cannabidiol (CBD) in particular since just after the passage of the 2018 Farm Bill, which legalized hemp (defined as cannabis plants with .3% THC or less). At that time, CBD, which can be derived from hemp, was booming in popularity across the country.
Once the 2018 Farm Bill was signed into law, it became the FDA’s responsibility to craft regulations for CBD products for human and animal use and consumption, from food to cosmetics. As the FDA crafts its approach, totally unregulated CBD products are sold in gas stations and pharmacies, and can be ordered online from any state, while state-regulated CBD products can be found in state-licensed and regulated cannabis shops.
“We knew that there would be differences between the 37 programs that we looked at. So, that finding wasn’t particularly surprising to us,” lead researcher Schuyler Pruyn told Cannabis Wire. “I think probably the biggest surprise really was that, to our knowledge, nobody has done this exercise before. We were unable to find a comparison like this, across a program specifically for quality related testing regulations.”
Taylor added that the research team hopes that the study informs some of the work that researchers, regulators, and others in the testing standards space are working on with regard to cannabis-derived products.
“The main goal” of the research, Taylor said, is to “provide these considerations, to help facilitate the development of these more consistent, high quality products for potential use in clinical trials as drugs.”
