Industrial Hemp and Medical Cannabis Research
The term cannabis is used to refer to both marijuana (medical cannabis) and industrial hemp. Both are originate from Cannabis satvia L. plants, differing in the concentration of the cannabinoid tetrahydrocannabinol (THC) at harvest. Marijuana refers to cannabis that is consumed directly for either its psychoactive properties and/or its medicinal properties. Marijuana (Medical Cannabis) is defined by relatively high concentrations of tetrahydrocannabinol (THC) and is classified as having greater than 0.3% THC concentration. Industrial hemp refers to cannabis grown with very low levels of THC and is classified as having less than 0.3% THC concentration (on a dry weight basis), which is further processed for fiber and/or seed and then used in a variety of industries (e.g., textiles, bio-energy, food, and manufacturing). Requirements and guidance for working with the two types of cannabis differ.
Prior to the passage of the Agricultural Improvement Act of 2018, products of the cannabis sativa A plants were classified as a Schedule 1 controlled substance, meaning it was considered to be a drug with no currently acceptable medical use and a high potential for abuse. The Agricultural Improvement Act of 2018 removed industrial hemp, which is defined as having a THC level of no higher than 0.3%, from the controlled substance schedules altogether. Nonetheless, industrial hemp continues to be subject to certain controls and restrictions as described below. The DEA will also assert jurisdiction over materials derived from high THC marijuana even if the materials themselves contain less than 0.3% THC. Georgia law regarding implementing the 2018 Farm Bill can be found at O.C.G.A. 2-23-1-12.
At the present time, Georgia Southern faculty may engage in research on CBD or other cannabis compounds without any licenses for growing or possessing it so long as it can be determined that the CBD or other compounds have been derived from industrial hemp and not marijuana. The supplier of any hemp materials for research purposes must 1) be working in a state that has received USDA approval for its state regulatory plan and be operating in accordance with that plan; or 2) obtained a license for hemp production directly from the USDA if the operator is operating in a state that has opted not to seek USDA approval for hemp production. 3) able and willing to provide documentation for the hemp classification
The 2018 Farm Bill legalizing industrial hemp specifically preserved the FDA’s authority to regulate products containing industrial hemp and hemp-derived products like CBD. The FDA continues to regulate these products as drugs that require its authorization. In addition, it is illegal to market CBD or a food containing CBD as a dietary supplement. Therefore, researchers conducting clinical investigations involving the use of hemp products for human use would likely need to submit an IND application with the FDA and obtain institutional approval in addition to IRB approval.
|Georgia Southern University Guidance on Cannabis Research, Teaching, and Outreach Activities||Guidelines that explain how GS fits into the legal and research framework surrounding current cannabis rules|
|2018 Georgia Farm Bill|
|Georgia Dept of Agriculture (GDA) Hemp Sampling Agent letter||GDA letter to hemp growers|
|Georgia Dept of Ag – Hemp Growing Rules||Growers and Processors|
|Agricultural Audits LLC||GDA current contract agent for Hemp testing|
|Disposal of non-compliant hemp||Section 40-32-2-.06 Rules of the GA Dept of Ag- Hemp|
|USDA Import Permit (Hemp seed and Plant)||Verified import permit for acquired foreign material|
|Hemp Project Concept Approval Request form||VPR Approval Required (approval does not replace IRB, IACUC or IBC approval)|
In general, research involving medical cannabis research can be either observational or experimental. At this time, researchers at GS can engage in observational studies but not experimental research. Observational research is defined as research about medical cannabis (marijuana) and its legalization that does not involve growth, production, procurement, administration or use of any cannabis product. Examples include:
- education and prevention research (epidemiological research on prevalence and demographics of marijuana use; prevention research on effective communication strategies for parents, schools, and communities; environmental impact studies on the impact of marijuana cultivation on the environment; risk and protective factors for marijuana use and dependence; effective prevention and harm reduction strategies);
- research on policy and legislative issues concerning marijuana; and research on societal implications of legalization (effects of legalization and community-level policies on crime, public health, and state economy).
- Data analysis of existing data sets from cannabis studies.
- Survey research or observational studies of current cannabis users so long as the consumption of the cannabis is done outside of the researchers presence and researchers are on no way assisting with the administration of the drug.
Cannabis may not be brought on campus for any research purposes.
|License and Registration Links|
|Controlled Substances Use In GS Research Guide||Step by step access to state and federal required license.|
|FDA – Cannabis Research||FDA has approved one cannabis-derived product for treatment of a disease or condition – Epidiolex (cannabidiol) commonly referred to as CBD|
|DEA – Diversion Control Division||U.S. Dept of Justice Website|
Last updated: 3/23/2022