Definitions
Hemp: The Agriculture Improvement Act of 2018 (AIA; Public Law 115-334), amended the definition of cannabis classified as ‘marijuana’ in the Controlled Substances Act (CSA) to exclude cannabis classified as ‘hemp.’ The AIA redefined hemp as “the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis (7 U.S.C. 1639o).” ’Marijuana’ is listed as a Schedule I controlled substance under the CSA and refers to the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of more than 0.3 percent by weight on a dry weight basis.
Questions related to the control status of the cannabis plant, its derivatives, or its components can be directed to DEA’s Diversion Control Division, Drug & Chemical Evaluation Section. Information can be found on the DEA’s Diversion Control Division website or questions can be emailed directly to their mailbox at DPE@dea.gov.
- When is a Schedule I research registration required for research on cannabis products?
Marijuana: Researchers must possess a Schedule I research registration from the Drug Enforcement Administration to conduct research with cannabis products classified as ‘marijuana’ containing more than 0.3% delta-9 THC on a dry weight basis (USDA; 7 CFR Part 990). Purchasing and handling cannabis products without an appropriate registration from the DEA is a violation of federal law and therefore a violation of the terms/conditions of an NIH research award.
Hemp: Anything that falls within the definition of hemp is not a controlled substance. Researchers studying products defined as hemp are not required to hold a Schedule I research registration to conduct research on products that qualify as hemp.
Other hemp-derived constituents: Neither the AIA nor CSA regulates plant-derived cannabinoids or cannabis constituents derived from products that meet the definition of “hemp”, including hemp-derived delta-8-, delta-10-THCnon-THC cannabinoids, e.g., cannabidiol, terpenes, or any cannabis compounds other than THC so long as the product(s) of origin contains no more than 0.3% THC by weight on a dry weight basis.
Non-hemp-derived synthetic equivalent cannabinoids: Researchers must possess a Schedule I research registration to conduct research on any synthetic equivalent cannabinoids (e.g., delta-8-THC, delta-10-THC) derived from non-hemp materials. - Where can NIH grant recipients obtain cannabis and cannabis products that are controlled under the CSA for research?
The University of Mississippi provides cannabis for research under a contract with the National Institute on Drug Abuse (NIDA) Drug Supply Program. The NIDA Drug Supply Program provides cannabis plant material and preparations containing various ratios of THC to cannabidiol. For information on available products and the requirements for obtaining cannabis products for research, visit the NIDA Drug Supply Program.
See also: NIDA's Role in Providing Cannabis for Research
Cannabis and cannabis products may also be imported from other countries with the proper authorizations. The DEA regulates the importation of controlled substances into the United States, and the U.S. Food and Drug Administration (FDA) regulates the importation of investigational new drugs. Researchers with questions about importing controlled substances should contact those agencies.
Using federal or non-federal funds, can NIH grant recipients purchase or handle cannabis products that are controlled under the CSA from state-authorized cannabis dispensaries for research?
Currently, federally-funded researchers cannot use federal or non-federal funds to obtain or handle cannabis or cannabis products that are subject to CSA regulation from a state dispensary. These materials and products continue to be controlled substances under federal law and currently, no state dispensaries have been approved by the DEA to supply cannabis for research.
- Using federal or non-federal funds, can NIH grant recipients purchase or handle cannabis products that are controlled under the CSA from state-authorized cannabis dispensaries for research?
Currently, federally-funded researchers cannot use federal or non-federal funds to obtain or handle cannabis or cannabis products that are subject to CSA regulation from a state dispensary. These materials and products continue to be controlled substances under federal law and currently, no state dispensaries have been approved by the DEA to supply cannabis for research.
- What kinds of research can NIH grant recipients conduct on cannabis products that are controlled under the CSA and obtained by research participants from non-federally approved sources (e.g., state-authorized dispensaries)?
NIH research funds may not be used to analyze or provide research participants with cannabis products obtained from non-federally approved sources.
NIH research funds can be used to: conduct epidemiological or observational studies that do not involve administering these cannabis products to research participants; collect self-report data on the use of such cannabis products; and collect self-report data on the behavioral effects and/or physiological effects, and exhalations and other biospecimens from research participants using such cannabis products as long as the researcher is not handling and distributing the products and the products are not consumed in federally-funded facilities (e.g., mobile laboratories).
- Do researchers need to apply for an FDA investigational new drug (IND) approval to administer hemp or hemp-derived products to human research participants?
If a hemp product fits the definition of a drug under the Federal Food Drug and Cosmetic Act (21 U.S.C. 9) and its use fits the definition of an interventional investigation with humans, an IND for drugs containing hemp is likely to be required. Questions about INDs for particular protocols should be directed to the FDA.
- Where can NIH grant recipients obtain hemp and hemp-derived products for research?
Researchers may obtain cannabis products classified as hemp from the NIDA Drug Supply Program or other non-NIDA sources. NIH funds can be used to obtain hemp or hemp-derived products for research from state-authorized dispensaries.
NIDA recommends that hemp samples obtained from non-NIDA sources be analyzed to confirm that the samples do not contain greater than 0.3% delta-9 THC on a dry weight basis and are therefore not scheduled under the CSA and subject to USDA requirements. NIDA further recommends that researchers confirm that the chosen analytical lab is a DEA registrant and approved for cannabis analysis by a recognized laboratory accreditation body.
July 17, 2024