Cannabis and Hemp Research

UC research involving possession, use, distribution or cultivation of marijuana must comply with all applicable university, local, state, and federal policies, statutes and regulations. This applies to any research conducted in the United States under the auspices of the University of California, regardless of whether or not the research is conducted on a UC campus or UC property.

Federal Regulations

The federal Controlled Substances Act creates a comprehensive federal framework that categorizes controlled substances into five “schedules.” “Schedule I” is the most strictly regulated category. Marijuana is categorized as a Schedule I drug by the Drug Enforcement Administration (DEA). This means that federal regulations do not permit the use, production, processing, sale or growth of marijuana, though there are limited exceptions for research.

In addition to the Controlled Substances Act, which has broad applicability, universities (like UC) receiving federal funds are also obligated to comply with the Safe and Drug-Free Schools and Communities Act and the Drug-Free Workplace Act. These federal laws require UC to implement policies that prohibit the unlawful manufacture, distribution, dispensing, possession, or use of any controlled substance at UC. Failure to comply could put federal funding at risk.

The federal government currently restricts marijuana research to projects approved by the DEA, but with significant controls (e.g., Schedule I registration, inspections, security, and source limitations). Synthetically-derived cannabis products are outside the scope of this consideration.

The Farm Bill of December 2018 amended the Controlled Substance Act for hemp (defined hemp as less than 0.3% THC by dry weight) and hemp derived CBD products but added regulatory requirements for growing hemp. The August 21, 2020 DEA Interim Final Rule allows for research without a Schedule I license if the end product of the plant being researched has less than 0.3% THC. This allows for CBD (and other) research even if the researcher does not know the original plant source (i.e., hemp vs. cannabis).

Helpful resources:

State Regulations

On November 8, 2016, California voters passed Proposition 64, which changed state law to allow adults aged 21 years or older to grow, possess and use marijuana (now generally referred to in state law as “cannabis”) for nonmedical (sometimes referred to as “recreational”) purposes, with certain restrictions. (Possession, cultivation and use of marijuana by patients for the patient’s personal medical use upon recommendation by a licensed physician has been permissible under state law since 1996, pursuant to passage of a previous voter initiative, Proposition 215.)

Proposition 64 did not change existing California state rules that require researchers to obtain approval from the Research Advisory Panel of California (RAPC) (within the state Attorney General’s office) before conducting research projects that involve use of marijuana (as with other research that involves Schedule I or Schedule II controlled substances).

Helpful resources:

Policies

The legal and regulatory landscape for both marijuana and industrial hemp research is complicated and continually evolving. Changes in California laws have decriminalized the sale, possession, distribution, and cultivation of marijuana. Federal law, however, still classifies marijuana and its compounds as Schedule I controlled substances regulated under the Controlled Substances Act. This conflict and other inconsistencies between federal and state regulations mean that federal law guides UC policies regarding research on and use of cannabis.

The guidance documents listed below summarize applicable laws, regulations, and UC policies related to marijuana and industrial hemp research.

Policy Guidance on Cannabis and Industrial Hemp Research at UC Davis

Industrial hemp (<0.3% THC)

  1. Do not need a DEA Schedule I registration for research projects
  2. May consider accepting research funding (not tied to cannabis industry)
  3. Research involving human or animal subjects remain subject to FDA requirements.
  4. Can analyze in laboratory
  5. Can provide advice to hemp growers in compliance with federal and state law
  6. Can cultivate under specific conditions:
    1. Ensure that individuals participating in cultivation do not have felony convictions for controlled substances.
    2. Maintain relevant information regarding the land on which hemp is to be grown for three years;
    3. Obtain seeds or cultivars certified to contain no more than 0.3% THC (importing from abroad, under a DEA import registration, is a clearly permissible avenue for obtaining viable industrial hemp seed and cultivars)
    4. A procedure for on-going testing of THC concentration levels of the hemp produced
    5. A procedure for effective disposal of plants, growing or not, and their derivatives, that exceed 0.3% concentration of THC.
    6. Notify county ag commissioner prior to cultivation, provide specified info
    7. Adequate signage indicating industrial hemp <0.3% THC
  7. May consider partnering with private hemp growers. UCOP advises campuses to evaluate risks on a case-by-case basis and to coordinate with campus counsel as appropriate.

Cannabis (>0.3% THC)

  1. Must obtain DEA Schedule I registration for research projects
  2. Must obtain cannabis from National Institute on Drug Abuse (NIDA), produced at University of Mississippi.
  3. Must obtain approval from Research Advisory Panel in CA Attorney General’s Office
  4. Must obtain approval from FDA for clinical and non-clinical research
  5. Cannot accept research funding from individuals or entities that directly obtain most of their revenue from the cannabis industry
  6. May consider accepting research funding from individuals or entities that directly obtain some revenue from cannabis but also have separately identifiable revenue streams not tied to cannabis
  7. May consider accepting research funding from individuals or entities that are indirectly tied to cannabis (e.g., a company that provides lighting to indoor cannabis business)
  8. Can analyze cannabis plants, seeds, extracts via UC Davis agreement with Biopharmaceutical Research Company (analysis must be at BRC lab, which has received DEA Analytical Registration)
  9. May conduct cannabis research that does not involve the direct use, possession, distribution, or cultivation of cannabis (e.g., surveying individuals who use cannabis, analyzing public records).
  10. Faculty conducting outside work not allowable under federal law would accept the risk as private citizens, would not be allowed to use UC resources and must make clear in publications that the work was not done with UC resources.

Documents

UC Davis Cannabis and hemp research: what we can and cannot do

FAQs

Is there a process to commence new cannabis or hemp research at UC Davis?

Can UC Davis researchers possess cannabis for research?

Are there any exceptions to federal law that allow researchers to possess cannabis?

Are there other requirements for conducting research with cannabis with a DEA Schedule I license?

Is it permissible to conduct research on cannabis extracts without a DEA Schedule I license?

Is there any research relating to cannabis that may be conducted without a DEA Schedule I license?

Can research be done with FDA approved drugs such as Marinol, Syndros and Epidiolex?

Can hemp industrial hemp (aka hemp) be grown at UC Davis?

Can UC faculty conduct research on cannabis without a DEA license off site?

Can researchers accept research funding or gifts from individuals or entities whose funding is derived from the cannabis industry?

Is there a process to commence new cannabis or hemp research at UC Davis?
YES – Please see the PI decision chart for details. Notify the Office of Research of any new cannabis and hemp research or of applications for funding by emailing [email protected]. If new research is to involve possession of cannabis (greater than 0.3% THC) seek guidance from the Cannabis Compliance Review Committee at [email protected].

Can UC Davis researchers possess cannabis for research?
NO (but see next question) – University of California (UC) research involving possession, use, distribution or cultivation of cannabis (marijuana) must comply with all applicable university, local, state, and federal policies, statutes and regulations. This applies to any research conducted in the United States under the auspices of UC, regardless of whether or not the research is conducted on a UC campus or UC property. As most use, possession, distribution and cultivation of cannabis remains illegal under federal law (Controlled Substances Act, Safe and Drug-Free Schools and Communities Act, Drug-Free Workplace Act), such research is currently prohibited for UC Davis researchers.

Are there any exceptions to federal law that allow researchers to possess cannabis?
YES – Research that involves possession of cannabis (marijuana) by researchers may be conducted if the researcher has a Drug Enforcement Administration (DEA) Schedule I license and follows all applicable DEA regulations and guidelines, including those pertaining to storage and disposal. Obtaining the license can be a lengthy process, taking up to a year. For information about obtaining a Schedule I license, contact Phillip Barruel, Controlled Substances Program Manager, via email at [email protected].

Also, pursuant to the Farm Bill of December 2018, hemp plants (often labeled “industrial hemp”) are legal and can be used for research so long as the Delta-9 Tetrahydrocannabinol (THC) concentration does not exceed 0.3 percent by dry weight. The August 21, 2020 DEA Interim Final Rule allows for research without a Schedule I license if the end product of the plant being researched has less than 0.3% THC. This allows for Cannabidiol (CBD) and other research even if the researcher does not know the original plant source (i.e., hemp vs. cannabis). More information on industrial hemp is below.

Are there other requirements for conducting research with cannabis with a DEA Schedule I license?
YES – Any research involving humans or animals must go through the Institutional Review Board (IRB) or Institutional Animal Care and Use Committee (IACUC) respectively. Also, under State law, any planned research project to be conducted in California requiring the use of a Schedule I or Schedule II Controlled Substance as its main study drug must be submitted to the Research Advisory Panel of California in the California Attorney General’s Office for review and approval. In addition, under current Federal rules, DEA Schedule I licensees may only obtain cannabis (marijuana) through the National Institute on Drug Abuse (NIDA) from a federally-approved source.

Is it permissible to conduct research on cannabis extracts without a DEA Schedule I license?
YES AND NO – Hemp extracts and products derived from hemp are legal and can be used for research. As stated above, the August 21, 2020 DEA Interim Final Rule allows for research without a Schedule I license if the end product of the plant being researched has less than 0.3% THC. This allows for extract research even if the researcher does not know the original plant source (i.e., hemp vs. cannabis), though it can be difficult to determine if Cannabidiol (CBD) products have been legally produced. Additionally, there is some evidence to suggest that use of these products can trigger a positive drug test result for cannabis use. Contact Phillip Barruel, Controlled Substances Program Manager, via email at [email protected] before proceeding.

Other than hemp products, the Controlled Substances Act (CSA) defines cannabis (“Marijuana”) to include all parts of the plant Cannabis sativa L., whether growing or not, including seeds, resin extracts, and every compound, manufacture, salt, derivative, mixture, or preparation of the plant, its seeds or resin, and the DEA has listed “marihuana extract” as a Schedule I controlled substance.

UCD researchers interested in conducting work with cannabis extract, including CBD, with greater than 0.3% THC must obtain a Schedule I registration. In cases where the cannabis extract is derived from part of the cannabis plant not included in the Controlled Substances definition of “marihuana,” again, contact the Controlled Substances Program Manager, Phillip Barruel ([email protected]) before proceeding with research involving substances derived from those parts.

Is there any research relating to cannabis that may be conducted without a DEA Schedule I license?
YES – Research about cannabis that does not involve the direct use, possession, distribution, or cultivation of cannabis in a research procedure does not require a DEA registration or approval by the Research Advisory Panel of California. (However, all the usual requisite approvals for research must be obtained including IRB and/or IACUC review, where applicable, for studies involving human subjects or animals).

  1. Research involving parts of the plant excluded from the definition of “marijuana” by the CSA such as: the mature stalks of such plant, fiber produced from such stalks, oil or cake made from the seeds of such plant, any other compound, manufacture, salt, derivative, mixture or preparation of such mature stalks (except resin extract), fiber, oil, or cake, and the sterilized seed of the plant which is incapable of germination; research involving DNA, if the DNA is extracted by non-University entities.
  2. Human observational studies in which research subjects use cannabis, but the researchers do not procure the cannabis and the cannabis is not used on campus.
  3. Environmental impact studies in which researchers observe the impact of cannabis cultivation, for example on wildlife, water resources, or other aspects of the natural habitat.
  4. Policy or legal studies looking at economic, social, political or other issues involving cannabis and cannabis legislation.

Can research be done with FDA approved drugs such as Marinol, Syndros and Epidiolex?
YES – FDA has approved one cannabis-derived drug product: Epidiolex (cannabidiol), and three synthetic cannabis-related drug products: Marinol (dronabinol), Syndros (dronabinol), and Cesamet (nabilone), and campus researchers can legally obtain the approved versions of these cannabis-derived drug products. While acquisition of Epidiolex does not require DEA registration, the other listed drug products need to be ordered by using the campus DEA registration, which is for Schedules II through V. Contact Phillip Barruel, Controlled Substances Program Manager, via email at [email protected] for more information.

Can industrial hemp (aka hemp) be grown at UC Davis?
YES – Industrial hemp is derived from the same plant but with a THC content of no more than 0.3% on a dry weight basis. While a Schedule I DEA registration is not necessary for an institution of higher education to cultivate industrial hemp for research purposes under the Farm Bill, there is still a federal requirement to obtain a federal DEA import registration in order to import non-sterilized hemp seeds or plants from abroad for use in research. Seeds or cultivars used to grow hemp must come from a state that has an approved state pilot program under the 2014 Farm Bill and university growers must have a mechanism to test for and destroy any plants that do not meet the definition of hemp.

California state law allows cultivation of industrial hemp (see Health & Safety Code 11018.5, and Food and Agricultural Code 81000 et seq., both amended by Prop 64) and provides for registration of commercial growers in the state. An “established agricultural research institution,” including an institution of higher education, is exempt from state registration requirements, and may grow industrial hemp without authorization from the state.

Can UC faculty conduct research on cannabis without a DEA license off site?
Generally, NO – UCOP guidance states that the limitations on cannabis (marijuana) research apply to any research conducted under the auspices of UC, regardless of whether the research is conducted on UC property. However, research in a jurisdiction where cannabis cultivation is legal (such as Canada) would not violate federal law or UC policy.

Can researchers accept research funding or gifts from individuals or entities whose funding is derived from the cannabis industry?
Before applying for and before accepting non-governmental research funding, whether through a grant or a gift, that comes from individuals or entities (e.g., companies, associations) whose funding is known to be directly derived from cannabis activities that appear to fall outside of what is permitted under federal law (for example, from the sale of cannabis by growers legally licensed in the state of California) researchers must consult with their campus Contracts & Grants/Sponsored Programs Office or external relations/development office, who in turn must contact the UC Office of the President’s Research Policy Analysis and Coordination (RPAC) office, which may seek advice from the Office of General Counsel (OGC) as needed. Researchers may also contact the Office of Research at [email protected] to commence this process. In evaluating requests to accept funding from such sources, a significant consideration is risk associated with potential federal criminal and civil enforcement.