In recent years, federal and state governments have taken action to make marijuana research easier. These actions are a step in the right direction, and researchers operating in the marijuana space must be aware of the regulatory requirements that are associated with conducting such research. In this article, we discuss some of the key considerations related to conducting marijuana research.
Key Federal Considerations
Researchers should consider whether the specific materials they are using for research are regulated by the Controlled Substances Act (CSA).
- As discussed in an internal Drug Enforcement Administration (DEA) directive in May 2018, “[p]roducts and materials that are made from the cannabis plant and which fall outside the CSA definition of marijuana (such as sterilized seeds, oil or cake made from the seeds, and mature stalks) are not controlled under the CSA.”
- Furthermore, in a December 20, 2022 letter, the DEA confirmed its view that, because the CSA excludes hemp from the definition of marijuana, any seed, tissue culture, or other genetic material that has a delta-9 tetrahydrocannabinol (THC) concentration of no more than 0.3% on a dry weight basis meets the definition of hemp and is not controlled under the CSA. Conversely, the DEA stated that, if those materials have a concentration of more than 0.3% delta-9 THC on a dry weight basis, they qualify as marijuana under CSA Schedule I. The DEA also indicated that the same analysis would apply to any seed that germinates into material containing delta-9 THC.
If the specific materials used for research are regulated by the CSA, researchers should obtain the appropriate DEA registration.
- The DEA promulgated a final rule on December 18, 2020, effective January 19, 2021, that amended “its regulations to facilitate the cultivation of marihuana for research purposes and other licit purposes to enhance compliance with the Controlled Substances Act, including registering cultivators consistent with treaty obligations.” Under the new rule, any person who seeks to plant, cultivate, grow, or harvest marijuana to supply researchers or for other uses permitted by the CSA (e.g., product development) must obtain a DEA manufacturing registration.
- The DEA also issues Certificates of Registration to persons seeking to conduct research on Schedule 1 controlled substances. See 21 C.F.R. § 1301.13. Under such a registration, a “researcher may manufacture or import the basic class of substance or substances for which registration was issued, provided that such manufacture or import is set forth in the protocol required in 1301.18 and to distribute such class to persons registered or authorized to conduct research with such class of substance or registered or authorized to conduct chemical analysis with controlled substances.” Id. We note, however, that the DEA’s proposed rescheduling of marijuana from Schedule I to Schedule III under the CSA, if finalized, could ease restrictions on marijuana researchers.
Key State Considerations
No researcher should conduct research on marijuana, or any materials that could qualify as marijuana, without obtaining the appropriate licenses. The types of licenses that may be required to conduct research on marijuana vary by state. Below are a few examples.
- In California, “[n]ursery licensees may maintain a research and development area, as identified in their cultivation plan, for the cultivation of mature plants. All mature plants shall be tagged with a plant tag pursuant to section 15048.4. All cannabis and cannabis products derived from these plants are prohibited from entering the commercial distribution chain or being transferred off the licensed premises.” Code Regs. tit. 4, § 16302; see also Cal. Code Regs. tit. 4, § 15049(b) (Each of the following activities shall be recorded in the track and trace system within 24 hours of occurrence … (4) Use of cannabis or cannabis product for internal quality control testing or product research and development.).
- Colorado issues marijuana research and development licenses for limited research purposes like conducting genomic, horticultural, or agricultural research. See Rev. Stat. § 44-10-507.
- Oregon issues marijuana research certificates “to qualifying public and private researchers who present research proposals that demonstrate: (a) The proposed research would benefit the state’s cannabis industry, medical research or public health and safety; and (b) The proposed operation and methodology complies with all applicable laws and administrative rules governing marijuana licensees and licensee representatives.” OAR 845-025-5300.
In addition to any state licensing requirements, researchers should consider whether it is lawful to ship research product interstate.
- Colorado, for example, authorizes retail and medical marijuana cultivation facilities to obtain, sell, transfer, or ship genetic materials to/from another person licensed in another jurisdiction to possess or cultivate cannabis. See Rev. Stat. §§ 44-10-602(12), 44-10-502(7); see also 1 CCR 212-3. “Genetic material” includes cannabis material used to propagate cannabis plants like immature plants, cannabis seeds, tissue culture, and small amounts or fragments of cannabis plants. See Colo. Rev. Stat. § 44-10-103(16.5). It is unclear whether other states offer similar authorizations.
- Washington has passed a law allowing the governor to enter into an agreement with another state to provide for the interstate shipment of cannabis under certain circumstances, but it is contingent on an amendment to federal law allowing for the interstate transfer of cannabis between authorized businesses, or a U.S. Department of Justice opinion allowing such interstate transfers. See Rev. Code Ann. § 43.06.495. Oregon and California passed similar laws in 2019 and 2022, respectively. See Oregon, Senate Bill 582 (2019); California Senate Bill 1326 (2022).
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Conducting research on marijuana, or any materials that qualify as marijuana, under federal and state law is subject to strict federal and state oversight. In some cases, the researcher may qualify as a cultivator, while in other cases it may qualify as a researcher under legal license categories. Researchers also need to consider the legal parameters for shipping their research products either inside or outside the states in which they are located.
Our Cannabis Practice provides advice on issues related to applicable federal and state law. Marijuana remains an illegal controlled substance under federal law.
