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In recent years, the federal and state governments took steps to make marijuana research easier. These actions are a positive step, but researchers working in the marijuana industry must be aware of regulatory requirements associated with conducting research. In this article we discuss some key considerations relating to marijuana research.

Key Federal Considerations

Researchers should check whether the materials they use for research are regulated under the Controlled Substances Act.

• As discussed in a Drug Enforcement Administration (DEA), internal discussion You can also contact us by clicking here. In May 2018,[p]The CSA does not regulate products and materials made from cannabis plants that do not meet the CSA definition for marijuana (such sterilised seeds, oil or cakes made from seeds, and mature stalks).
• In addition, in a December 20th, 2022 LetterThe DEA confirmed that, since the CSA excludes marijuana from the definition, any seed, tissue cultures, or other genetic materials that have a delta-9 tetrahydrocannabinol concentration of less than 0.3% dry weight are considered hemp and not controlled by the CSA. The DEA said that if these materials contain more than 0.3% delta-9 tetrahydrocannabinol on a weight basis, then they are marijuana under CSA Schedule 1. The DEA indicated that the same test would be applied to any seed that germinates and produces material containing delta-9-THC.

If the materials used in research are regulated under the CSA, then researchers should register with the DEA.

• The DEA Promulgated a final regulation On December 18, 2020 and January 19, 2021 respectively, the Controlled Substances Act (CSA) amended its regulations to “encourage the cultivation of marijuana for research purposes, as well as other licit purposes, to enhance compliance, including registering growers consistent with treaty agreements.”e.g., product development) must obtain a DEA manufacturing registration.
• The DEA also issues Certificates for Registration to those who wish to conduct research on Schedule 1 controlled drugs. See 21 C.F.R. SS 1301.13. A researcher can manufacture or import the substance or substances that were registered, as long as the protocol required is followed. 1301.18 “and to distribute such class to persons who are registered or authorized for research with such class or to conduct chemical analyses with controlled substances.” Id. We do note, however that the DEA’s proposed rescheduling If finalized, the move of marijuana from Schedule I under the CSA to Schedule III could ease restrictions for marijuana researchers.

Key State Considerations

Researchers should not conduct research on marijuana or any other materials that may qualify as marijuana without the proper licenses. State-specific licenses may be required for marijuana research. Here are some examples.

• “In California,[n]Licensed nurseries may cultivate mature plants in a designated research and development area. This area must be identified in the licensee’s cultivation plan. All mature plants must be tagged according to section 15048.4. It is prohibited for cannabis and cannabis-derived products to enter the commercial distribution chain, or be transferred from the licensed premises.” Code Regs. tit. 4, SS 16302; See also Cal. Code Regs. tit. 4, SS 15149(b) Each of the following activities must be recorded in the track-and-trace system within 24 hours. (4) Use cannabis or cannabis products for internal quality control testing, product research and development. ).
• Colorado issues marijuana research licenses to conduct limited research, such as genomic, horticultural or agricultural research. See Rev. Stat. Stat..
• Oregon issues marijuana certificates to “qualified public and private researchers” who submit research proposals that demonstrate the following: (a) the proposed research would benefit Oregon’s cannabis industry, public health and safety or medical research; and (b), the proposed operation and method comply with all applicable laws. OAR 845-025-5300.

Researchers should also consider whether it’s legal to ship research products interstate.

• Colorado, for instance, allows retail and medical marijuana cultivators to obtain, sell or transfer genetic material to/from a person licensed to possess or grow cannabis in another jurisdiction. See Rev. Stat. SSSS 44-10-602(12), 44-10-502(7); See also 1 CCR 212-3. “Genetic Material” includes cannabis material that is used to propagate cannabis, such as immature plants and seeds, tissue cultures, small amounts of cannabis plants or fragments, etc. See Colo. Rev. Stat. SS 44-10 103 (16.5). It is not clear whether other states provide similar authorizations.
• Washington has passed a new law that allows the governor to enter an agreement with another State to allow for the interstate shipment of marijuana under certain circumstances. However, this is dependent on either an amendment to federal laws allowing interstate transfers of cannabis between authorized businesses or an opinion from the U.S. Department of Justice allowing such interstate transactions. See Rev. Rev. SS 43.06.495. Oregon and California both passed similar laws, in 2019 and 2022. See Oregon Senate Bill 582; California Senate Bill 1326 (2022).

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Under federal and state law, conducting research on marijuana or any material that qualifies as marijuana is subject to strict federal oversight. In some cases the researcher will qualify as a grower, while in others it may qualify under legal license categories as a researcher. Researchers must also consider the legal parameters of shipping their research products within or outside the state in which they reside. We can answer any questions you may have about the regulatory requirements for conducting research on marijuana in this ever-changing landscape.

Our Cannabis Practice provides legal advice on federal and state laws. Marijuana is still illegal under federal law.