Cannabis research stalled by federal inaction
The agency did not respond to a request from C&EN asking about the timeline for the regulation, but the process is likely to take several more months, if not years. Under the proposed rule, potential growers of cannabis for research have to satisfy a list of public interest criteria spelled out in the US Controlled Substances Act (CSA).
The criteria include having effective controls against diversion of cannabis from research to illicit uses. The DEA interprets that to mean restricting the amount grown by limiting the number of registered manufacturers “to that which can produce an adequate and uninterrupted supply of marihuana under adequately competitive conditions.” It is unclear whether the DEA will cap the number of registered manufacturers to satisfy the diversion control criteria. In addition, growers must have a supply agreement with a researcher who has the appropriate DEA license to study cannabis. Alternatively, growers who plan to supply cannabis for their own research purposes must register with the DEA to study cannabis and can only grow the amount authorized in their research protocol. Potential growers also must be able to consistently produce and supply cannabis “of a high quality and defined chemical composition.” The DEA has yet to define exactly what that means. Moreover, applicants have to show “prior compliance with the CSA and DEA regulations.” It is possible that companies that have grown cannabis for state-authorized programs would be excluded from consideration because such activities are illegal under the CSA.