Researching one of the non-intoxicating components of marijuana, cannabidiol (CBD), will now be made easier because of new regulations released today by the US Drug Enforcement Administration. In line with a recommendation that has been endorsed and promoted by national marijuana education and advocacy group Smart Approaches to Marijuana (SAM), DEA has waived registration requirements for researchers conducting Food and Drug Administration-approved clinical trials on cannabidiol (CBD), an original component of the marijuana plant. Marijuana that is smoked or consumed recreationally today has almost 0% CBD.
According to a news release issued today by SAM, the new regulatory structure will speed the development and approval of safe, FDA-approved CBD medications, which can be used to treat epilepsy and seizure disorders in certain cases. “Given the potential benefit of CBD, waiving onerous research requirements is the right thing to do, and DEA should be commended,” said Dr. Kevin A. Sabet, a former White House drug policy advisor who serves now as President of Smart Approaches to Marijuana (SAM). “It shows that we do not have to legalize marijuana – either in name or de facto via state ‘medical’ programs – to provide for access to promising components of marijuana.”
Federal law requires researchers conducting CBD-based clinical trials under an FDA Investigational New Drug Application to have a DEA research registration. This registration permits the possession of an approved amount of CBD for a specific research protocol. Prior to this action, researchers looking to expand the scope of a study that required more CBD had to submit a written request to the DEA to modify their research registration. This caused delays in research while the request was reviewed for approval by the DEA and FDA.
Under the new change, a previously registered CBD clinical researcher who is granted a waiver can readily modify their protocol and continue their research seamlessly. This regulatory change by the DEA will speed up the research into the medical potential of CBD.
As interest has grown rapidly to research and utilize the medical potential of the chemical components of marijuana, Smart Approaches to Marijuana (SAM) released a new report in 2015 entitled Researching Marijuana’s Medical Potential Responsibly: A Six Point Plan. The report made a series of recommendations to improve medical research, including eliminating Public Health Service (PHS) review for marijuana research applications, and waiving DEA registration requirements for handling CBD. Shortly after SAM released its report, the Department of Health and Human Services adopted the first recommendation and eliminated the PHS review. Today’s action is in line with SAM’s second recommendation.
“We commend DEA Administrator Rosenberg for this reform,” remarked Dr. Stuart Gitlow, the Immediate Past President of the American Society of Addiction Medicine and Vice-Chair of SAM. “It’s time we do more research and, importantly, separate the medical use issue from the issue of legalizing the drug.”
For more information about marijuana use and its effects, visit SAM’s website, http://www.learnaboutsam.org