DEA WAIVES REGISTRATION REQUIREMENTS FOR
CBD RESEARCH, ADOPTING SAM RECOMMENDATION
FOR IMMEDIATE RELEASE
December 23, 2015
Contact: Jeffrey Zinsmeister
[WASHINGTON, DC] – Researching one of the non-intoxicating components of marijuana, cannabidiol (CBD), will now be made easier because of new DEA regulations released today. In line with SAM’s recommendation a few months ago, 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 smoked recreationally today has almost 0% CBD.)
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 now, researchers who expanded the scope of their studies and needed more CBD than they were initially approved for had to request, in writing, a modification to their DEA research registrations – potentially delaying that research while the modification underwent an approval process that includes both the DEA and the 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 waiver effectively removes a step from the approval process.
Given the increasing interest and demand for research into marijuana’s therapeutic potential, 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 the SAM report was released, the Department of Health and Human Services adopted the first recommendation and eliminated PHS review. Today, DEA follows suit by implementing the second and waiving registration requirements.
“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.”
“The interests of patients, researchers, and the public have won out here,” commented Jeffrey Zinsmeister, SAM’s Executive Vice President. “This is an important milestone, and DEA should be commended. It will help patients who need CBD products obtain them quickly but also through a safe FDA approval process.”
For more information about marijuana use and its effects, see https://learnaboutsam.org.
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