DEA Finally Close to Expanding the Number of Suppliers For Cannabis Research
The United States Drug Enforcement Administration (DEA) announced on Friday that it will be moving forward with a number of applications from companies looking to become federally authorized manufacturers of cannabis material for research purposes.
The announcement comes after the DEA adopted new rules in December 2020 to extend the administration’s control over cannabis cultivation and supply, and is one of the first major cannabis-related actions to come out of the Biden administration.
Ending the monopoly on research cannabis production
A single cultivation facility contracted by the National Institute of Drug Abuse (NIDA) and operated at the University of Mississippi has been the sole source of cannabis for scientific research in the United States since the 1960s. In 2016, the Obama administration announced that the DEA would begin accepting applications to approve additional manufacturers, but no approvals were ever made during the Trump administration.
Now, the DEA has announced that it has identified a number of manufacturers whose applications appear to meet all necessary standards. As a result, the DEA has awarded these firms a Memorandum of Agreement (MOA) as the next step in the approvals process.
“At this time, DEA has presented those manufacturers referenced above, who appear to meet the legal requirements, with an MOA outlining the means by which the applicant and DEA will work together to facilitate the production, storage, packaging, and distribution of marijuana under the new regulations as well as other applicable legal standards and relevant laws,” the DEA said.
“To the extent these MOAs are finalized, DEA anticipates issuing DEA registrations to these manufacturers. Each applicant will then be authorized to cultivate marijuana – up to its allotted quota – in support of the more than 575 DEA-licensed researchers across the nation.”
It is unclear how many manufacturers have been awarded an MOA, though the Wall Street Journal reports of at least three organizations which have confirmed receipt of an MOA: the Biopharmaceutical Research Company (BRC), Scottsdale Research Institute (SRI), and Groff NA Hemplex LLC.
The DEA announcement also states that the administration will continue to evaluate a remaining number of cultivation applications “and expects additional approvals in the future.”
Changes a long time in the making
After years of inaction following the initial intake of cultivation applications, the SRI filed a lawsuit against the DEA in 2019.
“To comply with federal law, SRI must use federally-sourced cannabis, grown exclusively on a single 12-acre farm run by the University of Mississippi,” the opening statement of the SRI lawsuit read.
“SRI used this cannabis for its Phase II trials. It arrived in powdered form, tainted with extraneous material like sticks and seeds, and many samples were moldy. Whatever reasons the government may have for sanctioning this cannabis and no other, considerations of quality are not among them. It is not suited for any clinical trials, let alone the ones SRI is doing. Simply put, this cannabis is sub-par.”
This poor quality is one of the central reasons why US cannabis researchers wish to see the number of approved cultivators expanded. Previous research has also shown that the cannabis material provided by the University of Mississippi cultivation facility is genetically closer to hemp than the cannabis strains being sold in state dispensaries, raising questions over the suitability of this product for research at all if it cannot reflect the real diversity of the market.
This legal challenge from the SRI was eventually dropped after the DEA provided a public status update. However, an additional lawsuit from the SRI did result in the release of a previously secret DEA memo that the SRI claimed the administration had used to delay taking action on expanding cannabis research. The memo revealed feelings within the administration that the current US licensing structure for cannabis cultivation had been in violation of international treaties for decades.
The new rules approved in December 2020 were a part of the DEA effort to address these complications with international treaties and allowed the DEA to finally begin to make headway on approving cultivator applications.
Sue Sisley, president and principal investigator at the SRI, told Science following the award of the institute’s MOA: “We were euphoric. This is a victory for scientific freedom. It’s finally a chance to use real-world cannabis in our own studies and supply genetically diverse cannabis to scientists across the nation.”
BRC CEO George Hodgin said in a press release that “this federal license will forever change the trajectory of our business and the medicinal cannabis industry.”
“The DEA’s leadership will set off a nationwide wave of innovative cannabis-derived treatments, unlock valuable intellectual property and create high quality American jobs,” he said.
As these MOA holders work with the DEA and are granted registrations, information on registered approved cultivators will be made available via the DEA Diversion Control website.
