US Lawsuits End DEA Restrictions On Sources of Cannabis for Researchers

Lawsuits in the US have overturned the requirement that researchers interested in studying cannabis can only purchase from a single licensed source. This may open up research opportunities into more strains for more applications.

Under rules established by the US Drug Enforcement Agency (DEA) and the Department of Justice, federally funded studies had to purchase supplies exclusively from the University of Mississippi, which was the only institution approved to grow cannabis for this purpose. This meant there was only a limited number of strains and harvest shortages could sometimes restrict access to them.

The university’s monopoly over cannabis for research has now been terminated. A series of lawsuits filed in federal court by two attorneys, Shane Pennington and Matt Zorn, from the law firms Vicente Sederberg and Yetter Coleman respectively, has finally seen a result. They were working on behalf of the Scottsdale Research Institute (SRI).

“If you wanted to study the stuff that people were using at the dispensaries, the DEA said that everything that was currently being grown was illegal and you couldn’t go get it,” Pennington told CBD-Intel. “You couldn’t go buy a cannabis plant at an ‘illegal’ dispensary and then go grow from there. That became a problem.”

DEA agrees to start processing applications

As part of an agreement to end the latest lawsuit, in May 2021 the DEA agreed to begin processing applications filed by qualified cannabis companies seeking to supply researchers.

Earlier this month, two of the companies whose applications were approved – Groff North American Hemplex and the Biopharmaceutical Research Company (BRC) – announced they had been registered and licensed by the DEA in 2021 and had already begun planting, growing, and harvesting cannabis for research. BRC finished its initial harvest last November and is currently tending its second bunch of crops. Groff completed its first harvest in late December.

The DEA has now increased its annual production quotas for Schedule I drugs that scientists and physicians can test, having called for increased production of substances such as psilocybin, psilocin, cannabis and cannabis extracts last year. This means shorter waiting times for research proposals from qualified researchers and provides another revenue stream to licensed growers while permitting clinical research to be closer to “real world” conditions.

“The DEA granted us everything we asked for,” BRC’s CEO George Hodgin said. “I think that what you saw over the past year, with respect to the DEA increasing the production quotas of controlled substances that includes cannabis, that regulatory action is directly, positively affecting the producers like us.”

The University of Mississippi achieved its monopoly as the exclusive supplier of cannabis for research as a consequence of the global “War on Drugs” launched more than five decades ago. In 1967 the US signed the UN Single Convention on Narcotic Drugs treaty, which included a pledge to carefully restrict access to cannabis even when it was being used for scientific or medical research. As a result, the National Institute on Drug Abuse (NIDA) concluded an agreement giving the University of Mississippi a complete monopoly. This created problems with research, said Pennington.

“You’re only allowed to study this study drug that’s grown at the University of Mississippi and no one across the country is using that study drug, they’re using very, very different strains that are from dispensaries,” he said. “You’re not studying what people are using.”

War on Drugs restricted research to harms, not benefits

The War on Drugs further tended to restrict research on cannabis to its potential harms rather than its potential benefits, for the past 50-plus years. This has led to the current situation where there is simply not enough evidence available to support many of the anecdotal claims being made about cannabis.

“Everybody’s using stuff from dispensaries across the country under the state laws and they’re saying this stuff really works and helps me,” Pennington added. “Then scientists want to study it, but they can’t, because the federal government doesn’t recognise those growers as legitimate.”

This was expected to change under the Obama administration. A proposal to change the rules and allow additional laboratories to enter the research cannabis industry as suppliers was made. Expecting big changes soon, the SRI applied for a growers’ licence with the DEA, as did more than 30 other companies.

However during the Trump Administration, the DEA stonewalled those companies, neither processing their applications nor offering them an explanation as to why they were failing to do so. Under the authority of Trump’s anti-cannabis attorney general Jeff Sessions, the DEA seemed determined to preserve the status quo.

Consequently, the SRI filed a lawsuit against the DEA and the US Department of Justice in 2019, in an attempt to get them moving. After Pennington and Zorn introduced their suit in the DC Circuit Court in August 2019, the DEA reversed course and approved SRI’s application, along with those of 32 other companies that had also petitioned to be included in the federal government’s cannabis research growing program.

However, the DEA then moved to say it could only begin issuing official licences after developing new and updated guidelines for managing the application-and-licensing system, leading to another lawsuit from Pennington and Zorn. This lawsuit was also eventually settled, leading to the DEA issuing the licences to a handful of companies last year.

What This Means: The changes to the supply system may revolutionise cannabis research in the US, leading to a large expansion in the available cannabis-related medical and scientific literature. This in turn could place further impetus on federal legalisation for medical or even recreational cannabis products.

This article was originally published by CBD-Intel and is republished with permission.

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– Sarah Ratliff CBD-Intel contributing writer