CANNABIS CULTURE – Dr. John Streicher of the University of Arizona says the DEA’s new regulations offer no help to researchers — and he’s not the only one.
“From my point of view it makes no difference at all,” Streicher says under the new rules he will still need to file for a Schedule I license with the DEA, as he did under the old regulations.
Streicher’s research focuses on pain management, often with opioids and requires a Schedule II license. With routine inspections, Streicher can research opioids: codeine, morphine, and oxycodone with little oversight.
The security requirements for storing Schedule I substances in the lab is far higher. Streicher says that isn’t the only difficulty, “It’s the additional burden of all the details.”
Researchers need to provide exact plans in their application for everything they want to do. “A lot of things change in research,” he says. “You make one discovery and that may lead to five new directions that you want to go in.” Streicher says de-scheduling cannabis is the only route to help research.
Dr. Josh Kaplan of Western Washington University says his research focuses on CBD because of the restrictions on THC. “There are companies right down the street that sell and produce products and I can’t bring them into the lab.” Kaplan believes that a little bit of THC in a larger CBD product could be beneficial for therapeutic purposes, “but once you bring THC into the lab, it becomes a lot more expensive and time-consuming in regard to paperwork.”
James Pokryfke, a Staff Coordinator in the Department of Justice wrote in an email the intention of the new regulations is to “increase the lawful supply of marihuana scientific and medical research that could ultimately result in the development of marihuana-based medicines approved by the FDA.”
The DEA’s document states two goals for the new regulations: Grant additional cannabis growing licenses for companies that are applying, and to establish new rules for purchase and sale of cannabis by the DEA to advance research.
Kaplan is glad the DEA is expanding the range of companies, even though there are bigger problems in the industry. Testing potency and pesticide content is famously inconsistent, “People have reported intoxicating effects from hemp products,” Kaplan said. Some states have baseline standards for testing, but there is no national standard.
Without proper products and adequate material, Kaplan questions how we can develop guidelines for proper use besides ‘start low, go slow.’
Kaplan sees this as more helpful to private investors. Besides agricultural schools, most space is at a minimum for universities.
Columbia Care filed an application in 2016 with 33 other companies and can scale up. In in a statement, they said their “purpose in applying is to provide a solution to the limitations and availability of the products currently manufactured.”
Even with these new rules set in place, there is no guarantee of acceptance or even response. A representative of Alaska-based Green Leaf said that he paid the application fee and hasn’t heard anything since.
Dr. Lyle Kraker of the University of Massachusetts, Amherst’s School of Agriculture has filed two lawsuits against the DEA to get a response. Kraker has been applying for a license for two decades. The most recent lawsuit stated the DEA did not start processing applications until 2019.
The DEA has only ever given out one cannabis cultivation license, and it belongs to the National Center for the Development for Natural Products at the University of Mississippi (Ole Miss).
If a researcher got a Schedule I license to study THC, the cannabis would come from Ole Miss. However, the university’s product has a historic reputation for poor quality.
Kraker’s lawsuit stated the cannabis was very different from the products used by patients and consumers right now, which negates all of the research coming out of that facility.
“We should be studying what people are using,” Kaplan said, “Even in the last five years, the average THC potency has gone up substantially.” Kaplan would love to test the claims that some of the companies make, like one product being used for arousal or another for sleep. “These companies are making claims and there is no empirical evidence to support any of that.”
The quota for Ole Miss is 2000 pounds per year. That quota will remain the same due to the DEA’s limited storage facilities. With this quota distributed throughout more companies, there is hope that a greater variety, reflecting what people are really using, will be available for research.
In total, 46 companies have submitted applications. According to the DEA report, the number of companies needed to meet their annual quota could range from 3 to 15. The new regulations are scheduled to go into effect January 19, 2021.