CANNABIS CULTURE – Dr. John Streicher at this University of Arizona claims that the DEA’s new regulations provide no aid to investigators — and he’s not the only person.
“In my standpoint it makes no distinction in any respect,” Streicher claims under the rules that he will still must apply for a program I permit together with the DEA, since he did under the previous regulations.
Streicher’s study concentrates on pain control, frequently using opioids and demands a Schedule II license. With regular reviews, Streicher can investigate opioids: codeine, morphine, and oxycodone with very little supervision.
The safety requirements for keeping Schedule I chemicals from the laboratory is much greater. Streicher claims that isn’t the sole problem, “It’s the extra burden of all of the specifics.”
Investigators will need to present specific programs within their program for whatever they would like to do. “Lots of things change from study,” he states. “You make a single discovery which may result in five new instructions you wish to go in.” Streicher states de-scheduling cannabis is the sole path to assist research.
Dr. Josh Kaplan of Western Washington University claims his study concentrates on CBD due to the limitations on THC. “There are businesses down the road that market and create products and I can’t bring them in the lab.” Kaplan considers that a small bit of THC at a bigger CBD product might be helpful for healing purposes, “however as soon as you attract THC into the laboratory, it will become far more costly and time consuming in respect 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 that the Ole Miss cannabis was highly processed and ground up into particles, genetically closer to hemp than marijuana, and contained unacceptable levels of mold.
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.