The Drug Enforcement Administration has said they are nearing a decision on a petition to reschedule cannabis. Anticipation has been high, because while the DEA has turned down other petitions, there is more momentum in America today than ever before–for both adult and medical use cannabis.
And there are signs that this time things will be different, based on conversations Cannabis Wire has had with the DEA, the director of the federal cannabis research farm, and our analysis of discussions at the federal level.
But those signs point not toward whole plant rescheduling, but rather toward one component of the cannabis plant that is more likely to be headed out of Schedule I: cannabidiol, or, CBD. This compound does not produce psychoactive effects, like the well-known THC, so it’s unlikely that people will seek to consume CBD for recreational purposes.
The entire cannabis plant (and its components) has remained in Schedule I since the Controlled Substances Act was enacted in 1970. Schedule I substances are deemed to have a high potential for abuse and no accepted medical use. The FDA has already made its recommendation to the DEA, and now the DEA is in the final steps of their own deliberations.
On July 13, a Senate judiciary committee held a hearing on “Researching the Potential Medical Benefits and Risks of Marijuana, which brought together some of the officials who are part of the rescheduling deliberations.
The hearing was called for by Senator Chuck Grassley, the committee chairman, and he focused almost solely on CBD. One passage from his statement (read it in its entirety here) noted that CBD alone is also being considered for rescheduling: “We asked [the DEA and Food and Drug Administration] to evaluate CBD using the appropriate scientific and medical factors to make a scheduling determination for it that is separate from the whole marijuana plant. If it turns out that CBD may be classified on a lower schedule than the entire marijuana plant, then research on it may proceed somewhat more easily.”
Another speaker, Susan Weiss of the National Institute on Drug Abuse (NIDA), spoke about the hurdles in classifying whole plant cannabis as a medicine before articulating why CBD is different.
“The marijuana plant itself is not considered an ideal medication candidate because: it is an unpurified plant containing numerous chemicals that have not been fully characterized; the variability of active components makes it difficult to reproduce a consistent dose; it is often consumed by smoking, potentially contributing to adverse effects on lung health,” Weiss said.
She continued, “Per the CSA, all of the cannabinoids in marijuana are considered Schedule I compounds. Currently, evidence suggests that CBD does not have abuse liability.”
Douglas Throckmorton of the FDA said, “Recently, there has been significant interest in one of marijuana’s constituent compounds, CBD,” and elaborated on Weiss’ statement. The FDA requested a “human abuse liability study” before making a recommendation on whether to reschedule CBD. Weiss’s comment hint strongly at the study’s findings.
Much has led to this moment.
Cannabidiol is, without a doubt, at the forefront of cannabis-based medicines, but it wasn’t always that way.
When we visited the cannabis research farm at the University of Mississippi in May 2013, while reporting for A New Leaf: The End of Cannabis Prohibition, there were no high-CBD strains being grown, and the outdoor cultivation space, behind barbed wire, was bare.
Around that time, a group of brothers in Colorado, now known as the Stanley brothers, had cultivated a high-CBD strain of cannabis. The mother of a then 7- year-old girl named Charlotte Figi who had Dravet Syndrome, a severe form of epilepsy, found that an oil produced from the strain reduced her daughter’s hundreds of seizures down to a handful. The brothers named the strain Charlotte’s Web.
In August 2013, a few months after our trek to the federal farm, CNN aired Sanjay Gupta’s documentary, Weed, which explored the research around medical cannabis and first brought to a national audience the story of Charlotte. Suddenly, hundreds of families flocked to Colorado to access CBD oil for their children, and since the documentary aired, more than a dozen states with no previous medical cannabis law passed legislation to permit access to CBD oil, though most only through an affirmative defense and no legal way to obtain the oil.
One month later, GW Pharmaceuticals, which already had a botanical cannabis extract–half CBD, half THC–in FDA clinical trials for multiple sclerosis, made an announcement.
“GW’s activities in the field of epilepsy have expanded in recent months as a result of emerging interest among U.S. pediatric epilepsy specialists and patient organizations in the potential role of a distinct cannabinoid product candidate, Cannabidiol (CBD), in treating intractable childhood epilepsy.” Further, GW wrote, the FDA would “allow treatment of a small number of pediatric epilepsy patients with a CBD formulation supplied by GW.”
Epidiolex, as the CBD formulation is now known, is now in the very final phases of FDA clinical trials, and could be approved this year. More than 400 children have received the drug as part of this trial. If approved, it would be the first CBD-based pharmaceutical in the U.S.
In contrast with our visit to the federal farm in 2013, the farm in 2015 offered high CBD strains and extracts to researchers.
“The cannabis plant, the good Lord put a lot of energy in that plant,” Mahmoud ElSohly, director of the federal facility, told Cannabis Wire in 2015. “The material that we have is a variety of the cannabis that’s high in CBD similar to Charlotte’s Web.”
It was somewhat surprising to hear ElSohly, who runs the cannabis cultivation facility on a federal government contract, refer to new CBD strains at the federal research facility as being like “Charlotte’s Web” considering the discovery of that strain, which fueled so much action at the federal level, happened through a state program (Colorado) that defies federal law.
Last summer, after the first ever senate hearing on CBD, Nora Volkow, director of the National Institute on Drug Abuse, wrote a piece that signaled a huge shift among federal officials: “Medical research can and is being done with schedule I substances; however, there are strict regulations and administrative hurdles associated with this status.”
Conversation about “hurdles” to cannabis research had previously been the battle cry of medical cannabis advocates, and among federal officials there was at best minimal public talk of changing the status quo.
The piece continued, “Addressing barriers that slow clinical research with CBD would accelerate progress. NIDA will do what we can to address such barriers and expedite the study of this potentially valuable compound, as well as other components of the marijuana plant.”
Then, in March 2016, Volkow for the first time explicitly expressed support for rescheduling. “I’m very much for facilitating research on cannabis and changing some of this scheduling of these substances,” she said.
Cannabis Wire asked the DEA when the decision on CBD might come, and whether it would be at the same time as the whole plant petition announcement. Russell Baer, a spokesperson for the DEA, said in July 2016 that the two decisions would come separately.
“They may be getting closer to making that ultimate determination if CBD is a medicine, but we’re not quite there yet,” he said. “We’re moving in that direction, it seems. We’re encouraged by what GW Pharmaceuticals has themselves reported; we’re aware of that information. And certainly we’re willing to engage in that narrative.”
It seems the writing is on the wall for CBD.
It’s unclear that, if the FDA approved Epidiolex, as it looks like might happen, whether only Epidiolex would be down scheduled, or whether all forms of CBD would be, too. (In the 1980s, the FDA approved Marinol, which has been used by AIDS patients to increase appetite, and by cancer patients to reduce nausea. Marinol contains only synthetic THC and is in Schedule III.)
This does not mean that whole plant cannabis will not be rescheduled, but, time and time again, federal officials point to the crude and varied nature of whole plant cannabis when it comes to whether it can be considered a medicine.
“We’re fathers, we’re parents, we’re brothers, sisters. We get the emotional side of the argument. But at the end of the day, from our perspective, a lot of the states that have taken either legislative action or ballot initiatives and public referendums, they kind of short-cutted the whole scientific process. And our system is set up to where the FDA has always been, and continues to be, the entity that determines the safety of all medicines, all substances. So we only ask that marijuana be held to the same level of scrutiny as all other substances and medicines,” the DEA’s Baer told Cannabis Wire.
In his statement at this latest hearing in mid July 2016, Douglas Throckmorton of the FDA reiterated an oft-quoted portion of a 1999 Institute of Medicine report called “Marijuana and Medicine: Assessing the Science Base,” which was commissioned by the White House Office of National Drug Control Policy (ONDCP): “If there is any future for marijuana as a medicine, it lies in its isolated components, the cannabinoids and their synthetic derivatives.
But, we wrote in A New Leaf about a “crucial caveat” included in the report that might explain why more than half of the states in the U.S. have passed whole-plant medical cannabis laws in these years since the report’s publication. The report also reads:
However, it will likely be many years before a safe and effective cannabinoid delivery system, such as an inhaler, is available for patients. In the meantime there are patients with debilitating symptoms for whom smoked marijuana might provide relief.