FDA called for public comments on the international drug scheduling of cannabis and cannabis-related substances in preparation for a meeting of the World Health Organization. In response, herbal experts and industry leaders urged the agency not to classify cannabis substances as Schedule I drugs.
Cannabis (Cannabis sativa) and its related extracts, such as CBD, continue to command the regulatory spotlight. In response to an FDA call for public comments on the global regulatory status of cannabis and cannabis-related substances, herbal experts and industry leaders have urged the agency not to classify cannabis and cannabis-related substances as Schedule I drugs.
In April, FDA invited the public to comment on “abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes” on products containing cannabis and cannabis derivatives. The agency sought these comments ahead of the upcoming 40th meeting of the World Health Organization’s Expert Committee on Drug Dependence (ECDD), taking place in June 2018 in Geneva. ECDD’s goal is to assess the international drug scheduling of psychoactive substances based on their potential for abuse, dependence, and potential to harm the public, and to recommend international restrictions for specific dangerous substances if deemed necessary.
During its 40th meeting, ECDD will conduct a pre-review of the status of cannabis and cannabis-related substances, including cannabis plant and cannabis resin, cannabis extracts and tinctures, delta-9-tetrahydrocannabinol (THC), and THC isomers. It will also, for the first time, begin to review the status of hemp-derived cannabidiol (CBD).
By gathering public comments here in the U.S., FDA is collecting information that will be used as the U.S. prepares for the upcoming ECDD meeting. As a party to the United Nations treaty, the 1971 Convention on Psychotropic Substances, the U.S., via the U.S. Department of Health and Human Services, is obligated to provide the international community with any new information about a substance that could impact the way the substance should be scheduled or controlled internationally.
How is the ECDD likely to regard cannabis-related substances at its 40th meeting and especially CBD, which the committee will be formally scrutinizing for the first time? The committee’s 39th report, following its November 2017 meeting, indicates that the committee’s early, informal reviews of CBD have not raised alarm over the safety of CBD.
In the 39th report, the committee noted that it had never previously pre-reviewed or critically reviewed CBD. It wrote in its report that “while the number of studies is limited, the evidence from well-controlled human experimental research indicates that CBD is not associated with abuse potential.” CBD is not currently specifically listed as a drug under the United Nations International Drug Control Conventions. In its report, ECDD said, “As CBD is not currently a scheduled substance in its own right (only as a component of cannabis extracts), current information does not justify a change in this scheduling status nor does it justify scheduling of the substance.”
In public comments sent to FDA, herbal leaders such as the American Herbal Products Association (AHPA; Silver Spring, MD) and the nonprofit American Botanical Council (ABC; Austin, TX) supported these early conclusions of the ECDD.
“AHPA supports the ECDD’s conclusion that CBD requires no international drug scheduling as an individual substance and recommends and requests that the United States also express support for this position,” wrote AHPA president Michael McGuffin in comments the association submitted to FDA on April 23.
“AHPA is aware of no information that suggests that extracts or preparations of Cannabis containing almost exclusively CBD are any more subject to abuse or dependence than CBD itself and therefore recommends and requests that the United States support a position to acknowledge that such extracts and preparations should not be scheduled under any international drug control convention to which the United States is a party,” McGuffin wrote.
In its public comments, the American Botanical Council urged that cannabis overall be removed from Schedule I of the Controlled Substances Act in the United States. Stefan Gafner, PhD, ABC’s chief science officer, highlighted the many therapeutic indications for cannabis and noted that the herb’s current status as a Schedule I drug is impeding research on the herb’s medicinal potential for conditions and diseases such as pain, epilepsy, and multiple sclerosis.
“Based on what clinical research and numerous case studies indicate as the promising medical benefits of cannabis as a medicine, we recommend that cannabis be taken off Schedule I of the Controlled Substances Act in the U.S. to allow for more thorough investigation of its therapeutic potential,” Gafner wrote.
He further noted that the Controlled Substances Act defines Schedule I drugs as drugs that have a high potential for abuse and that have no currently accepted purpose as a medical treatment. He also pointed out that, when the law was enacted, there was “scarce” information on the medical value of cannabis, whereas today there are “a number of clinical studies” on cannabis and cannabis isolates in relation to various health conditions.
Because cannabis is listed as a Schedule I drug, researchers must first undergo onerous hurdles, such as applying for Investigational New Drug applications and getting research sites registered by the Drug Enforcement Administration before studies can commence, Gafner wrote. “In addition, the cannabis has to be obtained through [the National Institute on Drug Abuse], which still uses the University of Mississippi as the only federally approved source that is allowed to legally grow cannabis for government-approved research studies,” he said.
All of these impediments, Gafner wrote, have limited researchers’ ability to study the health-promoting properties of cannabis products, writing that “the Schedule I status of cannabis is one of the most significant impediments to carry out such research.”
Because the studies that have been done do point to significant potential therapeutic properties of cannabis, Gafner wrote, “it seems clear” that “Schedule I of the Controlled Substances Act no longer applies to cannabis.”
The future status of cannabis and cannabis-related extracts like CBD on the global stage and within the ECDD remains to be seen. Here in the United States, indications are high that the legal doors for hemp-derived substances may soon open up through other avenues. In April, U.S. senators proposed the Hemp Farming Act of 2018, to de-schedule hemp as a Schedule I drug.