Congress Should Stop Scheduling Substances Without Consulting the Science
On March 26, the Health Subcommittee of the House of Representatives’ Energy and Commerce Committee will consider H.R. 8000 to place 7-hydroxymitragynine (an opioid-like substance derived from the kratom plant and commonly known as 7-OH) on Schedule I of the Controlled Substances Act. This move bypasses the standard eight-factor analysis that is central to the scheduling process and leapfrogs recent steps by the executive branch to consider a temporary emergency scheduling order.
Congress is likely trying to keep communities and constituents safer in response to claims about 7-OH’s addictive potential and possible role in overdoses. The substance does bind to the same receptors in the brain as opioid drugs like morphine, although it activates them differently and it is currently commercially available at gas stations, smoke shops, and convenience stores. As such it warrants study, both to understand its potential risks and its possible therapeutic uses. However, this rush to place 7-OH on the most restrictive level of the drug schedule before the science is clear deters that research and could have other unintended consequences.
Scheduling Impedes Scientific Study
Under the Controlled Substances Act, Schedule I defines substances as having “no currently accepted medical use and a high potential for abuse.” Once a substance is classified this way, it becomes extremely costly and difficult to study as scholars may struggle to access the substance altogether and must navigate a wide range of bureaucratic and funding barriers to conduct their research.
While it increasingly appears that 7-OH is not risk-free, placing it on Schedule I would only discourage important research. Current safety claims are largely based on very small numbers, especially considering that the products are commercially available and likely used by hundreds of thousands of people or more per year.
Given the commercial availability of the products and the anecdotal reports of both risk and medical potential, more research into 7-OH is essential for guiding regulatory next steps. Improving understanding of the risks associated with 7-OH use will provide medical professionals with important information about how to identify, prevent, and treat these issues. It will also help regulators know whether and how to restrict products and marketing. Secondly, because kratom and its derivatives have shown promise for treating pain and substance use disorders, it is important to facilitate research into 7-OH’s therapeutic potential.
Furthermore, once a substance is placed on Schedule I, rescheduling is an arduous and lengthy process, even if research reveals minimal potential for harm or strong evidence for medical use. Consequently, it is extremely rare, with the most recent rescheduling successes pertaining to specific compounds or products. Epidiolex—a purified cannabidiol (CBD) medication derived from the cannabis plant—was moved from Schedule I to Schedule V in 2018. Similarly, in 1985, the synthetic THC-based medication Marinol was originally approved by the U.S. Food and Drug Administration at Schedule II and not downgraded to Schedule III until 1999. It is noteworthy that although these examples are both related to cannabis, cannabis and CBD remain on Schedule I despite decades of efforts to re- or deschedule them. Thus, it is important that lawmakers exercise patience and allow more research before they act on 7-OH or other emerging substances.
Cutting Access Drives People to the Illicit Market
In addition to creating a barrier to research, placing 7-OH on Schedule I would make it an illicit drug and lead to its removal from shelves. In the absence of population-level research, the scale and scope of 7-OH addiction is unknown. However, suddenly losing access could have serious consequences. First, people who are self-medicating with 7-OH would lose their preferred treatment for pain or opioid use disorder. Second, individuals who have developed a physical dependence could experience very uncomfortable or debilitating withdrawal symptoms. These factors could potentially drive people to the illicit market, increasing risk for overdose and death, as we saw when doctors were urged to stop prescribing opioid painkillers.
Conclusion
Research is the cornerstone of drug scheduling according to the Controlled Substances Act, and it is essential to ensuring that these decisions do not hinder study of potential therapeutics or criminalize substances that do not represent a public health and safety threat. Congress’s current attempt to bypass this process and put the scheduling before the science, while well-intentioned, will have unintended consequences.