How a U.S. Ban on Lab-Modified Opioids Could Stifle Medical Research
A Rutgers Health scientist discusses how federal regulations aimed to protect the public from kratom derivatives could impact innovation
In August, the Department of Justice and the Drug Enforcement Administration placed three new lab-made opioids – known as MGPI, MGM-15, and MGM-16 – onto Schedule I of the Controlled Substances Act, the nation’s strictest illegal drug list.
These chemicals are stronger versions of products derived from kratom – a tropical tree native to Southeast Asia whose leaves are used by people for a variety of reasons, including managing pain, energy, mood or opioid withdrawal symptoms – and carry high risks of severe addiction and life-threatening breathing problems.
Jenny Wilkerson, a core faculty member at the Rutgers Brain Health Institute and an assistant professor of anesthesiology at Rutgers New Jersey Medical School, discusses the implications of this designation to the public and scientists.
What is kratom?
Leaves from kratom have been used traditionally in Southeast Asia for centuries, but over the past two decades it has developed a substantial following in the United States. It is sold here in forms ranging from dried leaf and powders to capsules, extracts and increasingly concentrated products. It has become increasingly visible in gas stations, smoke shops, supplement stores and online markets, but remains relatively unfamiliar to much of the broader medical community and public.
One reason kratom’s relative obscurity is changing rapidly is due to the emergence of highly concentrated kratom-derived products containing 7-hydroxymitragynine and other chemically modified compounds. This is where an important distinction is getting lost in the current discussion: These compounds are not readily interchangeable with traditional kratom leaf.
As kratom becomes more well-known in the U.S., how we talk about it needs to change. Using the blanket term “kratom” for everything is misleading and potentially dangerous because it lumps together fundamentally different substances: The botanical plant; its raw, natural active compounds; highly concentrated extracts; and chemically modified synthetic versions. Since these forms affect the body differently, distinguishing between them is essential for public safety.
Is botanic kratom safer than its synthetic derivatives?
The Department of Justice has stated that the federal government’s action is directed at the manufactured and concentrated opioid compounds, rather than traditional botanical kratom.
Although this current decision does not include whole-plant kratom, this does not mean kratom is harmless. Repeated kratom use can produce tolerance, dependence and withdrawal, and there are legitimate concerns about product quality, adulteration and interactions with other substances.
The Food and Drug Administration does not consider kratom to be lawfully marketed as a dietary supplement or approved drug in the United States.
What challenges do the regulations present for researchers?
There are legitimate reasons to regulate highly potent, concentrated and chemically modified opioid compounds, but regulatory decisions have consequences for science. This action can make it substantially more difficult to obtain, store, administer and study compounds in controlled laboratory settings.
Scientists are just beginning to figure out how kratom and its active chemical ingredients might be used as medicine, as well as what negative side effects they could cause.
