Science Over Misinformation: New study shows Kratom is not a narcotic-like opioid, despite FDA and DEA claims

Federal regulators have waged war on Kratom for years, but their recent fervor for prohibition has overshadowed an obligation to follow real science. The Food and Drug Administration (FDA) and the Drug Enforcement Agency (DEA) claim supplements naturally derived from Kratom leaves are dangerous and addictive with no medicinal value and should be a schedule 1 controlled substance like heroin. Not only are these assertions misleading, they’re dangerous to the millions of Americans who rely on Kratom to manage their health and well-being.

Both agencies have continued to issue  misinformed, exaggerated public warnings after their attempt to emergency schedule Kratom in 2016 was withdrawn due to intense public outcry — the first time in the history of the Controlled Substances Act that this occurred. In February, the FDA declared Kratom an opioid based on their PHASE (Public Health Assessment via Structural Evaluation) computer model. A model alone is not a comprehensive clinical study, and researchers who questioned this model disagree with its conclusions.

I am one of the millions of Americans taking Kratom to naturally manage my own well-being after I was prescribed pharmaceuticals that led me down a path of dependence. I’ve been telling my personal story and helping lead national efforts to keep Kratom legal, safe, and available for nearly 5 years. I implore legislators — as does the industry-leading Kratom Trade Association (KTA), other organizations and advocates — to “wait for the science,” because we know the findings will echo what consumers report anecdotally: natural Kratom is safe when appropriately regulated and about as addictive as a cup of coffee.

But what is Kratom, or Mitragyna speciosa, and why do we need more research?  It is a tree in the coffee family with nearly 40 active alkaloid compounds with potential benefits. The main two being mitragynine which comprises approximately 66 percent of alkaloid content, and 7-hydroxymitragynine (7-HMG) which generally represents less than 2 percent of alkaloid content. Both are partial mu-opioid receptor agonists, but Kratom leaves have only 0.5–1.5% alkaloid content, making effects fairly mild. It’s important to note that Kratom doesn’t cause respiratory depression and other side effects that classical opioids do.

Recently, Addiction Biology published a peer-reviewed, groundbreaking study reaffirming mitragynine as the primary alkaloid responsible for Kratom’s effects and that it “does not have abuse potential and reduces morphine intake,” making it a potential candidate for use in combating opiate addiction and withdrawal. Unlike the FDA’s flawed computer model, this study used clinical animal testing, the gold standard for such research, confirming mitragynine is not a narcotic-like opioid, and by extension neither is Kratom.

While 7-HMG does have high abuse potential, it is barely detectable (often undetectable) in Kratom products except when adulterated or extracted for higher concentrations — practices KTA strongly condemns. If Kratom were banned, this is where our scientific knowledge would end and this all-natural botanical, showing great promise to safely alleviate many health-care challenges, would be off the table. This would leave me and millions more Americans abandoned, potentially creating a dangerous, illicit black market.

Kratom advocates and consumers are hopeful this research opens a new avenue for compromise to protect Kratom from prohibition. The FDA and DEA should review and revise their stance on Kratom and work together with the industry to determine a maximum acceptable, safe level of 7-HGM in American Kratom products. Faced with an opioid epidemic claiming the lives of more than a hundred Americans daily, every avenue for recovery should be explored.

 

Susan Ash is an advisor and consumer liaison to the Kratom Trade Association.  For years, Susan has been a leader in the advocacy community committed to protecting Kratom as a safe, natural choice for millions of American consumers.