HART Statement on 7-Hydroxymitragynine (7-OH)

The U.S. opioid crisis is the leading public health challenge of the new millennium. There are more than 200 opioid overdoses and poisonings every day —and drug overdose is now the number one cause of death for 18-45-year-olds. To address this unprecedented crisis, policymakers and public health officials need to identify new tools for the toolbox.

HART believes that 7-hydroxymitragynine (7-OH), a metabolite of mitragynine, the most abundant alkaloid found in kratom, could provide a new set of tools to combat opioid misuse and improve public health. Proper regulation of this substance would also expand access to safe options for managing stress and decreasing reliance on harmful, illicit substances, while also supporting the transition from dependence on these substances.

7-OH products marketed by HART members comply with FDA’s adulteration standard for dietary supplements, in that they do not present a significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in labeling, or under ordinary conditions of use. Based on monitoring of consumer feedback and adverse event reports by HART members, there also do not appear to be safety signals with products currently on the market.

Unfortunately, there are current efforts in a number of state legislatures to ban 7-OH, which are largely driven by a kratom organization that views 7-OH as a threat to its market share. That group has paid scientists hundreds of thousands of dollars to make broad policy pronouncements based on very preliminary research and theory. This article describes the conflicted actors seeking to gain competitive advantage through the legislative process.

7-OH can be an invaluable harm reduction tool that should remain an option for the hundreds of thousands of consumers that rely on it. This was a key factor in HHS’ decision to reject efforts to ban kratom and 7-OH, stating that, by contrast, “there is significant risk of immediate adverse public health consequences for potentially millions of users if kratom and its components” were controlled as Schedule 1 drugs.

Instead of banning the compound, HART strongly supports robust regulation and is pursuing legislation federally, and in the states, to mandate that all 7-OH products are manufactured safely, are marketed transparently, and are kept out of the hands of children. In the meantime, HART is continuing its investment in self-regulation and the science supporting 7-OH’s safety.

To that end, we have engaged Pinney Associates and their specialists in central nervous system (CNS) active drugs to advise HART on the research approach needed to better understand 7-OH pharmacology, safety, addiction-related risks, and other health effects. We are also being advised by former White House Drug Czar Jim Carroll to promote self-regulation that includes compliance with legal and regulatory requirements, prioritizing consumer safety, preventing underage access, establishing best practices and guidelines, and differentiating from traditional kratom products.