The FDA announced that they will be recommending a rescheduling of certain 7-hydroxymitragynine (7-OH) kratom products under the Controlled Substances Act (CSA).
Kratom – a tropical tree native to Southeast Asia whose leaves contain psychoactive (mind-altering) opioid compounds – has seen an increase in popularity within the U.S. over the last several years as a consumer product that can be purchased in cafes, gas stations and online.
There are no FDA-approved kratom products, but despite this, kratom has seen growing use for the self-medication of pain, opioid withdrawal, anxiety, and depression, often being marketed for these purposes despite the fact that no scientific evidence shows kratom to be safe or effective for treating these concerns.
The FDA’s new recommendation is specifically targeting 7-OH, a concentrated byproduct of the kratom plant; it is not focused on natural kratom leaf products.
7-OH is increasingly recognized as having potential for abuse because of its ability to bind to opioid receptors. This recommendation follows a thorough medical and scientific analysis by the FDA and is one of several efforts to address the agency’s concerns around the growing availability and use of 7-OH opioid products.
The report claims 7-OH products have significant potential for abuse and associated harms. The 7-OH compound typically only makes up a 1.6%-2% constituent of kratom leaves, and these 7-OH products likely involve chemical synthetic steps by producers.
Past reviews of kratom products saw low 7-OH levels, but some recent reviews saw that some 7-OH products had 7-OH levels at 109-509% higher than expected at natural levels. These products may not be clearly or accurately labeled as to their 7-OH content and are sometimes disguised or marketed as kratom.
The FDA has claimed in educational materials that this is potentially a new wave in the opioid epidemic. The FDA also issued warning letters to seven companies for illegally distributing products containing 7-OH, including tablets, gummies, drink mixes and shots. Furthermore, the FDA is also issuing letters to health care professionals and is warning consumers about the risks associated with 7-OH products.
