The FDA is recommending a rescheduling of certain 7-hydroxymitragynine (7-OH) kratom products under the Controlled Substances Act (CSA). Consumer kratom product that can be purchased in cafes, gas stations and online. 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. The FDA found that 7-OH compounds typically only makes up a 1.6%-2% constituent of kratom leaves, and these 7-OH products likely involve chemical synthetic steps by producers, as some products saw 7-OH levels at 109-509% higher than expected at natural levels. 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.
