'Natural herb' marketing aside, a drug is a drug and should go through the same regulatory process as any drug. But kratom has gotten a free pass because of a President Clinton law that exempted supplements from FDA oversight as long as the label said that it was not a drug. But kratom clearly is a drug, it is an analgesic, and that is why people take it. But it is also an opioid, finds the US FDA in their analysis - 22 (including mitragynine) of the 25 compounds in kratom bind to mu-opioid receptors. Their new model, together with previously available experimental data, confirm that two of the top five most prevalent compounds (including mitragynine) are known to activate opioid receptors (“opioid agonists”).
So the good news is that supplement companies can finally claim a product of theirs does something. The bad news is it does something bad. The compounds share the most structural similarities with controlled opioid analgesics, such as morphine derivatives.
Their analysis also found that some of the kratom compounds may bind to the receptors in the brain that may contribute to stress responses that impact neurologic and cardiovascular function. The agency has previously warned of the serious side effects associated with kratom including seizures and respiratory depression. Using the resulting 3-D model, they were able to look at not just where those compounds bind, but how strongly they bind to their biological targets. Result: kratom has a strong bind to mu-opioid receptors, comparable to scheduled opioid drugs.
They also released the reports of the 36 deaths they referenced in November, which underscore the serious and sometimes deadly risks of using kratom and the potential interactions associated with this drug.
It's good that proponents are right and that kratom does work as an analgesic, But extensive review for safety and efficacy is now needed. Plant-derived or not, it is an opioid.