Kratom, or Mitragyna speciosa, is a plant in the coffee family that's native to Southeast Asia. In a statement, FDA Commissioner Scott Gottlieb, MD warned that kratom should not be used to treat medical conditions or be used as an alternative to prescription opioids.
"And it's an opioid that's associated with novel risks". Kratom however is available legally in stores, and online without a doctor's order. Others say it's helped them kick their opioid habit.
Those two uses are what Gottlieb appears to see as the most troubling. "From this analysis, the agency concluded that all of the compounds share the most structural similarities with controlled opioid analgesics, such as morphine derivatives", Dr. Gottlieb said.
The FDA's new analysis used computerized 3D modeling to investigate the molecular structure of the compounds that make up kratom. They also found that 22 of the 25 compounds in kratom bind strongly to mu-opioid receptors, comparable to opioid drugs.
In addition, there have been 44 reported deaths associated with the use of kratom, often in combination with other substances, Gottlieb said.
But those deaths are not as simple as they may seem.
US health authorities say an herbal supplement promoted as an alternative pain remedy contains the same chemicals found in opioids, the addictive family of drugs at the center of a national addiction crisis.
"There is no evidence to indicate that kratom is safe or effective for any medical use", Gottlieb said, adding that consumers using kratom for pain relief could seek other "safe" non-opioid options.
FDA has released details on some of the key scientific tools, data, and research that have contributed to the agency's concerns about kratom's potential for abuse, addiction, and serious health consequences.
There's still a lot we don't know about kratom.
Kratom is banned in Australia, Malaysia, Myanmar, and Thailand and in several USA states: Alabama, Arkansas, Indiana, Tennessee, and Wisconsin.
"Kratom has been proven to be a safe botanical used by consumers for centuries, and it is the very lack of using competent personnel and equipment in investigations on the cause of alleged overdose deaths that has led to numerous inaccurate and erroneous conclusions by law enforcement agencies, including the DEA", Dave Herman, chairman of the American Kratom Association told the Advance.
In 2016, the DEA proposed a ban on kratom but backtracked under pressure from some members of Congress and outcry from kratom advocates who said it could help treat opioid addiction. The scientific data and adverse event reports have "clearly revealed" that compounds in kratom render it more risky than "just a plant", he said.
So the good news is that supplement companies can finally claim a product of theirs does something.
Evidence suggests the stimulants could be similar to ephedrine, a compound derived from ephedra, the risky and lethal weight-loss supplement that the FDA banned in 2004.
The FDA previously placed kratom products on import alert to prevent them from entering the country illegally and has seized several batches.
This article was originally published by Business Insider.
"Whether it's on the bottle or not, there can be ingredients in there that can do harm".