FDA Says 'Kratom' Is An Opioid, Not Safe For Medical Use

The FDA says that kratom, an herbal supplement used as a pain reliever and to treat opioid withdrawal symptoms, is an opioid and that claiming it is benign because it's "just a plant" is shortsighted.

In an announcement Tuesday, the FDA said it has taken significant steps to advance scientific understanding of the product and how it works in the body because much remains unknown about the product. The FDA said it has identified adverse affects related to the use of the product and learned about deaths related to its use.

"The FDA stands ready to evaluate evidence that could demonstrate a medicinal purpose for kratom," the agency said in a statement. "However, to date, we have received no such submissions and are not aware of any evidence that would meet the agency’s standard for approval."

According to the FDA, a methodology developed by the agency known as PHASE (Public Health Assessment via Structural Evaluation) shows that compounds in kratom are predicted to affect the body just like opioids. In November, the FDA warned the public about reports of injury, addiction and death associated with the use of kratom.

Kratom is made from a plant native to Southeast Asia — in countries including Thailand, Malaysia, Indonesia and Papua New Guinea — and has gained popularity in the U.S. as a treatment for pain, anxiety and drug dependence. Users have opposed efforts to regulate the plant, saying it could be a safer alternative to opioid pain pills.

The FDA said it has reports of 44 deaths associated with the use of kratom, up from 36 in November when it issued its warning advisory. The FDA released some information about the deaths associated with kratom, saying at least one person who died had no known historical or toxicologic evidence of opioid use, except for kratom. The FDA said concerns were also raised that kratom is being used in combination with other drugs that affect the brain.

Kratom should not be used to treat medical conditions or as an alternate to prescription opioids, the FDA said, adding that there is no evidence to indicate it is safe or effective for any medical use.

"Further, as the scientific data and adverse event reports have clearly revealed, compounds in kratom make it so it isn’t just a plant – it’s an opioid," the FDA said. "And it’s an opioid that’s associated with novel risks because of the variability in how it’s being formulated, sold and used recreationally and by those who are seeking to self-medicate for pain or who use kratom to treat opioid withdrawal symptoms."

SEE ALSO: The Dangers And Potential Of 'Natural' Opioid Kratom

The Associated Press contributed to this report.

Photo by Mary Esch/Associated Press