Kratom plants are native to Malaysia, whose leaves have traditionally been used in tea for treating pain.
Kratom's also known as Thang, Kakuam, Thom, Ketom and Biak, according to the CDC, which said whole genome sequencing on the bacteria's DNA indicates the 28 people in the salmonella outbreak likely caught it from a common source. FDA warned the public in November 2017 that the plant has the same risks of abuse and addiction as opioids.
"There's no safe kratom product", Scott Gottlieb, MD, FDA Commissioner said in a statement. Eight of the 11 people, 73%, reported consuming kratom in pills, capsules, powder or tea. The agency recently developed a novel scientific analysis using a computer model which demonstrated stronger evidence of kratom compounds' opioid properties, which can lead to serious side effects like seizures and depression. The FDA is making efforts to tamp down on misbranded or unapproved drugs entering the country to stop the flow of kratom.
A number of kratom-containing dietary supplements are being recalled and destroyed by the manufacturer, the U.S. Food and Drug Administration announced Wednesday.
Kratom has never gained FDA approval and is largely unregulated - meaning that, as with most supplements, it's nearly impossible to verify what's actually in "kratom" pills, powders, or teas. It also said 11 cases involve hospitalizations, and no related deaths reported. "We appreciate the cooperation of companies now marketing any kratom product for human consumption to take swift action to remove these products from circulation to protect the public".
He noted that his agency "is taking new steps to bring new, safe and effective FDA-approved therapies to the market for treatment of opioid use disorder".
Kratom is marketed as a plant-based supplement to treat pain, anxiety and depression but its similarities to opioids have raised concerns that it can be addictive and unsafe.
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