Gottlieb also acknowledged that if proponents are right, and kratom could be used alternatively as a tool to treat opioid addiction, the agency owes them clear, reliable evidence to support those benefits.
The supplement, kratom, made from a plant native to Southeast Asia, has gained popularity in the U.S.as a treatment for pain, anxiety and drug dependence.
But Gottlieb's statement shows the government is still anxious about kratom, which people often use to treat conditions without seeing a doctor. "The FDA is devoted to expanding the development and use of medical therapy to assist in the treatment of opioid use disorder", said FDA Commissioner Dr. Scott Gottlieb in a statement.
"At a time when we have hit a critical point in the opioid epidemic, the increasing use of kratom as an alternative or adjunct to opioid use is extremely concerning".
Gottlieb acknowledged that some kratom users are after its euphoric effects, adding that allowing the legal use of the herb can only worsen the growing opioid crisis.
The Food and Drug Administration has issued a public health warning about kratom, an herbal supplement used by some to treat chronic pain, help with opioid withdrawals, and is used recreationally. But it has effects similar to opioids, such as codeine and morphine, and can lead to abuse, addiction, and death. Kratom may cause seizures, liver damage and withdrawal symptoms.
There are no FDA-approved therapeutic uses of kratom.
The health risks associated with kratom have also been clearly established as seen with a 10-fold increase (from 2010 to 2015) in calls to USA poison control centers regarding its use. At MedShadow, she reports on new findings and research on the side effects of prescription drugs. Additionally, the FDA is aware of reports of 26 deaths associated with the use of kratom-containing products, and that there have been reports of kratom being laced with other opioids like hydrocodone. The FDA says that review is underway.
The FDA has taken action against companies that use this substance in dietary supplements and has seized products.
Kratom is a controlled substance in 16 countries, including Thailand, Malaysia, Australia, Sweden, and Germany.
"While we remain open to the potential medicinal uses of kratom, those uses must be backed by sound-science and weighted appropriately against the potential for abuse", he wrote. "They must be put through a proper evaluative process that involves the DEA and the FDA". But the DEA almost made kratom a Schedule 1 drug, the same as heroin and marijuana, last year, and the FDA is now trying to stop shipments of kratom from entering the USA while it works on increasing regulatory oversight. Kratom, which has been banned in 16 countries and 5 U.S. states, has been labeled "unapproved" by the agency.