In the United States, there are no FDA-approved uses for kratom, which grows naturally in Southeast Asia. Users have opposed efforts to regulate the plant, saying it could be a safer alternative to opioid pain pills. "Before it can be legally marketed for therapeutic uses in the US, kratom's risks and benefits must be evaluated as part of the regulatory process for drugs that Congress has entrusted the FDA with".
Some patients with opioid addiction are using kratom to treat their addiction.
"FDA must use its authority to protect the public from addictive substances like kratom, both as part of our commitment to stemming the opioid epidemic and preventing another from taking hold".
Evidence suggests that kratom has similar effects to narcotics like opioids, and, according to Gottleib's statement, it has similar risks of abuse, addiction, and in some cases death, too.
The scientific research about kratom and its potential medical uses are very limited, but evidence of its risks are clear.
A year ago the Drug Enforcement Administration planned to make kratom a Schedule I drug, a category that includes marijuana and LSD, but decided against it after an outcry of opposition.
The FDA said it is aware of 36 deaths involving products made with kratom and hundreds of calls to poison control centers.
Aside from being marketed online and in largely unregulated supplements as a concentration booster and workout enhancer, kratom is being advertised as a replacement for opioid painkillers. Because it produces symptoms, such as euphoria, similar to opiates, it is also used recreationally.
"If they find people here who are opening the gates to these drugs, there may be opportunities for the FDA to investigate at a high level", former principal deputy FDA commissioner under the Obama administration, Joshua Sharfstein, told the news site.
The herb is banned in several states, such as Indiana, Tennessee, Alabama, Arkansas and Wisconsin.
Gottlieb said that the drug should be studied before people take it for any reason. Across the U.S., several reports of deaths and addiction led the Drug Enforcement Administration to place kratom on its list of "drugs and chemicals of concern". The agency has already detained hundreds of packages at worldwide mail facilities.
"While we remain open to the potential medicinal uses of kratom, those uses must be backed by sound science and weighed appropriately against the potential for abuse", Gottlieb added.
Whether kratom will eventually be banned, however, depends on the Drug Enforcement Administration.