Specifically, Gottlieb noted, poison control centers received ten times more calls about kratom in 2015 than they did in 2010.
Leaves from the kratom tree, which grows in Southeast Asia and is distantly related to coffee plants, have been touted as a potential treatment for opioid withdrawal, among other conditions. According to Bloomberg Businessweek, the American Kratom Association-yes, it exists-has lobbied to have kratom recognized as "a safe alternative to legal and illegal opioids".
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 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. Because the product is not regulated and is often bought online, it can sometimes be laced with other substances. "Patients addicted to opioids are using kratom without dependable instructions for use and more importantly, without consultation with a licensed health care provider about the product's dangers, potential side effects or iterations with other drugs". The advisory states, "To date, no marketer has sought to properly develop a drug that includes kratom".
Additionally, the FDA said it has identified kratom products on two import alerts, and is working to prevent shipments of the substance from entering the US, as well as detained hundreds of shipments at worldwide mail facilities.
The FDA has taken action against companies that use this substance in dietary supplements and has seized products. Officials are working to prevent shipments from entering the USA, and government officials have seized hundreds of shipments at global mail facilities. "We've used our authority to conduct seizures and to oversee the voluntary destruction of kratom products".
Kratom is a controlled substance in 16 countries, including Thailand, Malaysia, Australia, Sweden, and Germany.
Later in 2016, the DEA asked that the FDA provide a scientific and medical evaluation of the drug. Kratom is also banned in Alabama, Arkansas, Indiana, Tennessee, and Wisconsin.
"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.