The FDA's cautioning comes after the Drug Enforcement Administration's delay in listing kratom, a plant found in countries like Thailand and Malaysia, as a controlled substance. But it's now taken as a recreational drug, with its users saying it treats anxiety, depression and opioid withdrawal. Jessica Bardoulas of the American Osteopathic Association tells USA Today there's "anecdotal and scientific evidence indicating kratom could be an effective opioid alternative". After a public outcry, the DEA chose to postpone its decision, and asked the FDA to weigh in. "It's probably easier to "do it yourself" with kratom ordered over the internet than find - if it's available - and pay for FDA approved, doctor supervised treatment".
Since then, there have been reports of 36 deaths linked with the use of products containing kratom; it can cause serious side effects including seizures and liver damage, and can even trigger symptoms of withdrawal when use is stopped, according to the FDA.
The FDA said it is aware of 36 deaths involving products made with kratom and hundreds of calls to poison control centers. Others use kratom for its euphoric effects, or to wean addicts off opioids such as prescription painkillers or heroin, also without medical say-so. But it may be laced with other substances, such as opioids like hydrocodone, the FDA says. People who are taking the product to treat depression and opioid addiction may be putting themselves at risk, the agency says.
The regulator said there are now no approved therapeutic uses of kratom, which is linked to serious side effects such as seizures and liver damage. That way the product can be assessed for its safety and effectiveness.
So far, no marketer has tried "to properly develop a drug that includes kratom", Gottlieb said.
"I understand that there's a lot of interest in the possibility for kratom to be used as a potential therapy for a range of disorders", Gottlieb added.
The FDA said it is working to prevent shipments of kratom in the United States and has detained hundreds of these packages at global mail facilities. The agency has already detained hundreds of packages at global mail facilities. Across the United States, several reports of deaths and addiction led the Drug Enforcement Administration to place kratom on its list of "drugs and chemicals of concern".