"Alternatively, if proponents are right and kratom can be used to help treat opioid addiction, patients deserve to have clear, reliable evidence of these 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 it's now taken as a recreational drug, with its users saying it treats anxiety, depression and opioid withdrawal. "At a time when we have hit a critical point in the opioid epidemic", the FDA statement said, "the increasing use of kratom as an alternative or adjunct to opioid use is extremely concerning".
Still, Jessica Bardoulas of the American Osteopathic Association said many "were dismayed to learn of the DEA's plan to classify the plan as a Schedule 1 substance. despite 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.
Calls to USA poison control centers about kratom, which is made from a plant that grows in Asia, jumped tenfold from 2010 to 2015, according to the FDA.
For now, kratom is widely available online and in some stores.
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. "Patients addicted to opioids are using kratom without dependable instructions for use and more importantly, without consultation with a licensed healthcare provider about the product's dangers, potential side effects or interactions with other drugs".
Rather, he said, evidence shows that the herb has similar effects to narcotics like opioids, "and carries similar risks of abuse, addiction and, in some cases, death".
Kratom has grown in popularity in the USA, with circulating claims of it being a safe treatment with a range of healing properties. 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.
The group has said categorizing kratom as an illegal substance would stymie medical research into its potential therapeutic uses.
"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". A 2014 report found that more than two-thirds of the supplements purchased six months after being recalled still contained banned drugs. The DEA will review the FDA's assessment and make a determination, says DEA spokesperson Wade Sparks.