"And it's an opioid that's associated with novel risks because of the variability in how it's being formulated, sold, and used recreationally and by those who are seeking to self-medicate for pain or who use kratom to treat opioid withdrawal symptoms".
Kratom grows naturally in the Southeast Asian countries of Thailand, Malaysia, Indonesia and Papua New Guinea. Given these effects, there is an "urgent" need to study the abuse potential of kratom, according to the paper said.
In November, the FDA issued a warning urging consumers to not use kratom or any compounds found in the plant.
Depending on who you ask, kratom is either a wonder drug that can safely treat opioid addiction and pain relief, or a significant threat to public health. Based on this definition, compounds in kratom are opioids, because they do act on opioid receptors, said Wes Hunter, director of pharmacy at UCHealth Yampa Valley Medical Center in Steamboat Springs, Colorado.
The FDA's claims also have been questioned by kratom researcher Scott Hemby, chair of the department of basic pharmaceutical sciences at High Point University in North Carolina.
Doctors say a major concern about kratom is that people do not understand how much to take, which makes accidental overdoses far too common.
In the FDA statement, Gottlieb said that "cases of mixing kratom, other opioids, and other types of medication is extremely troubling".
Psychonaught Wikimedia Commons Kratom pills
According to the Centers for Disease Control and Prevention, an opioid is a natural or synthetic chemical that interacts with opioid receptors. Last year, the agency reported that 36 deaths had been associated with its use, and in yesterday's announcement, Gottlieb updated the figure to 44 deaths.
"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 interactions with other drugs", Gottlieb said in a previous statement in November.
Capsules of the herbal supplement Kratom are seen in Miami, Florida, on May 10, 2016.
Nevertheless, the drug has continued to pop up in supplements, despite an FDA health alert about kratom-containing dietary supplements and bulk dietary ingredients.
The FDA analyzed the chemical structures of the 25 most prevalent compounds in kratom. In January 2016, U.S. Marshals, at the FDA's request, seized almost 90,000 bottles of dietary supplements labeled as containing kratom and worth more than $400,000, and in August 2016, they seized more than 100 cases of products labeled as containing kratom and worth more than $150,000.