On Sept. 11, the Food and Drug Administration (FDA) announced it sent warnings to two companies that sell kratom and claim it treats opioid use disorder. The false advertising is dangerous and can lead to overdoses due to patients not seeking the correct treatment, the FDA said. Kratom can also have similar effects to opioids. Because it is easily ordered over the internet, cases of abuse are popping up nationwide.
“Epidemics don’t occur overnight,” Scott Gottlieb, M.D., head of the agency, said in a Sept. 11 statement The agency has been tackling more traditional drug abuse—like that of heroin, fentanyl, or prescription pills—but says it will “remain vigilant and aggressive against trends that threaten to reverse our progress, or substances that have the potential to cause new epidemics of abuse.”
The agency says that at least 36 people have died while using kratom in some capacity, but it is unclear exactly how many deaths it has directly caused.
Health agencies are still studying kratom and its health effects. It is made primarily in southeast Asia and thanks to the internet has spread west. It is made from a tropical tree called Mitragyna speciosa and is used as an herbal alternative to treat withdrawal symptoms of addictive substances like opioids, alcohol, or caffeine; however there is no science to back that up, according to the National Institute on Drug Abuse.
There is no federal ban on kratom, but Alabama, Arkansas, Indiana, Tennessee, Vermont, Wisconsin, and the District of Columbia have outlawed it.
The companies, Chillin Mix Kratom and Mitra Distributing Inc., were dinged for marketing kratom products that falsely claimed the drug could treat opiate withdrawal as well as diarrhea, depression, diabetes, obesity, high blood pressure, stomach parasites, diverticulitis, anxiety, and alcoholism. The websites have until Sept. 25 to respond to the agency, which sent the letters on Sept. 4.
Read more in Gottleib’s statement, the NIH webpage on kratom, the FDA warning letter to Chillin Mix Kratom, and the FDA warning letter to Mitra Distributing.
Selected information in the "Pharmaceutical Science Update" is compiled from summaries and articles from Bloomberg BNA.