By Pat Anson, PNN Editor

The Food and Drug Administration and Federal Trade Commission have sent warning letters to four kratom vendors saying they are in violation of federal law for selling “unapproved new drugs.” The letters to Herbsen Botanicals, Klarity Kratom, Kratom Exchange and YoKratom primarily focus on their marketing of kratom as a treatment for opioid addiction.

Kratom is a dietary supplement that comes from the leaves of the mitragyna speciosa tree in southeast Asia, where it has been used for centuries as a natural stimulant and pain reliever. In recent years, millions of Americans have discovered kratom and use it to self-treat their pain, anxiety, depression and addiction. Kratom is sold legally in most U.S. states, but vendors can run into trouble if they claim it can be used to treat medical conditions.

“You market kratom products for the treatment or cure of opioid addiction and withdrawal symptoms. However, these products have not been determined by FDA to be safe and effective for these (or any other) uses,” the agencies said in their letter to Herbsen Botanicals. “Further, the unproven treatments could cause patients to forego or delay FDA-approved treatments for opioid addiction or withdrawal. The marketing and sale of unapproved opioid addiction treatment products is a potentially significant threat to the public health.”

The letter cites several blog posts on Herbsen’s website, which claim that kratom is a “common recommendation to manage opioid addiction” and “delivers similar effects” as morphine and codeine. Herbsen also has a lengthy disclaimer on its website saying such statements “are not intended to diagnose, treat, cure or prevent any disease or ailment.”

The FDA has tried for years -- unsuccessfully – to schedule kratom as a controlled substance, which would effectively ban its sale and use in the United States. Having failed to achieve that goal, the agency has resorted to occasional warning letters, import alerts and seizures of kratom.   

In a recently updated online fact sheet, the FDA said kratom’s effects on the brain are similar to morphine and that kratom has “properties that expose users to the risks of addiction, abuse, and dependence.”

‘Kratom Saved My Life’

Addiction treatment is one of the main reasons that people use kratom. In a large PNN survey of over 6,400 kratom users, about one in ten said they primarily used the plant to treat opioid addiction or alcoholism. Several said it was more effective than methadone or Suboxone in relieving withdrawal symptoms.

“Kratom saved my life. I tried every other type of treatment for drug addiction over the past 10 years,” one respondent wrote. “After 2 years of Suboxone, I stopped treatment & began using kratom. I've made more progress toward my ultimate goal of total sobriety in 2 years of self-administered kratom then 5+ years of suboxone & methadone treatment.”

“Due to 3 surgeries, I became hooked on Oxy and had to take Suboxone to get off it. The problem is Suboxone withdrawals were nearly as bad, so I used Kratom to cure that,” said another.

“Not only is this a wonderful alternative for people with chronic pain. but this also could greatly reduce our heroin epidemic crisis going on in our country. After years of being physically dependent on legally prescribed Suboxone, I was unsuccessful at my attempts to get off of them. Kratom made it possible, and I believe would help others trying to get off any opiates and live full and productive life,” another poster said.

In recent testimony before Congress, FDA commissioner Dr. Robert Califf warned that kratom was a harmful substance that has caused “real adverse events, real negative things that have happened to people.” Califf also said the agency may need new authority from Congress to regulate kratom and other supplements that are not “traditional drugs.”