The herb kratom seemed to be suffering an identity crisis that asked: Is this botanical substance a dietary supplement — or is it an addictive drug? Now that question has been answered.
On Feb. 6, 2018, Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., said in a statement that "as the scientific data and adverse event reports have clearly revealed, compounds in kratom make it so it isn’t just a plant — it’s an opioid."
As HealthCentral reported here in November 2017, it had been associated with at least 36 deaths from kratom-containing products, according to Adriane Fugh-Berman, M.D., a professor in the department of pharmacology and physiology at Georgetown University Medical Center. She spoke with HealthCentral via telephone then.
FDA said on Feb. 6, 2018 that the reported death toll was at 44, at the time of the statement.
“Kratom is addictive,” she says. “This is a recreational drug currently misclassified as a dietary supplement.”
Consumers use it on their own to treat depression, anxiety, and pain. Kratom is also known to produce euphoria or a “high.” It does reduce symptoms of opioid withdrawal and is often used for that purpose.
“Kratom activates opioid receptors, so if it looks like an opioid and acts like an opioid, it probably is an opioid,” says Dr. Fugh-Berman.
FDA further clarified on Feb. 6, 2018 that kratom shouldn't be used "to treat medical conditions, nor should it be used as an alternative to prescription opioids. There is no evidence to indicate that kratom is safe or effective for any medical use."
In its latest updated statement, FDA says it is concerned about kratom's potential for abuse, addiction, and serious health consequences, including death.
The Drug Enforcement Administration (DEA) originally attempted to regulate kratom as a drug in August 2016, Dr. Fugh-Berman says, but was opposed by the American Kratom Association and other supporters.
“It’s not clear who funds the American Kratom Association but it does not have the hallmarks of a grassroots group,” says Dr. Fugh-Berman. “It seems to be promoting kratom in a way that’s clearly unethical. Companies are making big money selling kratom.”
The group’s website proclaims: “Never give up, never surrender” — which can be left to the reader’s interpretation.
Dr. Fugh-Berman warns that: “This is not a safe drug. People should get professional, medication-assisted treatment for opioid addiction through conventional means.”
Echoing that sentiment, Dr. Gottlieb says: "There are safe and effective, FDA-approved medical therapies available for the treatment of opioid addiction. Combined with psychosocial support, these treatments are effective."
Kratom is grown in Southeast Asia. “Remember that just because it comes from a plant doesn’t mean it’s not a recreational drug — think about marijuana and heroin,” she says.
Nomenclature for the lay person can sometimes be confusing when it comes to referring to a product as a supplement or a drug. An example of how this works can be seen with the popular supplement, St. John’s wort.
“It’s OK to say that ‘It improves emotional well-being,’ but not that 'It treats depression,’” says Dr. Fugh-Berman.
Protecting public health
The Columbus Dispatch recently reported that a regular female customer buys kratom in a local shop to alleviate her chronic spinal cord pain. She’s been on pain medication for 20 years and finally can reduce her pain medication, she says. The enthusiastic user also reports she’s more alert.
Kratom users can also freely purchase the product on the internet, which worries Dr. Fugh-Berman. She believes consumers don’t fully understand the risks they are taking — or what they are taking.
Meanwhile, the FDA has said U.S. poison control centers continue to receive hundreds of calls about kratom, and that it can cause serious side effects including seizures, liver damage, and withdrawal symptoms. It also may have undesirable interactions with other drugs.
What users report on online forums and share amongst each other is one thing, but proving scientific claims through a rigorous testing process, and bringing kratom to market is quite another. “To date, no marketer has sought to properly develop a drug that includes kratom,” according to the FDA.
The agency has detained kratom shipments, conducted seizures, and destroyed kratom products. The herb is a controlled substance in 16 countries, and is banned in at least five states.