·  Legal News, Analysis, & Commentary

Recalls & Safety Alerts

Kratom is Dangerous and Addictive, FDA Says

— July 10, 2019

Kratom is unsafe and can lead to addiction, the Food and Drug Administration warns.

The Food and Drug Administration (FDA) recently issued warnings to two businesses it claims are illegally marketing products that contain an herbal ingredient – kratom – as an effective treatment or cure for opioid addiction and withdrawal.  The agency warns these claims are “unproven” and the drug can be just as addictive.

Kratom, which is an herbal extract that naturally grows outside of the United States.  It is native to the tropical areas of Southeast Asia and is not approved for use by the FDA.  The drug is derived from evergreen trees in the coffee family and can act as a stimulant at low doses.  It can also reduce pain and cause euphoria when ingested in higher doses.  It has been used as a medication for treatment of many conditions in other areas of the world for centuries.

There have been some claims circulating that, because of these effects, kratom can be used to offset or reduce opioid withdrawal symptoms and can be used as an opioid alternative to treat pain.  However, the FDA says the drug affects the same brain receptors as morphine and can, itself, be addictive.

Kratom is Dangerous and Addictive, FDA Says
Photo by Marvin Esteve on Unsplash

The National Institute on Drug Abuse warns, “Kratom can cause effects similar to both opioids and stimulants.  Two compounds in kratom leaves, mitragynine and 7-α-hydroxymitragynine, interact with opioid receptors in the brain, producing sedation, pleasure, and decreased pain, especially when users consume large amounts of the plant.  Mitragynine also interacts with other receptor systems in the brain to produce stimulant effects.  When kratom is taken in small amounts, users report increased energy, sociability, and alertness instead of sedation.  However, kratom can also cause uncomfortable and sometimes dangerous side effects.”  Essentially, it can be just as addictive as opioids and users are simply trading one deadly addiction for another.

Well-known, negative side-effects associated with kratom include nausea, dizziness, drowsiness, breathing suppression, coma and even death.  The FDA has also linked kratom-based products with a multi-state salmonella outbreak.  The latest warning urges consumers not to use products made KratomNC, because of microorganisms found in the products which can lead to illness.  Last month, the FDA told KratomNC it should recall all of its inventory, but it has yet to comply.

“Despite our warnings, companies continue to sell this dangerous product and make deceptive medical claims that are not backed by science or any reliable scientific evidence,” acting FDA Commissioner Dr. Ned Sharpless said.

By marketing kratom as a potential treatment for opioid abuse, the FDA says, “California-based Cali Botanicals and North Carolina-based KratomNC could prevent people who are addicted to opioids from seeking proper care.”  Sharpless added, “As we work to combat the opioid crisis, we cannot allow unscrupulous vendors to take advantage of consumers by selling products with unsubstantiated claims that they can treat opioid addiction or alleviate other medical conditions.

“Reliance on products that don’t work put those who abuse opioids at greater risk of addiction,” the FDA said, rather than curtail it.  Cali Botanicals and KratomNC also said their kratom-based products could treat anxiety, depression, arthritis, insomnia, cancer and a multitude of other ailments.

Cali Botanicals removed much of the contact on its website related to kratom’s treatment of opioid addiction following the agency’s warning.  However, KratomNC is still marketing its drug for this purpose.

Editor’s note: While we appreciate reader comments, particularly those opening meaningful discussion, comments on this post have become just shy of abusive. Therefore, we regret that the comments are now closed.


National Institute on Drug Abuse: Kratom

FDA issues warnings to companies that claim an herbal drug can cure opioid addiction

Join the conversation!