FDA warns three more kratom marketers over opioid treatment, other disease claims

The US Food and Drug Administration sent warning letters​​ to Front Range Kratom of Aurora, CO; Kratom Spot of Irvine, CA and Revibe, Inc., of Kansas City, MO for selling kratom products that FDA alleged are in fact unapproved drug products making unproven claims about their ability to help in the treatment of opioid addiction and withdrawal.

FDA alleges the companies have also made claims about treating pain, as well as other medical conditions such as lowering blood pressure, treating cancer, and reducing neuron damage caused by strokes.

Gottlieb: Drug approval process is where kratom belongs

“Despite our warnings that no kratom product is safe, we continue to find companies selling kratom and doing so with deceptive medical claims for which there’s no reliable scientific proof to support their use,”​ said FDA Commissioner Scott Gottlieb, MD.

“Far from treating addiction, we’ve determined that kratom is an opioid analogue that may actually contribute to the opioid epidemic and puts patients at risk of serious side effects. If people believe that the active ingredients in kratom have drug-like effects that can treat pain or addiction, then the FDA is open to reviewing that data under our new drug approval process,”​ he said.

“In the meantime, I promised earlier this year that the FDA would step up our actions against unapproved and unsafe products that are being deceptively marketed for the treatment of opioid addiction and withdrawal symptoms,” ​Gottlieb continued.

Illegal claims

Among the illegal drug claims the companies were making, FDA said it found these:

• “Along with helping drug addiction, the health benefits of kratom leaves include their ability to lower blood pressure, relieve pain, boost metabolism, increase sexual energy, improve the immune system, prevent diabetes, ease anxiety, eliminate stress, and induce healthy sleep.”​
• “The mood elevation qualities of kratom reduces opiate withdrawal effects.”​
• “Kratom, like any other pain killer, relieves temporary or even chronic pain.”​
• “This plant can relieve headaches, vascular pain, arthritic pain, muscle pain among others.”​
• “Kratom can be used as a remedy for stroke-related ailments and condition as it is a powerful antioxidant that works to reduce neuron damage.”​
• “It can...help in lowering blood pressure.”​
• “Kratom is also said to have elements that control blood sugar levels in the body for diabetic patients.”​
• “It is said, that kratom is very effective against cancer.”​

Checkered regulatory history

While kratom (Mitragyna speciosa​) has a long history of use in Southeast Asia, it has had a checkered regulatory history in the United States.

Citing safety concerns, in 2014 FDA slapped an import ban on kratom products. At that time FDA also said that if companies wanted to bring it to market as a dietary ingredient, they should file a New Dietary Ingredient Notification, because there was no evidence that the botanical was on the market prior to the DSHEA grandfather date of Oct. 15, 1994.

Even so, the products have continued to find their way into the market. 

In 2016, stakeholders in the herbal dietary supplement sphere successfully argued against the federal Drug Enforcement Administration’s attempt to put two active constituents of kratom on its schedule one list of controlled substances​​. The argument, which was supported by industry groups as well as lawmakers, was that the emergency procedure was not called for by the facts of the case and that it was a violation of the doctrine of due process.

Advocacy group

Proponents of the herb have come together to form an industry association, the American Kratom Association, and an advocacy group called the Botanical Education Alliance, which was previously known as Botanical Legal Defense.

The group has worked to advocate for the legality of the kratom trade and the use of the herb at the state level in a strategy that is in some ways reminiscent of what advocates pursued with cannabis. 

AKA’s effectiveness may have been impaired in recent months when questions were raised about financial impropriety connected to founder and board chair Susan Ash. In a post this week on the AKA Facebook site, Ash said those concerns have been addressed​​ but that she would be associated with the organization going forward only in the role of advisor and board chair emeritus.