NEW YORK (PIX11) — A popular herbal supplement that has been touted as a miracle cure for pain and other things that ail you, continues to raise concerns among government regulators.   

Sold legally as Kratom, it is considered a substance of concern by the FDA. 

It is estimated that some 15 million Americans have used kratom. While some use it to treat a variety of medical conditions, health officials claim it mirrors the effects of opioid drugs and overdoses have resulted in serious side effects and several deaths. 

Kratom is an herbal extract from the leaves of an evergreen tree in Southeast Asia. It is processed and sold in capsules, liquid, and powder form. It is promoted to boost energy, treat pain and anxiety, provide a high, and even relieve symptoms of withdrawal from opioids.  

The American Kratom Association claims sales total more than $1 billion dollars a year. 

The Associations Mac Haddow insists, “With responsible use, kratom is safe like anything else.” However, that claim is not substantiated by the FDA which maintains Kratom is not safe. 

In a statement to PIX11 News, the FDA declares it “will continue to warn the public against the use of kratom, whether for medical or non-medical purposes.” 
Dr. Justin Kei, a psychiatrist at Hackensack University Medical Center worries people can become physiologically dependent on it. Side effects range from mild nausea to constipation, but there have been reports of severe effects such as liver problems, seizures, and coma.  

There have been a small number of deaths. 

According to the FDA, Kratom appears to have “properties that expose users to the risks of drug addiction, abuse, and dependence.”  some users have found Kratom as an alternative to opioids. 

The Kratom Association Mac Haddow disagrees. “It’s not a gateway to opioid use, it is not a replacement for opioid use. It is something that helps people get off opioid addictions,” he stated. 
The Long Island Council of Alcoholism and Drug Dependence feels this is not a healthy alternative to opioids. Executive Director Steve Chassman, contends, “There are FDA-approved medications to help with the treatment of an opioid disorder. Kratom is not listed. Kratom is said to create anxiety, but its proponents claim it can also eliminate it.  

“In higher doses, it does relieve anxiety and symptoms of depression,” according to Haddow,  

However, Chassman disagrees “That is not true, people looking for chemical and herbal supplements we know want best practice for depression and anxiety. There are regulated medications.  

Kratom is available online and at smoke shops, and buyers are advised to be cautious because without FDA oversight some worry products could be contaminated. 

“It can be contaminants such as heavy metals, bacteria, and in some cases illicit opioids,” Dr. Kei noted. 

However, Chassman declares, “We strongly deter individuals with opioid use disorder from using this product.”

Kratom is still unregulated at the federal level, but five states have bans on the substance. T 

The FDA is holding off on such a move, telling PIX11 News the agency will continue to monitor data to better understand Kraton, and will continue to warn against using it.