FDA Warns Over Misleading Opioid Treatments Claims in Kratom Marketing

This week, the United States Food and Drug Administration issued a warning to at least two businesses who, they claim, have illegally made “unproven” claims to market their products as a potential cure or treatment for opioid addiction and withdrawal.  What is most concerning about this case, is that these products contain the herbal drug known as kratom. 

Again, kratom is an herbal extract that is known to act as a stimulant at low doses.  At higher doses, kratom has been found to reduce pain with the potential, even, to cause euphoria in much higher quantities and concentrations.  Some advocates say the herbal extract could have a use as a means to appease symptoms of opioid withdrawal, with the possibility that it might provide an alternative to pain medications. 

Of course, kratom has not been approved by the FDA. The FDA says the drug affects the same brain receptors as opioid drugs like morphine and that means the drug has a high potential for both abuse and addiction. 

Now, kratom (or its derivative herb) is not native to the United States.  As such, the FDA has been able to issue a handful of safety warnings associated with using the herb in a way that could have helped to curb distribution.  The FDA warnings advise that kratom has been associated with various negative side effects including dizziness and drowsiness as well as breathing suppression which could eventually lead to coma and even death. 

The drug has also been linked with a multi-state salmonella outbreak. 

All this in mind, the FDA is also advising consumers not to use any products made by one company, specifically. This company is KratomNC and, as the FDA advises, they have determined these products are home to various microorganisms that could also cause illness. As a matter of fact, the agency has even recommended the company should recall of their products; KratomNC has yet to cooperate. 

As such, acting FDA Commissioner Dr. Ned Sharpless released a statement, on Tuesday, saying, “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.”

Sharpless goes on to advise that the FDA is working very hard to combat the opioid crisis and, in so doing, “cannot allow unscrupulous vendors to take advantage of consumers” through the sales of products that make such unsubstantiated claims like being a treatment for opioid addiction.