FDA Issues Warnings To Two Kratom Companies Over False Claims

By Lindsey Weedston 07/01/19

This is not the first time the FDA has had to issue warnings to companies about their sale and marketing of kratom.


The U.S. Food and Drug Administration is cracking down on companies that sell the herbal supplement, kratom, with claims that it treats conditions it has not been proven to treat, including opioid addiction and withdrawal.

In an official news release, the FDA named Cali Botanicals of Folsom, California, and Kratom NC of Wilmington, North Carolina, as the companies it warned “for illegally selling unapproved, misbranded kratom-containing drug products with unproven claims about their ability to treat or cure opioid addiction and withdrawal symptoms.”

According to the National Institute on Drug Abuse (NIDA), kratom is the name of a tropical tree found in Southeast Asia. The leaves of the kratom tree contain a substance that has “psychotropic (mind-altering) effects” and is not currently illegal in the U.S.

However, the FDA notes that kratom “is not legally marketed in the United States as a drug or dietary supplement” and claims that the substance may have “opioid properties” that could be addictive.

Government Doubles Down On Warnings

This is not the first time the FDA has had to issue warnings to companies about their sale and marketing of kratom, and it sounds like they’re fed up with being ignored.

“We have issued numerous warnings about the serious risks associated with the use of kratom, including warnings about the contamination of kratom products with high rates of salmonella that put people using kratom products at risk, and resulted in numerous illnesses and recalls,” says Acting FDA Commissioner Ned Sharpless, MD. “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.”

It’s not uncommon for herbal supplements and other products to be sold with false claims of treating addiction and withdrawal to opioids as the epidemic rages on in the U.S. The FDA is concerned that companies like Cali Botanicals and Kratom NC are taking advantage of desperate people, especially as there continues to be a lack of addiction treatment resources in many parts of the U.S.

A study published in early 2019 found that only 6% of treatment centers carried all of the three approved medications for treating opioid addiction.

The FDA has given the named companies 15 working days to respond, and further warned that “failure to correct violations may result in law enforcement action such as seizure or injunction.”

“Selling these unapproved products with claims that they can treat opioid addiction and withdrawal and other serious medical conditions is a violation of the Federal Food, Drug, and Cosmetic Act,” the agency stated.

Please read our comment policy. - The Fix

Lindsey Weedston is a Seattle area writer focused on mental health and addiction, politics, human rights, and various social issues. Her work has appeared in The Establishment, Ravishly, ThinkProgress, Little Things, Yes! Magazine, and others. You can find her daily writings at NotSorryFeminism.com. Twitter: https://twitter.com/LindseyWeedston