FDA Warns More Kratom Makers Over Illegal Sales, False Claims

Megan Brooks

Disclosures

June 25, 2019

The US Food and Drug Administration (FDA) has sent warning letters to two more companies — Cali Botanicals of Folsom, California, and Kratom NC of Wilmington, North Carolina — for illegally selling unapproved kratom products, which the companies claim can treat opioid addiction, withdrawal, and a host of other problems including depression, anxiety, and cancer.

It is the latest push by the FDA to crackdown on "unscrupulous vendors" of unapproved products containing kratom. In March 2018, the agency warned Front Range Kratom of Aurora, Colorado; Kratom Spot of Irvine, California; and Revibe Inc of Kansas City, Missouri, for illegally selling kratom products, as reported by Medscape Medical News.

"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," Acting FDA Commissioner Ned Sharpless, MD, said in a news release.

The FDA has also found high levels of heavy metals in kratom products.  

Yet despite FDA warnings, "companies continue to sell this dangerous product and make deceptive medical claims that are not backed by science or any reliable scientific evidence," said Sharpless.

"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," he added.

There are no FDA-approved uses for kratom and the agency has advised against using kratom or its psychoactive compounds mitragynine and 7-hydroxymitragynine in any form and from any manufacturer.

According to the FDA, the companies who received warning letters use websites and social media to illegally market kratom products, making unproven claims about the ability of the kratom drug products they distribute to cure, treat, or prevent disease. False claims include:

  • "Kratom acts as a μ-opioid receptor-like morphine."

  • "In fact many people use kratom to overcome opiate addiction."

  • "Of course, people who are using kratom to overcome a pre-existing opiate addiction may need to use kratom daily to avoid opiate withdrawal."

  • "Usage: It is for the management of chronic pain, as well as recreationally."

  • "Kratom is frequently used as a natural alternative to treat depression, anxiety, addiction, diabetes, chronic pain and fatigue. Kratom has been reported to have taken the place of brand name drugs like hydrocodone or oxycodone for individuals, all the way to weaning people off of heroin."

  • "Some researchers have even claimed that kratom can protect you against cancer!"

  • "Kratom is used for energy, to increase attention/focus, to relax, and also to treat pain and addiction. Here is just some of what our customers have used kratom to treat ... chronic pain, migraines, opiate addiction, ADHD/ADD, anxiety, depression, arthritis, insomnia and much more!"

"Health fraud scams like these can pose serious health risks. These products have not been demonstrated to be safe or effective for any use and may keep some patients from seeking appropriate, FDA-approved therapies," the FDA said.

The FDA has requested responses from both companies within 15 working days.

Healthcare professionals and consumers are encouraged to report any adverse events related to these products to the FDA's MedWatch Adverse Event Reporting program.

For more Medscape Psychiatry news, join us on Facebook and Twitter.

Comments

3090D553-9492-4563-8681-AD288FA52ACE
Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.
Post as:

processing....