Is kratom approved by the FDA?

Mitragyna speciosa, commonly known as kratom, is a plant that grows naturally in Thailand, Malaysia, Indonesia and Papua New Guinea. The FDA is concerned that kratom affects opioid receptors in the brain, such as morphine, and may have properties that put users at risk for addiction, abuse and dependence.

The FDA and kratom

No uses of kratom have been approved by the FDA and the agency has received reports regarding the safety of kratom. The FDA is carefully reviewing the published information on this topic and recommends that users refrain from using substances bearing any mention of kratom or mitragynine and 7-hydroxymitragynine. The FDA encourages further research to better understand the safety profile of kratom, including the use of kratom in combination with other drugs. For more information, see:

Import alert

Since the identification of kratom in an import alert for unapproved drugs in 2012 and a second import alert in February 2014 regarding dietary supplements containing kratom and bulk dietary ingredients, the FDA has taken a number of additional actions, including:
In September 2014, the US Marshals, at the request of the FDA, seized External Link Disclaimer more than 25,000 pounds of kratom raw material worth more than $5 million from Rosefield Management, Inc. in Van Nuys, California. In January 2016, the US Marshals, at the request of the FDA, seized nearly 90,000 bottles of dietary supplements labelled as containing kratom and valued at over $400,000. The US Marshals confiscated in August 2016, at the request of the FDA, about 100 boxes of kratom worth over $150,000. The products are distributed by Nature Therapeutics LLC, which does business as Kratom Therapy and is located in Grover Beach, California.