FDA and Kratom
The U.S. Food and Drug Administration is warning consumers not to use Mitragyna speciosa, commonly known as kratom, a plant which grows naturally in Thailand, Malaysia, Indonesia, and Papua New Guinea. FDA is concerned that kratom, which affects the same opioid brain receptors as morphine, appears to have properties that expose users to the risks of addiction, abuse, and dependence.
There are no FDA-approved uses for kratom, and the agency has received concerning reports about the safety of kratom. FDA is actively evaluating all available scientific information on this issue and continues to warn consumers not to use any products labeled as containing the botanical substance kratom or its psychoactive compounds, mitragynine and 7-hydroxymitragynine. FDA encourages more research to better understand kratom’s safety profile, including the use of kratom combined with other drugs.
Since identifying kratom on an import alert for unapproved drugs in 2012 and on a second import alert in February 2014 regarding kratom-containing dietary supplements and bulk dietary ingredients, FDA has taken a number of additional actions, including:
- In September 2014, U.S. Marshals, at the FDA’s request, seized more than 25,000 pounds of raw kratom material worth more than $5 million from Rosefield Management, Inc. in Van Nuys, California.
- In January 2016, U.S. Marshals, at the FDA’s request, seized nearly 90,000 bottles of dietary supplements labeled as containing kratom and worth more than $400,000. The product, manufactured for and held by Dordoniz Natural Products LLC, located in South Beloit, Illinois, is marketed under the brand name RelaKzpro.
- In August 2016, U.S. Marshals, at the FDA’s request, seized more than 100 cases of products labeled as containing kratom and worth more than $150,000. The products are distributed by Nature Therapeutics LLC, which does business as Kratom Therapy and is located in Grover Beach, California. The seized products are marketed under the brand name Kratom Therapy.
While FDA evaluates the available safety information about the effects of kratom, the agency encourages health care professionals and consumers to report any adverse reactions to the FDA’s MedWatch program:
- Complete and submit the report online: MedWatch Voluntary Reporting Form
- Download and complete the form, then submit it via fax at 1-800-FDA-0178
- FDA announces seizure of over 25,000 dietary products containing kratom
- FDA Announces Seizure of Adulterated Dietary Supplements Containing Kratom
- FDA issues warnings to companies selling illegal, unapproved kratom drug products marketed for opioid cessation, pain treatment and other medical uses
- FDA releases test results identifying dangerous levels of heavy metals in certain kratom products
- Statement from FDA Commissioner Scott Gottlieb, M.D., on new warning letters FDA is issuing to companies marketing kratom with unproven medical claims; and the agency’s ongoing concerns about kratom
- Statement from FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner for Foods and Veterinary Medicine Stephen Ostroff, M.D., on the ongoing risk of salmonella in kratom products
- FDA warns companies selling illegal, unapproved kratom products marketed for opioid cessation, pain treatment and other medical uses
- FDA orders mandatory recall for kratom products due to risk of salmonella
- FDA objects to kratom compound intended for use as an alternative to prescription opioids and promoted with unproven claims to treat addiction
- FDA Letter to Industrial Chemicals LLC and INI Botanicals Regarding Mitrasafe (mitragynine extract)
- FDA oversees destruction and recall of kratom products; and reiterates its concerns on risks associated with this opioid
- FDA Investigates Multistate Outbreak of Salmonella Infections Linked to Products Reported to Contain Kratom
- Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s scientific evidence on the presence of opioid compounds in kratom, underscoring its potential for abuse
- Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA advisory about deadly risks associated with kratom
- Remarks by Dr. Gottlieb at FDA’s Office of Criminal Investigations Meeting
- CFSAN Adverse Event Reporting System: Kratom Deaths (December 1, 2017) (PDF - 1.9MB)
- FDA Adverse Event Reporting System: Kratom Deaths (February 6, 2018) (PDF - 37MB)