Officials with the FDA have issued warning letters to 2 marketers and distributors of kratom products: Cali Botanicals, Folsom, California; and Kratom NC, Wilmington, North Carolina. The letters request actions to correct violations cited by the agency.

The letters were prompted by the illegal selling of unapproved, misbranded kratom-containing drug products with unproven claims about their ability to treat or cure opioid addiction and withdrawal symptoms, according to the FDA. These companies also make claims about treating pain, and other medical conditions, such as depression, anxiety and cancer.

A recent CDC study linked kratom to drug overdose deaths. The FDA is warning consumers not to use any products labeled as containing the botanical substance kratom or its psychoactive compounds, mitragynine and 7-hydroxymitragynine.

According to Acting FDA Commissioner Ned Sharpless, MD, the agency has issued numerous warnings to about serious risks associated with the use of kratom. These actions have included warnings about contamination of kratom products with high rates of Salmonella that have caused illnesses and prompted recalls.

“As part of our efforts to assess kratom for contamination in the products tested, we also found high levels of heavy metals in kratom products. 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,” said Acting FDA Commissioner Ned Sharpless, MD, in a prepared statement. “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.”

In addition to these letter, the FDA is continuing to warn consumers not to use Mitragyna speciosa, commonly known as kratom. This plant naturally grows in Thailand, Malaysia, Indonesia and Papua New Guinea. Kratom is not legally marketed in the United States as a drug or dietary supplement, and data suggest that certain substances in kratom have opioid 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 reports about the safety of kratom. The agency is encouraging more research to better understand kratom’s safety profile, including the use of kratom combined with other drugs.

The FDA has requested that Cali Botanicals and Kratom NC correct the violations outlined in their respective letters within 15 working days and to notify the agency of specific steps taken to alleviate the issues.


Reference

FDA issues warnings to companies selling illegal, unapproved kratom drug products marketed for opioid cessation, pain treatment and other medical uses [news release]. Silver Spring, MD; June 25, 2019: FDA website. https://www.fda.gov/news-events/press-announcements/fda-issues-warnings-companies-selling-illegal-unapproved-kratom-drug-products-marketed-opioid. Accessed June 25, 2019.