FDA Issues Warning Letters on Kratom Claims, the Most Recent Action in Kratom’s Troubled HistoryJuly 3, 2019
In late June, 2019, the U.S. Food and Drug Administration (FDA) sent warning letters to two companies involved in the marketing and distribution of kratom products. The FDA claims Cali Botanicals and Kratom NC are illegally selling kratom and making unsubstantiated medical claims about its benefits, including the ability to treat opioid addiction and manage withdrawal symptoms. Some of the other claims made by Cali Botanicals and Kratom NC include pain relief, treatment of depression and anxiety, cancer prevention, diabetes treatment, increased energy and focus, insomnia treatment, and treatment of arthritis.
Kratom is the common name for Mitragyna speciose, a plant commonly grown in areas of Southeast Asia. Kratom has many similar attributes to opioids and can cause addiction and myriad health problems in users, including the risk of death. According to FDA Commissioner Scott Gottlieb, M.D., “Kratom is not a safe, benign plant. Data continues to provide strong evidence that kratom compounds are opioids with potential for addiction and abuse.” The FDA has not approved kratom for any use.
Kratom has long been on the FDA’s radar, and these recent claims are especially troubling to the agency. Treating opioid addiction is a top priority at the FDA, and agency officials worry that individuals attempting to cure their addictions with kratom could instead exacerbate the addiction, being led away from legitimate treatments. In February of 2018, the FDA sent a warning letter to Mitrisafe for making similar claims about the use of kratom to treat opioid addiction, as well as making inaccurate claims about the company’s compliance with FDA requirements concerning kratom. Similar letters were issued in September of 2018 to Chillin Mix Kratom and Mitra Distributing.
Additionally, kratom has been the subject of other FDA actions. In early 2018, the agency began an investigation into the connection between kratom products and salmonella. Of the kratom samples tested, 52% tested positive for salmonella. The FDA requested the affected distributors of kratom issue voluntary recalls of the contaminated products. All but one distributor complied, resulting in the FDA issuing a mandatory recall of all kratom products from Triangle Pharmanaturals, LLC.
The FDA also tested kratom for any presence of heavy metals. In April of 2019, the agency released its findings, noting that lead and nickel were found in kratom in “significant levels.” Daily use of kratom could result in heavy metal poisoning, causing major health problems in the user.
Kratom continues to be shunned by the FDA. There is no known therapeutic benefit to the drug, and the FDA “strongly encourages” the public against consumption. Companies identifying medical benefits of kratom and representing compliance with FDA regulations or approval processes will continue to be sought out and disciplined by the agency.
FDA Orders Mandatory Recall for Kratom Products Due to Risk of Salmonella, https://www.fda.gov/news-events/press-announcements/fda-orders-mandatory-recall-kratom-products-due-risk-salmonella
FDA Issues Warnings to Companies Selling Illegal, Unapproved Kratom Drug Products Marketed for Opioid Cessation, Pain Treatment, and Other Medical Uses, https://www.fda.gov/news-events/press-announcements/fda-issues-warnings-companies-selling-illegal-unapproved-kratom-drug-products-marketed-opioid
Laboratory Analysis of Kratom Products for Heavy Metals, https://www.fda.gov/news-events/public-health-focus/laboratory-analysis-kratom-products-heavy-metals
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, https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-new-warning-letters-fda-issuing-companies-marketing
FDA In Brief: FDA Objects to Kratom Compound Intended for Use as an Alternative to Prescription Opioids and Promoted with Unproven Claims to Treat Addiction, https://www.fda.gov/news-events/fda-brief/fda-brief-fda-objects-kratom-compound-intended-use-alternative-prescription-opioids-and-promoted