The US Food and Drug Administration (FDA) has issued warnings to 3 companies selling kratom-containing products that include unsubstantiated claims regarding their effectiveness in conditions that include opioid withdrawal and addiction and chronic pain.
Of the 25 most abundant compounds in kratom — or Mytragyna speciosa — 22 are known to bind μ-opioid receptors and to effectively act as opioid agonists.
“As we work to combat the opioid epidemic, we cannot allow unscrupulous vendors to take advantage of consumers by selling products with unsubstantiated claims that they can treat opioid addiction.
Far from treating addiction, we [have] determined that kratom is an opioid analogue that may actually contribute to the opioid epidemic and puts patients at risk [for] serious side effects,” declared FDA Commissioner Scott Gottlieb, MD.
No evidence currently supports the safety or efficacy of kratom-based products — or of its psychoactive compounds, mitragynine and 7-hydroxymitragynine — for any medical condition. Marketing such products with wrongful claims therefore violates the Federal Food, Drug, and Cosmetics Act, and is therefore illegal, points out the agency. In addition, patients may use such products in place of effective FDA-approved drugs. Other conditions these companies claim can be treated with kratom-containing products include high blood pressure, anxiety, stroke-associated neuronal damage, and cancer.
A total of 65 kratom-containing products have been identified in products sold by these 3 companies and include terms such as “Maeng Da Red Vein Powder,” “Yellow Vietnam Kratom,” and “Borneo White Vein Kratom Powder.”
“If people believe that the active ingredients in kratom have drug-like effects that can treat pain or addiction, then the FDA is open to reviewing [those] data under our new drug approval process,” noted Dr Gottlieb. The agency is reviewing studies investigating the effectiveness of kratom and kratom compounds and encourages additional research on the safety of the plant.
The FDA has a resource for consumers and healthcare professionals to report any adverse events associated with drugs.
“Using products with unsubstantiated claims may prevent those addicted to opioids from seeking treatments that have been demonstrated to be safe and effective. Reliance on products with unsubstantiated claims may delay their path to recovery and put them at greater risk [for] addiction, overdose, and death,” noted the agency.
U.S. Food and Drug Administration. FDA warns companies selling illegal, unapproved kratom products marketed for opioid cessation, pain treatment and other medical uses [news release]. Available at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm608447.htm?utm_campaign=05222018_PR_kratom%20warning%20letters&utm_medium=email&utm_source=
Eloqua. May 22.2018. Accessed May 24, 2018.