FDA Issues Warning Letters to Companies Marketing Kratom

Sep 11, 2018
By Pharmaceutical Technology Editors

On Sept. 11, 2018, FDA Commissioner Scott Gottlieb, MD, issued a statement regarding new warning letters FDA is issuing to companies marketing kratom with unproven medical claims, as well as the agency’s ongoing concerns about kratom.

Kratom is a plant native to Thailand, Malaysia, Indonesia, and Papua New Guinea. According to the agency, there is evidence that certain substances found in kratom are opioids, and data suggests that one or more of these substances may have a potential for abuse. The plant is currently illegal or controlled in several other countries including Australia, Denmark, Germany, Malaysia, and Thailand as well as in a number of states and municipalities in the United States. FDA reports that to date, there have been no adequate and well-controlled scientific studies involving the use of kratom as a treatment for opioid-use withdrawal or other diseases in humans, nor have there been studies on how kratom, when combined with other substances, may impact the body.

Based on these concerns, FDA issued warning letters to two vendors, Chillin Mix Kratom and Mitra Distributing, for marketing kratom products with scientifically unsubstantiated claims, including to “relieve opium withdrawals” and to “treat a myriad of ailments including but not limited to: diarrhea, depression, diabetes, obesity, high blood pressure, stomach parasites, diverticulitis, anxiety, alcoholism, and opiate withdrawal.” In the warning letters, the agency states that both companies marketed unapproved new/misbranded drugs and have 15 days after receiving the letters to notify the agency in writing of the specific steps taken to correct violations.

According to FDA, in light of the current opioid epidemic, the agency continues to urge consumers not to consume kratom and to seek appropriate medical care from their health care provider and will continue to “…take action against those who put the safety of Americans at risk and who violate federal law by making unsubstantiated health claims about products that they seek to sell,” Gottlieb said in the statement.

Gottlieb also issued a statement in November 2017 warning about the risks associated with kratom. In February 2018, the Centers for Disease Control (CDC) and FDA announced that it was investigating a multi-state outbreak of Salmonella that infected 28 people in 20 states in the US. FDA and CDC worked with state and local health officials to discover the possible source and route of the contamination and found evidence that suggests that the source of the outbreak is possibly kratom.

Additionally, in February 2018, FDA announced that Divinity Products Distribution of Grain Valley voluntarily destroyed and recalled kratom-containing dietary supplements and has agreed to stop selling all products containing kratom. 

Source: FDA

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