FDA Cracks Down on Kratom

February 21, 2018
Pharmaceutical Technology Editors

Divinity Products Distribution of Grain Valley has voluntarily agreed to destroy and recall kratom-containing dietary supplements as part of FDA's crackdown on the plant.

FDA announced on Feb. 21, 2018 that Divinity Products Distribution of Grain Valley is voluntarily destroying and recalling kratom-containing dietary supplements and has agreed to stop selling all products containing kratom. The agency is also encouraging other companies to follow their lead and submit evidence regarding these products to FDA for evaluation through the regulatory pathway.

Kratom, a plant that grows in Thailand, Malaysia, Indonesia, and Papua New Guinea, is sometimes used to treat pain, anxiety, and depression. According to FDA, dietary supplements must go through New Dietary Ingredient Notification to demonstrate that they are safe. The agency has stated that it considers kratom to be a new dietary supplement and subject to review. Kratom has not been determined to be safe, according to FDA, and should not be used to treat medical conditions, particularly as an alternative to prescription opioids.

FDA has previously warned against the use of kratom or products containing kratom. According to the agency, kratom has shown to be harmful, with calls to poison control centers in the United States increasing 10-fold from 2010–2015. There have been 36 deaths associated with these products, and reports of kratom being laced with other opioids have been recorded. Serious side effects associated with use of kratom include seizures, liver damage, and withdrawal symptoms. The Centers for Disease Control have also warned that a recent outbreak of Salmonella may be associated with kratom.

“We know that some patients are using kratom because they believe it can help treat their opioid dependency, but there’s no reliable evidence to support kratom’s effectiveness for this use; and we’re deeply committed to making sure patients have access to safe, effective treatment options,” Commissioner Gottlieb said in an agency statement. “There are three FDA-approved products that are safe and effective for the treatment of opioid use disorder and we encourage patients to seek advice from their health care professional and pursue treatment for addiction. Additionally, the FDA is taking new steps to bring new, safe and effective, FDA-approved therapies to the market for treatment of opioid use disorder. We understand that patients suffering from opioid addiction need access to effective treatment options. Creating an efficient pathway for the development of these treatments is a very high priority of mine.”

Source: FDA