FDA warns about opioid-containing supplement

FDA said the manufacturer of dietary supplements containing kratom, a natural opioid used to treat opioid use disorder, agreed to destroy the supplements, and is again warning the public about kratom.

Divinity Products Distribution in Grain Valley, Mo., issued a voluntary nationwide recall of its Botany Bay, Enhance Your Life and Divinity supplements that contain kratom. The company also agreed to stop selling all kratom-containing products, FDA said in a statement.

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“The extensive scientific data we’ve evaluated about kratom provides conclusive evidence that compounds contained in kratom are opioids and are expected to have similar addictive effects as well as risks of abuse, overdose and, in some cases, death,” said FDA Commissioner Scott Gottlieb, MD, in the statement. “At the same time, there’s no evidence to indicate that kratom is safe or effective for any medical use,”

FDA’s new action follows previous warnings from the agency about kratom-a plant that grows in Thailand, Malaysia, Indonesia and Papua New Guinea. FDA is also assessing peer-reviewed research and a growing number of adverse event reports associated with kratom use, including 44 reported deaths.

“Based on the scientific evidence of the serious risks associated with the use of kratom, in the interest of public health, the FDA encourages all companies currently involved in the sale of products containing kratom intended for human consumption to take similar steps to take their products off the market and submit any necessary evidence, as appropriate, to the FDA to evaluate them based on the applicable regulatory pathway,” FDA said in the statement.

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In addition, FDA and the CDC are monitoring an active nationwide outbreak across 20 states of a rare type of salmonella associated with kratom products.

“This outbreak associated with kratom-containing capsules, teas and powders, underscores the risk that harmful bacteria may contaminate these products when not subjected to manufacturing controls to eliminate that risk, in addition to the overall safety concerns for kratom itself,” FDA said.

Plus, there is “no reliable evidence” to support kratom’s effectiveness to treat opioid dependency, according to Gottlieb. However, 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,” Gottlieb said. “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.”

FDA recommends that consumers not use these or any kratom products and dispose of any products currently in their possession. While FDA is not aware of recent reports of illness specifically associated with the use of Divinity Products’ kratom-containing products, the agency asks healthcare professionals and consumers to report adverse events or quality problems associated with the use of the company’s supplements-or any kratom product-to the agency’s online Safety Reporting Portal.

Recently, FDA communicated about a computational model developed by agency scientists, which-along with other scientific evidence evaluated by the agency-led to the FDA’s conclusion that compounds in kratom share the most structural similarities with controlled opioid analgesics, such as morphine derivatives, thus making kratom-containing products opioids.

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