FDA Cracks Down on Kratom Products

By Robert Preidt

HealthDay Reporter

WEDNESDAY, Feb. 21, 2018 (HealthDay News) -- A number of kratom-containing dietary supplements are being recalled and destroyed by the manufacturer, the U.S. Food and Drug Administration announced Wednesday.

Kratom -- a plant that grows in Asia -- poses serious health risks, according to the FDA. Earlier this month, the agency declared that kratom acts like an opioid in the human brain. And on Tuesday the botanical was linked to 28 cases of salmonella poisoning, including eight that had been confirmed to have used kratom.

Meanwhile, Missouri-based Divinity Products Distribution has promised to recall and destroy kratom-containing products sold across the United States under the brand names Botany Bay, Enhance Your Life and Divinity, the FDA said Wednesday. The agency added that the company has agreed to stop selling all products containing kratom.

The FDA said it wants all companies making similar products to take them off the market, and urged all consumers who have kratom-containing products to stop using them and throw them away.

"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," FDA Commissioner Dr. Scott Gottlieb said in a statement.

"At the same time, there's no evidence to indicate that kratom is safe or effective for any medical use," he added.

"To protect the public health, we'll continue to affirm the risks associated with kratom, warn consumers against its use and take aggressive enforcement action against kratom-containing products," Gottlieb said.

The American Kratom Association has stated that the FDA's decision to declare kratom an opioid is "an unprecedented abuse of science to create a new computer program that is clearly garbage in/garbage out, avoiding the rules of the Controlled Substances Act and making unproven claims that have been proven to be untrue."

Gottlieb acknowledged that some may be using kratom to wean themselves off of more powerful opioids.

"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," Gottlieb said.

He noted that his agency "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."

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SOURCE: U.S. Food and Drug Administration, news release, Feb. 21, 2018
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