Feb. 23 (UPI) — The U.S. Food and Drug Administration has announced the voluntary destruction and recall of a company’s dietary supplements that contain kratom, a potentially addictive opioid.
Divinity Products Distribution of Grain Valley, Mo., has voluntarily agreed to remove products under the brand names Botany Bay, Enhance Your Life and Divinity, the FDA announced Thursday. In addition, the company has agreed to stop selling all products containing kratom.
“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 Scott Gottlieb said in a press release. “At the same time, there’s no evidence to indicate that kratom is safe or effective for any medical use.”
FDA has issued previous warnings regarding kratom, a plant that grows in Thailand, Malaysia, Indonesia and Papua New Guinea, and is available in pills, powders and tea. On Feb. 6, the FDA declared kratom an opioid. Forty-four deaths have been documented by the FDA that were linked to the herb’s consumption.
Gottlieb praised the “swift action to remove these products from circulation to protect the public.”
The FDA said it has not seen evidence that kratom is safe as a dietary ingredient or other uses.
“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,” Gottlieb added.
The FDA and the Centers for Disease Control and Prevention also reported Tuesday they are monitoring an outbreak of 28 salmonella infections in 20 states linked to kratom use. No deaths have been reported in the outbreak.
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