FDA Recalls Weight Loss Supplements Containing Kratom
The Food and Drug Administration (FDA) recently announced a voluntary recall of dietary weight loss supplements which contain an herbal ingredient that is known to produce reactions similar to prescription opioids. Commissioner Scott Gottlieb, M.D., hopes manufacturers will stop selling products that contain the ingredient “kratom” altogether and encourages anyone with kratom in their possession to dispose of it immediately.
“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. At the same time, there’s no evidence to indicate that kratom is safe or effective for any medical use,” said Gottlieb. “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. We appreciate the cooperation of companies currently marketing any kratom product for human consumption to take swift action to remove these products from circulation to protect the public.”
The FDA found that some users were getting their hands on weight loss supplements and using them as an alternative to prescription opioids. Gottlieb indicated that the agency ensured the destruction of all pills containing kratom, including Botany Bay, Enhance Your Life, and Divinity by Divinity Products Distribution of Grain Valley, Missouri.
“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 added. “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.”
Gottlieb said there are no FDA approved therapeutic uses of weight loss supplements containing kratom and the agency has found it poses “significant safety issues,” citing a total of 44 reported deaths associated with its use. The herb has also been linked to an outbreak of salmonella in twenty states. This outbreak is associated with teas and powders containing the herbal ingredient and highlights the fact that harmful bacteria may contaminate these products when they are not subjected to certain manufacturing controls in place to eliminate risk.
While Gottlieb clarified that the FDA is not aware of any recent reports of illness specifically associated with the use of Divinity Products Distribution’s kratom containing products, the agency is asking health care professionals, consumers, and any other distributors to report notable adverse effects or quality problems to the agency as soon as possible. Kratom grows in Thailand, Malaysia, Indonesia and Papua New Guinea.
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FDA announces recall of dietary supplements after opioid declaration
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