FDA oversees destruction and recall of kratom products; and reiterates its concerns on risks associated with this opioid

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Feb 21, 2018, 11:43 ET

SILVER SPRING, Md., Feb. 21, 2018 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today announced the voluntary destruction and recall of a large volume of kratom-containing dietary supplements manufactured and distributed nationwide under the brand names Botany Bay, Enhance Your Life and Divinity by Divinity Products Distribution of Grain Valley, Missouri. In cooperation with the FDA, the company has also agreed to stop selling all products containing kratom. 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.

"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 FDA Commissioner Scott Gottlieb, M.D. "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."

When intended for use as or in a dietary supplement, the FDA considers kratom to be a new dietary ingredient. Generally, any dietary supplement containing kratom would need to be the subject of a New Dietary Ingredient Notification demonstrating that the product will reasonably be expected to be safe. To date, the FDA is not aware of any evidence of safety establishing that kratom (or any compounds derived from kratom) will reasonably be expected to be safe as a dietary ingredient. Additionally, kratom should not be used to treat any medical conditions, nor should it be used as an alternative to prescription opioids. There are currently no FDA-approved therapeutic uses of kratom and importantly, the FDA has evidence to show that there are significant safety issues associated with its use. Before it can be legally marketed for therapeutic uses in the U.S., kratom's risks and benefits must be evaluated as part of the regulatory process for drugs established by Congress.

"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."

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

Today's action follows previous warnings from the FDA regarding kratom – a plant that grows in Thailand, Malaysia, Indonesia and Papua New Guinea. Recently, the FDA also 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. The agency has also been assessing peer-reviewed research and a growing number of adverse event reports associated with kratom use, including 44 reported deaths.

Additionally, the FDA and the U.S. Centers for Disease Control and Prevention are carefully monitoring an active nationwide outbreak across 20 states of a rare type of salmonella associated with kratom products. The agencies will continue to communicate with the public as more information becomes available. 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.

For more information:

FDA and Kratom

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency's scientific evidence on the presence of opioid compounds in kratom, underscoring its potential for abuse

Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA advisory about deadly risks associated with kratom

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Lyndsay Meyer, 240-402-5345; [email protected]
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SOURCE U.S. Food and Drug Administration