FDA monitors destruction and recall of kratom products

U.S FDA had asserted the destruction and recall of large volume of kratom-containing dietary supplements that is ideally manufactured and distributed nationwide under the Brand names Botany Bay, Enhance Your Life and Divinity by Divinity Products Distribution of Grain Valley, Missouri.

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.

FDA Commissioner Scott Gottlieb, M.D claimed “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.”

As per the FDA approved therapeutic uses of kratom,  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.