Botany Bay, Enhance Your Life, and Divinity by Divinity Products Distribution are recalling and destroying dietary supplements that contain kratom, and have agreed to stop selling all products that contain kratom, as part of an agreement with the Food and Drug Administration (FDA). The large volume of kratom-containing products were distributed nationwide, and were recalled in the interest of public health because of the serious risks they pose to consumers.
The FDA is also encouraging all companies currently involved in the sale of products containing kratom to follow suit and remove their products from the market.
“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.”
Kratom is an herb that can give users a feeling of euphoria, and is sometimes used to treat opioid dependency. But the FDA says the product has not been found safe or effective for this use. “We’re deeply committed to making sure patients have access to safe, effective treatment options,” Dr. Gottlieb said.
Earlier this month, the FDA notified consumers that the compounds within kratom are similar to opioids and that the agency now considers the supplement an opioid. This classification further restricts the compound and is another step the agency is taking to fight the nation’s opioid epidemic.
Earlier this week, the FDA warned consumers that it was working with the Centers for Disease Control and Prevention (CDC) and other state and local officials to investigate a multi-state breakout of Salmonella infections linked to products reportedly containing kratom, and advised consumers to avoid kratom and kratom-containing products.
FDA News Release