No FDA-Approved Products with Kratom: Gottlieb

FDA commissioner Scott Gottlieb says the agency has issued a public health advisory related to growing concerns about risks associated with use of a botanical substance known as kratom. In a statement, Gottlieb emphasizes that there are no FDA-approved products containing kratom and that no drug manufacturer has filed an application that would trigger an agency evaluation of the safety and efficacy of such a product.

“FDA knows people are using kratom to treat conditions like pain, anxiety, and depression, which are serious medical conditions that require proper diagnosis and oversight from a licensed healthcare provider,” Gottlieb says. “We also know that this substance is being actively marketed and distributed for these purposes. Importantly, evidence shows that kratom has similar effects to narcotics like opioids, and carries similar risks of abuse, addiction, and in some cases death…. At a time when we have hit a critical point in the opioid epidemic, the increasing use of kratom as an alternative or adjunct to opioid use is extremely concerning.”

The commissioner says that before a kratom product can be legally marketed for therapeutic uses in the U.S., its risks and benefits would have to be evaluated as part of the regulatory process for drugs that Congress has given to FDA. Moreover, he says, Congress has established a specific set of review protocols for scheduling decisions concerning substances like kratom. “This is especially relevant given the public’s perception that it can be a safe alternative to prescription opioids,” he says.

The agency has exercised jurisdiction over kratom as an unapproved drug, Gottlieb says, and has also taken action against kratom-containing dietary supplements. Kratom products have been identified on two import alerts and FDA is actively working to prevent shipments of kratom from entering the U.S., he adds.