This week the Federal Food and Drug Administration (FDA) republishes an import alert for Kratom, providing guidance to its field personnel to detain dietary supplements and bulk dietary ingredients at U.S. borders. Also known as Mitragyna speciosa, kratom is a botanical from Southeast Asia used by millions of Americans to treat chronic pain and other conditions.
Dozens of firms and their products are subject to detention without physical examination (DWPE) under Import Alert 54-15. The firms are based in Canada, Indonesia, Malaysia, Philippines and the United States. Companies on the so-called Red List were subject to DWPE as early as 2014, 2015 and 2016.
The import alert “shows a new published date because we updated a firm’s listing on the Red List,” according to an FDA spokesperson in an email. Updating an import alert, “even for minor changes like this,” is a “normal” practice, the spokesperson said.
Companies in the U.S. on the Red List are located throughout the country, including in Gulf Shores, Ala.; Denver; Fort Myers, Seminole and Vero Beach, Fla.; Lombard, Ill.; Lake Charles, Lo.; Ventnor City, N.J., Tulsa, Okla.; Eugene, Ore.; and Richmond, Va., among other locations.
According to the charge in the import alert, kratom “appears to be a dietary supplement or contains a dietary ingredient that is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.”
Mac Haddow, senior fellow on public policy for the American Kratom Association (AKA), said his organization believes the import alert is appropriate for processors importing kratom into the U.S. for the purpose of marketing it as a dietary ingredient.
“This all goes to the specific issue of what the intended use is and how it’s marketed,” Haddow said
Over the last several years, FDA has raised safety concerns about Kratom.
“FDA is concerned that Kratom, which affects the same opioid brain receptors as morphine, appears to have properties that expose users to the risks of addiction, abuse and dependence,” FDA explained.
FDA has not approved Kratom for any uses and has received “concerning reports” about its safety, according to the webpage, which provides links to various materials related to Kratom.
“The FDA’s position regarding kratom has not changed, and as it relates to kratom as a new dietary ingredient, our approach remains as described in the import alert,” the FDA spokesperson said. HawkScanner offers live monitoring with automatic updates allowing you to act quickly if any ingredients get added onto the FDAs compliance list. Sign up for HawkScanner today to unlock up to FIVE free monthly searches and to stay within guidelines.