FDA on Monday republished an import alert, providing guidance to its field personnel to detain dietary supplements and bulk dietary ingredients containing kratom at the 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.
But he argued FDA has no authority to stop kratom raw materials from coming into the country by wholesalers. And he asserted FDA has no authority to take action against non-adulterated, uncontaminated kratom sold as food with no health or dietary ingredient claims.
“This all goes to the specific issue of what the intended use is and how it’s marketed,” Haddow said in an interview.
FDA did not immediately respond to a request to address Haddow’s specific comments.
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 on a webpage devoted to kratom and current as of September 2019.
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.
In January, AKA made public a 2018 letter from the U.S. Department of Health and Human Services (HHS), which rescinded a request for DEA to classify two constituents of the botanical kratom as a Schedule I controlled substance under the Controlled Substances Act (CSA).
In the 2018 letter to then-DEA Acting Administrator Uttam Dhillon, the then-Assistant Secretary for Health, Dr. Brett Giroir, recommended two constituents of kratom, mitragynine and 7-hydroxmitragynine, not be controlled either temporarily or permanently until such action is supported by scientific research. FDA is an agency within HHS.
“This decision is based on many factors, in part on new data, and in part on the relative lack of evidence, combined with an unknown and potentially substantial risk to public health if these chemicals were scheduled at this time,” Giroir wrote.
As many as 15 million Americans use kratom to treat “acute and chronic pain, and it’s saving lives,” Haddow said.
Haddow said AKA met with Giroir prior to HHS sending the letter to DEA. Rachel Levine was recently confirmed by the Senate as the new assistant secretary for health.
“That’s who we would look forward to meeting with obviously to continue this discussion about kratom,” Haddow said, referring to Levine.