FDA Continues Its Crackdown on Kratom

The FDA has continued its fight to keep the botanical kratom out of the hands of consumers, taking hold of approximately 90,000 bottles of dietary supplements containing the substance. 

 

The seized product, RelaKzpro, is manufactured and distributed by Dordoniz Natural Products LLC. The FDA estimated the value of the seized product at over $400,000.

 

 “We have identified kratom as a botanical substance that could pose a risk to public health and have the potential for abuse,” said Melinda Plaisier, the FDA’s associate commissioner for Regulatory Affairs. “The FDA will continue to exercise our full authority under law to take action on these new dietary ingredients, especially if they ignore the notification requirements, as part of our commitment to protecting the health of the American people.”

 

Kratom is a common name for Mitragyna speciosa, a naturally growing botanical found in Thailand, Malaysia, Indonesia and Papua New Guinea. It contains alkaloids that the FDA states have pharmacologic effects similar to morphine and other opiates. It is promoted on numerous websites and has a wide following on Twitter, but is not approved in the United States for any medical use.

 

In addition to its desired effects, kratom comes with inherent dangers. According to the FDA, consumption of kratom can lead to a number of health problems including respiratory depression, nervousness, agitation, aggression, sleeplessness, hallucinations, delusions, loss of libido, tremors, skin hyperpigmentation, nausea, vomiting, constipation, and severe withdrawal signs and symptoms.

 

The danger is real enough that in February 2014, the FDA utilized its powers under the Federal Food, Drug, and Cosmetic (FD&C) Act and filed a complaint in the U.S. District Court for the Central District of California alleging that kratom is an unapproved new drug as well as misbranded. It then issued an alert that cited its intention to instruct U.S. marshals to detain imported kratom without physical examination. In September 2014, U.S marshals, acting under direction of the FDA, seized 500 cartons of kratom bottles, weighing 25,000 pounds and worth an estimated $5 million, from Rosefield Management of Van Nuys, Calif. 

 

In January 2016, the FDA administratively detained RelaKzpro under the FD&C Act. Under its administrative detention authority, the agency can keep detained products out of the marketplace for a maximum of 30 days while it determines whether to take further enforcement action, such as seizure.

 

The FDA is warning consumers not to use any products labeled as containing kratom. Health care professionals and consumers should report any adverse events related to products containing kratom to the FDA’s MedWatch program by completing and submitting the report online at www.fda.gov/medwatch/report.htm; or downloading the form, completing it and then faxing it to 1-800-FDA-0178.

Based on a press release from the FDA.