U.S. Marshals at the request of the FDA recently seized more than 25,000 pounds of raw kratom material worth more than $5 million from Rosefield Management, Inc. in Van Nuys, California.
Mitragyna speciosa, commonly known as kratom, is a botanical substance that grows naturally in Thailand, Malaysia, Indonesia, and Papua, New Guinea. Kratom is promoted on numerous websites in the United States for its psychoactive and opioid-like analgesic effects and for use in the treatment of morphine and heroin addiction, but it is not approved in the United States for any medical use.
The kratom product, imported by Rosefield Management from C.V. Bali Herbal of Indonesia, contains alkaloids that have pharmacological effects similar to morphine and other opiates. 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.
“We have identified kratom as a botanical substance that poses a risk to public health and has the potential for abuse,” said Melinda Plaisier, the FDA’s associate commissioner for regulatory affairs. “This action was taken to safeguard the public from this dangerous product, and the FDA will continue to take aggressive enforcement actions against products that are promoted for uses that are unapproved.”
In February, the FDA issued an import alert that allows the agency to detain imported kratom without physical examination.
More than 500 cartons of kratom were seized from Rosefield’s Van Nuys facility. Rosefield distributed kratom after receiving instructions to do so from Wholesale Shamanic Herbs. Wholesale Shamanic Herbs promoted kratom on its website with claims that the product is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
The FDA filed a complaint in the U.S. District Court for the Central District of California alleging that kratom is an unapproved new drug and a misbranded drug under the Federal Food, Drug, and Cosmetic Act.
In a related matter, the FDA has seen an increase in the number of shipments of dietary supplements and bulk dietary ingredients that are, or contain kratom, also known as Mitragyna speciosa, mitragynine extract, biak-biak, cratom, gratom, ithang, kakuam, katawn, kedemba, ketum, krathom, krton, mambog, madat, Maeng da leaf, nauclea, Nauclea speciosa, or thang. These shipments of kratom have come in a variety of forms, including capsules, whole leaves, processed leaves, leaf resins, leaf extracts, powdered leaves, and bulk liquids made of leaf extracts. Importers websites have sometimes contained information about how their products are used.
Kratom is a botanical that qualifies as a dietary ingredient under section 201(ff)(1) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C.A. 321(ff)(1). When marketed as a dietary ingredient, the FDA also considers kratom to be a new dietary ingredient under section 413(d) of the Act, 21 U.S.C.A. 350b(d), because, to the best of the agency’s knowledge, there is no information demonstrating that this substance was marketed as a dietary ingredient in the United States before October 15, 1994.
Furthermore, based on the FDA’s review of the publicly available information regarding kratom, there does not appear to be a history of use or other evidence of safety establishing that kratom will reasonably be expected to be safe as a dietary ingredient. In fact, the scientific literature disclosed serious concerns regarding the toxicity of kratom in multiple organ systems. In the absence of a history of use or other evidence of safety establishing that kratom will reasonably be expected to be safe as a dietary ingredient, kratom and kratom-containing dietary supplements and bulk dietary ingredients are adulterated under section 402(f)(1)(B) of the Act (21 U.S.C. 342(f)(1)(B)), because they contain a new dietary ingredient for which there is inadequate information to provide reasonable assurance that the ingredient does not present a significant or unreasonable risk of illness or injury.
Districts may detain, without physical examination, the specified products from the firms identified in the red list of the FDA Import Alert 54-15. The specified dietary supplements and bulk dietary ingredients from the firms listed on the red list of this Import Alert have been found to contain kratom.
See the FDA Announcement
See the FDA Import Alert
See also Medical Law Perspectives, April 2013 Report: Complementary and Alternative Medicine: Practitioner Liability