Kratom-Navigating the Murky Regulatory Waters

Apr 7, 2021 | Dietary Supplements, FDA, Law & Regulatory

On March 29, 2021, the Food and Drug Administration (FDA) updated and republished Import Alert 54-15, which allows for the detention without physical examination of dietary supplements containing Mitragyna Speciosa, otherwise known as  Kratom. Kratom is a botanical from Southeast Asia used by millions of Americans to treat chronic pain and other conditions. Kratom has been a controversial ingredient from the start, including problems with potential addiction and Prop 65 issues with heavy metals. 

In FDA’s publication, it states, “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 various 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.”

The FDA classified Kratom as a dietary ingredient under section 201(ff)(1) of the Federal Food, Drug and Cosmetic Act (FD&C ). The FDA says that it is a new dietary ingredient as there is no evidence that it was marketed as a dietary ingredient prior to October 15, 1994, when Congress enacted The Dietary Supplement Health and Education Act of 1994 (DSHEA).

FDA has serious concerns about Kratom, “the scientific literature disclosed serious concerns regarding the toxicity of Kratom in multiple organ systems. Consumption of Kratom can lead to a number of negative health complications, including respiratory depression, nervousness, agitation, aggression, sleeplessness, hallucinations, delusions, tremors, loss of libido, constipation, skin hyperpigmentation, nausea, vomiting, and severe withdrawal signs and symptoms. In the absence of a history of use or other evidence to establish that Kratom can be expected to be reasonably safe as a dietary ingredient, Kratom and Kratom-containing dietary supplements and bulk dietary ingredients are considered  to be adulterated under section 402(f)(1)(B) of the FD&C Act [21 USC 342(f)(1)(B)] because they contain 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.”

A major dietary supplement trade association, United Natural Products Alliance (UNPA), is also not a fan of Kratom and requires its members not to use the ingredient as a condition of membership. Most insurance companies will not issue a general liability or product liability insurance policy that covers Kratom.

With all of these problems surrounding Kratom, how is it still legal to import and sell in the United States, and why?

In a recent article by Natural Products Insider, Mac Haddow, senior fellow on public policy for the American Kratom Association (AKA), stated, “FDA has no authority to stop Kratom raw materials from coming into the country by wholesalers.” He additionally asserted, “FDA has no authority to take action against non-adulterated, uncontaminated Kratom sold as food with no health or dietary ingredient claims.” In one interview, Haddow explained, “this all goes to the specific issue of what the intended use is and how it’s marketed.”

With the new Biden administration, it is uncertain as to what, if anything, the FDA will do to regulate Kratom products sold in the US. However, with the recent emphasis on Import Alert 54-15, it is certain that Kratom is still a priority for the FDA. 

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