The rest of the US needs to follow Florida’s lead and start regulating kratom extracts   

The rest of the US needs to follow Florida’s lead and start regulating kratom extracts   

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Over the summer, Florida became the 11th state to pass the Kratom Consumer Protection Act — a set of rules that protects consumers from the ever-popular kratom products that are known to produce stimulant- and opioid-like effects. We have been championing the statewide act all year, but there is still much more progress to be made on the federal level to protect national public health.   

Known by the botanical name Mitragyna speciosa, kratom is a traditional Southeast Asian medicine made from tree leaves that has been utilized by indigenous populations for centuries. The herb and its multiple products have attracted public and scientific attention throughout the past decade in the United States, and it garnered our interest as researchers during the global opioid crisis.   

When kratom leaves are dried and ground into powder, they are exported from Indonesia, Thailand and Malaysia for distribution on the international market. Approximately 2 to 20 million adults in the United States are currently using kratom. Claimed benefits include pain relief, mood elevation, improved focus and energy, and being able to transition from other substances. But none of these potential beneficial uses are approved by the U.S. Food and Drug Administration (FDA) and kratom remains federally unregulated, even with the Kratom Consumer Protection Act in place in several states.   

In the midst of this lack of regulation, kratom products are becoming increasingly more dangerous. While unaltered kratom leaf material contains the active ingredient mitragynine in amounts of about 2 percent, the recent emergence of kratom extracts has resulted in products containing 40 percent or more mitragynine by weight.   

Products containing kratom extracts may now be available in various formulations, such as tablets, capsules, liquid shots or gummies, that appeal to consumers based on better palatability (circumventing the unpleasant taste of native kratom leaf or powder material). Better taste can lead to ingestion of higher amounts of mitragynine, raising questions of consumer safety and abuse potential. It is well-documented that kratom misuse can lead to adverse and toxic effects, leading to a dependence described as “kratom use disorder.”   

That is why the enforcement of the Kratom Consumer Protection Act is so critical. It regulates kratom by adequately labeling products, preventing sales to minors, and imposing quality manufacturing standards that must be followed by sellers (typically internet vendors and proprietors of local gas stations and smoke shops).    

History has shown that developing enriched natural product elixirs or purified active agents, as with cocaine from the coca shrub and morphine from the opium poppy, can be both a blessing and a curse. The blessing is that some of these concentrates can be medically useful to improve quality of life for patients suffering from numerous disorders, but the curse is the increased risk of adverse effects and the potential for misuse.    

Concentrated kratom extracts are analogous to these historical examples. Though the extracts may provide benefits to some, they may also result in unpredictable, adverse effects and other potential harms resulting from dependence and drug-drug interactions.    

As researchers studying the therapeutic potential of kratom, while also desiring to reduce possible associated harms, we strongly recommend that kratom in its native form (unadulterated fresh or dried leaf material) remain available to consumers.   

In addition, there must be thorough and proper oversight and regulation, including clear labeling that describes the amount of mitragynine per kratom dose, recommended maximum daily doses, potential for drug interactions, and implementation of proper Good Manufacturing Practices (similar to what is done for other dietary supplements).   

We also urge healthcare providers to be open to discussing the potential use, drug interactions, and risks of kratom with patients. Finally, consumers should be informed about the possible risks of using certain kratom extract products, which may expose them to high doses of kratom alkaloids.   

Given the limited scientific data on the risks and toxicity of concentrated kratom products, consumers should approach them with extreme caution and hope for more government oversight. Florida passing the Kratom Consumer Protection Act was a significant step in the standardization and regulation of kratom products, and we sincerely hope other states continue to follow suit.   

Christopher R. McCurdy, Ph.D., is a professor of medicinal chemistry at the University of Florida (UF) College of Pharmacy and the director of the UF Translational Drug Development Core. Oliver Grundmann, Ph.D., is a clinical professor in the department of medicinal chemistry in UF’s College of Pharmacy.   

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