FDA Finds Kratom Capsules Safe, but Questions About Concentrated Forms Remain

An initial US Food and Drug Administration (FDA) study on kratom, a plant-based substance long consumed in Southeast Asia, has found that the compound appears safe when used in capsule form, even at high doses.

However, a Tuesday (September 17) Bloomberg article notes that the FDA's research did not include kratom-infused drinks or concentrates, which are more common in the US and may carry different risks.

Kratom, a botanical product derived from the leaves of Mitragyna speciosa, has been used in Southeast Asia for centuries, with users traditionally chewing the leaves for its mind-altering effects.

The FDA study involved 40 participants divided into five groups, each receiving either a placebo or escalating doses of kratom capsules. Participants were monitored for adverse reactions over two days.

The scope also focused on kratom leaf material, which was dried, ground into powder and encapsulated. The product closely resembles the form used traditionally in Thailand and Malaysia.

As mentioned, the study did not examine the effects of more concentrated kratom products, such as beverages or extracts. These tend to have higher concentrations of the compound and have been linked to more severe side effects.

Kratom has rapidly gained popularity in the US due to its widespread availability in gas stations, bars and convenience stores. Bloomberg states that on an annual basis more than 1.7 million people in the country report using the plant or consuming kratom-infused drinks; some fatalities have been linked to its increasing consumption.

Despite its growing use, scientific understanding of its long-term effects remains limited, as kratom tends to have higher concentrations of active compounds when used in non-traditional formats like beverages.

Christopher McCurdy, a professor at the University of Florida’s College of Pharmacy and a researcher involved in the study, told Bloomberg that the results only scratch the surface of what needs to be known about kratom.

“It gives you a snapshot, at least now, of what ranges appear to be safe and not cause any toxicity in humans,” he said, adding that some people have been using it for decades or more, but the impact on them isn't known.

Despite these unanswered questions, the researchers found no severe or life-threatening adverse effects associated with kratom capsules in the doses tested, though vomiting was a common side effect, especially at higher doses.

Kratom is largely unregulated in the US, but concerns about its safety have led at least six states to ban the substance.

The FDA has repeatedly issued warnings about kratom, citing its opioid-like properties and potential for abuse.

In 2019, the Centers for Disease Control and Prevention reported nearly 100 deaths involving kratom; however, most of those cases also involved other substances, primarily fentanyl. The FDA continues to raise concerns about kratom's use in higher-concentration forms, particularly in beverages marketed as alcohol alternatives.

While the results of the FDA study mark a significant step toward gaining a better understanding of the substance, experts agree that more data on kratom’s effects, particularly in its more concentrated forms, is needed.

In the meantime, the agency continues to urge consumers to exercise awareness and caution regarding kratom’s use in higher-concentration forms, particularly in beverages marketed as alcohol alternatives.

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Securities Disclosure: I, Giann Liguid, hold no direct investment interest in any company mentioned in this article.