FDA’s Abrupt Withdrawal: The Unfinished Kratom Study

FDA's Abrupt Withdrawal: The Unfinished Kratom Study

Kratom, a plant native to Southeast Asia, has increasingly become a subject of debate in the U.S. and beyond. Known for its pain-relief and stimulant properties, kratom has garnered significant attention due to its rising popularity and potential health risks. Recently, the U.S. Food and Drug Administration (FDA) decided to halt a proposed study on kratom, citing the need for changes in the study’s scope. This decision has sparked further discussion about the plant’s safety and the need for comprehensive research.

Understanding Kratom

Kratom has been used traditionally in Southeast Asia for its purported benefits, including pain relief, mood enhancement, and increased energy. In small doses, it acts as a stimulant, while larger doses can have opioid-like effects, which raises concerns about its potential for addiction and overdose. Despite its benefits, there have been instances where kratom use has been linked to fatal overdoses, making its safety profile a contentious topic.

FDA’s Study Withdrawal

Earlier this month, the FDA announced its plans to conduct a study to explore the risks and safety of kratom. However, just ten days later, the agency abruptly cancelled the study. According to FDA spokesperson Lauren-Jei McCarthy, the decision was made to change the study’s scope, indicating that the initial design was flawed. The study aimed to investigate motivations for using kratom alongside psychedelics, a comparison criticised by Mac Haddow, a senior fellow at the American Kratom Association, who argued that the two substances are fundamentally different and should not have been conflated in the same study.

Industry and Researcher Perspectives

The kratom industry and researchers have long been at odds with regulatory bodies over the plant’s classification and safety. The FDA’s withdrawal is seen by some as another chapter in the contentious relationship between kratom advocates and regulators. In 2016, the Drug Enforcement Administration’s attempt to classify kratom as a Schedule I drug was met with public backlash, leading to a temporary halt in reclassification.

Kratom researchers, including Christopher McCurdy from the University of Florida College of Pharmacy, highlight the complexities involved in studying kratom due to its numerous compounds. The lack of comprehensive data on kratom’s long-term effects, particularly during pregnancy or in combination with other drugs, underscores the need for further research. Kirsten Smith from Johns Hopkins University points out that there is a scarcity of researchers applying for grants to study kratom, further hindering progress in understanding its effects.

The Need for Comprehensive Research

Given the growing availability of kratom products in the U.S. market, understanding its impact is more crucial than ever. Despite its potential benefits, the unknowns surrounding its long-term use and interactions with other substances pose significant concerns. Advocacy groups and researchers alike call for more rigorous studies to evaluate kratom’s safety and efficacy comprehensively.

Source: Bloomberg

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