The U.S. Food and Drug Administration (FDA) has reiterated that kratom is not lawfully marketed in the United States as a drug product, dietary supplement, or food additive. This clarification comes amidst ongoing debates regarding the safety and efficacy of kratom, a substance derived from a tropical tree native to Southeast Asia, which has gained popularity for its purported pain-relieving and mood-enhancing properties.
This regulatory stance is significant as it underscores the FDA’s commitment to ensuring that products claiming therapeutic benefits meet established safety and efficacy standards. The agency has expressed concerns over the potential risks associated with kratom use, including addiction and adverse health effects, which further complicates its acceptance in the pharmaceutical landscape.
The implications for pharma B2B professionals are profound. Companies involved in sourcing, regulatory affairs, and quality assurance must remain vigilant as the landscape surrounding kratom evolves. Understanding the regulatory framework and potential market restrictions is crucial for navigating this contentious area, particularly as consumer interest continues to grow.
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