On May 18, 2018, the U.S. Food and Drug Administration (FDA) issued a warning letter to Kratom Spot, a retailer of kratom products, addressing significant regulatory violations. The letter highlighted concerns regarding unapproved drug claims made by the company, suggesting that its kratom products could treat or cure various medical conditions without the requisite FDA approval. Additionally, the FDA raised safety concerns related to the use of kratom, which has been linked to adverse health effects and risks. The warning emphasized the company’s failure to comply with regulations governing dietary supplements, underscoring the necessity for adherence to established safety and labeling standards. This action reflects ongoing scrutiny by the FDA regarding the safety and marketing practices of kratom products in the United States, aimed at protecting consumer health and ensuring regulatory compliance.

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