On September 4, 2018, the U.S. Food and Drug Administration (FDA) issued a warning letter to Chillin Mix Kratom, addressing significant safety concerns associated with the company’s kratom products. The letter emphasized potential health risks, including addiction and adverse effects on the central nervous system, associated with kratom consumption. The FDA highlighted instances of misleading claims made by the company regarding the efficacy of its products in treating or preventing various health conditions, which violate federal regulations governing dietary supplements. The agency mandated corrective actions to ensure compliance with safety and labeling standards, warning that failure to address these issues could lead to further regulatory enforcement actions. This letter serves as a critical reminder of the ongoing scrutiny faced by kratom products within the health and wellness industry.
An evaluation of adverse drug reactions and outcomes attributed to kratom in the US Food and Drug Administration Adverse Event Reporting System from January 2004 through September 2021
Expanded Summary (6th grade reading level): Kratom is a plant that grows in parts of Asia. Some people use kratom to treat pain, anxiety, and opioid