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Kratom Exchange was warned for selling unapproved new drug products, specifically various kratom powders marketed for treating or curing opioid addiction and withdrawal symptoms, in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act. The company made therapeutic claims on its website and Twitter that established the products as unapproved drugs without FDA safety and efficacy determinations. The FDA emphasized that marketing unproven opioid addiction treatments posed a significant public health threat, particularly given the ongoing national opioid crisis and the risk that consumers would forego FDA-approved addiction treatments.