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Klarity Kratom was warned for marketing unapproved kratom products as drugs in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act. The company made unsubstantiated claims on its website that kratom products could treat or cure opioid addiction and withdrawal symptoms, as well as other conditions such as rheumatoid arthritis, without FDA approval or demonstrated safety and efficacy. This enforcement action was prioritized due to the ongoing opioid crisis and the risk that unproven kratom treatments could delay or replace FDA-approved addiction therapies.