Loading…
Herbsens Botanicals was cited for marketing unapproved kratom products as drugs without FDA approval, specifically making claims that the products treat or cure opioid addiction and withdrawal symptoms in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act. The company's website established intended drug use through therapeutic claims, yet the products had not been determined safe and effective for any use. The FDA emphasized that marketing unproven opioid addiction treatments posed a significant public health threat during the ongoing opioid crisis, as consumers might forego or delay approved treatments based on these false claims.