The U.S. Drug Enforcement Administration (DEA) has not listed kratom, or its active alkaloids mitragynine and 7-hydroxymitragynine, as a Schedule I substance. In 2016, the DEA announced it would temporarily classify kratom as Schedule I, but after a massive public backlash from scientists, users, and members of Congress, it withdrew the proposal. In 2025, amid lawsuits over kratom‐related injuries and ongoing FDA deliberations to regulate the substance, it’s more important than ever to protect or start your business with robust legal safeguards and strategic partnerships.