The FDA has failed 3 times to schedule kratom: 2016, rejected by the DEA for insufficient evidence; 2018, rejected by HHS Asst. Sec. for Health for "embarrassingly poor evidence and data"; and in 2021 by the Expert Committee on Drug Dependence at the WHO for insufficient evidence.

In 2023, the FDA admitted to a Federal Judge they had not "determined if kratom is dangerous".

In 2024 the FDA conducted a dose finding study that proved kratom could be safety consumed, and found kratom appearted to be tolerated at all dose levels.

There is no scientific justification for scheduling of kratom.