On July 7, the FDA posted a batch of warning letters to websites selling ketamine directly to American consumers for depression and pain. The Center for Drug Evaluation and Research told the operators to stop, citing unapproved and misbranded products. All but one were based in the United States, with the remaining site in the Netherlands.
The letters make the safety case in unusually direct language. Ketamine is not FDA-approved for any psychiatric use at all, and the agency told one recipient that "Ketamine is not FDA-approved for the treatment of any psychiatric disorder."The approved derivative, esketamine, is sold as Spravato, is restricted to certified treatment centers, and carries a boxed warning.
