ABSTRACT

On February 10, 2012, the U.S. Food and Drug Administration (FDA) personnel warned their Neurological Device Panel (NDP) 25 times during the daylong meeting that cranial electrotherapy stimulation (CES) devices have the potential to cause seizures. While we were there, we were gagged having only been given 45 minute to speak in the morning and then not allowed to comment on the subject matter being presented all day. Finally, towards the end of the day, NDP member Michelle Carras from Johns Hopkins University Bloomberg School of Public Health asked the FDA to explain the details about the alleged seizures. FDA epidemiologist Lauren Min, PhD responded by making this statement, quoted here from the ofcial transcript.1