New Ban on Controversial Use of Electrical Stimulation Devices Proposed by FDA

Federal regulators have proposed a ban on electrical stimulating devices (ESDs) used to stop self-harm or aggressive behavior, after a growing number of critics have equated use to torture.

The U.S. Food and Drug Administration (FDA) announced the proposed electrical stimulation device ban on March 25. It is the agency’s second attempt at regulating these devices, after a first attempted ban was halted by the courts.

Now, FDA officials say they have determined that electrical stimulation devices present an “unreasonable and substantial risk of illness or injury” when used in some circumstances.

Electrical Stimulation Device Injury and Abuse Concerns

Electrical stimulation devices deliver electrical shocks through electrodes attached to the skin. The devices have numerous medical uses, but their most controversial use has been at the Judge Rotenberg Education Center in Canton, Massachusetts, which treats individuals with developmental disabilities and mental health disorders.

About 50 patients have a treatment plan that permits the use of electrical stimulation devices to correct aggressive behavior or efforts to commit self-harm. However, the FDA warns that some individuals who exhibit such behaviors have intellectual or developmental disabilities that make it difficult for them to communicate or make their own treatment decisions.

The agency has also determined that electrical stimulation devices may lead to psychological risks, including depression, anxiety, worsening of underlying symptoms, development of post-traumatic stress disorder (PTSD), and physical risks such as pain, burns, and tissue damage.

The Judge Rotenberg Education Center is the only known facility in the U.S. that uses electrical stimulation devices in this way, which has resulted in accusations of torture from the United Nations and others.

FDA Electrical Stimulation Device Ban

The FDA first proposed a similar electrical stimulation device ban in 2020. However, the ban was challenged in court and the proposed rule was vacated, after a judge determined the agency lacked the authority to ban the devices under the Food, Drug and Cosmetic Act.

However, changes to the law’s provisions enacted since then grant the FDA the regulatory power it previously lacked to legally enact the ban, agency officials argue. In addition, the agency says it has received additional scientific data since 2020, which only increased the FDA’s concerns for how the Rotenberg Center uses them.

The newly proposed ban applies only to electrical stimulation devices intended to be used to treat self-injury or aggressive behavior, not to aversive conditioning devices designed for other FDA-approved purposes, like smoking cessation.

The agency indicates those exposed to the devices regularly may need time to transition away from using them and have their treatment plans adjusted accordingly. FDA officials say they will consider the needs of the patients who use these devices if the ban is finalized.

The proposed rule is open to public comment until May 28, 2024. Comments can be submitted electronically at www.regulations.gov under docket number FDA-2023-N-3902 or via mail at:

Dockets Management Staff (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852