FDA Proposes Ban on Electric Shock Devices

The Food and Drug Administration has proposed a ban of electrical stimulation devices (ESDs) — a controversial tool used to try and stop self-injurious or aggressive behavior — for the second time.

The FDA says ESDs, which deliver electrical shocks through electrodes attached to an individual’s skin, present an unreasonable and substantial risk of illness or injury and should therefore be banned.

The proposed rule would specifically ban the use of ESDs to stop self-injurious or aggressive behavior. The FDA says this kind of treatment presents a number of psychological risks, including depression, anxiety, worsening of underlying symptoms, development of post-traumatic stress disorder, and physical risks such as pain, burns, and tissue damage.

“Notably, some people who exhibit self-injurious or aggressive behavior have intellectual or developmental disabilities that make it difficult for them to communicate or make their own treatment decisions,” said Owen Faris, Ph.D., acting director of the Office of Product Evaluation and Quality (OPEQ) in the FDA’s Center for Devices and Radiological Health, in a statement.

This is the second time the agency has attempted to ban these devices. The FDA first attempted to ban ESDs in 2020, but it was challenged in court and ultimately annulled based on interpretation of the FDA’s authorities under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The act has since changed to clarify that the FDA does have the authority to issue a ban like this as it applies to specific intended uses.

Currently, there is only one United States facility that reportedly uses these devices: the Judge Rotenberg Education Center in Canton, Massachusetts, a special needs day and residential school.

The facility has long faced protests surrounding its use of this method, and many former students have spoken out about the damaging treatment they received there. The FDA estimates that around 50 individuals at the facility currently have a treatment plan that includes the use, or potential use, of an ESD.

The FDA says the latest version of the proposed ban takes into account new information on the risks of using ESDs to treat self-injurious or aggressive behavior. This includes clinical and scientific data, input from experts in the field and state agencies, comments received from the previously proposed rule to ban ESDs, input from patients and parents of individuals who have been treated with ESDs, and disability rights groups, as well as insights from FDA advisory panels.

The agency says the new information supported and did not change “the FDA’s previous determinations regarding the risks and benefits associated with these devices when used for self-injurious or aggressive behavior, or the agency’s conclusion that these devices present unreasonable and substantial risk of illness or injury to the public.”

If it passes, this rule will remove ESDs from the market, and they will no longer be considered legally marketed. But the rule would only technically apply to ESDs intended to be used for self-injurious or aggressive behavior — not aversive conditioning devices used for other purposes, such as to quit smoking.

From now until May 28, anyone can comment on the proposed rule and provide their input. The FDA will then review and consider the comments before determining whether to issue a final rule.

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