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The FDA proposed a ban on electrical stimulation devices (ESDs) used to reduce or stop self-injurious or aggressive behavior, the Monday.

In a step "rarely" taken by the agency, the FDA deemed these devices -- which deliver electrical shocks through electrodes attached to an individual's skin -- to have "an unreasonable and substantial risk of illness or injury," including psychological risks, such as depression, anxiety, worsening of underlying symptoms, and 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," the FDA explained.

This isn't the first time the FDA proposed a ban on these devices. Back in 2014, members of an FDA advisory panel voted to ban use of these devices, with the agency finally moving to implement the ban in 2020.

However, by 2021, the ban was challenged and a federal appeals court in Washington, D.C. ruled against the FDA's ban. The annulment of the ban was based on the court's interpretation of the FDA's authority under the Federal Food, Drug, and Cosmetic Act. Since then, the FDA said it has made changes to this set of laws that "make clear" that the agency has the authority to issue such a ban.

If the ban is finalized for the second time, ESDs would be removed from the market. Currently, only one U.S. facility is still known to use these devices -- the Judge Rotenberg Educational Center in Canton, Massachusetts -- which enrolls people with developmental disabilities and emotional and behavioral disorders. Around 50 patients are estimated to currently have a treatment plan that may involve an ESD.

"Those exposed to these devices may need time to gradually transition away from this device and adjust treatment plans. The FDA intends to consider the needs of these patients should we finalize the proposed ban," the agency noted.

The proposed ban exclusively applies to ESDs intended to be used for self-injurious or aggressive behavior. It doesn't apply to aversive conditioning devices used for other purposes like smoking cessation, nor non-aversive electrical stimulators, used for cranial electrotherapy.

The FDA until May 28.

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