In a recent statement, the US Food and Drug Administration (FDA) has once again proposed a ban on electrical stimulation devices used to reduce or stop self-injurious or aggressive behavior. These devices deliver electrical shocks through electrodes attached to a person's skin in an attempt to curb harmful behaviors.

Currently, the only facility in the US utilizing these devices is the Judge Rotenberg Education Center in Canton, Massachusetts, where approximately 50 individuals have treatment plans that include the potential use of such a device, according to the FDA statement.

The FDA has taken the unprecedented step of banning a previously approved device, citing that electrical stimulation devices "present an unreasonable and substantial risk of illness or injury." This is the second time the FDA has proposed a ban on these devices, with the first attempt in 2020 being overturned by a federal appeals court.

Since the court ruling, changes to the Federal Food, Drug, and Cosmetic Act have granted the FDA the authority to issue a ban on these devices. The agency argues that electrical stimulation devices have significant psychological risks such as depression, anxiety, and the exacerbation of underlying symptoms. Physical risks include pain, burns, and tissue damage.

It is important to note that individuals who exhibit self-injurious or aggressive behavior often have intellectual or developmental disabilities that hinder their ability to communicate or make autonomous treatment decisions, according to the FDA.

The proposed ban, if enacted, would solely apply to electrical stimulation devices specifically designed for self-injurious or aggressive behavior. Aversive conditioning devices used for other purposes, such as smoking cessation, would not be affected.

The FDA recognizes the need for patients transitioning away from these devices and adjusting treatment plans. The agency intends to consider the welfare of these patients if the proposed ban becomes final.

In 2020, the FDA highlighted alternative approaches for treating self-injurious or aggressive behaviors, including positive behavioral support and medications.

The proposal is currently open for public comment until May 28. Following the comment period, the FDA will review and consider the feedback received before making a final ruling on the ban. This newly proposed ban aims to protect individuals from the potential risks associated with the use of electrical stimulation devices.