The U.S. FDA has taken a significant step by proposing a ban on electrical stimulation devices (ESDs) designed to mitigate self-injurious or aggressive behavior.

The agency determined that ESDs pose an unreasonable and substantial risk of illness or injury. Notably, this marks the second time the FDA has sought to prohibit the use of these specific devices.

Understanding the Proposed Ban

The FDA’s proposed ban targets ESDs utilized to alleviate behaviors which often afflict individuals with intellectual or developmental disabilities. These devices administer electrical shocks via electrodes attached to the skin..

Psychological and physical risks associated with ESDs include depression, anxiety, exacerbation of underlying symptoms, post-traumatic stress disorder, pain, burns, and tissue damage. The proposed rule aims to eliminate these devices from the market, rendering them legally unfit for distribution.

Implications for Users

Currently, the primary user of ESDs in the United States is the Judge Rotenberg Education Center in Canton, Mass, with around 50 individuals undergoing treatment plans involving these devices. The transition away from ESDs for these individuals may require an adjustment period for new treatments, according to the FDA. The agency said it would take the needs of patients into consideration when finalizing the proposed ban.

The FDA’s previous attempt to ban these devices in 2020 faced legal challenges and was ultimately nullified. However, recent amendments to the Federal Food, Drug, and Cosmetic Act have clarified the agency’s authority to enact such bans, particularly concerning specific intended uses like the treatment of self-injurious or aggressive behavior.

Evidence and Analysis

In formulating this proposal, the FDA thoroughly reviewed updated information, including clinical and scientific data, expert opinions, feedback from stakeholders, and insights from FDA advisory panels. This analysis reaffirmed the agency’s prior findings regarding the risks associated with ESDs for the targeted behaviors.

Importantly, the proposed ban solely pertains only to ESDs intended for self-injurious or aggressive behavior and excludes devices used for other purposes, such as smoking cessation.

The FDA’s Proposal to Ban Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior is open for public comment until May 28, 2024. Following the comment period, the FDA will evaluate feedback before making a final decision.