FDA May Finalize Ban On Shock Devices Used On People With Developmental Disabilities

Two years after the Food and Drug Administration proposed a ban on the use of electric shock devices to address behavior issues in those with disabilities, the agency says a decision is near.

In 2024, the FDA proposed barring the use of so-called electrical stimulation devices intended to reduce or stop self-injurious or aggressive behavior. The agency determined that the devices “present an unreasonable and substantial risk of illness or injury.”

Since then, the agency has been reviewing comments and considering whether to institute the ban.

But now a decision could be imminent. An FDA agenda indicates that a final rule on the proposal is expected this month.

“The docket for this rulemaking closed on May 28, 2024, and we are considering the comments received,” said Andrew Nixon, a spokesman for the U.S. Department of Health and Human Services. He indicated that the agenda “provides the currently available information.”

The devices are only believed to be used at one facility in the country — the Judge Rotenberg Educational Center in Canton, Mass., which serves children and adults with developmental disabilities as well as those with behavioral and emotional problems. Officials at the center have said that the shock devices are used with clients who have exhausted other treatment options.

The FDA previously finalized a ban of the shock devices in 2020 citing evidence of psychological and physical risks including burns, tissue damage, worsening underlying symptoms, depression, anxiety and post-traumatic stress disorder. That rule was overturned in 2021 when the U.S. Court of Appeals for the D.C. Circuit determined that the FDA had overstepped its authority. Congress later acted to stipulate that the FDA has the right to institute a ban.

Disability advocates are pressing the administration to follow through.

“This rule is crucially needed. Without it, people with disabilities are still being subjected to the abusive use of electrical stimulation devices,” said Robyn Linscott, director of education and family policy at The Arc of the United States.