The FDA is back to square one in its efforts to ban the use of electric shocks to stop aggressive behavior or self-injury, in a process that has spanned decades.
The agency previously took the rare step of banning the use of these devices in March 2020, with the finalization of a regulatory rule proposed four years prior—saying that changing the equipment’s labeling alone would be insufficient to protect the public’s health. The FDA has only banned two other devices in its history: prosthetic hair implants, in 1983, and powdered surgeons’ gloves, in 2017.
At the time, the agency said it was aware of only one location in the U.S. that was still employing the practice—the Judge Rotenberg Educational Center in Canton, Massachusetts, with around 50 adults and children with developmental and emotional disabilities undergoing electric shocks from remote-controlled equipment, manufactured by the center itself. The use of forced electroshock therapy has long been condemned as a method of torture by the United Nations.
But the FDA’s ban was overturned in July 2021 after the Rotenberg Center sued the agency.
In a 2-to-1 decision (PDF), the D.C. Circuit Court ruled that the FDA had overstepped its authority found in the Food, Drug and Cosmetics Act—vacating its tailored ban, which the court said interfered with the “off-label” usage of a device that should instead fall under state-level oversight of medical practices.
In the time since, Congress has passed changes to the FD&C Act that made it clear the FDA has the power to ban these electrical stimulation devices, also referred to as ESDs. And now, the agency has put forward a proposed rule to do just that.
“ESDs deliver electrical shocks through electrodes attached to an individual’s skin to attempt to reduce or stop harmful behaviors,” said Owen Faris, acting director of the Office of Product Evaluation and Quality in the FDA’s Center for Devices and Radiological Health, differentiating them from other cleared stimulators that may employ a much milder shock for the purposes of smoking cessation.
“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,” Faris said. “These devices present 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.”
This week’s proposal is currently scheduled to be open to public comment through May 28. After that, the FDA will issue another final rule. The agency previously said it received more than 1,500 comments on its 2016 proposal.