Dive Brief:

• The Food and Drug Administration is attempting for the second time to ban the use of electrical stimulation devices intended to stop self-injury or aggressive behavior. 
• The electric shock devices present “an unreasonable and substantial risk of illness or injury,” the FDA said on Monday. Disability rights groups and the United Nations Human Rights Council have been calling for the devices to be banned for years.
• The FDA tried to ban electric shock devices in 2020, but the decision was overturned by a federal appeals court, which found the agency didn’t have the authority to limit use of the devices. After that decision, Congress updated the Federal Food, Drug, and Cosmetic Act to allow the FDA to ban specific intended uses for a device.

Dive Insight:

Human rights groups wrote to the FDA and the Department of Health and Human Services in January, asking it to release a proposed ban of electric shock devices now that Congress has clarified its authority. More than 25 groups, including the American Civil Liberties Union, Autistic Self Advocacy Network and Epilepsy Foundation, urged HHS Secretary Xavier Becerra and FDA Commissioner Robert Califf to take action without delay. 

“It has now been eight years since the FDA released its first proposal to ban these devices and ten years since a panel of experts recommended that they be banned,” they wrote. “Over the decade that has passed since, people with disabilities have continued to suffer from painful and dangerous electric shocks. We urge you to take action now to end this abuse.”

The FDA said using electrical stimulation devices can worsen underlying symptoms and pose several risks to people’s mental and physical health. The risks include depression, anxiety, development of post-traumatic stress disorder, pain, burns and tissue damage. 

The agency also said some of the people the devices have been used on may have disabilities that make it difficult for them to communicate or make their own treatment decisions. 

Currently, just one facility in the U.S. uses electric shock devices: the Judge Rotenberg Education Center in Canton, Massachusetts, according to the FDA. It is also the only manufacturer of electric shock devices intended to stop self-injury or aggressive behavior. 

The Department of Justice investigated the school in 2010 for its use of electric shocks, and the FDA sent it a warning letter in 2012 for modifying its electric shock devices without clearance. 

The FDA estimated that about 50 people currently have a treatment plan that includes the use, or potential use, of an electric shock device. 

“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 FDA said in a statement. 

The FDA has only issued two other bans: one for powdered gloves in 2017 and one for synthetic hair implants in 1983. If finalized, the rule would remove electric shock devices from the market and make it illegal to market them.

The proposal is open for public comments until May 28.