The U.S. Food and Drug Administration (FDA) is once again seeking to ban the use of electrical stimulation devices in treating certain mental health issues.
According to a proposed rulemaking published in the Federal Register, electrical stimulation devices (ESDs) designed with the intent of reducing or stopping self-injurious or aggressive behaviors in humans “present an unreasonable and substantial risk of illness or injury.” Specifically, the FDA says that ESDs “present a number of psychological risks including depression, anxiety…and physical risks such as pain, burns, and tissue damage.”
If adopted, the new rules would require the removal of ESDs from the U.S. market and would prohibit the legal sale or marketing of such devices in the future.
The FDA first issued a ban on ESDs in 2020, but the rule was vacated in a court challenge. The FDA says that its current actions fall under the updated version of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that more clearly asserts the FDA’s authority to issue such bans.
