Cranial stimulator maker, users criticize new FDA proposed rule

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Alpha-Stim, a maker of cranial electrotherapy stimulators used to treat anxiety, depression, insomnia and pain, is campaigning against a proposed rule in the FDA’s premarket approval (PMA) process—and device users are joining the chorus.

The company released a statement Oct. 25 pointing out that the proposed rule would require PMA for all cranial electrotherapy stimulation devices despite the fact that the devices have been cleared by the FDA six times since 1981. The company also said the devices are sold over the counter in Canada, Europe and China.

Alpha-Stim stressed that its objections are backed by strong support from its customers—doctors, psychologists, addiction professionals and military communities—“resulting, to date, in over 100 written objections to this proposed rule on behalf of Alpha-Stim, indicating its safety, lack of side effects, and above all, its effectivenes.”

The company said it submitted its own comments to the proposed rule on Oct. 12, focusing on three main areas of concern: the FDA’s review of the science, its review of the safety data and its evaluation of the proposed rule’s economic impact.

“The economic impact of the ruling is to impose a process that the FDA estimates will cost the company $1 million, for a product they approved over 30 years ago,” read the statement.

The FDA docket on Alpha-Stim, which includes the proposed rule and the letters of support, is posted here.

Alpha-Stim is owned by EPI of Mineral Wells, Texas.