Originally created 08/30/97

Company charges FDA heist



WASHINGTON - The letter went out to at least 1,200 Americans, claiming the Food and Drug Administration first banned a "marvelous product" that relieved pain - and then seized money from consumers who tried to buy the device.

"Their money was virtually impounded by the FDA," declared the makers of the Stimulator, a device pushed for everything from headaches to arthritis.

The problem: The FDA didn't have anybody's money.

Nor does any evidence show that the Stimulator relieves any pain, the FDA said Thursday, after dozens of consumers and more than 30 members of Congress complained about the alleged government heist.

An attorney for the manufacturer, Akron, Ohio-based Universal Management Services, said he learned Thursday that 1,000 customer checks may have landed instead in a bank account owned by a man now in federal prison.

"Somehow they wound up being deposited into a renegade checking account that had nothing to do with my client's company and nothing to do with the FDA," attorney Ralph Burns said.

The FDA wouldn't comment on that charge, but warned consumers Thursday that the Stimulator essentially is a barbecue grill igniter modified for a better grip. When pressed against the skin, it sparks and causes a small electric shock.

At least six companies sold the device to relieve ailments from headaches, back pain and menstrual cramps to arthritis and flu. The FDA said the manufacturer did at least $40 million in sales.

In January, a federal judge in Ohio issued a preliminary injunction stopping Stimulator sales, agreeing that it was sold illegally without FDA approval.

But the saga wasn't over. In late June, Universal mailed its letter accusing the FDA of seizing potential customers' checks.

That's not the case, Mr. Burns acknowledged Thursday. He said the company is attempting to work out an agreement to sell the Stimulator again.

"We obviously believe the thing works," he said.