FDA: Sybaritic sold medical devices agency hadn't OKed

One product promises skin that is "soft, supple and youthful." Another, a laser therapy device, zaps unsightly veins, scars and unwanted hair. Still another, a hydrospa tub, provides the "ultimate luxury."

All are products made by Bloomington-based Sybaritic Inc., a world leader in the development of beauty and spa products used in laser surgery and dermatology and spa treatments.

But according to a post late last week on the Food and Drug Administration's (FDA) website, they weren't properly cleared by the agency and lack the proper federal review for safety and effectiveness.

The company has agreed to stop making the products in the United States until they are in compliance with FDA quality standards.

Although the FDA said it is not aware of any injuries associated with the use of Sybaritic products, it still advises consumers to stop using them.

The agreement with the FDA is part of a consent decree reached between the U.S. Department of Justice, which filed for an injunction late last year, and three of Sybaritic's top executives -- Chairman Steven Daffer, CEO Anthony Daffer and Product Manager Ronald Berglund.

"This action halts the manufacture of these products until the manufacturer comes into compliance with federal law," Dr. Jeffrey Shuren, acting director of the FDA's Center for Devices and Radiological Health, said in a statement. "It's critical that companies comply with laws that are in place to protect consumer health."

Sybaritic agreed to comply with FDA quality regulations for all of its devices and obtain appropriate agency clearance before selling or distributing any of its products. The company must also retain an independent expert to inspect its operations and to certify to the FDA that appropriate corrections have been made.

If the company fails to follow the consent decree, the FDA could order it to cease manufacturing and distributing the products and then could recall them. The company could also face damages of $15,000 a day and an additional $15,000 for each violation.

Sybaritic's attorney, Bob Klepinski, of the Minneapolis firm Fredrikson & Byron, said in a statement the company does not agree with the allegations, but is cooperating with the FDA to resolve the issues raised.

"We firmly stand behind the quality of all of our products and we are committed to promptly resolving any record-keeping issues and improving our quality system documentation and processes," he said.

Klepinski said that while the review is conducted, all manufacturing of exports and international sales of Sybaritic products will continue. U.S. sales of beauty, cosmetic and non-medical products will continue as well.