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FDA: Risks may lurk behind mask

Rejuvenique is supposed to shock facial muscles for a younger look. Regulators say there are no studies to prove it.

By DEBORAH O'NEIL

© St. Petersburg Times, published August 6, 2000


With dazzling promises of a younger-looking face, Clearwater inventor George E. Springer introduced a battery-powered face mask to the world five years ago.

He gave it a fancy, European sounding name, "Rejuvenique," and registered it with the U.S. Patent & Trademark Office.

At salons and trade shows in Tampa Bay and around the country, Springer peddled the Rejuvenique Ultimate Facial Toning System to middle-aged men and women searching for the fountain of youth.

Before long, the face mask hit the big time. Springer's company, Aesthetics. Inc., signed a deal with Housewares giant Salton/Maxim in January 1999 giving Rejuvenique widespread market exposure. Former Dynasty star Linda Evans became the paid spokeswoman for the mask, which has been claimed to tone skin and reduce fine lines and wrinkles by transmitting mild electric shocks to facial muscles.

But now, federal regulators are raising serious concerns about Rejuvenique, saying Salton and Springer have never scientifically documented that it works.

Because it is a medical device intended to affect the structure or function of the body, Rejuvenique "is not safe except under the supervision of a practitioner licensed by state law," the Food and Drug Administration wrote in a July 12 warning letter to the company.

But that's not how the mask is being sold and used. It's available to anyone online and in stores.

Without FDA approval, "marketing the Rejuvenique is a violation of the law," the letter to Salton and Springer's Clearwater offices says.

"Without FDA clearance there's no assurance it's safe or effective," said FDA spokeswoman Sharon Snider. "A warning letter is a very serious thing."

Snider said Rejuvenique officials responded to the letter within the required 15 days, but she would not say what was said. She also declined to say whether the company could legally continue to sell the product. "I cannot categorically tell you they have violated the law," she said.

The FDA has the authority to seize the company's inventory, seek a court injunction to stop sales or assess civil penalties of up to $15,000 per violation. In its letter, the FDA says a violation occurs "each and every time Salton Inc. ships a device."

Salton officials did not return calls, and the company's public relations representative said he couldn't reach anyone, either. Springer did not return numerous phone messages left for several days at his office and home.

Reached at his home, Rene Reed, one of Springer's partners who is listed in corporate records as director of Aesthetics Inc., said:

"Because of the situation, I'm not able to say anything about it. . . . We've said, "Hey it's being handled.' We're making no comment on it."

Springer hasn't always ducked the media, at least when it comes to hyping his invention. In 1995, Springer spoke with the St. Petersburg Times before staging a sales pitch at the Safety Harbor Spa. He acknowledged he was selling a dream. "The only difference is, this time it's a dream come true," he said.

Experts say otherwise.

In fact, Rejuvenique could be doing more harm than good, said New York dermatologist Dr. Debra Jaliman, a clinical instructor at Mount Sinai School of Medicine and a spokeswoman for the American Academy of Dermatology.

"The FDA should pull it off the market until he substantiates his claim," said Jaliman, who is familiar with the mask.

Skin naturally wrinkles and sags as it ages, and sun exposure can hasten the onset of wrinkles and lines. There are medically proven ways to reduce signs of aging -- procedures that are administered under the care of a doctor. Doctors say the best beauty product consumers can buy over the counter is sunblock. But everyone wants the magic bullet.

"The world is a wonderful place for entrepreneurs," said Clearwater dermatologist Dr. Roger S. Golomb, who has practiced for 26 years. "The Internet has opened it up even more. There's no supervision."

Rejuvenique claims that 26 contact points inside the mask exercise the facial muscles, toning and firming the skin. According to the Rejuvenique Web site, the mask "sends an invigorating yet relaxing microimpulse to the facial contact points. . . . These microimpulses will feel like a tapping or tingling sensation."

In a 1999 news release, the company claims that it has conducted clinical trials that show 80 percent of participants experienced a reduction in the appearance of lines "and a more radiant complexion."

"We already know the benefits of exercise for the rest of the body. The Rejuvenique System provides those same benefits for our face," Springer is quoted as saying in the release.

The problem is, Jaliman said, that principle is not grounded in science. Facial muscles are not like the muscles in your arms and legs.

"People are always exercising muscles. It sounds reasonable: "It makes your body look good,' " Jaliman said. "But facial muscles are totally different."

With facial muscles, the more you use them, the more lines you have, Jaliman explained.

"The more expressive your face, the more you move those muscles, the more lines you're going to have in your face," she said.

Rejuvenique, she continued, "goes against everything we know as dermatologists. You do not want to stimulate muscles in the face. . . . Don't buy it. Don't use it unless you want wrinkles."

Jaliman said a medical doctor would know that.

But 49-year-old inventor George Elmer Springer is often quoted as Dr. George Springer. The Times and other publications such as the Chicago Tribune have referred to Springer as a chiropractor, a practice that requires a medical license in Florida.

In a 1999 Rejuvenique infomercial, Springer identifies himself as "a past associate professor of dermatology who's also been practicing holistic medicine for the past 19 years," according to Ridiculous Infomercial Review, an online reviewer of infomercials.

But Florida Department of Health officials say there is no George E. Springer licensed to practice medicine here.

"We don't have a Springer by any name that's a chiropractor in the state of Florida," said Health Department spokesman Bill Parizek. "There is no George Elmer Springer licensed as any type of health professional in the state of Florida."

It is unclear whether he became a doctor in another state. He told the Times in 1995 that he moved to Clearwater from Colorado in 1992.

Rejuvenique has very likely made Springer and Salton a lot of money. At the Safety Harbor Spa in 1995, Springer was selling it for $395. Salton retails the mask for $180, along with a slew of Rejuvenique creams and gels that range from $5 to $50.

It can be purchased online, at beauty supply stores and even major department stores like Sears, according to the FDA. Salton officials say the mask is targeted to middle-age adults.

"We feel confident that the system will be a success within our target market -- the approximately 104-million Baby Boomers, or men and women between the ages of 35 and 55 years old, within the United States," Salton President and CEO Leon Dreimann said when the company joined Aesthetics Inc.

Doctors say the marketplace is full of products aimed at Baby Boomers.

"They're aging and they'll reach for anything," Jaliman said. "It's hope in a bottle. This is hope in a mask . . . It's very sad. You can sell people anything."

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