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http://www.nytimes.com/2002/09/11/health/11BOTO.html?tntemail0

Botox Commercials Mislead Consumers, Government Says

By SHERYL GAY STOLBERG

ASHINGTON, Sept. 10 — Botox, the wrinkle-reducing treatment that became a nationwide hit after the Food and Drug Administration approved it for cosmetic use five months ago, is starring in a multimillion-dollar television advertising campaign that the agency now says is misleading consumers.

In a Sept. 5 letter to Botox's manufacturer, Allergan Inc. of Irvine, Calif., the food and drug agency said the commercials violated federal law, in part because they did not specify the particular wrinkles Botox is approved to treat. The agency singled out an advertisement that says Botox "can dramatically reduce your toughest wrinkle within seven days." It demanded that the advertisements be withdrawn, and gave Allergan 10 days to respond.

Suki Shattuck, a spokeswoman for Allergan, said the company would not stop the campaign but would work with the agency to "resolve the issue without having to pull the ads."

News that the government was dissatisfied with the maker of the nation's most popular cosmetic treatment spread quickly among the Botox faithful, causing more than a few furrowed brows. Dr. Alan Matarasso, a plastic surgeon who was giving Botox injections to about 40 people today in his office in Manhattan, said patients were nervous.

"Just like patients were excited in April when it got government approval, now a lot of people can't fully digest what it means that the F.D.A. is mad at the drug company," said Dr. Matarasso, who is a spokesman for the American Society for Aesthetic Plastic Surgery and teaches courses on how to use Botox.

Botox, which is the commercial name for botulinum toxin A, the substance that causes botulism, was approved by the government more than a decade ago to treat crossed eyes and uncontrollable blinking. Over time, mostly by word of mouth, it became popular as a treatment for frown lines and wrinkles. It is injected into the muscles of the face, paralyzing them and thus eliminating wrinkles for three to four months.

In April, the food and drug agency approved Botox for cosmetic use, but only to treat glabellar lines — deep vertical lines between the eyebrows — in patients ages 18 to 65. The approval cleared the way for Allergan to promote the drug as Botox Cosmetic. Ms. Shattuck, the spokeswoman, said Allergan had spent $50 million this year on its marketing campaign, which includes national television advertising, patient brochures and physician education.

If Allergan does not comply with the F.D.A.'s demands, the agency could ultimately refer the case to the Justice Department for prosecution. But that is rare, said Mary Malarkey, the F.D.A. official who wrote the complaint.

Dr. Matarasso said a far more pressing problem than Allergan's advertising was the proliferation of "Botox parties" in doctors' offices and health spas.

"Any doctor can order the drug, and there are no guidelines as to where it can be administered," Dr. Matarasso said. "You can't have your face lifted in a gym, but you can have Botox in a gym."

If a problem develops, he asked, "Do you call the gym and say, `Is the doctor in today?' "

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