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CNN SATURDAY MORNING NEWS

FDA Calls Botox Ads Misleading

Aired September 14, 2002 - 08:47   ET

THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.


CATHERINE CALLAWAY, CNN ANCHOR: More people are getting a treatment to remove wrinkles from between their eyebrows. But the FDA wants the company that makes botox to change its advertising.
CNN health correspondent Kat Carney here with us for that.

You know, we do sort of know about botox being used for, that's how it's advertised, to get rid of the wrinkles on the forehead. What's wrong with that?

KAT CARNEY, CNN CORRESPONDENT: Exactly. And even though the fountain of youth drug botox is well known for removing headlines, it's been making news now -- in fact, it's been making headlines. And we've got a little package here to show you a little bit about it.

(BEGIN VIDEOTAPE)

CARNEY (voice-over): On the 5th of this month, the FDA sent what's called an untitled letter to Allergan, the manufacturer of botox cosmetic, a form of botulism, calling for the company to pull some of their advertising and marketing materials containing what the FDA calls misleading statements. Allergan now has 10 days to respond.

Among other things, the FDA points to a line in a patient brochure that describes botox cosmetic as "the highly effective, non- surgical procedure that can dramatically reduce your toughest wrinkle within seven days."

The FDA has taken the position that the term "toughest wrinkle" may lead consumers into thinking that botox cosmetic is for use on all tough wrinkles when it's only been approved for treating the area between the eyebrows.

The FDA also wants the patient brochures to more clearly indicate that prescription-controlled botox cosmetic is only approved for patients between ages 18 to 65. In a statement released Thursday, Allergan says that they plan to respond by the 15th of this month and, "If, after discussions with the FDA, changes to marketing materials are ultimately required, Allergan will, of course, make those changes."

(END VIDEOTAPE)

CARNEY: So you see there's a lot going on right now about botox.

CALLAWAY: You know, I hate to interrupt, but now I think we've got to go to Miles because Ashcroft is speaking. CARNEY: OK.

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