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FDA calls Botox ads misleading, asks for fix

September 9, 2002 --LOS ANGELES - Print and television ads for the wrinkle-smoothing drug Botox are misleading and should be pulled until they are changed, the US Food and Drug Administration told the drug's maker Allergan Inc.

The ads fail to emphasize that Botox is a temporary fix for wrinkles, suggest incorrectly that it can be used to treat all kinds of wrinkles and do not mention that the drug is approved only for people between the ages of 18 and 65, the regulatory agency said in a Sept. 5 letter to the company and posted on the agency's Web site.

The FDA instructed the company to immediately stop all broadcast ads and other promotional activities that contain misleading claims.

Officials at Allergan, based in Irvine, California, could not be immediately reached for comment.

Botox, a purified form of the toxin that causes botulism food poisoning, smooths out wrinkles by interfering with neurotransmitters and relaxing muscles.

Approved since 1989 for eye muscle disorders, and used for years ``off-label'' to freeze wrinkles, Botox was officially approved by the FDA in April for temporary improvement in the appearance of moderate to severe brow furrows.

The FDA said a brochure stating, ``It seems like everybody is talking about Botox Cosmetic, the highly effective, non-surgical procedure that can dramatically reduce your toughest wrinkle within 7 days,'' misleads because it does not state that the effect is temporary.

``Please immediately cease distribution of these, and similarly worded, materials and revise these statements to clearly emphasize the temporary duration of this product and to appropriately identify the approved indication for use, e.g. 'those tough lines between your eyebrows,''' Mary Malarkey, of the FDA's office of compliance and biologics quality, said in the letter.

The FDA also said Allergan was misleading consumers with statements like, ``If doing all you can to look your best is important to you, Botox Cosmetic may be for you,'' because they do not clearly define the age range it is approved for.

The agency singled out TV ads that focus attention on complexion and image, make repeated references to age and make the statement, ``Ask your dermatologist or plastic surgeon about Botox Cosmetic.''

The FDA also warned Allergan that dilution instructions for doctors posted on a company Web site promote several dilutions and doses that are not approved for cosmetic procedures.

The FDA requested that the company respond by Sept. 15.