FDA says Botox Ads Misleading

Thursday, March 23rd 2006

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The US Food and Drug Administration said magazine ads for the wrinkle-smoothing drug, Botox, are misleading and instructed the drug's maker, Allergan, to stop running them.

A spokeswoman for Allergan said the company thought it was complying with the FDA's guidance and "ultimately believes we can easily address the request"

The ads falsely identify the injection drug as a cosmetic treatment, fail to reveal important facts about its use and minimise its risks, the regulatory agency said in a letter posted on the FDA's website.

The agency also said Allergan, which forecast Botox sales at up to US$580 million ($999.48 million) this year, misleadingly suggested that the drug was effective for conditions such as temporary treatment of frown lines that go beyond its approved use as a treatment for improving brow furrows.

Three versions of the print ads have run in publications such as Newsweek and Glamour magazines, Allergen said.

The FDA last September issued a similar warning to Allergan, citing print and television ads that failed to emphasis that Botox was a temporary fix and that suggested it could be used to treat all kinds of wrinkles.

Allergan spokeswoman Christine Cassiano said one of the company's responses to the citation was to specify in the first paragraph of its 2003 ads that Botox was used for "frown lines between the brows" but subsequent references shortened that phrase to "frown lines"

The issue of describing the drug as a cosmetic treatment is less clear.
"Part of the difficulty is that the name of the product is Botox Cosmetic" Cassiano said. "This is a physician-administered product. We don't want to create the misperception that Botox is available over the counter."

She said Allergan is not running television ads for Botox, although ads were broadcast earlier in the year.

The FDA instructed the company to stop all ads and other promotions that contain the misleading claims and to respond to the letter in writing.

Approved since 1989 for eye-muscle disorders, and used for years "off-label" to freeze wrinkles, Botox was approved by the FDA last year for temporary improvement in the appearance of "moderate to severe" frown lines between the eyebrows.

Botox, a purified form of the toxin that causes botulism food poisoning blocks the release of a chemical by nerve cells that signal muscle contraction. By interfering with the underlying muscles' ability to contract, existing frown lines are smoothed out.

Source; New Zealand Herald, 28 June 2003

Footnote from Ideal Health

The following products are all useful for premature ageing & wrinkles:

Cocoa Butter Moisturising Cream
Eye Contour Day Cream
Firming Flax Cream
Imaglow Plus
Rose and Herb Radiance Oil
Silica Complex
Silicea Colloidal Mineral Silica Gel
Rosehip Oil Cream Cleanser
Rosehip Oil Eye Contour Cream
Rosehip Oil Gentle Facial Exfoliant
Rosehip Oil Purifying Masque
Rosehip Oil, 100% Pure Organic

Related health information can be found here:

Acne
Allergies
Colostrum, a universal healer with immune boosting properties
Dermatitis
Efamarine for healthy skin, hair and nails
Foods to help detoxification
Liver cleansing herbs
Psoriasis
Skin Health
Stretch Marks
Sunburn
Tea tree oil - antiseptic healer
Water, the elixir of life

Related articles can be found here:

Cosmetics Full of Suspect Chemicals

Question Marks Over Long-Term Effects of Botox

If you need help or advice, you are welcome to email our naturopathic team with your health question.

Disclaimer: The health information presented here has been written for the New Zealand health consumer. It is of a general nature and is only intended to provide a summary of the subjects covered. The information is not intended to be comprehensive or to provide medical advice to you. While all care has been taken to ensure the accuracy of the information, no responsibility or liability is accepted, and no person should act in reliance on any statement contained in the information provided. All health ailments should be treated by a qualified health professional.

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