Friday, February 6, 2009

When Does A Cosmetic Become a Drug?

The pharmaceutical giant, Allergan, which is also behind the Botox injections, gained FDA approval for its eyelash enhancer last December.

Marketed under the name Latisse, the product relies on the active ingredient bimatoprost, the eyelash enhancing effect of which was discovered when it was being trialled as a glaucoma drug.

However, this is not the first bimatoprost-containing product to hit the market. Californian cosmetic company Jan Marini Skin Research released a similar bimatoprost containing product, which was later removed from the market at the request of the FDA in 2006.
Marketing claims that suggested the product could physiologically alter the eyelashes, combined with the presence of bimatoprost that is approved by the FDA as a medicine, meant that Jan Marini’s eyelash conditioner edged rather too close to a medicine.

Cosmetics, according to the FDA’s definition, are for cleansing, beautifying, promoting attractiveness or altering the appearance. But if a product is intended to affect the structure or any function of the body then it becomes a drug. Too effective and it becomes a medicine.

This leaves cosmetics companies, like Scandle Body Candle, with a conundrum: make a product too effective and it may well become a drug, at which point the company will have to get involved with clinical trials that can last years and be cripplingly expensive; or, make the product less effective.

Clearly, the definition of the regulatory bodies has not kept up with what the science has made possible.

When the world’s largest pharmaceutical players are cashing in on advancements in the cosmetic field, and cosmetics companies are forced to make products less effective to avoid drug regulation they can’t afford, perhaps the time has come to rethink the legislation. What are your thoughts?

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