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The definition of a cosmetic may need some treatment

By Katie Bird , 02-Feb-2009

The approval of an eyelash enhancing prescription drug from Allergan suggests the time has come to clarify the difference between a cosmetic and a drug.

The pharmaceutical giant, 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 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.

Another offering that could straddle the cosmetics-pharma fence also hit the headlines last week when Australian company Clinuvel was granted permission by the US FDA to trial its melanin-enhancing photoprotective drug afamelanotide.

Although permission has been granted to start clinical trials for the treatment of a range of UV and light related skin disorders as well as cancer related treatments, it is not difficult to see the enormous potential this ‘tanning drug’ would hold for the world of cosmetics.

It remains to be seen whether Clinuvel will ever be able to cash in on the tanning aspect of its melanin boosting treatment. However, as another example of a product with clear cosmetic and pharmaceutical benefits, it questions the current boundary dividing the two worlds.

After all, as a number of industry insiders have pointed out, this boundary was constructed when cosmetics really were merely cosmetic.

Anti-aging creams that were once expected to simply smooth over and fill in the wrinkles, now promise to regenerate, synthesise and repair – claims that very obviously rely on their ability to affect the structure of the body.

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.

Katie Bird is a science reporter writing on industry-related issues in several Decision News Media publications. If you would like to comment on this article, please e mail Katie.Bird ‘at’ decisionnews.com.

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