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FDA Proposes a Ban on Skin Lightening Creams

Submitted by on August 31, 2006 – 6:08 pmNo Comment

The Food and Drug Administration very quietly proposed a ban of over-the-counter products containing Hydroquinone, a popular skin lightening ingredient that men and women use to erase uneven skin pigmentation caused by sun damage and acne.

Hydroquinone, and it’s sister ingredient Kojic Acid, don’t bleach your skin exactly. What they do is inhibit your skin from producing melanin, the stuff that gives your skin its color when you go out in the sun. When your skin goes a little crazy and produces too much melanin, you  might consider a bleaching cream. It takes about 4 to 6 weeks to see results, because your body has to exfoliate the pigmented skin before you’ll see the fresh brighter skin.
Hydroquinone has been a dermatologist-recommended product for many years and has safely treated millions of people. But, the worry is that the ingredient exhibited some cancer-causing potential in rats. The real worry is ochronosis, a darkening of the skin that dermatologists say only occurs in concentrations of 8% 10% or 12%. Over the counter products are limited to just 2% and most prescriptions are 4%.

The most shocking part of this ruling is that even prescription hydroquinone products such as TriLuma, will have to refile for approval with the FDA. That seems a bit absurd to me if they had to prove their safety and effectiveness to get approval in the first place.

The FDA is accepting comments from the public until December 26th.  My advice? Buy up all the Hydroquinone products you can find if you’re concerned about sun spots.

Here’s the filed proposal in PDF format.

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