FDA Plans to Sack OTC Skin-Bleaching Creams

Browse through the skin care aisle of any drug store and you are certain to find a quaint collection of fade creams. For decades, such creams have served men and women seeking an affordable, though lengthy, way to remove age spots and skin discolorations. But now, the active ingredient of most skin lightening agents, hydroquinone, is under the critical eye of the FDA.

For years hydroquinone has been banned from cosmetics in countries like Japan due to the ingredient’s potential carcinogenic effects. Here in the US, the Consumer Healthcare Products Association (CHPA) was charged determining if hydroquinone is indeed safe for human consumption.

However the CHPA has not produced any protocols to allow the FDA to effectively assess the safeness of hydroquinone. Due to this absence of information, the FDA most act on data from studies that show hydroquinone can cause ochronosis, a skin condition where the skin becomes darker, thicker, and exhibits dome-shaped tiny bumps and grayish-brown spots.

The FDA adds that consumers have developed ochronosis after using hydroquinone products for as little as three months. Typically, consumers need to use a hydroquinone product for at least two to three months before seeing a noticeable improvement in the appearance of age spots and blemishes.

According to an August 29 report in the Federal Register, the FDA is now considering withdrawing its initial monograph for hydroquinone after finding that this skin lightening agent is no longer safe or effective for consumer use.

In the future makers of skin lightening products may need to apply for a New Drug Application with the FDA and certainly remove hydroquinone from their ingredients list.