FDA Plans to Sack OTC Skin-Bleaching Creams: Cosmeceuticals Could Be Next

Based on overwhelming evidence of its consumer health risks, the FDA is considering reversing the monograph for the popular over-the-counter skin lightening ingredient hydroquinone. Could this latest ingredient re-evaluation just be the beginning of an industry war between pharmaceutical and cosmeceutical manufactures?

(PRWEB) September 10, 2006 -- 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 acted on data from hydroquinone studies conducted by agencies like the National Toxicology Program (NTP) and the Environmental Protection Agency (EPA).

Using such data, FDA now reports that hydroquinone is carcinogenic, possibly teratogenic, and can cause ochronosis, a skin condition where the skin becomes darker, thicker, and exhibits dome-shaped tiny bumps and grayish-brown spots.

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.

Naweko San-Joyz, who serves as chief product formulator for San Diego based image consulting company Noixia, views this latest monograph re-evaluation by the FDA as an industry-war induced trend.

San-Joyz remarked, “This is just the beginning of a watchdog trend that cosmetic companies should expect more of. This is not only because of consumer health issues, but because cosmetics are rampantly entering the territory of pharmaceutical companies with cosmeceuticals”.

Cosmeceuticals are skin enhancing cosmetics with drug-like effects.

While the FDA does not acknowledge the term “cosmeceuticals”, it does make a clear distinction between a drug and a cosmetic. Drugs affect the structure of the human body and treat disease and are approved by the FDA. Cosmetics are not FDA approved and cannot evince drug-like effects.

In the future makers of skin lightening products may need to apply for a New Drug Application (NDA) with the FDA and certainly remove hydroquinone from their ingredients list. San-Joyz adds that cosmetics companies can save themselves a lot of FDA grievances by, “instituting their own product safety standards”.

Regardless of their precautions, perhaps more cosmetic companies may need to familiarize themselves with the NDA process if their products continue to smear the line between drugs and cosmetics.

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