FDA PROPOSES RESTRICTIONS ON SKIN-BLEACHING CREAMS

A trade group's failure to make good on a commitment to the FDA has, in part, resulted in a decision by the agency to remove OTC status for all skin-bleaching creams because some contain a chemical that may cause cancer, according to the FDA.

Most of these creams contain the active ingredient hydroquinone, which studies have shown may be carcinogenic. Hydroquinone also has been shown to cause ochronosis, a skin condition characterized by darkening and thickening of the skin, yellow-to-brown, dome-shaped tiny bumps and grayish-brown spots, according to the FDA. Studies showed some people developed ochronosis after using hydroquinone skin-bleaching products for as little as three months, the agency said.

"FDA now tentatively concludes that skin-bleaching drug products, including but not limited to those that contain hydroquinone should be considered [not generally recognized as safe and effective]," the agency said in a notice published in the Aug. 29 Federal Register.

The agency said the move was partly based on the fact that the Consumer Healthcare Products Association (CHPA) has not provided any data from studies it agreed to conduct evaluating the safety of skin-bleaching creams.

According to the agency, the CHPA provided several projected dates between 1999-2002 on which it expected to initiate studies and submit study protocols for FDA review. "Since April 13, 1999," the date the organization submitted the projected timeline for completing the study-related actions, "CHPA has not provided any additional information," the notice said.