FDA Proposes Hydroquinone Ban
Medical Author: Melissa Conrad Stöppler, MD
Medical Editor: Jay W. Marks, MD

On August 29, 2006, the U.S. Food and Drug Administration (FDA) proposed a ban on over-the-counter sales of cosmetic products containing hydroquinone, a skin-bleaching (lightening) ingredient. According to the FDA, approximately 65 companies sell over 200 different types of skin-lightening products containing hydroquinone in the U.S. Currently, products that contain up to 2 percent hydroquinone may be sold in the U.S. without a prescription, and prescription skin-lightening products may contain up to 4 percent hydroquinone. Examples of prescription products containing hydroquinone are Lustra, Tri-Luma, and EpiQuin Micro.

Hydroquinone products are popular for their skin-lightening properties in Asian and African cosmetics markets. In the U.S., they also are marketed for reducing age spots and blemishes.

The reason cited for the proposed ban is that studies in rodents show "some evidence" that hydroquinone may act as a carcinogen or cancer-causing chemical, although its cancer-causing properties have yet to be proved in humans. Hydroquinone also has been linked with the medical condition known as ochronosis in which the skin becomes dark and thick. Dome-shaped yellowish spots and grayish-brown spots also are observed in ochronosis among black women and men in South Africa, Britain, and the U.S. Ochronosis has been observed in conjunction with hydroquinone use even in persons who have used hydroquinone-containing cosmetics for a short time. Some studies also report abnormal function of the adrenal glands and high levels of mercury in people who have used hydroquinone-containing cosmetics. For these reasons, hydroquinone has already been banned in Japan, the European Union, and Australia.

Any skin-lightening products containing hydroquinone would be considered new drugs, according to the proposed FDA regulations. The products would require FDA approval before being sold to the public and would only be available with a doctor's prescription.

Following the proposed ban, a four-month comment period is in effect regarding the proposed changes in regulations during which time physicians, skin care companies, and consumers may voice their opinions and concerns about the proposed ban. It is not yet known if and when the proposed ban would take effect.

Reference: Federal Register: August 29, 2006 (Volume 71, Number 167)
Proposed Rules, Page 51146-51155.