Hydroquinone ban proposed

November 1, 2006

Washington - A proposed Food and Drug Administration (FDA) rule that would ban over-the-counter sales of skin bleaching creams containing hydroquinone has many dermatologists wondering why the FDA has taken the step - and taking steps themselves to urge the agency to reconsider.

"From my standpoint, I worry that an excellent product that I consider to be safe, effective and affordable will now be unavailable to those who want it and need it," says dermatologist Susan Taylor, M.D., assistant professor of dermatology at Columbia University, New York.

In August, the FDA stated that hydroquinone is a potential carcinogen and proposed a ban on nonprescription sales of products containing the lightening agent, which is marketed by more than 60 companies in the United States.

Concerned dermatologists are objecting, and the American Academy of Dermatology (AAD) is preparing a formal comment urging the agency to reconsider the proposed ban, a spokeswoman said. The FDA's public comment period ends in December.

"From my standpoint, I worry that an excellent product that I consider to be safe, effective and affordable will now be unavailable to those who want it and need it," says dermatologist Susan Taylor, M.D., assistant professor of dermatology at Columbia University.

In August, the FDA stated that hydroquinone is a potential carcinogen and proposed a ban on nonprescription sales of products containing the lightening agent, which is marketed by more than 60 companies in the United States.

Under the proposal, all skin-bleaching products, both prescription and over-the-counter, would be considered "new drugs," and manufacturers would be required to have an FDA-approved new drug application (NDA) to continue selling them.

Concerned dermatologists are objecting, and the American Academy of Dermatology (AAD) is preparing a formal comment urging the agency to reconsider the proposed ban, a spokeswoman said. The FDA's public comment period ends in December.

Not safe?

The proposed rule would establish that OTC skin bleaching drug products, including those containing hydroquinone, are not generally recognized as safe and effective.

According to the agency, the proposed ban comes on the heels of its review of National Toxicology Program (NTP) toxicology and carcinogenesis studies that link hydroquinone to exogenous ochronosis and to cancer in laboratory rats and mice. The FDA also cites studies that have shown a possible effect on fertility.

Hydroquinone based cosmetic products have already been banned in the European Union, Australia and Japan.

But some doctors say the FDA proposal is alarmist and is based on scientific evidence that either is not applicable to humans or is inappropriate for the manner in which these creams are used in the United States.

"Most of the reports that the FDA cites are from Africa, where patients typically use very high doses of these creams daily over prolonged periods of time - as much as 10, 20 or 30 years or more - and over their entire bodies," Dr. Taylor says.

As for the risk of cancer, Dr. Taylor says the studies linking hydroquinone to cancer in rats and mice resulted from experiments in which hydroquinone was administered orally, not topically.