FDA Proposes Ban on Skin Lightening Creams, Citing Health Risks
The U.S. Food and Drug Administration Tuesday announced their proposal to ban the sales of over-the-counter skin-bleaching products, citing potentially severe safety risks.
According to studies conducted by the Environmental Protection Agency and the national Toxicology Program, skin lightening creams that contain the drug hydroquinone have been linked to some cases of cancer in rodents including liver lesions and leukemia.
“We ‘re acting for safety reasons,” said Susan Johnson, the associated director of the FDA’s Office of Nonprescription Products. “There is potential for hydroquinone to be a carcinogen in humans. We are looking for additional information.
Furthermore, the FDA cites widely documented reports that date back to 1975 in which hydroquinone containing creams caused the development of ochronosis, a serious skin-disfiguring condition in black men and women in the U.S., Britain, and South Africa.
Ochronosis causes the skin to darken and thicken and develop dome-shaped grayish-brown or yellow bumps leading to permanent disfigurement and in some cases malfunctioning adrenal glands. Some studies found the symptoms of the condition appeared even after short-term use of the creams. Other reports discovered women who had used the products had high levels of mercury in their bodies, which could lead to severe birth defects.
Under the FDA’s proposed guideline, all skin lightening products, whether prescription or over-the-counter, would be deemed new drugs and must go through the FDA approval process.
“The FDA tentatively concludes that the benefits of [over-the-counter] skin bleaching drug products are insignificant when compared to the potential risks,” the proposed rule stated.
Currently, about 65 U.S. companies sell an estimated 130 different skin lightening creams and other hydroquinone products.