FDA proposes new sunscreen rating system

Late last month the Food and Drug Administration proposed a regulation to amend the 1999 over-the-counter sunscreen rule by setting new standards for formulating, testing and labeling preparations that offer ultraviolet A (UVA) and ultraviolet B (UVB) protection for the skin.

For the last 30 years, label information has focused only on a product's capacity to block UVB, measured with sunburn protection factor, or SPF, values.

"Consumers will also now know the level of UVA protection in sunscreens, which will help them make informed decisions about protecting themselves and their children against the harmful effects of the sun," said FDA Commissioner Andrew C. von Eschenbach, MD.

Sunlight is composed of visible and ultraviolet light. Of the latter, UVA rays cause tanning, freckling and aging. UVB is the sunburn ray. Both increase skin cancer risks.

The American Academy of Dermatology estimates more than 1 million new cases of all types of skin cancer are diagnosed each year. Specifically, 45,625 people had melanomas of the skin in 2003 and 7,818 died, according to the Centers for Disease Control and Prevention.

The FDA proposal creates a four-star rating system for UVA sunscreen products.

One star would signal a low level of protection while four would indicate the highest. If the sunscreen does not meet the lowest threshold and, therefore, does not receive any stars, the agency would require it to bear a "no UVA protection" label marking near its SPF.

The following sun-alert statement also would be added to products' "Drug Facts" box: "UV exposure from the sun increases the risk of skin cancer, premature skin aging and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing and using a sunscreen."

FDA officials said this warning would strengthen existing labeling by educating consumers that sun protection involves more than sunscreen.

"This message is very important for primary care physicians to let their patients know," said Henry W. Lim, MD, chair of the Dept. of Dermatology at Henry Ford Health System in Detroit. It is also important to urge patients to look for both UVA and UVB protection. Currently, this level of protection is only found in products described as "broad spectrum."

The FDA will accept comments on this proposal until Nov. 26.