FDA's new sunscreen regulations will help reduce skin cancer risk

Jun 15 2011

The American Academy of Dermatology Association (Academy) today said that the U.S. Food and Drug Administration's (FDA) new sunscreen regulations will help Americans reduce their risk for skin cancer by guiding them to the most effective sunscreens and advising them on other sun-protection measures. During the FDA announcement of the new regulations, the Academy reviewed scientific data about skin cancer and outlined how people can reduce their skin cancer risk.

"For the first time, the FDA has clearly defined the testing required to make a broad-spectrum protection claim in a sunscreen and indicate which type of sunscreen can reduce skin cancer risk," said dermatologist Ronald L. Moy, MD, FAAD, president of the Academy.

Broad-spectrum protection means a sunscreen protects the skin from ultraviolet A (UVA) and ultraviolet B (UVB) rays, both of which can cause skin cancer, including basal cell carcinoma, squamous cell carcinoma, and melanoma, the deadliest form of skin cancer. UVB rays cause sunburn; UVA rays penetrate deeper, causing premature aging. Both rays damage the immune system. The amount of protection a sunscreen provides against UVB rays is indicated through its SPF (Sun Protection Factor) number, but until now, the FDA has not required a consistent standard for measuring a sunscreen's UVA protection.

"The FDA's sunscreen regulations will take the guesswork out of choosing an effective sunscreen," said Dr. Moy. "The regulations require more descriptive label information that will help consumers make informed decisions about buying and using sunscreen products, and taking other steps to protect their skin."

The American Academy of Dermatology Association submitted extensive, evidence-based recommendations to the proposed FDA sunscreen regulations in 2007. The Academy was among nearly 2,900 individuals and organizations that provided comments.

"The FDA clearly gave careful consideration to the comments and weighed the scientific evidence to prepare these regulations," said dermatologist Henry W. Lim, MD, FAAD, chair of the Academy's Council on Science and Research. "The FDA has now established testing guidelines that will ensure consumers who choose a broad-spectrum protection sunscreen with SPF 15 or higher will receive excellent protection from UVA and UVB rays."

The new FDA regulations will allow sunscreen products that pass the FDA's test for protection against both UVA and UVB rays to be labeled as "Broad Spectrum." To pass the test, a sunscreen must provide a certain percentage of protection against UVA rays compared to UVB rays. The new FDA regulations also require that sunscreen product labels include statements that educate the public about the dangers of sun exposure and how to protect themselves.

"This regulation will reinforce the simple steps consumers can take to reduce their risk for skin cancer," said Dr. Moy. "Broad-spectrum protection sunscreen with SPF 15 or higher is just one tool to help stop skin cancer. People also need to limit UV exposure by seeking shade, wearing protective clothing, hats and sunglasses, and avoiding tanning beds."

Every year, more than 3.5 million new cases of skin cancer affecting more than 2 million people will be diagnosed in the United States. Exposure to ultraviolet (UV) radiation is the most preventable cause of skin cancer.

"As the medical doctors who diagnose and treat skin cancer, dermatologists are committed to reducing its incidence and saving lives," said Dr. Moy. "We will continue to partner with the FDA and other stakeholders as we educate the public about the importance of UV protection."

SOURCE American Academy of Dermatology