Shady Sunscreens? FDA Pushes For Accurate Labels
WASHINGTON — Help is on the way to consumers confused by the jumble of sun protection numbers, symbols and other claims on sunscreens. Starting next summer, consumers can start looking for SPF 15 bottles with the label "broad spectrum" and feel confident they're being protected from an increased risk of cancer.
Currently, standards of protection apply only to one part of the sun's spectrum, ultraviolet B rays, which cause sunburn. Under new rules published Tuesday, they will also have to protect against the more penetrating ultraviolet A rays associated with skin cancer.
The guidelines, which spent more than 30 years in bureaucratic limbo, are designed to enhance the effectiveness of sunscreens and make them easier to use.
The key takeaway for consumers: Look for a sun protection factor, or SPF, of 15 and above that also says "broad spectrum." That's the new buzzword from the Food and Drug Administration to describe a product that does an acceptable job blocking both types of damaging rays.
Starting next summer, sunscreens with less than an SPF of 15 or that aren't "broad spectrum" will have to carry a warning label: "This product has been shown only to help prevent sunburn, not skin cancer or early skin aging."
That will help people like Paul Woodburn, 55, who says he mainly buys brands he trusts and judges sun screen by one factor
"The SPF number is what counts for me," the Indianapolis resident said as he sat next to a public pool. "Beyond the SPF, I don't think anybody really watches." Woodburn said he wasn't familiar with the difference between UVA and UVB rays or the broad spectrum label.
"These changes to sunscreen labels are an important part of helping consumers have the information they need so they can choose the right sun protection for themselves and their families," said Dr. Janet Woodcock, director of FDA's drug division.
The new regulations require testing for the more dangerous ultraviolet A rays, which can penetrate glass and pose the greatest risk of skin cancer and premature aging. Now, the FDA only requires testing for ultraviolet B rays that cause sunburn. That's what the familiar SPF measure is based on.
"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 Dr. Ronald L. Moy, president of The American Academy of Dermatology Association.
Under the new rules:
_ The FDA will prohibit sunscreen marketing claims like "waterproof" and "sweatproof," which the agency said "are exaggerations of performance."
_ The FDA also proposes capping the highest SPF value at 50, unless companies can provide results of further testing that support a higher number.
_ FDA says manufacturers must phase out a four-star system currently used by some companies to rate UVA protection.
In reviewing more than 3,000 comments submitted to the agency, the FDA decided the star system was too confusing. Instead, protection against UVA should be proportional to protection against UVB, which is already measured using SPF.
The SPF figure indicates the amount of sun exposure needed to cause sunburn on sunscreen-protected skin compared with unprotected skin. For example, an SPF rating of 30 means it would take the person 30 times longer to burn wearing sunscreen than with exposed skin.
The rules were decades in the making.
FDA announced its intent to draft sunscreen rules in 1978 and published them in 1999. The agency delayed finalizing its guidelines for years until it could address issues concerning both UVA and UVB protection.
Some consumer advocates complained that the agency's final guidelines were less strict than draft proposals circulated over the years.
"About 20 percent of products that meet the new FDA standards could not be sold in Europe, where UVA standards are strict," said David Andrews, senior scientist with the Environmental Working Group.
Many companies have already adopted the some of the labeling outlined by the government. For example, all Coppertone products from Merck & Co.'s Schering-Plough unit and Neutrogena sunscreens from Johnson & Johnson already boast "broad spectrum UVA and UVB protection."
Most dermatologists recommend a broad spectrum, water-resistant sunscreen of SPF 30 or higher every two hours while outside.
Last year an estimated 68,130 people in the U.S. were diagnosed with melanoma – the most dangerous form of skin cancer – and an estimated 8,700 died, according to the National Cancer Institute. Nearly $2 billion is spent treating the disease each year.
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AP Business Writer Tom Murphy contributed to this story from Indianapolis
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MATTHEW PERRONE 06/14/11 10:00 PM ET Associated Press