New rules to cut confusion on claims by sunscreen makers
Tuesday, June 21, 2011
Help is on the way if you’re confused by the maze of sun protection numbers and other claims on sunscreens.
Starting next summer, you can start looking for SPF 15 bottles and tubes with the label “broad spectrum” and feel confident they’re lowering your risk of skin cancer.
Under new rules published Tuesday, sunscreens will have to filter out the most dangerous type of radiation to claim they protect against skin cancer and premature aging. “Broad spectrum” is the new buzzword from the Food and Drug Administration to describe a product that does an acceptable job blocking both ultraviolet B rays and ultraviolet A rays.
If a sunscreen doesn’t protect against both, or the sun protection factor is below 15, then it has to carry a warning: “This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.”
The guidelines, which spent more than 30 years in bureaucratic limbo, are designed to help consumers like Paul Woodburn, who says he’s not sure of the difference between UVA and UVB rays and that he judges sunscreen by one factor alone.
“The SPF number is what counts for me,” the 55-year-old Indianapolis resident said as he sat next to a public pool. “Beyond the SPF, I don’t think anybody really watches.”
The new regulations require that sunscreens be tested for the ability to block the more dangerous UVA rays, which can penetrate glass and pose the greatest risk of skin cancer and wrinkles. FDA currently requires testing only for protection against UVB rays, which primarily cause sunburn but can also cause cancer and other damage. 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,” said Dr. Ronald L. Moy, president of The American Academy of Dermatology Association.
Under the new rules FDA will:
• Prohibit sunscreen marketing claims like “waterproof” and “sweatproof,” which the agency said “are exaggerations of performance.” Water-resistance claims will be allowed, but companies must explain how much time consumers can expect to get the same benefit while swimming or sweating.
• Cap the highest SPF value at 50, unless companies can provide results of further testing that support a higher number.
• Require that manufacturers 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.
SPF measures the amount of sun exposure needed to cause sunburn on UV-protected skin versus unprotected skin. The level of exposure varies by geography, time of day and skin complexion.
There is a popular misconception that SPF relates to time of solar exposure. Many consumers believe that if they normally get sunburn in one hour, then an SPF 15 sunscreen allows them to stay in the sun for 15 hours without burning. This isn’t true because SPF is not directly related to length of sun exposure.
The U.S. market for sunscreens has been growing steadily because of worries about cancer and an aging population. It now totals about $900 million annually, according to research firm IBISWorld.
The new rules were decades in the making.
FDA announced its intent to draft sunscreen rules in 1978 and published them in 1999. The agency then delayed finalizing the regulations until it could address concerns from both industry and consumers.
Some consumer advocates complained the agency’s final guidelines did not go far enough.
“FDA’s rule will allow most products on the U.S. market to use the label ‘broad spectrum sunscreen,’ even though some will not offer enough protection to assure Americans they can stay in the sun without suffering skin damage from invisible UVA radiation,” said David Andrews, senior scientist with the Environmental Working Group.
The FDA is still working on updated guidelines for sprayon products, which use different formulations from other sun-protection solutions.
Many companies have already adopted some of the language.
For example, all Coppertone products from Merck & Co.’s Schering-Plough unit and Neutrogena Sunblock from Johnson & Johnson 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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