Sunscreen rules toughened in U.S.
New rules coming for Canadian consumers
Help is on the way for American consumers confused by the jumble of sun protection numbers and other claims on sunscreens.
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 U.S. Food and Drug Administration to describe a product that does an acceptable job blocking both types of damaging rays.
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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."
"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 Moy, president of the American Academy of Dermatology Association.
Under the new rules:
- The FDA will prohibit sunscreen marketing claims like "waterproof" and "sweat proof," 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 FDA announced its intent to draft sunscreen rules in 1978 and published them in 1999. The agency then put the plan on indefinite hold until it could address issues concerning both UVA and UVB protection.
Several 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 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.
Health Canada said it is also making changes to sunscreen testing but did not say when the changes will go into effect.
"Health Canada requires testing for UVB. Currently, the department is revising its sunburn protectants monograph. This will include internationally acceptable test methods for UVA and UVB," the regulator said in an email.
"The revised Health Canada monograph will reflect similar changes to that of the U.S. FDA."
Last year, an estimated 5,300 people in Canada were diagnosed with melanoma — the most dangerous form of skin cancer — and an estimated 920 died, according to the Canadian Cancer Society.
Basal cell and squamous cell skin cancer are the two most prevalent forms of the disease, the Canadian Dermatology Association's fact sheet said. More than 74,000 new cases of non-melanoma skin cancer are expected this year.