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The Food and Drug Administration on Thursday proposed long-delayed rules covering the ingredients, labeling and testing of sunscreens that boast of protecting against both the sun's ultraviolet B rays, which cause sunburn, and the ultraviolet A rays that cause tanning but also are associated with more serious and longer-term damage.
The proposed rules keep in place the so-called SPF, or sun protection factor, numerical rating system for UVB protection, while tweaking the testing requirements. The FDA proposes capping the highest SPF value at 50, unless companies can provide the results of further testing that would support a higher number, implying better protection against UVB.
The proposal would add a requirement that sunscreen makers assess UVA protection in the laboratory and on people as well if they want to make any claim that their products protect against those rays, whose damage is rarely immediately apparent.
Until recently, most sunscreens sold in the United States have filtered out mostly UVB but not UVA rays
-- even if they promised broad protection.
The proposed rules would institute a four-star system to rate the UVA protection provided by sunscreens and spell out the protection level as "low," "medium," "high," or "highest."
"Under today's proposal, 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," FDA commissioner Dr. Andrew von Eschenbach said.
A product's UVB protection would also be described, alongside its SPF rating. Both the UVA and UVB ratings would receive equal prominence on sunscreen labels.
Companies that choose not to do the UVA testing would have to label their products "No UVA protection," according to the proposed rules. The FDA assumes three-quarters of the estimated 3,000 sunscreens on the market would undergo such testing.
Schering-Plough Corp., maker of Coppertone, is reviewing the rules, spokeswoman Mary-Fran Faraji said.
FDA announced its intent to draft sunscreen rules in 1978 and published them in 1999. The agency then put them on indefinite hold until it could address issues concerning both UVA and UVB protection.
While the FDA said it would work to expeditiously finalize the rules, it will be at least several years before they take effect.
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The agency will collect public comments for 90 days, make revisions as necessary and then publish a final rule. That rule, once it appears, would take effect only 18 months later
-- which puts it sometime in 2009, at earliest.
For Connecticut Attorney General Richard Blumenthal, that's not soon enough.
"Not only should these rules have been released earlier but they should have a swifter deadline for implementation," said Blumenthal, who petitioned the FDA earlier this year to release the rules. "These rules should be mandatory so they help consumers next summer."
Under the rules, sunscreen labels also would be updated to further encourage sunbathers to reapply sunscreen as needed. And those sunscreens making any claim for water resistance would have to list, in minutes, how long the products block the sun's rays before they have to be reapplied following swimming, or simply sweating.
Blumenthal and others who pushed for the new rules have long been worried about sunscreens that claim to be "waterproof" or offer "all-day" protection.
The FDA rules also propose allowing sunscreens to combine avobenzone and other existing ingredients, which could lead to more products, agency officials said.
While increased sun exposure has been linked to an increased risk of cancer, the FDA has no data that show sunscreen use reduces that risk, FDA scientist Matthew Holman said. Instead, the FDA proposes updating labels to stress that beyond using sunscreen, limiting sun exposure and wearing protective clothing also can help in guarding against the sun's effects.
"We don't want to give people a false sense of security," said Portland, Ore., dermatologist Dr. Diane Baker, president of the American Academy of Dermatology. "That's why I think the extra warnings are very important."
Melanoma, the most lethal skin cancer, will strike almost 60,000 Americans this year and kill some 8,100.
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On the Net:
FDA
consumer update on sunscreen
[Associated Press; by Andrew
Bridges]
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