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Editor: Katharine Van Tassel
Akron Univ. School of Law

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Saturday, August 2, 2008

Proposed Bill Would Finalize Sunscreen Labeling Rules

The New York Times reports on the Sunscreen Labeling Protection Act of 2008 proposed Friday [August 1, 2008], which would compel the FDA to make final comprehensive rules on sunscreen.  The new sunscreen rules would require manufacturers to test the efficacy of the products against the sun’s longer-wavelength ultraviolet A rays, which also can damage skin. Sunscreen labels would be required to display both the familiar SPF number and a new rating for UVA protection.  Natasha Singer writes,

SunscreenTwo United States senators on Friday introduced a bill that would compel the Food and Drug Administration to make final comprehensive rules on sunscreen.

Last summer, the agency proposed updated rules that would standardize the labeling on sunscreens, giving consumers more detailed information about their efficacy. But the agency has not made the regulations final, which must happen before they can be implemented.

Senator Christopher J. Dodd, Democrat of Connecticut, said the agency appeared to be moving at a deliberately slow pace for the benefit of sunscreen manufacturers. “The delay is happening for economic reasons,” Senator Dodd said. “The F.D.A. knows better.

“It sounds like an industry reluctant to have a standard set because that may open the doors to insisting upon more accurate labels on certain other products as well.”

The proposed Sunscreen Labeling Protection Act of 2008, sponsored by Senator Dodd and Senator Jack Reed, Democrat of Rhode Island, would give the F.D.A. 180 days to make its own rules final. If the agency fails to do so within 180 days of enactment of the bill, the proposed rules would take effect.

“We hope the mere introduction of the bill will have the desired effect,” Senator Dodd said.

Rita Chappelle, a spokeswoman for the F.D.A., said, “As a federal agency, F.D.A. will continue to work to finalize the sunscreen rule as soon as possible for the American public.”

Since 1978, sunscreens have used the SPF numbering system to rate protection against sunburn caused by the sun’s shorter-wavelength ultraviolet B rays.

The new sunscreen rules would require manufacturers to test the efficacy of the products against the sun’s longer-wavelength ultraviolet A rays, which also can damage skin. Sunscreen labels would be required to display both the familiar SPF number and a new rating for UVA protection.

According to F.D.A. documents, if the agency makes the proposed rule final, manufacturers would then have an implementation period of up to 24 months to comply.

But some sunscreen manufacturers are asking for at least 36 months to test and relabel products.

Manufacturers estimated that the industry would need to put 2,700 products through UVA testing, at a cost of $12,200 per product and $124.2 million industrywide, including relabeling costs, according to collective comments submitted to the agency by two trade groups.

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